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Radar On Market Access: Trump’s International Drug Pricing Order Is Still Missing; Rebate Order Draws Fire

September 16, 2020

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

Administration officials indicated during the rollout of the executive orders on July 24 that the international pricing order would be released within 30 days of the debut of the other three drug pricing orders. Yet the deadline passed and the administration at press time had not released the promised order.

Meanwhile, the executive orders that actually have been released are being criticized from stakeholders across health care. The order that would remove safe harbor protections from the Anti-Kickback Statute for prescription drug rebates in Medicare Part D has been panned even by conservatives.

Alex Brill, a resident fellow at the American Enterprise Institute (AEI), penned a white paper sponsored by PBM trade group Pharmaceutical Care Management Association (PCMA) that concluded the executive order would “restrict an important tool for providing savings to the federal government and Medicare Part D beneficiaries. Moreover, net drug costs and drug company revenues would rise significantly if the Medicare Part D safe harbor for rebates is eliminated.”

Mendelson says that the pharmaceutical industry is beginning to realize that it will have to change its business model one way or another.

“The pharmaceutical industry is facing a real pivot point where there are going to have to be more innovative ways to price for these products,” Mendelson observes. “…it’s really important that the industry start to figure out ways to engage positively with payers. And the government is the biggest payer.”

MMIT Reality Check on Acute Migraine (Sep 2020)

September 11, 2020

According to our recent payer coverage analysis for acute migraine treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for acute migraine treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for acute migraine treatments shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In February 2020, the FDA approved Biohaven Pharmaceuticals’ Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. The medication is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet, according to the company’s news release.

Trends That Matter for Large Employers in 2021

September 10, 2020

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

During an Aug. 18 press briefing, Business Group on Health President and CEO Ellen Kelsay attributed such findings to not only telehealth’s ability to offer more convenience and greater access for consumers, but also to the sheer necessity of pivoting to a different care modality amid widespread stay-at-home orders.

Regarding the controversial issue of telehealth reimbursement, which payers generally want to be lower than in-person visits but providers want to be equal, Kelsay said her organization supports payment flexibility over parity. In some cases, that “might mean less reimbursement for telehealth, and in other instances maybe increased reimbursement for telehealth if it’s a better modality for delivery, depending on the situation,” she added.

Kelsay also emphasized that there are still more questions than answers about how the pandemic will affect health care costs for companies and their workers. For 2021, the Business Group on Health is projecting the total cost of health benefits will rise by 5.3% — slightly higher than the 5% trend it predicted in the past few years.

Radar On Market Access: Amazon Moves Further Into Health Care Data, Sharp Deal Shows

September 10, 2020

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Health care industry insiders say that Amazon.com Inc.’s Aug. 27 deal to provide Halo fitness trackers to Sharp HealthCare indicates the retail and tech giant will make big bets on clinical and actuarial data analytics, AIS Health reported.

Sharp Chief Information and Innovation Officer Michael Reagin says that Amazon will provide the San Diego-based integrated plan and provider with about 500 of the wearable fitness trackers.

Sharp will use the devices in two pilot programs, Reagin says. The company will give “about 100” Halos to clinicians, who will wear them in order to track staff performance and prevent burnout. Reagin says the Halo’s much-discussed voice monitoring technology is an essential element of the clinician-focused effort.

The rest of the devices will go to Sharp Health Plan members for remote monitoring purposes.

Michael Abrams, co-founder and managing partner of health care consultancy Numerof & Associates, says that member engagement will be essential to the pilot program’s success. He says that remote monitoring can be stifled if patients don’t fully buy in.

Since the Halo will continually monitor members without any action in their part, Abrams is optimistic that the program will enjoy better adherence than other remote monitoring efforts.

“If plans can get member adoption and perseverance, this could be a great tool for seeing high-level, aggregated community trends and identifying specific interventions,” says Rajshri Ravi, the head of product and technology at ConsejoSano. “Population health management is all about data: the more, the better. It depends on how they use the data. Propensity modeling could predict member behavior and offer insights to increase retention.”

Friso van Reesema, a senior account executive for Eliza, Elli and Essette Solutions, says that Amazon is uniquely well-positioned to offer health plans technology and services that will process that data.

“In the next three years, we’’re going to see some really exciting artificial intelligence and improvement of these platforms that are leveraging these devices to power the platform and be able to roll out exciting algorithms, whether they’re retrospective, prospective, prescriptive,” van Reesema says.

He adds that the deal is likely an attempt by the tech giant to start training its AIs on population health models using data gathered from the Halo pilot.

Radar On Market Access: Some COVID Cost-Sharing Waivers Would Expire Soon

September 8, 2020

Although federal relief legislation tied to the pandemic required health insurers to waive cost sharing for COVID-19 testing, not treatment, many plans opted to do both anyway. In fact, a recent analysis from the Kaiser Family Foundation (KFF) found that 80% of enrollees in the individual and fully insured group insurance markets were in plans that voluntarily waived out-of-pocket costs for COVID-19 at some point during the pandemic, AIS Health reported.

Yet according to the Peterson-KFF Health System Tracker analysis, published Aug. 20, 20% of individual and fully insured group plan enrollees are in plans where a cost-sharing waiver for COVID-19 treatment has already expired, and another 16% are in plans where the waiver is scheduled to expire by the end of September.

Although federal relief legislation tied to the pandemic required health insurers to waive cost sharing for COVID-19 testing, not treatment, many plans opted to do both anyway. In fact, a recent analysis from the Kaiser Family Foundation (KFF) found that 80% of enrollees in the individual and fully insured group insurance markets were in plans that voluntarily waived out-of-pocket costs for COVID-19 at some point during the pandemic, AIS Health reported.

Yet according to the Peterson-KFF Health System Tracker analysis, published Aug. 20, 20% of individual and fully insured group plan enrollees are in plans where a cost-sharing waiver for COVID-19 treatment has already expired, and another 16% are in plans where the waiver is scheduled to expire by the end of September.

Daniel McDermott, a KFF research associate and co-author of the analysis, says that the calculus could change for some insurers as the pandemic wears on.

“Among the insurers who have pushed back their expiration date or extended it, a lot of them had initially set expiration deadlines in early spring — so around May — only to push those back as that date approached,” he says. “So I think it would be reasonable to expect that as some of these fall expiration dates approach, some insurers might take the opportunity to re-evaluate…and make a decision about whether to push back that expiration date again.”

Among enrollees in individual and fully insured group health insurance, 15% were in plans where the expiration date of the COVID-19 treatment cost-sharing waiver was either unspecified or set to end when the public health emergency does, observed the KFF analysis.

Meanwhile, KFF’s more recent report also found that 11% of individual market enrollees and 27% of fully insured group market enrollees are in plans that have offered some form of premium credit or reduction during the pandemic.

For the individual and fully insured group markets combined, just 7% of enrollees were in a plan that offered a premium grace period — in which insurers don’t immediately cancel policies for people who fail to pay their premiums on time, while just 2% were in a plan that offered fast-tracked medical loss ratio rebates.

MMIT Reality Check on Breast Cancer HR+/HER2- (Sep 2020)

September 4, 2020

According to our recent payer coverage analysis for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for breast cancer (HR+/HER2-) treatments shows that under the pharmacy benefit, about 52% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Teva Pharmaceuticals USA, Inc.’s and Endo International plc unit Par Pharmaceuticals’ everolimus for the treatment of advanced hormone receptor-positive, HER2- negative breast cancer in postmenopausal women, among other indications. The tablets are the first generics of Novartis International AG’s Afinitor (everolimus).

Perspectives on Telehealth Executive Order

September 3, 2020

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Avalere Health founder Dan Mendelson says that the order will have limited impact in the near term, but it speaks to the rapid entrenchment of telehealth.

“The administration is doing what they can with their existing authority. Notionally, it’s in the right direction,” says Mendelson. “It’s thoughtful and positive, but it’s also limited in terms of the practical effect because it’s focused on these rural geographies.”

Meanwhile, telehealth provider Teladoc Health Inc. reached a deal to acquire remote monitoring firm Livongo Health Inc. in a transaction announced Aug. 5, which the firms expect to close by the end of the year. In a July white paper prepared by members of its health care practice, KPMG predicted ample transactions in the telehealth space going forward.

James Gelfand, ERISA Industry Committee (ERIC) senior vice president for health policy, tells AIS Health via email that Congress needs to take telehealth reform further.

“ERIC urges Congress to follow the President’s lead and remove restrictions that ban employers from offering telehealth to all employees, opening up access to health care for millions of Americans nationwide permanently,” he wrote.

Mendelson makes a similar point. He says that Congress needs to set rules for complex, controversial issues like reimbursement. He adds that he expects action on telehealth after the election, if only for Medicare and Medicaid.

Radar On Market Access: Insurers Expand Flu Vaccination Outreach to Blunt COVID-19 Effects

September 3, 2020

Even as the COVID-19 crisis continues, public health officials are warning that an influenza pandemic might emerge this fall or winter. A double pandemic would kill even more people than COVID-19 on its own and strain the already overworked health care system. To prevent that deadly combination, plans have stepped up their usual flu-season member outreach programs, particularly for seniors, AIS Health reported.

In the Aug. 21 edition of its Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention tied improved flu vaccination rates to reducing the strain that COVID-19 has put on the health care system.

Even as the COVID-19 crisis continues, public health officials are warning that an influenza pandemic might emerge this fall or winter. A double pandemic would kill even more people than COVID-19 on its own and strain the already overworked health care system. To prevent that deadly combination, plans have stepped up their usual flu-season member outreach programs, particularly for seniors, AIS Health reported.

In the Aug. 21 edition of its Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention tied improved flu vaccination rates to reducing the strain that COVID-19 has put on the health care system.

Flu vaccines are fairly easy to access. However, Richard Hughes IV, managing director of Avalere Health’s vaccine team, says that payers need to consider how to make special accommodations for patients who are immunocompromised or have other viral infection comorbidities. He points out that those patients have the most need for the flu vaccine — but that they paradoxically have the highest risk from COVID-19 exposure.

“A lot of employers have workplace flu clinics,” Hughes adds. But now, he observes, “we have a lot of people working remotely in our economy. So I think you’re going to see some additional challenges to getting people vaccinated.”

UnitedHealth Group is taking a proactive approach to flu vaccination, according to Jennifer Brueckner, Pharm.D., head of the company’s Enterprise Flu Committee. She says the company will email all members who have an address on file and UnitedHealth will target certain at-risk members for extra communication.

Meanwhile, Cigna Corp. is also expanding its annual vaccine outreach. Cigna members do not pay any cost sharing for flu vaccinations if they get their shots at an in-network provider or pharmacy, according to a company statement.

Humana Corporate Medical Director Todd Prewitt, M.D., tells AIS Health via email that the insurer has expanded flu vaccination outreach beyond its usual scope.

“Humana has initiated our ‘Safer Sooner’ campaign theme to encourage all members to obtain the vaccination as soon as it is available through their local providers,” Prewitt explains. “As part of the campaign, we’ve distributed personal safety kits to over seven million members and associates including two cloth masks for personal protection,” he says.

Radar On Market Access: USPS Delivery Slowdown Is Unlikely to Cause Major Rx Fill Disruption

September 1, 2020

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts tell AIS Health the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

The recent, sudden disruption of U.S. Postal Service (USPS) deliveries has caused concern about people receiving their medications later than they normally would. While news reports and statements by lawmakers indicate that many Americans have lost prescriptions in the mail or received them late, drug benefit and supply chain experts tell AIS Health the disruption to the most vulnerable patients served by specialty and mail order pharmacies should be minimal.

An Aug. 24 Axios-Ipsos poll shows that one in five Americans received medication through the mail during the preceding week. One in four of that group, or 5% of Americans overall, didn’t receive their medication or got it late.

In addition, PBMs have not reported significant disruption to their supply chains.

“Most of the drugs shipped from a mail order pharmacy — a non-specialty pharmacy — you worry about them being perishable, but they tend to be pretty stable. They’re oral pills, things like that,” says Mike Schneider, a principal at Avalere Health.

Schneider also suggests that mail order pharmacies’ longer fills, which typically keep shipping costs down by filling for 90 days or more, should insulate patients from major disruptions. He adds that most mail order medication businesses also build logistical complications into their shipping schedules.

Omar Hafez, a principal at Avalere and a former supply chain executive at specialty pharmacy McKesson Specialty Health, says that time- and temperature-sensitive therapies have very specific delivery windows that are mandated by law. He says the strict requirements mean that the bulk of the supply chain for temperature-sensitive specialty drugs is managed by specialized logistics firms, not the USPS.

Schneider says the pharmacy supply chain as a whole has proved remarkably resilient over the course of 2020 — despite the tumult caused by the pandemic and the USPS brouhaha.

“I think a lot of supply chain issues never really materialized, at least not to my knowledge,” Schneider says. “There are a certain drugs that have shortages, but nothing that seemed like it was a national emergency. I think part of the reduced supply might have been everybody was going and filling their prescriptions as the virus was hitting, and everybody was getting some longer-term fills.”

MMIT Reality Check on Non-Small Cell Lung Cancer Systemic Therapy (Aug 2020)

August 28, 2020

According to our recent payer coverage analysis for non-small cell lung cancer systemic therapy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for non-small cell lung cancer systemic therapy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for non-small cell lung cancer systemic therapy treatments shows that under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: When the FDA approved Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) on May 6, 2020, it was the first of seven approvals in non-small cell lung cancer (NSCLC) through May 29.

Trends That Matter for Prostate Cancer Treatments

August 27, 2020

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

On May 15, the FDA gave accelerated approval to Clovis Oncology, Inc.’s Rubraca (rucaparib) for the treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Two other PARP inhibitors — GSK’s Tesaro, Inc.’s Zejula (niraparib) and Pfizer Inc.’s Talzenna (talazoparib) — are on the market, and both are in clinical trials for prostate cancer.

The graphic below show how prostate cancer medications are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.

Radar On Market Access: Payers Face Challenges to Enroll Newly Uninsured

August 27, 2020

Health insurers are conducting outreach to people who may have been left without coverage as a result of the COVID-19 crisis, but experts say they may be partially stymied in their efforts to get people enrolled in new plans by the difficulties of operating within a pandemic environment, AIS Health reported.

AmeriHealth Caritas, which is run by Independence Blue Cross in partnership with Blue Cross Blue Shield of Michigan, says it has launched a series of videos designed to help potential Medicaid enrollees learn how they can apply.

Health insurers are conducting outreach to people who may have been left without coverage as a result of the COVID-19 crisis, but experts say they may be partially stymied in their efforts to get people enrolled in new plans by the difficulties of operating within a pandemic environment, AIS Health reported.

AmeriHealth Caritas, which is run by Independence Blue Cross in partnership with Blue Cross Blue Shield of Michigan, says it has launched a series of videos designed to help potential Medicaid enrollees learn how they can apply.

Meanwhile, Fort Worth, Texas-based Care N’ Care Health Plan, which offers Medicare Advantage (MA) plans, is urging newly unemployed seniors — who already were Medicare-eligible but delayed signing up because they still had health insurance through a job — to get coverage now. So it’s deploying a public relations campaign stressing that those people don’t need to wait until open enrollment begins later this year to choose an MA plan.

In addition, most state Medicaid agencies have tried to make it easier for people to apply for coverage during the pandemic by offering a dedicated phone line for enrollment assistance, providing real-­time eligibility decisions, and waiving interviews and other documentation requirements, according to a Health Affairs blog post.

Medicaid managed care organizations are conducting their own outreach, and “they’re really great at consumer engagement with the Medicaid population,” Jerry Vitti, founder and CEO of Healthcare Financial, Inc., tells AIS Health. “But the folks who are newly uninsured are not a typical Medicaid population,” and states and plans may need different types of communications to reach people and enroll them, he says.

So far, Medicaid plans are not seeing as big an influx of enrollees as they might have expected in the pandemic.

“People are forgoing health care, mostly preventive non-emergency visits, in favor of more pressing needs like eating and paying rent — addressing these underlying social determinants of health is primary, so health coverage kind of falls between the cracks,” Vitti says. “Another reason may be that people are expecting to return to work when this is all over and are just waiting to get their old employer coverage back.”

Since “at the very least I think we’re looking at a protracted COVID-related recession,” he says, “we should eventually see the enrollment increase they were expecting.”

Radar On Market Access: Large Employers Expect Cost Uncertainty, More Virtual Care in 2021

August 25, 2020

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

While the COVID-19 pandemic has not caused employers to significantly alter their health care cost estimates for the coming year, it has unquestionably intensified their interest in embracing virtual care. Those are just a couple of the major findings from the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported.

Notably, 80% of respondents said they believe virtual health will play a significant role in how care is delivered in the future, up considerably from 64% last year. Further, when asked about actions they were taking to ease the burdens of COVID-19 for employees, the largest share of respondents — 76% — said they “made changes to allow for better access to virtual care solutions.”

During an Aug. 18 press briefing, Business Group on Health President and CEO Ellen Kelsay attributed such findings to not only telehealth’s ability to offer more convenience and greater access for consumers, but also to the sheer necessity of pivoting to a different care modality amid widespread stay-at-home orders.

Regarding the controversial issue of telehealth reimbursement, which payers generally want to be lower than in-person visits but providers want to be equal, Kelsay said her organization supports payment flexibility over parity. In some cases, that “might mean less reimbursement for telehealth, and in other instances maybe increased reimbursement for telehealth if it’s a better modality for delivery, depending on the situation,” she added.

Kelsay also emphasized that there are still more questions than answers about how the pandemic will affect health care costs for companies and their workers. For 2021, the Business Group on Health is projecting the total cost of health benefits will rise by 5.3% — slightly higher than the 5% trend it predicted in the past few years.

“There is a lot of uncertainty around what is actually going to manifest itself in terms of costs, both this year and next year,” Kelsay said. “Many employers are having a really hard time from a budgeting and actuarial perspective working with their health plan and consulting partners, to really get a good handle of what that means.”

MMIT Reality Check on Ulcerative Colitis (Aug 2020)

August 21, 2020

According to our recent payer coverage analysis for ulcerative colitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ulcerative colitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ulcerative colitis treatments shows that under the pharmacy benefit, about 69% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2020, the FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency approved — in both prefilled syringe and auto-injector presentations.

Perspectives on UnitedHealth, Humana’s Chronic Conditions Programs

August 20, 2020

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Meanwhile, Humana says it has contracted with REACH Kidney Care, an educational nonprofit affiliated with Dialysis Clinic, Inc., to provide kidney disease care coordination services to eligible Medicare Advantage and commercial members in Georgia, North Carolina, South Carolina and Tennessee. The collaboration is focused on early detection of chronic kidney disease, slowing disease progression and improving the patient experience.

Joseph Paduda, principal at Health Strategy Associates, LLC, notes that both programs are designed to reduce severity and therefore the cost of treating patients, identifying patients who are “heading in the wrong direction and likely intervening.” Still, Paduda says, “what’s notable is that both are focused on individual disease states, especially knowing more than a third of adults — and more than half of older adults — have multiple chronic conditions.”

William DeMarco, president of Pendulum HealthCare Development Corp., says that UnitedHealth has an in-house advantage with its Optum subsidiary, which connects the insurer’s data platforms for claims and clinical data. Therefore, more information and measures can be tracked electronically, reducing the need for physician or even nurse intervention except when needed, DeMarco says.

DeMarco says the applicability of digital care management solutions, versus more traditional solutions, depends on the condition — although technology always has a place.

“Diabetes is a data-driven disease,” and therefore particularly well-suited to digital therapy, observes Dan Mendelson, founder of Avalere Health. Other chronic conditions that are particularly data-driven include cardiovascular disease and Crohn’s disease, he says, and “any conditions that require regular medication management are likely to benefit from some kind of digital tools.”

Radar On Market Access: COVID-19 Pandemic Amps Up Interest in Home Care

August 20, 2020

As visits to hospitals and outpatient clinics have become sources of anxiety for patients worried about exposure to the novel coronavirus, plans and providers alike have begun to make major investments in home care, AIS Health reported.

Humana Inc., for example, recently announced a $100 million investment in home primary care startup Heal Inc. Heal CEO Nick Desai says his company will aid Humana’s long-term strategy to reduce the cost of care and improve quality.

As visits to hospitals and outpatient clinics have become sources of anxiety for patients worried about exposure to the novel coronavirus, plans and providers alike have begun to make major investments in home care, AIS Health reported.

Humana Inc., for example, recently announced a $100 million investment in home primary care startup Heal Inc. Heal CEO Nick Desai says his company will aid Humana’s long-term strategy to reduce the cost of care and improve quality.

Heal’s model places patients with a consistent primary care physician who makes house calls. The doctors are dispatched and routed using an app and driven to visits with a medical assistant, and they input notes and update care plans into an electronic health record between visits.

“Our doctors are paid on a salary basis, so they don’t worry about the billing,” Desai explains. “They have incentives and bonuses for delivering quality, but never for seeing more patients. We’re fundamentally economically aligned around the delivery of value, not volume.”

Where payers will find significant appeal in home care is in reducing the duration and number of inpatient visits, says Ashraf Shehata, KPMG national sector leader for health care and life sciences.

Shehata says that building home care capacity will give plans more flexibility to meet patients on their own terms and could improve outcomes in a post-acute context. Still, he suggests that there are substantial barriers to scaling up home care to that level. Those include regulatory standards, including special certifications that are required for licensed home care providers. He also notes lagging EHR interoperability impedes the flow of information between home care providers and other parts of the health care system.

COVID-19 has thrown a bright light on existing incentives for hospital systems to reduce inpatient stays. In the spring, Utah-based integrated health system Intermountain Healthcare launched a pilot program to move post-acute patients and low-acuity emergency patients to home care.

Nick Bassett, vice president for population health services at Intermountain subsidiary Castell, says the pilot is tied to health system’s longer-term value-based care strategy. He adds that the pilot has shown promising savings — mainly from reducing the physical plant and staffing costs of a hospital stay.

Radar On Market Access: Anthem, Cigna, CVS Report Strong PBM Performance Amid COVID-19

August 18, 2020

For PBMs, 2020 has been far from business as usual, given the myriad ways the COVID-19 pandemic has changed how people interact with the health care system. However, during their second-quarter earnings conference calls, companies that own some of the largest PBMs emphasized that they are largely satisfied with how the PBM segments of their businesses are performing, AIS Health reported.

Anthem, Inc. Chief Financial Officer John Gallina said during the insurer’s earnings call that “IngenioRx is actually doing quite well, and has really done a nice job of meeting our expectations.”

For PBMs, 2020 has been far from business as usual, given the myriad ways the COVID-19 pandemic has changed how people interact with the health care system. However, during their second-quarter earnings conference calls, companies that own some of the largest PBMs emphasized that they are largely satisfied with how the PBM segments of their businesses are performing, AIS Health reported.

Anthem, Inc. Chief Financial Officer John Gallina said during the insurer’s earnings call that “IngenioRx is actually doing quite well, and has really done a nice job of meeting our expectations.”

Anthem is on track this year to realize $900 million in operating profit contributed from its relatively new PBM, which exceeds its prior expectation of $800 million, Credit Suisse analyst A.J. Rice pointed out in a July 29 note to investors. But he also noted that while maintenance prescription volume was steady compared with the prior-year quarter, “new scripts saw a 10-15% drop in April versus normal utilization. Thus, IngenioRx captured less profit in Q2.”

CVS Health Corp., which owns the PBM Caremark, reported that operating income and adjusted operating income for its pharmacy services segment increased 6.2% and 2.4%, respectively, from the prior-year quarter. Those results were “primarily driven by growth in specialty pharmacy and improved purchasing economics,” but they were offset by “continued price compression and previously disclosed client losses,” the company said in its earnings release.

Cigna Corp. reported on July 30 that for its health services segment — which houses the PBM Express Scripts — pretax adjusted income from operations increased 7% relative to the second quarter of 2019.

Executives from Anthem, Cigna and CVS all acknowledged that the PBM selling season for 2021 was affected by the shutdowns and economic uncertainty ushered in by the COVID-19 pandemic.

Anthem President and CEO Gail Boudreaux described the selling season as “an interesting operating environment, given all the change.” As the insurer mentioned in its first-quarter earnings call, “things are, I would say, at least slightly delayed, as customers try to work through their own stability across their business,” Boudreaux said.

Alan Lotvin, M.D., the executive vice president and president of Caremark, offered: “I’d say the season itself has been interesting in the lumpiness with COVID, but overall ending up about where we thought.”

MMIT Reality Check on Duchenne Muscular Dystrophy (Aug 2020)

August 14, 2020

According to our recent payer coverage analysis for Duchenne muscular dystrophy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Duchenne muscular dystrophy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for Duchenne muscular dystrophy treatments shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: More recently, in August 2020, the agency gave accelerated approval to NS Pharma, Inc.’s Viltepso (viltolarsen) for people amenable to exon 53 skipping therapy.

Trends That Matter for Major Insurers’ Performance Amid COVID-19

August 13, 2020

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

At its lowest point in April, inpatient care volume — including care for COVID-19 patients — was about three quarters less than normal, UnitedHealth Group Chief Financial Officer John Rex said during a July 15 conference call to discuss the company’s second-quarter earnings. At that same low point, utilization of outpatient and physician services fell to roughly 60% of normal levels. But in June, UnitedHealth saw inpatient volume recover to nearly 95% of baseline, and as June turned to July, outpatient and physician services were “tracking above 90%,” Rex said. “These national trends have continued thus far in July, even as certain states are seeing short-term deferral of services where there are elevated levels of infection and hospitalization,” he added.

Indeed, the company predicts that overall, “utilization’s going to come back during the second half of the year,” UnitedHealthcare CEO Dirk McMahon said.

In a note to investors, Citi analyst Ralph Giacobbe observed that the executives’ comments about health care utilization returning to normal were “surprising to us.”

“Ultimately we believe healthcare cost trends will remain muted, and as we look out over the next 12+ months we see those trends driving upside, and lower headline risk post-election driving multiples higher,” Giacobbe added.

Below shows the key financial data for leading health plans in the second quarter of 2020 and 2019.

Radar On Market Access: Trump Administration Issues Telehealth Executive Order, More Acts Are Needed

August 13, 2020

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

Recent events indicate the telehealth boom caused by the COVID-19 pandemic will result in a permanent expansion of virtual care. On Aug. 3, the Trump administration issued an executive order directing HHS to make permanent some of the telehealth regulations it relaxed for Medicare beneficiaries during the public health emergency, AIS Health reported.

The executive order directs officials to issue proposed regulations that will lock in some of the changes in telehealth policy that the Trump administration included as part of pandemic relief. In response to the order, CMS on Aug. 3 proposed a rule that would permanently allow Medicare to reimburse for certain services that are furnished virtually, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments.”

Avalere Health founder Dan Mendelson says that the order will have limited impact in the near term, but it speaks to the rapid entrenchment of telehealth.

“The administration is doing what they can with their existing authority. Notionally, it’s in the right direction,” says Mendelson. “It’s thoughtful and positive, but it’s also limited in terms of the practical effect because it’s focused on these rural geographies.”

Meanwhile, telehealth provider Teladoc Health Inc. reached a deal to acquire remote monitoring firm Livongo Health Inc. in a transaction announced Aug. 5, which the firms expect to close by the end of the year. In a July white paper prepared by members of its health care practice, KPMG predicted ample transactions in the telehealth space going forward.

James Gelfand, ERISA Industry Committee (ERIC) senior vice president for health policy, tells AIS Health via email that Congress needs to take telehealth reform further.

“ERIC urges Congress to follow the President’s lead and remove restrictions that ban employers from offering telehealth to all employees, opening up access to health care for millions of Americans nationwide permanently,” he wrote.

Mendelson makes a similar point. He says that Congress needs to set rules for complex, controversial issues like reimbursement. He adds that he expects action on telehealth after the election, if only for Medicare and Medicaid.

Radar On Market Access: FDA Approved Two PARP Inhibitors for Prostate Cancer

August 11, 2020

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

On May 15, the FDA gave accelerated approval to Clovis Oncology, Inc.’s Rubraca (rucaparib) for the treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Two other PARP inhibitors — GSK’s Tesaro, Inc.’s Zejula (niraparib) and Pfizer Inc.’s Talzenna (talazoparib) — are on the market, and both are in clinical trials for prostate cancer.

Lynparza’s and Rubraca’s approvals are “indicative of the growing knowledge we are gaining with respect to the intermediary pathways within the cells regulating DNA repair as it relates to tumor growth,” says Winston Wong, Pharm.D., president of W-Squared Group.

The PARP inhibitors will impact “refractory patients who have failed standard-of-care therapies,” notes Mesfin Tegenu, R.Ph., president of PerformRx, LLC. First-line treatment will be with antiandrogens or taxanes, he explains: Zytiga, Yonsa, Jevtana (cabazitaxel), Taxotere (docetaxel) or Xtandi. Then the top competitors in the second-line setting will be Lynparza, Rubraca and Keytruda (pembrolizumab), he says.

Asked how the two PARP inhibitors compare with other therapies in the class, Tegenu points out that “Lynparza had higher objective response rates and better radiographic progression-free survival compared to enzalutamide and abiraterone. It also showed benefit compared to docetaxel. Men with specific mutations may benefit more with PARP inhibitors.”

“Rubraca after receiving taxane therapy showed benefit,” he continues. “It is currently being compared to abiraterone, enzalutamide or docetaxel in an ongoing clinical trial. It has accelerated approval contingent upon verification of success in this trial.”

MMIT Reality Check on Parkinson’s Disease (Aug 2020)

August 7, 2020

According to our recent payer coverage analysis for Parkinson’s disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Parkinson’s disease treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for Parkinson’s disease treatments shows that under the pharmacy benefit, about 36% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In May 2020, the FDA approved Sunovion Pharmaceuticals Inc.’s Kynmobi (apomorphine) for the acute, intermittent treatment of “off” episodes in people with Parkinson’s disease.

Perspectives on Remdesivir’s $3,120 Price Tag

August 6, 2020

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

“So they’re saying by shortening hospital stays, the system is going to save all these monies, but I always ask the question, ‘Why is it that the drug company should get to pocket all or some substantial portion of that savings?'” says Jack Hoadley, Ph.D., a research professor emeritus at Georgetown University’s Health Policy Institute. “That’s a savings we should accumulate for consumers, for payers [and] everybody else.”

Hoadley is not alone in those views. The advocacy group Patients for Affordable Drugs, in a June 29 statement, wrote that “Gilead’s price for remdesivir shows once again that we can’t trust Big Pharma to act responsibly — even in the face of a global pandemic.”

The U.S. government helped fund the development of remdesivir, and dexamethasone — a generic steroid — is priced at less than $1 per day even though it ‘showed promise for combating severe COVID-19 cases and reducing potential mortality rates,” the organization said.

The Institute for Clinical and Economic Review (ICER) also brought up dexamethasone in its statement. The U.S. price range of $2,340 to $3,120 is “is largely in line with ICER’s independent assessment suggesting that a price of approximately $2,800 would be reasonable in proportion to the added benefits for patients and the cost offsets in the health system now that dexamethasone is rapidly becoming standard of care,” wrote ICER President Steven D. Pearson, M.D.

Leerink analyst Geoffrey Porges, in a June 29 note to investors, pointed out that the U.S. commercial price set for remdesivir was below his firm’s expectations. Still, “we believe the disclosed [remdesivir] pricing is reasonable, and should provide significant value to the Gilead shareholders and still deflect much of the criticism the company might face in this emergency,” Porges wrote.

Radar On Market Access: Anthem Warns of Greater Commercial Enrollment Drop in Second Half

August 6, 2020

While Anthem, Inc. has seen less of an enrollment dip in its commercial business than it originally feared when the COVID-19 pandemic and economic recession first took hold, the insurer’s executives said during a July 29 earnings conference call that they expect that attrition to accelerate in the coming months as some furloughs become permanent job losses, AIS Health reported.

From March 31 to June 30, Anthem saw enrollment in its commercial and specialty business lines drop by 290,000. “But as you think about unemployment, that was fairly muted,” especially when it comes to Anthem’s risk-based business, President and CEO Gail Boudreaux said during the earnings call. She and other Anthem executives attributed that effect to the fact that many companies have thus far furloughed rather than laid off workers, thanks in part to federal stimulus funding.

While Anthem, Inc. has seen less of an enrollment dip in its commercial business than it originally feared when the COVID-19 pandemic and economic recession first took hold, the insurer’s executives said during a July 29 earnings conference call that they expect that attrition to accelerate in the coming months as some furloughs become permanent job losses, AIS Health reported.

From March 31 to June 30, Anthem saw enrollment in its commercial and specialty business lines drop by 290,000. “But as you think about unemployment, that was fairly muted,” especially when it comes to Anthem’s risk-based business, President and CEO Gail Boudreaux said during the earnings call. She and other Anthem executives attributed that effect to the fact that many companies have thus far furloughed rather than laid off workers, thanks in part to federal stimulus funding.

“We can’t predict exactly what’s going to happen when they come off [furlough]; it will depend on the strengthening of the economy and what happens there and what employers decide to do,” Boudreaux said.

Ultimately, “we do expect further declines, assuming the economy continues to operate at less than full capacity,” Boudreaux said of Anthem’s commercial business. Meanwhile, Anthem’s Medicaid and Medicare enrollment grew by 599,000 from the first quarter of 2020 to the second quarter. Overall medical enrollment rose by 0.7% between the first and second quarters of this year, and it increased 3.9% in the second quarter of 2020 compared with the prior-year quarter.

Anthem reported adjusted earnings per share of $8.91 per share in the quarter, compared with $4.36 during the prior-year period. The insurer’s quarterly operating revenue was $29.2 billion — an increase of $4 billion, or 15.9% compared with the prior-year quarter — which Anthem attributed to “pharmacy product revenue related to the launch of IngenioRx,” the company’s PBM.

Radar On Market Access: Experts Are Skeptical of Trump Administration’s Drug Pricing Executive Orders

August 4, 2020

In executive orders released July 24, the Trump administration renewed its push toward a signature campaign issue: lowering drug prices. The three executive orders call for regulations allowing drugs to be imported from other countries, requiring Federally Qualified Health Centers to make insulin and epinephrine available to low-income members of the public at the discounted prices set by the 340B Drug Pricing Program, and removing safe harbor protections under the Anti-Kickback Statue for prescription drug rebates in Medicare Part D, AIS Health reported.

“I think that what you have here is a collection of policies that are intended to make noise, but will have little to no practical effect on drug prices before the election,” Avalere founder Dan Mendelson says.

In executive orders released July 24, the Trump administration renewed its push toward a signature campaign issue: lowering drug prices. The three executive orders call for regulations allowing drugs to be imported from other countries, requiring Federally Qualified Health Centers to make insulin and epinephrine available to low-income members of the public at the discounted prices set by the 340B Drug Pricing Program, and removing safe harbor protections under the Anti-Kickback Statue for prescription drug rebates in Medicare Part D, AIS Health reported.

“I think that what you have here is a collection of policies that are intended to make noise, but will have little to no practical effect on drug prices before the election,” Avalere founder Dan Mendelson says.

Marc Samuels, CEO of ADVI, says that the proposals seem half-baked, and will likely draw strong opposition. “These executive orders are consistent with the previous [drug pricing] blueprint adopted by the Administration and debated in part in Congress. But having the authority to make quick changes doesn’t mean doing so is a good idea, especially so close to an election,” he says.

The idea of importing drugs from other developed countries, and relying on their drug safety inspection regimes, has popped up in the past. Mendelson, who ran the health division of the Office of Management and Budget between 1998 and 2000, says that although the Clinton administration considered the idea seriously, it found that it wasn’t feasible.

“We looked at it and rejected the policy because we were concerned that it wouldn’t work, and that in fact it would not only compromise the pharmaceutical supply chain but also likely be rejected by the very countries we would want to import the drugs from,” Mendelson explains.

The rebate order addresses a persistent challenge for the administration. And Citi analyst Ralph Giacobbe is skeptical that the proposal will actually manifest substantial changes in the way PBMs do business.

“While this will resurrect some debate on the PBM business model, we see the likelihood as either low or limited in scope,” Giacobbe wrote in a note. “Additionally, [with] the language of HHS having to confirm that this action does not increase federal spending, Medicare beneficiary premiums or out-of-pocket cost may make it a moot point since premiums will definitively rise, in our opinion.”

A fourth executive order would tie drug prices to their list prices in countries with Most Favored Nation status. That order has not yet been released, but could be in the coming weeks.

MMIT Reality Check on Kidney Cancer (July 2020)

July 31, 2020

According to our recent payer coverage analysis for kidney cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for kidney cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for kidney cancer treatments shows that under the pharmacy benefit, about 62% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Teva Pharmaceuticals USA, Inc.’s and Endo International plc unit Par Pharmaceuticals’ everolimus for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; renal angiomyolipoma and tuberous sclerosis complex; progressive neuroendocrine tumors of pancreatic origin; and progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable.

Trends That Matter for Medicaid MCOs

July 30, 2020

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

The Menges Group-AHIP white paper, which had a national scope, found that Medicaid MCO enrollment increased by 121% between fiscal years 2010 and 2018, from 26 million to over 56 million members, and that as of 2018, more than 75% of all Medicaid enrollees are members of an MCO, up from 50% in 2010. The report also found that, since 2017, capitated payments to MCOs have exceeded fee-for-service expenditures.

The RWJF-Urban Institute paper, which relied on case study surveys in Arkansas, California, Florida, New York, Ohio, and Washington state, concluded that MCOs offer coverage that is at least as good as commercial plans in the low end of the Affordable Care Act individual market.

“Many [stakeholders] feel there are no longer major distinctions between Medicaid and commercial insurers in the marketplaces. Most interviewees have positive perceptions of Medicaid insurers, crediting their ability to increase choice and affordability in the individual health insurance market,” wrote the paper’s authors.

Radar On Market Access: UnitedHealth, Humana Launch Programs for Chronic Conditions

July 30, 2020

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Both UnitedHealthcare and Humana Inc. are rolling out new disease-specific care management programs aimed at providing patients with the tools they need to help control their chronic conditions, AIS Health reported.

The new initiatives highlight new digital and time-tested interpersonal ways of managing chronic conditions, observers say.

UnitedHealth said it has launched its new digital therapy for people with type 2 diabetes that combines wearable technology and customized personal support. The therapy, called Level2, helps participants gain real-time insights about their condition, using a mobile continuous glucose monitor, activity tracker, app-based alerts and one-on-one clinical coaching.

Meanwhile, Humana says it has contracted with REACH Kidney Care, an educational nonprofit affiliated with Dialysis Clinic, Inc., to provide kidney disease care coordination services to eligible Medicare Advantage and commercial members in Georgia, North Carolina, South Carolina and Tennessee. The collaboration is focused on early detection of chronic kidney disease, slowing disease progression and improving the patient experience.

Joseph Paduda, principal at Health Strategy Associates, LLC, notes that both programs are designed to reduce severity and therefore the cost of treating patients, identifying patients who are “heading in the wrong direction and likely intervening.” Still, Paduda says, “what’s notable is that both are focused on individual disease states, especially knowing more than a third of adults — and more than half of older adults — have multiple chronic conditions.”

William DeMarco, president of Pendulum HealthCare Development Corp., says that UnitedHealth has an in-house advantage with its Optum subsidiary, which connects the insurer’s data platforms for claims and clinical data. Therefore, more information and measures can be tracked electronically, reducing the need for physician or even nurse intervention except when needed, DeMarco says.

DeMarco says the applicability of digital care management solutions, versus more traditional solutions, depends on the condition — although technology always has a place.

“Diabetes is a data-driven disease,” and therefore particularly well-suited to digital therapy, observes Dan Mendelson, founder of Avalere Health. Other chronic conditions that are particularly data-driven include cardiovascular disease and Crohn’s disease, he says, and “any conditions that require regular medication management are likely to benefit from some kind of digital tools.”

Radar On Market Access: Manufacturers, Payers Wait on Federal COVID-19 Vaccine Distribution Plan

July 28, 2020

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

Those guidelines will be important to insurers, as vaccine doses aren’t likely to be available to everyone immediately, according to Mike Schneider, a principal at Avalere Health. Though some firms have already begun manufacturing doses of their vaccine in parallel to testing, the immediate availability of hundreds of millions of doses at the time of FDA approval would be unprecedented.

Schneider notes that multiple vaccines may be available at the same time, and one may offer greater protection from COVID-19 than others. Protocols will need to be developed to determine which patients will be first in line for the most effective vaccine. Schneider says that plans need to start thinking about their internal guidelines now.

He adds that PBMs, which often have the most robust data about a patient’s drug regimen and immunization status, will be essential to tracking who has been vaccinated and screened.

Schneider says that plans are unlikely to favor one vaccine over another in their formularies. For example, Prime Therapeutics, a PBM owned by Blue Cross and Blue Shield affiliates, says it is committed to obtaining a supply of COVID-19 vaccine as soon as possible, seemingly regardless of who manufactures it.

A July 20 analysis prepared by health care investment bank SVB Leerink LLC takes a different view of the shape of the initial vaccine market than Schneider’s prediction of scarcity, arguing that the sheer volume of development efforts makes more than one breakout product likely.

In any case, Schneider predicts that the initial rollout will be unusual when compared with other vaccine distribution.

“This won’t just be going to your pharmacy and your pharmacist gives you a vaccine, like the flu vaccine,” Schneider says. He suspects that rollout will involve specialized facilities that combine rapid screening with inoculations at the same site.

MMIT Reality Check on Bipolar Disorder (July 2020)

July 24, 2020

According to our recent payer coverage analysis for bipolar disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for bipolar disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for bipolar disorder treatments shows that under the pharmacy benefit, about 23% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: A new brand drug, Allergan plc’s Vraylar (cariprazine), for bipolar disorder will have little impact on how health plans cover these medications, experts say. Health plans will continue to encourage the use of less expensive generic bipolar drugs.

Perspectives on Trump Admin’s COVID-19 Testing Payment Guidance

July 23, 2020

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

“Testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope” of the requirements embedded in the legislation approved by Congress earlier this year that requires insurers to pay for COVID-19 testing, the FAQ document said.

“I think now that [the insurers] have had this clarification, they’re going to use that as part of their determination of coverage,” Ashraf Shehata, KPMG national sector leader for health care and life sciences, tells AIS Health.

Richard Hughes IV, managing director at Avalere Health, says that it’s possible to argue that Congress intended insurers to cover all tests for their members, regardless of whether a physician ordered them, whether the person was symptomatic, or whether the test was needed to return to work.

However, Hughes says it’s also possible to argue that Congress gave CMS the authority to implement these testing requirements with some restrictions. “There could be tremendous variability across payers’ approaches to coverage policy and how they process claims,” he says.

In fact, many insurers already have moved to limit testing coverage in some ways, although their policies are fluid and have been updated frequently, says Danielle Showalter, principal at Avalere.

Individuals whose plans will not cover a test can turn to what Shehata calls the “retail model,” which is direct-to-consumer COVID-19 testing sites that don’t require a health care provider’s permission. Costs vary for this type of testing, which generally wouldn’t be covered by insurance unless the person is symptomatic.

Radar On Market Access: Despite Coronavirus Surge, UnitedHealth Expects Care Utilization to Rebound This Year

July 23, 2020

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

At its lowest point in April, inpatient care volume — including care for COVID-19 patients — was about three quarters less than normal, UnitedHealth Group Chief Financial Officer John Rex said during a July 15 conference call to discuss the company’s second-quarter earnings. At that same low point, utilization of outpatient and physician services fell to roughly 60% of normal levels. But in June, UnitedHealth saw inpatient volume recover to nearly 95% of baseline, and as June turned to July, outpatient and physician services were “tracking above 90%,” Rex said. “These national trends have continued thus far in July, even as certain states are seeing short-term deferral of services where there are elevated levels of infection and hospitalization,” he added.

Indeed, the company predicts that overall, “utilization’s going to come back during the second half of the year,” UnitedHealthcare CEO Dirk McMahon said.

In a note to investors, Citi analyst Ralph Giacobbe observed that the executives’ comments about health care utilization returning to normal were “surprising to us.”

“Ultimately we believe healthcare cost trends will remain muted, and as we look out over the next 12+ months we see those trends driving upside, and lower headline risk post-election driving multiples higher,” Giacobbe added.

In the second quarter, UnitedHealth’s adjusted earnings per share of $7.12 easily beat the consensus estimate of $5.28, and the firm nearly doubled its adjusted EPS compared with the second quarter of 2019. UnitedHealth also maintained its 2020 EPS outlook of $15.45 to $15.75 ($16.25 to $16.55 on an adjusted basis).

Meanwhile, job losses tied to the COVID-19 pandemic and ensuing recession led to a decline in revenue and enrollment for UnitedHealth’s commercial insurance business. But revenue rose on the government business side as Medicare and Medicaid enrollment grew “by nearly 600,000 additional people served year to date,” per the company’s earnings release.

Radar On Market Access: Trump Admin’s COVID-19 Testing Payment Guidance Stirs Debate

July 21, 2020

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

James Gelfand, senior vice president of health policy at the ERISA Industry Committee (ERIC), tells AIS Health that he’s fielded concerns that since insurers aren’t paying for back-to-work testing, workers might have to. But in reality, many of the large, self-insured businesses that ERIC represents “are starting to reopen and relaunch back up to full capacity, but most of them are not using a robust testing regime to do so.” The reason, he says, is that diagnostic tests “are essentially taking a snapshot of a moment in time with sometimes a 10-day lag time,” so they’re not very helpful to employees who need to know right away if they’re safe to go back to work.

Steve Wojcik, vice president of public policy at the Business Group on Health, says he sees the logic behind not forcing health insurers to pay for back-to-work testing.

“If there is a medical reason…to get tested, and a doctor is recommending it, then the health plan would cover it, but if testing is part of return to work, some employers may be incorporating testing [costs] into their return-to-work plans,” he points out.

According to Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy, a separate problem is the fact that private insurers are required to pay for out-of-network COVID-19 testing at whatever cash price that a lab or provider lists on a public website. Because those prices aren’t necessarily constrained by prevailing market rates, that can “put a lot of upward pressure on insurance reimbursement for tests,” she says.

MMIT Reality Check on Psoriatic Arthritis (July 2020)

July 17, 2020

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for psoriatic arthritis treatments shows that under the pharmacy benefit, about 77% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA approved Amgen Inc.’s Avsola (infliximabaxxq) for the treatment of psoriatic arthritis, moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn’s disease in adult and pediatric populations, moderate-to-severe ulcerative colitis in adult and pediatric populations, chronic severe plaque psoriasis and ankylosing spondylitis. It is the fourth biosimilar of Remicade (infliximab) from Janssen Biotech, Inc., a Johnson & Johnson company, that the agency has approved.

Radar On Market Access: IngenioRx Acquires ZipDrug to Improve Medication Adherence, Affordability

July 16, 2020

In what one expert calls a “logical” move for a PBM vying for business from cost-conscious payers, Anthem, Inc.’s IngenioRx said on July 6 that it acquired ZipDrug, a company that focuses on improving patients’ medication adherence and affordability, AIS Health reported.

“As plan sponsors and members opt in for the service, ZipDrug ensures members are matched with the best high-quality pharmacy to fulfill their needs,” Justin Petronzi, IngenioRx’s vice president of strategic growth, explains to AIS Health via email. Services offered by ZipDrug include “guaranteed prescription delivery, multi-dose compliance packaging that provides specific instructions to empower patients to manage their medications at home safely on a daily basis, along with other targeted clinical programs,” he says.

In what one expert calls a “logical” move for a PBM vying for business from cost-conscious payers, Anthem, Inc.’s IngenioRx said on July 6 that it acquired ZipDrug, a company that focuses on improving patients’ medication adherence and affordability, AIS Health reported.

“As plan sponsors and members opt in for the service, ZipDrug ensures members are matched with the best high-quality pharmacy to fulfill their needs,” Justin Petronzi, IngenioRx’s vice president of strategic growth, explains to AIS Health via email. Services offered by ZipDrug include “guaranteed prescription delivery, multi-dose compliance packaging that provides specific instructions to empower patients to manage their medications at home safely on a daily basis, along with other targeted clinical programs,” he says.

Petronzi adds that IngenioRx’s interest in ZipDrug materialized after it began a pilot program in 2018 in New York and New Jersey markets that was focused on matching members with the best pharmacy for their needs and providing deliveries of lower cost prescriptions.

To Avalere Health consultant Tim Epple, IngenioRx’s purchase of ZipDrug makes sense. “It’s an investment that follows a lot of trends and themes that we’re seeing in the industry,” he tells AIS Health. “And I think certainly from a PBM perspective, [ZipDrug’s services are] something that we’re hearing that a lot of payers and a lot of plans want, because they’re thinking through these same strategies on their end, and giving them the ability to do that in a sort of ‘one-stop shop’ is a logical and probably good move.”

In general, “we’ve actually seen a lot more interest in the pharma services sector,” Epple says, explaining that helping “lowest-hanging fruit patients” — those who are high cost but struggle with medication adherence — is an area that plan sponsors “are really looking hard at now as they think about how to bend the cost curve and really figure out where they can save money at a relatively simple level.”

The acquisition also aligns with the ongoing trend of specializing pharmacy assets, he adds. “I think we’re seeing a little bit of a movement toward specialty pharmacy platforms that really have specific expertise in either certain disease states, certain patient types [or] certain intervention types,” Epple says.

Trends That Matter for Racial Disparities in MA Plans

July 16, 2020

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

Meanwhile, CMS’s Office of Minority Research in April released a stratified report highlighting the racial and ethnic differences in health care experiences and care of Medicare Advantage (MA) enrollees. The data showed that black members enrolled in MA plans in 2018 received worse clinical care than white enrollees on 20 out of 44 measures, similar care for 20 and better care for four. And all minority populations reported experiences with care that were either worse than or similar to the experiences reported by white enrollees, including the experience measure for getting appointments and care quickly.

Not getting the proper care when it’s needed is a reflection of the provider network, says John Gorman, chairman and CEO of Nightingale Partners LLC. “And then when you look at the clinical measures where there’s huge racial disparities, all of those tie back to a lack of culturally competent physicians serving these populations in a manner that speaks to the way that they need to access health care,” he observes.

Radar On Market Access: Remdesivir’s $3,120 Price Tag Stirs Debate

July 14, 2020

Gilead Sciences, Inc. recently revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

Gilead Sciences, Inc. recently revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

“So they’re saying by shortening hospital stays, the system is going to save all these monies, but I always ask the question, ‘Why is it that the drug company should get to pocket all or some substantial portion of that savings?'” says Jack Hoadley, Ph.D., a research professor emeritus at Georgetown University’s Health Policy Institute. “That’s a savings we should accumulate for consumers, for payers [and] everybody else.”

Hoadley is not alone in those views. The advocacy group Patients for Affordable Drugs, in a June 29 statement, wrote that “Gilead’s price for remdesivir shows once again that we can’t trust Big Pharma to act responsibly — even in the face of a global pandemic.”

The U.S. government helped fund the development of remdesivir, and dexamethasone — a generic steroid — is priced at less than $1 per day even though it ‘showed promise for combating severe COVID-19 cases and reducing potential mortality rates,” the organization said.

The Institute for Clinical and Economic Review (ICER) also brought up dexamethasone in its statement. The U.S. price range of $2,340 to $3,120 is “is largely in line with ICER’s independent assessment suggesting that a price of approximately $2,800 would be reasonable in proportion to the added benefits for patients and the cost offsets in the health system now that dexamethasone is rapidly becoming standard of care,” wrote ICER President Steven D. Pearson, M.D.

Leerink analyst Geoffrey Porges, in a June 29 note to investors, pointed out that the U.S. commercial price set for remdesivir was below his firm’s expectations. Still, “we believe the disclosed [remdesivir] pricing is reasonable, and should provide significant value to the Gilead shareholders and still deflect much of the criticism the company might face in this emergency,” Porges wrote.

MMIT Reality Check on Acute Lymphoblastic Leukemia (July 2020)

July 10, 2020

According to our recent payer coverage analysis for acute lymphoblastic leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for acute lymphoblastic leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for acute lymphoblastic leukemia treatments shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA cleared an investigational new drug (IND) application for Autolus Therapeutics plc’s AUTO1, a CD19-targeting chimeric antigen receptor T-cell therapy for the treatment of adults with acute lymphoblastic leukemia.

Radar On Market Access: Upheld Transparency Rule Is Slated to Reshape Payer-Provider Negotiations

July 9, 2020

In another blow to an industry already beleaguered by the COVID-19 pandemic, a federal judge recently upheld a federal rule that requires hospitals to engage in unprecedented price transparency measures, AIS Health reported.

The rule would require hospitals to disclose the rates they negotiate with payers for all items and services they offer. It is slated to go into effect on Jan. 1, 2021, but the American Hospital Association (AHA) and other trade groups and health systems sued to block it.

In another blow to an industry already beleaguered by the COVID-19 pandemic, a federal judge recently upheld a federal rule that requires hospitals to engage in unprecedented price transparency measures, AIS Health reported.

The rule would require hospitals to disclose the rates they negotiate with payers for all items and services they offer. It is slated to go into effect on Jan. 1, 2021, but the American Hospital Association (AHA) and other trade groups and health systems sued to block it.

The crux of the plaintiffs’ argument in American Hospital Association v. Azar is that CMS exceeded its authority by redefining the “standard charges” that hospitals must disclose under the Affordable Care Act to include negotiated rates. But in a decision issued June 23, U.S. District Court Judge Carl Nichols determined that CMS’s interpretation of the statute was reasonable.

The AHA has already appealed the decision, and depending on how the D.C. Circuit Court rules on that appeal, the case could make it to the Supreme Court, says David Kaufman, a partner at Laurus Law Group LLC.

“Insurers today actually do have a pretty good sense of how hospitals are charging, but this is going to be a quantum leap forward for them in understanding the strategy that hospitals take in negotiating across insurance markets,” Dan Mendelson, founder of Avalere Health says regarding what will happen if the rule does take effect.

However, “the insurer will have more information, but I question whether they will have more leverage,” Mendelson says. “I think over time what this [rule] is likely to do is to drive more consistency in pricing — not necessarily lower prices across the board.”

Kaufman observes that the disclosure of hospitals’ negotiated rates may not have a uniform impact across different types of insurers.

“In certain ways, it’s a procompetitive kind of rule by providing more transparency,” he says. “However, large established insurers that have the advantage of broad networks with lower prices based on their large membership benefit by keeping their prices confidential. It helps them with providing better prices to large employers, etc. So by making those prices more transparent, it might ease barriers to entry [for] other insurers.”

Perspectives on MedImpact’s New Program to Accelerate Pharmacogenomics

July 9, 2020

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

“Pharmacogenetics, in the most basic sense, is looking at someone’s genes to determine their drug-metabolizing enzymes,” explains Emily Cicali, a clinical assistant professor at the University of Florida’s College of Pharmacy. For people who have lower levels of drug-metabolizing enzymes, certain medications may be less effective or ineffective, and for those have too much of those enzymes, that could overactivate drugs and “put people at risk for toxicity,” Cicali adds.

The concept of a PBM having a PGx program isn’t new, MedImpact acknowledges in its release. But up until now, most PGx programs generally operated along the lines of “one gene being tested for one drug at one point in time” to determine if there’s a potential conflict, says Karen Geary, the company’s vice president of strategy and innovation. MedImpact’s program, however, screens for genetic interactions with more than 240 commonly prescribed medications and then reviews all future prescriptions for potential drug-gene issues.

Michael Schneider, a principal at Avalere Health, says that if a program like MedImpact’s is able to significantly avert problems like adverse drug events, “then I think this type of analysis could have a big impact on the PBM industry and potentially become the standard of care.”

However, if genetic testing becomes more commonplace across wider swaths of the population, there could be downsides, he suggests. For example, the expense of large-scale genetic testing might trickle down from plan sponsors to consumers in the form of higher premiums.

Radar On Market Access: Reports Show Medicaid MCOs Are ‘Dominant,’ Increase Affordability

July 7, 2020

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

Two recent reports found that Medicaid managed care plans now enroll most Medicaid members, help keep costs and premiums low in the markets where they participate, and are competitive with commercial plans at the low end of the individual market in areas including network quality and benefit design, AIS Health reported.

One white paper was prepared by consultancy The Menges Group for America’s Health Insurance Plans (AHIP), and the other was authored by researchers at the Robert Wood Johnson Foundation (RWJF) and Urban Institute.

The Menges Group-AHIP white paper, which had a national scope, found that Medicaid MCO enrollment increased by 121% between fiscal years 2010 and 2018, from 26 million to over 56 million members, and that as of 2018, more than 75% of all Medicaid enrollees are members of an MCO, up from 50% in 2010. The report also found that, since 2017, capitated payments to MCOs have exceeded fee-for-service expenditures.

The RWJF-Urban Institute paper, which relied on case study surveys in Arkansas, California, Florida, New York, Ohio, and Washington state, concluded that MCOs offer coverage that is at least as good as commercial plans in the low end of the Affordable Care Act individual market.

“Many [stakeholders] feel there are no longer major distinctions between Medicaid and commercial insurers in the marketplaces. Most interviewees have positive perceptions of Medicaid insurers, crediting their ability to increase choice and affordability in the individual health insurance market,” wrote the paper’s authors.

Most of the surveyed stakeholders, which the paper says “included representatives from state departments of insurance, hospital associations, medical or primary care provider associations, insurance brokers, and consumer advocates,” believe that Medicaid MCOs have improved the level of competition in their state marketplace, and offer their members similar network quality to commercial plans.

MMIT Reality Check on Hemophilia A or B With Inhibitors (July 2020)

July 3, 2020

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 48% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved Laboratoire Francais du Fractionnement et des Biotechnologies S.A.’s Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes in people at least 12 years old with hemophilia A or B with inhibitors.

Trends That Matter for DMD Therapies

July 2, 2020

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

In February 2017, the FDA approved then-manufacturer Marathon Pharmaceuticals LLC’s Emflaza (deflazacort). The company said it would be priced at $89,000, which sparked outrage since people have been buying a generic version from overseas since the 1990s for about $1,000 per year. After the backlash, Marathon ultimately sold the drug to PTC Therapeutics Inc., which launched it later that year with a $35,000 annual price tag. Since then, PTC has raised the price to more than Marathon’s original one.

In September 2016, the FDA gave accelerated approval to Sarepta Therapeutics, Inc.’s Exondys 51 (eteplirsen). The dystrophin gene has 79 exons, and about 80% of people with DMD have genotypes that are amenable to exon skipping. Exondys 51 targets those with a mutation of the DMD gene that is amenable to exon 51 skipping.

Sarepta also has a second exon-skipping therapy, Vyondys 53 (golodirsen), which treats DMD in people with a mutation amenable to exon 53 skipping. The FDA gave the drug accelerated approval in December, almost four months after the agency rejected the drug through a complete response letter.

Both drugs are weight-based with similar prices: about $300,000 per year but up to $1 million annually.

“It’s unclear how much a health plan may spend on someone with DMD; however, a recent study from the Muscular Dystrophy Association found that the annual cost for DMD for U.S. society as a whole is around $362-$488 million dollars,” says Tegenu. “The price of the newer DMD therapies (Exondys 51 and Vyondys 53) are both estimated to cost approximately $750,000 per year for the treatment of one patient.”

Radar On Market Access: Insurers Are Required to Cover Only ‘Medically Necessary’ COVID-19 Tests

July 2, 2020

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

“Testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope” of the requirements embedded in the legislation approved by Congress earlier this year that requires insurers to pay for COVID-19 testing, the FAQ document said.

“I think now that [the insurers] have had this clarification, they’re going to use that as part of their determination of coverage,” Ashraf Shehata, KPMG national sector leader for health care and life sciences, tells AIS Health.

Richard Hughes IV, managing director at Avalere Health, says that it’s possible to argue that Congress intended insurers to cover all tests for their members, regardless of whether a physician ordered them, whether the person was symptomatic, or whether the test was needed to return to work.

However, Hughes says it’s also possible to argue that Congress gave CMS the authority to implement these testing requirements with some restrictions. “There could be tremendous variability across payers’ approaches to coverage policy and how they process claims,” he says.

In fact, many insurers already have moved to limit testing coverage in some ways, although their policies are fluid and have been updated frequently, says Danielle Showalter, principal at Avalere.

Individuals whose plans will not cover a test can turn to what Shehata calls the “retail model,” which is direct-to-consumer COVID-19 testing sites that don’t require a health care provider’s permission. Costs vary for this type of testing, which generally wouldn’t be covered by insurance unless the person is symptomatic.

Radar On Market Access: CMS Proposes New Medicaid Best Price Rules for Pricey Therapies

June 30, 2020

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules, AIS Health reported.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules, AIS Health reported.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

New curative therapies present a novel financial challenge for payers. Curative therapies eliminate the need for intensive treatment of chronic and terminal conditions, which create substantial savings for payers, patients and providers alike.

However, their high up-front cost is borne by payers and patients, and the initial payer may not see the entire financial benefit of the curative therapy. What’s more, under a traditional payment model, insurers are unable to recoup costs if a new, experimental therapy with curative potential has limited effect.

In order to spread risk and value across all stakeholders involved, some drug benefit industry leaders have called for broad adoption of the value-based pricing methods CMS’s proposed rule seeks to create, backed by a reinsurance mechanism.

Avalere Health principal Mike Schneider tells AIS Health that, although CMS’s proposal does not include a reinsurance mechanism, it should advance adoption of curative therapies. He says that, as they are currently implemented, Medicaid’s best price rules have made it difficult for commercial payers to negotiate with drug manufacturers to include outcomes and proof of concept in purchasing agreements.

Though the proposed rule applies directly to state Medicaid plans, Schneider says that the rule could have a substantial impact on the commercial market as plans bidding on Medicaid contracts gain experience with the new paradigm.

Still, barriers remain in adopting new curative therapies. Drug Channels Institute CEO Adam Fein points out that the rule does not address the challenge presented by copay accumulators to patients who might benefit from expensive, new specialty drugs — which suggests the rule might not speed up curative therapy adoption as quickly as patients might hope.

MMIT Reality Check on Ankylosing Spondylitis (June 2020)

June 26, 2020

According to our recent payer coverage analysis for ankylosing spondylitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ankylosing spondylitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ankylosing spondylitis treatments shows that under the pharmacy benefit, about 69% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The FDA’s recent approvals of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis, a less advanced form of ankylosing spondylitis, provide a new mechanism of action.

Perspectives on COVID-19 Vaccine Rollout

June 25, 2020

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

David Simchi-Levi, Ph.D., a systems engineer who studies manufacturing and supply chain at MIT, tells AIS Health that it’s inevitable that vaccine supply will not meet demand when it is available. “The question will be, who gets it?” he says.

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

David Simchi-Levi, Ph.D., a systems engineer who studies manufacturing and supply chain at MIT, tells AIS Health that it’s inevitable that vaccine supply will not meet demand when it is available. “The question will be, who gets it?” he says.

Mike Schneider, a principal at Avalere Health and a former executive at CVS Health Corp.’s Caremark PBM, says that given the likely scarcity of the vaccine, areas hardest hit by COVID-19 should be the focus of the initial supply.

“I think the payers will probably try to stay out of the way as much as possible, and let local laws determine who can get a vaccine and probably local health departments determine who can get the vaccine before others,” Schneider says. He adds that payers should also use prior authorization matched to FDA guidance to ensure the right people are dosed.

When a vaccine is available, Schneider expects retail pharmacies to play a large role in delivery. He cites retail pharmacy chains’ rollout of drive-through SARS-CoV-2 testing and the annual ritual of getting a flu shot from a pharmacist as examples of what delivering the coronavirus vaccine could look like. Along the same lines, he expects primary care practitioners to perform some inoculations.

Even a well-managed rollout will only be a first step. Manufacturing and supply chain concerns will dictate the supply of vaccines available in the U.S. going forward. So will trade, as most medicines are manufactured in China and India. Those countries will certainly want to care for their own citizens as soon as possible, which could delay the release of vaccine here.

Given all that uncertainty, Schneider expects that a SARS-CoV-2 vaccine could be a perennial component of formularies, along the lines of the flu vaccine. Schneider expects that receiving the coronavirus vaccine will be a routine preventive treatment that costs patients little to nothing.

Radar On Market Access: Telehealth Regulation and Reimbursement Issue Sparks Debates

June 25, 2020

Telehealth use has surged during the COVID-19 pandemic, and is likely to remain higher than it was before the crisis on a permanent basis. However, the difficult work of regulating and establishing rate structure for telehealth beyond the COVID-19 pandemic has only just started, AIS Health reported.

On June 17, the Senate Health, Education, Labor and Pensions Committee held a hearing about how to consolidate the gains in telehealth made necessary by the pandemic.

Telehealth use has surged during the COVID-19 pandemic, and is likely to remain higher than it was before the crisis on a permanent basis. However, the difficult work of regulating and establishing rate structure for telehealth beyond the COVID-19 pandemic has only just started, AIS Health reported.

On June 17, the Senate Health, Education, Labor and Pensions Committee held a hearing about how to consolidate the gains in telehealth made necessary by the pandemic.

The most important policy decision that Congress must make is on reimbursement. CMS has elected to compensate telehealth visits at the same rate as in-person visits for the duration of the pandemic, but whether that will continue is likely to be decided in the coming weeks. At present, commercial plans have a wide variation in telehealth reimbursement amounts.

Providers will likely oppose setting telehealth reimbursement at rates lower than in-person visits, and experts predict the balance of visits will shift more heavily toward remote consultations going forward.

Yet part of the allure of telehealth for payers and patients is that a remote visit generally costs less than an in-person consultation. The stakes are high for the payer industry: Provider services seem to be the main driver behind higher overall health care spending in the last decade. If telehealth visits account for a meaningful share of overall visits across the industry, a lower rate of reimbursement will make a big difference in lowering costs.

The other major regulatory challenge for telehealth is provider licensing. State medical boards exercise control over whether a clinician can practice in their state, and it is typically illegal for a practitioner licensed in one state to care for patients in another.

“We think the best way to handle [state licensure] is through a compact,” said Krista Drobac, the executive director of the Alliance for Connected Care, during a session at America’s Health Insurance Plans’ Institute & Expo. “We would like to see licensure reciprocity or mutual recognition, what we refer to as licensure portability.…Congress can’t step in and take over licensing — that’s just not a federal responsibility.”

Yet Avalere Health founder Dan Mendelson takes a different view. “The licensure issues are problematic. The Congress needs to act more aggressively to make it easier to deliver telemedicine in the United States,” he says.

Radar On Market Access: CMS Report Shows Increasing Racial Disparities in MA Plans

June 23, 2020

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

Meanwhile, CMS’s Office of Minority Research in April released a stratified report highlighting the racial and ethnic differences in health care experiences and care of Medicare Advantage (MA) enrollees. The data showed that black members enrolled in MA plans in 2018 received worse clinical care than white enrollees on 20 out of 44 measures, similar care for 20 and better care for four. And all minority populations reported experiences with care that were either worse than or similar to the experiences reported by white enrollees, including the experience measure for getting appointments and care quickly.

Not getting the proper care when it’s needed is a reflection of the provider network, says John Gorman, chairman and CEO of Nightingale Partners LLC. “And then when you look at the clinical measures where there’s huge racial disparities, all of those tie back to a lack of culturally competent physicians serving these populations in a manner that speaks to the way that they need to access health care,” he observes.

John Weis, CEO of Quest Analytics, LLC, predicts that “there will be a significant impact on practice consolidation” from the pandemic. “Given the potential risk to providers, we predict that coming out of COVID, we’ll see an uptick in providers that want to minimize their exposure and consider retirement,” he suggests. And with fewer providers available, “if plans are not prepared, this will drive both out-of-network utilization and increase health care costs in rural areas.”

Dan Mendelson, founder of Avalere Health, suggests that while MA plans have the tools to address racial disparities, they don’t necessarily have the incentives to prioritize them. “I think Medicare Advantage plans are uniquely equipped to measure, understand, identify and mitigate disparities…. So, a proactive form of engagement that is focused on disparities can work,” says Mendelson. “One thing that is not there at this point is any kind of direct incentive to the plans to act.”

MMIT Reality Check on Urothelial/Bladder Cancer (June 2020)

June 19, 2020

According to our recent payer coverage analysis for urothelial/bladder cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for urothelial/bladder cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for urothelial/bladder cancer treatments shows that under the pharmacy benefit, about 54% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved UroGen Pharma Ltd.’s Jelmyto (mitomycin) for adults with low-grade upper tract urothelial cancer. The agency gave the pyelocalyceal solution priority review, breakthrough therapy, fast track and orphan drug designations.

Trends That Matter: Enrollment Shift Into ACA Exchanges

June 18, 2020

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one recent analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one recent analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

Such growth, the report said, “will come from newly unemployed individuals in all states who exceed Medicaid eligibility thresholds” because of money they receive from the Coronavirus Aid, Relief, and Economic Security Act. And in states that haven’t expanded Medicaid, nearly all of the newly unemployed who earn below 100% of the federal poverty level could qualify for Affordable Care Act premium subsidies.

Another analysis from the Urban Institute and Robert Wood Johnson Foundation (RWJF), estimated that if U.S. unemployment reaches 20%, 25 million people would lose employer-sponsored health insurance. “Of these, 11.8 million would gain Medicaid coverage, 6.2 million would gain marketplace or other private coverage, and 7.3 million would become uninsured,” it stated.

Katherine Hempstead, the senior adviser to the executive vice president at RWJF, says it’s possible the coming enrollment shifts will cause some health insurers to re-evaluate their level of participation in the ACA exchanges, which some large insurers left in 2017 and 2018 before the market stabilized.

Radar On Market Access: Pricey Treatments Face Challenges on Cost Sharing and Data Analysis

June 18, 2020

Genomic, curative drugs for chronic and terminal diseases are perhaps the most exciting new treatments in medicine. But even though these highly tailored therapies come to market with the potential to save costs for the health care system, the industry is struggling to pay for them because of their high up front costs, AIS Health reported.

Neil Lund, chief actuary and vice president emeritus of CVS Health Corp., observes that PBMs are already perceived as honest brokers by the plans they contract with. He says PBMs are a possible conduit to share the information necessary for the evaluations of health care products and services with all stakeholders.

Genomic, curative drugs for chronic and terminal diseases are perhaps the most exciting new treatments in medicine. But even though these highly tailored therapies come to market with the potential to save costs for the health care system, the industry is struggling to pay for them because of their high up front costs, AIS Health reported.

Neil Lund, chief actuary and vice president emeritus of CVS Health Corp., observes that PBMs are already perceived as honest brokers by the plans they contract with. He says PBMs are a possible conduit to share the information necessary for the evaluations of health care products and services with all stakeholders.

“At the core [of a PBM] is this claims processing engine,” Lund says. “[They have] a lot of real-time electronic data and the ability with really excellent record keeping as the fundamentals involved.”

While the rebate-driven model for purchasing traditional pharmacy products works well for maintenance and incidental treatments, purchasing curative specialty pharmacy products is more complicated. For payers, such therapies have the benefit of reducing the need for chronic care and lessening risk of an inpatient stay, but they also have to front a high capital cost that disproportionately benefits providers and manufacturers, Lund observes.

Yet different metrics can yield different understandings of a new therapy’s value, said Brian Leinwand, an associate principal for health economics at Avalere Health, during a recent webinar on alternative financing models for emergent therapies.

“[Decision-makers] typically evaluate products’ incremental cost per quality-adjusted life-year gained compared to another therapy or therapies. However, a quality-adjusted life-year is not always the most useful metric for decision-makers in these scenarios, [and] other techniques can be employed.”

Lund says member churn adds complication to curative therapy pricing. If a member receives an expensive curative therapy with one plan but departs for a new one a few years later, the new plan benefits but doesn’t share in the cost.

“In the short term, the base case issue here is whoever is covering the person at the time of the very expensive treatment, in the way we handle everything today, is on the hook for the full cost,” Lund observes. “Subsequent insurers or organizations reap the benefit of that, not the organization that necessarily footed the bill.”

Radar On Market Access: MedImpact’s New Program Aims to Accelerate Pharmacogenomics

June 16, 2020

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

With precision medicine an increasingly hot topic in health care, MedImpact is betting that a newly launched program — which reviews every drug prescribed to patients against their genetic profile — will simultaneously give the PBM a competitive edge and improve care, AIS Health reported.

In a Feb. 26 press release, MedImpact describes its new program as the industry’s first “any drug, any time, any prescriber” approach to pharmacogenomics (PGx).

“Pharmacogenetics, in the most basic sense, is looking at someone’s genes to determine their drug-metabolizing enzymes,” explains Emily Cicali, a clinical assistant professor at the University of Florida’s College of Pharmacy. For people who have lower levels of drug-metabolizing enzymes, certain medications may be less effective or ineffective, and for those have too much of those enzymes, that could overactivate drugs and “put people at risk for toxicity,” Cicali adds.

The concept of a PBM having a PGx program isn’t new, MedImpact acknowledges in its release. But up until now, most PGx programs generally operated along the lines of “one gene being tested for one drug at one point in time” to determine if there’s a potential conflict, says Karen Geary, the company’s vice president of strategy and innovation. MedImpact’s program, however, screens for genetic interactions with more than 240 commonly prescribed medications and then reviews all future prescriptions for potential drug-gene issues.

Michael Schneider, a principal at Avalere Health, says that if a program like MedImpact’s is able to significantly avert problems like adverse drug events, “then I think this type of analysis could have a big impact on the PBM industry and potentially become the standard of care.”

However, if genetic testing becomes more commonplace across wider swaths of the population, there could be downsides, he suggests. For example, the expense of large-scale genetic testing might trickle down from plan sponsors to consumers in the form of higher premiums.

Since MedImpact rolled out its new program, client interest has been high, Geary says. However, “the challenge that I’ve recently run into is that employers are sitting there looking at what would be a benefit enrichment while, because of COVID-19, they’re having to lay off staff,” she adds.

MMIT Reality Check on Endometriosis (June 2020)

June 12, 2020

According to our recent payer coverage analysis for endometriosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for endometriosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access forendometriosis treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, Myovant Sciences reported positive results in its Phase III studies of once-daily relugolix combination therapy for pain associated with endometriosis.

Perspectives on ACA Exchanges Amid COVID-19

June 11, 2020

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

Such growth, the report said, “will come from newly unemployed individuals in all states who exceed Medicaid eligibility thresholds” because of money they receive from the Coronavirus Aid, Relief, and Economic Security Act. And in states that haven’t expanded Medicaid, nearly all of the newly unemployed who earn below 100% of the federal poverty level could qualify for Affordable Care Act premium subsidies.

Another analysis from the Urban Institute and Robert Wood Johnson Foundation (RWJF), estimated that if U.S. unemployment reaches 20%, 25 million people would lose employer-sponsored health insurance. “Of these, 11.8 million would gain Medicaid coverage, 6.2 million would gain marketplace or other private coverage, and 7.3 million would become uninsured,” it stated.

Katherine Hempstead, the senior adviser to the executive vice president at RWJF, says it’s possible the coming enrollment shifts will cause some health insurers to re-evaluate their level of participation in the ACA exchanges, which some large insurers left in 2017 and 2018 before the market stabilized.

In fact, Maryland Gov. Larry Hogan (R) said on May 12 that UnitedHealth filed to offer plans on the sate’s ACA exchange in 2021, bringing the total number of insurers in that market from two to three.

Ari Gottlieb, a principal at A2 Strategy Group, says the effect may be even stronger after 2021.

“If the market doubles to 25 or 30 million, some of that will probably fall off, but some of that will probably stay,” he says. “I think even a year or two from now, we’re going to have a bigger individual market than we had before.”

Radar On Market Access: Uncertainties Over Effectiveness and High Costs Surround DMD Therapies

June 11, 2020

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

In February 2017, the FDA approved then-manufacturer Marathon Pharmaceuticals LLC’s Emflaza (deflazacort). The company said it would be priced at $89,000, which sparked outrage since people have been buying a generic version from overseas since the 1990s for about $1,000 per year. After the backlash, Marathon ultimately sold the drug to PTC Therapeutics Inc., which launched it later that year with a $35,000 annual price tag. Since then, PTC has raised the price to more than Marathon’s original one.

In September 2016, the FDA gave accelerated approval to Sarepta Therapeutics, Inc.’s Exondys 51 (eteplirsen). The dystrophin gene has 79 exons, and about 80% of people with DMD have genotypes that are amenable to exon skipping. Exondys 51 targets those with a mutation of the DMD gene that is amenable to exon 51 skipping.

Sarepta also has a second exon-skipping therapy, Vyondys 53 (golodirsen), which treats DMD in people with a mutation amenable to exon 53 skipping. The FDA gave the drug accelerated approval in December, almost four months after the agency rejected the drug through a complete response letter.

Both drugs are weight-based with similar prices: about $300,000 per year but up to $1 million annually.

“It’s unclear how much a health plan may spend on someone with DMD; however, a recent study from the Muscular Dystrophy Association found that the annual cost for DMD for U.S. society as a whole is around $362-$488 million dollars,” says Tegenu. “The price of the newer DMD therapies (Exondys 51 and Vyondys 53) are both estimated to cost approximately $750,000 per year for the treatment of one patient.”

Pharma manufacturers continue to focus on the DMD space, and several products, including gene therapies, are in the pipeline.

Radar On Market Access: 2021 MA, Part D Bids Face Challenges Amid COVID-19

June 9, 2020

There are always uncertainties when it comes to projecting plan costs for the year ahead, but Medicare Advantage and Part D organizations that submitted bids on June 1 faced a particularly unpredictable set of circumstances created by the COVID-19 pandemic.

“I think we will all look back on the 2021 bids as the year of COVID-19,” Brad Piper, a principal and consulting actuary in Milliman’s Milwaukee office, tells AIS Health. “That was a big challenge for the organizations that are in the Medicare Advantage program — [perhaps more so] than on the Part D side — and it impacted both sides of the coin: costs and revenue.”

There are always uncertainties when it comes to projecting plan costs for the year ahead, but Medicare Advantage and Part D organizations that submitted bids on June 1 faced a particularly unpredictable set of circumstances created by the COVID-19 pandemic.

“I think we will all look back on the 2021 bids as the year of COVID-19,” Brad Piper, a principal and consulting actuary in Milliman’s Milwaukee office, tells AIS Health. “That was a big challenge for the organizations that are in the Medicare Advantage program — [perhaps more so] than on the Part D side — and it impacted both sides of the coin: costs and revenue.”

From a cost perspective, unknowns include whether there will be “pent-up demand” for health care services next year given that many beneficiaries have deferred doctors’ appointments and elective/non-urgent procedures to avoid the risk of coronavirus exposure.

Adding to that is the question of whether there will be a second wave of COVID-19 “and how much COVID-related utilization and services will occur that plans will have to bear,” points out Matt Kazan, principal with Avalere Health. A third concern is “how much of the cost of all the things Congress is saying plans will need to cover in terms of testing, vaccines…will impact plans,” says Kazan, referring to various legislative requirements, some of which are still pending.

Preparing bids on the revenue side was equally challenging, since it’s the 2020 diagnosis information that drives reimbursement for next year, adds Piper. “As we’re trying to forecast what 2021 revenue will look like, we’ve got to look at what’s going on in today’s environment and understand if we’re not seeing our members as often…that potentially creates a challenge for health plans to capture all that diagnosis information in 2020, which in turn drives their 2021 revenue amount.”

On the Part D side, Milliman principal and consulting actuary Shelly Brandel says COVID-19 had less of an impact on costs because prescription drug utilization or fills weren’t “delayed to the same degree as medical services had been.” The risk score impact, however, created a similar challenge because Part D risk scores are based on medical diagnoses, she adds.

MMIT Reality Check on Chronic Idiopathic Constipation (June 2020)

June 5, 2020

According to our recent payer coverage analysis for chronic idiopathic constipation treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for chronic idiopathic constipation treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for chronic idiopathic constipation treatments shows that under the pharmacy benefit, about 41% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2020, the FDA approved Sebela Pharmaceuticals’ Pizensy (lactitol) for oral solution for the treatment of chronic idiopathic constipation in adults. Unlike solid oral treatments, the medication can be mixed with the patient’s fluid of choice, including water, juice, coffee, tea and soda.

Trends That Matter: The Future of Value-Based Agreements

June 4, 2020

The challenge of improving patient access while reducing treatment costs has led the healthcare sector to explore innovative contract arrangements. Using value-based agreements (also referred to as risk-sharing or outcomes-based contracts) biopharmaceutical manufacturers and payers agree to link coverage and reimbursement levels to a drug’s effectiveness and usage. These agreements have been a necessity in providing patients access to high-cost and high-value gene therapies. However, in chronic disease states like diabetes and cardiovascular disease, value-based contracts have been essential to managing treatment costs associated with the high-volume utilization of these treatments.

The challenge of improving patient access while reducing treatment costs has led the healthcare sector to explore innovative contract arrangements. Using value-based agreements (also referred to as risk-sharing or outcomes-based contracts) biopharmaceutical manufacturers and payers agree to link coverage and reimbursement levels to a drug’s effectiveness and usage. These agreements have been a necessity in providing patients access to high-cost and high-value gene therapies. However, in chronic disease states like diabetes and cardiovascular disease, value-based contracts have been essential to managing treatment costs associated with the high-volume utilization of these treatments.

Current challenges in value-based care include stakeholders’ alignment on which metrics are measurable and are valuable to include in an agreement, along with the presence of extensive technology and an unbiased third-party administrator to track and report on treatment outcomes. Successful implementation of such programs also involves patient adherence to treatments coordinated and monitored by physician practices or hospital systems.

That said, the question remains, how are value-based agreements going to evolve in the future?

Value-based agreements are becoming more prevalent and will continue to grow over the next two years. MMIT’s Special Report on Value Based Agreements Between Payers and Manufacturers surveyed 50 decision-makers covering 136 million commercial members and found that engagement in value-based contracts has steadily increased over the past three years. In this same survey, payers covering 85% of those commercial members reported that they anticipate increasing their participation in such agreements over the next two years.

In addition, the COVID-19 crisis is pushing integrated delivery networks and health care systems to their limits financially, which may prompt them to re-evaluate or renegotiate existing value-based agreements to prioritize their financial recovery. Similarly, accountable care organizations (ACOs) facing a similar financial crisis may experience challenges in meeting their existing value-based contract goals. To alleviate some of the concerns that such organizations are facing, CMS recently announced that it will work toward relaxing quality reporting requirements and prorate losses suffered by Medicare ACOs in 2020.

The special report also illustrates another critical finding – the surveyed payers rated their organizations as highly capable of entering value-based agreements. As a result of the pandemic, recent research suggests there is an increased likelihood of additional vertical integration of payers on one side, in addition to smaller physician practices’ integration into larger hospital systems. This trend stands to improve payers’ and physicians’ ability to track outcomes more effectively, which will bode well for value-based agreements, since they often require interoperability between payers, providers and careful monitoring of patient adherence.

If payers relax their initial and reauthorization restrictions on therapies to ease drug access during the pandemic, they will likely have a chance to revisit existing policies once the dust settles. Exploring innovative contracting methods to help payer organizations control and recuperate costs in the aftermath of the pandemic may become a necessity that could create new opportunities for value-based contracts. With an increasing number of members filing for unemployment and moving to the Medicaid line of business, this segment could also be a focus area for such agreements.

To learn more about the special report on value-based agreements between payers and manufacturers, visit https://bit.ly/3ewzTLV. For more information about the impact of COVID-19 and resources that provide actionable insights, visit https://bit.ly/2yDQoGu.

Radar On Market Access: 1.7K Plans Apply for Trump Admin’s Fixed-Insulin-Copay Program for Seniors

June 4, 2020

The Trump administration on May 26 shared new details about a program that offers diabetic seniors access to a variety of insulin products for a maximum $35-per-month copay, AIS Health reported.

More than 88 health insurers offering about 1,750 standalone Medicare Part D Prescription Drug Plans and Medicare Advantage plans with prescription drug coverage have now applied to participate in the Part D Senior Savings Model, which CMS unveiled in mid-March. Medicare beneficiaries in all 50 states, the District of Columbia and Puerto Rico will be able to enroll in a participating plan during the Medicare open enrollment period that lasts from Oct. 15 to Dec. 7, 2020, for Part D coverage that begins on Jan. 1, 2021.

The Trump administration on May 26 shared new details about a program that offers diabetic seniors access to a variety of insulin products for a maximum $35-per-month copay, AIS Health reported.

More than 88 health insurers offering about 1,750 standalone Medicare Part D Prescription Drug Plans and Medicare Advantage plans with prescription drug coverage have now applied to participate in the Part D Senior Savings Model, which CMS unveiled in mid-March. Medicare beneficiaries in all 50 states, the District of Columbia and Puerto Rico will be able to enroll in a participating plan during the Medicare open enrollment period that lasts from Oct. 15 to Dec. 7, 2020, for Part D coverage that begins on Jan. 1, 2021.

That “widespread voluntary participation” from health plans “was essential for the program’s success,” says Marc Guieb, Pharm.D., a consultant at Milliman, Inc. Still, “many plans were hesitant to participate in the inaugural year of this program due to uncertainty around its financial impact,” he says. “It is likely that, in future years, more plans will jump on the bandwagon.”

CMS estimates that Medicare beneficiaries who use insulin and join a plan participating in the Part D Senior Savings Model could save an average of $446 annually on out-of-pocket insulin costs, or 66%. Three insulin manufacturers — Eli Lilly and Co., Novo Nordisk Inc. and Sanofi U.S. — have agreed to participate.

On the one hand, the concept of a fixed insulin copay should be attractive to seniors and can improve medication adherence, says Brian Anderson, a principal at Milliman. Still, “the benefit coordination and claims processing is going to be tricky,” he suggests, adding that “the pharmacy reimbursements, manufacturer payments, application of the Part D benefit phases and reinsurance will all come into play.”

“Overall, this has the opportunity to improve the Part D benefit and drive formulary competition from a cost standpoint,” Anderson concludes.

America’s Health Insurance Plans (AHIP) gave the program a glowing assessment. “Innovative voluntary programs like this Part D Senior Savings Model are an excellent example of public-private partnerships where everyone wins, but especially patients,” AHIP President and CEO Matt Eyles said in a statement released May 26.

Radar On Market Access: Payers and PBMs May Play Key Role in COVID-19 Vaccine Rollout

June 2, 2020

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

The rollout of a vaccine for SARS-CoV-2, the virus that causes COVID-19, is an unprecedented logistical challenge. So will be deciding who gets it: experts say that the initial vaccine supply will not be large enough to dose everyone who wants it — and payers and PBMs will have a large role to play in distributing the medicine to the right people quickly.

David Simchi-Levi, Ph.D., a systems engineer who studies manufacturing and supply chain at MIT, tells AIS Health that it’s inevitable that vaccine supply will not meet demand when it is available. “The question will be, who gets it?” he says.

Mike Schneider, a principal at Avalere Health and a former executive at CVS Health Corp.’s Caremark PBM, says that given the likely scarcity of the vaccine, areas hardest hit by COVID-19 should be the focus of the initial supply.

“I think the payers will probably try to stay out of the way as much as possible, and let local laws determine who can get a vaccine and probably local health departments determine who can get the vaccine before others,” Schneider says. He adds that payers should also use prior authorization matched to FDA guidance to ensure the right people are dosed.

When a vaccine is available, Schneider expects retail pharmacies to play a large role in delivery. He cites retail pharmacy chains’ rollout of drive-through SARS-CoV-2 testing and the annual ritual of getting a flu shot from a pharmacist as examples of what delivering the coronavirus vaccine could look like. Along the same lines, he expects primary care practitioners to perform some inoculations.

Even a well-managed rollout will only be a first step. Manufacturing and supply chain concerns will dictate the supply of vaccines available in the U.S. going forward. So will trade, as most medicines are manufactured in China and India. Those countries will certainly want to care for their own citizens as soon as possible, which could delay the release of vaccine here.

Given all that uncertainty, Schneider expects that a SARS-CoV-2 vaccine could be a perennial component of formularies, along the lines of the flu vaccine. Schneider expects that receiving the coronavirus vaccine will be a routine preventive treatment that costs patients little to nothing.

MMIT Reality Check on Narcolepsy (May 2020)

May 29, 2020

According to our recent payer coverage analysis for narcolepsy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for narcolepsy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for narcolepsy treatments shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In August 2019, the FDA approved Harmony Biosciences, LLC’s Wakix (pitolisant) for the treatment of excessive daytime sleepiness in adults with narcolepsy. The product is a first-in-class medicine, a selective histamine 3 (H3) receptor antagonist/inverse agonist.

Radar On Market Access: Will COVID-19 Advance Automatic Health Insurance Enrollment?

May 28, 2020

As the COVID-19 pandemic continues to ravage the U.S. economy, it would seem to be the perfect time for policymakers to explore a policy option that has garnered rare bipartisan support: automatic health insurance enrollment.

As the COVID-19 pandemic continues to ravage the U.S. economy, it would seem to be the perfect time for policymakers to explore a policy option that has garnered rare bipartisan support: automatic health insurance enrollment.

“We have huge numbers of people who are losing employer-based coverage; most of them are eligible for some kind of help, but we know historically most laid-off workers do not enroll in coverage for which they qualify,” Stan Dorn, director of the National Center for Coverage Innovation and senior fellow at Families USA, told AIS Health. “It’s just overwhelming to be grappling with job loss and therefore it becomes imperative to make enrollment as easy, seamless and automatic as possible.”

Dorn was among several panelists who spoke during a May 18 webinar about automatic health insurance enrollment, hosted by the USC-Brookings Schaeffer Initiative for Health Policy and the American Enterprise Institute. Current crisis aside, Dorn said he advocates helping eligible uninsured individuals sign up for coverage when they’re filing their tax returns.

Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy, said that “retroactive enrollment” is the best option. A federal “backstop” program would pay all claims for uninsured people when they receive care, but when filing taxes they would be responsible for paying income-adjusted premiums for the “plan” they used. “It’s the path toward universal coverage that is in my view most feasible,” she said.

Other panelists advocated for a more state-driven approach. One way to accomplish that would be for the federal government to create an incentive program that grants states new tools and authorities to build automatic enrollment programs, according to James Capretta, a visiting fellow at the American Enterprise Institute and senior fellow at the Ethics and Public Policy Center.

During the current pandemic-related economic downturn, one solution could be for states to move people who have lost their employer-based coverage to a comparable Affordable Care Act marketplace plan, suggested Lanhee Chen, a David and Diane Steffy fellow in American public policy studies at the Hoover Institution. “I think certainly that would be a more affordable route than, for example, subsidizing COBRA continuation coverage,” he said.

Perspectives on Surge of Mental Health Meds Use Amid COVID-19

May 28, 2020

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Industry consultants tell AIS Health that they’re not at all surprised that the use of such medications is spiking. And they say that situation creates an urgent opportunity for companies that combine a health insurer with a PBM — like Express Scripts parent company Cigna Corp. and its peers — to leverage their unique insights into members’ health.

“Pharmacies are often the most utilized part of the benefit compared to medical or behavioral, but now, an increase in some pharmacy utilization can actually signal a need to use more of the behavioral benefit,” Peter Manoogian, principal at the health care consulting firm ZS Associates, tells AIS Health.

Rita Numerof, Ph.D., president and founder of the consulting firm Numerof & Associates, says health care organizations should conduct generalized outreach to members that stresses non-pharmaceutical coping mechanisms when appropriate. “Practical guidance, and not looking at this as a mental illness or a mental health issue, in the face of this kind of crisis, is really important,” she tells AIS Health.

For its part, UnitedHealth opened up an emotional support help line and is offering a free on-demand emotional support mobile app called Sanvello to help people “cope with stress, anxiety and depression during the COVID-19 pandemic,” according to a company spokesperson.

Express Scripts, meanwhile, is offering a “digital mental health platform” to its clients at no cost, which “enables members to build resilience and develop skills to better manage stress and sleep issues,” according to Rochelle Henderson, Ph.D., vice president of health services research at the PBM.

Radar On Market Access: COVID-19 Pandemic May Change Rx Delivery Permanently

May 26, 2020

Industry experts expect the COVID-19 pandemic and related economic crisis, in addition to the trend of vertical integration in the PBM sector, will increase those companies’ direct interaction with consumers, AIS Health reported.

Industry experts expect the COVID-19 pandemic and related economic crisis, in addition to the trend of vertical integration in the PBM sector, will increase those companies’ direct interaction with consumers, AIS Health reported.

The recent wave of payer acquisitions of PBMs has kept the latter on strong footing despite the crisis. CVS Health Corp.’s Caremark, UnitedHealth Group’s OptumRx and Cigna Corp.’s Express Scripts control approximately 74% of the market, according to a January 2020 estimate by Drug Channels Institute CEO Adam Fein, Ph.D.

Fein said in a May 8 webinar that he expects the dominant PBMs’ bargaining clout, deepening synergies and cash reserves to drive more aggressive formulary management during the COVID-19 crisis.

Vertical integration has changed the revenue mix of large PBMs. According to Fein, rebates account for a declining amount of profits for the big three PBMs, and they are largely passed through to payer clients.

The vertical integration trend has also helped PBMs adapt to new consumer choices driven by COVID-19, according to Fein. “Mail pharmacies [had] a huge spike [in fills] into March, and right now, mail pharmacy growth has now flatlined again. Retail pharmacy has taken a very big hit. Once the lockdown started to go into effect, [retail] prescriptions started to decline because people couldn’t get to the retail pharmacy,” Fein said.

Still, he is skeptical about the durability and scale of the consumer shift away from retail toward mail order.

“[Mail order] gained a little, but it’s not some runaway shift in the market,” Fein explained, citing its still-small share of the overall prescription drug market. “The notion of a retail-to-mail shift — it’s going to happen, but it may not last too much longer. So for PBMs, it’s a short-term boost, but perhaps not a long-term shift.”

However, Mike Schneider, a principal at Avalere Health, says that he’s bullish on the trend toward mail order. Schneider says consumers with chronic conditions and long-term medications are likely to stick with mail-order fills — assuming they are still available after the pandemic ends. The key to continuing that trend, he adds, is whether seniors, the largest demographic group of prescription drug users, take a liking to the mail order system.

MMIT Reality Check on Low Testosterone (May 2020)

May 22, 2020

According to our recent payer coverage analysis for low testosterone treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for low testosterone treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for low testosterone treatments shows that under the pharmacy benefit, about 58% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In February 2020, Clarus Therapeutics, Inc. said that its Jatenzo (testosterone undecanoate) is available by prescription in the U.S. In March 2019, the FDA approved the medication for the treatment of males with low testosterone levels because of specific genetic disorders or pituitary glanddamaging tumors.

Trends That Matter for Medical-Benefit Drug Spending

May 21, 2020

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

“The increase in medical pharmacy spend seems to largely be driven by inflation,” Kristen Reimers, Magellan’s senior vice president of specialty clinical solutions, tells AIS Health. “This can be a combination of two things, increasing costs of existing drugs and providers utilizing newer more expensive drugs. The pipeline was extremely robust and new therapies to market are contributing to inflation, driving the trend.”

According to the report, new oncology therapies are both emblematic and a primary driver of growth in drug prices. A new generation of highly effective, biologic oncology drugs have emerged in the last decade. However, these pioneering drugs are expensive. According to the report, oncology drugs and the drugs needed to support them accounted for 43% of per-patient per-month medical pharmacy spending for commercial carriers.

Like other biologic drugs, most biologic oncology drugs have yet to see significant biosimilar competition due to barriers in the biosimilar market and development pipeline.

“The most exciting biosimilars are those currently in the oncology space. Herceptin, Avastin and Rituxan have been the top five drugs in terms of spend for the last 10 years,” says Reimers. “Rituxan and Avastin now have two biosimilars on the market, and Herceptin has five marketed products. There will be competition, which will help to flatten the trend for these products, although there is still expected to be growth.”

Radar On Market Access: COVID-19 Pandemic Drives Home Infusion Utilization

May 21, 2020

With numerous hospitals focused on the COVID-19 pandemic and many areas under stay-at-home mandates, home infusion is more important than ever. Changes within the industry already have been seen, and the current situation is likely to result in permanent shifts within the home infusion space, AIS Health reported.

With numerous hospitals focused on the COVID-19 pandemic and many areas under stay-at-home mandates, home infusion is more important than ever. Changes within the industry already have been seen, and the current situation is likely to result in permanent shifts within the home infusion space, AIS Health reported.

“If you can do infusion at home, you need to do it there,” maintains Ashraf Shehata, KPMG national sector leader for Healthcare & Life Sciences. “This is about controlling infection risk in the near term, and many home infusion candidates are in a high-risk category. Longer term, there has been a shift toward delivering care in the most economical and clinically appropriate setting, largely driven by payers.”

“We have seen an increase in some home infusion utilization of select therapies in certain markets where patient administration sites of care are shifting from the acute care or hospital outpatient setting to the home, related to the pandemic,” says Drew Walk, CEO of Soleo Health.

Some plans already have been shifting administration of certain therapies to patient homes and provider offices, which are more cost-effective settings than hospitals, points out Elan Rubinstein, Pharm.D., EB Rubinstein Associates.

“There could be more home infusion, with drugs that pose low risk of serious adverse events during or immediately after infusion or where a patient tolerated prior infusions of these drugs with no or minimal difficulty,” says Rubinstein.

Lisa Kennedy, Ph.D., chief economist and managing principal at Innopiphany LLC, points out that while CMS has changed some policies in support of home infusion, “not everyone is on board.” She notes that the Community Oncology Alliance “has raised safety concerns about home infusion centered on a lack of training of those in the community administering treatment at home versus trained oncology nurses.”

“Going forward there will be a lot of candidates for home infusion, and some customers/patients may like the convenience of getting care at home,” says Shehata. “There might be opportunities for alternative care models to be introduced here. The ability for nurses to teach patients how to self-administer the medicines is an important facet to this.”

Radar On Market Access: PBMs See Solid 1Q Results Despite Challenges Ahead

May 19, 2020

Major PBMs reported strong results for the first quarter of 2020 as members rushed to fill prescriptions in March ahead of the COVID-19 pandemic. However, financial analysts warn the pandemic could have unpredictable effects on PBMs’ finances for the rest of 2020 and moving into 2021, AIS Health reported.

Major PBMs reported strong results for the first quarter of 2020 as members rushed to fill prescriptions in March ahead of the COVID-19 pandemic. However, financial analysts warn the pandemic could have unpredictable effects on PBMs’ finances for the rest of 2020 and moving into 2021, AIS Health reported.

The 2021 PBM selling season could be disrupted in still-unknown ways, analysts said, and members are cutting back on routine physician visits and elective procedures, resulting in lower script volume overall.

Anthem, Inc., posted a particularly strong start for its new IngenioRx PBM, with earnings of $349 million, well above the $275 million to $300 million quarterly earnings that had been expected.

The impact from COVID-19 included a large spike in prescription refills during March, which helped the PBM’s performance, Anthem Executive Vice President and CFO John Gallina said in the company’s earnings conference call. Still, investors shouldn’t expect script numbers to remain elevated, he added: “We have seen a slight drop in new scripts here in April over historical patterns.”

CVS Health Corp. reported first-quarter earnings per share (EPS) of $1.91, well above what analysts had anticipated. Citi analyst Ralph Giacobbe wrote in a May 6 investor note that the company’s Caremark PBM “put up solid results with revenue and operating profit also exceeding consensus with higher claims growth of 12.4%.” This was “aided by pull-forward of scripts due to COVID-19,” plus the partnership between CVS and Anthem on IngenioRx.

Cigna Corp.’s first-quarter adjusted EPS came in 8% above consensus, with better-than-anticipated performances in its Health Services unit, which houses PBM Express Scripts, and in its Integrated Medical segment. Health Services reported an operating profit of $1.08 billion, slightly ahead of expectations, with revenue well ahead of projections — $27.2 billion versus $25.1 billion expected, noted Giacobbe.

At UnitedHealth Group, earnings for Optum, the division that includes OptumRx, missed analysts’ expectations by about 5%, despite stronger-than-expected revenue, Jefferies equities analyst David Windley wrote in a note to investors. “OptumHealth and OptumRx both contributed to the underperformance,” which was offset by stronger-than-expected performance by OptumInsight, he said.

MMIT Reality Check on Pain Narcotic Opioid (May 2020)

May 15, 2020

According to our recent payer coverage analysis for pain narcotic opioid treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for pain narcotic opioid treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for pain narcotic opioid treatments shows that under the pharmacy benefit, about 35% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Many brand name products (Xtampza ER, Oxaydo) continue to enter this market despite the numerous generics. Given assumed parity in efficacy among remaining name-brand products, contracting for position after a generic is common.

Perspectives on Coronavirus Antibody Testing

May 14, 2020

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

“It’s not exactly a surprise, [but] I don’t know that it was 100% expected,” Jason Karcher, a Milliman Inc. actuary, tells AIS Health regarding the requirement. “It seems like as much a point of clarification rather than a ‘hey, we’re going to require something totally out of the blue.'”

So far, at least serological tests have received an Emergency Use Authorization from the FDA.

Cost information is not as readily available for serological tests as it is for tests that diagnose COVID-19, which cost around $51 until CMS increased the reimbursement rate for “high-throughput” diagnostic tests to $100. Cellex, which makes one of the antibody tests that received emergency authorization by the FDA, did not respond to an inquiry about the price of its test as of press time, but Vox reported that “a serological test can be less than $10.”

William Schaffner, M.D., a professor of preventive medicine and infectious diseases at Vanderbilt University, says there are good reasons to temper expectations about how testing people for COVID-19 antibodies could help the U.S. reopen businesses, schools and events.

Since the FDA is essentially allowing companies to do their own evaluation of serological tests’ effectiveness, that will naturally invite questions about whether their results can be trusted, Schaffner says, suggesting that some tests may be more rigorously evaluated than others. “Then there’s the question of availability of the tests — we’ve been down this road once before, where people were told that the nasal swab test for the virus itself would be widely available, and anybody can have it who wants it,” he says. “Well, we’re still struggling with that, and we would like not to repeat that fiasco.”

Radar On Market Access: COVID-19 May Drive More Insurers Into ACA Exchanges

May 14, 2020

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

As the impact of the COVID-19 pandemic continues to reverberate throughout the U.S. economy, it’s become clear that there will be a major enrollment shift away from employer-sponsored plans and into Medicaid and the individual market, AIS Health reported.

In fact, one recent analysis suggested that there could be “unprecedented growth” in the individual health insurance market. “The impact of COVID-19-related job losses will likely more than double the current enrollment in Individual & Marketplace plans, with the potential for the Individual market to triple in size to over 35 million in a sustained and severe economic contraction,” stated the analysis from A2 Strategy Group.

Such growth, the report said, “will come from newly unemployed individuals in all states who exceed Medicaid eligibility thresholds” because of money they receive from the Coronavirus Aid, Relief, and Economic Security Act. And in states that haven’t expanded Medicaid, nearly all of the newly unemployed who earn below 100% of the federal poverty level could qualify for Affordable Care Act premium subsidies.

Another analysis from the Urban Institute and Robert Wood Johnson Foundation (RWJF), estimated that if U.S. unemployment reaches 20%, 25 million people would lose employer-sponsored health insurance. “Of these, 11.8 million would gain Medicaid coverage, 6.2 million would gain marketplace or other private coverage, and 7.3 million would become uninsured,” it stated.

Katherine Hempstead, the senior adviser to the executive vice president at RWJF, says it’s possible the coming enrollment shifts will cause some health insurers to re-evaluate their level of participation in the ACA exchanges, which some large insurers left in 2017 and 2018 before the market stabilized.

In fact, Maryland Gov. Larry Hogan (R) said on May 12 that UnitedHealth filed to offer plans on the sate’s ACA exchange in 2021, bringing the total number of insurers in that market from two to three.

Ari Gottlieb, a principal at A2 Strategy Group, says the effect may be even stronger after 2021.

“If the market doubles to 25 or 30 million, some of that will probably fall off, but some of that will probably stay,” he says. “I think even a year or two from now, we’re going to have a bigger individual market than we had before.”

Radar On Market Access: CVS Sees COVID Testing Sites as Part of Bigger HealthHUB Strategy

May 12, 2020

Since acquiring Aetna, CVS Health Corp. has touted its HealthHUB stores — which include expanded clinics, labs for health screening and space for wellness pursuits — as the linchpin of its plan to stand out among other large, diversified firms that include a health insurer. Yet as one analyst pointed out during CVS’s first-quarter 2020 earnings call on May 6, that strategy could face new challenges amid the COVID-19 pandemic when many people are reluctant to venture outside their homes.

Since acquiring Aetna, CVS Health Corp. has touted its HealthHUB stores — which include expanded clinics, labs for health screening and space for wellness pursuits — as the linchpin of its plan to stand out among other large, diversified firms that include a health insurer. Yet as one analyst pointed out during CVS’s first-quarter 2020 earnings call on May 6, that strategy could face new challenges amid the COVID-19 pandemic when many people are reluctant to venture outside their homes.

CVS executives said that while the company is indeed seeing less foot traffic at its brick-and-mortar locations, it is still leveraging the power of having a vast retail footprint by offering testing for the new coronavirus, AIS Health reported.

The firm teamed up with federal, state and local governments to open “large-scale diagnostic testing sites across five states,” according to a slide deck that accompanied CVS’s earnings presentation. As of May 4, the company had administered nearly 90,000 tests, and it is planning to establish additional testing sites.

As CEO Larry Merlo put it: “We’re focused on COVID testing today, but there is a broader universe of diagnostics and monitoring that we see becoming an important part of our HealthHUB strategy.”

Merlo also pointed out that virtual visits through the company’s MinuteClinic platform rose 600% in the first three months of 2020 compared with the prior-year quarter. Retail prescription home delivery increased more than 1,000% and specialty pharmacy digital refills jumped about 50%.

The effects of the COVID-19 crisis weren’t all rosy, however. Jonathan Roberts, CVS’s executive vice president and chief operating officer, acknowledged that “the biggest headwind we’re seeing now in pharmacy is really around new therapy starts.” Because doctor visits have decreased significantly, CVS saw at least a 25% dip in new prescriptions in April compared with the same month in 2019, whereas it normally sees about 7% growth.

Overall in the quarter, CVS recorded adjusted earnings per share (EPS) of $1.91, “well above” the Wall Street consensus of $1.62, as Citi analyst Ralph Giacobbe highlighted in a May 6 investor note. Total revenues increased 8.3% in the first quarter of 2020 compared with the prior-year quarter.

MMIT Reality Check on Anemia — Chronic Kidney Disease (May 2020)

May 8, 2020

According to our recent payer coverage analysis for anemia treatments due to chronic kidney disease, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for anemia treatments due to chronic kidney disease, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for anemia treatments due to chronic kidney disease shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In November 2019, AstraZeneca said its FibroGen-partnered drug roxadustat, an oral first-in-class drug to treat anemia in patients with chronic kidney disease, demonstrated positive results in its Phase III trial.

Trends That Matter for Biosimilar Medications Cost Savings

May 7, 2020

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

“We could see and empirically prove that patients…tended to be better off if they were on the biosimilar,” Mariana Socal, a physician and researcher at the Johns Hopkins Bloomberg School of Public Health and one of the study’s authors, tells AIS Health. “They had lower out-of-pocket costs when they were on the biosimilar.”

While 16 biosimilars have earned FDA approval, according to the report, most of those drugs are the only biosimilar in their category, creating a duopoly price structure rather than robust market competition with at least three drugs.

Per the report, multiple biosimilars have entered the market for only two drugs, Remicade (infliximab) and Neupogen (filgrastim). The report concludes that, in those categories, biosimilar competition has generated remarkable cost savings and has the potential to generate much more through increased biosimilar use.

For infliximab, the reference biologic Remicade currently has the most covered lives among commercial formularies, while for filgrastim, Zarxio (a biosimilar for Neupogen) is the leader in market access, according to MMIT data.

Radar On Market Access: Anthem, Cigna Brace for Recession-Induced Enrollment Shift

May 7, 2020

Anthem, Inc., and Cigna Corp. both reported slightly better-than-expected medical loss ratios (MLRs) as part of their first-quarter 2020 earnings, in part due to delays in elective procedures resulting from the COVID-19 pandemic. Both insurers also reaffirmed their overall earnings-per-share (EPS) guidance for 2020, AIS Health reported.

Anthem, Inc., and Cigna Corp. both reported slightly better-than-expected medical loss ratios (MLRs) as part of their first-quarter 2020 earnings, in part due to delays in elective procedures resulting from the COVID-19 pandemic. Both insurers also reaffirmed their overall earnings-per-share (EPS) guidance for 2020, AIS Health reported.

But the insurers warned that MLRs may tick up later this year. In addition, they predicted that the impact of COVID-19 may lead to significant shifts in enrollment, as workers who are laid off shift to Medicaid or to the Affordable Care Act exchanges.

Anthem posted a first-quarter MLR of 84.2%, slightly better than the consensus estimate of 84.3%, “likely aided to a limited degree by COVID-19 toward the latter part of the quarter,” Citi analyst Ralph Giacobbe pointed out in an investor note.

Anthem’s second-quarter MLR “should be historically low” due to delayed procedures, but that will be offset by a rebound in volumes, buyback suspension and low net interest/investment income during the second half of the year, Jefferies equities analyst David Windley wrote in an investor note.

Anthem management indicated that 40% to 50% of disenrolled commercial lives will move to Medicaid, while 30% will move into individual health insurance, Windley wrote. “However, this creates an unfavorable mix,” with lower per-member per-month payments, especially in Medicaid, and a move to lower-margin products, he noted.

Meanwhile, Cigna reported an MLR of 78.3%, compared with analysts’ consensus estimate of 79.3%, Giacobbe pointed out in an investor note. Cigna is maintaining its 2020 guidance for EPS and revenue, while dropping its outlooks for MLR and other specific financial metrics.

“The impact of COVID-19 is still developing,” Cigna President and CEO David Cordani said April 30. “We clearly see headwinds driven by the recession that it’s causing, including, for example, disenrollment within our commercial customers, both in our integrated medical business [and] our health service business, as well as some pressure in our group disability business.”

However, Cigna expects “the strength of our first quarter to drive us to another strong year for revenue, earnings and free cash flow,” he added.

Radar On Market Access: Humana, Centene Maintain 2020 Earnings Outlook Amid COVID-19 Pandemic

May 5, 2020

Humana Inc. and Centene Corp. are both maintaining their 2020 earnings outlook despite the emergence of the COVID-19 pandemic and economic contraction at the end of the first quarter, AIS Health reported.

Humana Inc. and Centene Corp. are both maintaining their 2020 earnings outlook despite the emergence of the COVID-19 pandemic and economic contraction at the end of the first quarter, AIS Health reported.

Humana’s revenues increased to $18.9 billion, and it reported $5.40 in adjusted earnings per share (EPS), beating the Wall Street consensus of $4.66 adjusted EPS. Centene’s first quarter revenues increased 41% year-over-year to $26 billion, and it reported an adjusted EPS of $0.86. Centene fell short of the consensus with $0.99 adjusted EPS. Both insurers affirmed their projections for the end of the year, with Humana forecasting adjusted EPS of $18.25 to $18.75 and Centene $4.56 to $4.76.

But both companies warned that the pandemic and recession presented substantial risk, and noted that utilization could spike in the latter half of 2020 due to pent-up demand. They also reported that utilization dropped toward the end of the first quarter, and anticipated the same result for the second.

Analysts were cautiously optimistic about both firms’ outlook for the rest of the year. “We believe that Humana boasts a compelling growth opportunity in the increasingly appealing [Medicare Advantage] market. Furthermore, the company also has an opportunity to drive margins given a potentially more favorable reimbursement environment and the maturation of its high-growth member base,” Oppenheimer’s Michael Wiederhorn wrote in an April 29 note.

Despite Centene’s seemingly less impressive results, analysts were positive or neutral about the firm’s first-quarter performance.

Windley wrote in an April 28 note regarding Centene that “we aren’t expecting ridiculously low 2Q [medical loss ratios] as management guards against an increase in utilization and claims severity. That said, the delay in procedures and incremental revenue from higher Medicaid/[health exchange] membership helps absorb new headwinds such as slower WellCare synergy capture, COVID-19 treatment costs, and adverse impacts on investment income/interest expense.”

Though Centene’s results were less robust than Humana’s, the company indicated it is in a strong position for the remainder of the year. The company has a large Medicaid managed care book, and Medicaid enrollment is certain to spike due to layoffs caused by the COVID-19 pandemic.

MMIT Reality Check on Ophthalmic Anti-Inflammatory (Apr 2020)

May 1, 2020

According to our recent payer coverage analysis for ophthalmic anti-inflammatory treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ophthalmic anti-inflammatory treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ophthalmic anti-inflammatory treatments shows that under the pharmacy benefit, almost 57% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In March 2020, Noveome Biotherapeutics said it will evaluate its ST266, a first-of-its-kind cell-free platform biologic drug that was initially developed for ophthalmology indications, as a potential treatment of severe cytokine storm associated with COVID-19.

Perspectives on ACA and Medicaid Enrollment Growth Amid COVID-19

April 30, 2020

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

“This would be the first recession since the Affordable Care Act went into effect, so we are in somewhat uncharted territory in terms of what might happen in a recession under both the ACA marketplace and the Medicaid expansion,” Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, said during a March 18 conference call with reporters.

Levitt said the ACA marketplace is likely to see rapid growth in enrollment as workers lose jobs or hours, making them eligible for special enrollment periods in some cases.

“Household income is going to tend to fall, and that will put more people into that lowest income category with the broadest enrollment in the ACA marketplace,” Levitt said. That influx of enrollees, he added, “has the potential to improve the risk pool in the ACA marketplace and shouldn’t, by itself, have a big effect on premiums.”

Meanwhile, “as people lose their jobs and their incomes fall below 138% of poverty in those states that have expanded Medicaid, we’re likely to see growth in Medicaid enrollment — as we typically do during recessions,” Levitt said.

“Medicaid traditionally has been countercyclical….It’s an economic balancer,” says David Anderson, a health policy researcher at Duke University’s Margolis Center for Health Policy. “In 2009 [during the last economic recession], the federal government raised the federal payment rate — the federal share of Medicaid — by 6.2 points. What that did is it gave states breathing room in their budget…That extra federal share takes a little bit of pressure off the rest of the state budget.”

To that end, President Donald Trump on March 18 signed the Families First Coronavirus Response Act, which, among a host of other provisions, temporarily increased the Medicaid federal medical assistance percentage by 6.2 points.

Radar On Market Access: Oncology Drugs Drive Price Growth in Medical-Benefit Spend

April 30, 2020

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

Spending on prescription drugs that are covered under the medical benefit increased by 65% between 2014 and 2018 for commercial insurers and 40% for Medicare, according to Magellan Rx Management’s annual Medical Pharmacy Trend Report.

“The increase in medical pharmacy spend seems to largely be driven by inflation,” Kristen Reimers, Magellan’s senior vice president of specialty clinical solutions, tells AIS Health. “This can be a combination of two things, increasing costs of existing drugs and providers utilizing newer more expensive drugs. The pipeline was extremely robust and new therapies to market are contributing to inflation, driving the trend.”

According to the report, new oncology therapies are both emblematic and a primary driver of growth in drug prices. A new generation of highly effective, biologic oncology drugs have emerged in the last decade. However, these pioneering drugs are expensive. According to the report, oncology drugs and the drugs needed to support them accounted for 43% of per-patient per-month medical pharmacy spending for commercial carriers.

Like other biologic drugs, most biologic oncology drugs have yet to see significant biosimilar competition due to barriers in the biosimilar market and development pipeline.

“The most exciting biosimilars are those currently in the oncology space. Herceptin, Avastin and Rituxan have been the top five drugs in terms of spend for the last 10 years,” says Reimers. “Rituxan and Avastin now have two biosimilars on the market, and Herceptin has five marketed products. There will be competition, which will help to flatten the trend for these products, although there is still expected to be growth.”

Emerging competition could bolster the already-improving price outlook for more established biologic drugs. However, growth in oncology spending is not likely to stop any time soon. In some ways, this is good news for patients: according to Reimers and the Magellan report, promising new, targeted therapies for hard-to-treat cancers will account for much of the increased spending in coming years.

“The pipeline for oncology is extremely robust, with over 700 drugs being studied for a variety of different cancer types,” Reimers says.

Radar On Market Access: PBMs Say Use of Mental Health Meds Surges Amid COVID-19

April 28, 2020

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Newly released data from Express Scripts shows that the number of prescriptions filled per week for antidepressants, anti-anxiety and anti-insomnia medications combined jumped 21% between mid-February and mid-March — reaching a zenith during the week ending March 15, when the COVID-19 outbreak officially reached pandemic status. And analytics from UnitedHealth Group’s OptumRx showed prescription increases of 15% for anti-anxiety medications, 14% for antidepressants and 5% for anti-insomnia medications during the month of March.

Industry consultants tell AIS Health that they’re not at all surprised that the use of such medications is spiking. And they say that situation creates an urgent opportunity for companies that combine a health insurer with a PBM — like Express Scripts parent company Cigna Corp. and its peers — to leverage their unique insights into members’ health.

“Pharmacies are often the most utilized part of the benefit compared to medical or behavioral, but now, an increase in some pharmacy utilization can actually signal a need to use more of the behavioral benefit,” Peter Manoogian, principal at the health care consulting firm ZS Associates, tells AIS Health.

Rita Numerof, Ph.D., president and founder of the consulting firm Numerof & Associates, says health care organizations should conduct generalized outreach to members that stresses non-pharmaceutical coping mechanisms when appropriate. “Practical guidance, and not looking at this as a mental illness or a mental health issue, in the face of this kind of crisis, is really important,” she tells AIS Health.

For its part, UnitedHealth opened up an emotional support help line and is offering a free on-demand emotional support mobile app called Sanvello to help people “cope with stress, anxiety and depression during the COVID-19 pandemic,” according to a company spokesperson.

Express Scripts, meanwhile, is offering a “digital mental health platform” to its clients at no cost, which “enables members to build resilience and develop skills to better manage stress and sleep issues,” according to Rochelle Henderson, Ph.D., vice president of health services research at the PBM.

MMIT Reality Check on Juvenile Idiopathic Arthritis (Apr 2020)

April 24, 2020

According to our recent payer coverage analysis for juvenile idiopathic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for juvenile idiopathic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for juvenile idiopathic arthritis treatments shows that under the pharmacy benefit, about 70% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In November 2019, the FDA approved Pfizer Inc.’s Abrilada (adalimumab-afzb) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. It is the fifth biosimilar of AbbVie Inc.’s Humira (adalimumab) that the agency has approved.

Trends That Matter for Bipolar Disorder Medications

April 23, 2020

A recently approved brand drug for bipolar disorder will have little impact on how health plans cover these medications, experts tell AIS Health. Health plans will continue to encourage the use of less expensive generic bipolar drugs.

A recently approved brand drug for bipolar disorder will have little impact on how health plans cover these medications, experts tell AIS Health. Health plans will continue to encourage the use of less expensive generic bipolar drugs.

The brand drug, Allergan plc’s Vraylar (cariprazine), was approved by the FDA to treat depressive episodes associated with bipolar 1 disorder in adults. It is an oral, once-daily atypical antipsychotic.

Health plans employ several utilization management techniques for bipolar drugs, according to Mesfin Tegenu, R.Ph., president of PerformRx. Some examples include prior authorization, duplicate therapy edits, age restrictions and step therapy.

For Vraylar, health plans will use prior authorization or steps to encourage the use of a generic bipolar drug first, Michael Schneider, a principal at Avalere Health, tells AIS Health. There also could be some higher out-of-pocket costs for Vraylar even when compared to some of the other branded antipsychotic drugs.

Vraylar is in a protected drug class on the Medicare side, Schneider says. Because it is the first brand drug of a particular chemical entity, plans have to cover it. In some Medicare plans, Vraylar is disadvantaged because even through it is in a protected class, there are still utilization management techniques placed on the product, as well as higher cost sharing, he says.

In Medicaid, many states require all the antipsychotic bipolar drugs to be on the formulary with no utilization management, Schneider adds.

The graphic below show how bipolar disorder medications are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.

Radar On Market Access: Medicaid MCOs Are Likely to See COVID-Related Enrollment Growth

April 23, 2020

As the COVID-19 pandemic continues to dominate the news cycle, headlines related to rising unemployment often underscore the impact to Medicaid, but what about the Medicaid managed care organizations that will absorb the newly jobless and uninsured?

As the COVID-19 pandemic continues to dominate the news cycle, headlines related to rising unemployment often underscore the impact to Medicaid, but what about the Medicaid managed care organizations that will absorb the newly jobless and uninsured?

“I think that Medicaid MCOs are clearly in the best position to handle the influx of folks,” remarks Jerry Vitti, founder and CEO of Healthcare Financial, Inc. While onboarding a wave of new members may put some initial stress on plans, the real “strain” will come from covering new members who have unmet health care needs, he tells AIS Health.

Vitti says new enrollees will likely fall into one of two buckets. “One is the previously insured folks who had commercial insurance before they lost their job and have been in the health care system,” he observes. This is not likely to be a “super high-demand population.” But the second grouping, previously uninsured individuals who may end up enrolling as awareness goes up and barriers to enrollment go down, are likely to have “pent-up and untreated medical [needs] and substance use issues,” he predicts.

“I’m hearing from plans I’ve worked with that on both the MA and the Medicaid side…their [medical loss ratios] have dropped substantially,” says Jeff Myers, senior vice president, reimbursement strategy and market access with Catalyst Health Care Consulting. “And though I think their net income is certainly looking up, that means they’re busy strengthening their capital position for what they expect to be the next phase, which is a big enrollment spike on both the [Affordable Care Act] marketplace and Medicaid programs.”

Myers points out that this is usually the time when managed care rate negotiations would begin with states. “I think the challenge for the few state folks I’ve talked to is modeling out, in states with extensive managed care programs, what that influx of people is going to look like given what the unemployment rate may look like, and also given whether they’ve expanded [Medicaid] or not,” he adds.

For states whose budgets have been stretched thin by COVID-19 testing and presumptive eligibility determinations to guarantee payments to hospitals, the pandemic could be the driving factor in expanding Medicaid where a legislature has historically blocked it. Or it may result in states seeking to expand federal Medicaid funding rather than limit it through block grants, suggests Myers.

Radar On Market Access: Insurers Are Now Required to Cover Coronavirus Antibody Testing

April 21, 2020

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.

“It’s not exactly a surprise, [but] I don’t know that it was 100% expected,” Jason Karcher, a Milliman Inc. actuary, tells AIS Health regarding the requirement. “It seems like as much a point of clarification rather than a ‘hey, we’re going to require something totally out of the blue.'”

So far, at least serological tests have received an Emergency Use Authorization from the FDA.

Cost information is not as readily available for serological tests as it is for tests that diagnose COVID-19, which cost around $51 until CMS increased the reimbursement rate for “high-throughput” diagnostic tests to $100. Cellex, which makes one of the antibody tests that received emergency authorization by the FDA, did not respond to an inquiry about the price of its test as of press time, but Vox reported that “a serological test can be less than $10.”

William Schaffner, M.D., a professor of preventive medicine and infectious diseases at Vanderbilt University, says there are good reasons to temper expectations about how testing people for COVID-19 antibodies could help the U.S. reopen businesses, schools and events.

Since the FDA is essentially allowing companies to do their own evaluation of serological tests’ effectiveness, that will naturally invite questions about whether their results can be trusted, Schaffner says, suggesting that some tests may be more rigorously evaluated than others. “Then there’s the question of availability of the tests — we’ve been down this road once before, where people were told that the nasal swab test for the virus itself would be widely available, and anybody can have it who wants it,” he says. “Well, we’re still struggling with that, and we would like not to repeat that fiasco.”

MMIT Reality Check on Acute Myeloid Leukemia (Apr 2020)

April 17, 2020

According to our recent payer coverage analysis for acute myeloid leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for acute myeloid leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for acute myeloid leukemia treatments shows that under the pharmacy benefit, about 65% and 80% of the lives under commercial and Medicare formularies are covered with utilization management restrictions.

Trends: In June 2019, Daiichi Sankyo Company, Ltd. said that the FDA had issued a complete response letter (CRL) for its new drug application (NDA) for quizartinib for the treatment of adults with R/R FLT3-internal tandem duplications acute myeloid leukemia.

Perspectives on COVID-19 Outbreak’s Impact on Drug Supply

April 16, 2020

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

“We are told at this point that we’re not seeing any [drug] shortages in the marketplace today,” says Kelly McGrail-Pokuta, Prime Therapeutics’ vice president of pharmaceutical trade.

On Feb. 27, FDA Commissioner Stephen Hahn released a statement that said disruptions to the pharmaceutical supply chain have been minimal so far. The statement also said that the FDA was especially focused on 20 manufacturers that are particularly dependent on operations in China, and found that “none of these firms have reported any shortage to date.”

But on March 10, the FDA postponed all inspections of overseas drug manufacturing facilities “through April, effective immediately,” according to another statement released by Hahn.

During a pandemic, the CDC recommends anyone taking prescription medication to manage a chronic condition keep an expanded supply of their medicine on hand. As more people self-isolate, and consumers seek to spend less time in stores and other public places, demand for backup medication is likely to increase.

Mike Schneider, a principal at Avalere Health who previously worked for CVS Caremark, says PBMs and payers will have to rethink their typical posture toward chronic medication as enrollees stock up in anticipation of self-isolation.

“Hopefully, with everything going on related to coronavirus and people wanting to stock up, those quantity limits would be eased or eliminated for the most part for chronic meds,” says Schneider.

The Blue Cross Blue Shield Association’s “network of 36 independent and locally operated” affiliates have all decided to waive prescription refill limits on maintenance medications, according to America’s Health Insurance Plans. Other non-Blues insurers have also taken steps to allow members to refill prescriptions in advance.

Experts say it’s difficult to know whether the drug supply will be affected down the road. Schneider says consumer stockpiling and the FDA’s move to suspend foreign inspections could both make an impact on future supply.

Radar On Market Access: Slow Biosimilar Adoption and Opaque Markets Impede Potential Savings

April 16, 2020

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

Biosimilar medications can offer meaningful cost savings for payers, but market and regulatory barriers are still preventing them from realizing their full economic potential, according to a March 31 Johns Hopkins University study funded by the ERISA Industry Committee.

“We could see and empirically prove that patients…tended to be better off if they were on the biosimilar,” Mariana Socal, a physician and researcher at the Johns Hopkins Bloomberg School of Public Health and one of the study’s authors, tells AIS Health. “They had lower out-of-pocket costs when they were on the biosimilar.”

While 16 biosimilars have earned FDA approval, according to the report, most of those drugs are the only biosimilar in their category, creating a duopoly price structure rather than robust market competition with at least three drugs.

Per the report, multiple biosimilars have entered the market for only two drugs, Remicade (infliximab) and Neupogen (filgrastim). The report concludes that, in those categories, biosimilar competition has generated remarkable cost savings and has the potential to generate much more through increased biosimilar use.

Socal says she believes opaque markets are to blame for biologics’ limited impact on drug markets at scale.

“When we looked at [the study companies’] formularies and their utilization, we were surprised to see that even within the same company, they had such a remarkable diversity in terms of biosimilar market share, in terms of the prices they were paying, and how much biosimilars they were able to use,” Socal says. She adds that PBMs should do more to inform their clients about the potential savings from higher biosimilar use in formularies.

Steve Cutts, head of specialty pharmacy for the PBM Magellan Rx Management, says that Magellan makes an overt effort to tell clients about the potential price savings from biosimilars.

Cutts says that many biologics are administered through a medical benefit, rather than a pharmacy benefit. That claims structure could explain some of the limited visibility of biosimilar substitution opportunities for plan administrators designing formularies, and would require coordination with providers to be addressed.

Radar On Market Access: PBMs Use Dispensing Limits to Halt Hoarding of Trump-Touted Malaria Drugs

April 14, 2020

With the death toll from COVID-19 continuing to rise in the U.S., President Donald Trump and some of his advisers have repeatedly touted the promise of anti-malarial drugs to combat the disease caused by the novel coronavirus. That enthusiasm has sparked increasing concern that the surge in demand for such drugs, hydroxychloroquine and chloroquine, is imperiling access for patients who take them to treat autoimmune conditions such as lupus and rheumatoid arthritis, AIS Health reported.

With the death toll from COVID-19 continuing to rise in the U.S., President Donald Trump and some of his advisers have repeatedly touted the promise of anti-malarial drugs to combat the disease caused by the novel coronavirus. That enthusiasm has sparked increasing concern that the surge in demand for such drugs, hydroxychloroquine and chloroquine, is imperiling access for patients who take them to treat autoimmune conditions such as lupus and rheumatoid arthritis, AIS Health reported.

To help alleviate the issue, some major PBMs are placing utilization management controls on off-label use of hydroxychloroquine, chloroquine and other drugs with the potential to treat COVID-19.

CVS Health Corp.’s Caremark unit is placing “appropriate limits” on the quantity of medicines including hydroxychloroquine, the antibiotic azithromycin, one type of protease inhibitor used to treat HIV, and albuterol inhalers that are approved to treat asthma, per a news release. UnitedHealth Group’s OptumRx s limiting prescriptions for hydroxychloroquine and chloroquine to 30 tablets within a 90-day time period, “with an automatic bypass for members utilizing for chronic conditions such as rheumatoid arthritis or systemic lupus,” says Chief Medical Officer Sumit Dutta, M.D. And Prime Therapeutics, LLC, the PBM owned by 18 Blue Cross Blue Shield plans, tells AIS Health that it’s taking similar measures.

“These measures have been effective in controlling the surge in demand that occurred in the first two weeks of March,” for hydroxychloroquine and chloroquine, says Marc Guieb, Pharm.D., a consultant with Milliman, Inc. But with some plans reporting significant spikes in utilization for the medicines, “the alarming question that we should be wondering is, ‘How were patients getting so many prescriptions for these drugs in the first place?'” he tells AIS Health via email.

Results from two small studies — one in China and one in France — have fueled interest in the use of hydroxychloroquine and chloroquine to treat COVID-19, but more evidence is needed to determine whether they’ll actually be effective against the disease, says Esther Krofah, executive director of FasterCures at the Milken Institute.

MMIT Reality Check on Opioid Dependence (Apr 2020)

April 10, 2020

According to our recent payer coverage analysis for Opioid Dependence treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Opioid Dependence treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for opioid dependence treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In April 2019, the FDA approved Teva Pharmaceuticals’ generic naloxone nasal spray, an equivalent to Emergent BioSolutions’ Narcan, which can be used to reverse opioid overdoses.

Trends That Matter for Cost Impact of Coronavirus Treatment

April 9, 2020

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

According to the analysis, from the Peterson Center on Healthcare and the Kaiser Family Foundation (KFF), the average total cost — combining employer-plan spending and patient out-of-pocket costs — for a pneumonia-related hospital stay “with major complications and comorbidities” was $20,292 in 2018. For a stay “with complications or comorbidities,” the average cost was $13,767, and for patients without complications, the price tag was $9,763. Looking at out-of-pocket costs alone, the average cost for patients with major complications or comorbidities was $1,300.

But those estimates can only tell us so much about the financial impact of the pandemic, KFF Executive Vice President for Health Policy Larry Levitt said during a March 18 web briefing with reporters.

“We have some information about what the cost for each patient will be, but we have very little information yet about how many patients there may be,” Levitt said in response to a question from AIS Health. “And that’s the big area of uncertainty — how widespread the infection will be and how many people will become severely ill and require hospitalization. So insurers at this point are running blind on how much the total cost may be.”

Generally, regulators do not permit health insurers to recoup prior-year losses through premium increases, “so insurers are going to be focusing a lot on what the ongoing cost” of the coronavirus outbreak could be when pricing their products, Levitt said.

Radar On Market Access: Amid COVID-19 Outbreak, CMS Relaxes Rules on MA Data Collection

April 7, 2020

As efforts to contain the outbreak of COVID-19 continue to evolve, the Trump administration on March 30 issued a series of new flexibilities aimed at increasing hospital and provider capacity. At the same time, CMS in a March 30 memo provided some respite to Medicare Advantage and Part D plans dealing with the crisis by suspending audit and quality reporting activities so that plans and states can focus on providing care to the increasing number of beneficiaries affected by the new coronavirus, AIS Health reported.

As efforts to contain the outbreak of COVID-19 continue to evolve, the Trump administration on March 30 issued a series of new flexibilities aimed at increasing hospital and provider capacity. At the same time, CMS in a March 30 memo provided some respite to Medicare Advantage and Part D plans dealing with the crisis by suspending audit and quality reporting activities so that plans and states can focus on providing care to the increasing number of beneficiaries affected by the new coronavirus, AIS Health reported.

As physicians cater to patients who are or may be infected with COVID-19, and as the federal government advises adults to delay elective surgeries and nonessential procedures during the outbreak, plans are likely to face issues with reporting quality data used to determine future star ratings.

CMS in an interim final rule issued March 30 said it will allow for several key changes to the calculations for the 2021 and 2022 Parts C and D star ratings to account for the expected impact of the public health emergency on data collection and performance.

Up until this point, the potential impact of COVID-19 on CMS’s quality agenda and more specifically quality-based payments to MA plans was a major area of uncertainty for insurers, points out Dan Mendelson, founder of Avalere Health. “The MA quality payment system is based largely on visits that are not possible in a world where COVID-19 has changed the face of American health care, so this program needs to be fundamentally modified for 2021,” says Mendelson. “It appears that CMS still intends to use star ratings, albeit a very different version that relies largely on historical data — which will advantage plans that had a strong prior year.”

But in addition to the interim final rule, more guidance may be needed on the potential impact of COVID-19 on MA payment rates for 2021. And the most important additional guidance that the industry needs, Mendelson says, is for CMS “to allow for telehealth visits to fully substitute for face-to-face visits during this critical and uncertain period of time.”

MMIT Reality Check on COPD (Apr 2020)

April 3, 2020

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for glaucoma treatments shows that under the pharmacy benefit, about 60% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In March 2020, the FDA approved Allergan plc’s Durysta (bimatoprost implant) 10 mcg to treat open-angle glaucoma or ocular hypertension. This is the first intracameral biodegradable sustained-release implant for the indication.

Perspectives on New Generic HIV Drug

April 2, 2020

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved by the FDA in 2004 to treat HIV infection in combination with other antiretroviral drugs. In 2012, it also was approved as the first drug for PrEP. In March 2019, Gilead announced that it had entered into an agreement with Teva Pharmaceutical Industries Ltd. to allow the company to launch its generic version on Sept. 30, 2020.

Payer coverage of PrEP also will be affected by a recommendation from the U.S. Preventive Services Task Force (USPSTF). In 2019, the USPSTF recommended PrEP therapy for those at high risk of HIV acquisition, according to a white paper written by Lynn Nishida, R.Ph., vice president of clinical product and contracting for WithMe Health.

“With the USPSTF recommendation, Medicaid expansion programs and health plans are going to have to cover PrEP without any cost sharing,” says Tim Horn, director of medication access and pricing at the National Alliance of State & Territorial AIDS Directors. Therefore, payers will move toward generic versions.

Dan Mendelson, founder and former CEO of consulting firm Avalere Health, says that whenever a drug goes generic, payers usually have a plan in place to make sure the generic is used. “The more expensive the drug, the more likely that the plan will be comprehensive and aggressive,” he says.

Since HIV is one of the six protected classes in the Medicare Part D program, Part D plans typically cover all HIV products, says Michael Schneider, principal at Avalere Health, as there is little to no rebating in the category. “So, there is really no incentive for the PBMs acting on behalf of their clients, the plans, to do anything in terms of a utilization management standpoint or negotiation standpoint outside of just bringing the generics on formulary.”

Most of the branded HIV products are in the Part D specialty tier, requiring coinsurance, due to their high cost. When a generic comes on the market, plans typically will remove the branded product and then place the generic in the specialty tier or the preferred brand tier depending on the cost of the generic product, he says.

Radar On Market Access: Congress Could Pass Medicare Part D Reform Even Amid COVID-19 Outbreak

March 31, 2020

With the federal government consumed by responding to the COVID-19 outbreak, the possibility of Congress passing drug-pricing legislation might seem dim. But analysts say it’s very possible that something like an overhaul of the Medicare Part D benefit could still make its way into legislation that federal lawmakers pass in the coming weeks or months to address the ongoing public health crisis, AIS Health reported.

With the federal government consumed by responding to the COVID-19 outbreak, the possibility of Congress passing drug-pricing legislation might seem dim. But analysts say it’s very possible that something like an overhaul of the Medicare Part D benefit could still make its way into legislation that federal lawmakers pass in the coming weeks or months to address the ongoing public health crisis, AIS Health reported.

Congress’ latest coronavirus-related stimulus package, which is worth more than $2 trillion, also contains provisions that would extend some Medicare and public health funding. That’s important for those watching drug-price reform because, when Congress failed to include measures addressing surprise medical billing or drug pricing in the budget bill it passed in December, many expected those issues to be addressed in legislation passed by a May 22 deadline to renew certain health care “extenders.”

However, just because the latest stimulus bill wiped out the May deadline, it doesn’t preclude the possibility of Congress passing other health care legislation in the near future that could be a vehicle for drug-pricing measures, Matt Kazan, a principal at Avalere Health, tells AIS Health.

In fact, because so many Americans will be struggling economically in the coming months, the calls for the Trump administration and lawmakers to increase drug affordability will only get “louder and louder,” Andrew Baum, the head of global health care research at Citi, said during a March 24 call with analysts about the effect of the coronavirus on the health care sector.

And it appears that the drug-pricing measure with the greatest chance of passing is an overhaul of the Medicare Part D benefit, Miryam Frieder, a practice director at Avalere Health, said during a recent webinar hosted by the consultancy. It’s the one provision in drug-pricing legislation Congress has considered in the past year that both political parties largely agree on, she pointed out.

Michael Schneider, a principal at Avalere, added that Part D plans need to be prepared for the benefit to get a makeover.

“This is just going to mean that plans are going to have to look at their membership and some other factors and start to decide how they’re going to overcome that additional liability without premiums going through the roof,” Schneider said.

MMIT Reality Check on Glaucoma (Mar 2020)

March 27, 2020

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for glaucoma treatments shows that under the pharmacy benefit, about 60% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In March 2020, the FDA approved Allergan plc’s Durysta (bimatoprost implant) 10 mcg to treat open-angle glaucoma or ocular hypertension. This is the first intracameral biodegradable sustained-release implant for the indication.

Trends That Matter for Asthma Medications

March 26, 2020

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

Every member with asthma should have an asthma action plan, says Karen Meyerson, director of commercial care management at Michigan-based Priority Health. Such a plan, which is completed by a patient’s doctor, should include a medication list, tips on recognizing worsening symptoms and steps for responding in an emergency.

Priority Health members can also use a cost-estimator tool to shop for the lowest-cost drugs. For example, members can use the tool to discover a less-expensive generic drug and a pharmacy where their asthma medications cost less.

Nurses and social workers at EmblemHealth conduct home visits to assess the level of dust and mold in asthma patients’ environments, Richard Dal Col, M.D., the insurer’s chief medical officer, tells AIS Health.

To help promote medication adherence, EmblemHealth charges members who use combination inhalers one copay, instead of two. The insurer also allows a 90-day supply for rescue and maintenance medications; depending on their plan design, members may be able to pay one copay, rather than three.

The graphic below show how Asthma medications are covered among commercial health plans, health exchange programs and Medicare programs under the pharmacy benefit.

Radar On Market Access: ACA Plans and Medicaid May See Enrollment Growth Amid COVID-19 Pandemic

March 26, 2020

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

The COVID-19 pandemic is shaping up to be a stress-test for the post-Affordable Care Act insurance market. The crisis has already caused mass layoffs, and experts say the individual health insurance exchanges and Medicaid could see record enrollment in the coming months as a result, AIS Health reported.

“This would be the first recession since the Affordable Care Act went into effect, so we are in somewhat uncharted territory in terms of what might happen in a recession under both the ACA marketplace and the Medicaid expansion,” Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, said during a March 18 conference call with reporters.

Levitt said the ACA marketplace is likely to see rapid growth in enrollment as workers lose jobs or hours, making them eligible for special enrollment periods in some cases.

“Household income is going to tend to fall, and that will put more people into that lowest income category with the broadest enrollment in the ACA marketplace,” Levitt said. That influx of enrollees, he added, “has the potential to improve the risk pool in the ACA marketplace and shouldn’t, by itself, have a big effect on premiums.”

Meanwhile, “as people lose their jobs and their incomes fall below 138% of poverty in those states that have expanded Medicaid, we’re likely to see growth in Medicaid enrollment — as we typically do during recessions,” Levitt said.

“Medicaid traditionally has been countercyclical….It’s an economic balancer,” says David Anderson, a health policy researcher at Duke University’s Margolis Center for Health Policy. “In 2009 [during the last economic recession], the federal government raised the federal payment rate — the federal share of Medicaid — by 6.2 points. What that did is it gave states breathing room in their budget…That extra federal share takes a little bit of pressure off the rest of the state budget.”

To that end, President Donald Trump on March 18 signed the Families First Coronavirus Response Act, which, among a host of other provisions, temporarily increased the Medicaid federal medical assistance percentage by 6.2 points.

Radar On Market Access: Questions Remain About Cost Impact of Coronavirus Treatment

March 24, 2020

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

Though many health insurers have removed cost barriers related to testing patients for the new coronavirus that’s sweeping the globe, they largely haven’t pledged to waive out-of-pocket costs for severely sickened members who require hospitalization. A new analysis suggests that the cost of caring for those patients could be steep for members and health plans alike, but experts tell AIS Health it may be too early to say what that will actually mean for commercial insurance markets.

According to the analysis, from the Peterson Center on Healthcare and the Kaiser Family Foundation (KFF), the average total cost — combining employer-plan spending and patient out-of-pocket costs — for a pneumonia-related hospital stay “with major complications and comorbidities” was $20,292 in 2018. For a stay “with complications or comorbidities,” the average cost was $13,767, and for patients without complications, the price tag was $9,763. Looking at out-of-pocket costs alone, the average cost for patients with major complications or comorbidities was $1,300.

But those estimates can only tell us so much about the financial impact of the pandemic, KFF Executive Vice President for Health Policy Larry Levitt said during a March 18 web briefing with reporters.

“We have some information about what the cost for each patient will be, but we have very little information yet about how many patients there may be,” Levitt said in response to a question from AIS Health. “And that’s the big area of uncertainty — how widespread the infection will be and how many people will become severely ill and require hospitalization. So insurers at this point are running blind on how much the total cost may be.”

Generally, regulators do not permit health insurers to recoup prior-year losses through premium increases, “so insurers are going to be focusing a lot on what the ongoing cost” of the coronavirus outbreak could be when pricing their products, Levitt said.

MMIT Reality Check on Major Depressive Disorder (Mar 2020)

March 20, 2020

According to our recent payer coverage analysis for major depressive disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for major depressive disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for major depressive disorder treatments shows that under the pharmacy benefit, about 36% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Nasal spray Spravato (esketamine) entered the market in spring 2019 as the first truly new product for major depressive disorder in years, but despite its potential to be a game-changer for those with treatmentresistant depression, most people with the condition will continue to be treated with tried-and-true generics.

Perspectives on Legality of Closed Medicaid Formularies

March 19, 2020

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

“For the first time, participating states will have more negotiating power to manage drug costs by adopting a formulary similar to those provided in the commercial market, with special protections for individuals with HIV and behavioral health conditions,” CMS said in its press release unveiling the Healthy Adult Opportunity demonstration, which states can apply for via a Section 1115 Medicaid waiver.

Currently, states’ Medicaid programs must cover all FDA-approved drugs, as mandated by federal law. But CMS is suggesting that states can waive that requirement for the population they choose to cover under their demonstration — likely people who are covered by Medicaid expansion — and still participate in the Medicaid Drug Rebate Program.

But some industry experts tell AIS Health they’re not sure whether that will be legally permissible.

“I have my doubts as to whether this will bear legal scrutiny because it goes against the entire Medicaid Drug Rebate Program, which is rebates in exchange for open formularies,” says Jeff Myers, the former CEO of Medicaid Health Plans of America and founder of health care consulting firm OptDis.

Indeed, “the legal side is obviously the giant question with the whole Healthy Adult Opportunity program,” Jason Karcher, an actuary with Milliman, Inc., tells AIS Health. “We just don’t know how the courts will ultimately see this, although I think it would be fair to be skeptical that we’ll actually get to see a waiver under this [guidance] make it in the near future.”

Radar On Market Access: COVID-19 Outbreak Could Impact Drug Supply Long-Term

March 19, 2020

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

“We are told at this point that we’re not seeing any [drug] shortages in the marketplace today,” says Kelly McGrail-Pokuta, Prime Therapeutics’ vice president of pharmaceutical trade.

On Feb. 27, FDA Commissioner Stephen Hahn released a statement that said disruptions to the pharmaceutical supply chain have been minimal so far. The statement also said that the FDA was especially focused on 20 manufacturers that are particularly dependent on operations in China, and found that “none of these firms have reported any shortage to date.”

But on March 10, the FDA postponed all inspections of overseas drug manufacturing facilities “through April, effective immediately,” according to another statement released by Hahn.

During a pandemic, the CDC recommends anyone taking prescription medication to manage a chronic condition keep an expanded supply of their medicine on hand. As more people self-isolate, and consumers seek to spend less time in stores and other public places, demand for backup medication is likely to increase.

Mike Schneider, a principal at Avalere Health who previously worked for CVS Caremark, says PBMs and payers will have to rethink their typical posture toward chronic medication as enrollees stock up in anticipation of self-isolation.

“Hopefully, with everything going on related to coronavirus and people wanting to stock up, those quantity limits would be eased or eliminated for the most part for chronic meds,” says Schneider.

The Blue Cross Blue Shield Association’s “network of 36 independent and locally operated” affiliates have all decided to waive prescription refill limits on maintenance medications, according to America’s Health Insurance Plans. Other non-Blues insurers have also taken steps to allow members to refill prescriptions in advance.

Experts say it’s difficult to know whether the drug supply will be affected down the road. Schneider says consumer stockpiling and the FDA’s move to suspend foreign inspections could both make an impact on future supply.

Radar On Market Access: Insurers, Pharma Spar Over Copay Accumulator Provision

March 17, 2020

Health insurers are praising a provision in a recently proposed regulation that gives commercial plans greater leeway to run so-called copay accumulator programs, which prevent drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits. But the pharmaceutical industry slammed the proposal as “misguided” and liable to prevent patients from getting vital medications.

Health insurers are praising a provision in a recently proposed regulation that gives commercial plans greater leeway to run so-called copay accumulator programs, which prevent drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits. But the pharmaceutical industry slammed the proposal as “misguided” and liable to prevent patients from getting vital medications.

“I do think these programs are here to stay, and I do think they will continue to grow in terms of the absolute numbers as we head into ’22 and beyond,” Jayson Slotnik, a partner at Health Policy Strategies, LLC., tells AIS Health. From insurers’ point of view, copay accumulator programs help combat the perverse incentives that drug manufacturer coupons create: steering patients to pricey brand-name drugs by obscuring their true cost.

In its 2021 proposed Notice of Benefit and Payment Parameters, CMS clarifies that all non-grandfathered individual and group market health plans “have the flexibility to determine whether to include or exclude coupon amounts from the annual limitation on cost sharing, regardless of whether a generic equivalent is available.”

To America’s Health Insurance Plans, it’s important to allow the use of copay accumulator programs even for drugs that don’t have a generic version in order to spur competition between branded drugs that can treat the same condition. “Drug manufacturers recognize this and spend billions of dollars to dilute the impact of competition by providing coupons for brand drugs that do not have a generic equivalent,” the trade group wrote in its comment letter about the proposed rule.

But the Pharmaceutical Research and Manufacturers of America (PhRMA) sees it very differently.

“It would compromise patients’ ability to adhere to prescribed medicines at a moment when insurance coverage for medicines continues to erode; it would put patient health and financial security in danger; it would run directly counter to the Administration’s stated policy of lowering patient out-of-pocket costs for prescription drugs; and it could undermine the appeal and availability of high-deductible health plans,” PhRMA wrote.

MMIT Reality Check on Hereditary Angioedema (Mar 2020)

March 13, 2020

According to our recent payer coverage analysis for hereditary angioedema treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hereditary angioedema treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hereditary angioedema treatments shows that under the pharmacy benefit, about 67% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The FDA will review BioCryst Pharmaceuticals, Inc.’s application for oral, once daily berotralstat for the prevention of swelling attacks in patients with hereditary angioedema, with a decision expected by early December 2020.

Trends That Matter for Diabetes Drug Costs

March 12, 2020

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

Mike Schneider, a principal in the commercialization and market access practice at Avalere Health, says the plan is innovative. “You’ve seen Express Scripts do something where they’re offering specific insulins at very low out-of-pocket costs, but this is the first time I’ve seen a PBM come up with a way to eliminate out-of-pocket costs completely,” he tells AIS Health.

With the elimination of copays and other cost-sharing payments for diabetes drugs, CVS is betting members will better adhere to drug regimens and potentially avoid unnecessary hospitalizations and other services.

In January, Eli Lilly and Co. said it planned to sell new versions of Humalog Junior KwikPen and Humalog Mix 75-25 at half of their current U.S. list prices. Novo Nordisk A/S also started to offer generic versions of its frequently prescribed insulin drugs Novolog and Novolog Mix 70-30 at a 50% discount compared to the current list price. The graphics below show how these four medications are covered among commercial health plans, health exchange programs and Medicare and Medicaid programs.

Radar On Market Access: Insurers Deploy Array of Strategies to Manage Asthma

March 12, 2020

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

While payers have long used telephone-based care management teams to improve outcomes for members with asthma, now they’re also deploying other strategies to fine-tune their outreach to those who are in most need of support, AIS Health reported.

Every member with asthma should have an asthma action plan, says Karen Meyerson, director of commercial care management at Michigan-based Priority Health. Such a plan, which is completed by a patient’s doctor, should include a medication list, tips on recognizing worsening symptoms and steps for responding in an emergency.

Priority Health members can also use a cost-estimator tool to shop for the lowest-cost drugs. For example, members can use the tool to discover a less-expensive generic drug and a pharmacy where their asthma medications cost less.

Nurses and social workers at EmblemHealth conduct home visits to assess the level of dust and mold in asthma patients’ environments, Richard Dal Col, M.D., the insurer’s chief medical officer, tells AIS Health.

To help promote medication adherence, EmblemHealth charges members who use combination inhalers one copay, instead of two. The insurer also allows a 90-day supply for rescue and maintenance medications; depending on their plan design, members may be able to pay one copay, rather than three.

Blue Shield of California members with asthma can receive a home visit by a nurse or a physician. Phillip Baldi, D.O., lead medical care director at the insurer, says while home visits seem expensive, the insurer’s rates with a company providing home visits is comparable to what it pays for an in-person visit to a doctor’s office. “If we can divert five emergency room visits, we can have 50 home visits,” he tells AIS Health.

The insurer is also evaluating offering select maintenance drugs at lower or no copays for members with asthma.

Radar On Market Access: Florida Saw Strong MA, Individual Results and More Consolidations

March 10, 2020

Florida’s health insurers remain highly profitable as the overall market has grown significantly more concentrated, with companies such as Anthem, Inc. and Florida Blue snapping up numerous smaller HMOs over the past several years, particularly in the Medicare Advantage (MA) space, says the author of a new report on the Florida market.

Florida’s health insurers remain highly profitable as the overall market has grown significantly more concentrated, with companies such as Anthem, Inc. and Florida Blue snapping up numerous smaller HMOs over the past several years, particularly in the Medicare Advantage (MA) space, says the author of a new report on the Florida market.

Independent analyst and consultant Allan Baumgarten, who studies state health care markets, tells AIS Health that he expects consolidation to continue.

“There is a new crop of insurers that started business in 2019, including some new Medicare Advantage plans, plus Bright Health and Oscar [Health Insurance],” Baumgarten says. “I think that the Medicare Advantage plans, if they grow to a certain threshold size — maybe 25,000 enrollees or more — will be targets for acquisition. In fact, I think some of the entrepreneurs that started those new plans [did so] as a build and then sell strategy.”

Baumgarten’s report, which looked at enrollment, profitability and acquisitions in 2018, found that HMOs enjoyed strong profits in 2018 despite enrollment that slipped around 2.2%, mainly as a result of fewer people in Medicaid HMOs.

“For the health plans, two lines of business have been especially profitable — Medicare Advantage, consistently for the past eight years or more, and individual health plans [including exchange coverage] in the past two years,” Baumgarten says.

“The premiums paid to Medicare Advantage plans in Florida are among the highest in the country, which is why health plans are eager to start or acquire Medicare plans here,” the report explains.

Insurers weren’t the only health care players pursuing mergers and acquisitions in 2018, says. Overall, the report spotlights “growing consolidation on both the hospital system and health insurer sides, leading to strong profitability for both hospitals and health plans,” Baumgarten says.

MMIT Reality Check on HIV (Mar 2020)

March 6, 2020

According to our recent payer coverage analysis for HIV treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for HIV treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for HIV treatments shows that under the pharmacy benefit, about 78% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: In September 2019, the FDA expanded the indications of Pifeltro (doravirine) in combination with other antiretroviral agents and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) as a complete regimen to treat adults with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated to resistance to Pifeltro or Delstrigo’s components.

Perspectives on ACA Exchange Draft Regulation

March 5, 2020

On Jan. 31, CMS released the 2021 Notice of Benefit and Payment Parameters (NBPP), which is the annual omnibus regulation that outlines the rules of the game for Affordable Care Act (ACA) exchange plans. But that was only after a trade group for safety-net health plans sent a strongly worded letter warning the Trump administration that the clock is ticking for issuers to finalize their 2021 premiums and benefit designs.

On Jan. 31, CMS released the 2021 Notice of Benefit and Payment Parameters (NBPP), which is the annual omnibus regulation that outlines the rules of the game for Affordable Care Act (ACA) exchange plans. But that was only after a trade group for safety-net health plans sent a strongly worded letter warning the Trump administration that the clock is ticking for issuers to finalize their 2021 premiums and benefit designs.

In its Jan. 27 letter, the Association for Community Affiliated Plans (ACAP) complained to CMS that the proposed 2021 NBPP “appears to be stalled at the Office of Management and Budget.” (The OMB completed its review of the regulation on Jan. 29.) Insurers need to submit qualified health plan (QHP) applications starting in early May, ACAP pointed out. “Building in a minimum 30-day comment period in addition to 30 days for the Department to review, revise, and release the final [rule] would allow just one month for issuers to operationalize and implement necessary updates,” the group wrote. “This timeframe will not allow issuers sufficient time to prepare products and operations for Benefit Year 2021.”

Fritz Busch, an actuary with Milliman Inc., tells AIS Health that the final NBPP has come out in April during the past two years, but before that arrived much earlier. The delay of the NBPP “presents operational challenges for a lot of plans, because so many plans are right in the middle of doing their pricing and other planning for the year,” he adds.

As for the content of the draft NBPP, the most attention-grabbing proposed changes to the rules surrounding subsidy eligibility. CMS said it’s seeking public comment on “new automatic re-enrollment processes for enrollees whose share of the premium after applying premium subsidies is $0, in order to reduce the risk of incorrect expenditures on subsidies that cannot be recovered through reconciliation.” In addition, “periodic data matching standards would be amended to help ensure premium subsidies are not inappropriately paid to enrollees who are determined to be deceased, or dually eligible for Medicare.”

Radar On Market Access: New Generic HIV Drug May Impact PrEP Coverage, Not HIV Coverage

March 5, 2020

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved by the FDA in 2004 to treat HIV infection in combination with other antiretroviral drugs. In 2012, it also was approved as the first drug for PrEP. In March 2019, Gilead announced that it had entered into an agreement with Teva Pharmaceutical Industries Ltd. to allow the company to launch its generic version on Sept. 30, 2020.

Payer coverage of PrEP also will be affected by a recommendation from the U.S. Preventive Services Task Force (USPSTF). In 2019, the USPSTF recommended PrEP therapy for those at high risk of HIV acquisition, according to a white paper written by Lynn Nishida, R.Ph., vice president of clinical product and contracting for WithMe Health.

“With the USPSTF recommendation, Medicaid expansion programs and health plans are going to have to cover PrEP without any cost sharing,” says Tim Horn, director of medication access and pricing at the National Alliance of State & Territorial AIDS Directors. Therefore, payers will move toward generic versions.

Dan Mendelson, founder and former CEO of consulting firm Avalere Health, says that whenever a drug goes generic, payers usually have a plan in place to make sure the generic is used. “The more expensive the drug, the more likely that the plan will be comprehensive and aggressive,” he says.

Since HIV is one of the six protected classes in the Medicare Part D program, Part D plans typically cover all HIV products, says Michael Schneider, principal at Avalere Health, as there is little to no rebating in the category. “So, there is really no incentive for the PBMs acting on behalf of their clients, the plans, to do anything in terms of a utilization management standpoint or negotiation standpoint outside of just bringing the generics on formulary.”

Most of the branded HIV products are in the Part D specialty tier, requiring coinsurance, due to their high cost. When a generic comes on the market, plans typically will remove the branded product and then place the generic in the specialty tier or the preferred brand tier depending on the cost of the generic product, he says.

Radar On Market Access: Tenn. Blues’ White Bagging Policy Sees Pushback from Providers

March 3, 2020

BlueCross BlueShield of Tennessee, Inc. has received tremendous pushback from physicians on its decision to implement a policy requiring them to get provider-administered therapies from specialty pharmacies, AIS Health reported.

BlueCross BlueShield of Tennessee, Inc. has received tremendous pushback from physicians on its decision to implement a policy requiring them to get provider-administered therapies from specialty pharmacies, AIS Health reported.

Providers traditionally have acquired therapies they administer through a practice known as buy and bill, by which they will purchase a drug from a wholesaler or distributor, keep it in their office and administer it to patients as needed, submitting a claim to the payer afterwards.

But some payers mandate that providers purchase these drugs through a specialty pharmacy, a practice known as white bagging. This means the provider never takes ownership of the drug, and a patient will pay their copayment or coinsurance to the specialty pharmacy after the physician orders the drug. The specialty pharmacy then delivers the medication directly to the provider.

The Tennessee Blues plan launched a white-bagging program Jan. 1, with a six-month transition period, for self-funded employers who opt into it. But many physicians have spoken out against the new policy, and, most recently, a Feb. 6 letter from eight specialty societies asked the Tennessee Blues plan to reconsider the program altogether.

The writers maintained that “practices currently engaging in the buy-and-bill model operate under thin margins,” which would be eliminated with the implementation of white bagging. They maintained that the results would be a shift in site of care from provider offices to the more expensive hospital setting, boosting costs for both the insurer and its members.

While provider margins would decline, offices’ administrative costs would increase. They also asserted that the policy would result in drug waste since a white-bagged drug is specific to a patient, as opposed to buy and bill, which does not have patient-specific therapies.

Yet according to Bill Sullivan, principal consultant at Specialty Pharmacy Solutions LLC, the contention that specialty pharmacies cannot ensure the proper handling and safe delivery of drugs “is simply false.” He also pointed out that from 2014 to 2018, the average price of provider-administered drugs rose 73%.

In Jan. 8 article on the Tennessee Blues plan’s website, Natalie Tate, Pharm.D., vice president of pharmacy at the Blues plan, said that the policy will apply to about 5,500 of its 3.5 million members. Tate also said that 100 employer groups had opted in to participate, and the plan estimated that they would save approximately 20% on the drugs.

MMIT Reality Check on Rheumatoid Arthritis (Feb 2020)

February 28, 2020

According to our recent payer coverage analysis for rheumatoid arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for rheumatoid arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for rheumatoid arthritis treatments shows that under the pharmacy benefit, about 71% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In November 2019, the FDA approved Pfizer Inc.’s Abrilada (adalimumab- afzb) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. It is the fifth biosimilar of AbbVie Inc.’s Humira (adalimumab) that the agency has approved.

Trends That Matter for Nebraska Medicaid Expansion

February 27, 2020

With Medicaid demonstration programs that include work requirements struck down in three states, it’s become increasingly clear that such waivers may not survive legal scrutiny. So Nebraska, which submitted its own Section 1115 waiver application in December, is trying a different tactic, AIS Health reported.

With Medicaid demonstration programs that include work requirements struck down in three states, it’s become increasingly clear that such waivers may not survive legal scrutiny. So Nebraska, which submitted its own Section 1115 waiver application in December, is trying a different tactic, AIS Health reported.

In its application to CMS, the state proposes to modify voter-approved Medicaid expansion by creating two tiers of coverage: Basic, which includes “comprehensive medical, behavioral health and prescription drug coverage” as required by federal law, and Prime, which is the Basic package plus vision, dental and over-the-counter medication coverage.

“Unlike other states, everyone who meets underlying eligibility criteria will receive at least the robust Basic benefits package,” the application notes.

A recent Kaiser Family Foundation analysis shows that if all 14 non-expansion states expanded Medicaid, about 4.8 million additional people would be eligible for coverage, including 2.3 million adults in the coverage gap — whose income is above current Medicaid eligibility but below the lower limit for marketplace premium tax credits — and 2.1 million adults with incomes between 100% and 138% of the poverty threshold.

Radar on Market Access: Future of Medicaid Work Requirements Dims After Arkansas Demo Is Struck Down Again

February 27, 2020

A three-judge federal appeals court panel on Feb. 14 sided with a lower court and unanimously ruled that Arkansas’ Medicaid work requirements are unlawful because they don’t align with the chief objective of the Medicaid program — providing access to medical care to those who can’t afford it, AIS Health reported.

A three-judge federal appeals court panel on Feb. 14 sided with a lower court and unanimously ruled that Arkansas’ Medicaid work requirements are unlawful because they don’t align with the chief objective of the Medicaid program — providing access to medical care to those who can’t afford it, AIS Health reported.

“This certainly puts a damper on their plans,” says Joan Alker, a research professor and executive director of the Georgetown Center for Children and Families, referring to other states’ hopes to set up similar Medicaid waiver demonstrations.

In addition to Arkansas’ program, CMS has approved Medicaid waivers that include work requirements in Arizona, Indiana, Kentucky, Michigan, New Hampshire, Ohio, South Carolina, Utah and Wisconsin. Both Kentucky and New Hampshire’s waiver programs have been struck down in court, and Kentucky has since abandoned its appeal after a Democratic governor, Andy Beshear, replaced Republican Matt Bevin.

Arizona and Indiana voluntarily suspended their programs, Alker noted in a Feb. 14 blog post, while Michigan’s has been challenged in court. Meanwhile, an additional 10 states have applied for Medicaid waivers that include work requirements.

“I do think it [the appeals court ruling] will likely inhibit states from moving forward with work requirements waivers that have already been approved by CMS,” says Charles Luband, a partner in the health care practice of the law firm Dentons. “It is possible that CMS will continue to accept requests for work requirements and may even continue to approve them, but if they do, CMS is going to have to try harder to meet the standard that’s set out here” in the appeals court ruling, Luband says.

CMS, for its part, is reviewing and evaluating the appeals court’s opinion in order to determine next steps. Arkansas Gov. Asa Hutchinson (R) said in a statement that he hopes the Supreme Court will review the ruling in the case.

However, Luband says that may not be likely. “The [Supreme] Court generally likes to take cases when there is a split between the circuits, and there’s none here,” he says.

Radar On Market Access: CVS Touts Aetna’s Contribution; Molina Exchange Business Stumbles

February 25, 2020

During a Feb. 12 presentation outlining its 2019 financial results, CVS Health Corp. touted a “successful first full year with Aetna,” saying the transaction produced “synergies above expectations” at approximately $500 million. And CVS’s Health Benefits segment posted a “solid” fourth quarter, in the words of Citi Research securities analyst Ralph Giacobbe.

During a Feb. 12 presentation outlining its 2019 financial results, CVS Health Corp. touted a “successful first full year with Aetna,” saying the transaction produced “synergies above expectations” at approximately $500 million. And CVS’s Health Benefits segment posted a “solid” fourth quarter, in the words of Citi Research securities analyst Ralph Giacobbe.

Across its enterprise in 2019, CVS delivered adjusted earnings per share (EPS) of $7.08 with total revenues of nearly $257 billion — a 32% year-over-year increase, CEO Larry Merlo told investors during the company’s earnings call, per a transcript of the call published by the Motley Fool.

For the fourth quarter of 2019, CVS reported an EPS of $1.73, topping the consensus estimate of $1.68. Giacobbe noted that revenue “was particularly better” in CVS’s PBM segment.

For Molina Healthcare Inc., the firm “was perhaps a victim of its own success” in the fourth quarter of 2019, Jefferies analysts David Windley and David Styblo advised investors on Feb. 12. The company’s management “has executed the turnaround story so well that we and others expected the ’20 HIX [health insurance exchange] pivot to land gently as well,” they wrote. Instead, that business segment missed its earnings target by roughly $75 million, the Jefferies analysts advised.

Molina’s Affordable Care Act exchange “pivot” involved the insurer lowering its prices in a bid to increase enrollment, Windley and Styblo explained. However, Molina’s lower prices “weren’t, by themselves, enticing enough,” they wrote. “With lower pricing, standard broker expenses, and an infrastructure built for larger membership, ’20 margins get squeezed by 550 [basis points], or 53%, leading to the 50% profit decline.”

However, Molina’s two pending acquisitions — a $40 million deal to buy New York Medicaid insurer YourCare HealthPlan and a $50 million deal to add Illinois-based NextLevel Health Partners — “present upside,” the analysts advised.

MMIT Reality Check on Type 2 Diabetes (GLP-1 and Combo) (Feb 2020)

February 21, 2020

According to our recent payer coverage analysis for type 2 Diabetes (GLP-1 and Combo) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for type 2 Diabetes (GLP-1 and Combo) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for type 2 Diabetes (GLP-1 and Combo) treatments shows that under the pharmacy benefit, almost 37% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs. For some, that might include a strategy similar to the one unveiled by CVS Health Corp.’s Caremark unit in 2020. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

 

Perspectives on Part D Reform in 2020

February 20, 2020

If Congress or the Trump administration are able to enact any type of drug-pricing reform during 2020, it’s likely to be a redesign of Medicare Part D, industry experts tell AIS Health.

If Congress or the Trump administration are able to enact any type of drug-pricing reform during 2020, it’s likely to be a redesign of Medicare Part D, industry experts tell AIS Health.

In the Senate, tweaking the Part D benefit is part of a larger piece of bipartisan legislation (S. 2543), championed by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.). From the House, there’s the sweeping legislation (H.R. 3) proffered by Speaker Nancy Pelosi (D-Calif.).

Both bills would implement out-of-pocket spending caps for Part D beneficiaries and considerably change how costs are divided up in the catastrophic phase of coverage. They would also require drug manufacturers to repay Medicare if certain Part B or Part D drug prices rise faster than inflation.

“If you look at both the House and the Senate bills that have been put forward here, those [Part D] designs look very similar to one another, so I’m somewhat optimistic that…maybe there’s an opportunity for that to move forward,” says Stacie Dusetzina, an associate professor of health policy at the Vanderbilt University School of Medicine.

However, Elizabeth Carpenter at Avalere Health contends that “it is unlikely in this environment that any drug pricing legislation would move as a standalone bill.” The most likely pre-election vehicle for a Part D redesign would be the health care extenders package that expires in May, she adds.

Gerard Anderson, a professor at Johns Hopkins University Bloomberg School of Public Health, is more optimistic. “Drug pricing is the No. 1 issue for most voters when they’re talking about health care,” he points out. “So they’re going to feel a strong pressure” to pass something in Congress. Given that dynamic, he says he expects the Wyden/Grassley bill is likely to pass this year.

In whatever form a Part D redesign passes, Dusetzina says the biggest winner would be patients. While manufacturers and health plans would be on the hook for more spending in the catastrophic coverage phase, “on net, it probably isn’t very harmful for any one entity,” she contends.

Radar On Market Access: Payers Try New Strategies to Control Diabetes Drug Costs

February 20, 2020

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

Mike Schneider, a principal in the commercialization and market access practice at Avalere Health, says the plan is innovative. “You’ve seen Express Scripts do something where they’re offering specific insulins at very low out-of-pocket costs, but this is the first time I’ve seen a PBM come up with a way to eliminate out-of-pocket costs completely,” he tells AIS Health.

With the elimination of copays and other cost-sharing payments for diabetes drugs, CVS is betting members will better adhere to drug regimens and potentially avoid unnecessary hospitalizations and other services.

But these types of plans might not work for all member populations. Marc Guieb, a pharmacy consultant at Milliman, Inc., says member satisfaction can play a part in whether a plan sponsor goes this route, or sticks to a more traditional strategy that places higher-cost drugs in a step therapy plan.

The market for diabetes drugs is tight, with a few big manufacturers that all have similar prices. But there’s one new player, Civica Rx, that’s aiming to change that. In January, 18 plans in the Blue Cross Blue Shield Association joined with Civica Rx to produce up to 10 generic drugs at low cost by 2021.

Included in the partnership is Blue Shield of California, where Alison Lum is the vice president of pharmacy services. “The way that we’ve managed [drugs] in the past probably won’t get us to be sustainably affordable in the future,” Lum says. “We have to think about new ways of doing things.”

Radar On Market Access: Some Experts Question Legality of Closed Medicaid Formularies

February 18, 2020

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

“For the first time, participating states will have more negotiating power to manage drug costs by adopting a formulary similar to those provided in the commercial market, with special protections for individuals with HIV and behavioral health conditions,” CMS said in its press release unveiling the Healthy Adult Opportunity demonstration, which states can apply for via a Section 1115 Medicaid waiver.

Currently, states’ Medicaid programs must cover all FDA-approved drugs, as mandated by federal law. But CMS is suggesting that states can waive that requirement for the population they choose to cover under their demonstration — likely people who are covered by Medicaid expansion — and still participate in the Medicaid Drug Rebate Program.

But some industry experts tell AIS Health they’re not sure whether that will be legally permissible.

“I have my doubts as to whether this will bear legal scrutiny because it goes against the entire Medicaid Drug Rebate Program, which is rebates in exchange for open formularies,” says Jeff Myers, the former CEO of Medicaid Health Plans of America and founder of health care consulting firm OptDis.

Indeed, “the legal side is obviously the giant question with the whole Healthy Adult Opportunity program,” Jason Karcher, an actuary with Milliman, Inc., tells AIS Health. “We just don’t know how the courts will ultimately see this, although I think it would be fair to be skeptical that we’ll actually get to see a waiver under this [guidance] make it in the near future.”

MMIT Reality Check on Neutropenia (Feb 2020)

February 14, 2020

According to our recent payer coverage analysis for neutropenia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for neutropenia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for neutropenia treatments shows that under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: This is becoming a crowded market. Multiple other companies have filed applications with the FDA, and more treatments are in the pipeline. The surge of pipeline biosimilars will mean increased competition.

Trends That Matter for Kansas Medicaid Expansion

February 13, 2020

Kansas Gov. Laura Kelly (D) and Republican Senate Majority Leader Jim Denning on Jan. 9 said they’d reached a compromise proposal to extend Medicaid coverage to an estimated 130,000 more low-income Kansans, AIS Health reported.

Kansas Gov. Laura Kelly (D) and Republican Senate Majority Leader Jim Denning on Jan. 9 said they’d reached a compromise proposal to extend Medicaid coverage to an estimated 130,000 more low-income Kansans, AIS Health reported.

If approved, Kansas will pursue a full expansion of Medicaid to 138% of the Federal Poverty Level (FPL) with a 90/10 funding match. The state will also seek Section 1332 waiver approval to establish a reinsurance program and Section 1115 waiver approval to transition individuals whose incomes fall between 100% and 138% of the FPL from Medicaid to the exchange no later than Jan. 1, 2022, although expansion is not dependent on those waivers. If CMS denies either waiver, full Medicaid expansion will be implemented on Jan. 1, 2021, according to a summary of the pending legislation.

Kansas would be the 37th state to expand Medicaid. Ballot initiatives are pending in Missouri and Oklahoma, while voters in Nebraska and Utah have already approved expansion. The 10 remaining non-expansion states are largely concentrated in the South.
A new study in Health Affairs found that Medicaid expansion improved health outcomes in southern U.S. states, causing fewer self-reported declines in health status among low-income residents.

Radar On Market Access: ACA Exchange Draft Regulation Drops

February 13, 2020

On Jan. 31, CMS released the 2021 Notice of Benefit and Payment Parameters (NBPP), which is the annual omnibus regulation that outlines the rules of the game for Affordable Care Act (ACA) exchange plans. But that was only after a trade group for safety-net health plans sent a strongly worded letter warning the Trump administration that the clock is ticking for issuers to finalize their 2021 premiums and benefit designs.

On Jan. 31, CMS released the 2021 Notice of Benefit and Payment Parameters (NBPP), which is the annual omnibus regulation that outlines the rules of the game for Affordable Care Act (ACA) exchange plans. But that was only after a trade group for safety-net health plans sent a strongly worded letter warning the Trump administration that the clock is ticking for issuers to finalize their 2021 premiums and benefit designs.

In its Jan. 27 letter, the Association for Community Affiliated Plans (ACAP) complained to CMS that the proposed 2021 NBPP “appears to be stalled at the Office of Management and Budget.” (The OMB completed its review of the regulation on Jan. 29.) Insurers need to submit qualified health plan (QHP) applications starting in early May, ACAP pointed out. “Building in a minimum 30-day comment period in addition to 30 days for the Department to review, revise, and release the final [rule] would allow just one month for issuers to operationalize and implement necessary updates,” the group wrote. “This timeframe will not allow issuers sufficient time to prepare products and operations for Benefit Year 2021.”

Fritz Busch, an actuary with Milliman Inc., tells AIS Health that the final NBPP has come out in April during the past two years, but before that arrived much earlier. The delay of the NBPP “presents operational challenges for a lot of plans, because so many plans are right in the middle of doing their pricing and other planning for the year,” he adds.

As for the content of the draft NBPP, the most attention-grabbing proposed changes to the rules surrounding subsidy eligibility. CMS said it’s seeking public comment on “new automatic re-enrollment processes for enrollees whose share of the premium after applying premium subsidies is $0, in order to reduce the risk of incorrect expenditures on subsidies that cannot be recovered through reconciliation.” In addition, “periodic data matching standards would be amended to help ensure premium subsidies are not inappropriately paid to enrollees who are determined to be deceased, or dually eligible for Medicare.”

Radar On Market Access: New Oncology Biosimilar Launches Could Prompt Preferencing

February 11, 2020

So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products and, in turn, realizing savings in some costly therapeutic classes.

So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products and, in turn, realizing savings in some costly therapeutic classes.

Although the FDA had approved 26 biosimilars as of the end of January, only half of them are available in the U.S., with many of the drugmakers tied up in patent litigation with reference drug manufacturers.

Although the FDA had approved 26 biosimilars as of the end of January, only half of them are available in the U.S., with many of the drugmakers tied up in patent litigation with reference drug manufacturers.

2019 saw the launch of the first oncology biosimilars when Amgen and Allergan plc launched Kanjinti (trastuzumab-anns), a Herceptin (trastuzumab) biosimilar, and Mvasi (bevacizumab-awwb), an Avastin (bevacizumab) biosimilar, on July 18. Both reference drugs are from Genentech USA, Inc., a Roche Group unit. Then, on Nov. 7, Teva Pharmaceuticals USA, Inc. and Celltrion launched Truxima (rituximab-abbs), with reference drug Rituxan (rituximab) from Genentech and Biogen.

The Dec. 2 launch of Mylan N.V. and Biocon Ltd.’s Ogivri (trastuzumab-dkst) brought a second biosimilar of Herceptin onto the U.S. market, with a third — Pfizer’s Trazimera (trastuzumab-qyyp) — expected Feb. 15. Also expected to launch in the first part of this year are Ontruzant (trastuzumab-dttb) from Samsung Bioepis Co., Ltd. and Herzuma (trastuzumab-pkrb) from Celltrion and Teva.

A second Avastin biosimilar came onto the U.S. market Dec. 31 when Pfizer launched Zirabev (bevacizumab-bvzr). Rituxan also had additional biosimilar competition on Jan. 23 when Pfizer’s Ruxience (rituximab-pvvr) launched.

Kanjinti is priced 15% less than Herceptin, and its average sales price (ASP) is 13% below the reference drug. Ogivri’s price is “at a competitive discount,” according to Mylan and Biocon. Mvasi is priced 15% less than Avastin, and its ASP is 12% less than that of the reference drug. Zirabev is priced 23% less than Avastin, and Ruxience is 24% less than Rituxan.

“As more health plans set biosimilars on a preferred status, adoption and utilization should increase,” says Martin Burruano, R.Ph., vice president, pharmacy services at Independent Health. “As more become available, there will be opportunity to plan formulary selection to drive costs down. Projections are modest at 12%-15% cost savings initially but will potentially reach 70% cost savings in five years.”

MMIT Reality Check on Multiple Sclerosis (Feb 2020)

February 7, 2020

According to our recent payer coverage analysis for multiple sclerosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for multiple sclerosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for multiple sclerosis treatments shows that under the pharmacy benefit, about half of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In October 2019, the FDA approved Biogen Inc. and Alkermes plc’s Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsingremitting disease and active secondary progressive disease.

Perspectives on Consolidated PBMs in 2020

February 6, 2020

Though the two major transactions that upended the PBM landscape — Cigna Corp. buying Express Scripts Holding Co. and CVS Health Corp. acquiring Aetna Inc. — have already taken place, that doesn’t mean the sector won’t see more changes this year, industry experts tell AIS Health.

Though the two major transactions that upended the PBM landscape — Cigna Corp. buying Express Scripts Holding Co. and CVS Health Corp. acquiring Aetna Inc. — have already taken place, that doesn’t mean the sector won’t see more changes this year, industry experts tell AIS Health.

“The market is evolving,” says Brian Anderson, a principal with Milliman, Inc. The year 2020 will be marked by a presidential election and significant price pressure on manufacturers, along with pharmacies trying to retain their margin, he adds, “so it’s going to be a really wild year.”

Indeed, 2019 ended with Prime Therapeutics LLC and Express Scripts unveiling a three-year collaboration in which the latter PBM will negotiate with pharmaceutical manufacturers, on behalf of Prime’s members, for drugs covered on the pharmacy benefit, as well as provide services related to retail network contracting.

By teaming up with Prime, Express Scripts will be leading rebate negotiations and pharmacy network development for 103 million people, Adam Fein, Ph.D., CEO of Pembroke Consulting, Inc.’s Drug Channels Institute, wrote in a blog post. “This combined volume of Express Scripts and Prime will have enormous leverage with manufacturers and pharmacies,” he noted.

To Ashraf Shehata, KPMG national sector leader for health care and life sciences, the Prime/Express Scripts partnership is yet another example of “pure play” PBMs’ move toward consolidation. Given that trend, the opportunity to scale up both organizations’ purchasing power, and “the ability to kind of lock in Blue clients,” Shehata says, “I think it makes a lot of sense” for the two PBMs to team up.

Employers, meanwhile, are likely to press PBMs of all varieties for innovative solutions — not just deep drug-pricing discounts — during the selling season for 2021 contracts, Anderson says.

Therefore, “there’ll probably be a lot of new innovators in the market — people coming up with new products that maybe look and sound different,” he says. “But the question people are going to have to ask is, how different really is it? And is it really a differentiator in the marketplace?”

Radar On Market Access: Sanofi Backs Away From U.S. PCSK9 Market, While Novartis Bets Big With Inclisiran

February 6, 2020

Sanofi S.A. is cutting its losses on its PCSK9 inhibitor, exiting the U.S. market for the drug completely after various tactics, including slashing prices and promoting value-based contracts to payers, failed to spark sales for the high cholesterol treatment. But at the same time, Novartis International AG is betting big on the PCSK9 market by acquiring the manufacturer of an investigational PCSK9 that has strong Phase 3 results, AIS Health reported.

Sanofi S.A. is cutting its losses on its PCSK9 inhibitor, exiting the U.S. market for the drug completely after various tactics, including slashing prices and promoting value-based contracts to payers, failed to spark sales for the high cholesterol treatment. But at the same time, Novartis International AG is betting big on the PCSK9 market by acquiring the manufacturer of an investigational PCSK9 that has strong Phase 3 results, AIS Health reported.

Sanofi, which had partnered with Regeneron Pharmaceuticals on Praluent (alirocumab), will turn the U.S. marketing of Praluent over to Regeneron beginning in the first quarter of 2020, and availability of the drug is not expected to be affected.

The company’s decision points to the difficulty inherent in pitting an expensive new product against long-standing successful drugs, in this case statins and other cardiovascular therapies, one observer says. Both Praluent and competitor Repatha (evolocumab) from Amgen have failed to catch on in a big way.

“These products do have a place in therapy but to expect them to be blockbusters isn’t realistic, since the class is satisfied with a lot of cheaper generic alternatives,” Mesfin Tegenu, R.Ph., president of PerformRx, tells AIS Health.

However, Novartis is bucking the PCSK9 trend, betting that a third PCSK9 therapy could become a blockbuster. Novartis announced plans on Nov. 24 to purchase the Medicines Company for $9.7 billion, citing “potentially transformational” potential for the company’s investigational product inclisiran.

The Medicines Company has wrapped up Phase 3 studies and has reported positive results. Inclisiran’s biologic mechanism enables twice-yearly subcutaneous dosing, which the manufacturer says could improve adherence and patient outcomes.

Inclisiran “could become one of the largest products by sales in [the] Novartis portfolio,” the company said. The firm also previewed “flexible market access strategies and value-based pricing,” which it said “can enable broad access.”

According to Novartis CEO Vas Narasimhan, “inclisiran is a potentially transformational medicine that reimagines the treatment of atherosclerotic heart disease and familial hypercholesterolemia. With tens of millions of patients at higher risk of cardiovascular events from high LDL-C, we believe that inclisiran could contribute significantly to improved patient outcomes and help health care systems address the leading global cause of death.”

Radar on Market Access: Nebraska Proposes A Two-Tiered Medicaid Expansion

February 4, 2020

With Medicaid demonstration programs that include work requirements struck down in three states, it’s become increasingly clear that such waivers may not survive legal scrutiny. So Nebraska, which last month submitted its own Section 1115 waiver application, is trying a different tactic, AIS Health reported.

With Medicaid demonstration programs that include work requirements struck down in three states, it’s become increasingly clear that such waivers may not survive legal scrutiny. So Nebraska, which last month submitted its own Section 1115 waiver application, is trying a different tactic, AIS Health reported.

In its application to CMS, the state proposes to modify voter-approved Medicaid expansion by creating two tiers of coverage: Basic, which includes “comprehensive medical, behavioral health and prescription drug coverage” as required by federal law, and Prime, which is the Basic package plus vision, dental and over-the-counter medication coverage.

“Unlike other states, everyone who meets underlying eligibility criteria will receive at least the robust Basic benefits package,” the application notes.
One of the questions surrounding Nebraska’s unique waiver request is whether it could better withstand legal scrutiny than the Arkansas, Kentucky and New Hampshire work requirements waivers, which have been blocked by federal judges, according to Patricia Boozang, a senior managing director at Manatt Health.

Rather than threatening to end Medicaid coverage for people who don’t comply with the state’s requirements, Nebraska would simply give them a less-generous benefits package, Boozang tells AIS Health.

“The courts really have to opine on that,” she adds regarding whether Nebraska’s approach is more legally permissible.

However, even if the waiver survives a court challenge, that “doesn’t mean it’s good policy,” says Jerry Vitti, founder and CEO of Healthcare Financial, Inc.

Nebraska is asking people who are very vulnerable, who often have language or literacy barriers, and who may even be transient, to comply with “a pretty burdensome requirement for that demographic,” he says. “It’s counterintuitive to me that you’re going to cut benefits for those least able to comply.”

Both Vitti and Boozang agreed that if approved, Nebraska’s waiver program could add some administrative burden for the state and, depending on how it organizes the program, its Medicaid MCOs.

MMIT Reality Check on Immune Globulin (PID) (Jan 2020)

January 31, 2020

According to our recent payer coverage analysis for immune globulin (PID) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for immune globulin (PID) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for immune globulin (PID) treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2019, the FDA approved Grifols’ Xembify (immune globulin subcutaneous human-klhw) to treat primary humoral immunodeficiency disease in people at least two years old.

Trends That Matter for New Sickle Cell Medications

January 30, 2020

The first targeted therapy to treat pain crises in people with sickle cell disease presents a “welcome” new option that payers likely will embrace, a PBM head tells AIS Health. While the drug’s manufacturer cites “positive” early discussions with payers on it, some experts note the lifetime treatment — via a monthly intravenous infusion — is costly: around $100,000 annually.

The first targeted therapy to treat pain crises in people with sickle cell disease presents a “welcome” new option that payers likely will embrace, a PBM head tells AIS Health. While the drug’s manufacturer cites “positive” early discussions with payers on it, some experts note the lifetime treatment — via a monthly intravenous infusion — is costly: around $100,000 annually.

On Nov. 15, the FDA approved Novartis’ Adakveo (crizanlizumab-tmca), a treatment to fight the underlying cause and reduce the frequency of vaso-occlusive crisis, described as a common and painful complication of sickle cell disease. It is approved for patients ages 16 and older with the genetic blood disorder.

Hydroxyurea, a drug approved by the FDA in 1998, is now generic, costs about $1,000 a year, and is approved for children, the New York Times reported on Dec. 7. The two newcomers are Adakveo and Global Blood Therapeutics’ Oxbryta (voxelotor), a daily pill granted accelerated approval by the FDA 10 days after Adakveo’s approval. This led one expert to tell the news outlet that insurers likely will want to begin with hydroxyurea as the front-line therapy.

Yet Mesfin Tegenu, R.Ph., president of PerformRx, LLC, says that “options for patients with sickle cell disease have been very limited up to this point, so the approval of Adakveo is a welcome addition in the treatment of this debilitating disease.”

The graphics below show how sickle cell disease medications are covered among commercial health plans, health exchange programs and Medicare and Medicaid programs, and their utilization management restrictions.

Radar on Market Access: Disappointing MCOs, Supreme Court Won’t Expedite Obamacare Decision

January 30, 2020

In a blow to the managed care industry, the Supreme Court chose to delay intervening in Texas v. United States, the Republican state attorneys general-led lawsuit that would overturn the Affordable Care Act (ACA), AIS Health reported.

In a blow to the managed care industry, the Supreme Court chose to delay intervening in Texas v. United States, the Republican state attorneys general-led lawsuit that would overturn the Affordable Care Act (ACA), AIS Health reported.

“By declining to take up this case in an expedited manner, the Supreme Court leaves in place the cloud of uncertainty that hangs over the Affordable Care Act,” said Association for Community Affiliated Plans (ACAP) CEO Margaret A. Murray in a press release. “We are disappointed in the Court’s decision. Consumers will continue to pay the price for this confusion as the case stagnates, but we remain confident the ACA will withstand this challenge.”

ACAP cited general regulatory uncertainty as a significant source of risk for the managed care industry, and argued that the ambiguous outlook for the ACA contributes to rising costs for care and resulting higher premiums. “That uncertainty has already spread across the health care system. Plans will postpone investment and innovation in the individual market, dampening competition,” Murray said.

Though the high court’s delay in reviewing the case against the ACA was unpopular in the health insurance industry, it wasn’t entirely unexpected. According to press reports, the court rarely intervenes in lower court decisions unless there is an urgent matter at hand. Payer groups’ arguments that uncertainty could severely disrupt health care markets apparently did not meet that standard of crisis.

With the court’s decision, the suit could now stay out of the 2020 election’s limelight. If the Supreme Court declines to hear the case at all (which the justices haven’t yet decided), it will return to U.S. District Judge Reed O’Connor’s Fort Worth courtroom and, if necessary, make its way through the regular appeals process, which could take months or years. O’Connor, who was appointed to the bench by George W. Bush in 2007, first heard the case in 2018 and ruled that the entire ACA was unconstitutional.

Radar on Market Access: Could Part D Reform Move Forward in 2020?

January 28, 2020

If Congress or the Trump administration are able to enact any type of drug-pricing reform during 2020, it’s likely to be a redesign of Medicare Part D, industry experts tell AIS Health.

If Congress or the Trump administration are able to enact any type of drug-pricing reform during 2020, it’s likely to be a redesign of Medicare Part D, industry experts tell AIS Health.

In the Senate, tweaking the Part D benefit is part of a larger piece of bipartisan legislation (S. 2543), championed by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.). From the House, there’s the sweeping legislation (H.R. 3) proffered by Speaker Nancy Pelosi (D-Calif.).

Both bills would implement out-of-pocket spending caps for Part D beneficiaries and considerably change how costs are divided up in the catastrophic phase of coverage. They would also require drug manufacturers to repay Medicare if certain Part B or Part D drug prices rise faster than inflation.

“If you look at both the House and the Senate bills that have been put forward here, those [Part D] designs look very similar to one another, so I’m somewhat optimistic that…maybe there’s an opportunity for that to move forward,” says Stacie Dusetzina, an associate professor of health policy at the Vanderbilt University School of Medicine.

However, Elizabeth Carpenter at Avalere Health contends that “it is unlikely in this environment that any drug pricing legislation would move as a standalone bill.” The most likely pre-election vehicle for a Part D redesign would be the health care extenders package that expires in May, she adds.

Gerard Anderson, a professor at Johns Hopkins University Bloomberg School of Public Health, is more optimistic. “Drug pricing is the No. 1 issue for most voters when they’re talking about health care,” he points out. “So they’re going to feel a strong pressure” to pass something in Congress. Given that dynamic, he says he expects the Wyden/Grassley bill is likely to pass this year.

In whatever form a Part D redesign passes, Dusetzina says the biggest winner would be patients. While manufacturers and health plans would be on the hook for more spending in the catastrophic coverage phase, “on net, it probably isn’t very harmful for any one entity,” she contends.

MMIT Reality Check on Epilepsy (Jan 2020)

January 24, 2020

According to our recent payer coverage analysis for epilepsy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for epilepsy treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for epilepsy treatments shows that under the pharmacy benefit, almost 31% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In January 2020, the FDA approved Neurelis, Inc.’s Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are different from usual seizure patterns in people at least 6 years old with epilepsy.

Perspectives on MA Supplemental Benefits

January 23, 2020

Despite Medicare Advantage insurers’ enthusiasm for increased flexibility in allowable supplemental benefits and a slew of recent plan press releases touting goodies such as pest control and “Papa Pals” for the 2020 plan year, uptake of more “resource intensive” benefits geared toward seriously ill seniors remains relatively modest, according to a new report from the Duke Margolis Center for Health Policy.

Despite Medicare Advantage insurers’ enthusiasm for increased flexibility in allowable supplemental benefits and a slew of recent plan press releases touting goodies such as pest control and “Papa Pals” for the 2020 plan year, uptake of more “resource intensive” benefits geared toward seriously ill seniors remains relatively modest, according to a new report from the Duke Margolis Center for Health Policy.

The December report, “Improving Serious Illness Care in Medicare Advantage: New Regulatory Flexibility for Supplemental Benefits,” showed that a total of 507 standard MA plans in 2019 offered one of five types of benefits addressing serious illness, accounting for roughly 11% of the approximately 4,500 standard MA plans in 2019, AIS Health reported. By contrast, 377 in 2020 offered at least one of the five benefits highlighted in the report, while no plans in 2019 offered more than one of these benefits. But that drop was mainly driven by one major carrier abandoning its caregiver support benefit for 2020. Meanwhile, about 175 plans offered at least two of these types of these benefits, according to Robert Saunders, research director and one of the report’s authors.

Despite the decrease in caregiver support, which had the greatest initial uptake of the five benefit categories in 2019, researchers saw meaningful increases for 2020 in benefits such as adult day care and palliative care that “more directly address the needs of members with serious illness.”

The study also linked the PBP data to MA enrollment figures by plan and by county to assess the geographic impacts of the policy changes. For 2020, many parts of the country do not have any plans offering new supplemental benefits, and those aimed at serious care were likely to be offered in urban counties, said the report.

Barring any major disruption, 2021 will likely be the year of growth for new flexible benefits, as it takes plans a couple years to price, test and stand up ones that will have a lasting impact, adds Saunders.

Radar on Market Access: Supreme Court to Determine States’ Ability to Regulate PBMs

January 23, 2020

The Supreme Court has agreed to hear a case that observers say ultimately could upend state-based efforts to regulate PBMs and potentially even lead to legislation on the federal level to rein them in, AIS Health reported. The lawsuit, which was brought by the Pharmaceutical Care Management Association, challenges a 2015 Arkansas law that requires PBMs to reimburse pharmacies at or above their wholesale cost for generic drugs.

The Supreme Court has agreed to hear a case that observers say ultimately could upend state-based efforts to regulate PBMs and potentially even lead to legislation on the federal level to rein them in, AIS Health reported. The lawsuit, which was brought by the Pharmaceutical Care Management Association, challenges a 2015 Arkansas law that requires PBMs to reimburse pharmacies at or above their wholesale cost for generic drugs.

The case boils down to whether PBMs are acting as agents under the Employee Retirement Income Security Act of 1974 (ERISA) and therefore are exempt from state-level regulation, or whether they are a “non-interested party and therefore subject to regulation,” says Jeff Myers, founder of health care consulting firm OptDis. He says that he believes it’s likely the high court justices will side with PCMA and the PBM industry, agreeing that ERISA bars state laws like the one at issue in Arkansas.

“If the Supreme Court were to say states have the ability to regulate the PBM marketplace inside ERISA plans…it would give states an almost unlimited ability to force payers to pay a rate [to pharmacies] they deem sufficient,” Myers says. Independent pharmacy lobbies generally are quite powerful in states, and would demand higher rates, he says, adding that this would lead to higher drug prices overall.

If the Supreme Court rules that states can’t directly regulate PBMs, he adds, states may try to regulate them via insurers instead, and “stop attacking PBMs directly.” He says this is the more likely scenario, and something the nine justices could be keeping in mind as they consider this case.

“If the PBMs win, the precedent it sets is that states have no ability to control” them under ERISA plans, Myers says. “The only way you can do it is by going to the actual payer and saying, ‘This is a requirement for offering insurance in my state.'”

Radar on Market Access: Kansas Works Out Medicaid Expansion Deal

January 21, 2020

Kansas Gov. Laura Kelly (D) and Republican Senate Majority Leader Jim Denning on Jan. 9 said they’d reached a compromise proposal to extend Medicaid coverage to an estimated 130,000 more low-income Kansans, AIS Health reported.

Kansas Gov. Laura Kelly (D) and Republican Senate Majority Leader Jim Denning on Jan. 9 said they’d reached a compromise proposal to extend Medicaid coverage to an estimated 130,000 more low-income Kansans, AIS Health reported.

If approved, Kansas will pursue a full expansion of Medicaid to 138% of the Federal Poverty Level (FPL) with a 90/10 funding match. The state will also seek Section 1332 waiver approval to establish a reinsurance program and Section 1115 waiver approval to transition individuals whose incomes fall between 100% and 138% of the FPL from Medicaid to the exchange no later than Jan. 1, 2022, although expansion is not dependent on those waivers. If CMS denies either waiver, full Medicaid expansion will be implemented on Jan. 1, 2021, according to a summary of the pending legislation.

Kansas would be the 37th state to expand Medicaid. Ballot initiatives are pending in Missouri and Oklahoma, while voters in Nebraska and Utah have already approved expansion. The 10 remaining non-expansion states are largely concentrated in the South.

According to a summary of the pending Kansas legislation, the compromise proposal would feature a “robust work referral program,” “modest” premiums of up to $25 per month for an individual (or $100 per family) and no lockout provisions. But the expansion deal does not include work requirements.

Compared with other states that have attempted to require able-bodied expansion enrollees to seek work or other volunteer activities or risk losing their Medicaid coverage, the Kansas tactic is “a kinder, gentler approach to work,” remarks Jerry Vitti, founder and CEO of Healthcare Financial, Inc.

In a Jan. 9 research note from Evercore ISI, securities analyst Michael Newshel noted that if the approximately 130,000 additional lives that would be covered by expansion were split evenly among the state’s three contracted MCOs — which are units of Centene Corp., CVS Health Corp.-owned Aetna and UnitedHealthcare — they would each gain roughly $250 million in annual revenues.

MMIT Reality Check on Prostate Cancer (Jan 2020)

January 17, 2020

According to our recent payer coverage analysis for prostate cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for prostate cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for prostate cancer treatments shows that under the pharmacy benefit, almost half of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2019, the FDA granted another indication to Xtandi (enzalutamide) for the treatment of men with metastatic castrationsensitive prostate cancer.

Trends That Matter for New Multiple Sclerosis Value-Based Contract

January 16, 2020

Under a value-based contracting agreement believed to be the first of its kind, UPMC Health Plan will receive discounts for two Biogen Inc. multiple sclerosis (MS) drugs — Tecfidera (dimethyl fumarate) and Avonex (interferon beta-1a) — based on patient-reported measures of disability progression. The agreement is also based on research with a panel of key MS stakeholders who identified the most meaningful outcomes in relapsing forms of MS, AIS Health reported.

Under a value-based contracting agreement believed to be the first of its kind, UPMC Health Plan will receive discounts for two Biogen Inc. multiple sclerosis (MS) drugs — Tecfidera (dimethyl fumarate) and Avonex (interferon beta-1a) — based on patient-reported measures of disability progression. The agreement is also based on research with a panel of key MS stakeholders who identified the most meaningful outcomes in relapsing forms of MS, AIS Health reported.

UPMC’s Center for Value-Based Pharmacy Initiatives led the research and developed the value-based contract.

Previous value-based contracts for MS drugs have connected payment to outcome indicators derived from claims and electronic health record data, says Rochelle Henderson, Ph.D., Express Scripts’ vice president of research and a co-author of the study report.

“This research [gives] a greater level of transparency into the outcome indicators that rank the highest in terms of value for stakeholders,” she says. “The key advantage of patient-reported outcomes is that it gets at information that can be used to evaluate the success of a medication where that information is not available by traditional means.”

The graphic below shows the current market access to Tecfidera and Avonex for all controllers under the pharmacy benefit.

Radar on Market Access: State Lawmakers Tee Up Bills on PBMs, Drug Pricing This Year

January 16, 2020

State lawmakers will continue to focus on the cost of prescription drugs as the 2020 legislative season gets underway, potentially advancing measures to require the disclosure of manufacturer drug pricing information and bills to limit or eliminate the role PBMs play in state Medicaid programs, AIS Health reported.

State lawmakers will continue to focus on the cost of prescription drugs as the 2020 legislative season gets underway, potentially advancing measures to require the disclosure of manufacturer drug pricing information and bills to limit or eliminate the role PBMs play in state Medicaid programs, AIS Health reported.

However, the abbreviated length of the election-year legislative sessions, plus some unexpected hiccups in states that already have passed bills on those issues, could limit how much actually gets done at the state level in 2020, legislative observers say.

“We expect considerable action this year, but it is a short session in most states, which limits the number of bills that will be considered,” says Trish Riley, executive director of the National Academy for State Health Policy. “We expect to see bills that address prices, address price gouging [and] allow importation. Several states may advance bills to allow a buy-in to public programs and the ability to bulk purchase drugs.”

In recent years, state lawmakers have been looking into managed care programs and their drug spend, turning to their PBM contracts as a source of potential savings, says Matt Magner, director of state government affairs for the National Community Pharmacists Association. West Virginia, for example, decided in 2017 to carve out its pharmacy benefits from its Medicaid program, Magner says, noting, “they saved $54 million in the first year they did that.”

Still, the pace of state legislative action regarding PBMs may not be as brisk in 2020 as it was in 2019. Riley says that PBMs already have been the subject of considerable state action, so it’s not clear how many more states will consider bills on PBM issues in 2020. “We may see several more states eliminate or deeply regulate PBMs in Medicaid and develop more enforceable contracts to ensure discounts are passed through,” she says.

Drug pricing likely will stay in the news, says Jeff Myers, founder of OptDis, but he anticipates a slowdown in drug price transparency legislation, in part because states that have approved such legislation are running into roadblocks in implementation.

Radar On Market Access: 2020 Could Be ‘Wild Year’ for Consolidated PBMs

January 14, 2020

Though the two major transactions that upended the PBM landscape — Cigna Corp. buying Express Scripts Holding Co. and CVS Health Corp. acquiring Aetna Inc. — have already taken place, that doesn’t mean the sector won’t see more changes this year, industry experts tell AIS Health.

Though the two major transactions that upended the PBM landscape — Cigna Corp. buying Express Scripts Holding Co. and CVS Health Corp. acquiring Aetna Inc. — have already taken place, that doesn’t mean the sector won’t see more changes this year, industry experts tell AIS Health.

“The market is evolving,” says Brian Anderson, a principal with Milliman, Inc. The year 2020 will be marked by a presidential election and significant price pressure on manufacturers, along with pharmacies trying to retain their margin, he adds, “so it’s going to be a really wild year.”

Indeed, 2019 ended with Prime Therapeutics LLC and Express Scripts unveiling a three-year collaboration in which the latter PBM will negotiate with pharmaceutical manufacturers, on behalf of Prime’s members, for drugs covered on the pharmacy benefit, as well as provide services related to retail network contracting.

By teaming up with Prime, Express Scripts will be leading rebate negotiations and pharmacy network development for 103 million people, Adam Fein, Ph.D., CEO of Pembroke Consulting, Inc.’s Drug Channels Institute, wrote in a blog post. “This combined volume of Express Scripts and Prime will have enormous leverage with manufacturers and pharmacies,” he noted.

To Ashraf Shehata, KPMG national sector leader for health care and life sciences, the Prime/Express Scripts partnership is yet another example of “pure play” PBMs’ move toward consolidation. Given that trend, the opportunity to scale up both organizations’ purchasing power, and “the ability to kind of lock in Blue clients,” Shehata says, “I think it makes a lot of sense” for the two PBMs to team up.

Employers, meanwhile, are likely to press PBMs of all varieties for innovative solutions — not just deep drug-pricing discounts — during the selling season for 2021 contracts, Anderson says.

Therefore, “there’ll probably be a lot of new innovators in the market — people coming up with new products that maybe look and sound different,” he says. “But the question people are going to have to ask is, how different really is it? And is it really a differentiator in the marketplace?”

MMIT Reality Check on Cystic Fibrosis (Jan 2020)

January 10, 2020

According to our recent payer coverage analysis for cystic fibrosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for cystic fibrosis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for cystic fibrosis treatments shows that under the pharmacy benefit, almost 45% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Cystic fibrosis transmembrane conductance regulator (CFTR) modulators (Vertex Pharmaceuticals’ Trikafta, Symdeko, Orkambi and Kalydeco) are the first type of CF therapy to treat the root cause of the disease rather than the symptoms. Although costly, these therapies have made a large impact on market value.

Perspectives on UnitedHealth/Diplomat Deal

January 9, 2020

Diplomat Pharmacy, Inc., which has been in a tailspin amid mounting financial losses, agreed to a deal with UnitedHealth Group on Dec. 9 that will see the larger firm’s OptumRx division purchase the midsized specialty pharmacy provider/PBM, AIS Health reported.

Diplomat Pharmacy, Inc., which has been in a tailspin amid mounting financial losses, agreed to a deal with UnitedHealth Group on Dec. 9 that will see the larger firm’s OptumRx division purchase the midsized specialty pharmacy provider/PBM, AIS Health reported.

Diplomat’s difficulties began to come into focus earlier this year, when the firm disclosed customer losses in its PBM business and “increased competitive pressure in the specialty market.” In August, Diplomat said it was “reviewing strategic alternatives” to maximize shareholder value. Then on Dec. 9, UnitedHealth disclosed that it agreed to pay $4 per share for Diplomat’s outstanding stock and assume its debt. Equities analysts noted that Diplomat’s stock was trading at $5.81 as of market close on the Friday before the transaction was unveiled.

Adam Fein, Ph.D., CEO of Pembroke Consulting, Inc.’s Drug Channels Institute, says that “the specialty pharmacy market is reaching maturity, as PBMs and insurers dominate specialty drug dispensing channels.” Diplomat, he says, “was unable to navigate the industry’s evolution.”

“Diplomat’s sale at a bargain basement price signals that the shakeout is underway,” Fein adds. “Fewer new specialty pharmacies are starting up, the bigger companies are getting acquired, and market share is concentrating further with the biggest players.”

Ashraf Shehata, KPMG’s national sector leader for health care and life sciences, says that the purchase of Diplomat comes as the rivalry is intensifying between UnitedHealth and its two big consolidated rivals, CVS Health Corp. and Cigna Corp.

Now that those companies have completed major transactions to assemble their assets — with CVS buying health insurer Aetna and Cigna acquiring the PBM Express Scripts — “we’re kind of seeing what I call the second phase right now of the competition really heating up between the big players,” he says.

Growth continues to be the “name of the game” for those three companies, Shehata says, but it’s difficult to come by in an industry that’s already so consolidated. Because of that, “now you might see some growth on the edges” in the same vein as the UnitedHealth/Diplomat deal, he adds.

Radar On Market Access: Health Care Deals May Slow in 2020, but Government Markets Remain Hot

January 9, 2020

The pace of health care mergers and acquisitions likely will cool slightly in 2020, some industry experts tell AIS Health. Still, insurers are likely to seek out companies with assets such as care management or information technology solutions, while provider consolidation will continue in certain markets, AIS Health reported.

The pace of health care mergers and acquisitions likely will cool slightly in 2020, some industry experts tell AIS Health. Still, insurers are likely to seek out companies with assets such as care management or information technology solutions, while provider consolidation will continue in certain markets, AIS Health reported.

“We expect that payer M&A will continue into 2020, with a bias toward vertical rather than horizontal deals,” says Michael Abrams, managing partner of Numerof & Associates, Inc. “Payers will use such deals to expand into adjacent market spaces to differentiate their offerings as integrated platforms that can deliver superior value, customer experience and innovation.”

Joe Paduda, a principal with Health Strategy Associates, says he expects less M&A generally in 2020, for several reasons. “There aren’t as many assets to buy after the multiple deals done over the last few years; buyers are waiting to see results of the elections, which will drive their future strategy; and asset prices have edged even higher, making transactions more expensive and leaving less margin for error.”

Dan Mendelson, the founder of consulting firm Avalere Health, says he still sees plenty of potential targets for horizontal mergers, along with more targets for vertical deals.

“Health plans are in a transformative phase right now. There are three major areas of focus: government markets, care management, and the information technology needed to support quality improvement and cost reduction,” says Mendelson.

“In government markets, there are a range of quality assets that the larger plans could still acquire,” he adds. “There are also some non-profits that could engage in collaboration with for-profit organizations to expand their scope and reach.”

Medicare Advantage plans will be “a very strong target for M&A” in 2020, says Ashraf Shehata, KPMG’s national sector leader for health care and life sciences.

Shehata says he also expects insurers to “amass capabilities around their PBMs.” This, he says, could include bolstering their specialty pharmacy capabilities and building out technology.

Radar On Market Access: Navajo Nation, Molina Partner on Medicaid Managed Care in New Mexico

January 7, 2020

The business arm of the Navajo Nation plans to contract with Molina Healthcare, Inc., to offer Medicaid managed care as part of a partnership between New Mexico, tribal officials and the insurer, AIS Health reported.

The business arm of the Navajo Nation plans to contract with Molina Healthcare, Inc., to offer Medicaid managed care as part of a partnership between New Mexico, tribal officials and the insurer, AIS Health reported.

The program would be the first-ever Medicaid managed care program dedicated solely to the health care, cultural needs and geographic needs of native populations living in the Navajo Nation, according to Molina.

The new managed care plan — which Navajo Nation-owned Naat’aanii Development Corporation hopes to launch in 2020 — could cover up to 75,000 Navajos who live in New Mexico.
“This is very much led by the Navajo Nation,” says Sandeep Wadhwa, M.D., chief health officer and senior vice president of government programs for Solera Health.

The deal appears to be the first between a managed care company and an organization that is owned by a Native entity, Wadhwa, who is not affiliated with Molina, tells AIS Health. “There is a dimension of self-determination by the tribe and by American Indians that hadn’t been realized previously,” he says.

Under Medicaid, state-contracted managed care plans may be an option for American Indians and Alaska Natives, but this is the first time a tribal nation has contracted with a state Medicaid program, Wadhwa adds.

Approximately 100,000 Navajos live in New Mexico, and around three-quarters of them are eligible for Medicaid, according to the New Mexico Human Services Department (HSD). Navajos experience a heavy disease burden, with a mortality rate that’s 31% higher than the overall U.S. rate, HSD figures show.

If this arrangement with Molina and the Navajo Nation helps to improve health outcomes and reduce costs, there may be other tribes and tribal nations that consider similar initiatives, Wadhwa says.

MMIT Reality Check on Growth Hormone Deficiency (Jan 2020)

January 3, 2020

According to our recent payer coverage analysis for growth hormone deficiency treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for growth hormone deficiency treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for growth hormone deficiency treatments shows that under the pharmacy benefit, more than 63% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: As more growth hormone products become available, payers have even more tactics available to them to manage this specialty class. In particular, payers can manage their unit costs for these therapies by contracting with manufacturers to prefer products.

Trends That Matter for New Acute Migraine Medications

January 2, 2020

New oral medications for acute migraine — one pending launch and two more that could be approved in the coming months — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts tell AIS Health.

New oral medications for acute migraine — one pending launch and two more that could be approved in the coming months — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts tell AIS Health.

Eli Lilly and Co. on Oct. 11 received FDA approval for its drug Reyvow (lasmiditan), an oral medication that’s the first serotonin (5-HT)1F receptor agonist to be approved for migraine. Meanwhile, Allergan on Nov. 19 said it’s on track for December FDA consideration of ubrogepant, an oral CGRP receptor antagonist for acute migraine. Biohaven Pharmaceuticals also has applied for FDA approval on its oral CGRP antagonist rimegepant.

Mesfin Tegenu, R.Ph., president of PerformRx, doesn’t expect widespread uptake of Reyvow. “The launch of lasmiditan will likely not change the formulary status quo when it hits the market, as it most likely will become a niche medication for patients inadequately controlled on triptans, or for those who cannot take triptans,” Tegenu tells AIS Health. “This is primarily due to warnings on the label for driving impairment and central nervous system depression.”

The graphics below show the current market access to acute migraine medications for all payers under the pharmacy benefit.

Radar On Market Access: New Sickle Cell Medications Offer Both Opportunities and Challenges

January 2, 2020

The first targeted therapy to treat pain crises in people with sickle cell disease presents a “welcome” new option that payers likely will embrace, a PBM head tells AIS Health. While the drug’s manufacturer cites “positive” early discussions with payers on it, some experts note the lifetime treatment — via a monthly intravenous infusion — is costly: around $100,000 annually.

The first targeted therapy to treat pain crises in people with sickle cell disease presents a “welcome” new option that payers likely will embrace, a PBM head tells AIS Health. While the drug’s manufacturer cites “positive” early discussions with payers on it, some experts note the lifetime treatment — via a monthly intravenous infusion — is costly: around $100,000 annually.

On Nov. 15, the FDA approved Novartis’ Adakveo (crizanlizumab-tmca), a treatment to fight the underlying cause and reduce the frequency of vaso-occlusive crisis, described as a common and painful complication of sickle cell disease. It is approved for patients ages 16 and older with the genetic blood disorder.

Hydroxyurea, a drug approved by the FDA in 1998, is now generic, costs about $1,000 a year, and is approved for children, the New York Times reported on Dec. 7. The two newcomers are Adakveo and Global Blood Therapeutics’ Oxbryta (voxelotor), a daily pill granted accelerated approval by the FDA 10 days after Adakveo’s approval. This led one expert to tell the news outlet that insurers likely will want to begin with hydroxyurea as the front-line therapy.

Yet Mesfin Tegenu, R.Ph., president of PerformRx, LLC, says that “options for patients with sickle cell disease have been very limited up to this point, so the approval of Adakveo is a welcome addition in the treatment of this debilitating disease.”

Eric Althoff, a Novartis spokesperson, says the company anticipates that health plans will see a value proposition with Adakveo. “Early discussions with payers are positive,” Althoff says. “In fact, a number of payers have already added Adakveo to medical policy including state Medicaid [programs].” Florida and Alabama’s Medicaid programs have agreed to cover Adakveo, Reuters reported on Dec. 20.

MMIT Reality Check on Ovarian Cancer (Dec 2019)

December 27, 2019

According to our recent payer coverage analysis for ovarian cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ovarian cancer treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ovarian cancer treatments shows that under the medical benefit, almost 46% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Most products are limited by their policies for treatment at specific stages of ovarian cancer. This may not remain true as we see clinical trials proving that targeted therapies can provide improvement earlier in the disease cycle and during the maintenance phase.

Radar On Market Access: Health Insurers Receive Multiple Gifts In Year-End Spending Package

December 26, 2019

For health insurers, there’s a lot to like in a spending package passed by Congress to avoid a government shutdown.

One of the two measures that make up the $1.4 trillion spending package will completely repeal the long-reviled health insurer fee (HIF) starting in 2021, which will especially help insurers in the Medicare Advantage business. The legislation also includes two provisions to that could stabilize the Affordable Care Act exchanges by thwarting any attempts to ban silver loading or auto-reenrollment, AIS Health reported.

For health insurers, there’s a lot to like in a spending package passed by Congress to avoid a government shutdown.

One of the two measures that make up the $1.4 trillion spending package will completely repeal the long-reviled health insurer fee (HIF) starting in 2021, which will especially help insurers in the Medicare Advantage business. The legislation also includes two provisions to that could stabilize the Affordable Care Act exchanges by thwarting any attempts to ban silver loading or auto-reenrollment, AIS Health reported.

And portions of the Lower Health Care Costs Act of 2019 — including new transparency requirements for contracts between providers and health plans, and a solution to surprise medical billing that involved arbitration — neither passed on their own nor made it into the spending package.

President Donald Trump signed the spending package into law on Dec. 20 after both the House and Senate passed the legislation.

The HIF repeal, effective starting in 2021, is the most significant portion of the spending package for the managed care industry.

“This legislation is an early Christmas gift for healthcare stocks across the board,” Evercore ISI analyst Michael Newshel advised investors in a Dec. 16 research note. “We had been anticipating HIF relief for 2021 and maybe 2022 too, but permanent repeal is of course better and removes any future uncertainty about the fee’s possible return [after 2020],” he wrote.

Citi Research analyst Ralph Giacobbe added that the HIF’s repeal is “a major win for the MCOs, particularly those with significant Medicare Advantage exposure like [Humana] given the dynamics of that end market and the inability to pass through the tax.”

In the commercial insurance market, carriers have largely passed the cost of the HIF onto their members, “so eliminating it would have the impact of reducing premiums for consumers, which would be politically expedient,” Credit Suisse analyst A.J. Rice wrote in a Dec. 16 note.

Perspectives on Dual Eligible SNPs

December 26, 2019

Through strategic acquisitions, product launches and geographic expansions, Medicare Advantage insurers across the U.S. are offering new Special Needs Plans (SNPs) aimed at improving the lives of members who are dually eligible for Medicare and Medicaid, AIS Health reported.

Through strategic acquisitions, product launches and geographic expansions, Medicare Advantage insurers across the U.S. are offering new Special Needs Plans (SNPs) aimed at improving the lives of members who are dually eligible for Medicare and Medicaid, AIS Health reported.

According to an analysis of the 2020 “landscape” files posted by CMS in September, Chicago health care consultancy Clear View Solutions, LLC, estimates that there are 171 net new SNP IDs, up from 60 net new plans in 2019. And 97 of those net new plans are dual eligible SNPs, compared with 47 D-SNPs that were introduced for 2019.

“I do think there is some ‘pent up energy’ from plans, and now that there is clarity with permanency and the requirements for integration, plans are ready to move forward,” Cheryl Phillips, M.D., CEO of the SNP Alliance, says in an email to AIS Health.

Phillips says plans may also be “working to better position themselves” for managed long-term services and supports, as states sharpen their focus on rebalancing their long-term care populations and shift more of the responsibility to managed care organizations.

A review of the new D-SNP offerings for 2020 indicates that larger players such as Anthem, Inc., Centene Corp., Humana Inc., Molina Healthcare, Inc. and UnitedHealthcare are leading the charge, but numerous plans have been introduced on a local level.

For instance, UCare, the largest provider of SNPs in Minnesota, said it is expanding its UCare Connect + Medicare plans to mirror the 62-county UCare Connect service area. And Priority Health is preparing to launch its first D-SNP, which will serve all 68 counties of Michigan’s lower peninsula.

Radar On Market Access: Uptake of New MA Supplemental Benefits Remains Modest in 2020, Report Says

December 24, 2019

Despite Medicare Advantage insurers’ enthusiasm for increased flexibility in allowable supplemental benefits and a slew of recent plan press releases touting goodies such as pest control and “Papa Pals” for the 2020 plan year, uptake of more “resource intensive” benefits geared toward seriously ill seniors remains relatively modest, according to a new report from the Duke Margolis Center for Health Policy.

Despite Medicare Advantage insurers’ enthusiasm for increased flexibility in allowable supplemental benefits and a slew of recent plan press releases touting goodies such as pest control and “Papa Pals” for the 2020 plan year, uptake of more “resource intensive” benefits geared toward seriously ill seniors remains relatively modest, according to a new report from the Duke Margolis Center for Health Policy.

The December report, “Improving Serious Illness Care in Medicare Advantage: New Regulatory Flexibility for Supplemental Benefits,” showed that a total of 507 standard MA plans in 2019 offered one of five types of benefits addressing serious illness, accounting for roughly 11% of the approximately 4,500 standard MA plans in 2019, AIS Health reported. By contrast, 377 in 2020 offered at least one of the five benefits highlighted in the report, while no plans in 2019 offered more than one of these benefits. But that drop was mainly driven by one major carrier abandoning its caregiver support benefit for 2020. Meanwhile, about 175 plans offered at least two of these types of these benefits, according to Robert Saunders, research director and one of the report’s authors.

Despite the decrease in caregiver support, which had the greatest initial uptake of the five benefit categories in 2019, researchers saw meaningful increases for 2020 in benefits such as adult day care and palliative care that “more directly address the needs of members with serious illness.”

The study also linked the PBP data to MA enrollment figures by plan and by county to assess the geographic impacts of the policy changes. For 2020, many parts of the country do not have any plans offering new supplemental benefits, and those aimed at serious care were likely to be offered in urban counties, said the report.

Barring any major disruption, 2021 will likely be the year of growth for new flexible benefits, as it takes plans a couple years to price, test and stand up ones that will have a lasting impact, adds Saunders.

MMIT Reality Check on Migraine (Dec 2019)

December 20, 2019

According to our recent payer coverage analysis for migraine treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for migraine treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for migraine treatments shows that under the pharmacy benefit, almost 47% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: New oral medications for acute migraine — Eli Lilly and Co.’s Reyvow (lasmiditan), Allergan’s ubrogepant and Biohaven Pharmaceuticals’ CGRP antagonist rimegepant — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts say.

Trends That Matter for Anti-VEGF Market

December 19, 2019

In October 2019, the FDA approved Beovu (brolucizumab-dbll) from Novartis Pharmaceuticals Corp. for the treatment of neovascular (wet) age-related macular degeneration (AMD). The intravitreal injection will compete in a fairly crowded anti-vascular endothelial growth factor (anti-VEGF) market that is led by Eylea (aflibercept) from Regeneron Pharmaceuticals, Inc., AIS Health reported.

In October 2019, the FDA approved Beovu (brolucizumab-dbll) from Novartis Pharmaceuticals Corp. for the treatment of neovascular (wet) age-related macular degeneration (AMD). The intravitreal injection will compete in a fairly crowded anti-vascular endothelial growth factor (anti-VEGF) market that is led by Eylea (aflibercept) from Regeneron Pharmaceuticals, Inc., AIS Health reported.

Novartis priced Beovu at $1,850 per vial — the same per-dose price as Eylea. Following three initial monthly doses, Beovu can be administered every eight to 12 weeks. Eylea also has three initial monthly doses and then may be administered every four, eight or 12 weeks..

For the Managed Care Biologics and Injectables Index: Q4 2018, Zitter surveyed pharmacy and therapeutics (P&T) committee members who work for 51 commercial payers with 139.8 million covered lives between Nov. 30, 2018, and Jan. 7, 2019. When asked about how they would manage Beovu and Eylea, 49% said they were more likely than unlikely or significantly likely to manage the two drugs at parity.

Thirty-five percent said they were more likely than unlikely or significantly likely to start discussions with Regeneron to prefer Eylea over Beovu. Sixteen percent said it was likely or significantly likely that they would prefer Beovu over other anti-VEGF agents besides Eylea.

The graphic below shows the current market access to age-related macular degeneration medications for all payers under the pharmacy benefit.

Radar On Market Access: Patient-Reported Outcomes Play Key Role in New Multiple Sclerosis Value-Based Contract

December 19, 2019

Under a value-based contracting agreement believed to be the first of its kind, UPMC Health Plan will receive discounts for two Biogen Inc. multiple sclerosis (MS) drugs — Tecfidera (dimethyl fumarate) and Avonex (interferon beta-1a) — based on patient-reported measures of disability progression. The agreement is also based on research with a panel of key MS stakeholders who identified the most meaningful outcomes in relapsing forms of MS, AIS Health reported.

Under a value-based contracting agreement believed to be the first of its kind, UPMC Health Plan will receive discounts for two Biogen Inc. multiple sclerosis (MS) drugs — Tecfidera (dimethyl fumarate) and Avonex (interferon beta-1a) — based on patient-reported measures of disability progression. The agreement is also based on research with a panel of key MS stakeholders who identified the most meaningful outcomes in relapsing forms of MS, AIS Health reported.

UPMC’s Center for Value-Based Pharmacy Initiatives led the research and developed the value-based contract.

Previous value-based contracts for MS drugs have connected payment to outcome indicators derived from claims and electronic health record data, says Rochelle Henderson, Ph.D., Express Scripts’ vice president of research and a co-author of the study report.

“This research [gives] a greater level of transparency into the outcome indicators that rank the highest in terms of value for stakeholders,” she says. “The key advantage of patient-reported outcomes is that it gets at information that can be used to evaluate the success of a medication where that information is not available by traditional means.”

Similarly, Henderson says, many outcomes that are important to payers are not available in the electronic medical record. “What we learned is that stakeholders rated ‘worsening physical disability’ and ‘functional impairment’ as the most valuable indicators for providing information about the status of MS.”

Payer interest and participation in outcomes-based contracting with manufacturers continues to grow. “Based on our research and our discussions with stakeholders in health care, there are a number of organizations on the payer side who would like to go in this direction,” says Avalere Health’s John E. Linnehan, practice director of health economics and advanced analytics.

“Payers typically are looking for outcomes-based contracting in conditions with high prevalence, high costs, or both,” Linnehan says, adding that because the MS category includes new entrants and generics, it is a focus of interest for outcomes-based contracts.

Radar On Market Access: UnitedHealth Makes Deal to Buy Diplomat as Industry Consolidation Enters ‘Second Phase’

December 17, 2019

Diplomat Pharmacy, Inc., which has been in a tailspin amid mounting financial losses, agreed to a deal with UnitedHealth Group on Dec. 9 that will see the larger firm’s OptumRx division purchase the midsized specialty pharmacy provider/PBM, AIS Health reported.

Diplomat Pharmacy, Inc., which has been in a tailspin amid mounting financial losses, agreed to a deal with UnitedHealth Group on Dec. 9 that will see the larger firm’s OptumRx division purchase the midsized specialty pharmacy provider/PBM, AIS Health reported.

Diplomat’s difficulties began to come into focus earlier this year, when the firm disclosed customer losses in its PBM business and “increased competitive pressure in the specialty market.” In August, Diplomat said it was “reviewing strategic alternatives” to maximize shareholder value. Then on Dec. 9, UnitedHealth disclosed that it agreed to pay $4 per share for Diplomat’s outstanding stock and assume its debt. Equities analysts noted that Diplomat’s stock was trading at $5.81 as of market close on the Friday before the transaction was unveiled.

Adam Fein, Ph.D., CEO of Pembroke Consulting, Inc.’s Drug Channels Institute, says that “the specialty pharmacy market is reaching maturity, as PBMs and insurers dominate specialty drug dispensing channels.” Diplomat, he says, “was unable to navigate the industry’s evolution.”

“Diplomat’s sale at a bargain basement price signals that the shakeout is underway,” Fein adds. “Fewer new specialty pharmacies are starting up, the bigger companies are getting acquired, and market share is concentrating further with the biggest players.”

Ashraf Shehata, KPMG’s national sector leader for health care and life sciences, says that the purchase of Diplomat comes as the rivalry is intensifying between UnitedHealth and its two big consolidated rivals, CVS Health Corp. and Cigna Corp.

Now that those companies have completed major transactions to assemble their assets — with CVS buying health insurer Aetna and Cigna acquiring the PBM Express Scripts — “we’re kind of seeing what I call the second phase right now of the competition really heating up between the big players,” he says.

Growth continues to be the “name of the game” for those three companies, Shehata says, but it’s difficult to come by in an industry that’s already so consolidated. Because of that, “now you might see some growth on the edges” in the same vein as the UnitedHealth/Diplomat deal, he adds.

MMIT Reality Check on Multiple Myeloma (Dec 2019)

December 13, 2019

According to our recent payer coverage analysis for multiple myeloma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for multiple myeloma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for multiple myeloma treatments shows that under the pharmacy benefit, almost 52% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2019, the FDA gave accelerated approval to Karyopharm Therapeutics Inc.’s Xpovio (selinexor) in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody.

Perspectives on Preferred Cost-Sharing Pharmacy Networks

December 12, 2019

In the Medicare Part D market in 2020, preferred cost-sharing pharmacy networks continue to be king. But because independent pharmacies often find themselves shut out of such arrangements, recently introduced legislation is seeking to change that dynamic.

In the Medicare Part D market in 2020, preferred cost-sharing pharmacy networks continue to be king. But because independent pharmacies often find themselves shut out of such arrangements, recently introduced legislation is seeking to change that dynamic.

“The Part D plans have fully adopted preferred networks over the last few years,” Adam Fein, Ph.D., president of Pembroke Consulting, Inc., and CEO of Drug Channels Institute, tells AIS Health. “The [retail] chains obviously have some different strategies but are looking for the foot traffic” that comes from offering lower cost sharing as part of a preferred network.

Meanwhile, many independent pharmacies and the pharmacy services administrative organizations (PSAOs) that represent them in negotiations with health plans are moving away from preferred Part D networks.

Fein says they “have concluded that the incremental traffic they’re going to get is not worth the profit they’re going to sacrifice.”

Ultimately, “I think the open question is, will this create access problems to preferred networks, and does CMS care?” he says.

The National Community Pharmacists Association (NCPA) isn’t counting on regulatory intervention. The organization is supporting a bill — introduced last month by U.S. Reps. Peter Welch (D-Vt.) and Morgan Griffith (R-Va.) — which would allow any pharmacy located in an underserved area to participate in a Part D preferred network as long as that pharmacy accepts the terms and conditions.

“We’re not asking for different terms and conditions, [or] higher reimbursement; we’re just asking to be able to see what the terms and conditions are to be in the preferred network and then make our best decision if we want to participate or not,” says Ronna Hauser, the president of policy and government affairs operations at NCPA.

The Pharmaceutical Care Management Association opposes the bill.

“The proposed any willing pharmacy provisions threaten the effectiveness of selective contracting with pharmacies as a tool for lowering costs,” says as statement from the PBM trade group.