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MMIT Reality Check on HeFH (Mar 2021)

March 26, 2021

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

According to our recent payer coverage analysis for HeFH 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 HeFH treatments shows that under the pharmacy benefit, about 66% of the lives under commercial formularies are covered with utilization management
restrictions.

Trends: In February 2020, the FDA approved Esperion Therapeutics, Inc.’s Nexletol (bempedoic acid) tablet, a once-daily, non-statin LDL-cholesterol-lowering medicine, for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

Radar On Market Access: Health Insurers May See Earnings Hit From COVID Vaccine Reimbursement Hike

March 25, 2021

CMS has significantly boosted the amount that Medicare will pay for administering COVID-19 vaccines, a move that appears to be a positive development for health care providers and retail pharmacies but a potential headwind for commercial health insurers, AIS Health reported.

Previously, the national average Medicare payment rate for administering single-dose vaccines was $28, but CMS on March 15 increased that to $40. For two-dose vaccines, the rate rose from $45 to $80.

CMS has significantly boosted the amount that Medicare will pay for administering COVID-19 vaccines, a move that appears to be a positive development for health care providers and retail pharmacies but a potential headwind for commercial health insurers, AIS Health reported.

Previously, the national average Medicare payment rate for administering single-dose vaccines was $28, but CMS on March 15 increased that to $40. For two-dose vaccines, the rate rose from $45 to $80.

Since the federal government has already purchased large quantities of the three FDA-authorized COVID-19 vaccines and distributed them free of charge to providers, neither public nor private health plans will have to absorb the cost of the vaccines themselves. But federal rules require non-grandfathered individual and group plans to pay both in and out-of-network providers a “reasonable rate” for administering the vaccines that references Medicare’s reimbursement rate as a guideline.

Given the increased Medicare payment rates for COVID vaccine administration, “CMS will expect commercial carriers to continue to ensure that their rates are reasonable in comparison to prevailing market rates,” the agency said in its March 15 press release.

In a March 16 note to investors, Credit Suisse analyst A.J. Rice deemed the heightened Medicare reimbursement rate for administering COVID vaccines a “modest headwind for commercial health plans.” He predicted a larger negative impact on “more heavily concentrated commercial plans” such as Anthem, Inc. and Centene Corp., and a smaller hit for government-focused insurers like Humana Inc. and for diversified firms including Cigna Corp., CVS Health Corp. (which owns Aetna) and UnitedHealth Group.

Health care providers, on the other hand, welcomed CMS’s move. In a statement, American Medical Association President Susan R. Bailey, M.D., wrote that “this has been a trying time for physician practices, and we thank the administration for acknowledging the challenges of practicing medicine during a pandemic.”

Companies with significant retail pharmacy holdings also stand to gain from CMS’s move. Citi analyst Ralph Giacobbe estimated in a March 16 research note that Medicare’s reimbursement increase could boost CVS Health’s earnings per share by approximately 39 cents and Walgreens Boots Alliance’s by about 52 cents.

Trends That Matter for New Heart Failure Drugs

March 25, 2021

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis’ Entresto (sacubitril/valsartan) and Amgen’s Corlanor (ivabradine) — are important additions to prescribers’ clinical arsenals against the high-mortality condition, industry insiders tell AIS Health.

“Generic heart failure drugs, including beta blockers, ACE inhibitors, and ARBs [angiotension receptor blockers] have historically been used and continue to be the backbone of therapy,” says April Kunze, Pharm.D., senior director of clinical program development for Prime Therapeutics. “However, in the past few years, additional treatment options have become available. Entresto is now recommended as a first-line treatment option in patients with an ejection fraction <= 40%."

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis’ Entresto (sacubitril/valsartan) and Amgen’s Corlanor (ivabradine) — are important additions to prescribers’ clinical arsenals against the high-mortality condition, industry insiders tell AIS Health.

“Generic heart failure drugs, including beta blockers, ACE inhibitors, and ARBs [angiotension receptor blockers] have historically been used and continue to be the backbone of therapy,” says April Kunze, Pharm.D., senior director of clinical program development for Prime Therapeutics. “However, in the past few years, additional treatment options have become available. Entresto is now recommended as a first-line treatment option in patients with an ejection fraction <= 40%.”

Novartis said Feb. 16 that Entresto won an expanded indication from the FDA to reduce the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure. “Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal,” the drugmaker said.

Prime Therapeutics currently prefers Entresto on formulary, and the PBM recommends that plans remove prior authorizations for Entresto in order to encourage its use, Kunze says.

Mesfin Tegenu, CEO and chairman of RxParadigm, says that Entresto, which has an average retail price of around $600 per month, typically is placed on formularies as a preferred brand drug. Meanwhile, Amgen’s Corlanor can be beneficial in reducing heart failure-associated hospitalization for patients with symptomatic (NYHA Class II-III) stable chronic heart failure with a left ventricular ejection fraction of less than or equal to 35% who are receiving a maximal tolerated targeted dose of a beta blocker and in sinus rhythm with a heart rate of 70 beats per minute or greater at rest, Tegenu says.

The graphic below show how key chronic heart failure medications are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.

Radar On Market Access: How Will Subsidy Expansion Impact ACA Marketplaces?

March 23, 2021

For an individual health insurance market that is already hitting its stride, the new pandemic relief legislation’s expansion of Affordable Care Act (ACA) subsidies is yet another positive catalyst that should make the exchanges more attractive to insurers and customers alike, experts tell AIS Health.

Under the American Rescue Plan, which President Joe Biden signed into law on March 11, individuals who already qualified for premium tax credits under the ACA will see more generous financial aid. In addition, people who earn more than 400% of the federal poverty level (FPL) will be eligible for reduced premiums for the first time thanks to a provision that caps marketplace premiums at 8.5% of all enrollees’ income.

For an individual health insurance market that is already hitting its stride, the new pandemic relief legislation’s expansion of Affordable Care Act (ACA) subsidies is yet another positive catalyst that should make the exchanges more attractive to insurers and customers alike, experts tell AIS Health.

Under the American Rescue Plan, which President Joe Biden signed into law on March 11, individuals who already qualified for premium tax credits under the ACA will see more generous financial aid. In addition, people who earn more than 400% of the federal poverty level (FPL) will be eligible for reduced premiums for the first time thanks to a provision that caps marketplace premiums at 8.5% of all enrollees’ income.

Fritz Busch, an actuary at Milliman, Inc., says the newly expanded ACA subsidies will likely bring even more people into the exchanges than the pandemic-related special enrollment period that started Feb. 15. And, “it’s generally agreed that more membership in the individual market means favorable morbidity,” so actuaries will need to figure out just what the impact of that will be, he adds.

Looking ahead to 2022, not only will the revamped subsidies bring more people into the marketplaces, but they will also likely change how people sort themselves among the different coverage tiers — and how insurers respond, Busch says.

“The higher subsidies go, the more likely it is going to be that someone is eligible for a free plan — particularly bronze plans, so there could be some movement towards bronze because of that,” he explains. Health insurers, then, “will want to make sure that they’re in position for [enrollees] to select their bronze plan as a free plan. If their bronze plans are too expensive, they’re not going to be free anymore.”

“We’ll also have an extensive increase of competition in marketplaces in 2022, ’23 and ’24,” says David Anderson, a research associate at the Duke-Margolis Center for Health Policy. He predicts that more insurers will enter the marketplaces and spread their footprints within states where they already operate.

With that increased competition, which will continue a trend already taking place on the exchanges, “the opportunity for monopoly pricing…is going down dramatically,” according to Anderson.

MMIT Reality Check on Immune Globulin (PID) (Mar 2021)

March 19, 2021

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 54% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Few plans have shifted towards specialty pharmacy procurement for immunoglobulin products. Since CMS allowed a step therapy in Medicare Part B in 2019, many plans implemented a step therapy strategy that includes immunoglobulin therapy.

Radar On Market Access: Orphan Drug Act Has Been Overused, A New Study Shows

March 18, 2021

A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.

The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.

A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.

The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.

The new paper found that 70.7% of spending on drugs designated as orphan drugs went “to nonorphan indications,” and noted that in 2017, 25% of U.S. prescription drug spending was for orphan drugs.

Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, asserts that the orphan drug designation is being abused by drug companies.

“They [orphan drugs] treat a small number of patients, but at the same time they can be used to treat much more common diseases. So they [drugmakers] can still charge a high price and take the tax credit, while at the same time enjoying their impressive commercial success,” Bai says.

Bai adds that drugmakers have become adept at coordinating outside pressure to convince the FDA to expand orphan drug designations beyond their intended purpose.

“We have so many patient advocacy groups — they are representing rare disease patients. And many of those advocacy groups are heavily sponsored by drug manufacturers,” Bai says. “You cannot just single out the drugs that are being most abused — because even those drugs do have orphan drug features….It’s very hard to disentangle.”

Similarly, Avalere Health’s Lilian Buch and David Kowalsky observed during a Feb. 26 podcast that the orphan drug advocacy work that manufacturers coordinate with patients does serve an important purpose and can improve patient outcomes on an individual basis. Kowalsky is director of the consulting firm’s commercialization and regulatory strategy practice, while Buch is an associate principal in the same practice.

Buch added that, for some rare disease patients with acute symptoms, drug manufacturers sometimes offer the kind of support services more often provided by plans or providers.

Perspectives on Stock Selloff Following CVS 4Q Earnings Report

March 18, 2021

Although CVS Health Corp.’s stock price dropped about 5% after the company reported its fourth-quarter and full-year 2020 financial results on Feb. 16, equities analysts seemed to be unshaken in their view that the firm — which owns health insurer Aetna — has strong fundamentals, AIS Health reported.

For the fourth quarter of 2020, CVS’s net income of $975 million was down 44% compared with the prior-year period, a result the company partially attributed to lower operating income driven by the impact of the COVID-19 pandemic on its Health Care Benefits and Retail/Long-Term Care segments. For the full year 2020, CVS’s operating income and net income increased relative to 2019.

Although CVS Health Corp.’s stock price dropped about 5% after the company reported its fourth-quarter and full-year 2020 financial results on Feb. 16, equities analysts seemed to be unshaken in their view that the firm — which owns health insurer Aetna — has strong fundamentals, AIS Health reported.

For the fourth quarter of 2020, CVS’s net income of $975 million was down 44% compared with the prior-year period, a result the company partially attributed to lower operating income driven by the impact of the COVID-19 pandemic on its Health Care Benefits and Retail/Long-Term Care segments. For the full year 2020, CVS’s operating income and net income increased relative to 2019.

Total revenues in the fourth quarter and full-year 2020 increased 4% and 4.6%, respectively, compared with the prior year, according to CVS’s earnings release. The company’s fourth-quarter adjusted earnings per share of $1.30 beat the Wall Street consensus of $1.24.

In a Feb. 17 note, Citi analyst Ralph Giacobbe said his firm views CVS’s results “as generally balanced, with better performance within PBM and health benefits, and in line for its retail segment.” Nevertheless, he acknowledged that “we received a number of calls/emails on the heels of the CVS 4Q20 print/guidance and the subsequent sell-off in shares.”

In their own Feb. 17 note, Evercore ISI analysts weighed in that “CVS’s stock price is down ~5% as we write, which seems overdone to us.” The company’s 2021 guidance “was in-line with prior commentary, which makes sense given that there is little incentive to be aggressive at this point in the year and with Karen [Lynch] just taking over the reins,” they added. Lynch, formerly president of Aetna, replaced the retiring Larry Merlo as CVS CEO on Feb. 1.

Giacobbe observed that CVS’s “commentary around utilization assumptions for the year also raised questions/concerns, as management noted that it was not projecting high levels of pent-up demand given system capacity constraints.”

Lynch said during earnings call that in the fourth quarter the company saw utilization of total health care services “return to more near-normal seasonal levels as higher COVID-related costs were partially offset by somewhat lower levels of traditional services.”

CVS said total medical membership in its Health Care Benefits segment rose by about 140,000 from the third to fourth quarters, reaching 23.4 million. That largely reflected enrollment increases in its Medicaid and Medicare plans, but those gains were partially offset by a 35,000 decline in commercial enrollment.

Radar On Market Access: Ohio Names New Medicaid PBM, Sues One of Current Vendors

March 16, 2021

Ohio recently cleared a key hurdle in its plan to revamp how Medicaid enrollees’ pharmacy benefits are managed, choosing Gainwell Technologies as the single PBM that will replace big-name firms including Cigna Corp.’s Express Scripts, CVS Heath Corp.’s Caremark, UnitedHealth Group’s OptumRx and Centene Corp.’s Envolve Pharmacy Solutions, AIS Health reported.

Although PBMs and insurers generally oppose state moves to carve out pharmacy benefits from their Medicaid managed care contracts, Ohio says it expects the new single-PBM approach will “drive transparency, reduce pharmacy costs and simplify provider administration.”

Ohio recently cleared a key hurdle in its plan to revamp how Medicaid enrollees’ pharmacy benefits are managed, choosing Gainwell Technologies as the single PBM that will replace big-name firms including Cigna Corp.’s Express Scripts, CVS Heath Corp.’s Caremark, UnitedHealth Group’s OptumRx and Centene Corp.’s Envolve Pharmacy Solutions, AIS Health reported.

Although PBMs and insurers generally oppose state moves to carve out pharmacy benefits from their Medicaid managed care contracts, Ohio says it expects the new single-PBM approach will “drive transparency, reduce pharmacy costs and simplify provider administration.”

“The main idea was to make sure that any PBMs that were serving the Ohio Medicaid managed care plans didn’t have conflicts of interest [and] weren’t steering business toward their sister companies — and also to save money for the state,” says Margaret Scott, an associate principal at Avalere Health who oversaw the Ohio Dept. of Medicaid’s pharmacy program until 2017.

Gainwell fits the bill in that it “doesn’t own any retail or specialty pharmacies; they don’t have any incentives to encourage members to go to one pharmacy or another or to use one drug or another. They’re free of any conflicts in that way,” Scott explains.

Ohio’s transition from multiple MCO-contracted PBMs to a single vendor is the culmination of a series of events in which the state publicly took PBMs to task for their business practices and decided to overhaul its entire Medicaid managed care program. In the most recent salvo, Ohio Attorney General Dave Yost (R) revealed on March 11 that the state is suing Centene Corp. “for an elaborate scheme to maximize company profits at the expense of the Ohio Department of Medicaid (ODM).” Centene, however, said the state’s claims are unfounded, and that Envolve Pharmacy Solutions “will aggressively defend the integrity of the pharmacy services provided to the State of Ohio.”

Ohio is not the only state to rethink how its Medicaid program interacts with PBMs. California and New York will effectively carve out pharmacy benefits from their managed care programs starting in April.

Such moves, Scott adds, are “part of a larger trend where states are taking more control of their pharmacy benefits — whether it’s doing it with a single PDL [prescription drug list] so that they’re maximizing their rebates and getting the lowest net cost on drugs, or it’s carving out pharmacy, or in other ways ensuring transparency in PBM contracts.”

MMIT Reality Check on Non-Small Cell Lung Cancer EGFR Mutated (Mar 2021)

March 12, 2021

According to our recent payer coverage analysis for non-small cell lung cancer EGFR mutated 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 EGFR mutated 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 EGFR mutated treatments shows that under the pharmacy benefit, about 60% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Many drugs to treat NSCLC are on the market today, and multiple ones are in Phase III trials. The discovery of genetic alterations that drive tumor growth has changed the clinical management of the disease and produced specific targeted therapies to treat the various genetic mutations.

 

Radar On Market Access: Cigna’s Evernorth to Acquire MDLive in Telehealth Expansion

March 11, 2021

Health insurers have begun to consolidate their position in the telehealth market, as indicated by a recent move by Cigna Corp. to acquire MDLive Inc. Meanwhile, lawmakers are beginning to consider the future of telehealth regulation and payment, AIS Health reported.

Cigna’s Evernorth health services arm announced on Feb. 26 that it had reached an agreement with MDLive to acquire the virtual care provider, according to MDLive’s website. MDLive has been available in-network as a primary care option to all members of Cigna’s commercial plans since January 2020.

Health insurers have begun to consolidate their position in the telehealth market, as indicated by a recent move by Cigna Corp. to acquire MDLive Inc. Meanwhile, lawmakers are beginning to consider the future of telehealth regulation and payment, AIS Health reported.

Cigna’s Evernorth health services arm announced on Feb. 26 that it had reached an agreement with MDLive to acquire the virtual care provider, according to MDLive’s website. MDLive has been available in-network as a primary care option to all members of Cigna’s commercial plans since January 2020.

Ashraf Shehata, national sector leader for health care and life sciences at KPMG, says he expects even more efforts by payers to offer telehealth benefits directly to members.

He adds that the COVID-19 pandemic has acted as an accelerant for telemedicine use. He expects patients will continue to demand telemedicine options even after the pandemic subsides, and that payers will see that demand as an opportunity to narrow the gap between themselves and members.

“We saw that with massive and immediate uptake of the platforms — all the platforms, I should say. Not only did [payers] use their existing platform relationships, but they added new platforms because demand is so high,” Shehata explains.

Shehata adds that robust, internal telemedicine options offer plans an opportunity to exercise leverage in negotiations with provider systems, which have sought to have virtual visits reimbursed at the same rate as traditional visits.

The payment equity question is central to the coming regulatory battle over telemedicine. Payer and plan sponsor lobbying groups will square off against providers in Congress over whether virtual visits should be reimbursed at the same rate as in-person visits. Early in the pandemic, the Trump administration mandated that Medicare must reimburse most telehealth visits at parity with traditional visits.

Also at issue is whether the full menu of services authorized in response to the pandemic will continue to be eligible for Medicare reimbursement. CMS expanded the types of services that could be delivered via telehealth to Medicare beneficiaries, temporarily adding 135 services. Unless Congress acts or the Biden administration issues new rules, the remaining expanded services will expire either at the end of 2021, or when the pandemic public health emergency ends.

In a March 2 hearing of the House Committee on Energy and Commerce’s Subcommittee on Health, legislators indicated that they are studying both issues.