Member: Spotlight on MMIT Solutions

Pallavi Garg

September 9, 2019

Pallavi Garg is a client success analyst (CSA) at MMIT. Garg has always enjoyed working with data, but it wasn’t until she took a consulting position at Biogen that she discovered her love of market access data. In her CSA role, Pallavi works with the client experience team to create custom reporting to help clients better understand MMIT data.

Q: Tell us more about your role.

A: I’m a CSA and in this role,

Pallavi Garg is a client success analyst (CSA) at MMIT. Garg has always enjoyed working with data, but it wasn’t until she took a consulting position at Biogen that she discovered her love of market access data. In her CSA role, Pallavi works with the client experience team to create custom reporting to help clients better understand MMIT data.

Q: Tell us more about your role.

A: I’m a CSA and in this role, I work very closely with the client success leads (CSLs), who are the leads on the accounts, to help solve our clients’ data questions. When clients have questions about our data, connecting tables in the data feed, or they need an “ad hoc” report, the CSAs are the ones who have the answers. When our clients need insight on their product’s coverage in the market, the CSA team can help give perspective by creating different visuals and tables depending on the client’s needs. It’s a very customizable service, as we are helping clients understand our data quickly and helping them resolve any questions or special requests they may have.

Q: What’s your day to day like?

A: The main focus of my role is working with CSLs to ensure as a team we are creating a seamless experience for the client from the time they make their requests to the time we deliver the data, and ensuring that we deliver a high quality product for the client. In this role, the CSL is your client, so every day I’m helping them with answering any data questions the clients may have or coming up with solutions to client data requests. When a client doesn’t have a huge analytics team, they may come to the CSL and ask for help understanding their product’s coverage in the market both historically and currently. The CSL will then come to me, and we work together to analyze the relevant datapoints and then deliver the findings to the client in their preferred mode, whether that be our Analytics 3 platform, a PowerPoint or an Excel file.

Q: What are some of the larger projects you’re working on?

A: As MMIT is continuing to grow, we’re exploring different services we can offer to our clients. One of the larger projects we’ve been working on is replacing one of our pharma client’s internal tools and data with MMIT’s tools and data. For this project we used the client’s custom alignments for over 10 indications and provided them with data through our Analytics tool. We also had to create several custom reports to enable the client to view their coverage in multiple views such as by channel, by preferred status, and by regions. We didn’t have a lot of experience working on these kinds of reports, but we were able to work with the different teams at MMIT to develop a product that the client was satisfied with, and it’s a service we’ll be able to offer to other clients in the future.

Q: What are some of the challenges of your role?

A: The biggest challenge is understanding the client’s vision and solving any issues clients need help with. This is where the partnership between CSA and CSL is so important. As a CSA we typically do not interact with the client, so the back story and all the relevant information about the request is given to us through the CSL. Communicating with and asking the CSL questions is key in understanding the request. Once we establish what issue they are experiencing, we can pull the data and create a report that fits the client’s needs.

Q: What’s your favorite part of your job?

A: I love working with the data to solve complex problems and coming up with solutions to fit our clients’ business needs. There are times when a client comes to a CSL with a request, but they’re not able to fully articulate what it is they’re asking. In these scenarios we present the client with the same data visually represented in multiple ways and they can pick and choose what suits their needs.

I also love that the leadership in our organization encourages you to ask questions. If I believe a process is inefficient or won’t provide the right results, I know I can go to our leadership and make my case and they’re willing to listen and make changes where necessary. It’s a great environment to work in because I feel encouraged and appreciated for my work, and it makes me want to continue working harder.

Q: What’s been your biggest victory with the company so far?

A: The biggest victory has been creating the custom reporting for one of our large pharma clients. This was a new experience for MMIT and for me, and it was exciting to be involved in all aspects of the project, from developing the tool to testing the user interface. We recently delivered the reports to the clients, and we’ve received lots of positive feedback about the functionality and the data. It was rewarding to handle a project of this size, and I learned so much about both our data and the client’s data while also improving my skills. Going forward I’m more confident managing these larger projects because I now have so much more knowledge of our data and experience coordinating with the other teams at MMIT to produce a quality product.

Q: What do you like to do outside of work?

A: I lead a pretty normal life; work, home, and doing my hobbies on the side. I’ve recently been teaching myself how to cook, so I’ve been exploring different cuisines. I also take care of plants in my free time, and I enjoy taking long walks and hiking in the summer. I also love to travel and have visited Amsterdam, Sweden, and my husband and I vacationed in Cancun for our honeymoon.

by Amanda Tadrzynski

Pediatric Managed Medicaid ACO Touts Crucial Role of Its Pharmacists

September 9, 2019

For a pediatric accountable care organization (ACO) that contracts with Ohio’s Medicaid managed care plans, improving care for children would be a much more difficult job without the expertise of pharmacists who understand the unique needs of those patients.

“Our MCO partners are often really well versed in the adult patient population and chronic diseases that afflict their adult patients — but sometimes the pediatric population’s chronic conditions are different,” Brigid Groves, a clinical pharmacist specializing in population health at Columbus-based Nationwide Children’s Hospital,

For a pediatric accountable care organization (ACO) that contracts with Ohio’s Medicaid managed care plans, improving care for children would be a much more difficult job without the expertise of pharmacists who understand the unique needs of those patients.

“Our MCO partners are often really well versed in the adult patient population and chronic diseases that afflict their adult patients — but sometimes the pediatric population’s chronic conditions are different,” Brigid Groves, a clinical pharmacist specializing in population health at Columbus-based Nationwide Children’s Hospital, tells AIS Health.

Groves is one of two pharmacists employed by Partners for Kids (PFK), the ACO affiliated with Nationwide Children’s Hospital that receives capitated payments from the state’s five MCOs to manage care for 330,000 children in central and southeastern Ohio.

As an example of how PFK pharmacists intervened to advocate for pediatric patients, Groves points to when the manufacturer of one type of inhaler shifted to a new, non-child-friendly delivery mechanism for the steroid that’s dispensed by the device.

As an example of how PFK pharmacists intervened to advocate for pediatric patients, Groves points to when the manufacturer of the inhaler Qvar (beclometasone dipropionate) changed the delivery mechanism for the steroid that’s dispensed by the device — requiring patients to “use their own breath and pull in like they’re drinking a thick milkshake through a straw to inhale that medication.” Adults and teenagers can follow those directions, but for four- or five-year-olds, “it’s pretty difficult to get them to put their socks on in the morning,” let alone teach them how to use such a device, Groves points out.

“When the manufacturer changed that product, our MCO plans were just kind of like, ‘great new product, put it on there’ [their formularies]. And it really impacted a lot of our kids because they weren’t able to get their steroid inhalers or use them appropriately,” she says. But PFK’s pharmacists explained the situation to the MCOs, and “our plans were then able to make appropriate changes on their formularies to allow our kids to have something that they could appropriately use that was clinically effective for the condition, as well as cost neutral.”

Hospitalizations, ER Visits Decreasing

One of the MCOs that contracts with PFK, CareSource, is currently making changes to how it covers the immunosuppressive drug Remicade (infliximab), and “we’ve worked with Partners for Kids pharmacists on our clinical criteria for prior authorization with pediatric use of that medication,” adds Nicholas Trego, Pharm.D., associate vice president of pharmacy for the insurer’s Ohio market.

On the clinical side, PFK’s pharmacists are spearheading a quality-improvement project focused on reducing asthma-related emergency room and inpatient visits by “ensuring that patients with asthma are appropriately diagnosed, evaluated and managed by pediatricians,” according to Groves’ study. In that effort, one measure Groves focuses on is patients’ asthma medication ratio (AMR), which shows how often patients fill prescriptions for rescue inhalers compared to controller inhalers. Having an AMR above 0.5 — meaning 50% of the time or more, patients have a controller inhaler on hand — is associated with fewer ER visits, she notes.

So, “we work with our practices out in the community to help them identify which patients they should target for asthma-related interventions using their AMR value,” Groves says.

As a result of that work, “we have seen changes in our AMR value as a network,” which means that “more patients are under control with their asthma, therefore less likely to go to the emergency department or be hospitalized,” she explains.

PFK pharmacists also collaborate with Ohio’s contracted Medicaid MCOs on the use of specialty pharmacy products for the pediatric population. “Obviously, those are very high-cost agents, so we want to use them judiciously,” Groves says. “When you have good relationships [with MCOs], you can work through those conversations and have a better impact up front on some of the prior authorization criteria.”

That may involve explaining that “’these are the things our kids are experiencing,’ or, ‘this is the study that shows why they need this medication,’” she adds.

CareSource also sees value in that form of collaboration. “They know what we’re looking for on the prior authorizations,” Trego says of PFK’s pharmacists, and they help physicians by filling out the forms with the correct information that CareSource needs to get medication approved faster for members.

MCOs Expect to See Savings

In addition to allowing practices to provide medications to patients more efficiently, “CareSource has probably seen administrative savings based on the fact that we’re not going back and forth, back and forth, back and forth with prior authorization requests like we do with many other specialty clinics that don’t have pharmacists embedded,” adds Jennifer Szumowicz, director of specialty pharmacy at CareSource.

PFK’s pharmacists also help advise patients and their families on how to use specialty medications, what side effects to expect and how to mitigate those effects, Trego notes.

“They honestly just teach the member and the member’s family about the medication, which is of great value to us, so the member knows exactly how to use the medication, when to use the medication, what to expect from the medication — so we can expect the adherence to the medication to be very high as a result of that work that they do,” he says.

While CareSource is not yet measuring how pharmacist-led interventions are improving medication adherence in the MCO’s pediatric population, the organization is currently “working out the logistics” with PFK on such an effort, according to Szumowicz.

by Leslie Small

 

New Radar Enhancement Allows for Email Alerts

Improved functionality for MMIT’s Radar Surveillance tool will make it easier for users to monitor assessments of policies. The new enhancement, to be made available in mid-September, will allow users to monitor assessments directly via email, in addition to being able to check the portal for updates.

Currently, Radar Surveillance provides daily alerts to users to let them know when MMIT has collected new pharmacy and medical benefit policy documents and forms. Our alerts are sent the day after collection, so users can access documents as soon as possible.

Users are then able to monitor those documents within our Radar platform, so that as our policy assessment teams review policies, users can easily view the new assessments and compare new assessments to previous versions. However, this requires the user to login to the platform and monitor documents to which they have already been alerted.

With the new enhancement, MMIT will send users daily alerts when we have completed assessments on documents previously collected. The alert will have two sections: (1) new documents and (2) new assessments of previously alerted documents. It links directly into the portal for easy access to full assessment details and to leverage other features of our portal.

The new assessment alert will notify clients of changes in prior authorization status, step therapy status, and other key policy and restriction data. Users will be able to see which benefit type, accounts, and channel the assessments apply to directly within the email as well.


 

 


 

Health Plans Must Cover PrEP for Free After USPSTF Recommendation

August 26, 2019

A few recent actions, as well as one expected next year, are expected to help bring down rates of HIV infection. And while the efforts should make it easier for certain populations to gain access to preexposure prophylaxis (PrEP) that helps prevent them from acquiring HIV, some issues are likely to stand in the way of eliminating all infections.

The FDA initially approved Gilead Sciences, Inc.’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in 2004 to treat HIV infection.

A few recent actions, as well as one expected next year, are expected to help bring down rates of HIV infection. And while the efforts should make it easier for certain populations to gain access to preexposure prophylaxis (PrEP) that helps prevent them from acquiring HIV, some issues are likely to stand in the way of eliminating all infections.

The FDA initially approved Gilead Sciences, Inc.’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in 2004 to treat HIV infection. But in 2012, the agency approved it to reduce the risk of HIV infection in adults, the only therapy indicted for this use.

In its final recommendation, published June 11, the U.S. Preventive Services Task Force (USPSTF) recommended that “clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition,” giving the recommendation an “A” rating. This grade, the highest one possible, means that the USPSTF recommends the service, as “there is high certainty that the net benefit is substantial.”

The grade also means that, per the Affordable Care Act, “a group health plan and a health insurance issuer offering group or individual health insurance coverage” must provide coverage for free of items or services that the USPSTF gives an “A” or “B” ranking (see box, p. 4). PrEP coverage must be in effect no later than the 2021 plan year. Grandfathered plans are excepted.

Payers will still be able to impose “reasonable medical management techniques,” such as prior authorization, notes Elan Rubinstein, Pharm.D., principal, EB Rubinstein Associates.

“PrEP is an invaluable tool in the fight to end the HIV epidemic, and this decision comes as the nation is opening a new front in the war on HIV. Making PrEP available without cost-sharing eliminates a major barrier to this landmark HIV prevention tool,” said Michael Ruppal, executive director of The AIDS Institute. “At a time when out-of-pocket costs are rising for patients as they seek access to medications, this recommendation is a win both for patients and public health.”

The USPSTF move comes a few months after President Donald Trump’s Feb. 5 State of the Union address, in which he unveiled a multipronged initiative “to eliminate the HIV epidemic within 10 years.”

Gilead Stays in the Spotlight

In May, Gilead said it would donate up to 2.4 million bottles of Truvada per year to the Centers for Disease Control and Prevention that could treat up to 200,000 uninsured Americans. That decision was unveiled after reports that the Department of Justice was reviewing a government patent for Truvada, which costs around $2,000 per month. Gilead CEO Daniel O’Day also was questioned during a congressional hearing about the research and development behind the drug, as well as its ever-increasing price.

That same month, Gilead revealed that Teva Pharmaceuticals USA’s generic emtricitabine/tenofovir disoproxil fumarate would be available in the U.S. next year. The FDA approved the drug in June 2018 for both treatment of HIV infection and PrEP.

Gilead estimates that only about 200,000 of the 1.1 million in the U.S. who are estimated to be at risk of infection are on PrEP.

While access to the drug is obviously a barrier to treatment, additional roadblocks include stigma around HIV, limited provider and patient knowledge of PrEP and lack of access to health care, points out Rubinstein.

“Greater access to and broader education around PrEP is the only thing that will improve PrEP persistence and adherence,” says Bruce Packett, executive director of the American Academy of HIV Medicine.

He points out that many at-risk communities around the country face additional issues that impact treatment, including “economic disinvestment, structural issues of race, paucity of access to public services, substance abuse and other widespread mental health issues.”

And even when people gain access to PrEP, adherence can still be an issue, and the therapy’s effectiveness is directly correlated to levels of adherence. Studies have shown efficacy of between 90% and 100% when patients use it as prescribed, notes Rubinstein.

Read the final recommendation at https://bit.ly/2RrQMx2/.

by Angela Maas

 


MMIT’s Take: PrEP and HIV/AIDS

Access to Gilead Sciences’ Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce HIV transmission in individuals at high risk for acquisition is set to expand following an independent panel’s final recommendation in June. The U.S. Preventive Services Task Force (USPSTF) in June gave PrEP an “A” rating, endorsing it as highly effective when taken as prescribed by people at high risk of HIV acquisition through sexual practices or injection drug use.

The Affordable Care Act requires non-grandfathered private health plans and Medicaid to cover USPSTF “A”- or “B”-recommended preventive services for members free of cost-sharing. Beginning in 2021, health plan members at high risk of HIV acquisition will be able to access PrEP, related lab services and office visits without charge. Payers are permitted to apply management tools such as prior authorization to ensure safe and appropriate use.

Currently, Gilead’s Truvada is the only available antiretroviral approved for PrEP. The once-daily single pill is labeled for use in combination with safer sex practices to reduce the risk of sexually acquired HIV in at-risk adults and adolescents weighing at least 35 kg. Prior to initiation of Truvada for PrEP, individuals must test negative for HIV. Thereafter, quarterly documentation of HIV status is required. Renal function monitoring may also be necessary.

Gilead announced in May that Teva Pharmaceutical Industries Ltd. will launch a generic version of Truvada for PrEP in September 2020, a year ahead of schedule. (The companies reached a patent agreement in 2014). Teva’s generic will have exclusivity for about a year. One component, tenofovir disoproxil fumarate, is now off patent; the other, emtricitabine, will lose patent protection in 2021. In addition to the upcoming generic — and subsequent generic versions of Truvada — a robust HIV/PrEP drug pipeline is positioned to offer new therapeutic options and, potentially, broader access.

The Centers for Disease Prevention and Control (CDC) estimates that 1.1 million individuals are now living with HIV in the U.S. The number of people at high risk of HIV acquisition is unknown, but research suggests it is vast. CDC data suggests that some 1.2 million individuals were eligible for PrEP in 2015. Of those, 51% were heterosexually active adults; 40% were men who have sex with men; and 9% were people who inject drugs.

Yet in 2017, only about 100,300 individuals nationwide were taking a PrEP regimen. That year, nearly 40,000 newly diagnosed HIV infections were reported to the CDC (81% males, 19% females). Over 700,000 people have died of AIDS in the U.S. since the first cases were reported in 1981.

PrEP uptake varies by gender, race, geographic region, insured status, insurance type, and other demographic and socioeconomic factors. USPSTF’s recommendation to make PrEP available to those at high risk for HIV acquisition is an important step forward in slowing the HIV epidemic, and many insured individuals will benefit. Making PrEP available to uninsured and underserved individuals remains a critical linchpin to ending the epidemic.

by Amy Karpinksi


 

 

New Nonmetastatic CRPC Drug Will Add to Competition in Class

by Angela Maas

When the FDA approved Erleada (apalutamide) for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC) on Feb. 14, 2018, it was the first therapy that the agency had approved for that indication. Following the July 30 approval of Bayer’s Nubeqa (darolutamide), three FDA-approved agents, all oral androgen receptor inhibitors, are available to treat the condition, offering a choice of treatment options.

Besides Erleada, from Janssen Biotech, Inc., a unit of Johnson & Johnson, and Nubeqa, Xtandi (enzalutamide) from Astellas Pharma US, Inc. and Pfizer Inc. also is approved for this indication. That therapy initially came onto the U.S. market following its Aug. 31, 2012, approval for metastatic CRPC; it gained the nonmetastatic approval July 13, 2018.

All three drugs are similar in price, coming in around $12,000 for a 30-day supply.

Before Nubeqa’s approval, payer management of Erleada and Xtandi varied greatly, according to Zitter Insights’ Managed Care Oncology Index: Q3 2018. The company surveyed pharmacy and therapeutics (P&T) committee members who work for 51 commercial payers with 177.9 million covered lives between Oct. 3, 2018, and Nov. 9, 2018.

A little more than one-quarter of respondents said they were significantly likely or more likely than unlikely to cover the two drugs at parity (see chart below). Nineteen percent said they were likely to implement step therapy requiring the use of Xtandi first, and 13% said they would likely put Xtandi on a more preferable tier than Erleada.

When it came to oncologists’ prescribing patterns for nonmetastatic CRPC, based on surveys conducted during the same time frame, 45% of the 106 providers whom Zitter surveyed said they would prescribe Xtandi over Erleada for this condition, while 29% said they would prescribe Erleada over Xtandi.

In addition, 20% of the surveyed oncologists said they would transition patients on Xtandi to Erleada, and 16% said they would transition Erleada patients to Xtandi.

With Nubeqa’s approval — which came three months ahead of its FDA action date — the three drugs will now compete head-to-head within this indication.

 

Reality Check: Parkinson’s Disease

 

Coverage


Pharmacy Benefit

Under the pharmacy benefit, about 45% of the lives under commercial formularies are covered without utilization management restrictions. Almost 64% of the lives under Medicare formularies are not covered for at least one of the drugs.


Medical Benefit

With Apokyn and Duopa covered under the medical benefit, about 23% of the lives under commercial policies have access to the medications with utilization management restrictions. Under the Medicare policies, about 46% of the lives are covered with restrictions, and 38% do not have access to at least one of the drugs.

 

Trends From AIS Health


FDA Approved New Formulations for Nuplazid

In June 2018, the FDA approved 34 mg capsule and 10 mg tablet formulations for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Recommended dosing is 34 mg once daily, but dosing for people also taking a CYP3A4 inhibitor is 10 mg once daily. GoodRx lists the price of 60 17 mg tablets as more than $2,700.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online


FDA Approved Osmolex ER

In February 2018, the FDA approved Osmotica Pharmaceutical US LLC’s Osmolex ER (amantadine) for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adults. Dosing is patient-specific.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

 


FDA Approved Gocovri

In August 2017, the FDA approved Adamas Pharmaceuticals, Inc.’s Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in people with Parkinson’s disease who are being treated with levodopa-based therapy. The agency gave the product orphan drug status. Amantadine is available as a generic, though it is not an extended-release version. Dosing is once daily. The company says the drug will be priced between $10,000 and $30,000.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

 

Key Findings


Market Events Drive Changes

In February 2018, the FDA approved Osmotica Pharmaceutical US LLC’s Osmolex ER (amantadine) for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adults. After Actavis and Allergan each filed abbreviated new drug applications for generic versions of Rytary, Impax sued them for patent infringement. Both companies settled the litigation in June 2018 with Amneal, which merged with Impax shortly before the agreements.

Competitive Landscape

The Parkinson’s market is continually growing, with many drugs in the pipeline. Contracting may occur with multiple monoamine oxidase-B inhibitors available. This therapeutic class includes many quality therapeutic options, both generic (the majority) and brand. New players emerge, but big prescription sales are illusive compared with the oral market of old. Despite advantages to injectables and transdermal patches, physician behavior and coverage are slower compared with oral agents.

Payer Coverage

Given the number of generic orals, management of the remaining name-brand oral products is restrictive but less so than in other classes. Drugs are covered primarily under the pharmacy benefit, although Apokyn and Duopa have both pharmacy and medical benefit coverage. With many strong orals available, understanding how restrictions translate (or don’t) to brand-name products is critical. When PA is defined, diagnosis and clinical documentation are required.

Plans Offer More $0 Copay Drugs to Boost Adherence, Member Outcomes

August 12, 2019

As various players in the health care industry sharpen their focus on disease prevention, some experts say they’re seeing health plans offering more and more “preventive” drugs at no cost to members.

For example, in a recent press release, Dean Health Plan said it’s “adding even more preventive drugs to our list of drugs available to [members] for $0.” Additions to the list, which total more than 200, include Advair inhalers (fluticasone propionate and salmeterol) for asthma,

As various players in the health care industry sharpen their focus on disease prevention, some experts say they’re seeing health plans offering more and more “preventive” drugs at no cost to members.

For example, in a recent press release, Dean Health Plan said it’s “adding even more preventive drugs to our list of drugs available to [members] for $0.” Additions to the list, which total more than 200, include Advair inhalers (fluticasone propionate and salmeterol) for asthma, the diabetes drug Januvia (sitagliptin), and Alendronate for osteoporosis, says Kevin Engelien, manager of large group product and market research at the Wisconsin-based insurer.

The reason for maintaining such a list — and adding to it — is simple, according to Engelien. “We do this because we feel taking these medications on a regular basis or as prescribed can help avoid more serious health problems or complications,” he says.

Currently, the benefit is available for Dean Health Plan’s large group commercial members, small-group members on pre-Affordable Care Act plans and pre-ACA individual plan members.

For ACA-compliant plans, the law requires that a set list of preventive drugs and services must be available to members at no cost, such as oral contraceptives and certain statins. The list must include all those medications and services given an “A” or “B” rating by the U.S. Preventive Services Task Force (USPSTF), meaning there is a good chance the net benefit is anywhere from moderate to substantial.

The ACA-mandated spate of preventive drugs is a “fine list,” Engelien tells AIS Health, but Dean Health Plan sees a “market demand” to offer a more comprehensive list of drugs at a $0 copay.

Larger Lists Becoming More Common

To decide what goes on that list, Dean Health Plan works with its PBM, Navitus Health Solutions, in a “no less than monthly” process of reviewing the utilization and effectiveness of drugs, as well as any changing mandates, Engelien says. (For example, USPSTF recently gave an “A” rating for pre-exposure prophylaxis, or PrEP, for patients who are at high risk of acquiring HIV, meaning ACA-compliant plans must cover it at no cost.)

As part of the formulary review process, “there’s a peer review that’s done, which is you look left and you look right at what other carriers are doing, and sometimes that’s either brought to you from an employer where they were previously, or just the PBM in some cases can do that, because PBMs do work with multiple carriers,” Engelien says.

In general, Dean Health Plan is seeing more comprehensive lists of $0 copay preventive drugs from other carriers, particularly large national ones, he says. So the Wisconsin plan “tried to find what we thought was a comfortable place” with its own list based on not only what competitors are doing, but also how it interprets the definition of preventive and what drugs it determines will truly drive better outcomes for patients, according to Engelien.

It’s not just smaller regional insurers like Dean Health Plan that are making more drugs available to members at no cost. “I do think there is a trend in non-grandfathered self-insured clients offering preventive drug lists, and also kind of widening their preventive drug lists,” says Stephen Wolff, a pharmacy consultant in Milliman’s Chicago office.

Chronic Conditions Are a ‘Driving Force’

While Wolff says self-insured plans “love to benchmark their benefits against each other” to stay competitive, he doesn’t necessarily see them benchmarking $0 copay preventive drug lists.

Rather, he attributes the expansion of those lists to the rise of high-deductible health plans in the employer-sponsored insurance market.

“I think the driving force, to the plans that I consult to, is more in trying to make sure that people with chronic conditions get the treatment necessary,” he says. “So even if you have a deductible, you can get first-dollar coverage on diabetes meds, for example.”

“That way, members will continue to use these drugs even when they have a deductible and hopefully save the plans money in the long run.”

Some large PBMs offer “off-the-shelf recommendations” for preventive drug lists, but often larger employers tap firms like Milliman to customize their lists, according to Wolff. For such clients, the reasoning goes that they “want to really be thoughtful” with their drug spend in order to help people with chronic illnesses keep taking medications that are going to lower the total cost of care, he adds.

However, the fact that different health plans define preventive drugs differently — and thus have variable lists of $0 copay medications — can sometimes be a “pain point” for consumers, Engelien points out.

“There can be disruption on the coverage side when there’s not consistency,” he says. “So you’re on…what we define as kind of an expanded preventive drug list at $0 cost to you with one carrier and then your employer moves to another carrier, and now you’re paying $800 out-of-pocket a month [for a medication].”

That issue aside, Dean Health Plan’s goal is simply to put together a list of $0 copay preventive drugs that it feels best serves members, according to Engelien.

“So you balance what you have to be responsible for on the mandated side to what you think is going to be right for the most effective outcomes,” he says. “And then there’s obviously the financial piece of it too, and you need to manage that as well.”

View Dean Health Plan’s release at https://bit.ly/2Jsxmpp and its list of covered preventive drugs at https://bit.ly/2xGuEFT.

by Leslie Small

 

MMIT Integrates MCOs Into Data Hierarchy

MMIT has introduced a new level of granularity to its Analytics data hierarchy with the integration of Managed Care Organizations (MCOs). MCOs are unique entities within MMIT’s identified payers that offer plans directly to the market under their own branding, or within their own business unit of an organization.

MMIT is introducing this new level within the data hierarchy to help users better understand access within these regional roll-ups. MMIT recognizes the importance in understanding access at various levels, including plan, formulary, and payer/PBM. Integrating MCOs into the hierarchy adds a level of granularity between the Payer/PBM and formulary level. Users will be able to understand access at a level that is higher than an individual formulary, and more detailed than a payer or PBM.

In Analytics, users can orient the hierarchy in the app’s Details View to the MCO perspective, which provides the ability to see data (coverage, lives, etc.) for a given MCO. To set the MCO as the highest level in the hierarchy, users will click on the controller filter and then select MCO from the drop down. The details grid will then replace the controller names with the MCOs. Users can then use the gray arrows to drill down on the channel, formulary and plan level. MMIT has also integrated MCOs into the controller filter, which allows users to narrow the data to a specific MCO.

MMIT is actively exploring implementing MCO data into its other tools. Client success leads are already working with clients to implement MCO-level data as a field in data feeds, and MMIT is exploring exposing MCOs into the Coverage Search app. Users who are interested in implementing MCO data into their data feed should contact their client success lead.

by Amanda Tadrzynski

 

Will Blockchain Transform Relationships Industry Wide?

Industry consultants from Milliman Inc. assert in a July 11 report that blockchain — which is described as a real-time digital ledger for building secure networks — “could potentially transform the relationship between payers, pharmaceutical manufacturers, wholesalers, and pharmacies by offering an alternative, transparent mechanism for processing, pricing, and validating prescription transactions.”

Milliman says this approach could result in “less waste, reduced pricing variations between pharmacies, and a better app-based purchasing experience for consumers, through transparency of the true cost of prescription drugs.”

Using blockchain technology, payers and pharmacies would reduce the time they spend validating insurance coverage, making phone calls and managing data, Milliman explains. The firm is urging PBMs to work to “evaluate a blockchain alternative now with an eye toward a more efficient drug financing system” capable of handling additional technology improvements.

“We’re just trying to get people thinking outside the box, and I believe blockchain has applications with supply chain management, claim-processing and transparency to the consumer,” says Brian Anderson, a principal for Milliman and co-author of the blockchain paper.

In the Milliman report, Anderson and his colleagues, Gregory Callahan and Michael DiPrima, note the current electronic approach to processing pharmacy claims is a sometimes opaque, centralized database management system managed by the PBM.

‘Transparency for Everyone’ Possible

By contrast, blockchain’s database management system model would be decentralized. Milliman explains that means a distributed network of “nodes” would validate all transactions and would store data throughout the distributed network rather than in a centralized server. “Simply put: all participants of the system (that are running a node) validate a transaction before it is committed, ensuring transparency for everyone,” the report says.

As Milliman explains, claims transactions, “like the contents of the glass safe deposit boxes, can be viewed, validated, and distributed by all stakeholders simultaneously.” And this type of system could “fuel an entirely different consumer experience. A consumer could walk into a retail pharmacy and, using a phone or card, pay for a prescription, and have the relevant claims data, utilization, cost, and rebates all calculated concurrently at the point of sale using blockchain technology.”

The Milliman consultants conclude blockchain technology “appears to hold great promise for the PBM marketplace.” But they concede there are obstacles to overcome, explaining that while blockchain has shown great potential for security in cryptocurrency, its true potential in health care has not yet been evaluated. Thus, more testing and implementation would be required before a blockchain application could be used on a large scale in the PBM marketplace, which would mean payers, providers, pharmacies and PBMs must agree on validation and approval criteria — and finding consensus may prove challenging.

“Solutions have to be offered to the industry, and employers can evaluate whether it’s a good change for them,” Anderson says. “Payers, health plans, employers, [and health] systems will be challenging vendors to find innovations.”

by Judy Packer-Tursman


 

 


 

 


 

Part D Rebate Rule’s Demise Quells Some Uncertainty for Plans, PBMs

July 22, 2019

In a move that Wall Street analysts deemed a win for the managed care industry, the Trump administration decided to withdraw a proposed rule that would have overhauled the prescription drug rebate system in Medicare Part D.

The proposed rule, first released in February, would have removed safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs, Part D plans and Medicaid managed care organizations, and it would have created a new safe-harbor protection for point-of-sale drug discounts.

In a move that Wall Street analysts deemed a win for the managed care industry, the Trump administration decided to withdraw a proposed rule that would have overhauled the prescription drug rebate system in Medicare Part D.

The proposed rule, first released in February, would have removed safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs, Part D plans and Medicaid managed care organizations, and it would have created a new safe-harbor protection for point-of-sale drug discounts.

Citi analyst Ralph Giacobbe told investors his firm expects the news “to be favorable most specifically to entities with larger PBM exposure (Cigna Corp., CVS Health Corp./Aetna and UnitedHealth Group) as it eliminates the uncertainty and overhang that the rebate rule had on those companies.”

“We view the news favorably for PBMs,…but continue to believe the industry is best served to continue providing transparent options to employers/plans/customers and must work to prevent the ‘sticker shock’ at the counter that initially drove the rebate rule,” Giacobbe said.

In accordance with CMS guidance issued earlier this year, Part D plan sponsors submitted their 2020 bids in June assuming the status quo on drug rebates still applied, Credit Suisse analyst A.J. Rice pointed out in a note to investors on July 11. CMS had also floated a two-year, voluntary demonstration project that would protect plan sponsors from downside risk associated with the rebate system overhaul.

“Nevertheless, we believe that the threatened release of the rule had been an overhang on sentiment toward the MCO group, even with the CMS demonstration project,” Rice wrote. “Also, longer term, we believe that a shift by the Administration toward more direct ways to reduce drug costs will take PBMs and to a lesser degree health plans out of the crosshairs on this issue.”

Oppenheimer & Co.’s Michael Wiederhorn views politics as holding sway on the matter. “It was too expensive ($180B over a decade) and would raise Medicare Part D premiums in front of the election,” he said. “All the PBM-impacted insurers (Cigna, CVS, Humana, UnitedHealth, Centene Corp….) should be strong on this news, with Cigna and CVS the most likely to benefit.” He said the decision is a positive for insurers, “as this removes an overhang in the marketplace, especially given some noise that the rule would be implemented mid-year.”

Experts Are ‘Surprised’ by the Shift

Meanwhile, industry experts expressed surprise at the administration’s pullback on the rebate proposal and its timing.

“My initial reaction is it’s surprising given the amount of capital the administration has put into this policy,” says Matt Kazan, a principal in Avalere Health’s policy practice. He adds dropping the rebate rule increases the likelihood that the Trump administration will move forward on other proposals to show progress in its vow to lower drug costs.

Kazan points to various implications for health plans in the rebate rule’s demise. “Certainly, a lot of the uncertainty about 2020 and 2021 goes away in terms of bidding and Part D,” he says. But if the focus shifts to structural changes for the Part D program, he says there could be greater liability for plans in the catastrophic phase of the benefit and imposition of an out-of-pocket (OOP) cap: the two main proposals that Congress is mulling over in the Part D space.

As for PBMs, it remains to be seen what role, if any, they could play in the IPI proposal, and how any structural changes to Part D might affect them, Kazan says.

The Pharmaceutical Research and Manufacturers of America (PhRMA) described the administration’s decision not to move forward on the proposed drug rebate rule as “a blow to seniors who could have paid less for their medicines at the pharmacy counter.”

by Leslie Small and Judy Packer-Tursman

 

Medicaid Enrollment Sees First Decline Since Expansion as Managed Care Takes Hold

by Carina Belles

Health care analysts in recent months have raised concerns that Medicaid enrollment is experiencing a decline for the first time since the introduction of Medicaid expansion under the Affordable Care Act, which caused large waves of new Medicaid enrollment between 2014 and 2016, particularly in managed care plans, as more people became eligible for the program (see timeline below). From the fourth quarter of 2017 to the first quarter of 2019, however, overall Medicaid enrollment shrunk 2.3%, to 72.6 million lives, according to an analysis of data from the Centers for Medicare and Medicaid Services (CMS) and AIS’s Directory of Health Plans. The trend raises “questions about whether individuals losing Medicaid and CHIP coverage are becoming uninsured or transitioning to other coverage,” asserts a May 2019 study of similar data from the Kaiser Family Foundation. This shift has occurred as an increasing number of Medicaid eligibles are enrolled into contracted managed care plans and actively transitioned out of the traditional fee-for-service system, with 11 states having more than 90% of their Medicaid populations enrolled in managed care. Just nine states saw increases in their managed Medicaid populations from June 2018 to June 2019. See a state-by-state analysis of current managed care penetration and year-over-year enrollment change below.

NOTE: Due to changes in AIS’s research methodology and CMS reporting practices, the above analysis does not include approximately 1.2 million Medicaid beneficiaries in Puerto Rico.
SOURCE: DHP, AIS’s Directory of Health Plans; Centers for Medicare and Medicaid Services (CMS). View the Kaiser study: https://bit.ly/2XSRRiX.

 

Payers Say Step Therapy Is Their No. 1 PID Management Tactic

by Angela Maas

When the FDA approved Grifols’ Xembify (immune globulin subcutaneous human-klhw) on July 4 to treat primary humoral immunodeficiency disease (PID) in people at least two years old, the therapy joined a fairly crowded class. With competitors in the double digits, 60% of commercial payers responding to a Zitter Insights survey say they plan to implement step therapy by the end of 2020 to manage immunodeficiency medications.

Between Nov. 20, 2018, and Jan. 7, 2019, Zitter polled 26 pharmacy and therapeutics (P&T) committee members who work for commercial payers covering 104.0 million lives about how they manage the immunotherapy class.

Respondents ranked step therapy as the No. 1 tactic they plan to implement by fourth-quarter 2020, followed by selecting preferred agents, at 56%, and conducting a cost analysis to help take steps toward controlling costs, cited by 52% (see chart below).

Responses from different sets of commercial P&T committee members that Zitter polled in late 2017 into early 2018 and late 2018 into early 2019 showed, though, that levels of management aggressiveness actually dropped from 2017 to 2018.

In 2017, respondents from 46 commercial payers representing 134.6 million covered lives ranked their aggressiveness in managing PID at 5.70 out of a top aggression level of 10. The following year, respondents from 51 commercial payers with 139.8 million covered lives ranked their current aggressiveness at 4.98 out of 10.

Sixty-six percent of those 51 commercial payers said they were not at all likely or more unlikely than likely to contract with manufacturers for immunoglobulins in PID in 2019, while only 2% responded that their plan was significantly likely or more likely than unlikely to take this action.

But for 2020, the percentage of respondents saying they were not at all likely or more unlikely than likely to contract for these therapies had dropped to 27%, while the percentage of respondents saying their plan was significantly likely or more likely than unlikely to contract had risen to 39%.

 

Reality Check: Psoriatic Arthritis

 

Coverage


Pharmacy Benefit

Under the pharmacy benefit, about 74% of the lives under commercial formularies are covered with utilization management restrictions. Almost 65% of the lives under Medicare formularies are not covered for at least one of the drugs.

 


Medical Benefit

About 46% of the lives under commercial and health exchange policies have access to the medications with utilization management restrictions. Under Medicare policies, about 28% of the lives are covered without restrictions in place, and 23% do not have access to at least one of the drugs.

 

Trends From AIS Health


FDA Approves Eticovo

In April 2019, the FDA approved Samsung Bioepis Co., Ltd.’s Eticovo (etanercept-ykro) for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis in people at least four years old, psoriatic arthritis and polyarticular juvenile idiopathic arthritis in children at least two years old. The drug is the second FDA-approved biosimilar of Amgen’s Enbrel (etanercept).

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online


FDA Approves Hyrimoz

In October 2018, the FDA approved Sandoz’s Hyrimoz (adalimumab-adaz) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in people at least four years old, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The drug from the Novartis division is the third biosimilar of AbbVie Inc.’s Humira (adalimumab)
that the FDA has approved.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online


Payers Apply Indication-Based Formularies

As the anti-inflammatory therapeutic class consistently ranks at the top of the costliest specialty classes in the pharmacy benefit, some payers began offering indication-specific formularies within the class. President of PerformRx Mesfin Tegenu said that the PBM has finalized an indication-based formulary for inflammatory conditions, including psoriatic arthritis and others, which would take effect in the first quarter of 2019.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

 

Key Findings


Market Events Drive Changes

Significant change is expected in this market short and long term. More biosimilar versions of Remicade, Humira and Enbrel on the way in the long term, and Taltz, Xeljanz and Orencia have recently gained approvals.

Contracting Landscape

Manufacturers with franchises across indications often hold contracting power and improved position, which is everything in this market. In terms of contracting, Humira is the product to beat, and Enbrel battles for second place. Biosimilars are hitting the market, with more on the way. SubQ products have patient preference, but less so on the payer side. While a TNFa is nearly always the first-line biologic after generics, there are situations where others (like anti-JAK) have been placed on this tier. There is significant opportunity to contract for position. Cost sharing on the specialty tier is common, with patient support available.

Payer Coverage

Medical benefit and pharmacy benefit coverage is present for many products, with even infusions covered under the pharmacy benefit..