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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.