Market access

MMIT Reality Check on Non-Small Cell Lung Cancer Systemic Therapy (3Q2023)

A review of market access for non-small cell lung cancer systemic therapy treatments shows that under the pharmacy benefit, about 38% of the lives under commercial formularies are covered with utilization management restrictions. Around 67% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Uncertainties Still Loom Over IRA Negotiations

The guessing game surrounding the identities of the first 10 drugs to be selected for Medicare price negotiations under the Inflation Reduction Act (IRA) finally ended on Aug. 29 when CMS published the list of agents. While many on the list were expected, there were still a few surprises, and other uncertainties around the process remain, industry experts say.

The first 10 Medicare Part D drugs selected by CMS to be negotiated — listed in order of their total Part D gross covered prescription drug cost from June 1, 2022, through May 31, 2023 — are:

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Majority of Drugs Selected for Price Negotiation Are on ‘Preferred’ Tiers in Medicare

Major blood thinners are among the first 10 prescription drugs for which the Biden administration will seek lower Medicare prices as part of the Inflation Reduction Act (IRA). The negotiated prices will be announced on Sept. 1, 2024, and go into effect in 2026.

Medicare beneficiaries who filled prescriptions for the 10 selected drugs paid a total of $3.4 billion in out-of-pocket costs for those therapies in 2022. The Medicare program paid more than $50 billion for the drugs between June 2022 and May 2023, CMS reported. Bristol Myers Squibb’s blood thinner Eliquis (apixaban) alone accounted for more than $16 billion.

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MMIT Reality Check on Ulcerative Colitis (3Q2023)

A review of market access for ulcerative colitis treatments shows that under the pharmacy benefit, about 54% of the lives under commercial formularies are covered with utilization management restrictions. Around 32% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Majority of Drugs Selected for Price Negotiation Are on ‘Preferred’ Tiers in Medicare

Major blood thinners are among the first 10 prescription drugs for which the Biden administration will seek lower Medicare prices as part of the Inflation Reduction Act (IRA). The negotiated prices will be announced on Sept. 1, 2024, and go into effect in 2026.

Medicare beneficiaries who filled prescriptions for the 10 selected drugs paid a total of $3.4 billion in out-of-pocket costs for those therapies in 2022. The Medicare program paid more than $50 billion for the drugs between June 2022 and May 2023, CMS reported. Bristol Myers Squibb’s blood thinner Eliquis (apixaban) alone accounted for more than $16 billion.

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CVS Launches New Biosimilar White Label, But Can it Bring Down Costs?

CVS Health Corp. plans to launch its own white-label line of biosimilars, the retail and health care giant said on Aug. 23, in a play to lower specialty pharma costs. Experts say that it could be years before anyone is able to tell whether the venture has brought down costs — especially since the biosimilar market itself is still in its early stages of development.

The new CVS brand, Cordavis, will be “a wholly owned subsidiary that will work directly with manufacturers to commercialize and/or co-produce biosimilar products,” a press release said. The division “will help ensure consistent long-term supply of affordable biosimilars,” and, in doing so, leverage “one of the biggest opportunities for reducing drug costs for employers and consumers.”

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MMIT Reality Check on Duchenne Muscular Dystrophy (3Q2023)

A review of market access for Duchenne muscular dystrophy treatments shows that under the pharmacy benefit, about 44% of the lives under commercial formularies are covered with utilization management restrictions. Around 35% of the lives under health exchange formularies are not covered for at least one of the drugs.

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Preventive Services Recommendation May Not Increase Injectable PrEP Access

A federal panel of medical experts on Aug. 22 recommended that pre-exposure prophylaxis be prescribed to people at increased risk of HIV infection, and included long-lasting, physician-administered injectable forms of PrEP in its guidance. However, a leading vaccine expert says the decision by the U.S. Preventive Services Task Force (USPSTF) is unlikely to increase access to PrEP, especially given an ongoing conservative-led legal battle that threatens to overturn the preventive services mandate included in the Affordable Care Act.

USPSTF granted PrEP an “A” grade, its highest rating. In the rating, USPSTF experts “recommend[ed] that healthcare professionals prescribe PrEP to people at increased risk for HIV to help prevent HIV.” Notably, the new rating mentions injectable PrEP, Apretude (cabotegravir extended-release injectable suspension), which had not been included in USPSTF PrEP recommendations before. In a 2019 PrEP endorsement, the task force only mentioned oral PrEP.

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News Briefs: CVS Launches Biosimilar-Focused Subsidiary

CVS Health Corp. on Aug. 23 launched a subsidiary called Cordavis, which will work with drug manufacturers to “commercialize and/or co-produce biosimilar products.” CVS said it has contracted with Sandoz to bring Hyrimoz, a Humira biosimiliar, to market in the first quarter of 2024 under a private Cordavis label. The list price of Cordavis Hyrimoz, the company said, will be “more than 80% lower than the current list price of Humira.” Sandoz launched a branded, high-concentration formulation of Hyrimoz on July 1, joining several other Humira biosimilars that launched in the same month.

On Aug. 21, Pfizer Inc.’s Abrysvo became the first vaccine approved by the FDA for use in pregnant people to prevent respiratory syncytial virus (RSV) in infants. The vaccine, which is administered in one dose, is approved for use at 32 through 36 weeks gestational age of pregnancy, and it can prevent lower respiratory tract disease caused by RSV in infants from birth through six months old. In May, the FDA approved Abrysvo for the prevention of lower respiratory tract disease cause by RSV in people age 60 and older. The FDA in July approved AstraZeneca and Sanofi’s Beyfortus (nirsevimab-alip) for preventing RSV in infants, and the Centers for Disease Control and Prevention in early August recommended the vaccine be given to all infants under 8 months and some older babies at increased risk of severe illness starting this fall.

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MMIT Reality Check on Parkinson’s Disease (3Q 2023)

A review of market access for Parkinson’s disease treatments shows that under the pharmacy benefit, about 34% of the lives under commercial formularies are covered with utilization management restrictions. Around 56% of the lives under Medicare formularies are not covered for at least one of the drugs.

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