Specialty Drugs

MMIT Reality Check on Follicular Lymphoma (4Q2023)

A review of market access for follicular lymphoma treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions. Around 44% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Colorectal Cancer (4Q2023)

A review of market access for colorectal cancer treatments shows that under the pharmacy benefit, about 51% of the lives under commercial formularies are covered with utilization management restrictions. Around 41% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Cystic Fibrosis (4Q2023)

A review of market access for cystic fibrosis treatments shows that under the pharmacy benefit, about 63% of the lives under commercial formularies are covered with utilization management restrictions. Around 21% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Medicare Part D Coverage for Humira Biosimilars Has Inspector General’s Attention

The HHS Office of Inspector General will evaluate the extent and quality of Medicare Part D plan coverage for biosimilars to AbbVie Inc.’s Humira (adalimumab) and expects to issue a report on the study in 2025, according to a recent update to the OIG’s work plan.

The study could provide fodder for reforms to pharmacy benefit manager rebating practices and for changes in Part D coverage policy that could help boost the uptake of biosimilars. Stakeholders and policy makers have viewed adalimumab biosimilars as a test case for the viability of the biosimilar model.

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Papers Delve Into Payment Options for Gene Therapies

Most employer-sponsored plans that have stop-loss insurance coverage should be able to pay for expensive gene therapies that have proven to be cost-effective, according to a recent paper from Health Affairs Scholar. However, a separate Health Affairs analysis published this month argues that payers must assess alternative payment models to afford the medications, which can cost more than $1 million per dose.

Aaron S. Kesselheim, M.D., one of the authors of the latter Health Affairs paper says that plans have taken varied approaches to paying for gene therapies ranging from “extremely permissive to extremely tight coverage.”

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FDA Approves Multiple Ulcerative Colitis Agents, Bringing New Drugs, Routes of Administration to Class

The ulcerative colitis (UC) space has seen multiple new approvals recently that could focus payer management even more on the condition. Payers already take an aggressive approach toward managing branded agents within the class, according to a Zitter Insights survey.

While no cure exists for the inflammatory bowel disease, the FDA has approved numerous agents to treat signs and symptoms of the condition. In addition to the nine biosimilars of AbbVie Inc.’s Humira (adalimumab) that have launched in the U.S. in 2023, a handful of other therapies have been approved by the agency since late September. All of the agents offer maintenance dosing either through an oral or subcutaneous route of administration.

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Biosimilar Market Has Had Tremendous Year, With No Signs of Slowing

Since the FDA approved the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, then a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved more than 40 additional agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). This past year has been especially busy in the space, with highlights including the launch of nine biosimilars of AbbVie Inc.’s Humira (adalimumab) and approvals of the first biosimilars of three different biologics: Biogen’s Tysabri (natalizumab), Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group and Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson. As the FDA approves more biosimilars, uptake of these agents will continue to increase, say industry experts.

“2023 was a banner year for the biosimilar market,” contends Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth. “The availability of biosimilars across multiple therapeutic areas provides opportunities for physicians, patients and payers to have additional clinical and cost-saving treatment choices.”

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News Briefs: Ventegra Will Prefer Yuflyma

Celltrion USA, Inc. signed a contract with Ventegra to include its Yuflyma (adalimumab-aaty) as a preferred drug on its formulary in both public and private insurance markets, the manufacturer said Oct. 5. Ventegra is a “major U.S. Medical Benefits Manager (MBM) who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional” PBMs. The move gives Celltrion access to approximately 3.6% of the U.S. The company says it will increase its marketing so that the drug has “coverage and/or access for 40% of the U.S. population by the end of the year.” Yuflyma, a high-concentration biosimilar of AbbVie Inc.’s Humira (adalimumab), launched in July with a wholesale acquisition cost of $6,576. Celltrion also said that Yuflyma has been added to CarePartners Pharmacy’s cost savings programs. With its partners, the specialty pharmacy has access to more than 10 million plan members. It is fully accredited and licensed to service patients in all 50 states and Washington, D.C. According to The Korea Economic Daily, “CarePartners will sidestep the original Humira from its roster and refrain from enlisting other competing adalimumab biosimilars, effectively making Yuflyma the sole adalimumab product in its offerings.”

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Survey Highlights Dynamic Employer Response to Rising Obesity Drug Costs

A recent survey from WTW found 38% of employer-sponsored health plans provide coverage for anti-obesity medications, while another 22% are planning on or considering covering those drugs in 2024 or 2025. Meanwhile, about two-thirds of employers that are members of WTW’s Rx Collaborative cover anti-obesity drugs, according to Cody Midlam, a director in the company’s Pharmacy Community group.

Midlam tells AIS Health, a division of MMIT, that “we’re definitely seeing the trend is leaning towards adding coverage” of the medications, which are expected to be costly for plans in the coming years. Morgan Stanley, for instance, projected in a September report that the global market for weight management medications could reach $77 billion in 2030, up from just $2.4 billion last year.

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Biosimilar Market Has Had Tremendous Year, With No Signs of Slowing

Since the FDA approved the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, then a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved more than 40 additional agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). This past year has been especially busy in the space, with highlights including the launch of nine biosimilars of AbbVie Inc.’s Humira (adalimumab) and approvals of the first biosimilars of three different biologics: Biogen’s Tysabri (natalizumab), Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group and Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson. As the FDA approves more biosimilars, uptake of these agents will continue to increase, say industry experts.

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© 2024 MMIT