Radar on Specialty Pharmacy

When the Federal Trade Commission on July 9 released an interim report based on its yearslong investigation of PBMs, criticism of the document abounded, with even an FTC Commissioner saying it wasn't nearly comprehensive enough to publish. However, one day later the FTC appeared to prove its critics wrong, with the Wall Street Journal reporting that it plans to sue the three largest PBMs over their business practices related to the rebates they negotiate with drug manufacturers for products like insulin. 

The FTC has not yet confirmed the WSJ report, which cited a person familiar with the matter. But it would not be the first time the federal government attempted to reform how PBMs treat drug rebates. The Trump administration proposed a rule in 2019 that would have effectively forced PBMs to pass negotiated rebates on to consumers at the point of sale in Medicare Part D and managed Medicaid, but it later tabled the regulation. 

Cancer has become the top condition driving costs for employers, and a recent report found that most of them expect their annual spend on the condition will increase by up to 9% each year over the next three years. Last fall, the Midwest Business Group on Health and the Florida Alliance for Healthcare Value, in collaboration with MBGH employer members, shared information around the management of oncology benefits with an eye on making sure that the right care is given to the right person at the right place, right time and right price, for both the employer and the member.

Among the topics of discussion for the Oncology Learning Collaborative were prevention, including screening and early identification; navigation, including psychosocial support and return to work; and diagnosis, including a second opinion, biomarkers and treatment.

In May, the FDA approved three interchangeable biosimilars that were the first for their reference drugs. With an additional three approvals in June, that brings the total number of biosimilars to 57 since the agency’s green lighting of Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. With the three agents approved in May also gaining interchangeability status, that brings the count of interchangeable biosimilars to 15. While the market is certainly heating up, it still is grappling with issues such as expected rebates, maintains one industry expert.

On May 20, the FDA approved the first biosimilars of Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept): Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf) and Samsung Bioepis Co., Ltd. and Biogen Inc.’s Opuviz (aflibercept-yszy). On June 28, the FDA approved a third Eylea biosimilar, Formycon AG and Klinge Biopharma GmbH’s Ahzantive (aflibercept-mrbb) for the same indications as the first two agents, but it does not have interchangeable status.

With more than 4,000 cell and gene therapies (CGTs) in development, plan sponsors should not be ignoring or underestimating the potential impact of these agents, not only on their beneficiaries’ health but also on their own bottom lines. A recent report by Pharmaceutical Strategies Group (PSG), an EPIC company, found that some improvement is needed in this area.

Sponsored by Prescryptive Health and published June 11, “2024 Trends in Drug Benefit Design Report,” examines trends among traditional — or nonspecialty — drug benefits, as well as gene therapies.

June 7: The FDA expanded the treatment area of Almirall, LLC’s Klisyri (tirbanibulin) from up to 25 cm² of the face or scalp to up to 100 cm² for the treatment of adults with actinic keratosis.  The agency first approved the microtubule inhibitor on Dec. 14, 2020. Dosing is one unit-dose packet on the face or scalp once daily for five consecutive days. Drugs.com lists the price of five packets of the ointment as more than $1,179.

June 10: The FDA gave another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Kevzara (sarilumab) for the treatment of people weighing at least 63 kg with active polyarticular juvenile idiopathic arthritis. The agency initially approved the interleukin-6 (IL-6) receptor antagonist on May 22, 2017. The recommended dose is 200 mg via subcutaneous injection every two weeks. Drugs.com lists the price of both the 150 mg/1.14 mL and 200 mg/1.14 mL as more than $4,582.