Radar on Specialty Pharmacy

GoodRx will offer Boehringer Ingelheim’s adalimumab-adbm, a biosimilar of AbbVie Inc.’s Humira (adalimumab), at a cash price of $550 per two-pack, revealed the companies on July 18. The price for the citrate-free biosimilar is 92% off that of its reference drug. It is available as both high-concentration and low-concentration formulations. The FDA has approved the 50 mg/mL version as interchangeable with Humira. Consumers may purchase the lower-cost tumor necrosis factor (TNF) inhibitor — which also is available as brand drug Cyltezo — at more than 70,000 retail pharmacies across the U.S.

Walmart is opening 25 new autoimmune-focused Specialty Pharmacies of the Community (SPOC) across five states, said Kevin Host, Pharm.D., senior vice president of pharmacy at Walmart Health and Wellness Pharmacy, on July 25. In October 2023, the company launched six SPOC, which are now available in nine states: Alabama, Idaho, Louisiana, New York, Oregon, Pennsylvania, Rhode Island, Texas and Wisconsin.

When the biosimilar pathway was first established, it created a two-tier system of biosimilars and interchangeable biosimilars, but multiple attempts have been made recently to level the playing field. In the latest move, the FDA proposed doing away with switching studies for interchangeables. But while the move could bring biosimilars onto the U.S. market faster and result in more competition, industry efforts are divided about whether it could prompt broader payer uptake.

As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

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.