Radar on Specialty Pharmacy

When benefits managers from a range of employers gathered at the Midwest Business Group on Health’s (MBGH) recent forum in Chicago, the final session of the day revealed that specialty drugs were some of their top concerns. And it appears employers are getting savvier about managing them.

A big focus of the conference was benefits managers’ fiduciary duty to their employees — and how shirking that duty could land them in hot water.

“If you haven't done a market check, do a market check,” recommended Dan Dentzer, manager of health and wellness design for United Airlines, at the June 26 MBGH Employer Forum on Pharmacy Benefits, Specialty and Biopharma Therapies. “I do market checks like I change my socks because you have to know what's going on out there. You have to know what others are doing. You have to know you're getting the best deal possible. If you haven't done that, please do.”

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.