Radar on Specialty Pharmacy

A newly approved immune globulin for primary immunodeficiency will bring another option to a class of products that often is plagued by shortages. It is also a crowded space, and payers have several considerations when deciding on the coverage of these agents, say industry experts.

On June 13, the FDA approved Grifols Group company Biotest AG’s Yimmugo (immune globulin intravenous, human-dira) for the treatment of primary humoral immunodeficiency in people at least 2 years old. Dosing via intravenous infusion is every three to four weeks, with the first infusion started at 0.5 mg/kg per minute and increasing up to 3.0 mg/kg per minute; afterwards, the maintenance infusion rate is 13 mg/kg per minute. The dosage can be adjusted over time to achieve the desired trough levels and clinical response.

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.