Radar on Specialty Pharmacy
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In 2024, Payers Refined Specialty Management Tactics By Taking More Active Role
As more specialty drugs and cell and gene therapies launch onto the U.S. market, payers are increasingly deploying utilization management (UM) tactics in order to focus more on targeted clinical criteria to manage them. Other strategies include shifting medical benefit drugs to the pharmacy benefit and implementing value-based contracts (VBCs). AIS Health, a division of MMIT, asked industry experts about these approaches and others that payers are taking in their management of specialty drugs for our annual look back at the year. (Editor’s note: These comments have been edited for length and clarity.)
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2024 Trends Include PBM Private-Label Subsidiaries, Biosimilar Guidance
New specialty drugs and emerging cell and gene therapies continue to garner much of the attention in the pharmaceutical arena, but other pharma occurrences have made headlines over the past year. Three industry experts gave AIS Health, a division of MMIT, their thoughts on the most noteworthy occurrences within the specialty pharmacy industry in 2024, from PBMs’ private-label subsidiaries to proposed FDA biosimilar guidance, as well as some of those approvals. (Editor’s note: These comments have been edited for length and clarity.)
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In 2024, FDA Approved Innovative Treatments for Several Complex Diseases
While the FDA’s 44 novel drug approvals as of Dec. 11 may have been lower than 2023’s 55, the agency still green-lighted some impressive agents. Among those were the first agent for a liver disease that can have serious complications; the most expensive gene therapy ever, which was approved for a disease that shortens lifespans, particularly among children; and a first-in-class therapy for a solid tumor. The agency also granted additional indications to already-available treatments, including several chimeric antigen receptor T cell (CAR-T) therapies. Industry experts spoke with AIS Health about some of the top FDA approvals of 2024. (Editor’s note: These comments have been edited for length and clarity.)
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FDA Approved 18 New Biosimilars This Year, Impacting 2024 Market Dynamics
In 2024, the FDA almost doubled its previous annual highest number of biosimilar approvals, besting 2019’s 10 by green-lighting an additional eight agents and bringing the total approved since 2015 to 63. Arguably the biggest story was that biosimilars of AbbVie Inc.’s best-selling Humira (adalimumab) finally began picking up market share. Speaking with AIS Health, a division of MMIT, industry experts reflect on the impact biosimilars had in 2024. (Editor’s note: These comments have been edited for length and clarity.)
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Dual IL-17A, IL-17 F Inhibitor Bimzelx Should Have Some Impact in PsA Space
UCB, Inc.’s Bimzelx (bimekizumab-bkzx) recently gained FDA approval for the treatment of psoriatic arthritis (PsA), bringing a new mechanism of action to the therapeutic class. Industry experts say it may be challenging to break into the crowded space, but if successful, it could impact coverage of and prescribing for the class.
On Sept. 20, the FDA approved three more indications for Bimzelx for the treatment of adults with active PsA, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis. Two months later, on Nov. 20, the FDA gave the drug another approval, for the treatment of moderate-to-severe hidradenitis suppurativa.
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