Spotlight on Market Access

The second administration of Donald Trump may well run the gamut as far as its impact on health care and pharma. Biotech companies may benefit from a good business environment, prompting more mergers and acquisitions, but they may also experience challenges in working with what could be somewhat unconventional leaders of federal agencies, such as Robert F. Kennedy Jr., whom President-elect Trump tapped on Nov. 14 to run HHS.

RFK Jr., a politician and environmental activist who has questioned the safety and efficacy of vaccines and spread misinformation about them, has said that “there are entire departments, like the nutrition department, at FDA that have to go, that are not doing their job.”

A recently approved treatment for psoriatic arthritis (PsA) brings a new mechanism of action to the therapeutic class. And while payers and rheumatologists varied in their expectations of what the drug’s impact on coverage of and prescribing for the class will be, almost half said they expect it to have at least some effect, according to a survey by Zitter Insights.

On Sept. 20, the FDA approved three more indications for UCB, Inc.’s Bimzelx (bimekizumab-bkzx) 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.

With Donald Trump set to be the 47th president and Republicans in control of both chambers of Congress, 2025 is shaping up to be a year in which the GOP has enough political might to pass PBM reform — if it has the political will.

Yet two pharmaceutical industry trade groups do not appear to be counting on Republicans’ ability to quickly prioritize a health care issue. Instead, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Association of Manufacturers (NAM) are both launching ad blitzes aimed at pressing Congress to target PBMs before the year is over.

Copay maximizer programs are gaining popularity among payers while copay accumulators appear to be losing some of their appeal, according to the annual Copay Accumulator & Maximizer Programs Special Report published by AIS Health’s parent company, MMIT. The report was based on surveys of 35 commercial insurers and PBMs representing 121.0 million lives.

About 39% of people were enrolled in plans with copay accumulators in 2024 on average, down from 47% in 2023. And 47% of enrollees were in plans with copay maximizer programs. On average, payers anticipated that about 48% and 57% of plan members will be covered by plans with copay accumulators and maximizers within the next 12 months, respectively.

While changes to the Medicare Part D benefit resulting from the Inflation Reduction Act (IRA) are already underway, Part D plans and manufacturers still face a good deal of uncertainty as to how the Medicare landscape is going to shake out. Changes to Medicare Part D plans in 2025 will almost certainly impact a large swath of beneficiaries, as well as manufacturers’ contracting strategies for 2026, said industry experts at a recent webinar hosted by Avalere. However, following the outcome of the U.S. election, the future of the IRA may be a bit murky.

“We are at an interesting moment for Part D,” observed Ethan Hall, associate principal on the client solutions team for Avalere, during an Oct. 30 webinar that he moderated.