Spotlight on Market Access

A Medicare Part D policy forbidding plan sponsors’ formularies from excluding nearly all drugs in six “protected” classes hinders payers’ ability to negotiate prices and may lead to significantly higher costs to the health care system, according to a recent analysis published in Health Affairs. The study’s lead author notes this is the first peer-reviewed trial suggesting Part D plans “can’t negotiate as high of rebates as they might otherwise be able to” for drugs in the protected classes.

HealthCare.gov enrollees have more health plan options in 2025 compared to previous years, yet the average benchmark plan premium in states that use the federal enrollment platform increased modestly, according to CMS.

In most states, the open enrollment period for Affordable Care Act marketplace coverage runs from Nov. 1, 2024, to Jan. 15, 2025. Out of the 31 states that are using HealthCare.gov, eight have more Qualified Health Plan (QHP) issuers in 2025 than in 2024, and 97% of enrollees have access to three or more issuers, compared to 78% in 2021. Seven HealthCare.gov states have counties with a single QHP issuer in 2025, compared to nine states in 2024. Georgia stopped using HealthCare.gov in 2024 and transitioned to a state-run exchange, and Illinois is scheduled to move to a state-based marketplace for the 2026 plan year.

All of the Big Three PBMs have added private-label subsidiaries into their fold that are working closely with some manufacturers. And while industry experts say that the companies offer certain benefits to the U.S. health care system overall, questions about them remain. Still, the entities could offer benefits to their pharma partners, including better formulary positioning and potentially even moving away from rebates.

Two of the companies, both based in Ireland, seem to be mainly, if not exclusively, focused on biosimilars, starting with those of AbbVie Inc.’s best-selling Humira (adalimumab).

Last month’s FDA approval of a drug to treat atopic dermatitis brings a new agent to a growing class of medications that payers say they consider a high priority to manage.

On Sept. 13, the FDA approved Lilly’s Ebglyss (lebrikizumab-lbkz) for the treatment of people at least 12 years old who weigh at least 40 kg with moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription medications or when those medications are not advisable. Dosing for the interleukin-13 (IL-13) antagonist is 500 mg via two 250 mg subcutaneous injections at weeks zero and two and then 250 mg every two weeks until week 16 or later, when an adequate clinical response is achieved. At that point, maintenance dosing is 250 mg every four weeks. The drug’s WAC is $3,500 for a 250 mg/2 mL single-dose prefilled pen or prefilled syringe.

In the seven years since the approval of the first chimeric antigen receptor T-cell (CAR-T) therapy, the agents have proved to be effective in the treatment of non-Hodgkin lymphoma. But the one-time-use agents come with risks, including the potentially fatal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), so the FDA requires patients remain near their treatment center for four weeks after administration, which can be onerous for patients. But a recent study finds that side effects were rare after the first two weeks post-infusion, perhaps helping lead to less of a burden for patients.