Spotlight on Market Access

Prescription drug affordability boards (PDABs) have been rising in popularity as a way for states to tamp down on soaring drug prices. But a recent lawsuit filed by one drugmaker and public remarks from the industry’s main trade group make it clear that the pharma sector sees such boards — and the price caps some are authorized to set — as a major threat.

In a suit filed on March 22, Amgen Inc. takes aim at Colorado’s Prescription Drug Affordability Review Board, which is the closest to becoming the first state board to set an upper payment limit (UPL) on a drug. The state in late February initiated formal rulemaking to set a UPL for Enbrel (etanercept), Amgen’s rheumatoid arthritis treatment, after determining it was unaffordable.

One in five state Medicaid programs covered at least one anti-obesity medication in 2023, while the amount of reimbursement for these drugs has increased dramatically over the past decade, according to a recent JAMA study.

The researchers studied state Medicaid coverage policies for six anti-obesity drugs approved by the FDA through 2022 — orlistat, lorcaserin, phentermine-topiramate, bupropion-naltrexone, liraglutide, and semaglutide. For the two GLP-1s — liraglutide and semaglutide — the study examined both their branded versions for obesity treatment (Saxenda and Wegovy) and the versions to treat diabetes (Victoza and Ozempic). (It is likely, per news reports, that a substantial amount of diabetes-coded utilization of GLP-1s is actually off-label weight loss utilization.)

In newly released guidance, CMS told Medicare Part D plans that they’re allowed to cover weight-loss drugs if they’ve been approved for another medical use — a description fitting Novo Nordisk’s Wegovy (semaglutide) after it recently received an FDA nod for preventing major heart problems.

So far, CVS Health Corp., Elevance Health, Inc. and Kaiser Permanente have said their Part D plans will cover Wegovy for its newest approved use: reducing the risk of heart attacks and strokes in people who have cardiovascular disease and who meet body-weight criteria, the Wall Street Journal reported on March 28.

The growing use of biosimilars has reduced spending in the Medicare Part B program, but there are opportunities to further reduce costs — through greater use of more affordable biosimilars and through the implementation of different payment policies, according to a study published by the HHS Office of Inspector General (OIG).

The OIG analyzed the average sales prices, utilization and costs of 21 biosimilar drugs and their reference biologic products in the Medicare Part B program between 2015 and 2021. The agency found that overall use rate of biosimilars in Part B jumped from 18% in 2015 to 62% in 2021. While the adoption of biosimilars has lowered both the prices of biologics and biosimilars, Part B spending could have been reduced by $179 million in 2021 if the five biosimilars that cost less than their reference products — epoetin alfa, infliximab, bevacizumab, rituximab and trastuzumab — had been used at the same rate as the most widely used biosimilar, filgrastim.

The FDA recently approved a first-in-class agent to treat a particularly deadly cancer. The therapy signifies a promising new development in the treatment of solid tumors, which represent about 90% of all cancers in the U.S.

On Feb. 16, the FDA gave accelerated approval to Iovance Biotherapeutics, Inc.’s Amtagvi (lifileucel) for the treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. The agency gave the therapy orphan drug, regenerative medicine advanced therapy, fast track and priority review designations.