Sotatercept

A year after warning that new medicines were becoming increasingly expensive and difficult to obtain, the Institute for Clinical and Economic Review (ICER) says US drug launch prices remain stubbornly high, while patients continue to face barriers in accessing new treatments."Overpayment for drugs beyond their value to patients is contributing to decreased patient access," said ICER CEO Sarah Emond. "Now more than ever, it is crucial that we start working towards the goal of pairing fair pricing with fair access."In its second annual Launch Price and Access Report, released Tuesday with West Health, the watchdog found that median annual net launch prices rose 35% between 2022 and 2025, reaching approximately $257,000 last year, while around a quarter of newly launched drugs carried annual net price tags exceeding $500,000 and two drugs topped $2 million.ICER's inaugural report last October had identified a 51% inflation-adjusted jump in median net launch prices between 2022 and 2024.The latest analysis suggests the pace of increases may have eased; most of the rise was concentrated between 2022 and 2023, and prices remained "relatively stable" thereafter, "with a slight decrease observed in 2025," the report said.However, ICER cautioned that changes in the mix of medicines entering the market could obscure that launch prices may "still be drifting upward." Last year's crop of approved treatments, for example, skewed away from the priciest categories, such as gene and cell therapies, biologics and ultra-rare disease drugs, the report noted.Value gapMeanwhile, of the 26 drugs previously reviewed by ICER between 2022 and 2025, 18 launched above its Health Benefit Price Benchmark, the price range the watchdog considers a fair reflection of a treatment's value to patients over their lifetimes.Among the largest discrepancies, according to Tuesday's report, were Insmed's Brinsupri (brensocatib), Merck & Co.'s Winrevair (sotatercept), BridgeBio's Attruby (acoramidis) and Bristol Myers Squibb's Camzyos (mavacamten), which ICER estimated would each need discounts ranging from roughly 82% to 95% to reach a cost-effectiveness threshold of $100,000 per quality-adjusted life year (QALY) gained.By contrast, some multimillion-dollar gene therapies, including Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel), as well as Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy (exagamglogene autotemcel), required smaller percentage reductions, ranging from 39% to 46%. Both are administered as one-time treatments.New-to-market blocksThe report also said insurance restrictions continue to stand between patients and newly approved medicines. According to ICER, nearly four in 10 prescriptions for outpatient drugs approved between July 2024 and June 2025 were rejected due to non-coverage, while only a third of outpatient prescriptions for newly launched drugs were filled within 30 days."With an average launch net price of over $250,000, and many drugs priced out of line with value, new-to-market blocks to temporarily delay coverage pending clinical and economic review and utilisation strategies to ensure that only patients for whom a treatment is clinically appropriate receive insurance coverage have become routine," the report said. "While these measures are intended to help keep insurance premiums more affordable for patients and all health plan members, they also risk delaying care or creating other barriers to effective care for certain patients."