Summary

The Institute for Clinical and Economic Review (ICER) published a report on October 20, 2026. Specifically, it reviewed 26 drugs approved in the United States between 2022 and 2025. Two-thirds launched at prices well above ICER’s own cost-effectiveness threshold. Notably, that threshold is $100,000 to $150,000 per quality-adjusted life year. Median inflation-adjusted net prices rose from about $190,000 in 2022 to $257,000 in 2025. Moreover, nearly a quarter of 2025 launches carried net prices above $500,000. Consequently, ICER is urging drugmakers to adopt what it calls fair pricing, and insurers to widen access.

Access Impact

A high launch price does not buy automatic coverage. In fact, ICER’s data show the opposite pattern taking hold. Insurers rejected four in ten prescriptions for the drugs it reviewed. Notably, rejection rates were worse for Medicare patients. This is the core concern of MARA’s Cost-Effectiveness domain. Specifically, a price unsupported by a clear value case invites restriction, delay, or non-coverage. Two drugs show the gap most starkly. ICER says Brinsupri (Insmed) and Winrevair (Merck & Co.) would each need a discount of roughly 90% to meet its value benchmark. By contrast, Journavx (Vertex Pharmaceuticals) priced within ICER’s thresholds. Therefore, this shows that price and evidence can align. It is not merely a theoretical goal.

Cost-Effectiveness

ICER’s benchmark converts clinical benefit into a dollar figure per quality-adjusted life year. It then compares that figure to the launch price. Casgevy (Vertex Pharmaceuticals and CRISPR Therapeutics) is a one-time gene-editing therapy. Specifically, it carries a net price of $2.2 million. ICER estimates a reduction of about 7% would align it with its benchmark. Carvykti (Janssen and Legend Biotech), by contrast, is a cell therapy for multiple myeloma. It is priced at $465,000, with an estimated gap of roughly one-third. In short, even strong clinical data can sit alongside a real cost-effectiveness mismatch. As a result, payers are positioned to act on that mismatch.

Budget Impact

Price alone does not capture the full access risk. The number of patients who can receive a therapy matters just as much. Specifically, a single-patient, one-time gene therapy priced in the millions poses a different budget question than a chronic therapy. ICER’s review does not separate budget impact from net price. However, the distinction still matters for portfolio planning. A drug that clears a cost-effectiveness bar can still strain a payer’s annual budget if uptake is high. Likewise, a drug that fails the bar can still gain conditional coverage if the affected population is small. Therefore, price and population size should be read together, not apart.

Comparator Selection

ICER’s value calculation depends on the comparator used in each trial. Specifically, a placebo-controlled trial and an active-comparator trial can produce different cost-effectiveness estimates. This holds even for the same drug. However, the report does not detail comparator choice for each of the 26 drugs. That is itself a transparency gap. Without knowing what a drug was measured against, a discount estimate is hard to judge. It may reflect the drug’s true clinical benefit. Instead, it may simply reflect the chosen baseline.

Risk Signal

A rising median price, with rejection climbing alongside it. For portfolio and investment decisions, this report makes one thing clear. Regulatory approval and commercial access are two separate hurdles. Notably, they are cleared on different evidence. Therefore, a launch price set without a transparent value case is a price set for renegotiation. It is not a price set for revenue certainty. Nearly a quarter of 2025 launches already sit above $500,000 in net price. Moreover, insurers are rejecting four in ten prescriptions for the group as a whole. For an asset in diligence, or a portfolio under review, the question is specific. Does this drug’s price rest on a published, defensible cost-effectiveness case? Or, instead, does it rest on the assumption that approval alone will carry it to reimbursement?

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