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BOSTON, May 4, 2026 – The Institute for Clinical and Economic Review (ICER) posted a Protocol today outlining how it will conduct its second annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group* consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.
In the upcoming report, to be released in October 2026, ICER will analyze launch price trends over four years (2022-2025). ICER is also conducting an in-depth review of newly launched drugs (July 2024 to June 2025 novel drug approvals) by:
- Evaluating the impact of pricing above ICER’s Health Benefit Price Benchmark (HBPB)† for drugs that ICER has previously reviewed.
- Evaluating patient access to newly launched drugs using real-world pharmacy and medical claims data, payer coverage policies, and direct patient surveys.
The complete timeline for ICER’s Launch Price and Access report is available here.
Manufacturer Survey: Call to Submit List and Net Price Data at Launch
ICER is committed to using the most accurate pricing information in our work. In this report, ICER plans to use multiple drug pricing data sources, such as SSR Health, IPD Analytics, and the Federal Supply Schedule.
Manufacturers of any drug in scope approved between 2022 to 2025 may submit annual list and net price data at launch through our manufacturer submission survey. Submissions must be received by 5 PM ET on June 1, 2026. Data submitted by manufacturers and deemed reliable may be used publicly in the report and may replace previously used estimates of net price.
*None of the Working Group members should be assumed to agree with any of the specific methods, findings, or perspectives presented in this protocol or in the ultimate report.
†ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, net of all rebates and discounts, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.
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