— Report to be issued in October 2025 —
BOSTON, May 19, 2025 – The Institute for Clinical and Economic Review (ICER) posted a Protocol today outlining how it will conduct a new 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*.
ICER will:
- Analyze trends in both list and net prices of novel drugs approved by the FDA in the past three years (2022 – 2024), as well as assess the impact of various relevant drug characteristics, such as drug type, therapeutic area, and population size, on launch prices.
- Conduct an in-depth review of the drugs in scope that have been previously reviewed by ICER; assess the prices of these drugs in relation to ICER’s health benefit price benchmark (HBPB), estimate potential savings in healthcare spending, and identify any opportunity costs associated with overspending on these drugs.
- Evaluate data on coverage restrictions, patient cost-sharing, and patient experiences on access for a selection of drugs in scope.
ICER’s first Launch Price and Access report is scheduled to be released on October 23, 2025. The complete timeline for this initiative is available here.
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.
* None of the Working Group members should be assumed to agree with any of the specific methods, findings, or perspectives presented in this report.
About ICER
The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.