ICER sets out protocol for first annual launch price and access

19 May 2025

The USA’s Institute for Clinical and Economic Review (ICER) has 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 Food and Drug Administration (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*.

The health technology assessor said it 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.

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