Timing of health technology assessment in the United States: An evaluation of ICER reviews over 8 years.

Abstract

The Institute for Clinical and Economic Review (ICER) aims to publish health technology assessment (HTA) reports at or near the time of drug approval by the US Food and Drug Administration (FDA) to provide a timely, independent evaluation of the benefits, risks, and economic considerations surrounding a new therapy. To evaluate the timelines of ICER reports to inform pricing and coverage decisions, using FDA approval and list price announcement dates as a benchmark. With these data, we evaluated the availability of clinical evidence, specifically completion of pivotal trials and publication in peer-reviewed journals, at the time of ICER's review. We included drugs that were the primary intervention of interest in ICER reviews between 2017 and 2024. We extracted information on regulatory approval and list price announcements, and publication dates of ICER reports. We also extracted dates of publication of the pivotal trials that informed each ICER assessment to evaluate the time span between trial completion and publication. Our analysis of 73 ICER drug assessments showed that, on average, the launch price is announced on the same day as FDA approval. The majority of the ICER draft, evidence, and final assessments were published on or before the FDA approval and price announcement date (82%, 61%, 55%, respectively). In terms of data availability, the median time from primary trial completion to peer-review publication was 15 months. There were an average of 2 pivotal trials per drug assessment. The majority (71%) of the pivotal trials informing ICER assessments were published in peer-reviewed journals before the completion of the ICER draft assessment, although these publications were, on average, published approximately 1 month prior to the completion of the assessments. The majority of ICER drug assessments are published before FDA approval and price announcements, making them available for early decision-making at the time of drug launch. However, data availability is still a major challenge in making HTA available immediately after approval. Prioritizing early sharing of clinical trial data would foster timely and robust HTA, ensure clinical decisions and coverage policies are well informed, and improve early patient access.