Presentation (CTI)

OBJECTIVES: In many countries, there is a delay between regulatory approvals of new therapies and HTA assessments that inform pricing and coverage decisions. The Institute for Clinical and Economic Review (ICER) aims to issue HTA reports at or near the time of 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. In this retrospective analysis, we evaluated the timing of ICER reports relative to FDA approval and pricing decisions in the US.
METHODS: Drugs evaluated by ICER over seven years (2017 to 2023) were included. For each drug, we collected data on the ICER report dates, FDA submission and approval date, type of FDA review, type of data available for ICER HTA, peer-reviewed publication date of pivotal trials, and price announcement date.
RESULTS: The mean time between FDA approval and price announcement was 10 days, with a median of 0 days. Most (78%) ICER HTAs of novel drugs were published on or before FDA approval and price announcement date. For those published after FDA approval, most drugs were granted priority review (75%), and median time between approval and HTA was 69 days. Reasons why the HTA was published after FDA approval, included: FDA approved earlier than their goal date, selected by ICER regardless of expected approval date because of payer or policy implications, and mismatch between expected and actual regulatory decision date. At the time of the ICER HTA, 66% of trials informing the assessment had been published in peer-reviewed journals. Other sources of data included conference abstracts, clinicaltrials.gov, manufacturer submissions, among others.
CONCLUSIONS: The majority of ICER HTAs are published on or before FDA approval and price announcement. Improved data and information sharing can ensure that HTA can be most informative to stakeholders.