New research presented at AMCP Nexus 2023 shows that the Institute for Clinical and Economic Review (ICER) rejects the vast majority (97%) of evidence submitted by manufacturers during the institute’s process of evaluating unsupported price increases (UPIs).
ICER creates UPI reports to identify drugs with substantial price increases that lack new evidence to justify those increases, explained authors Jane Y. Ha, PharmD, MS, and Kimberly Westrich, MA, of Xcenda/AmerisourceBergen in Conshohocken, Pa. The researchers undertook the study to evaluate trends in what manufacturers submit and how ICER appraises that evidence. They specifically aimed to understand the quantity and quality of evidence that tends to meet ICER’s standards, such as specific study characteristics.
They reviewed all evidence that manufacturers submitted for the four UPI reports published from 2019 to 2022. The four reports involved 44 drugs, and manufacturers submitted 1,145 pieces of evidence for 34 of those drugs. The average number of pieces of evidence submitted for drugs declined year over year. The researchers coded and categorized each piece of evidence and documented reasons for accepting or rejecting each piece of evidence.
ICER rejected an average of 97% of evidence submissions: 99% in 2019, 97% in 2020, 93% in 2021, and 94% in 2022. Only 38 pieces of evidence were accepted, indicating that ICER deemed those select pieces of information high-quality proof that a price increase was warranted. The accepted evidence was from 18 randomized, controlled, Phase 3 (n=17) or Phase 4 (n=1) trials. Most of the accepted trials were double-blinded. The reasons for rejection were not meeting UPI criteria (64%) and not meeting the criteria for new moderate- to high-quality evidence (36%).
Over time, ICER refined their definition of acceptable evidence. In 2019, the threshold was longer-term data with improved outcomes. In later years, ICER indicated acceptance of evidence that supported FDA label expansion for a new or existing indication, supported accelerated approval, extended the evidence base to new populations, or strengthened existing guideline recommendations.
“Accepted evidence was typically from Phase 3, double-blinded, randomized, controlled trials that demonstrated new information on improved outcomes or supported FDA label expansion,” the authors wrote. “Manufacturers appeared to become increasingly selective over time with evidence they submitted.”
Reference
Ha J, Westrich K. Making the Cut: A Review of Evidence Trends in the Institute for Clinical and Economic Review’s Unsupported Price Increase Reports. Poster U12. Presented at AMCP Nexus 2023; Oct. 16‒19, 2023; Orlando, Fla.
