PNS175 A DESCRIPTIVE ANALYSIS OF ICER ACCEPTANCE OF PHARMACEUTICAL MANUFACTURERS COMMENTS

Abstract

BACKGROUND: The Institute for Clinical and Economic Review (ICER) is an independent non-profit organization that has increasingly gained prominence in the United States (US) as it continues to produce reports on the value of drugs and other medical services. Given ICER’s increased influence with some private and public US payers, pharmaceutical manufacturers often participate actively during the review process spending significant time and resources in voicing their points of view via the public comment process. To describe to what extent ICER incorporates manufacturers’ comments in the final report and whether there are any changes in ICER’s receptivity from 2017 to 2018. Two independent reviewers collected the total number of comments submitted on the draft report and whether they were incorporated in the final report. The data was gathered directly from the ICER website on reports published between January 1st, 2017 and October 31st, 2018. Descriptive statistics are presented overall and by year and by company size, which was defined by 2017 worldwide revenue. Overall, pharmaceutical manufacturers that had their products reviewed by ICER during 2017-2018, and collectively submitted 1,298 comments on the draft report out of which 481 (37.1%) were incorporated by ICER in the final report. The acceptance rate was 27.1%, 41.1% and 34.5% for small, mid-size and large companies, respectively. The acceptance rate was 28.5% in 2017 and 50.4% for the first 10 months of 2018. This descriptive analysis suggests that ICER’s acceptance rate of manufacturers’ comments appears to be increasing based on a year over year trend. Company size does not appear to be directly related to the acceptance rate. Additional research is needed to examine the relationship of ICER’s acceptance rate with changes in the recommended value-based prices between the draft and final report.