Unsupported policy information: Insights from Jane Ha
By Jane Ha, PharmD, MS
Discussing the Institute for Clinical and Economic Review’s Unsupported Price Increase (UPI) reports
What inspired this research?
The research started as my fellowship research project and has continued with each new Unsupported Price Increase (UPI) report released by the Institute for Clinical and Economic Review (ICER). Initially, this topic was driven by questions from manufacturers regarding these UPI reports, which was an area with limited existing research.
In these reports, manufacturers submit evidence they believe justifies a price increase for their drugs. When we first started this research, we knew that ICER rejected the majority of submitted evidence but lacked details on the types of evidence and ICER’s reasons for rejecting or accepting evidence. Over the years, we reviewed and compiled evidence submitted to the existing UPI reports to determine trends in submissions and ICER’s determinations.
What are the key takeaways from your research?
The rejection rate remains consistently high in the 90th percentile; this year’s research found that ICER rejected 96% of evidence submissions across the five reports published from 2019-2023, which calls into question the policy relevance of the UPI reports.
Accepted evidence was limited to 21 distinct randomized controlled trials (RCT). We outlined the RCT characteristics, such as study phases from two to four, and comparing open-label versus double-blind studies as well as placebo control versus active control. Most of the accepted evidence were phase three, double-blinded studies, but for the first time in 2023, we observed ICER accepted evidence as early as phase two.
What are the next steps from this research?
ICER released its protocol for the new report this past April and plans to publish the full report in December 2024. 1 We plan to update our research once that report is available.
In the near term, we are working on our annual managed care trends survey. We are currently crafting questions to understand how payers are utilizing UPI reports and how these reports influence their decision-making. This year, we are adding a few new questions to delve deeper into how payers use these reports and quantify their impact on decision-making.
Citations relevant to the content described herein are provided in the article linked here. Readers should review all available information related to the topics mentioned herein and rely on their own experience and expertise in making decisions related thereto.
1 ICER. Institute for Clinical and Economic Review Publishes 2024 Research Protocol for Assessing Unsupported Price Increases on Prescription Drugs. https://icer.org/news-insights/press-releases/icer-publishes-2024-research-protocol-for-assessing-unsupported-price-increases-on-prescription-drugs/
