How are United States ICER'S evidence ratings determined?: A systematic review of ICER'S evidence ratings in evidence reports for new drugs in 2020 and 2021. Ronquest N, Clinkscales M, Paret K.
The Institute for Clinical and Economic Review, or ICER, is an independent organization that evaluates health technologies in the US. ICER’s value assessment framework is similar to frameworks used by major global HTA bodies. However, ICER’s method for assigning comparative effectiveness is unique, with evidence ratings defined by the level of certainty and comparative net health benefit.
We conducted a systematic review of evidence reports to better understand how evidence ratings are assigned and identify key factors which influence ICER’s rating decisions. A total of 68 evidence ratings were reviewed, across 17 assessments published in 2020 and 2021.
As part of our analysis, we identified trends in the strength of evidence required for each rating. Assessments with ratings of B+ were typically associated with a substantial improvement in clinical outcomes without longer-term safety evidence OR less impressive efficacy with longer-term safety evidence. To achieve an A rating, ICER required substantial efficacy benefits AND longer-term safety data.
We found only 4 instances where evidence ratings changed between draft and final reports, supporting our previous research, which suggested that stakeholder input rarely impacts clinical rating. Future research is warranted to better characterize and quantify the health benefit needed to achieve each clinical rating.
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