In September 2019, the Institute for Clinical and Economic Review (ICER) announced its assessment of the clinical effectiveness and value of CFTR modulator therapies, including elexacaftor/tezacaftor/ivacaftor (Trikafta™). ICER is a research organization that assesses whether the benefits a medication delivers to patients is aligned with the current cost. This is referred to as a cost-effectiveness analysis. ICER's report will look at how well Trikafta and other modulators work, how they compare to available treatments, and the relative value they provide to patients and the health care system overall.
Throughout the eight-month development of their evaluation, ICER invites people with CF to participate in the process to help inform and shape their final report. The Cystic Fibrosis Foundation also is providing input to ICER throughout the process to help them understand cystic fibrosis and the complexities of the disease. Our goal is to help ensure any assessment of CF therapies reflects the experiences and insights of people with CF, their loved ones, and their clinicians.
The 2020 ICER Review Timeline:
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February 20: ICER published a draft report and draft voting questions and opened their public comment period on their draft report through March 25.
- April 27: ICER published their revised evidence report and its response to public comments. The report will be presented and discussed at a public meeting (postponed due to the COVID-19 pandemic). Visit ICER's website to read the report and public comments.
Note: Due to the COVID-19 pandemic, ICER has decided to indefinitely postpone their public meeting, originally scheduled for April 30 and the publication of their final evidence report. The CF Foundation plans to participate in the meeting and will keep the community updated if/when we learn more about the status for the review.
The CF Foundation's Comments to ICER:
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October 21, 2019: CF Foundation provided comments to ICER on a draft document on the scope of their 2020 assessment.
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March 24, 2020: CF Foundation provided comments to ICER on a draft evidence report.
See the CF Foundation's Comments in Response to ICER's 2018 review
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November 20, 2017: Cystic Fibrosis Foundation Comments on ICER Draft Scoping Document
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April 12, 2018: Cystic Fibrosis Foundation Comments on ICER Draft Evidence Report of CFTR Modulators
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May 3, 2018: ICER Releases Final Evidence Report of CFTR Modulators. The Foundation posted a news story in response.