ICER Posts Draft Scoping Document for Assessment of Triple Combination Therapy

The Institute for Clinical and Economic Review (ICER) recently posted a draft scoping document to outline their planned assessment of the clinical effectiveness and value of the triple combination (also known as elexacaftor/tezacaftor/ivacaftor). The document is open for public comment through October 21.

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On September 30, the Institute for Clinical and Economic Review (ICER) posted the proposed scope of their assessment of cystic fibrosis therapies. This follows ICER's announcement in early September that they would be reviewing CFTR (cystic fibrosis transmembrane conductance regulator) modulators, including elexacaftor/tezacaftor/ivacaftor (VX-445), the triple-combination therapy currently under review by the U.S. Food and Drug Administration.

ICER is inviting people from the CF community to provide public comment on the proposed scope to help inform and shape the assessment and final report. The input period runs through October 21. Comments can be submitted by email to There will be additional opportunities for the CF community to provide their input in the coming months.

The Cystic Fibrosis Foundation will provide feedback to ICER on the scoping document to help ensure they understand the complexities of CF, the importance of CFTR modulators in treating cystic fibrosis, and that the scope reflects available evidence.

ICER is an independent nonprofit research institute that assesses whether the benefit a medication delivers to patients is aligned with its current cost. The final ICER report on CFTR modulators will be released in May 2020. 

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