ICER planned to assess the comparative clinical effectiveness and value of obeticholic acid (Intercept) for the treatment of non-alcoholic steatohepatitis (NASH).

For questions, please contact info@icer.org.

Update as of July 1, 2020:

  • ICER will not hold the August 2020 Midwest CEPAC public meeting to discuss the comparative clinical effectiveness and value assessment of obeticholic acid for the treatment of non-alcoholic steatohepatitis (NASH).
  • This decision is the result of the Food and Drug Administration issuing a Complete Response Letter to Intercept Pharmaceuticals, stating that the current efficacy and safety data was insufficient to support accelerated approval.

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Final Documents

Below you will find the final documents from the assessment review process:

Evidence ReportDownload
Response to Public CommentsDownload
Public Comments on Draft Evidence ReportDownload