ICER planned to assess the comparative clinical effectiveness and value of obeticholic acid (Intercept) for the treatment of non-alcoholic steatohepatitis (NASH).
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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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Below you will find the final documents from the assessment review process: