Posted by Michael Wonder on 01 Jul 2020
ICER cancels public meeting for non-alcoholic steatohepatitis assessment
1 July 2020 - August 2020 public meeting cancelled; evidence report being posted on 21 July 2020.
The Institute for Clinical and Economic Review (ICER) announced today that it 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 recently issuing a Complete Response Letter to Intercept Pharmaceuticals, stating that the current efficacy and safety data was insufficient to support accelerated approval.
