Nonalcoholic Steatohepatitis

Midwest CEPAC

Key Dates

Associated Materials

10/08/2019 – 10/25/2019
Open Input Period

10/30/2019

10/30/2019 – 11/20/2019

10/30/2019

12/02/2019

01/15/2020

02/05/2020

03/19/2020

03/19/2020

03/19/2020 – 06/24/2020
Public Comments

07/21/2020
Revised Voting Questions

07/21/2020
Evidence Report

07/21/2020
Response to Comments

08/13/2020
  • 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 recently issuing a Complete Response Letter to Intercept Pharmaceuticals, stating that the current efficacy and safety data was insufficient to support accelerated approval.
Meeting Agenda

08/13/2020
  • 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 recently issuing a Complete Response Letter to Intercept Pharmaceuticals, stating that the current efficacy and safety data was insufficient to support accelerated approval.
Evidence Presentation

09/03/2020
Final Policy Recommendations

09/03/2020
Final Evidence Report and Meeting Summary

09/03/2020
Report-at-a-Glance