Nonalcoholic Steatohepatitis

Midwest CEPAC

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

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 recently issuing a Complete Response Letter to Intercept Pharmaceuticals, stating that the current efficacy and safety data was insufficient to support accelerated approval.
  • ICER is currently finalizing its revised Evidence Report on obeticholic acid, which we still plan to publish on July 21, 2020.

For questions, please contact info@icer-review.org .

ASSOCIATED MEETING & MATERIALS

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

07/21/2020
Revised Voting Questions

07/21/2020

07/21/2020

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


ASSOCIATED MEETING & MATERIALS

New England CEPAC

The Westin Portland Harborview
157 High Street
Portland, ME 04101

The New England CEPAC convened to deliberate and vote on evidence presented in ICER's report on obeticholic acid (Intercept Pharmaceuticals, Inc.) for use in PBC and NASH.

Obeticholic acid (OCA) is a novel bile acid analogue that has shown positive effects on biochemical markers of liver function in phase II trials (NCT00550862) and is currently under consideration by the FDA for treatment of primary biliary cholangitis (PBC) after failure of Ursodeoxycholic Acid (UDCA). Primary biliary cholangitis (PBC), which has until recently been called primary biliary cirrhosis, is a rare, chronic, progressive autoimmune liver disease that affects mainly middle-aged women. In the US, up to 130,000 individuals may have PBC.
In January 2015, obeticholic acid also received a breakthrough designation for treatment of non-alcoholic steatohepatitis (NASH) with concomitant liver fibrosis. Interim findings from the phase III trial are not expected to be available until March 2017; however, clinical interest in potential off-label use of obeticholic acid is likely to be great, given the lack of available treatments with liver-specific effects. NASH is form of nonalcoholic fatty liver disease (NAFLD) that can progress to cirrhosis, liver failure, and cancer. NASH is present in about 30 million adults in the US.
Intervention of Interest: Obeticholic Acid (Intercept Pharmaceuticals, Inc.)

Date of Review: July 2016

For questions or additional information, please contact info@icer-review.org

Key Dates

Associated Materials