This week Global Liver Institute (GLI) submitted comments on the Institute for Clinical and Economic Review (ICER) draft evidence report entitled “Obeticholic Acid for the Treatment of Nonalcoholic Steatohepatitis with Fibrosis.”

Founded in 2006, ICER is an independent research organization that evaluates the clinical and economic value of prescription drugs, medical tests, and other health care and health care delivery innovations. ICER is currently assessing the comparative clinical effectiveness and value of Obeticholic Acid (Intercept) for the treatment of NASH.

There have been concerns voiced by many advocacy organizations, and GLI in the past, about ICER’s use of discriminatory measures to argue for reduced access to life-changing treatments.

In response to ICER’s draft evidence report, GLI collaborated with GLI’s NASH Council and found six core issues that should be considered and addressed as ICER advances towards a final report:


      1. Lack of Patient Inclusive Language and Impact on Quality of Life

      1. Model Assumption: NASH Standard of Care

      1. Model Assumption: “Gold” Standard Diagnostic

      1. Model Assumption: Length of Treatment

      1. Solution at Every Stage

      1. The Cost of Not Treating NASH

    There is no “silver bullet” response to NASH. While prevention and weight loss management can be effective earlier, it is difficult, and less effective at later stages. Treatment options for advanced NASH should also not be forced upon earlier, less advanced patients with NASH.

    It is important to be cognizant of the unique issues and costs at each stage of the disease when painting a complete cost picture for NASH along with considering potential other benefits offered by the intervention. We hope that by listening to comments from the NASH community ICER can accurating capture the burden and costs associated with this life-threatening disease.

    Read the letter