Washington, DC, May 01, 2023 (GLOBE NEWSWIRE) -- On Friday, the Institute for Clinical and Economic Review (ICER) held a public hearing to review its draft assessment of Resmetirom and Obeticholic Acid (OCA) for Non-Alcoholic Steatohepatitis: Effectiveness and Value. While the evidence presented for both drugs was deemed effective in fibrosis regression, ICER inconsistently voted to show that there was only a net health benefit in favor of resmetirom, being superior to lifestyle management alone, and not in OCA.
ICER's voting questions and assumptions failed to reflect the complexities of the NASH patient experience. Donna R. Cryer, JD, President & CEO of Global Liver Institute and 28-year liver transplant survivor said, "ICER has conducted a fundamentally flawed review based on faulty assumptions and oversimplifies a complex disease and the existing data."
NASH Patients’ 5 top takeaways from the ICER Meeting:
- “We’re not brand new” - NASH patient Kimberly Martinez emphatically stated to ICER Policy Roundtable members. Barriers to care in the form of step therapy and cumbersome documentation of repeated attempts at weight loss, delaying care, and allowing people to get sicker will not be tolerated by the advocacy community once FDA-approved therapies for NASH are available.
- Cardiovascular side effects were weighed heavily by members of the Midwest CEPAC, even if those effects were manageable by statins and for an uncertain duration.
- Few Midwest CEPAC members voted to recognize caregiver impact despite NASH patient caregiver, support group leader, and co-founder of NASH KNOWLEDGE, Betsy Villotti’s stirring testimony that families are “being held hostage by liver disease” as their loved one descended into hepatic encephalopathy and other NASH complications.
- ICER wants to have it both ways - rushing to do their review before outcomes data, long-term studies, prices and other essential elements of an accurate model are available. Then, they cast doubt and lowered their scores and grades for lack of robust data.
- ICER president Steve Pearson conjured the dark days of Hepatitis C restrictions and offered several utilization management scenario options to Policy Roundtable members. This should not be the case study to follow and instead should serve as a cautionary tale when even today, years after approval of an innovative cure, only about 1 in 3 individuals with Hep C with insurance get timely treatment and people with Medicaid were 46% less likely to receive treatment. Unnecessary loss of life, particularly among the most vulnerable should not be our goal, as discussed in the recent JAMA article by Special Advisor to the President, Dr. Francis Collins.
Advocates’ deep familiarity with the existing data and recently published NASH Clinical Care guidelines and guidances was evident, a level of knowledge that few on the committee possessed. Despite the diverging opinions of the physician and expert panelists within the committee, the unwavering voice of the advocates throughout left a united message emphasizing the importance of a suspension or reduction of disease progression giving the liver more time, and providing patients, clinicians, and researchers a better chance to combat NASH.
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GLI is a patient-founded and led 501(c)3 nonprofit organization committed to liver health which focuses on advancing patient-centered research, education, and care delivery models for those living with NAFLD/NASH. Global Liver Institute’s NASH Council, which launched in 2017 at the Milken Institute at the George Washington School of Public Health coalesces a diverse set of more than 80 stakeholders around the urgency for developing preventive, diagnostic, and treatment solutions for all stages of NAFLD and NASH in the U.S. and abroad. GLI equips advocates to identify and solve the problems that matter to liver patients. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube.
