The difference between the evidence needed to gain a US Food and Drug Administration approval and what physicians and payers might desire for widespread prescribing was on display at the Institute for Clinical and Economic Review’s (ICER) 26 April meeting on Madrigal Pharmaceuticals, Inc. and Intercept Pharmaceuticals, Inc. non-alcoholic steatohepatitis drugs.
‘Leaps of Faith:’ ICER Meeting Suggests Reimbursement Hurdles For NASH Drugs
Lack of long-term clinical outcomes data on a slowly progressing, common condition combined with a rapidly changing treatment space for obesity and health system cost issues may present problems for two NASH treatments even if they win accelerated approval from US FDA.
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