Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications.
Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10. In this opening conversation, Roger Green introduces the ICER document and prompts panelists to share initial impressions around the assumptions and platforms that underlie it. Before diving in, Jörn Schattenberg briefly recaps the benefit behind obtaining relatively large datasets on safety and efficacy for resmetirom and obeticholic acid. Veronica asserts that she is “quite astounded” that this report would be generated before the emergence of a formal, peer-reviewed publication on the data. This leads Roger to note the competing interests of acquiring unassailable data (which can take endless time) versus serving the more immediate needs of patients desperate for solutions now.
Jeff discloses that while he is pleased with ICER’s inclusion of patient participation in the report, several critical shortcomings need addressing. The major concern: a statement claiming that NASH and NAFLD are not progressive diseases. Jörn responds to this statement with an anecdote from his specialty care clinic where patients do in fact arrive symptomatic as related to their troubled liver health. Surf on to the next conversation to hear what the others think.
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