S4-12.3 – Keeping Regulatory Pace with Field Advancements

S4-12.3 - Keeping Regulatory Pace with Field Advancements
The Surfers provide an analysis of a recent draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. In this conversation, the panelists discuss how to effectively collect and implement changes reflected by the explosion of data emerging from the NAFLD and NASH space.

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.

The session begins with questions from Roger Green around the report’s dated figures on disease prevalence. This leads Louise Campbell to note the intensity and speed in which the Fatty Liver field has developed over the previous decade. Provided this explosion in knowledge, she wonders whether we are able to effectively collect and implement the changes reflected by all this emerging data. Jeff and Roger add that socioeconomic shifts and the COVID-19 pandemic further amplify already swelling rates of incidence.

As this session winds down, Jörn Schattenberg poses a cogent line of questioning to consider in establishing a cost-effective intervention:

Who was enrolled in the clinical trials?
Where’s the evidence that there is a subgroup of patients benefiting from the therapy?
How can we identify them moving forward and outside of clinical trials?
This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at questions@SurfingNASH.com. If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions.

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