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.
Veronica begins this segment with comments alluding to the dichotomy of the biopsy. On one hand, there is an emergence of AI-assisted histological assessment of fibrosis that lends fascinating insights into the nuances of the liver as an organ. On the other hand, the field is still stuck with a very blunt tool inadequate in assessing the effectiveness of a drug. She states that it “hurts to see that this is what happens when we are not applying the right diagnostic markers and tools.” She goes on to say that “in a couple of years we’ll be in a totally different data zone” in terms of having much more quantitative data to employ when assessing the safety and efficacy of these drugs. This leads Roger Green to read out his least favorite sentence from the document: “the exact prevalence of NASH is uncertain since diagnosis requires liver biopsy and many patients with NAFLD do not undergo biopsy.”
The group goes on to discuss some more of the challenges in the document and data sets and before shifting to a payoff question around the impact of the ICER report. The panel notes that ICER has produced what is fundamentally private draft report with no impact on how the drug is assessed by the FDA. However, Hannah points out that while ICER sometimes issues updates, it’s uncommon. She suggests that this trial provides no guidance on how we determine which patients are F2 or F3, which will provide a real challenge for payers trying to determine the economic impacts of the drugs. While ICER is a private organization, its recommendations carry weight with those assessing the value and pricing of new medications. As such, this report has the potential to leave a significant footprint in commercial space.
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