This conversation is part of a March, 2023 interview between co-hosts Louise Campbell and Roger Green and Jeff McIntyre of Global Liver Institute, one of the guests on the S5 E2 panel. This particular conversation focuses largely on Jeff’s insights around the imminent anticipated drug approvals of obeticholic acid (which was withdrawn several months later) and resmetirom (whose PDUFA date is next month).
Jeff’s analysis includes mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft’s reference to NASH as a non-progressive disease – a position which the panelists readily refute. Jeff’s positive note is that the report carefully considers patient perspective and he was able to participate as an expert reviewer.
The conversation shifts to speculations around the future standard for noninvasive testing and biomarkers. Jeff emphasizes the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines’ referral to FIB-4 as such a test. This summons quote of Quentin Anstee’s repeated admonition that “we not let the perfect be the enemy of the good.” For whatever shortcomings of FIB-4, if it can be done now and it’s two generations of successive approximation of what we’ve had before.
As the session winds down, Louise Campbell asserts further comments around the ICER draft and NASH as a progressive disease. She recollects the podcast’s recent conversation with Tim Jobson, founder of Predictive Health Intelligence, (S4 E5) which discusses developing a simple tool to identify patients at risk of liver disease by analyzing the results of blood tests given throughout their lives.