ICPT—From a strictly medical standpoint, I actually think the non-invasive tests available today are sufficient for treating NASH patients, unless the doctor suspects that a patient has a different liver disease—or two liver diseases (NASH + something else) simultaneously.
However, for third-party payers, insisting on a biopsy seems like a no-brainer given the large patient population, the estimated yearly Ocaliva price,* and the probable need for rest-of-life treatment.
*The NASH price at 25mg/day will presumably be priced differently on a per-milligram basis than the PBC price at 5-10mg/day.