Biotech Values

[Mufaso]

MDGL- Rezdiffra supposedly has coverage currently in place for 30% of the US according to the article you referenced:

Commercial coverage for Rezdiffra is currently in place for 30% of U.S. lives, tracking in line with Madrigal’s goal to reach 80% by the year’s end, according to Sibold.

I assume these insurers do not require biopsy for diagnosis or I assume it would vave been noted by the VA.

Noninvasive testing and what insurers will do has always been the key question for MASH drugs. It looks like MDGL is starting off pretty well in this regard. According to Madrigal (at the JPM conference in January/at their approval cc) most hematologists/GI and specialists who are treating MASH don't use Liver biopsies to diagnose MASH severity anymore. These specialists have been using Fibroscan ( FibroScan is a type of liver elastography using ultrasound) and FIB4 blood tests. My understanding as these tests together have become the new defacto gold standard for diagnosis of MASH.

Regarding the VA requirement to have a biopsy, I assume they are simply delaying the process as MDGL suggests. The FDA label doesn’t require it as it appears most Experts don’t think it’s the current standard so it appears they are an outlier.

Now that a drug is approved for MASH, I would be interested in any legal opinions anyone has (Mouton?) on whether insurers would have any liability if they denied or delayed coverage because of the biopsy requirement that led to a bad outcome (e.g. liver cancer) Would this make insurers more likely to not require a biopsy?

Also- does anyone have a legal opinion if insurers could refuse to cover MASH for a covered person now that a drug is available and what legal liability they might face for non-coverage?