Biotech Values

[DewDiligence]

ABBV/ENTA—So what the heck happened, you think?

The patient deaths that triggered the FDA warning fall into three groups: 1) Patients with Child-Pugh-B (or even more advanced) cirrhosis who were prescribed V-Pak even though the FDA label did not recommended V-Pak for such patients; 2) Patients who were prescribed V-Pak in accordance with the label but nevertheless had a rare drug-related reaction; and 3) Patents whose death was not drug-related.

The FDA warning and revised label will fix the problem for group #1, and there is no problem that needs fixing for group #3. That leaves group #2 as the only lingering concern, and it’s reasonable to surmise from the phase-3 data mentioned in #msg-117976477 that the probability of any given V-Pak patient being in group #2 is very small.

…do you actually think ESRX will change its formulary?

I think ESRX will issue a statement saying that its personnel will scrutinize V-Pak prescriptions to ensure that they comply with the revised FDA label; however, that’s the only change I expect ESRX to make. To go further than that would invite a lawsuit from ABBV and would increase ESRX’s reimbursement outlays.