Bylvay (odevixibat) — United Healthcare

Progressive Familial Intrahepatic Cholestasis (PFIC) with moderate to severe pruritus

Initial criteria

Confirmed molecular diagnosis of progressive familial intrahepatic cholestasis (PFIC)
Patient does not have a ABCB11 variant resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3)
Patient is experiencing moderate to severe pruritus associated with PFIC
Patient has a serum bile acid concentration above the upper limit of the normal reference range for the reporting laboratory
Patient has had an inadequate response to at least two other conventional treatments for the symptomatic relief of pruritus (e.g., uroseoxycholic acid, diphenhydramine, cholestyramine, rifampin, naltrexone, sertraline)
Prescribed by a gastroenterologist or hepatologist

Documentation of positive clinical response to Bylvay therapy (e.g., reduced serum bile acids, improved pruritis and less sleep disturbance)
Prescribed by a gastroenterologist or hepatologist

12 months