Bylvay (odevixibat) — Highmark
progressive familial intrahepatic cholestasis (PFIC) type 1 or type 2 with bile salt export pump protein (BSEP-3) function
Initial criteria
- age ≥ 3 months
- diagnosis of one (1) of the following confirmed by genetic testing: PFIC type 1 OR PFIC type 2 with bile salt export pump protein (BSEP-3) function
- diagnosis of pruritus (ICD-10: L29.8, L29.9)
- elevated serum bile acids above the laboratory reference range
- member does not have cirrhosis, portal hypertension, or history of hepatic decompensation
Reauthorization criteria
- member has experienced improvement in pruritus
- member has experienced a decrease in serum bile acids from baseline
- prescriber attests that the member has not progressed to cirrhosis, portal hypertension, or hepatic decompensation
Approval duration
initial up to 6 months; reauthorization up to 12 months