Bylvay (odevixibat) — Highmark

Initial criteria

• age ≥ 12 months
• diagnosis of Alagille syndrome confirmed by genetic testing demonstrating a JAGGED1 or NOTCH2 deletion or mutation
• elevated serum bile acid levels above the laboratory reference range
• provider attests that the member experiences cholestatic pruritus explained only by liver disease
• 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