Bylvay (odevixibat) — Point32Health

Initial criteria

• Documented diagnosis of progressive familial intrahepatic cholestasis
• Documentation of molecular genetic testing confirming both of the following: Diagnosis of progressive familial intrahepatic cholestasis AND No indication of progressive familial intrahepatic cholestasis type 2 with ABCB11 variants encoding for nonfunction or absence of bile salt export pump protein (BSEP-3)
• Prescribed by or in consultation with a hepatologist, gastroenterologist, or a provider who specializes in progressive familial intrahepatic cholestasis
• Patient age ≥ 3 months
• Documentation of moderate to severe pruritus
• Documentation of trial and failure with at least one systemic medication considered standard of care for progressive familial intrahepatic cholestasis unless contraindicated (e.g., antihistamines, cholestyramine, rifampicin, ursodiol)
• Documentation the patient has not had a liver transplant

Reauthorization criteria

• Documented diagnosis of progressive familial intrahepatic cholestasis
• Documentation of molecular genetic testing confirming both of the following: Diagnosis of progressive familial intrahepatic cholestasis AND No indication of progressive familial intrahepatic cholestasis type 2 with ABCB11 variants encoding for nonfunction or absence of bile salt export pump protein (BSEP-3)
• Prescribed by or in consultation with a hepatologist, gastroenterologist, or a provider who specializes in progressive familial intrahepatic cholestasis
• Patient age ≥ 3 months
• Documentation of a positive clinical response as evidenced by one of the following: Improvement in severity of pruritus OR Reduction in serum bile acid from baseline
• Documentation the patient has not had a liver transplant

Approval duration

initial 6 months; reauth 12 months