Bylvay (odevixibat) — CareFirst (Caremark)

Initial criteria

• Member has a confirmed molecular diagnosis of PFIC (e.g., ATP8B1, ABCB11, ABCB4, TJP2, or MYO5B gene variants).
• Member has evidence of cholestasis (e.g., elevated serum bile acid level).
• Member does not have any other concomitant liver disease (e.g., biliary atresia, liver cancer, alternate non-PFIC related etiology of cholestasis).
• Member has not received a liver transplant.
• Member is age ≥ 3 months.
• The medication will not be used concomitantly with any other ileal bile acid transporter (IBAT) inhibitor (e.g., Livmarli).
• Medication is prescribed by or in consultation with a hepatologist or gastroenterologist.

Reauthorization criteria

• Member is experiencing benefit from therapy (e.g., improvement in pruritus).

Approval duration

Initial: 6 months; Reauthorization: 12 months