Bylvay (odevixibat) — CareFirst (Caremark)

Initial criteria

• Member has a diagnosis of ALGS established by one of the following: genetic testing (e.g., JAG1 or NOTCH2 gene variants); or family history of ALGS and one or more major clinical features of ALGS; or bile duct paucity and three or more major clinical features of ALGS; or four or more major clinical features of ALGS.
• Member has evidence of cholestasis (e.g., elevated serum bile acid level).
• Member does not have a history or presence of other concomitant liver disease (e.g., biliary atresia, PFIC, liver cancer).
• Member has not received a liver transplant.
• Member is age ≥ 12 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