Livmarli (maralixibat) — Point32Health

Initial criteria

• Documented diagnosis of progressive familial intrahepatic cholestasis
• Documentation of molecular genetic testing confirming both: diagnosis of PFIC AND no indication of PFIC type 2 with ABCB11 variants encoding for nonfunctional or absent bile salt export pump protein
• Prescribed by or in consultation with a hepatologist, gastroenterologist, or provider specializing in PFIC
• Patient age ≥ 12 months
• Documentation of moderate to severe pruritus
• Documentation of trial and failure with at least one systemic medication considered standard of care for PFIC, unless contraindicated (e.g., antihistamines, cholestyramine, rifampicin, ursodiol)
• Documentation that the patient has not had a liver transplant

Reauthorization criteria

• Documented diagnosis of progressive familial intrahepatic cholestasis
• Documentation of molecular genetic testing confirming both: diagnosis of PFIC AND no indication of PFIC type 2 with ABCB11 variants encoding for nonfunctional or absent bile salt export pump protein
• Prescribed by or in consultation with a hepatologist, gastroenterologist, or provider specializing in PFIC
• Patient age ≥ 12 months
• Documentation of a positive clinical response as evidenced by improvement in severity of pruritus OR reduction in serum bile acid from baseline
• Documentation that the patient has not had a liver transplant

Approval duration

initial 6 months; reauth 12 months