Bylvay — Medical Mutual

Initial criteria

• Patient age ≥ 3 months; AND
• Patient has moderate-to-severe pruritus, according to the prescriber; AND
• Diagnosis of PFIC confirmed by genetic testing demonstrating a gene mutation affiliated with PFIC (ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, or MYO5B); AND
• Patient does not have cirrhosis OR portal hypertension OR history of a hepatic decompensation event (variceal hemorrhage, ascites, hepatic encephalopathy); AND
• Patient has serum bile acid concentration above the upper limit of the normal reference range; AND
• Patient has tried at least two systemic medications for PFIC (cholestyramine, naltrexone, rifampicin, sertraline, ursodeoxycholic acid) unless contraindicated; AND
• Medication prescribed by or in consultation with a hepatologist, gastroenterologist, or physician specializing in PFIC

Reauthorization criteria

• Patient does not have cirrhosis OR portal hypertension OR history of a hepatic decompensation event; AND
• Patient had response to therapy as determined by the prescriber (e.g., decrease in serum bile acids, decrease in pruritus); AND
• Medication prescribed by or in consultation with a hepatologist, gastroenterologist, or physician specializing in PFIC

Approval duration

initial 6 months, reauth 1 year