Livmarli — Medical Mutual

Initial criteria

• Patient is age ≥ 12 months; AND
• Patient has moderate-to-severe pruritus, according to the prescriber; AND
• Diagnosis of progressive familial intrahepatic cholestasis was confirmed by genetic testing demonstrating a pathogenic gene variant affiliated with PFIC (ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, or MYO5B); AND
• Patient has a serum bile acid concentration above the upper limit of the normal reference range for the reporting laboratory; AND
• Patient has tried at least two systemic medications for progressive familial intrahepatic cholestasis, unless contraindicated; AND
• Patient does not have any of the following: cirrhosis OR portal hypertension OR history of a hepatic decompensation event; AND
• The medication is prescribed by or in consultation with a hepatologist, gastroenterologist, or a physician who specializes in progressive familial intrahepatic cholestasis

Reauthorization criteria

• Patient does not have any of the following: 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 and decrease in pruritus); AND
• The medication is prescribed by or in consultation with a hepatologist, gastroenterologist, or a physician who specializes in progressive familial intrahepatic cholestasis

Approval duration

6 months initial, 1 year reauth