Rezdiffra — Blue Cross Blue Shield of Illinois

Initial criteria

• Diagnosis of noncirrhotic NASH or MASH (medical records required)
• Stage F2 or F3 fibrosis confirmed by BOTH: (A) FIB-4 score consistent with F2/F3 adjusted for age AND (B) ONE of the following: liver biopsy within past 2 years OR vibration-controlled transient elastography (VCTE) OR enhanced liver fibrosis (ELF) score OR magnetic resonance elastography (MRE)
• If the patient has an FDA labeled indication, then ONE of the following: (A) Patient’s age is within FDA labeling OR (B) There is support for use at the patient’s age for the indication
• ONE of the following for alcohol consumption: (A) Female < 20 grams/day OR (B) Male < 30 grams/day
• Patient is being monitored and/or treated for any comorbid conditions (e.g., cardiovascular disease, diabetes, dyslipidemia, hypertension)
• Patient is currently on AND will continue a weight management regimen including low-calorie diet, increased physical activity, and behavioral modifications
• Patient does NOT have ANY of the following: decompensated cirrhosis, moderate to severe hepatic impairment (Child-Pugh B or C), or other liver diseases (e.g., Wilson’s disease, hepatocellular carcinoma, hepatitis)
• Prescriber is a specialist in hepatology/gastroenterology or has consulted with one
• Patient does NOT have any FDA labeled contraindications
• Alternative approval path: Member resides in Ohio AND plan is Fully Insured or HIM Shop AND ALL of the following: no FDA labeled contraindications AND ONE of: (1) another FDA labeled indication for route; (2) other compendia-supported indication; (3) submission of two major peer-reviewed journal articles supporting proposed use

Reauthorization criteria

• Patient previously approved through the plan’s PA process
• Alcohol consumption remains within limits: Female < 20 g/day or Male < 30 g/day
• Patient remains on and will continue weight management regimen (low-calorie diet, physical activity, behavioral modifications)
• Patient does NOT have ANY of the following: decompensated cirrhosis, moderate to severe hepatic impairment (Child-Pugh B or C), other liver disease (e.g., Wilson’s disease, hepatocellular carcinoma, hepatitis)
• Patient has had clinical benefit with the requested agent
• Prescriber is a specialist in hepatology/gastroenterology or has consulted with one
• Patient does NOT have any FDA labeled contraindications

Approval duration

12 months