Rezdiffra — Blue Cross Blue Shield of Alabama

Initial criteria

• The patient has a diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction associated steatohepatitis (MASH) (medical records required)
• The patient has stage F2 or F3 fibrosis as confirmed by BOTH of the following (prior to therapy with the requested agent): A FIB-4 score consistent with stage F2 or F3 fibrosis adjusted for age (medical records required) AND ONE of the following: liver biopsy within the past 2 years OR transient elastography OR enhanced liver fibrosis (ELF) score OR magnetic resonance elastography (MRE)
• ONE of the following: If female, alcohol consumption < 20 grams/day OR If male, alcohol consumption < 30 grams/day (medical records required)
• The patient is being monitored and/or treated for any comorbid conditions (e.g., cardiovascular disease, diabetes, dyslipidemia, hypertension)
• BOTH of the following: The patient is currently on a weight management regimen of low-calorie diet, increased physical activity, and behavioral modifications AND The patient will continue the weight management regimen in combination with the requested agent OR The patient has another FDA labeled indication for the requested agent
• If the patient has an FDA labeled indication, then ONE of the following: The patient’s age is within FDA labeling for the requested indication OR There is support for using the requested agent for the patient’s age for the requested indication
• The patient does NOT have any of the following (medical records required): decompensated cirrhosis; moderate to severe hepatic impairment (Child-Pugh Class B or C); any other liver disease (e.g., Wilson's disease, hepatocellular carcinoma, hepatitis)
• The prescriber is a specialist in hepatology/gastroenterology or has consulted with a specialist in the area of the patient’s diagnosis
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has a diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction associated steatohepatitis (MASH)
• ONE of the following: If female, alcohol consumption < 20 grams/day OR If male, alcohol consumption < 30 grams/day
• BOTH of the following: The patient is currently on a weight management regimen of a low-calorie diet, increased physical activity, and behavioral modifications AND The patient will continue the regimen in combination with the requested agent

Approval duration

12 months