Rezdiffra — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. The patient has a diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction associated steatohepatitis (MASH) (medical records required)
• 2. The patient has stage F2 or F3 fibrosis as confirmed by BOTH of the following (prior to therapy with the requested agent): A. A FIB-4 score consistent with stage F2 or F3 fibrosis adjusted for age AND B. The patient has ONE of the following: 1. A liver biopsy within the past 2 years OR 2. Vibration-controlled transient elastography (VCTE, e.g., Fibroscan) OR 3. Enhanced liver fibrosis (ELF) score OR 4. Magnetic resonance elastography (MRE)
• 3. If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. There is support for using the requested agent for the patient’s age for the requested indication
• 4. ONE of the following: A. If female, alcohol consumption <20 grams/day OR B. If male, alcohol consumption <30 grams/day
• 5. The patient is being monitored and/or treated for any comorbid conditions (e.g., cardiovascular disease, diabetes, dyslipidemia, hypertension)
• 6. BOTH of the following: A. The patient is currently on a weight management regimen of a low-calorie diet, increased physical activity, and behavioral modifications AND B. The patient will continue the weight management regimen in combination with the requested agent
• 7. The patient does NOT have ANY of the following: A. Decompensated cirrhosis AND B. Moderate to severe hepatic impairment (Child-Pugh Class B or C) AND C. Any other liver disease (e.g., Wilson's disease, hepatocellular carcinoma, hepatitis)
• 8. The prescriber is a specialist in hepatology or gastroenterology or has consulted with a specialist in the area of the patient’s diagnosis
• 9. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 2. ONE of the following: A. If female, alcohol consumption <20 grams/day OR B. If male, alcohol consumption <30 grams/day
• 3. BOTH of the following: A. The patient is currently on a weight management regimen of a low-calorie diet, increased physical activity, and behavioral modifications AND B. The patient will continue the weight management regimen in combination with the requested agent
• 4. The patient does NOT have ANY of the following: A. Decompensated cirrhosis AND B. Moderate to severe hepatic impairment (Child-Pugh Class B or C) AND C. Any other liver disease (e.g., Wilson's disease, hepatocellular carcinoma, hepatitis)
• 5. The patient has had clinical benefit with the requested agent
• 6. The prescriber is a specialist in hepatology or gastroenterology or has consulted with a specialist in the area of the patient’s diagnosis
• 7. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months