resmetirom — Blue Cross Blue Shield of Texas
metabolic dysfunction associated steatohepatitis (MASH)
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 stage F2 or F3 fibrosis adjusted for age AND (B) ONE of: liver biopsy within past 2 years, vibration-controlled transient elastography (VCTE, e.g., Fibroscan), enhanced liver fibrosis (ELF) score, or magnetic resonance elastography (MRE)
- If patient has FDA labeled indication, ONE of: (A) Age is within FDA labeling for the requested indication OR (B) Support for use outside labeled age
- Alcohol consumption limits: if female < 20 grams/day OR if male < 30 grams/day
- Patient being monitored and/or treated for comorbid conditions (e.g., cardiovascular disease, diabetes, dyslipidemia, hypertension)
- Patient currently on a weight management regimen of low-calorie diet, increased physical activity, and behavioral modifications AND will continue this regimen with requested agent
- Patient does NOT have ANY of: 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)
- Prescriber is a specialist in area of patient’s diagnosis (e.g., hepatologist, gastroenterologist) or has consulted with one
- No FDA labeled contraindications to the requested agent
Reauthorization criteria
- Previously approved for requested agent through plan’s prior authorization process
- Alcohol consumption within limits: female < 20 grams/day OR male < 30 grams/day
- Patient currently on and will continue weight management regimen (low-calorie diet, increased physical activity, behavioral modifications)
- Patient does NOT have ANY of: 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)
- Patient has had clinical benefit with requested agent
- Prescriber is a specialist in area of diagnosis or has consulted with one
- No FDA labeled contraindications to requested agent
Approval duration
12 months