resmetirom — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following:
• A. ALL of the following:
• 1. Diagnosis of noncirrhotic NASH or MASH (medical records required) AND
• 2. Stage F2 or F3 fibrosis confirmed by BOTH of the following (prior to therapy):
• A. FIB-4 score consistent with stage F2 or F3 fibrosis adjusted for age (medical records required) AND
• B. ONE of the following (medical records required): liver biopsy within past 2 years OR transient elastography OR enhanced liver fibrosis (ELF) score AND
• 3. No more than mild alcohol intake (≤20 g/day for women; ≤30 g/day for men) (medical records required) AND
• 4. Patient is being monitored and/or treated for any comorbid conditions (e.g., cardiovascular disease, diabetes, dyslipidemia, hypertension) AND
• 5. BOTH of the following: patient currently on a weight management regimen (low-calorie diet, increased physical activity, behavioral modifications) AND patient will continue weight management regimen in combination with requested agent OR
• B. Patient has another FDA labeled indication for the requested agent AND
• 2. If FDA labeled indication: ONE of the following: patient’s age is within FDA labeling OR there is support for use in patient’s age for the indication AND
• 3. 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) AND
• 4. Prescriber is a specialist in the area of diagnosis (e.g., hepatologist, gastroenterologist) or has consulted with one AND
• 5. Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. Patient previously approved for requested agent through plan’s Prior Authorization process AND
• 2. ONE of the following:
• A. ALL of the following: diagnosis of noncirrhotic NASH or MASH AND currently on weight management regimen (low-calorie diet, increased physical activity, behavioral modifications) AND will continue weight management regimen in combination with requested agent OR
• B. Diagnosis other than NASH or MASH AND
• 3. Patient has had clinical benefit with the requested agent AND
• 4. Patient does NOT have any of the following: 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) AND
• 5. Prescriber is a specialist in the area of diagnosis (e.g., hepatologist, gastroenterologist) or has consulted with one AND
• 6. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months