Wegovy (semaglutide) — Point32Health
Noncirrhotic metabolic dysfunction-associated steatohepatitis (NASH/MASH)
Initial criteria
- Patient age ≥ 18 years
- Submission of chart note or medical record confirming diagnosis of noncirrhotic, non-alcoholic steatohepatitis (or metabolic dysfunction-associated steatohepatitis) (NASH/MASH)
- Submission of chart note or medical record confirming fibrosis stage F2 or F3 as confirmed by one of the following: (a) both of the following: (i) Fibrosis 4 index (FIB-4) score ≥ 1.3 AND (ii) one of: Enhanced liver fibrosis (ELF) test OR Liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) (e.g., FibroScan); OR (b) one of: FibroScan aspartate aminotransferase (FAST) OR MRI aspartate aminotransferase (MAST) OR Magnetic Resonance Elastography combined with fibrosis-4 index (MEFIB) OR Liver biopsy within the past 12 months
- Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
- Alcohol consumption ≤ 20 g/day for women and ≤ 30 g/day for men
- Prescribed by a gastroenterologist or hepatologist
- Patient does not have documentation for any of the following: (a) Presence or history of human immunodeficiency virus (HIV) infection or chronic liver disease other than nonalcoholic fatty liver disease (NAFLD), including no known presence of hepatitis C virus (HCV) RNA within 2 years of screening and no known presence of hepatitis B at any timepoint; (b) Estimated glomerular filtration rate < 30 mL/min/1.73 m2; (c) Type 1 diabetes; (d) New York Heart Association (NYHA) class IV heart failure
Reauthorization criteria
- First Reauthorization: Member is adherent to therapy as defined by consistently filled prescriptions over the past 4 months
- One of the following: (a) Patient is currently on maintenance dose 2.4 mg once weekly OR (b) Patient is on 1.7 mg once weekly if 2.4 mg not tolerated
- Documentation by prescribing physician that patient is adherent to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
- Alcohol consumption ≤ 20 g/day for women and ≤ 30 g/day for men
- Prescribed by or in consultation with a gastroenterologist or hepatologist
- Patient does not have documentation for any of the following: (a) Progression to cirrhosis; (b) Presence or history of HIV infection or chronic liver disease other than NAFLD, including no known presence of HCV RNA within 2 years and no known presence of hepatitis B; (c) Estimated glomerular filtration rate < 30 mL/min/1.73 m2; (d) Type 1 diabetes; (e) NYHA class IV heart failure
- Subsequent Reauthorization: Patient demonstrates positive response to therapy as documented by MASH resolution, fibrosis stage improvement, or no worsening of fibrosis via liver biopsy or elastography
- Member is adherent to therapy as above
- One of the following: (a) 2.4 mg once weekly maintenance dose OR (b) 1.7 mg once weekly if 2.4 mg not tolerated
- Documentation by prescribing physician that patient is adherent to lifestyle modification
- Alcohol consumption ≤ 20 g/day for women and ≤ 30 g/day for men
- Prescribed by or in consultation with gastroenterologist or hepatologist
- Patient does not have documentation for any of the following: (a) Progression to cirrhosis; (b) Presence or history of HIV infection or other chronic liver disease; (c) Type 1 diabetes; (d) Estimated glomerular filtration rate < 30 mL/min/1.73 m2; (e) NYHA class IV heart failure
Approval duration
initial 6 months; first reauth 6 months; subsequent reauth 12 months