Wegovy — Medica

Initial criteria

• age ≥ 18 years
• does not have cirrhosis
• diagnosis of MASH/NASH confirmed by liver biopsy within 3 years showing NAFLD activity score ≥ 4 with score ≥ 1 in steatosis, ballooning, and lobular inflammation OR by imaging (elastography, CT, or MRI) within 6 months preceding treatment [documentation required]
• prior to treatment has stage F2 or F3 fibrosis [documentation required]
• has ≥ 1 managed metabolic risk factor (central obesity, hypertriglyceridemia, reduced HDL cholesterol, hypertension, or elevated fasting plasma glucose)
• alcohol consumption <20 g/day (female) OR <30 g/day (male)
• used in combination with appropriate diet and exercise therapy
• prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist

Reauthorization criteria

• has completed ≥ 1 year of Wegovy therapy and has not had worsening of fibrosis or MASH/NASH
• has not progressed to stage F4 (cirrhosis)
• metabolic risk factors managed per standard of care
• alcohol consumption <20 g/day (female) OR <30 g/day (male)
• used in combination with appropriate diet and exercise therapy
• prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist

Approval duration

1 year