Rezdiffra — Medica

Non-Alcoholic Steatohepatitis (NASH)

Initial criteria

age ≥ 18 years
Diagnosis of MASH/NASH confirmed by ONE of the following: (a) Liver biopsy performed within 3 years showing NAFLD activity score ≥ 4 with a score of ≥ 1 in steatosis, ballooning, and lobular inflammation; OR (b) Imaging exam (elastography, computed tomography, or magnetic resonance imaging) performed within 6 months prior to treatment
Patient has stage F2 fibrosis OR stage F3 fibrosis
Patient has THREE or more metabolic risk factors managed according to standard of care (central obesity, hypertriglyceridemia, reduced high-density lipoprotein cholesterol, hypertension, elevated fasting plasma glucose indicative of diabetes or pre-diabetes)
Alcohol consumption is < 20 grams/day for female patients OR < 30 grams/day for male patients
Medication will be used in combination with appropriate diet and exercise therapy
Prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist

Patient has completed ≥ 1 year of therapy with Rezdiffra
According to the prescriber, patient has not had worsening of fibrosis or MASH/NASH
Patient has not progressed to stage F4 (cirrhosis)
Metabolic risk factors are managed according to standard of care
Alcohol consumption is < 20 grams/day for female patients OR < 30 grams/day for male patients
Medication will be used in combination with appropriate diet and exercise therapy
Prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist

1 year