Rezdiffra (resmetirom) — Point32Health

Initial criteria

• Documentation of BOTH of the following as confirmed by liver biopsy or elastography: a. Documented diagnosis of noncirrhotic, non-alcoholic steatohepatitis (or metabolic dysfunction-associated steatohepatitis) (NASH/MASH); b. Fibrosis stage 2 or 3
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
• Alcohol consumption of no more than 20 g per day for women and no more than 30 g per day for men
• Prescribed by or in consultation with a gastroenterologist or hepatologist

Reauthorization criteria

• Patient demonstrates positive response to therapy (e.g., NASH resolution, fibrosis stage improvement, etc.) or no worsening of fibrosis
• Documentation by the prescribing physician that the patient is adherent to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
• Alcohol consumption of no more than 20 g per day for women and no more than 30 g per day for men

Approval duration

12 months initial, 12 months reauthorization