FDA APPROVES WEGOVY FOR METABOLIC DYSFUNCTION–ASSOCIATED STEATOHEPATITIS (MASH)
The question now is what will insurance companies require to cover it
Straight Healthcare
August 2025
August 2025
Metabolic dysfunction–associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis, is a common condition, affecting an estimated 25% of American adults and up to 90% of people with a BMI of 40 or greater. Until recently, the only FDA-approved MASH therapy was Resmetirom (Rezdiffra), a thyroid hormone receptor-beta (THR-β) partial agonist. On August 15, 2025, the FDA approved Wegovy for MASH based on an interim analysis of the ESSENCE study that compared Wegovy to placebo in 1,197 patients with MASH and fibrosis stage 2 or 3. At 72 weeks, resolution of steatohepatitis without worsening of fibrosis was observed in 63% of Wegovy-treated patients and 34% of placebo-treated patients (P<0.001). A reduction in liver fibrosis without worsening of steatohepatitis occurred in 37% and 22%, respectively (P<0.001). The Wegovy group lost 10.5% of their body weight compared to 2% in the placebo group.
Less than 20% of commercial health insurance plans cover Wegovy for weight loss, so a MASH indication is encouraging since it may increase access. However, a looming question is what criteria will insurance companies require for a MASH diagnosis. In the ESSENCE study, MASH was diagnosed with a liver biopsy, and only patients with stage 2 or 3 fibrosis were enrolled. Prior authorization criteria for Rezdiffra, which has the exact same indication as Wegovy, vary by insurance, but I know some plans require the following: (1) diagnosis by liver biopsy, Fibroscan, or magnetic resonance elastography (MRE), (2) prescribed by a gastroenterologist or hepatologist. Fibroscan is a specialized ultrasound typically found in gastroenterology practices, and MRE is a specific type of MRI that is not widely available. If insurance companies have the same criteria for Wegovy, it will create a significant barrier to access, especially in primary care.
Tirzepatide (Zepbound) has also been shown to improve MASH, and Eli Lilly is in the process of pursuing a MASH indication for it.
Less than 20% of commercial health insurance plans cover Wegovy for weight loss, so a MASH indication is encouraging since it may increase access. However, a looming question is what criteria will insurance companies require for a MASH diagnosis. In the ESSENCE study, MASH was diagnosed with a liver biopsy, and only patients with stage 2 or 3 fibrosis were enrolled. Prior authorization criteria for Rezdiffra, which has the exact same indication as Wegovy, vary by insurance, but I know some plans require the following: (1) diagnosis by liver biopsy, Fibroscan, or magnetic resonance elastography (MRE), (2) prescribed by a gastroenterologist or hepatologist. Fibroscan is a specialized ultrasound typically found in gastroenterology practices, and MRE is a specific type of MRI that is not widely available. If insurance companies have the same criteria for Wegovy, it will create a significant barrier to access, especially in primary care.
Tirzepatide (Zepbound) has also been shown to improve MASH, and Eli Lilly is in the process of pursuing a MASH indication for it.
- ESSENCE study - Wegovy vs Placebo for MASH, NEJM (2025)
- Resmetirom (Rezdiffra®) review
- SYNERGY-NASH trial - Tirzepatide vs Placebo for MASH, NEJM (2024)
