WHA
 

Rezdiffra (resmetirom) - NF

Indications for Prior Authorization

Rezdiffra (resmetirom)
  • For diagnosis of Nonalcoholic steatohepatitis (NASH)
    Indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use: Avoid use of Rezdiffra in patients with decompensated cirrhosis.

Criteria

Rezdiffra

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming all of the following:
    • Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH)
      • AND
    • Patient does not have cirrhosis (e.g., decompensated cirrhosis)
      • AND
    • Disease is fibrosis stage F2 or F3 as confirmed by one of the following: [4]
      • Enhanced liver fibrosis (ELF) test
      • Liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) (e.g., FibroScan)
      • FibroScan aspartate aminotransferase (FAST)
      • MRI aspartate aminotransferase (MAST)
      • Magnetic Resonance Elastography combined with fibrosis-4 index (MEFIB)
      • Liver biopsy within the past 12 months
    AND
  • Patient is 18 years of age or older
    • AND
  • Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
    • AND
  • Prescribed by or in consultation with one of the following:
    • Gastroenterologist
    • Hepatologist
    • Endocrinologist
    AND
  • Medication will not be used in combination with Wegovy (semaglutide) for the treatment of MASH
Rezdiffra

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming patient demonstrates positive response to therapy (e.g., improvement in liver function tests [LFTs], fibrosis stage improvement, improvement from baseline on metabolic dysfunction-associated steatohepatitis [MASH]-specific imaging [VCTE >/= 25%, MRE >/= 20%, etc.] etc.)
    • AND
  • Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
    • AND
  • Submission of medical records (e.g., chart notes) confirming patient has not progressed to cirrhosis
    • AND
  • Medication will not be used in combination with Wegovy (semaglutide) for the treatment of MASH

  • Guideline ID
    GL-637188

  • Formulary
    ehb

  • Effective date
    Jul 1, 2026

  • P&T approval date

P & T Revisions

2026-06-09

  1. Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, et al. AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease.
  2. Rezdiffra Prescribing Information. Madrigal Pharmaceuticals. West Conshohocken, PA. December 2025.
  3. Harrison SA, Bedossa P, Guy CD, et al. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. The New England Journal of Medicine. 2024;390(6):497-509.
  4. Noureddin, Mazen et al. Expert Panel Recommendations: Practical Clinical Applications for Initiating and Monitoring Resmetirom in Patients with MASH/NASH and Moderate to Noncirrhotic Advanced Fibrosis.
  • 2026-06-09: New NF criteria created mirroring criteria for commercial standard.