Pharmacy Prior Authorization Criteria

Rezdiffra (resmetirom) - PA, 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

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH)
AND
• Patient does not have cirrhosis (e.g., decompensated cirrhosis)
AND
• Submission of medical records (e.g., chart notes) confirming disease is fibrosis stage F2 or F3 as confirmed by one of the following: [4]
• Both of the following:
• Serum biomarker [e.g., enhanced liver fibrosis (ELF) test, fibrosis-4 index (FIB-4)]
• Imaging biomarker [e.g., FibroScan, magnetic resonance imaging-proton density fat fraction (MRI-PDFF)]
OR
• One of the following:
• 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
• Presence of greater than or equal to 3 metabolic risk factors (e.g., Type 2 diabetes, hypertension, obesity) [3]
AND
• Submission of medical records (e.g., chart notes) confirming drug is 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

Rezdiffra

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive response to therapy (e.g., NASH resolution, fibrosis stage improvement, etc.)
AND
• Submission of medical records (e.g., chart notes) confirming drug will continue to be 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

Rezdiffra

Non Formulary

Length of Approval: 12 Month(s)

• Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH)
AND
• Patient does not have cirrhosis (e.g., decompensated cirrhosis)
AND
• Submission of medical records (e.g., chart notes) confirming disease is fibrosis stage F2 or F3 as confirmed by one of the following: [4]
• Both of the following:
• Serum biomarker [e.g., enhanced liver fibrosis (ELF) test, fibrosis-4 index (FIB-4)]
• Imaging biomarker [e.g., FibroScan, magnetic resonance imaging-proton density fat fraction (MRI-PDFF)]
OR
• One of the following:
• 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
• Presence of greater than or equal to 3 metabolic risk factors (e.g., Type 2 diabetes, hypertension, obesity)
AND
• Submission of medical records (e.g., chart notes) confirming drug is 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

P & T Revisions

2024-10-02, 2024-04-03, 2024-03-20, 2024-03-19, 2024-03-15

References

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. March 2024.
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.

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Revision History

• 2024-10-02: Updated guideline
• 2024-04-03: Update to initial authorization duration and update to reauth criteria
• 2024-03-20: Guideline update
• 2024-03-19: Added GPI
• 2024-03-15: New Program

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