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L.5.01.612
Rezdiffra (resmetirom)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Metabolic dysfunction-associated steatotic liver disease (MASLD; previously termed nonalcohol-associated fatty liver disease [NAFLD]) is a spectrum of liver disease characterized by excess triglyceride storage in the liver, the presence of at least one cardiometabolic risk factor, and the absence of harmful alcohol consumption.
Metabolic dysfunction-associated steatohepatitis (MASH; previously termed nonalcoholic steatohepatitis [NASH]) is the more severe end of the spectrum and is associated with inflammation and hepatocellular injury that can lead to fibrosis and cirrhosis. MASLD has become the most common chronic liver disease and is linked with type 2 diabetes, obesity, and other cardiometabolic risk factors. MASLD is associated with an increased risk of cardiovascular events, chronic kidney disease, liver failure, and hepatocellular carcinoma. Since weight loss is the cornerstone of management, treatment of MASLD should include comprehensive lifestyle modification (diet, exercise, behavior modifications) along with optimal control of comorbid metabolic conditions.
Rezdiffra (resmetirom) is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with 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.
Rezdiffra (resmetirom) is considered investigational as there is insufficient evidence of clinical benefit.
Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
01/15/2025: New policy added.
12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Treatment of Noncirrhotic Non-alcoholic Steatohepatitis (NASH)" to "Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)." Policy description updated regarding metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis. Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Sources updated.
Chopra S, Lai M. Management of metabolic dysfunction-associated steatotic liver disease (nonalcoholic fatty liver disease) in adults. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed on September 26, 2025. https://www.uptodate.com/contents/management-of-metabolic-dysfunction-associated-steatotic-liver-disease-nonalcoholic-fatty-liver-disease-in-adults
Rezdiffra prescribing information. Madrigal Pharmaceuticals, Inc. February 2025. Last accessed September 2025.
S. Department of Health and Human Services. (2021, April). Definition & Facts of NAFLD & Nash - NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases.
https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts
. Last accessed October 2024.
Tacke, Frank et al. EASL–EASD–EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). Journal of Hepatology, Sept 2024. Volume 81, Issue 3, 492 – 542.
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