CurrentUnitedHealthcarePolicy 2025 P 2338-4

Rezdiffra (resmetirom) prior authorization/medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for Rezdiffra (resmetirom) for adults with noncirrhotic MASH/NASH with fibrosis stage F2–F3, including initial and reauthorization requirements and prescriber restrictions.

Policy Summary

PayerUnitedHealthcare

PolicyRezdiffra (resmetirom) prior authorization/medical necessity

Policy CodePolicy 2025 P 2338-4

Change TypeMaterial updates (criteria and attestation added)

Effective Date2/1/2026

Next Review Date

Key ActionSubmit medical records documenting fibrosis stage F2 or F3 confirmed by VCTE (FibroScan), MRE, or liver biopsy within the past 12 months and attest that Rezdiffra will not be started concurrently with Wegovy for the same indication.

SourceLink

POLICY UPDATE CHANGES

Added combination use language (provider attestation that Rezdiffra will not be initiated at the same time as Wegovy (semaglutide)).

Revised initial authorization criteria to require medical record submission documenting fibrosis stage F2 or F3.

Added reauthorization requirement that patient has not progressed to cirrhosis.

New prior authorization program established for Rezdiffra.

12 monthsAuthorization duration

F2–F3Required fibrosis stage for coverage

AdultsAge population indicated

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Coverage Criteria for Rezdiffra (resmetirom)

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Member has a diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) [formerly known as nonalcoholic steatohepatitis (NASH)].

Fibrosis documentation: Submission of medical records documenting fibrosis stage F2 or F3 confirmed by ONE of: LSM by vibration-controlled transient elastography (VCTE) (e.g., FibroScan), LSM by magnetic resonance elastography (MRE), or liver biopsy within the past 12 months.within the past 12 months for liver biopsy

Lifestyle counseling: Patient has received comprehensive counseling regarding lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program).

Combination therapy attestation: Provider attests that Rezdiffra will not be initiated at the same time as Wegovy (semaglutide) for treatment of the same indication.

Prescriber: Medication is prescribed by or in consultation with a gastroenterologist or hepatologist.

Reauthorization

Covered when ALL of the following are met:

Clinical response: Documentation of positive clinical response to Rezdiffra therapy (e.g., improvement in or stabilization of fibrosis).

No progression to cirrhosis: Patient has not progressed to cirrhosis.

Authorization issued for 12 months.

Prescriber: Medication is prescribed by or in consultation with a gastroenterologist or hepatologist.

Use of Rezdiffra (resmetirom) is avoided in patients with decompensated cirrhosis. This limitation of use reflects the product’s contraindication/precaution in individuals with advanced liver decompensation and should be confirmed from the member’s clinical record before authorization.

Use of Rezdiffra is not supported when required documentation does not confirm eligibility criteria. Specifically, therapy is not supported if fibrosis stage is documented outside F2–F3, if medical records documenting fibrosis stage (via LSM by VCTE, LSM by MRE, or liver biopsy) are not submitted or are older than the required timeframe, or if at reauthorization the patient has progressed to cirrhosis. Additionally, initial prescriptions must be by or in consultation with a gastroenterologist or hepatologist and include documentation of lifestyle counseling and the provider attestation regarding concurrent initiation with Wegovy; absence of these items may result in denial.

Coding and Test Documentation

Referenced coding/claim logicmixed

No codes listed

Liver biopsy recency — key facts

Required recencyLiver biopsy must have been performed within the past 12 months

Accepted confirmation methodsFibrosis stage F2–F3 may be confirmed by LSM via VCTE (e.g., FibroScan), LSM via MRE, or liver biopsy within past 12 months

Documentation requirementSubmission of medical records documenting fibrosis stage F2 or F3 is required

Prescriber Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for initiation and reauthorization of Rezdiffra (resmetirom). Providers must submit a completed prior authorization request with supporting medical records that document diagnosis, fibrosis stage, prescriber specialty, and attestation statements. Approval is contingent on meeting all criteria listed below.

Submit medical records showing diagnosis of metabolic dysfunction‑associated steatohepatitis (MASH/NASH).
Include documentation confirming fibrosis stage F2 or F3 by one of: LSM by VCTE (e.g., FibroScan), MRE, or liver biopsy within the past 12 months.
Provider specialty: prescribing provider must be a gastroenterologist or hepatologist, or treatment must be documented as in consultation with one of these specialists.
Reauthorization requires documentation that the patient has not progressed to cirrhosis.

Documentation Required

Combination Therapy Attestation

Background

Rezdiffra (resmetirom) is a thyroid hormone receptor‑beta (THR‑β) agonist indicated, in conjunction with diet and exercise, for adults with noncirrhotic metabolic dysfunction‑associated steatohepatitis (MASH, formerly NASH) and moderate to advanced fibrosis. Initial authorization requires documented MASH with fibrosis stage F2 or F3 confirmed by LSM via VCTE (e.g., FibroScan), LSM via MRE, or liver biopsy within the past 12 months, evidence of comprehensive lifestyle counseling, a prescriber attestation that Rezdiffra will not be started concurrently with Wegovy (semaglutide) for the same indication, and that the medication is prescribed by or in consultation with a gastroenterologist or hepatologist.

Definitions

MASH (NASH) definition

DefinitionMASH = metabolic dysfunction-associated steatohepatitis (formerly known as NASH)

Indication contextRezdiffra is indicated for adults with noncirrhotic MASH/NASH with moderate to advanced fibrosis (F2–F3)

Avoidance noteAvoid Rezdiffra in patients with decompensated cirrhosis