CurrentmeridianPolicy MDN.CP.PHAR.647

Clinical Policy: Resmetirom (Rezdiffra)

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Defines medical necessity and authorization criteria for coverage of resmetirom (Rezdiffra) for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH/NASH) with stage F2–F3 fibrosis under Meridian Health Plan (Medicaid). Applies to prescribers and reviewers processing benefit requests.

Policy Summary

Payermeridian

PolicyClinical Policy: Resmetirom (Rezdiffra)

Policy CodePolicy MDN.CP.PHAR.647

Change TypeNo material changes

Effective DateApr 1, 2025

Last ReviewApr 9, 2026

Next Review DateApr 9, 2026

Key ActionSubmit prior authorization with documentation proving diagnosis, fibrosis stage confirmation, enrollment in a physician-directed weight-loss program, prescriber specialty attestation, and adherence to weight-based dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

F2–F3required fibrosis stage for coverage

≥18minimum age for coverage

12 moapproval duration

1 tab/daymax daily dosing

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CurrentmeridianPolicy MDN.CP.PHAR.647

Clinical Policy: Resmetirom (Rezdiffra)

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Policy Summary

Payermeridian

PolicyClinical Policy: Resmetirom (Rezdiffra)

Policy CodePolicy MDN.CP.PHAR.647

Change TypeNo material changes

Effective DateApr 1, 2025

Last ReviewApr 9, 2026

Next Review DateApr 9, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

F2–F3required fibrosis stage for coverage

≥18minimum age for coverage

12 moapproval duration

1 tab/daymax daily dosing

<100kg:80mg; ≥100kg:100mgweight-based dosing

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval for MASH: 1. Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH; formerly known as NASH). 2. Prescribed by or in consultation with a hepatologist or gastroenterologist. 3. Age ≥ 18 years. 4. MASH with stage F2 or F3 fibrosis confirmed by ONE of the following: (a) liver biopsy within the last 3 years; OR (b) BOTH: (i) a serum-based assessment (e.g., FIB-4, NFS, ELF) and (ii) an imaging-based assessment (e.g., VCTE, MRE, MRI-PDFF) performed within the last 6 months. 5. Documentation of active enrollment in a physician-directed weight loss program that includes reduced calorie diet, increased physical activity, and behavioral modification: (a) actively enrolled for at least the last 6 months; and (b) will continue enrollment while prescribed Rezdiffra. 6. Prescriber attestation that the member is receiving standard of care management for related conditions (eg, T2DM, dyslipidemia, hypertension). 7. Rezdiffra is not prescribed concurrently with Wegovy (semaglutide). 8. Dose does not exceed 1 tablet per day and weight-based dosing is followed: (a) actual body weight < 100 kg = 80 mg/day; (b) actual body weight ≥ 100 kg = 100 mg/day.

Continued Therapy

Continued coverage requires ALL of the following:

Continued Therapy for MASH: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, OR member has continuity of care per state/product regulations. 2. Member is responding positively to therapy as evidenced by at least one of: (a) improvement in fibrosis ≥ 1 stage from baseline with no worsening of MASH (no worsening hepatocellular ballooning, lobular inflammation, or steatosis); (b) resolution of MASH with no worsening of fibrosis; (c) no increase in fibrosis stage and no worsening of MASH from baseline. 3. Documentation of continued active enrollment in a physician-directed reduced calorie diet, increased physical activity, and behavioral modification program. 4. Prescriber attestation that member is receiving standard of care management for related conditions (eg, T2DM, dyslipidemia, hypertension). 5. Rezdiffra is not prescribed concurrently with Wegovy. 6. If dose increase requested, new dose does not exceed 1 tablet per day and follows weight-based dosing: (a) actual body weight < 100 kg = 80 mg/day; (b) actual body weight ≥ 100 kg = 100 mg/day.

Non–FDA approved indications that are not expressly addressed within this policy are not authorized for coverage unless there is adequate documentation demonstrating efficacy and safety consistent with Meridian’s off‑label policy. For Medicaid members, off‑label uses must be supported by CP.PMN.53 (Off‑Label Use Policy) or by applicable evidence of coverage documents.

For Medicaid members, when a state Medicaid coverage provision conflicts with the coverage provisions contained in this clinical policy, the state Medicaid coverage provision takes precedence. Refer to the applicable state Medicaid manual for specific state requirements that govern coverage decisions for this therapy.

Initial Therapy

Covered when ALL of the following are met:

Continuation / Renewal Criteria

Continued Therapy

Continued coverage requires ALL of the following:

Coding and Assessment Requirements

Liver assessment window

Liver assessment windowAcceptable documentation for fibrosis confirmation: a liver biopsy performed within the last 3 years OR both a serum-based assessment and an imaging-based assessment performed within the last 6 months.

Serum-based assessment examplesFIB-4, NAFLD Fibrosis Score (NFS), Enhanced Liver Fibrosis (ELF) test (see Appendix E).

Imaging-based assessment examplesVibration-controlled transient elastography (VCTE/FibroScan), magnetic resonance elastography (MRE), MRI-PDFF (see Appendix E).

Provider Actions and Authorization

Prior Authorization

Prior authorization required — submit documentation that member meets ALL approval criteria

Prior authorization must be obtained and the request must include supporting documentation that the member meets all approval criteria (diagnosis of MASH, specialist prescriber or consult, fibrosis confirmation, enrollment in a physician-directed weight‑loss program, prescriber attestation of standard‑of‑care management, avoidance of concurrent Wegovy, and weight‑based dosing limits).

Include evidence of fibrosis stage (biopsy within 3 years OR both serum- and imaging-based assessments within 6 months).
Document enrollment in a physician-directed weight loss program (≥6 months) and commitment to continue while on therapy.
Provide prescriber specialty/consult and attestation of standard‑of‑care management for related conditions.

Note

Policy guidance for prior authorization and coverage decisions

This clinical policy provides medical necessity guidance used to assist in making coverage decisions and administering benefits; any prior authorization requirements and final coverage decisions are determined per the Health Plan and member benefit documents.

Step Therapy / Therapeutic Alternatives

Step	Requirement / restriction	Therapeutic alternative
{"text":"1","status":""}\|{"text":"Rezdiffra (resmetirom) must not be prescribed concurrently with Wegovy (semaglutide).","status":""}\|{"text":"Wegovy (semaglutide) — see Appendix B (initiate 0.5 mg SC weekly, titrate to maintenance 2.4 mg weekly; 2.4 mg/week maximum).","status":""}

Quantity Limits and Dosing

Resmetirom (Rezdiffra) — Quantity limit & dosing summary

Quantity limit1 tablet per day.

Weight-based dosing<100 kg: 80 mg PO daily; ≥100 kg: 100 mg PO daily.

Maximum daily doseDose must not exceed 1 tablet per day.

Definitions

MASH (Metabolic dysfunction‑associated steatohepatitis) definition

MASH definitionMetabolic dysfunction-associated steatohepatitis (MASH) is defined by presence of ≥5% hepatic steatosis with inflammation and hepatocyte injury (hepatocyte ballooning), with or without evidence of liver fibrosis.

Nomenclature noteMASH replaces the former term NASH per international liver disease societies consensus (June 2023).

Clinical featuresRequires steatosis plus inflammation and hepatocyte ballooning; fibrosis may be present or absent.

Serum-based fibrosis assessments (examples)

ELFEnhanced Liver Fibrosis (ELF) test — listed as an example of a serum-based assessment for fibrosis evaluation.

FIB-4Fibrosis-4 (FIB-4) — listed as an example of a serum-based assessment for fibrosis evaluation.

Background

Resmetirom (Rezdiffra) is a thyroid receptor‑beta agonist approved in adults, in combination with diet and exercise, for treatment of noncirrhotic metabolic dysfunction‑associated steatohepatitis (MASH/NASH) with stage F2–F3 fibrosis under accelerated FDA approval. Use is intended for noncirrhotic disease and should be avoided in decompensated cirrhosis; continued approval may depend on availability of confirmatory trial data.

Policy Summary

Payermeridian

PolicyClinical Policy: Resmetirom (Rezdiffra)

Policy CodePolicy MDN.CP.PHAR.647

Change TypeNo material changes

Effective DateApr 1, 2025

Last ReviewApr 9, 2026

Next Review DateApr 9, 2026

SourceLink

On This Page

Policy is a guide to medical necessity, not a guarantee of payment.

Step Therapy

Therapeutic alternative and concurrency rule — Wegovy

Wegovy (semaglutide) is listed as a therapeutic alternative in Appendix B and Rezdiffra (resmetirom) must not be prescribed concurrently with Wegovy.

Appendix B lists Wegovy (semaglutide) as a therapeutic alternative (maintenance dose 2.4 mg weekly).
Concurrent prescription of Rezdiffra and Wegovy is explicitly disallowed.

Note

Provider action — include complete clinical support with requests

Ensure all prior authorization requests include the clinical documentation listed in the policy; missing or incomplete supporting information may delay or prevent approval.

Follow the clinical policy guidance and Health Plan procedures when submitting documentation.

Documentation Required

Required documentation — office notes, labs, imaging, program enrollment

Providers must submit office chart notes, relevant laboratory results, imaging reports or other clinical information that demonstrate the member meets the policy's approval criteria (including fibrosis confirmation and weight‑loss program enrollment).

Fibrosis evidence: liver biopsy within 3 years OR both serum- and imaging-based assessments within 6 months.
Proof of active enrollment in a physician-directed weight loss program for ≥6 months and commitment to continue.

Billing Rule

Policy limits and benefit verification reminder — verify member benefits

This clinical policy is a guide to medical necessity and does not guarantee payment; providers must verify member benefits and follow the applicable evidence of coverage, contracts, and Health Plan administrative policies.

Coverage decisions and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents.
Follow member benefit documents, state/federal requirements, and Health Plan-level policies.

Denial Risk

Denial triggers — missing documentation or failure to meet criteria

Requests may be denied if required documentation is missing or the member does not meet the policy criteria (e.g., no confirmed F2–F3 fibrosis, not enrolled in a physician-directed weight‑loss program, prescriber specialty not documented, dosing limits exceeded, or concurrent Wegovy use).

Denials can result from absent fibrosis confirmation or inadequate documentation of the required assessments.
Concurrent prescription with Wegovy or doses exceeding 1 tablet/day (weight‑based limits) are denial triggers.
Failure to provide prescriber attestation of standard‑of‑care management or proof of program enrollment may lead to denial.

Note

Coverage decisions subject to plan terms, exclusions, and legal requirements

Coverage decisions and the administration of benefits remain subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable legal/regulatory requirements.

State Medicaid provisions take precedence where they conflict with this clinical policy for Medicaid members.

NFSNAFLD Fibrosis Score (NFS) — listed as an example of a serum-based assessment for fibrosis evaluation.

Clinical policy — purpose and scope

PurposeThis clinical policy is guidance developed by appropriately experienced and licensed health care professionals based on review of standards, literature, approvals, and guidelines to assist in making coverage decisions and administering benefits.

Not medical adviceThe policy does not constitute medical advice, medical treatment, or medical care and is not intended to dictate how to practice medicine; providers must exercise professional judgment.

LimitsCoverage decisions remain subject to the terms, conditions, exclusions, and limitations of the coverage documents and applicable legal/regulatory requirements.