ModifiedCentenePolicy CP.PHAR.647

Resmetirom (Rezdiffra) for metabolic dysfunction-associated steatohepatitis (MASH)

Covers medical necessity criteria, dosing, and authorization requirements for Resmetirom (Rezdiffra) for adults with noncirrhotic MASH (formerly NASH) with stage F2–F3 fibrosis for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyResmetirom (Rezdiffra) for metabolic dysfunction-associated steatohepatitis (MASH)

Policy CodePolicy CP.PHAR.647

Change TypeCriteria revised, Wegovy step therapy added/exclusion, diagnostic lookback updated

Effective Date03.14.24

Next Review Date

Key ActionSubmit prior authorization with documentation of MASH diagnosis, fibrosis staging (biopsy within 3 years or combined serum and imaging within 6 months), BMI and physician-directed weight loss program adherence, and Wegovy failure for F2 when required.

SourceLink

POLICY UPDATE CHANGES

Added new MASH terminology and updated criteria per FDA labeling including MASH fibrosis diagnostic test options and timeframe from within the last 6 months.

Updated BMI lower limit for documentation of adherence to lifestyle modification from 27 kg/m2 to 25 kg/m2 and clarified physician-directed weight loss program definition.

Biopsy lookback period revised from 6 months to 3 years per AASLD guidance; replaced FibroScan with VCTE as an example of imaging-based assessment.

Added redirection to Wegovy and exclusion for concurrent Wegovy use; clarified that members with moderate fibrosis (F2) require failure of Wegovy.

F2–F3fibrosis stages eligible

≥18minimum patient age (years)

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recommended daily doses

No Wegovyconcurrent therapy exclusion

03.14.24policy effective

Coverage Criteria for Resmetirom (Rezdiffra)

Initial Therapy (MASH)

Covered when ALL of the following are met:

Initial MASH criteria: 1) Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH; formerly 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 a serum-based assessment and an imaging-based assessment within the last 6 months (see Appendix E for examples). 5) Documentation supports participation in a physician-directed weight loss program that: (a) has been active for ≥ 6 months prior to request; and (b) will continue while on therapy. 6) Prescriber attestation that member is currently receiving standard-of-care management for concomitant related conditions (e.g., T2DM, dyslipidemia, hypertension). 7) For members with moderate fibrosis (F2): failure of a ≥ 6-month trial of Wegovy unless contraindicated or intolerant (Illinois HIM exception applies as of 1/1/2026). 8) Rezdiffra (resmetirom) is not prescribed concurrently with Wegovy. 9) Dose does not exceed 1 tablet per day and is weight-based: (a) actual body weight < 100 kg: 80 mg/day; (b) actual body weight ≥ 100 kg: 100 mg/day.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation criteria: 1) Member currently receiving medication via Centene benefit or continuity of care applies. 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 of 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 that member remains actively enrolled in a physician-directed weight loss program (reduced calorie diet, increased physical activity, behavioral modification). 4) Prescriber attestation that member is currently receiving standard-of-care management for concomitant related conditions (e.g., T2DM, dyslipidemia, hypertension). 5) Rezdiffra is not prescribed concurrently with Wegovy. 6) If request is for a dose increase, new dose must not exceed 1 tablet per day and follow weight-based limits: <100 kg = 80 mg/day; ≥100 kg = 100 mg/day.

Approval duration: 12 months.

Coverage criteria (initial and continued therapy highlights)

Covered when ALL of the following are met (as revised in policy updates):

Diagnosis and staging: Confirmed MASH diagnosis with fibrosis staging by liver biopsy or acceptable imaging/noninvasive assessments within specified lookback periods: biopsy up to 3 years (per AASLD-guided revision) or combined serum and imaging assessments within 6 months.

Noninvasive scores (MAST, FAST, MEFIB) moved to Appendix E; VCTE used as example imaging-based assessment replacing FibroScan.

BMI and weight-loss program: Member has documentation of adherence to a physician-directed weight loss program; policy lower BMI limit for documentation revised to ≥ 25 kg/m2.BMI >= 25 kg/m2

Policy originally used 27 kg/m2 and later revised to 25 kg/m2.

Prescriber attestation: Prescriber must attest member is receiving standard-of-care management for concomitant related conditions and, for continued therapy, attest ongoing adherence to the physician-directed weight loss program.

Requests for uses that are not FDA‑approved and are not addressed in this policy will not be authorized under this policy unless there is sufficient documentation of safety and efficacy consistent with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

This policy excludes concurrent use of Resmetirom with Wegovy. For members with moderate fibrosis (F2), the policy requires documentation of failure of a ≥6‑month trial of Wegovy prior to approval unless contraindicated or not tolerated. The policy history notes addition of Wegovy redirection and an explicit concurrent‑use exclusion, and a later clarification that the Wegovy failure requirement applies to members with F2 fibrosis.

The full policy includes additional conditions and standard "not medically necessary" scenarios that are not detailed in this excerpt. Providers should consult the complete policy for the list of specific NMN conditions and related exclusions that apply to Resmetirom requests.

Dosing, Testing Windows, and Coding Parameters

inv-07: weight-based dosing cutpoint — < 100 kg vs ≥ 100 kg.

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

Maximum dose guidanceDose not to exceed 1 tablet/day per FDA-labeled maximum

Policy change noteMaximum FDA-labeled dosing updated per 04.09.24 policy revision

inv-08: Biopsy lookback period — revised from within last 6 months to within last 3 years per AASLD guidance.

Biopsy lookback periodLiver biopsy within the last 3 years (revised from within last 6 months per AASLD guidance)

Imaging/noninvasive assessmentsAlternatively, combined serum-based and imaging-based assessments within the last 6 months may be used

Prior Authorization, Documentation, and Step Therapy Requirements

Documentation Required

PROVIDER ACTIONS — Documentation Required

Provider must submit documentation (such as office chart notes, lab results, imaging, or biopsy reports) supporting that the member has met all approval criteria. Requests lacking required documentation or requesting non‑FDA uses without appropriate off‑label evidence will be handled per applicable off‑label policies and may be denied.

Acceptable documentation: office notes, specialist consultation notes, laboratory results, imaging reports (VCTE, MRE, MRI‑PDFF), liver biopsy report.
Non‑FDA uses: require supporting evidence per CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid).

Prior Authorization

Initial Authorization Requirements

Prior authorization is required for initial therapy. For initial authorization, provider must submit documentation demonstrating all of the following: diagnosis of metabolic dysfunction‑associated steatohepatitis (MASH), prescriber is a hepatologist or gastroenterologist (or consult documented), member age ≥18 years, confirmation of stage F2 or F3 fibrosis by accepted testing, participation in a physician‑directed weight loss program, prescriber attestation of standard‑of‑care management for related conditions, Wegovy trial failure for F2 when applicable, and dosing within labeled limits.

Background on Resmetirom (Rezdiffra)

Resmetirom (Rezdiffra) is a thyroid receptor‑beta agonist approved under an accelerated pathway as an adjunct to diet and exercise for adults with noncirrhotic metabolic dysfunction‑associated steatohepatitis (MASH, formerly NASH) with stage F2–F3 fibrosis. Continued approval may depend on confirmatory trials; the policy emphasizes avoidance of use in decompensated cirrhosis and aligns diagnostic and management requirements with FDA labeling and subsequent guidance updates.

Definitions and Program Descriptions

inv-19: MASH — definition (Metabolic dysfunction-associated steatohepatitis, formerly NASH).

TermMetabolic dysfunction-associated steatohepatitis (MASH) — formerly referred to as NASH

DefinitionPresence of ≥ 5% hepatic steatosis with inflammation and hepatocyte injury (hepatocyte ballooning), with or without fibrosis

FDA indication contextRezdiffra indicated for adults with noncirrhotic MASH (stages F2–F3 fibrosis)

inv-20: Physician-directed weight loss program — defined as reduced calorie diet, increased physical activity, behavioral modification; documentation required for BMI criteria and continued therapy.

Program definitionPhysician-directed weight loss program: reduced calorie diet, increased physical activity, and behavioral modification

Duration/documentation

Policy Summary

PayerCentene

PolicyResmetirom (Rezdiffra) for metabolic dysfunction-associated steatohepatitis (MASH)

Policy CodePolicy CP.PHAR.647

Change TypeCriteria revised, Wegovy step therapy added/exclusion, diagnostic lookback updated

Effective Date03.14.24

Next Review Date

SourceLink

On This Page

Required per policy updates.

Step therapy for moderate fibrosis: For members with moderate fibrosis (F2), documentation of failure of Wegovy is required prior to approval; concurrent use of Wegovy is excluded.

Added per SDC and clarified in subsequent updates (Illinois exception noted separately).

Appendix relocationNoninvasive score examples (MAST, FAST, MEFIB) moved to Appendix E

inv-09: BMI lower limit for eligibility — revised from 27 kg/m2 to 25 kg/m2.

BMI lower limit for eligibilityDocumentation of BMI ≥ 25 kg/m2 (revised from 27 kg/m2)

Context for revisionChange made to align with overweight BMI range per 04.09.24 update

Requirement linkageBMI documentation used in assessing adherence to physician-directed weight loss program for initial and continued therapy

Fibrosis confirmation options: liver biopsy within last 3 years OR both a serum‑based assessment and an imaging‑based assessment within the last 6 months (examples in Appendix E).
Weight loss program: actively enrolled ≥6 months and will continue while on therapy.
Prescriber attestation: current standard‑of‑care management for T2DM, dyslipidemia, hypertension, etc.

Denial Risk

Documentation and Attestation Requirements — Denial Risk

Documentation and attestation must explicitly show required diagnostic testing within specified lookback periods and the prescriber’s attestations. Failure to document required diagnostic testing (e.g., biopsy within 3 years or serum + imaging assessments within 6 months) or to provide required attestations may result in denial of the request.

If relying on non‑invasive assessments, include test name, values, date, and interpretation (e.g., FIB‑4, NFS, ELF, VCTE, MRE, MRI‑PDFF).
Operative note or pathology report required if relying on liver biopsy.

Step Therapy

Step Therapy: Wegovy Requirement

For members with moderate fibrosis (F2), prior authorization requires documentation of failure of a ≥6‑month trial of semaglutide (Wegovy®) unless contraindicated or intolerant. Prior authorization may also be required for Wegovy separately. Rezdiffra must not be prescribed concurrently with Wegovy; requests for concurrent use will be denied.

Documented trial of Wegovy: start/end dates, dose, reason for discontinuation (inefficacy, contraindication, or adverse effects).
Exception: Illinois HIM requests — step therapy requirement does not apply per IL HB 5395 effective 01/01/2026.

Documentation Required

Requests Lacking Documentation or Off‑Label Uses

Requests that lack documentation showing the member meets all approval criteria, or that seek non‑FDA uses without appropriate off‑label support, will be processed per policy and may be denied. Providers should include all supportive records at time of initial request to avoid delays.

Include office notes showing enrollment and adherence to a physician‑directed weight loss program (≥6 months).
Include prescriber attestation of ongoing standard‑of‑care management for related comorbidities.
Attach all relevant diagnostic test results within lookback periods to prevent administrative denial.

Documentation of participation for ≥ 6 months and ongoing enrollment is required for initial approval and continued therapy

PurposeEvidence of adherence is required to meet BMI-related eligibility and as part of prescriber attestation for continued benefit