CurrentHealth NetPolicy CP PHAR.647

Resmetirom (Rezdiffra) coverage for metabolic dysfunction‑associated steatohepatitis (MASH/NASH)

Defines medical necessity, initial and continued therapy criteria, dosing limits, documentation and approval duration for Rezdiffra for adults with noncirrhotic MASH (formerly NASH) with stage F2–F3 fibrosis across Commercial, HIM and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyResmetirom (Rezdiffra) coverage for metabolic dysfunction‑associated steatohepatitis (MASH/NASH)

Policy CodePolicy CP PHAR.647

Change TypeClinical/coverage revisions

Effective DateMar 14, 2024

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical documentation demonstrating the member meets all approval criteria, including diagnosis, fibrosis staging within 6 months, BMI/lifestyle documentation where applicable, prescriber attestation of standard of care, and weight-based dosing verification.

SourceLink

POLICY UPDATE CHANGES

Updated terminology to MASH, added broader diagnostic test options and required timeframe (within last 6 months), lowered BMI threshold for lifestyle documentation from 27 to 25, added prescriber attestation of standard of care management, updated maximum FDA‑labeled dosing, and added MASH resolution as a positive response option.

12Approval duration (months)

≥18Age threshold (years)

F2–F3Fibrosis stage required

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

BMI documentation threshold (kg/m2)

1Dose limit (tablets/day)

Medical Necessity Criteria for Rezdiffra (Resmetirom)

Initial Approval — Metabolic Dysfunction‑Associated Steatohepatitis (MASH)

Rezdiffra is medically necessary when ALL of the following are met:

ALL of the following

ALL of the following
- Diagnosis of metabolic dysfunction‑associated steatohepatitis (MASH; formerly NASH)
- Prescribed by or in consultation with a hepatologist or gastroenterologist
Fibrosis stage confirmation (must be F2 or F3) within the last 6 months confirmed by ONE of the following
- Liver biopsy
- Serum-based assessment (e.g., FIB-4, NAFLD fibrosis score [NFS], enhanced liver fibrosis test [ELF])
- Imaging-based assessment (e.g., FibroScan, magnetic resonance elastography [MRE], MRI‑PDFF)
- MEFIB score (measured by FIB‑4 and MRE)
- MAST score (measured by MRI‑PDFF, MRE, and serum AST)
Age ≥ 18 years
BMI requirement
- If body mass index (BMI) ≥ 25 kg/m2, documentation of adherence to lifestyle modification including participation in a physician‑directed diet and exercise program for at least the last 6 months is required
- If BMI < 25 kg/m2, the BMI-specific lifestyle documentation requirement is not required per policy
Weight‑based dosing must be respected
- Actual body weight < 100 kg: 80 mg PO once daily
- Actual body weight ≥ 100 kg: 100 mg PO once daily
- Maximum: 1 tablet per day; dose must not exceed weight‑based maximum
Prescriber attestation that member is currently receiving standard of care management for concomitant related conditions (including type 2 diabetes, dyslipidemia, hypertension)

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria including fibrosis staging within the last 6 months, BMI/lifestyle documentation where applicable, and prescriber attestation of standard of care.

Continued Therapy — Metabolic Dysfunction‑Associated Steatohepatitis (MASH)

Approval for continued therapy is authorized when ONE of the following is met and additional conditions apply:

ALL of the following

ANY of the following
- Member is currently receiving medication via Centene benefit or has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (see state addendums CC PHARM.03A and CC PHARM.03B)
Clinical response for continued approval (must meet all listed response criteria)
- Evidence of positive response (one or more of the following)
  - Improvement in fibrosis by at least 1 stage from baseline with no worsening of MASH (no worsening of hepatocellular ballooning, lobular inflammation, or steatosis)

Not Authorized / Exclusions

Coverage is NOT authorized for:

ALL of the following

Non‑FDA approved indications not addressed in this policy, unless there is sufficient documentation of efficacy and safety per off‑label use policies (CP.CPA.09, HIM.PA.154, CP PMN.53)
Use in patients with decompensated cirrhosis (explicit limitation of use in FDA labeling)

Requests for non‑formulary or otherwise excluded uses should be referred to the line-of-business no coverage/non-formulary and off‑label policies noted in the policy (see related policies).

Product, Dosing and Code References

Product and dosingNDC|descriptionCovered

Rezdiffra

Resmetirom oral tablets; available strengths and example: 80 mg and 100 mg tablets (policy notes 60, 80 mg, 100 mg presentation text). Weight-based dosing: actual body weight < 100 kg: 80 mg PO once daily; actual body weight ≥ 100 kg: 100 mg PO once daily; maximum 1 tablet per day.

What Providers Must Do

Prior Authorization

Prior authorization required with specialty prescriber

Rezdiffra must be prescribed by or in consultation with a hepatologist or gastroenterologist. Prior authorization requests must include the prescriber’s attestation that the member is currently receiving standard‑of‑care management for related conditions (e.g., type 2 diabetes, dyslipidemia, hypertension).

Documentation Required

Submit supporting documentation

Submit office chart notes, laboratory results, and other clinical documentation demonstrating the member meets all approval criteria, including diagnosis, fibrosis staging within the last 6 months, BMI/lifestyle documentation when applicable, and prescriber attestation of standard‑of‑care management.

Chart notes documenting diagnosis of MASH
Fibrosis staging result obtained within the last 6 months (biopsy, serum‑based, imaging‑based, or combined scores such as MEFIB/MAST)
If BMI ≥25 kg/m2: documentation of adherence to physician‑directed diet and exercise program for ≥6 months

Key Thresholds and Defined Terms

Key clinical thresholds

Fibrosis stageF2 or F3 (noncirrhotic moderate to advanced fibrosis)

Age≥ 18 years

BMI lifestyle documentation thresholdDocumentation required if BMI ≥ 25 kg/m2 for ≥ 6 months

Dose limitsWeight‑based: <100 kg = 80 mg PO daily; ≥100 kg = 100 mg PO daily; maximum 1 tablet/day

Diagnostic timeframeFibrosis confirmation within the last 6 months

Definitions (as used in this policy)

MASH

Clinical and Regulatory Background

Resmetirom (Rezdiffra) is a thyroid hormone receptor‑beta agonist that is FDA‑approved under accelerated approval to treat adults with noncirrhotic nonalcoholic steatohepatitis — now termed metabolic dysfunction‑associated steatohepatitis (MASH/NASH) — with moderate to advanced fibrosis (stage F2–F3), to be used in conjunction with diet and exercise. The accelerated approval was granted based on improvements in NASH and fibrosis, and the policy notes that continued approval may be contingent on verification of clinical benefit in confirmatory trials. The FDA labeling also includes a limitation to avoid use in patients with decompensated cirrhosis and specifies weight‑based dosing recommendations and a 12‑month approval duration in the policy.

Policy Updates

2024-07-15revised

4Q 2024 annual review revised biomarker language to broader applicable assessments, added MRE as an example of imaging-based assessment, removed redirection to pioglitazone per competitor analysis, and updated references.

2024-05-24revised

P&T-approved update reflecting FDA labeling: added MASH terminology, expanded fibrosis diagnostic test options and timeframe (within the last 6 months), lowered BMI lifestyle documentation threshold from 27 to 25, added prescriber attestation of standard-of-care management, updated maximum FDA-labeled dosing, and added MASH resolution as a positive response option.

2024-04-09revised

Policy Summary

PayerHealth Net

PolicyResmetirom (Rezdiffra) coverage for metabolic dysfunction‑associated steatohepatitis (MASH/NASH)

Policy CodePolicy CP PHAR.647

Change TypeClinical/coverage revisions

Effective DateMar 14, 2024

Next Review Date

SourceLink

On This Page

Resolution of MASH with no worsening of fibrosis

No increase in fibrosis stage and no worsening of MASH from baseline

If request is for a dose increase

New dose must not exceed appropriate weight‑based dose (80 mg if <100 kg; 100 mg if ≥100 kg) and 1 tablet per day

Approval duration: 12 months

Prescriber attestation that member is receiving standard‑of‑care management for concomitant conditions

Documentation Required

Weight‑based dosing verification

Document the member’s actual body weight to confirm weight‑based dosing: 80 mg PO once daily if actual body weight is <100 kg; 100 mg PO once daily if actual body weight is ≥100 kg. Ensure dosing will not exceed one tablet per day.

Record of actual body weight used to determine dose (<100 kg = 80 mg; ≥100 kg = 100 mg)
Statement that total daily dose will not exceed 1 tablet

Prior Authorization

Continued therapy evidence requirement

For continuation of therapy, provide documentation of a positive therapeutic response such as improvement in fibrosis by at least 1 stage from baseline with no worsening of MASH, or resolution of MASH with no worsening of fibrosis; alternatively, continuation may be allowed under continuity of care criteria where applicable.

Evidence of improvement in fibrosis stage (≥1 stage) with no worsening of hepatocellular ballooning, lobular inflammation, or steatosis
Alternatively, documentation of resolution of MASH with no worsening of fibrosis
If continuity of care applies, documentation of current medication via Centene benefit or applicable state/product continuity rules

Denial Risk

Denial risk for non‑FDA uses

Requests for uses not approved by the FDA and not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP PMN.53).

If the requested indication is not listed in this policy, submit evidence per commercial and Medicaid off‑label policies referenced in the policy

Metabolic dysfunction‑associated steatohepatitis (term updated from NASH). Defined by ≥5% hepatic steatosis with inflammation and hepatocyte injury (ballooning), with or without fibrosis.

FIB‑4Fibrosis‑4 index, a noninvasive serum‑based fibrosis assessment.

MREMagnetic resonance elastography, an imaging‑based assessment of liver fibrosis.

MEFIBA combined score measured by FIB‑4 and MRE used to assess fibrosis.

MASTScore measured by MRI‑PDFF, MRE, and serum AST to assess MASH.

CP PMN.16 - Non‑formulary policy (Medicaid)read_with

References reviewed and drug updated; criteria updated per FDA labeling to add MASH terminology, broaden fibrosis diagnostic options and timeframe, lower BMI documentation threshold to 25, add prescriber attestation, update dosing, and include MASH resolution as a response option.

2024-03-14revisedLatest

Policy effective date for Resmetirom (Rezdiffra) clinical policy CP PHAR.647 with documentation of the revision log incorporating terminology change to MASH and criteria aligned to FDA-approved indication.

Resmetirom (Rezdiffra) coverage for metabolic dysfunction‑associated steatohepatitis (MASH/NASH)

Medical Necessity Criteria for Rezdiffra (Resmetirom)

Product, Dosing and Code References

What Providers Must Do

Key Thresholds and Defined Terms

Clinical and Regulatory Background

Other Policies to Read

Policy Updates