CurrentCignaPolicy IP0642

Rezdiffra (resmetirom) for non-cirrhotic NASH (MASH) with F2–F3 fibrosis

This Cigna coverage policy governs prior authorization, documentation, and medical necessity criteria for Rezdiffra (resmetirom) in adults with non-cirrhotic metabolic dysfunction–associated steatohepatitis (MASH)/NASH with stage F2–F3 fibrosis.

Policy Summary

PayerCigna

PolicyRezdiffra (resmetirom) for non-cirrhotic NASH (MASH) with F2–F3 fibrosis

Policy CodePolicy IP0642

Change TypeMaterial operational clarifications and eligibility expansions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of F2–F3 fibrosis (biopsy within 3 years or VCTE/MRE/ELF within 6 months) and prescriber statement of metabolic risk factor(s) and concomitant diet/exercise.

SourceLink

POLICY UPDATE CHANGES

Initial therapy criterion changed so a liver biopsy performed within the 3 years preceding treatment is acceptable (previously 6 months).

For patients currently receiving Rezdiffra, the requirement was revised so completion of ≥ 1 year of therapy plus prescriber statement of no worsening of fibrosis or MASH/NASH can qualify for continued approval.

The number of required metabolic risk factors for initial therapy was changed from three or more to one or more, per prescriber statement.

Imaging timeframes were standardized: VCTE, MRE, or ELF within 6 months; biopsy within 3 years; ELF score must be between 9.2 and 10.5.

F2–F3Required fibrosis stage for approval

≥18Minimum patient age for coverage

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Coverage Criteria for Rezdiffra (resmetirom)

FDA-Approved Indication

Approve for 1 year if the patient meets ONE of the following (A or B):

A: Initial Therapy

Initial Therapy criteria
- Age: Patient is ≥ 18 years of age
- Fibrosis stage documentation: Patient has stage F2 or F3 fibrosis prior to initiating treatment identified by ONE of: (a) liver biopsy performed within the 3 years preceding treatment; (b) VCTE performed within the 6 months preceding treatment; (c) MRE performed within the 6 months preceding treatment; (d) ELF test performed within the 6 months preceding treatment with a score of ≥ 9.2 to ≤ 10.5
- Metabolic risk factors: According to the prescriber, the patient has ONE or more metabolic risk factors managed according to standard of care (central obesity; hypertriglyceridemia; reduced HDL cholesterol; hypertension; elevated fasting plasma glucose)
- Alcohol use: According to the prescriber, alcohol consumption is < 20 grams/day for female patients or < 30 grams/day for male patients
- Concomitant therapy: Medication will be used in combination with appropriate diet and exercise therapy
- Prescriber specialty: Prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist

B: Patient Currently Receiving Rezdiffra

Continuation criteria
- Duration: Patient has completed ≥ 1 year of therapy with Rezdiffra (patients with <1 year or restarting should be considered under Initial Therapy)
- No cirrhosis: According to the prescriber, the patient does not have cirrhosis (F4)
- Metabolic management: According to the prescriber, metabolic risk factors are managed according to standard of care
- Alcohol use: According to the prescriber, alcohol consumption is < 20 grams/day for female patients or < 30 grams/day for male patients

Rezdiffra (resmetirom) is not medically necessary for treatment of MASLD/NAFLD (non‑NASH steatosis). The policy specifies that resmetirom is indicated for patients with non‑cirrhotic NASH with moderate to advanced fibrosis, and use for MASLD/NAFLD — conditions characterized by steatosis without the inflammatory and hepatocellular injury of NASH — is excluded from coverage.

Use of Rezdiffra for any indication other than non‑cirrhotic NASH with F2–F3 fibrosis is considered not medically necessary. The policy explicitly lists exclusions including MASLD/NAFLD and NASH with cirrhosis (F4), noting that the safety and effectiveness of Rezdiffra have not been established for cirrhotic NASH.

Coding and Test Thresholds

No specific CPT/HCPCS/ICD codes listed in documentmixed

No codes listed

ELF score guidance (inv-05)

Recommended ELF score range for selecting patients with ≥F2 fibrosisELF score ≥ 9.2 to ≤ 10.5

Purpose of rangeGuides selection of appropriate candidates for MASH/NASH therapy to detect ≥F2 fibrosis

Action if value above rangeIf ELF > 10.5, consider excluding cirrhosis/portal hypertension using VCTE or MRE before treatment

VCTE threshold example (inv-06)

VCTE liver stiffness threshold (MAESTRO‑NASH prescreening)Liver stiffness ≥ 8.5 kPa

Context of useUsed in MAESTRO‑NASH prescreening to identify patients with fibrosis for trial eligibility

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Rezdiffra. All approvals are provided for the duration noted in the clinical criteria. Because of the specialized skills required for evaluation, diagnosis, monitoring of adverse events, and long-term efficacy, Rezdiffra must be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist.

Prior Authorization Required for Rezdiffra

Documentation Required

Therapy Should Be Used in Combination with Diet and Exercise

Therapy must be used in combination with appropriate diet and exercise therapy. Best practices for management include comprehensive lifestyle modification (nutrition, exercise, behavioral modification) and optimal control of comorbid metabolic conditions; prescribers should document that metabolic risk factors are being managed according to standard of care.

Use in combination with diet and exercise

Definitions and Clinical Thresholds

ELF test definition and guidance (inv-12)

DefinitionEnhanced Liver Fibrosis (ELF) is a blood-based biomarker test used to estimate liver fibrosis

Recommended score rangeELF score range of 9.2–10.5 is recommended to guide selection for treatment of ≥F2 fibrosis

Time window for documentationELF must be performed within 6 months preceding treatment to meet documentation requirements

Alcohol thresholds for inclusion (inv-13)

Female alcohol thresholdAlcohol consumption < 20 grams/day

Male alcohol thresholdAlcohol consumption < 30 grams/day

Background

Rezdiffra (resmetirom) is a thyroid hormone receptor‑beta (THRβ) agonist developed for treatment of non‑cirrhotic NASH with moderate to advanced fibrosis. It was approved under an indication limited to non‑cirrhotic NASH; because safety and effectiveness in patients with NASH cirrhosis have not been established, the policy excludes use in cirrhosis and in MASLD/NAFLD without NASH.