CurrentBlue Cross Blue Shield - IowaPolicy 05.05.40

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

Policy defines coverage and prior authorization criteria for Rezdiffra (resmetirom) for adults with noncirrhotic metabolic dysfunction‑associated steatohepatitis (MASH, formerly NASH) with F2‑F3 fibrosis, including initial and continuation criteria, prescribing specialties, documentation requirements, dosing/quantity limits, and billing guidance.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRezdiffra (resmetirom) for metabolic dysfunction‑associated steatohepatitis (MASH/NASH)

Policy CodePolicy 05.05.40

Change TypeRevised (Jan 2026)

Effective DateMar 17, 2026

Next Review Date

Key ActionSubmit chart notes/medical records confirming MASH diagnosis, F2‑F3 fibrosis by biopsy or specified noninvasive tests, ≥3 metabolic risk factors, alcohol within limits, and engagement in lifestyle modifications; for continuation submit records showing positive clinical response.

SourceLink

POLICY UPDATE CHANGES

Reviewed and revised January 2026; current effective date 3/17/2026.

Adults ≥18Covered Population

F2-F3Covered Fibrosis Stages

≥3Required Metabolic Risk Factors

30Tablets per 30 days

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12 moAuthorization Duration

Coverage Summary

Coverage stance: covered_with_criteria — Rezdiffra (resmetirom) is covered when all prior authorization criteria are met. Scope: policy covers adults >=18 years with noncirrhotic metabolic dysfunction‑associated steatohepatitis (MASH, formerly NASH) with fibrosis stages F2 to F3. FDA accelerated approval: Rezdiffra is approved under accelerated approval for treatment of adults with noncirrhotic NASH/MASH F2‑F3 and continued approval may depend on confirmatory trials. Avoid use in patients with decompensated cirrhosis. Authorization duration and limits: initial and reauthorization approvals are for 12 months; standard quantity limits are 30 tablets per 30 days with FDA-recommended, weight‑based dosing (<100 kg: 80 mg daily; ≥100 kg: 100 mg daily, with reduced doses when coadministered with moderate CYP2C8 inhibitors).

Rezdiffra (resmetirom) coverage thresholds

Age>= 18 years

Fibrosis stageF2 to F3 (moderate to advanced liver fibrosis)

Alcohol limits<=20 g/day (females); <=30 g/day (males)

Metabolic risk factors required>= 3 risk factors

Initial / Reauthorization durations12 months (initial); 12 months (reauthorization)

Quantity limitStandard Limit = 30 tablets per 30 days

Initial Therapy Criteria (12 months)

Initial Approval (12 months)

Authorization of 12 months may be granted when ALL the following criteria are met:

ALL of the following

Member is 18 years of age or older.
ONE of
- Liver biopsy
- FAST (FibroScan‑AST)
- MAST (derived from MRI‑PDFF, MRE, and AST)

Continuation Therapy Criteria (12 months)

Continuation of Therapy (12 months)

Authorization of 12 months may be granted for reauthorization when ALL the following criteria are met:

ALL of the following

Member has achieved or maintained a positive clinical response to the requested drug (e.g., improvement in liver function such as reduction in alanine aminotransferase [ALT], reduction of liver fat content by imaging such as MRI‑PDFF or FibroScan controlled attenuation parameter [CAP]).

Exclusions / Not Medically Necessary

ALL of the following

Rezdiffra is considered not medically necessary for members who do not meet the criteria set forth above.
Avoid use of Rezdiffra in patients with decompensated cirrhosis.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required with documentation

Submit chart notes or medical records confirming diagnosis of metabolic dysfunction‑associated steatohepatitis (MASH) and evidence of F2–F3 fibrosis by liver biopsy or an accepted noninvasive test (FAST, MAST, MEFIB). Include documentation of at least three metabolic risk factors (e.g., obesity, hypertriglyceridemia, low HDL, hypertension, elevated fasting glucose), alcohol use within limits (≤20 g/day females; ≤30 g/day males), and evidence the patient is engaging in healthy lifestyle modifications (diet/exercise/behavioral support). For continuation requests, include medical records (chart notes, lab tests, imaging) demonstrating a positive clinical response from baseline (e.g., reduced ALT or decreased liver fat by MRI-PDFF or FibroScan CAP).

Chart notes confirming MASH diagnosis and F2–F3 fibrosis (biopsy or FAST/MAST/MEFIB)
Documentation of ≥3 metabolic risk factors
Alcohol consumption within policy limits (≤20 g/day females; ≤30 g/day males)
Evidence of engagement in lifestyle modifications (diet, exercise, behavioral support)
For continuation: records demonstrating positive clinical response (ALT reduction, MRI-PDFF or FibroScan CAP improvement)

Required Documentation for Prior Authorization

Submission of the following information is necessary to initiate the prior authorization review:

ALL of the following

Chart notes or medical records documenting clinical findings supporting the diagnosis of metabolic dysfunction‑associated steatohepatitis (MASH).
Chart notes demonstrating the patient is engaging in healthy lifestyle changes (e.g., heart‑healthy diet and exercise regimen).
For continuation requests: medical records (e.g., chart notes, laboratory tests) demonstrating positive clinical response from baseline.

When providing documentation to support fibrosis confirmation, include exact test dates and results (for example, liver biopsy date and pathology report or specific imaging values such as FibroScan/FAST, MRI‑PDFF/MRE/MAST, MEFIB/FIB‑4 values). Redact patient-identifiable health information as needed per PHI rules while ensuring clinical data and dates remain available for review.

Prescriber Specialty Requirement

The requested medication must be prescribed by or in consultation with one of the following:

ANY of the following

Gastroenterologist
Hepatologist
Cardiometabolic specialist

Applicable Codes

Procedures and Billing Codesmixed

No codes listed

Clinical Evidence & Background

Background: Rezdiffra (resmetirom) received accelerated FDA approval (package insert March 2024) for use in adults with noncirrhotic nonalcoholic steatohepatitis (NASH), now described as metabolic dysfunction‑associated steatohepatitis (MASH), with moderate to advanced fibrosis consistent with F2–F3. The approval was based on improvement in NASH and fibrosis and the manufacturer and regulators note that continued approval may be contingent on verification of clinical benefit in confirmatory trials. Clinical guidance and evidence sources referenced include the Rezdiffra package insert (Mar 2024), Lexicomp, and recent AASLD practice guidance updates (2023–2025). Avoid use in patients with decompensated cirrhosis.

Policy metadata

Evidence sourcesRezdiffra package insert (Mar 2024); Lexicomp; AASLD practice guidance updates/guidance (2023-2025)

Policy number05.05.40

Scope summaryCoverage and prior authorization criteria for Rezdiffra for adults with noncirrhotic MASH (formerly NASH) with F2-F3 fibrosis, including initial & continuation criteria, prescriber specialties, documentation, dosing/quantity limits.

Definitions

MASH: Metabolic dysfunction‑associated steatohepatitis (term formerly used for noncirrhotic NASH).

FAST: FibroScan‑AST score (FibroScan combined with aspartate aminotransferase).

MAST: Composite metric derived from MRI‑PDFF, magnetic resonance elastography (MRE), and AST.

MEFIB: MRE combined with the fibrosis‑4 index (FIB‑4).

Revision History

2026-03-17revisedLatest

Reviewed and revised January 2026; current effective date 3/17/2026

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRezdiffra (resmetirom) for metabolic dysfunction‑associated steatohepatitis (MASH/NASH)

Policy CodePolicy 05.05.40

Change TypeRevised (Jan 2026)

Effective DateMar 17, 2026

Next Review Date

SourceLink

On This Page

MEFIB (MRE combined with FIB‑4)

At least 3 of the following

Obesity
Hypertriglyceridemia
Reduced high‑density lipoprotein (HDL) cholesterol
Hypertension
Elevated fasting plasma glucose indicative of pre‑diabetes or diabetes

Member does not have evidence of Cirrhosis, hepatic decompensation, or hepatocellular carcinoma (HCC).

Member has an alcohol consumption of ≤20 g/day in females and ≤30 g/day in males.

The requested drug will be used in conjunction with healthy lifestyle modifications (e.g., dietary or caloric restriction, exercise, behavioral support, community‑based program).

Documentation Required

Prescriber specialty

The medication must be prescribed by or in consultation with an appropriate specialist. Accepted prescriber specialties are: Gastroenterologist, Hepatologist, or Cardiometabolic specialist.

Gastroenterologist
Hepatologist
Cardiometabolic specialist

Billing Rule

Quantity limits and dosing per weight

Follow FDA weight‑based dosing and standard quantity limits. Recommended dosage based on actual body weight: patients <100 kg — 80 mg once daily; patients ≥100 kg — 100 mg once daily. Standard quantity limit: 30 tablets per 30 days. If used with a moderate CYP2C8 inhibitor (e.g., clopidogrel), reduce the dose (for <100 kg reduce to 60 mg once daily; for ≥100 kg reduce to 80 mg once daily).

FDA weight-based dosing: <100 kg = 80 mg daily; ≥100 kg = 100 mg daily
Standard limit = 30 tablets per 30 days
Reduce dose when coadministered with moderate CYP2C8 inhibitors (e.g., clopidogrel): <100 kg → 60 mg; ≥100 kg → 80 mg

Denial Risk

Denial if criteria not met

Claims may be denied or considered not medically necessary if the member does not meet all initial or continuation criteria (e.g., age ≥18, confirmed MASH with F2–F3 fibrosis, ≥3 metabolic risk factors, alcohol limits, lifestyle modification) or has exclusions/contraindications such as evidence of cirrhosis, hepatic decompensation, or hepatocellular carcinoma. Avoid use in patients with decompensated cirrhosis.

Denial possible if initial/continuation criteria are not met
Contraindication: decompensated cirrhosis (avoid use)
Exclusions include cirrhosis, hepatic decompensation, or HCC

Providers should submit required documentation to initiate prior authorization, including chart notes/medical records confirming MASH diagnosis, fibrosis confirmation by biopsy or specified noninvasive tests, evidence of ≥3 metabolic risk factors, alcohol use within limits, and documentation of lifestyle modifications; continuation requests should include records demonstrating positive clinical response. Operational tip: follow the "Prior authorization required with documentation"/"Required Documentation" instructions when submitting to avoid delays and ensure the request is reviewed promptly.