CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rezdiffra

Defines initial and continuation prior authorization clinical criteria, quantity limits, prescriber requirements, and documentation for coverage of Rezdiffra (resmetirom) for treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH/NASH) with moderate to advanced fibrosis (F2-F3).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezdiffra

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date2025-09

Key ActionPrescriber must submit prior authorization documentation verifying age ≥18, specialty or consultation, diagnosis of non-cirrhotic MASH/NASH with F2-F3 fibrosis, baseline fibrosis confirmation within 6 months, evidence of ≥3 managed metabolic risk factors, alcohol use within limits, diet/exercise plan, and GLP-1 trial/status as applicable.

SourceLink

POLICY UPDATE CHANGES

No material changes

F2-F3Covered fibrosis stages

1/dayQuantity limit

≥3Required metabolic risk factors

6 monthsGLP-1 trial/therapy

Coverage Summary

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Coverage stance: covered_with_criteria for Rezdiffra (resmetirom) for treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH/NASH) with F2–F3 fibrosis. Prescribing must be by or in consultation with a gastroenterologist or hepatologist.

Authorization period: 12 months for both initial and continuation approvals when criteria are met.

Required baseline and ongoing documentation includes objective confirmation of F2–F3 fibrosis within the past 6 months by non-invasive liver disease assessment (e.g., ultrasound-based elastography, MRE) or historical liver biopsy, documentation that the member has ≥ 3 metabolic risk factors managed per standard of care, alcohol use within specified limits (female < 20 grams/day; male < 30 grams/day), and a plan to use the medication with a reduced-calorie diet and increased physical activity.

GLP-1 requirement: If GLP-1 naïve, documentation of inadequate response, intolerance, or contraindication to a 6-month trial of Wegovy (semaglutide); if already on a GLP-1, must remain on an FDA-approved maintenance dose for 6 months with updated labs/imaging submitted afterward.

Quantity limits: 1 tablet per day (per labeled Rezdiffra strengths).

Quick facts / Thresholds

Fibrosis stageTreatment indicated for F2 to F3 fibrosis (non-cirrhotic MASH/NASH)

Alcohol consumption - female< 20 grams/day (one standard drink ≈ 14 grams)

Alcohol consumption - male< 30 grams/day (one standard drink ≈ 14 grams)

Quantity limit1 tablet per day (Rezdiffra 60mg, 80mg, 100mg)

GLP-1 requirement6 months (document 6-month Wegovy trial if GLP-1 naïve; if on GLP-1, remain on FDA‑approved maintenance dose for 6 months with updated labs/imaging)

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required with documentation

Prescriber must submit documentation verifying age ≥18, specialty, diagnosis of non-cirrhotic MASH/NASH with F2-F3 fibrosis, baseline fibrosis confirmation within 6 months (non-invasive assessment or prior biopsy), evidence of ≥3 metabolic risk factors and alcohol use within allowable limits, and plan for diet/exercise and GLP-1 status.

Age ≥ 18
Prescriber is gastroenterologist or hepatologist (or consult documented)
Diagnosis: non-cirrhotic MASH/NASH with fibrosis stage F2–F3
Baseline fibrosis confirmation within past 6 months by one of: non-invasive elastography (e.g., ultrasound-based elastography, MRE) or historical liver biopsy
Documentation of THREE or more metabolic risk factors (central obesity; hypertriglyceridemia; reduced HDL cholesterol; hypertension; elevated fasting glucose)
Alcohol consumption within allowable limits (female < 20 g/day; male < 30 g/day)
Plan for reduced calorie diet and increased physical activity
GLP-1 status (see GLP-1 prior therapy documentation): if GLP-1 naïve, evidence re: 6-month Wegovy trial failure/intolerance/contraindication; if on GLP-1, documentation of 6 months on FDA‑approved maintenance dose and updated labs/imaging

Documentation Required

Document positive clinical response for continuation

For renewal, prescriber must document clinical benefit demonstrated by MASH/NASH resolution or ≥1-stage fibrosis improvement (or no worsening after ≥2 years) and provide objective lab/imaging evidence such as reduced ALT, improved ELF score, or improved liver stiffness measurement (LSM).

Documentation Required

GLP-1 prior therapy documentation

If GLP-1 naïve: provide documentation of inadequate response, intolerance, or contraindication to a 6-month trial of Wegovy (semaglutide); if currently on a GLP-1, document 6 months on an FDA‑approved maintenance dose and submit updated labs/imaging after that period.

Billing Rule

Quantity limit

Limit to 1 tablet per day.

Rezdiffra 60mg — 1 tablet per day
Rezdiffra 80mg — 1 tablet per day
Rezdiffra 100mg — 1 tablet per day

Documentation Required

Management of metabolic risk factors

Prescriber must document that the member's metabolic risk factors are being managed according to standard of care.

Clinical Evidence and Background

Background: Rezdiffra (resmetirom) is indicated for treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) with moderate to advanced liver fibrosis consistent with F2–F3 stages. The policy aligns coverage with specialty prescribing, objective fibrosis confirmation, management of metabolic comorbidities, alcohol consumption limits, and GLP-1 trial/therapy requirements.

Specialty alignment and prescriber requirements: Medication must be prescribed by, or in consultation with, a gastroenterologist or hepatologist, and prior authorization requires documentation of age ≥18 and specialist involvement.

Objective fibrosis confirmation: Baseline confirmation of F2–F3 within the past 6 months is required by ONE of the following: non-invasive liver disease assessment (for example ultrasound-based elastography or magnetic resonance elastography [MRE]) or historical liver biopsy.

Metabolic comorbidity management: Prescriber must document the member has at least three metabolic risk factors managed according to standard of care: central obesity; hypertriglyceridemia; reduced HDL cholesterol; hypertension; and elevated fasting plasma glucose (diabetes or pre-diabetes).

Alcohol limits: Prescriber must document alcohol consumption within allowable thresholds: female < 20 grams/day and male < 30 grams/day. One standard drink is defined as approximately 14 grams of pure alcohol (12 oz beer, 5 oz wine, 1.5 oz distilled spirits).

GLP-1 trial/therapy requirement: If GLP-1 naïve, provide documentation of inadequate response, intolerance, or contraindication to a 6-month trial of Wegovy (semaglutide) for MASH/NASH. If currently on a GLP-1 (e.g., Ozempic, Rybelsus, Trulicity), the member must remain on therapy for 6 months at an FDA‑approved maintenance dose before starting Rezdiffra and submit updated labs/imaging after that period.

Definitions: One standard drink ≈ 14 grams pure alcohol (12 oz beer, 5 oz wine, 1.5 oz distilled spirits). MASH is metabolic dysfunction-associated steatohepatitis (formerly NASH).

Evidence sources: Package insert: Rezdiffra [package insert], Madrigal Pharmaceuticals; February 2025; Guidance: AASLD Practice Guidance on the Clinical Assessment and Management of Nonalcoholic Fatty Liver Disease (Hepatology 2023).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezdiffra

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date2025-09

SourceLink

On This Page

OpenPayer

Rezdiffra

Coverage Summary

Initial Therapy — Approval Criteria (12 months)

Continuation of Therapy — Renewal Criteria (12 months)

Provider Actions and Authorization Requirements

Applicable Codes

Clinical Evidence and Background

Revision History

Rezdiffra 60mg	Rezdiffra tablet 60 mg (quantity limit: 1 tablet per day)
Rezdiffra 80mg	Rezdiffra tablet 80 mg (quantity limit: 1 tablet per day)
Rezdiffra 100mg	Rezdiffra tablet 100 mg (quantity limit: 1 tablet per day)