CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rezdiffra (resmetirom) for NASH/MASH

Medicaid coverage policy for Rezdiffra (resmetirom) defining initial and continuation authorization criteria, quantity limit, required prescriber specialties, laboratory/imaging documentation, alcohol limits, concomitant GLP-1 trial requirements, and duration of authorization (12 months).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezdiffra (resmetirom) for NASH/MASH

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2024

Next Review Date

Key ActionSubmit required documentation (biopsy or qualifying imaging, documentation of ≥3 metabolic risk factors, alcohol use, and GLP-1 history) to request a 12-month authorization.

POLICY UPDATE CHANGES

No material changes to clinical coverage or authorization criteria.

12 monthsAuthorization duration

1/dayQuantity limit

≥3Required metabolic risk factors

≥4NAFLD activity score threshold

Coverage Summary

Medicaid coverage policy for Rezdiffra (resmetirom) defining initial and continuation authorization criteria, quantity limit, required prescriber specialties, laboratory/imaging documentation, alcohol limits, concomitant GLP-1 trial requirements, and duration of authorization (12 months). Coverage stance: covered_with_criteria.

Key thresholds and policy stats

Authorization duration12 months

Quantity limit1 tablet per day (available strengths: 60 mg, 80 mg, 100 mg)

Required metabolic risk factorsDocumentation of ≥3 metabolic risk factors (examples: central obesity, hypertriglyceridemia, hypertension, low HDL, elevated fasting glucose)

NAFLD activity score threshold>= 4 with component scores >1 in steatosis, lobular inflammation, and ballooning

Biopsy recencyBiopsy performed within 6 months prior to treatment

Imaging recencyQualifying imaging performed within 3 months prior to treatment

Alcohol limitsFemale ≤ 20 grams/day; Male ≤ 30 grams/day (one standard drink ≈ 14 grams ethanol)

Provider Actions & Prior Authorization Requirements

Prior Authorization

Authorization requirement and duration

Authorization of 12 months may be granted when initial or continuation criteria are met; provider must submit required documentation (biopsy or imaging, metabolic risk factors, alcohol use, GLP-1 history) to obtain approval.

Documentation Required

Histology or imaging documentation

Submit liver biopsy results (within 6 months) showing NAFLD activity score ≥4 with component scores >1 OR qualifying imaging (within 3 months) demonstrating stage F2 or F3 fibrosis.

Documentation Required

Metabolic risk factors

Submit prescriber documentation that the patient has three or more metabolic risk factors and that they are managed per standard of care.

Documentation Required

GLP-1 therapy history

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

Denial Risk

Alcohol limits enforcement

Claims may be denied if patient exceeds alcohol consumption limits (female >20 g/day, male >30 g/day) per prescriber documentation requirement.

Billing Rule

Daily dosing

Limit to 1 tablet per day for each available strength (60 mg, 80 mg, 100 mg).

Clinical Evidence & References

References: AASLD 2023 guidance; Rezdiffra package insert (Madrigal) cited; Lexicomp and Micromedex referenced. The brief cites these evidence sources but does not provide trial metrics or detailed efficacy data within the policy text.

Selected definitions

One standard drinkApproximately 14 grams of pure alcohol (12 oz beer, 5 oz wine, or 1.5 oz distilled spirits)

NAFLD activity score requirementScore ≥4 with component scores >1 in steatosis, lobular inflammation, and ballooning

Background

Rezdiffra (resmetirom) is a therapy for noncirrhotic NASH/MASH. Intended population and policy aim: to treat adults with confirmed noncirrhotic NASH/MASH who meet histologic or imaging fibrosis criteria (stage F2–F3), have documented metabolic risk factors, meet alcohol consumption limits, and have appropriate GLP-1 therapy documentation and lifestyle intervention plans; the policy links these requirements to authorization decisions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezdiffra (resmetirom) for NASH/MASH

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2024

Next Review Date

Key ActionSubmit required documentation (biopsy or qualifying imaging, documentation of ≥3 metabolic risk factors, alcohol use, and GLP-1 history) to request a 12-month authorization.

On This Page

Rezdiffra 60 mg tablet	Quantity limit: 1 tablet per day
Rezdiffra 80 mg tablet	Quantity limit: 1 tablet per day
Rezdiffra 100 mg tablet	Quantity limit: 1 tablet per day

OpenPayer

Rezdiffra (resmetirom) for NASH/MASH

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions & Prior Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History