CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rezdiffra (resmetirom) coverage for noncirrhotic NASH/MASH

Policy governs prior authorization, continuation, and quantity limits for Rezdiffra (resmetirom) for treatment of noncirrhotic nonalcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis in adults for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezdiffra (resmetirom) coverage for noncirrhotic NASH/MASH

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating age ≥18, specialist prescriber/consult, diagnostic confirmation (biopsy within 6 months or qualifying imaging within 3 months), F2–F3 fibrosis, managed metabolic risk factors, alcohol within limits, and GLP‑1 trial/maintenance as specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

18+minimum age

F2-F3fibrosis stage

1/dayquantity limit

6 monthsGLP-1 requirement

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Coverage Criteria for Rezdiffra (resmetirom)

inv-01: Initial Therapy

An authorization of 12 months may be granted when ALL of the following are met:

Initial Approval

Patient is 18 years or older.
Medication is prescribed by, or in consultation with, a gastroenterologist or hepatologist.
Diagnostic confirmation
- Liver biopsy performed within the 6 months preceding treatment AND biopsy shows NAFLD activity score ≥ 4 with a score of >1 in steatosis, ballooning, and lobular inflammation.
- One qualifying imaging exam performed within the 3 months preceding treatment (elastography — e.g., FibroScan or other transient/magnetic resonance/shear wave elastography — OR computed tomography OR magnetic resonance imaging).
Fibrosis stage
- Patient has stage F2 fibrosis.
- Patient has stage F3 fibrosis.
Documentation from prescriber that the patient has three or more metabolic risk factors (central obesity; hypertriglyceridemia; reduced HDL cholesterol; hypertension; elevated fasting plasma glucose consistent with diabetes or pre-diabetes) managed according to standard of care.
Documentation from prescriber that alcohol consumption is within limits (female < 20 grams/day OR male < 30 grams/day).
Medication will be used in combination with an appropriate diet and exercise program.
GLP-1 requirement
- If GLP-1 naïve: documentation of inadequate response, intolerance, or contraindication to a 6-month trial of Wegovy (semaglutide) for MASH/NASH.
- If currently on a GLP-1: patient must remain on therapy for 6 months at an FDA‑approved maintenance dose prior to starting Rezdiffra, with updated labs/imaging submitted after the 6-month GLP-1 treatment period.

Initial Approval (summary text): Patient is 18 years or older; medication prescribed by or in consultation with a gastroenterologist or hepatologist; diagnosis of noncirrhotic NASH/MASH confirmed by liver biopsy within 6 months meeting NAFLD activity score criteria OR by qualifying imaging within 3 months; fibrosis stage F2 or F3; prescriber documents ≥3 managed metabolic risk factors; alcohol use within limits; medication used with diet and exercise; GLP-1 trial or maintenance requirements met as specified.

inv-02: Continuation Therapy

An authorization of 12 months may be granted when ALL of the following are met:

Continuation Approval

Patients who have received < 1 year of therapy or who are restarting therapy are considered under Initial Therapy and should not use continuation criteria.
Clinical benefit for year 2
- Patient has completed ≥ 1 year and < 2 years of therapy and has derived benefit as demonstrated by at least ONE: MASH/NASH resolution AND no worsening of fibrosis.
- Patient has completed ≥ 1 year and < 2 years of therapy and has derived benefit as demonstrated by at least ONE: no worsening of MASH/NASH AND improvement in fibrosis by ≥ 1 stage.
For patients starting their third year or later (completed ≥ 2 years of therapy): according to the prescriber, the patient has not had worsening of fibrosis or MASH/NASH.

Patients who have progressed to stage F4 (cirrhosis) are excluded from continuation approval for Rezdiffra. Continuation criteria require that the patient has not progressed to stage F4 as part of the conditions for ongoing authorization.

Timing and Diagnostic Documentation

inv-04: Liver biopsy timing — within 6 months preceding treatment

Timing requirementLiver biopsy must have been performed within the 6 months preceding treatment with Rezdiffra.

PurposeConfirms diagnosis of noncirrhotic NASH/MASH when biopsy criteria are met.

Referenced findingUsed as one pathway to satisfy diagnostic confirmation for initial approval.

inv-05: Imaging timing — within 3 months preceding treatment

Timing requirementQualifying imaging exam must have been performed within the 3 months preceding treatment with Rezdiffra.

Accepted modalitiesElastography, CT, or MRI are specified as qualifying imaging exams.

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization required. An authorization (initial and continuation) may be granted for up to 12 months when all applicable criteria are met.

Prior authorization required for initiation of Rezdiffra (resmetirom).
Authorization decisions consider both Initial and Continuation criteria; initial approvals are 12 months.
Prescriber specialty requirement and diagnostic confirmation (see Documentation) are enforced.

Documentation Required

Required Documentation

Prescriber must document age, specialist involvement or consultation, diagnostic confirmation, fibrosis stage, metabolic risk factors, and concomitant therapies. Requests lacking required documentation are at high risk for denial.

Required documentation must include: age ≥ 18; prescriber is a gastroenterologist or hepatologist or documentation of specialist consultation; diagnostic confirmation by qualifying liver biopsy or qualifying imaging (timing requirements apply).

Background on Condition and Drug

Nonalcoholic steatohepatitis (NASH), also referred to as metabolic dysfunction–associated steatohepatitis (MASH), is a form of fatty liver disease associated with metabolic risk factors and progressive fibrosis. This policy addresses treatment with Rezdiffra (resmetirom) in adults with noncirrhotic NASH/MASH, targeting patients with stage F2–F3 fibrosis and requiring objective diagnostic confirmation, management of metabolic comorbidities, and documentation of clinical benefit for continuation.

Diagnostic and Lifestyle Definitions

inv-11: Diagnostic confirmation (biopsy) — Liver biopsy within 6 months prior to treatment showing NAFLD activity score ≥ 4 with component scores >1.

Biopsy timing and requirementLiver biopsy performed within 6 months prior to treatment showing NAFLD activity score ≥ 4 is required for biopsy-based diagnostic confirmation.

Component scoresBiopsy must show a score >1 in ALL of the following components: steatosis, ballooning, and lobular inflammation.

Role in approvalMeeting these biopsy criteria satisfies the diagnostic confirmation pathway for initial authorization of Rezdiffra.

inv-12: Diagnostic confirmation (imaging) — One qualifying imaging exam (elastography, CT, or MRI) performed within 3 months prior to treatment.

Required imaging timingOne qualifying imaging exam (elastography, CT, or MRI) must be performed within 3 months prior to treatment.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezdiffra (resmetirom) coverage for noncirrhotic NASH/MASH

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Patient has not progressed to stage F4 (cirrhosis).

Documentation that the patient achieved or maintained a positive clinical response to the drug (examples: reduction in ALT, reduction of liver fat by imaging such as MRI‑PDFF or FibroScan CAP).

Documentation from the prescriber that metabolic risk factors are managed according to standard of care.

Documentation from the prescriber that alcohol consumption is within limits (female < 20 grams/day OR male < 30 grams/day).

Medication will be used in combination with an appropriate diet and exercise program.

Medication is prescribed by or in consultation with a gastroenterologist or hepatologist.

Continuation Approval (summary text): Patients completing ≥1 year must show benefit (MASH/NASH resolution with no worsening fibrosis OR no worsening with ≥1 stage fibrosis improvement); patients completing ≥2 years must have no worsening per prescriber; patient must not have progressed to F4; documentation of positive clinical response and managed metabolic risk factors; alcohol within limits; medication used with diet/exercise; prescribed by or in consultation with gastroenterologist or hepatologist.

PurposeProvides an alternative diagnostic confirmation pathway when biopsy is not used.

Biopsy criteria: performed within 6 months before treatment and NAFLD Activity Score ≥4 with >1 in steatosis, ballooning, and lobular inflammation.

Imaging criteria: one qualifying imaging (elastography, CT, or MRI) performed within 3 months before treatment.

Documentation of stage F2 or F3 fibrosis.

Documentation of three or more metabolic risk factors (central obesity, hypertriglyceridemia, low HDL, hypertension, elevated fasting glucose/diabetes or pre-diabetes).

Documentation that medication will be used with appropriate diet and exercise program.

Step Therapy

GLP-1 Trial / Maintenance Requirement

GLP-1 treatment history must be documented. If GLP-1 naïve, provide documentation of inadequate response, intolerance, or contraindication after a 6-month trial of Wegovy (semaglutide) for MASH/NASH. If currently on a GLP-1, patient must remain on an FDA‑approved maintenance dose for 6 months prior to starting Rezdiffra and submit updated labs/imaging after the 6‑month GLP‑1 treatment period.

If GLP-1 naïve: documentation of a 6-month trial of Wegovy with inadequate response, intolerance, or contraindication.
If currently on a GLP-1: documentation patient has been on an FDA‑approved maintenance dose for at least 6 months and provide updated labs/imaging following that period.

Denial Risk

Grounds for Denial

Requests may be denied if the patient does not meet age, diagnostic, fibrosis staging, or other exclusion requirements. Common denial grounds include unconfirmed diagnosis, incorrect or outdated biopsy/imaging timing, fibrosis stage outside F2–F3, missing specialist involvement, insufficient metabolic risk factor documentation, or failure to meet GLP‑1 trial/maintenance rules.

Denial may occur if patient is under 18.
Denial may occur if diagnosis of noncirrhotic NASH/MASH is not confirmed by required biopsy (within 6 months meeting NAFLD activity score criteria) or qualifying imaging (within 3 months).
Denial may occur if fibrosis stage is not F2 or F3 (e.g., F0–F1 or F4).
Denial may occur if prescriber specialty/consultation is not documented.
Denial may occur if documentation of three metabolic risk factors is not provided or if GLP‑1 trial/maintenance requirements are not met.

Examples of elastography

Includes vibration-controlled transient elastography (e.g., FibroScan), transient elastography, magnetic resonance elastography, acoustic radiation force impulse imaging, shear wave elastography.

Role in approvalA qualifying imaging study within the 3-month window provides the alternative diagnostic confirmation pathway to biopsy.

inv-13: Alcohol use limits — Females: <20 grams/day; Males: <30 grams/day (one standard drink ≈14 grams alcohol).

Female limitAlcohol consumption must be less than 20 grams per day for female patients.

Male limitAlcohol consumption must be less than 30 grams per day for male patients.

Standard drink equivalenceOne standard drink contains roughly 14 grams of pure alcohol (12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).