CurrentMass General Brigham Health PlanPolicy N/A

Rezdiffra (resmetirom) — Prior Authorization for Noncirrhotic NASH/MASH (F2–F3)

Prior authorization policy for Rezdiffra (resmetirom) for adults with noncirrhotic NASH/MASH with stage F2–F3 fibrosis under the pharmacy benefit; applies to Commercial/Exchange members of Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRezdiffra (resmetirom) — Prior Authorization for Noncirrhotic NASH/MASH (F2–F3)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization under the pharmacy benefit with documentation showing diagnosis of MASH/NASH, F2–F3 fibrosis, age ≥18, prescriber specialty, and absence of listed exclusions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moApproval duration

F2–F3Fibrosis stages

≥18Minimum age

Commercial/ExchangePlan applicability

Prior AuthProgram type

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Coverage Criteria for Rezdiffra (resmetirom)

Initial Therapy

Authorization may be granted when ALL of the following diagnosis-specific criteria are met:

Initial authorization: Member has a diagnosis of metabolic dysfunction-associated steatohepatitis (MASH), also known as noncirrhotic nonalcoholic steatohepatitis (NASH).

Initial authorization: Member has a diagnosis of F2 or F3 fibrosis.

Initial authorization: Member is 18 years of age or older.

Initial authorization: Requested medication is prescribed by or in consultation with a gastroenterologist or hepatologist.

Initial authorization

Exclusions list: a. Cirrhosis
Exclusions list: b. Hepatocellular carcinoma
Exclusions list: c. MELD score ≥ 12 (unless due to therapeutic anticoagulation)
Exclusions list: d. Hepatic decompensation
Exclusions list: e. Chronic liver disease other than MASH/NASH

Continuation of Therapy

Reauthorization (continuation of therapy) will be approved when ALL of the following are met:

Continuation: Documentation (e.g., medical records) demonstrating the member has had a positive clinical response to therapy.

Approval period up to 12 months.

Authorization will be denied for members who meet any of the listed clinical exclusion criteria. Specifically, do not approve resmetirom for members with cirrhosis or hepatocellular carcinoma, or for those with evidence of hepatic decompensation. Members with a MELD score ≥ 12 are excluded unless the elevated score is attributable to therapeutic anticoagulation. Other exclusions include chronic liver disease diagnoses other than MASH/NASH, active autoimmune disease, an ALT > 250 U/L, history of bariatric surgery, A1C ≥ 9%, or untreated/active thyroid disease (defined as TSH > 7 IU/L with hypothyroid symptoms or TSH > 10 IU/L without symptoms).

Key Clinical Thresholds and Laboratory Criteria

MELD score

ThresholdMELD < 12 (unless elevated due to therapeutic anticoagulation)

ContextUsed as an exclusion criterion for Rezdiffra; MELD ≥ 12 leads to denial unless elevation is from therapeutic anticoagulation

Source guidanceSee exclusion list under authorization criteria: 'MELD score ≥ 12 (unless due to therapeutic anticoagulation)'

ALT

ThresholdALT ≤ 250 U/L

ContextALT > 250 U/L is listed as an exclusion for therapy

Use in decision-making

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit for this product. Authorization may be granted when diagnosis-specific clinical criteria are met (see criteria in policy).

Pharmacy benefit: prior authorization required
Contact for pharmacy benefit: Phone: 800-711-4555; Fax: 844-403-1029

Documentation Required

Required Documentation for New-to-Plan Members

For members new to the plan (coverage effective date ≤ 90 days), submit medical records documenting the member is currently receiving treatment with the requested drug. Acceptable documentation includes clinic notes, infusion records, prescription history, or other medical records; exclude samples or manufacturer's patient assistance program supplies.

New-to-plan member rule: coverage effective date ≤ 90 days
Required documentation: medical records showing current treatment (exclude samples and patient assistance program supplies)

Key Definitions

MASH / NASH

DefinitionMetabolic dysfunction-associated steatohepatitis (MASH), also known as noncirrhotic nonalcoholic steatohepatitis (NASH)

Indication contextIndicated diagnosis for Rezdiffra authorization when member has F2–F3 fibrosis and is ≥ 18 years

Clinical noteRezdiffra should be avoided in patients with decompensated cirrhosis; chronic liver disease other than MASH/NASH excludes therapy

Background

Resmetirom (Rezdiffra) is a thyroid hormone receptor–beta agonist indicated, in conjunction with diet and exercise, for the treatment of adults with noncirrhotic metabolic dysfunction–associated steatohepatitis (MASH), also described as noncirrhotic nonalcoholic steatohepatitis (NASH), with moderate to advanced fibrosis (stages F2–F3). The policy applies to members aged 18 years and older and requires that prescriptions be written by or in consultation with a gastroenterologist or hepatologist. Resmetirom should be avoided in patients with cirrhosis or decompensated liver disease and is subject to the clinical exclusion and laboratory thresholds listed elsewhere in this policy.