CurrentMass General Brigham Health PlanPolicy N/A

Forzinity (elamipretide) prior authorization for Barth syndrome

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Defines prior authorization, coverage criteria, and limits for Forzinity (elamipretide) for commercial/exchange pharmacy benefit members with Barth syndrome; applies to specialty pharmacy dispensing and prescribers in specified specialties.

Policy Summary

PayerMass General Brigham Health Plan

PolicyForzinity (elamipretide) prior authorization for Barth syndrome

Policy CodePolicy N/A

Change TypeNew policy

Effective DateMay 1, 2026

Last ReviewFeb 11, 2026

Next Review DateN/A

Key ActionObtain prior authorization and ensure specialty pharmacy dispensing for Forzinity; submit medical records confirming Tafazzin mutation and member weight ≥ 30 kg.

SourceLink

POLICY UPDATE CHANGES

Forzinity (elamipretide) is listed with prior authorization requirements and specialty pharmacy dispensing for Commercial/Exchange members.

>= 30 kgMinimum patient weight for treatment

6 moInitial approval duration

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CurrentMass General Brigham Health PlanPolicy N/A

Forzinity (elamipretide) prior authorization for Barth syndrome

Customize your policy alerts

Sign up for all Mass General Brigham Health Plan policy alerts

Know when Mass General Brigham Health Plan releases new policies or updates existing guidance.

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Policy Summary

PayerMass General Brigham Health Plan

PolicyForzinity (elamipretide) prior authorization for Barth syndrome

Policy CodePolicy N/A

Change TypeNew policy

Effective DateMay 1, 2026

Last ReviewFeb 11, 2026

Next Review DateN/A

Key ActionObtain prior authorization and ensure specialty pharmacy dispensing for Forzinity; submit medical records confirming Tafazzin mutation and member weight ≥ 30 kg.

SourceLink

POLICY UPDATE CHANGES

Forzinity (elamipretide) is listed with prior authorization requirements and specialty pharmacy dispensing for Commercial/Exchange members.

>= 30 kgMinimum patient weight for treatment

6 moInitial approval duration

Coverage Criteria for Forzinity (elamipretide)

Initial Authorization

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

Initial authorization criteria: 1. Diagnosis of Barth syndrome; 2. Submission of medical records (e.g., chart notes) confirming presence of a mutation in the Tafazzin gene; 3. Member's weight is greater than or equal to 30 kilograms; 4. Requested medication is prescribed by or in consultation with one of the following specialists: a. Geneticist; b. Cardiologist; c. Neurologist; d. Specialist focused on the treatment of metabolic disorders.>= 30 kilograms

Include genetic confirmation and appropriate specialist involvement.

Continuation of Therapy

Reauthorization will be approved when ALL of the following are met:

Continuation criteria: Submission of medical records (e.g., chart notes) demonstrating the member has had a positive clinical response to therapy (e.g., improvement in knee extensor muscle strength or 6-minute walking test, quality of life).

Objective or documented patient-reported improvement required.

Members weighing less than 30 kilograms are not eligible for coverage under this policy. The indication and authorization requirements specify a minimum patient weight of >= 30 kilograms for Forzinity (elamipretide).

Requests that do not include genetic confirmation of a Tafazzin (TAZ) mutation, are not prescribed by or in consultation with an appropriate specialist (geneticist, cardiologist, neurologist, or a specialist focused on metabolic disorders), or are for patients who weigh less than 30 kilograms do not meet the medical necessity criteria and will not be approved. For members new to the plan (coverage effective date ≤ 90 days), medical records documenting current treatment with the requested drug must be submitted.

Key Coding & Limits

Minimum weight

Minimum patient weight for treatment>= 30 kilograms

Ineligibility under this policyMembers weighing less than 30 kilograms are not eligible per the indication and policy requirements.

Source indication languageIndicated for patients with Barth syndrome weighing at least 30 kilograms (Forzinity product overview).

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization required for Forzinity (elamipretide) under the pharmacy benefit. Specialty pharmacy dispensing is required.

Program Type: Prior Authorization
Benefit: Pharmacy Benefit
Specialty: Must be filled through a contracted specialty pharmacy

Step Therapy

No step therapy requirement specified for this medication.

Denial Risk

Definitions and Response Criteria

Positive clinical response

Definition of positive clinical responseDocumentation of improvement in clinical measures such as knee extensor muscle strength, the 6-minute walk test, or quality of life.

Required evidence for reauthorizationSubmission of medical records (e.g., chart notes) demonstrating the member has had a positive clinical response to therapy.

Examples of measurable outcomesImprovement in knee extensor muscle strength; improvement in 6-minute walking test distance; documented improvement in patient-reported quality of life.

Background

Elamipretide (Forzinity) is a mitochondrial cardiolipin binder indicated to improve muscle strength in adults and pediatric patients with Barth syndrome who meet the policy criteria. Authorization may be granted when all of the following are met: diagnosis of Barth syndrome; submission of medical records confirming a mutation in the Tafazzin gene; member weight of >= 30 kilograms; and the medication is prescribed by or in consultation with a geneticist, cardiologist, neurologist, or a specialist focused on metabolic disorders. For members new to the plan (coverage effective date ≤ 90 days), submit medical records documenting current treatment with the requested drug (excluding samples or manufacturer patient assistance program supplies).