CurrentUnitedHealthcarePolicy 2025 P 2304-3

Skyclarys (omaveloxolone) prior authorization and medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for Skyclarys (omaveloxolone) for treatment of Friedreich's ataxia in eligible members, including initial and reauthorization requirements and prescriber qualifications.

Policy Summary

PayerUnitedHealthcare

PolicySkyclarys (omaveloxolone) prior authorization and medical necessity

Policy CodePolicy 2025 P 2304-3

Change TypeAnnual review — no material changes

Effective Date8/1/2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis of Friedreich's ataxia, confirmed FXN gene mutation, and prescriber specialty or consultation.

SourceLink

POLICY UPDATE CHANGES

Annual review with no updates to coverage criteria. Updated reference.

Annual review with no updates to coverage criteria. Updated references.

New program established for Skyclarys prior authorization/medical necessity.

16+indicated age

12 monthsauth duration

3prescriber specialties

2025-05P&T approval

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

COVERAGE CRITERIA

Covered when ALL of the following are met

Initial Authorization

Criterion A: Diagnosis of Friedreich's ataxia
Criterion B: Confirmed presence of a mutation in the frataxin (FXN) gene
Criterion C: Prescribed by, or in consultation with, a neurologist, neurogeneticist, or physical medicine and rehabilitation physician (physiatrist)
Authorization will be issued for 12 months

COVERAGE CRITERIA

Covered when ALL of the following are met

Reauthorization

Criterion A: Documentation of positive clinical response to Skyclarys therapy
Criterion B: Prescribed by, or in consultation with, a neurologist, neurogeneticist, or physical medicine and rehabilitation physician (physiatrist)
Authorization will be issued for 12 months

Coverage is subject to state mandates and the member's specific benefit plan; these may limit or modify coverage determinations for Skyclarys (omaveloxolone). Any applicable federal regulatory requirements also apply. In addition, other UnitedHealthcare policies and utilization management programs may affect coverage or authorization decisions for this medication.

Provider Actions and Requirements

Prior Authorization

Prior authorization required (Program 2025 P 2304-3)

Prior authorization is required under Clinical Pharmacy Programs Program Number 2025 P 2304-3. Initial approval will only be issued when all initial authorization criteria are met: diagnosis of Friedreich's ataxia; confirmed presence of a mutation in the frataxin (FXN) gene; and prescribed by, or in consultation with, a neurologist, neurogeneticist, or physical medicine and rehabilitation physician. Authorization is issued for 12 months.

Step Therapy

Automated approval and supply limits may apply

UnitedHealthcare may use automated approval or re-approval processes based on previous claim/medication history, diagnosis codes (ICD-10), and claim logic. Supply limits may also be applied.

Documentation Required

Documentation required for initial and reauthorization

Initial prior authorization requests must document a diagnosis of Friedreich's ataxia and the confirmed presence of a mutation in the frataxin (FXN) gene. Reauthorization requests must include documentation of a positive clinical response to Skyclarys therapy. Prescriber must be, or consult with, a neurologist, neurogeneticist, or physical medicine and rehabilitation physician.

Denial Risk

Triggers for denial — missing diagnosis, genetic confirmation, or specialist involvement

Absence of a documented diagnosis of Friedreich's ataxia, lack of a confirmed FXN gene mutation, or failure to have the drug prescribed by or in consultation with an approved specialist may result in denial of the request.

Definitions

Confirmed FXN mutation

DefinitionConfirmed presence of a mutation in the frataxin (FXN) gene

Clinical significanceRequired documentation for initial authorization of Skyclarys (omaveloxolone) for Friedreich's ataxia

Where requiredMust be included in initial prior authorization request per Program Number 2025 P 2304-3

Associated authorization durationAuthorization issued for 12 months when criteria met

Related provider requirementPrescriber must be, or consult with, a neurologist, neurogeneticist, or physiatrist

Background

Skyclarys (omaveloxolone) is indicated for treatment of Friedreich's ataxia in eligible members. The policy establishes clinical criteria that require a confirmed genetic diagnosis and specialist involvement for initiation and continuation of therapy, and notes that authorizations are issued for 12 months. Coverage may be influenced by state mandates, federal requirements, and the member's benefit plan, and other UnitedHealthcare policies or utilization management programs may apply.

Revision History

5/2023program_creation

New prior authorization/medical necessity program established for Skyclarys (omaveloxolone).

5/2024annual_review

Annual review completed with no updates to coverage criteria; references updated.

5/2025annual_reviewLatest

Annual review completed with no updates to coverage criteria; reference updated.