CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Skyclarys (omaveloxolone) for Friedreich's ataxia

Covers Skyclarys (omaveloxolone) for treatment of Friedreich's ataxia in adults and adolescents >=16 years when specified clinical and documentation criteria are met; all other indications are considered experimental/investigational and not medically necessary. Policy includes initial and continuation authorization durations and a quantity limit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkyclarys (omaveloxolone) for Friedreich's ataxia

Policy CodePolicy N/A

Change TypeClarified (no material changes)

Effective Date

Next Review Date2025-07

Key ActionPrior authorization is required; request up to 6 months initial or continuation authorizations when criteria (specialist prescriber, FXN gene mutation confirmation, ambulatory status, clinical manifestations) are documented.

SourceLink

POLICY UPDATE CHANGES

Reviewed: 7/23, 6/24, 7/25 (no specific clinical policy changes noted in document).

1Covered Indication (Friedreich's ataxia)

3/dayQuantity limit

16Minimum age

Coverage Summary

Covers Skyclarys (omaveloxolone) for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older when specified clinical and documentation criteria are met. All other indications are considered experimental/investigational and not medically necessary. This aligns with the FDA-approved indication. Note the policy enforces a quantity limit of 3 capsules per day for Skyclarys 50 mg.

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Initial Therapy Criteria (up to 6 months)

Initial Authorization (up to 6 months) - Friedreich's ataxia

Authorization of 6 months may be granted when ALL of the following criteria are met:

Specialist prescriber: Medication is prescribed by or in consultation with a neurologist or physician who specializes in the treatment of Friedreich's ataxia
Genetic confirmation: Documentation that the member has a diagnosis that is confirmed by detection of a mutation of the FXN gene
Clinical manifestations: Documentation that the member exhibits clinical manifestations of disease (e.g., muscle weakness, decline in coordination, frequent falling)
Age requirement: Documentation that the member is 16 years of age or older>= 16 years
Ambulatory status: Documentation that the member is ambulatory

Continuation Therapy Criteria (up to 6 months)

Continuation of Therapy (up to 6 months)

Authorization of 6 months may be granted for continued treatment when ALL of the following are met:

Meets initial criteria/indication: Indication is Friedreich's ataxia (member meets initial criteria)
Improved or stabilized disease: Documentation that the disease has improved or stabilized
Examples include improvement in speech or swallowing, upper/lower limb coordination, upright stability

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization for Skyclarys is required; initial and continuation authorizations are granted for up to 6 months when criteria are met.

Documentation Required

Specialist involvement and genetic confirmation

Provider must document specialist prescriber (neurologist or physician specializing in Friedreich's ataxia) and confirmatory FXN gene mutation testing in the medical record.

Documentation Required

Ambulatory status and clinical manifestations

Provider must document that the member is ambulatory and exhibits clinical manifestations of Friedreich's ataxia (e.g., muscle weakness, decline in coordination, frequent falling).

Documentation Required

Continuation: improvement or stability required

For continuation, provider must document disease improvement or stabilization (examples: improved speech/swallowing, limb coordination, upright stability).

Billing Rule

Quantity limit enforcement

Limit Skyclarys 50 mg capsules to 3 capsules per day.

Background & Clinical Evidence

Skyclarys (omaveloxolone) is FDA-approved for treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. The policy restricts use to the FDA-approved indication and requires that the medication be prescribed by or in consultation with a neurologist or physician who specializes in Friedreich's ataxia, and that the diagnosis be confirmed by detection of a mutation in the FXN gene. References include the FDA package insert and NORD information.

Primary reference: Skyclarys [package insert], Reata Pharmaceuticals, Inc.; December 2024.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkyclarys (omaveloxolone) for Friedreich's ataxia

Policy CodePolicy N/A

Change TypeClarified (no material changes)

Effective Date

Next Review Date2025-07

SourceLink

On This Page

OpenPayer

Skyclarys (omaveloxolone) for Friedreich's ataxia

Coverage Summary

Initial Therapy Criteria (up to 6 months)

Continuation Therapy Criteria (up to 6 months)

Not Covered / Experimental Indications

Applicable Codes

Provider Actions & Requirements

Background & Clinical Evidence

Definitions

Revision History