CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Skyclarys (omaveloxolone) for Friedreich's ataxia — Coverage Criteria

Policy governs coverage and authorization criteria for Skyclarys (omaveloxolone) for treatment of Friedreich's ataxia in members, including initial and continuation therapy and quantity limits; applies to Medicaid members under Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkyclarys (omaveloxolone) for Friedreich's ataxia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for 6 months and document genetic confirmation of an FXN mutation and required clinical information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16+minimum age for coverage

6 moauthorization period

3/dayquantity limit

FXN reqgenetic confirmation

Coverage Criteria for Skyclarys (omaveloxolone)

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.

Initial Therapy

Covered when ALL of the following are met:

Initial Coverage Criteria: A. The medication is prescribed by or in consultation with a neurologist or physician who specializes in the treatment of Friedreich's ataxia; B. Diagnosis confirmed by detection of a mutation of the FXN gene; C. Member exhibits clinical manifestations of disease (e.g., muscle weakness, decline in coordination, frequent falling); D. Member is 16 years of age or older; E. Member is ambulatory.

Authorization of 6 months may be granted when all criteria are met.

Continuation Therapy

Covered for continued treatment when ALL of the following are documented:

Continuation Criteria: Documentation that the disease has improved or stabilized (e.g., improvement in speech or swallowing, upper/lower limb coordination, upright stability).

Authorization of 6 months may be granted for continued treatment.

Use of Skyclarys (omaveloxolone) is limited to the FDA-approved indication. Specifically, Skyclarys is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. Any use for an indication other than Friedreich's ataxia is considered experimental/investigational and not covered.

Treatments with Skyclarys for conditions beyond the FDA-approved indication of Friedreich's ataxia are considered not medically necessary and are not covered. Prior authorization may be denied for requests that do not align with the approved indication.

Pharmacy Product and Quantity Limits

Pharmacy product and quantity limitNDC|productCovered

Skyclarys 50 mg capsule

Quantity limit: 3 capsules per day

Daily quantity limit — 3 capsules per day

Daily quantity limitSkyclarys (omaveloxolone) 50 mg: 3 capsules per day

Applicable product form50 mg capsules

Limit descriptionQuantity limit applies to daily dispensing/administration

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Skyclarys (vutrisiran) for the treatment of Friedreich's ataxia. Initial and renewal authorizations are for up to 6 months. Quantity limit: 3 capsules (50 mg) per day.

Prior authorization required for Skyclarys.
Initial authorization: up to 6 months.
Renewal authorization: up to 6 months.
Quantity limit: 3 capsules (50 mg) per day.

Documentation Required

Prescriber Specialty Required

Prescribe or obtain consult from a neurologist or physician who specializes in Friedreich's ataxia. Include specialty of requesting clinician in the request.

Prescribing clinician specialty must be documented (neurologist or FA specialist).

Documentation Required

Required Clinical Documentation

Clinical documentation must include genetic testing confirming detection of an FXN gene mutation, clinical manifestations consistent with Friedreich's ataxia (for example, muscle weakness, decline in coordination, frequent falls), the member's age (must be ≥16 years), and that the member is ambulatory.

Documentation of FXN gene mutation (genetic test result).
Clinical signs/symptoms of Friedreich's ataxia (examples provided).
Member age ≥16 years.
Evidence patient is ambulatory.

Documentation Required

Continuation (Renewal) Documentation

For continuation (renewal) requests, provide documentation that the disease has improved or stabilized while on therapy. Examples include improved speech or swallowing, improved upper or lower limb coordination, or improved upright stability. Renewal authorization may be denied if required evidence of benefit or stabilization is not provided.

Provide objective or clinician-documented evidence of improvement or stabilization (e.g., documented neurologic exam findings, functional assessments, speech/swallow evaluations).
Renewals granted for up to 6 months.
Lack of evidence of benefit may result in denial.

Denial Risk

Indication Restriction

Use of Skyclarys is restricted to the FDA-approved indication: Friedreich's ataxia in patients aged 16 years and older. All other uses are considered experimental/investigational and not medically necessary.

Covered only for Friedreich's ataxia (ages ≥16).
Non-FDA or off-label indications are not covered.

Denial Risk

Genetic Confirmation Required

Genetic confirmation of an FXN mutation is required; authorization may be denied if genetic testing does not detect a pathogenic FXN mutation. Include the genetic test report with the prior authorization submission.

Attach genetic test report documenting FXN mutation.
Absence of detected FXN mutation may lead to denial of authorization.

Definitions and Clinical Response Criteria

Genetic confirmation (FXN mutation) definition — diagnosis confirmation requirement

DefinitionDiagnosis must be confirmed by detection of a mutation of the FXN gene

Required documentationGenetic testing report showing FXN gene mutation must be provided

Consequence of missing confirmationAuthorization may be denied if FXN mutation is not detected

Clinical response for continuation — examples of improvement or stabilization

Required clinical response for continuationDocumentation that disease has improved or stabilized — e.g., improvement in speech or swallowing, upper/lower limb coordination, or upright stability

Examples of improvementImproved speech or swallowing function

Examples of stabilizationMaintenance or no further decline in limb coordination or upright stability

Documentation sourceClinical notes or assessments demonstrating change from baseline must be submitted for 6-month renewal

Background on Friedreich's Ataxia and Therapy

Friedreich's ataxia is a progressive neurodegenerative disorder. Skyclarys (omaveloxolone) is FDA-approved to treat Friedreich's ataxia in adults and adolescents aged 16 years and older. Coverage under this policy applies when the member meets the specified clinical and documentation requirements for treatment of Friedreich's ataxia.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkyclarys (omaveloxolone) for Friedreich's ataxia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for 6 months and document genetic confirmation of an FXN mutation and required clinical information.

SourceLink

On This Page