ModifiedmhnPolicy CP.PHAR.590

Omaveloxolone (Skyclarys)

Defines medical necessity and prior authorization criteria for omaveloxolone (Skyclarys) for patients with Friedreich's ataxia aged 16 years and older across Commercial, ICHRA, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyOmaveloxolone (Skyclarys)

Policy CodePolicy CP.PHAR.590

Change TypeMaterial revisions to criteria and approval duration

Effective DateFeb 28, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including genetic testing showing a GAA triplet-repeat expansion, recent baseline mFARS, and baseline LVEF ≥ 40%.

SourceLink

POLICY UPDATE CHANGES

Extended initial and continued approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

Added requirement for genetic testing showing a GAA triplet-repeat expansion in the FXN gene and removed prior mFARS range restriction and several prior exclusions per product labeling and trial alignment.

Added baseline left ventricular ejection fraction requirement ≥ 40% and dosing limits consistent with FDA labeling (150 mg/day, 3 capsules/day).

≥16minimum age for FDA indication

150 mg/daymaximum daily dose

12 monthsapproval duration

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baseline cardiac requirement

50 mg capsuleproduct availability

Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial FA criteria: 1. Diagnosis of Friedreich's ataxia (FA); 2. Documentation of genetic testing that shows a GAA triplet-repeat expansion in the frataxin (FXN) gene; 3. Prescribed by or in consultation with a neurologist; 4. Age ≥ 16 years; 5. Recent (within the last 30 days) baseline modified Functional Assessment Rating Scale (mFARS) score; 6. Recent (within the last 30 days) baseline left ventricular ejection fraction ≥ 40%; 7. Dose does not exceed both: a) 150 mg per day; b) 3 capsules per day.

Approval duration: 12 months

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued FA criteria: 1. Member meets one of the following (a or b): a) Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b) Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by improvement or stabilization in FA symptoms or mFARS score; 3. If request is for a dose increase, new dose does not exceed both: a) 150 mg per day; b) 3 capsules per day.

Approval duration: 12 months

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use or evidence‑of‑coverage policies. For Commercial, follow CP.CPA.09; for Health Insurance Marketplace/ICHRA, follow HIM.PA.154; for Medicaid, follow CP.PMN.53.

When a state Medicaid program’s coverage provisions conflict with the provisions of this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules that may override this policy.

Use of omaveloxolone for non‑FDA approved indications without sufficient supporting documentation is not authorized. Requests for off‑label use must include documentation demonstrating efficacy and safety consistent with the Health Plan’s off‑label use or evidence‑of‑coverage policies; absent that documentation, the request may be denied.

Coding and Product Information

Product availability / NDCNDC

NDC not listed

Product availability: Capsule 50 mg (no NDC provided in document)

inv-07: Maximum daily dose — 150 mg/day (3 capsules/day)

Maximum daily dose150 mg per day (3 capsules per day)

Dosing regimen (FA)150 mg PO once daily

Dose limit enforcementApproval requires dose not to exceed both 150 mg/day and 3 capsules/day per policy

inv-08: Baseline left ventricular ejection fraction — >= 40%

Baseline LVEF requirement>= 40%

Timing for baseline LVEFRecent baseline LVEF must be obtained within the last 30 days

Role in approval

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage. Approvals are issued for a maximum of 12 months. Providers must obtain prior authorization before dispensing and may request renewal with required documentation.

Approval duration: 12 months

Documentation Required

Documentation Required — Risk of Denial if Insufficient

Provider must submit documentation (e.g., office chart notes, lab results, genetic testing reports, mFARS score, left ventricular ejection fraction) supporting that the member meets all approval criteria. Requests lacking required documentation or for non‑covered indications risk denial.

Required documentation includes genetic testing demonstrating GAA triplet‑repeat expansion in FXN for Friedreich's Ataxia, recent (within 30 days) baseline mFARS score, and recent (within 30 days) baseline LVEF ≥ 40%.

Background

Friedreich’s ataxia (FA) is a progressive, life‑shortening neurodegenerative disorder characterized by progressive gait and limb ataxia, areflexia, dysarthria, and frequent cardiomyopathy and metabolic disturbances. Omaveloxolone (Skyclarys) is an Nrf2 pathway activator approved to treat FA in patients aged ≥ 16 years, and clinical assessments such as the disease‑specific mFARS (modified Functional Assessment Rating Scale) are used to document baseline and follow‑up neurological status.

Definitions

inv-19: mFARS (modified Functional Assessment Rating Scale) — disease-specific neurological rating scale

DefinitionmFARS is a disease-specific, exam-based neurological rating scale for Friedreich's ataxia

Scale rangeMaximum cumulative value of 93 points; higher scores indicate greater disability

Assessed domainsBulbar function, upper and lower limb coordination, and upright stability

inv-20: Nrf2 — nuclear factor erythroid 2-related factor 2

AcronymNrf2 = nuclear factor erythroid 2-related factor 2

RelevanceNrf2 is the pathway activated by omaveloxolone (Skyclarys)

Policy Summary

Payermhn

PolicyOmaveloxolone (Skyclarys)

Policy CodePolicy CP.PHAR.590

Change TypeMaterial revisions to criteria and approval duration

Effective DateFeb 28, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including genetic testing showing a GAA triplet-repeat expansion, recent baseline mFARS, and baseline LVEF ≥ 40%.

SourceLink

On This Page

Baseline LVEF >= 40% is required for initial therapy approval

inv-09: Baseline mFARS — Recent baseline mFARS score required (no numeric range required)

Baseline mFARS requirementRecent baseline mFARS score required (within the last 30 days)

mFARS purposeDisease-specific, exam-based neurological rating scale assessing bulbar function, limb coordination, and upright stability

Timing for assessmentBaseline must be recent (within 30 days) per policy Appendix D

Documentation Required

Documentation and Compliance

Coverage is subject to the Health Plan's coverage documents, state and federal requirements, and Health Plan administrative policies. The Health Plan may change this clinical policy or the prior authorization requirements at any time.

Coverage decisions are subject to terms, conditions, exclusions, and limitations in evidence of coverage or contract documents.
Health Plan retains the right to amend or withdraw this clinical policy and related PA requirements.

Note

Policy Routing for Label Changes or Off‑Label Uses

If the drug's FDA label has recently changed (e.g., new indication, age expansion, dosing) or the requested use is off‑label and not specifically addressed in this policy, follow the referenced formulary/off‑label policies for the applicable line of business.

Formulary/non‑formulary routing: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable.
Off‑label use policies: CP.CPA.09, HIM.PA.154, CP.PMN.53.

Note

Provider Responsibilities

Providers are expected to exercise professional medical judgment and are responsible for member care. The Health Plan does not provide medical advice and providers remain independent. Providers submitting requests must ensure compliance with all applicable policies and include any additional information reasonably necessary for review.

Described in policy as the pathway activated by omaveloxolone

inv-21: Health Plan — definition of Health Plan / Centene

DefinitionHealth Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

RoleThe Health Plan issues coverage decisions and may change, amend, or withdraw this clinical policy

Compliance noteCoverage decisions are subject to terms, conditions, exclusions, limitations of coverage documents, and state/federal requirements