CurrentCentenePolicy CP.PHAR.590

Omaveloxolone (Skyclarys)

Defines medical necessity criteria, documentation, dosing limits, approval durations, continued therapy requirements, and exclusions for coverage of omaveloxolone (Skyclarys) for members (Commercial, HIM/ICHRA, Medicaid) aged ≥16 with Friedreich's ataxia.

Policy Summary

PayerCentene

PolicyOmaveloxolone (Skyclarys)

Policy CodePolicy CP.PHAR.590

Change TypeMaterial revisions and clarifications (2023–2026)

Effective Date02.28.23

Next Review Date

Key ActionSubmit documentation showing GAA expansion, baseline mFARS and LVEF within 30 days and obtain prior authorization for a 12-month approval when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition and added ICHRA line of business.

Per FDA labeling, added requirement for baseline LVEF ≥ 40% and revised dosing limits; removed prior exclusions (e.g., pes cavus, swallowing ability) and modified baseline mFARS requirements.

Changed continued therapy evidence requirement wording to 'improvement or stabilization' in FA symptoms or mFARS and standardized approval duration to 12 months.

Removed requirement for maximal exercise testing on a recumbent stationary bicycle.

Added genetic testing requirement specifying GAA triplet-repeat expansion in FXN gene and removed prior numeric mFARS range requirement.

Annual reviews in 2024 and 2025 noted no significant changes; references updated.

1Covered Indication (FDA)

16Minimum age (years)

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Coverage Summary

Covered with criteria: Omaveloxolone (Skyclarys) for Friedreich's ataxia (FA) in patients aged ≥ 16 years; prior authorization required with documentation of genetic testing for a GAA triplet‑repeat expansion in the FXN gene, baseline mFARS and baseline LVEF within 30 days, prescribed by or in consultation with a neurologist, and dose limits of ≤ 150 mg/day and ≤ 3 capsules/day. Approval duration: 12 months. Policy effective 02.28.23; last reviewed 05.26 (P&T 05.26.2026).

Key thresholds and stats

Age≥ 16 years

Baseline mFARS timingwithin the last 30 days

Baseline LVEF≥ 40%

Max daily dose150 mg per day

Max capsules/day3 capsules per day

Approval duration12 months

PayerCentene-affiliated health plans (Commercial, HIM/ICHRA, Medicaid)

Policy numberCP.PHAR.590

Initial Therapy Criteria

Initial Therapy - Friedreich's Ataxia (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Friedreich's ataxia (FA)
Documentation of genetic testing that shows a GAA triplet-repeat expansion in the frataxin (FXN) gene
Prescribed by or in consultation with a neurologist
Age ≥ 16 years
Recent (within the last 30 days) baseline modified Functional Assessment Rating Scale (mFARS) score (see Appendix D)

Continuation Therapy Criteria

Unapproved Indications / Exclusions

Applicable Codes

Product NDC / HCPCS / CPTmixed

No codes listed

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required and approval duration is 12 months for initial and continued therapy when criteria are met.

Documentation Required

Submit supporting documentation

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria, including genetic testing showing a GAA triplet-repeat expansion in the FXN gene, baseline mFARS score and baseline left ventricular ejection fraction (LVEF) within 30 days.

Genetic testing demonstrating GAA triplet-repeat expansion in the FXN gene
Baseline modified Functional Assessment Rating Scale (mFARS) score within 30 days
Baseline left ventricular ejection fraction (LVEF) within 30 days (≥ 40%)

Clinical Evidence

MOXIePrimary RCT: MOXIe study (Lynch et al., Ann Neurol. 2021)

Lynch 2021Key randomized controlled trial supporting efficacy

Skyclarys PI Dec 2024Prescribing information: Reata Pharmaceuticals, Inc.; December 2024

Omaveloxolone is an Nrf2 pathway activator approved for treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older and was studied in the MOXIe trials. Friedreich's ataxia is a progressive disorder with neurologic disability and cardiomyopathy manifestations. Clinical assessment and monitoring use the modified Functional Assessment Rating Scale (mFARS) as a baseline and response measure, and cardiac safety is assessed by baseline left ventricular ejection fraction with a requirement of LVEF ≥ 40% prior to therapy.

Definitions

mFARS: modified Functional Assessment Rating Scale, a disease‑specific neurologic rating scale with a maximum of 93 points; higher scores indicate greater disability.

FA: Friedreich's ataxia, a progressive, life‑shortening ataxia with neurologic and cardiomyopathy manifestations.

FXN: frataxin gene; genetic testing demonstrating a GAA triplet‑repeat expansion in FXN is required for coverage.

LVEF: left ventricular ejection fraction; baseline measurement must be ≥ 40% within 30 days prior to request.

Revision History

03.30.26; P&T Approval Date 05.26revisedLatest

Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition and added ICHRA line of business (material change).

04.11.23 – 11.08.23; P&T Approval Date 05.23; P&T Approval Date = 02.24revised

Per FDA labeling (RT1 and subsequent updates), added requirement for baseline LVEF ≥ 40% and revised dosing limits; removed prior exclusions (e.g., pes cavus, swallowing ability) and modified baseline mFARS requirements (material change).

11.08.23; P&T Approval Date = 02.24

Initial Therapy - Other diagnoses/indications

Covered when ANY of the following are met:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, follow the applicable formulary or non-formulary policy for the relevant line of business: for drugs on the formulary/PDL use the no coverage criteria policy (CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, CP.PMN.255 for Medicaid); for drugs NOT on the formulary/PDL use the non-formulary policy (CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, CP.PMN.16 for Medicaid).
If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.