CurrentHealth NetPolicy N/A

Clinical Policy: Omaveloxolone (Skyclarys)

Defines medical necessity criteria, initial and continued therapy requirements, dosing limits, excluded indications, documentation and applicable line-of-business references for omaveloxolone (Skyclarys) for commercial, HIM, and Medicaid lines.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Omaveloxolone (Skyclarys)

Policy CodePolicy N/A

Change TypeRevised / Clarified

Effective Date02.28.23

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Policy updated to FDA labeling: revised dosing; added requirement for baseline LVEF ≥ 40%; added genetic testing requirement showing GAA triplet-repeat expansion in FXN.

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

2Q 2024 annual review: no significant changes; references reviewed and updated.

1Covered Indication (FA)

≥16Minimum Age (years)

150 mg/dayMaximum Daily Dose

12 months

Approval Duration (continued)

Coverage Summary

Coverage stance: covered with criteria for omaveloxolone (Skyclarys) for the treatment of Friedreich's ataxia (FA) in patients aged ≥ 16 years, aligned to FDA labeling and MOXIe study evidence. The policy defines medical necessity with initial and continued therapy requirements including genetic confirmation of FA, prescribing by or in consultation with a neurologist, baseline mFARS and cardiac assessment, and dosing limits per labeling.

Quick thresholds

Age≥ 16 years

Baseline LVEF≥ 40% (within last 30 days)

Baseline mFARSDocumentation within last 30 days

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

Approval duration (continued therapy)12 months

Initial Therapy Criteria

Initial Approval Criteria

Skyclarys is medically necessary when ALL of the following are met:

ALL of the following

Friedreich's ataxia (must meet all)
- Diagnosis of Friedreich's ataxia (FA)
- Genetic testing: Documentation of genetic testing that shows a GAA triplet-repeat expansion in the frataxin (FXN) gene
- Prescriber specialty: Prescribed by or in consultation with a neurologist

Continuation Therapy Criteria

Continued Therapy (Renewal) Criteria

Member must meet ONE of the following (a or b) AND continued therapy-specific requirements:

Continuity requirement (one of)

Current Centene benefit or prior initial approval: Member is currently receiving medication via Centene benefit or has previously met initial approval criteria
State continuity of care: Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums)

Continued therapy-specific requirements

Response evidence: Member is responding positively to therapy as evidenced by improvement or stabilization in FA symptoms or mFARS score (see Appendix D)

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

Non-authorized indications: Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided per off-label use policies or other evidence of coverage documents

Refer to off-label use policies: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid

Provider Actions & Documentation Requirements

Documentation Required

Submit supporting documentation

Submit office chart notes, lab results, or other clinical information that support the member meets all approval criteria.

Prior Authorization

Prescriber specialty requirement

Initial prescriptions must be by or in consultation with a neurologist.

Documentation Required

Applicable Codes & Product Availability

Product Availability (informational)NDC

50 mg capsule

Product available as 50 mg capsules (informational)

Clinical Evidence

Key evidence and references: MOXIe Study reporting effects on mFARS (Ann Neurol. 2021;89(2):212-225) and the Skyclarys Prescribing Information (Reata Pharmaceuticals, January 2024). Policy aligns coverage to FDA labeling and MOXIe trial outcomes on mFARS, and uses the prescribing information for dosing and safety parameters.

Background

Background: Omaveloxolone (Skyclarys) is an Nrf2 pathway activator indicated for Friedreich's ataxia in adults and adolescents 16 years and older. The policy aligns to FDA labeling and evidence from the MOXIe trial and specifies requirements including documentation of a GAA triplet-repeat expansion in the frataxin (FXN) gene, prescribing by or in consultation with a neurologist, and baseline assessments of left ventricular ejection fraction and modified Friedreich Ataxia Rating Scale (mFARS).

Definitions: The mFARS (modified Friedreich Ataxia Rating Scale) is a disease-specific, exam-based neurological rating scale (maximum 93 points) assessing bulbar function, upper and lower limb coordination, and upright stability, where higher scores indicate greater disability.

FXN refers to the frataxin gene; genetic testing for a GAA triplet-repeat expansion in FXN is required to document Friedreich's ataxia.

FA (Friedreich's ataxia) is a progressive, life-shortening ataxia with cardinal symptoms including progressive limb ataxia, areflexia, extensor plantar responses, and dysarthria, and may involve cardiomyopathy and metabolic disturbances.

Revision History

2023-02-28policy_effective

Policy effective date established aligning coverage to FDA labeling and MOXIe evidence; initial approval criteria include diagnosis of FA, genetic testing showing GAA triplet‑repeat expansion in FXN, neurologist involvement, age ≥16, baseline mFARS and baseline LVEF ≥40%, and dosing limit of 150 mg/day (max 3 capsules).

04.11.23material_revision

Revised to align with FDA labeling: dosing updated to 150 mg/day (150 mg QD), added requirement for baseline left ventricular ejection fraction ≥40% and references to cardiac history per PI; policy updated per FDA labeling and MOXIe trial evidence. (Marked material change.)

08.16.23material_revision

Policy Summary

PayerHealth Net

PolicyClinical Policy: Omaveloxolone (Skyclarys)

Policy CodePolicy N/A

Change TypeRevised / Clarified

Effective Date02.28.23

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Baseline mFARS: Recent (within the last 30 days) baseline modified Friedreich Ataxia Rating Scale (mFARS) score (see Appendix D)within 30 days

mFARS: disease-specific neurological rating scale (max 93 points)

Baseline LVEF: Recent (within the last 30 days) baseline left ventricular ejection fraction >= 40%>=40% within 30 days

Dose limit (both must be met)

Dose mg limit: Dose does not exceed 150 mg per day<=150 mg/day
Maximum daily dose per policy
Dose capsule limit: Dose does not exceed 3 capsules per day<=3 capsules/day
Product is 50 mg capsules

Continued dose mg: Dose for continued therapy is 150 mg per day<=150 mg/day

Dose increase rule: If request is for a dose increase, new dose does not exceed both: 150 mg per day and 3 capsules per day<=150 mg/day; <=3 capsules/day

Prior Authorization

Renewal approval duration

Approval duration: 12 months. Renewal requires documentation showing improvement or stabilization in Friedreich's ataxia (FA) symptoms or in the mFARS score; continued therapy approvals are granted for 12 months.

Baseline assessments required

Document recent (within 30 days) baseline modified Friedreich Ataxia Rating Scale (mFARS) score and baseline left ventricular ejection fraction (LVEF) ≥ 40%.

Billing Rule

Dose limits enforceable

Enforce dose limits: maximum 150 mg per day and maximum 3 capsules per day. Any request for a dose increase must adhere to these limits.

Prior Authorization

Continued therapy evidence

For renewal, provide documentation showing improvement or stabilization in FA symptoms or mFARS score to justify continued coverage. Renewal approvals are granted for 12 months.

Removed requirement for maximal exercise testing on a recumbent stationary bicycle as it is not required per the Prescribing Information. (Marked material change.)

11.08.23material_revision

Multiple clarifications and removals: added explicit genetic testing requirement showing a GAA triplet‑repeat expansion in the FXN gene; removed the prior mFARS 20–80 band; removed exclusions for history of clinically significant left‑sided heart disease/cardiac disease and for pes cavus; removed requirement for ability to swallow capsules; changed continued therapy language from 'improvement' to 'improvement or stabilization' and extended approval duration from 6 months to 12 months. (Marked material change.)

01.18.24annual_reviewLatest

2Q 2024 annual review: no significant changes; references reviewed and updated.