CurrentCentenePolicy N/A

Omaveloxolone (Skyclarys)

Defines medical necessity criteria, initial and continued therapy requirements, dosing limits, required documentation, covered population (Friedreich's ataxia patients ≥16 years), exclusions for non‑FDA indications, and approval duration for Skyclarys across Centene lines of business.

Policy Summary

PayerCentene

PolicyOmaveloxolone (Skyclarys)

Policy CodePolicy N/A

Change TypeMultiple material updates (dosing/LVEF/genetic testing/criteria)

Effective DateFeb 28, 2023

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria, including baseline mFARS and LVEF within 30 days.

POLICY UPDATE CHANGES

Policy updated per FDA labeling to revise dosing and added requirement for LVEF ≥ 40%.

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

Modified baseline mFARS score requirement by removing prior 20–80 score range.

For genetic testing, specified that testing shows a GAA triplet‑repeat expansion in the FXN gene.

Removed exclusion for history of clinically significant left-sided heart disease and pes cavus, and removed requirement that member has ability to swallow capsules.

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

1Covered Indication (FDA)

16Minimum Age

150 mg/day