Skyclarys (omaveloxolone)
Indications for Prior Authorization
Skyclarys (omaveloxolone)
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For diagnosis of Friedreich's ataxia
Indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.
Criteria
Skyclarys
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- Diagnosis of Friedreich's ataxia confirmed via genetic testing demonstrating mutation in the FXN gene AND
- Patient is 16 years of age or older AND
- Patient has a B-type natriuretic peptide value less than or equal to 200 pg/mL AND
- Prescribed by or in consultation with one of the following:
- Neurologist
- Neurogeneticist
- Physiatrist (Physical Medicine and Rehabilitation Specialist)
Skyclarys
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient demonstrates positive clinical response to therapy
P & T Revisions
2024-12-20, 2024-05-21, 2023-10-04, 2023-06-16, 2023-05-23
References
- Skyclarys Prescribing Information. Reata Pharmaceuticals, Inc. Cambridge, MA. January 2024.
End Notes
- Patients enrolled in the trial were those with an mFARS score between 20 and 80. There is no evidence of benefit for patients with severe neurologic dysfunction with an mFARS score of greater than 80.
Revision History
- 2024-12-20: Removed mFARS score criteria from guideline to align with FDA-approved indication and to allow for better prevention of progression results.
- 2024-05-21: 2024 annual review: no criteria changes.
- 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
- 2023-06-16: Added EHB formulary.
- 2023-05-23: New program for Skyclarys
HEALTHY LIVING