Pharmacy Prior Authorization Criteria

Skyclarys (omaveloxolone)

Indications for Prior Authorization

Skyclarys (omaveloxolone)

• 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 Modified Friedreich's Ataxia Rating Scale (mFARS) score of greater than or equal to 20 and less than or equal to 80
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
AND
• Patient has a Modified Friedreich's Ataxia Rating Scale (mFARS) score of less than or equal to 80 [A]

P & T Revisions

2024-05-21, 2023-10-04, 2023-06-16, 2023-05-23

References

1. Skyclarys Prescribing Information. Reata Pharmaceuticals, Inc. Cambridge, MA. January 2024.

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End Notes

1. 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.

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Revision History

• 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

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