Skyclarys (omaveloxolone capsules - Reata/Biogen) — Cigna

Friedreich’s ataxia

Initial criteria

Patient is ≥ 16 years of age; AND
Patient has had genetic testing confirming biallelic pathogenic variants in the frataxin (FXN) gene consistent with a diagnosis of Friedreich’s ataxia [documentation required]; AND
Patient has had ALL of the following in the last year (a, b, and c): a) Patient has a B-type natriuretic peptide (BNP) ≤ 200 pg/mL [documentation required]; AND b) Patient has a left ventricular ejection fraction ≥ 40% [documentation required]; AND c) Patient has a hemoglobin A1c ≤ 11% [documentation required]; AND
Patient has been assessed using the modified Friedreich’s Ataxia Rating Scale and has a score ≥ 20 but ≤ 80 [documentation required]; AND
Patient is ambulatory; AND
Patient does not have pes cavus; AND
Medication is prescribed by or in consultation with a neurologist or a physician who specializes in ataxias and/or neuromuscular disorders

Patient is ≥ 16 years of age; AND
Patient has had genetic testing confirming biallelic pathogenic variants in the frataxin (FXN) gene consistent with a diagnosis of Friedreich’s ataxia [documentation required]; AND
Patient is ambulatory; AND
According to the prescriber, the patient continues to benefit from therapy, as demonstrated by a slowed progression on the modified Friedreich’s Ataxia Rating Scale; AND
The medication is prescribed by or in consultation with a neurologist, or a physician who specializes in ataxias and/or neuromuscular disorders

1 year