Skyclarys (omaveloxolone) — Medica

Friedreich’s ataxia

Initial criteria

Patient is ≥ 16 years of age
Patient has had genetic testing confirming biallelic pathogenic variants in the frataxin (FXN) gene consistent with a diagnosis of Friedreich’s ataxia [documentation required]
Patient has had ALL of the following in the last year: (a) B-type natriuretic peptide (BNP) ≤ 200 pg/mL [documentation required]; (b) left ventricular ejection fraction ≥ 40% [documentation required]; (c) hemoglobin A1c (HbA1c) ≤ 11% [documentation required]
Patient has been assessed using the modified Friedreich’s Ataxia Rating Scale and has a score ≥ 20 and ≤ 80 [documentation required]
Patient is ambulatory
Patient does not have pes cavus
The 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
Patient has had genetic testing confirming biallelic pathogenic variants in the frataxin (FXN) gene consistent with a diagnosis of Friedreich’s ataxia [documentation required]
Patient is ambulatory
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
The medication is prescribed by or in consultation with a neurologist, or a physician who specializes in ataxias and/or neuromuscular disorders

1 year