HSE Approves Reimbursement for Friedreich's Ataxia Drug Skyclarys

Ireland's Health Service Executive has approved state reimbursement for the drug Skyclarys, the first treatment for the rare neurodegenerative disorder Friedreich's ataxia, following a decision by its Senior Management Team on August 25, 2026. The approval reverses a recommendation from the HSE Drugs Group earlier in August and comes after an intensive, last-minute negotiation with the drug's manufacturer, Biogen.

The HSE stated the decision followed a "substantially improved financial offer" from Biogen, which had moved from its previous position. While the SMT acknowledged the limited efficacy shown for the drug and its high cost even with the improved offer, it concluded that reimbursement was justified on balance. The team cited the "substantial unmet need" of patients and the absence of any other medicines to treat the condition, which affects approximately 200 people in Ireland.

Friedreich's ataxia is a progressive, inherited disorder that damages the nervous system, often beginning in childhood and leading to severe movement and coordination problems. Skyclarys, or omaveloxolone, is not a cure, but patients and advocates state it can slow disease progression by up to 55%,...