HSE approves reimbursement of Skyclarys for patients with Friedreich’s Ataxia

The HSE’s Senior Management Team (SMT) today approved the reimbursement of Skyclarys for patients with Friedreich’s Ataxia.

The SMT took account of a substantially improved financial offer made in recent days by the company Biogen to the HSE arising from intensive discussions. Biogen has moved substantially from its previous position, and the HSE wants to express its appreciation of the flexible and constructive approach shown by the company.

The HSE SMT therefore considered a very different commercial offering to that which the HSE Drugs Group considered. On balance the SMT decided to approve reimbursement for Skyclarys based on the new commercial offering. It concluded that had it been asked to consider the same terms the HSE Drugs Group considered, it would have come to the same position as the Drugs Group and would not have proposed reimbursement.

The SMT also considered the limited efficacy that has been shown for the drug, and the high cost that remains despite the improved financial offer. It considered some of the potential weaknesses in the clinical evidence and other relevant matters the Drugs Group considered under the Health (Pricing and Supply of Medical Goods) Act 2013.

However, it also agreed with the observations of the Drugs Group in relation to the substantial unmet need of patients suffering from what is a devastating disease and the absence of any other medicines to treat it. 

Engagements are ongoing with Biogen to finalise the administrative arrangements which will underpin reimbursement. The HSE will progress these engagements quickly, and understands that Biogen are also committed to finalising details at an early stage.