Further delay in Skyclarys approval
Michael Collins again sought urgent intervention to place Skyclarys on the HSE drugs group agenda, citing families left waiting. The Taoiseach outlined the application, health-technology assessment and company submissions, and said he would clarify the remaining process.
The Taoiseach has answered a question on this already. Perhaps he would give us a timeline. Will he urgently intervene to ensure that the drug, Skyclarys, is included in the HSE's drugs group agenda for tomorrow, 10 June? I raised this issue in the Dáil a number of months ago. I have also written directly to the Minister for health about it, yet here we are again with no progress and families left in limbo. I am speaking on behalf of Emma O'Shea from Bantry who was first diagnosed at ten years of age, and others who are living with Friedreich's ataxia, a cruel and relentlessly progressive disease where every single month lost means a permanent loss of mobility and quality of life. Skyclarys is the first treatment proven to slow the condition. It is already approved and being provided in countries across Europe and in the United States, yet Ireland's patients are once again left behind because of delays in the system. Will the Taoiseach intervene today with the Minister and the HSE to ensure Skyclarys is considered immediately? Does he accept that families cannot continue to wait while time and their health slip away because of bureaucracy?
Comment on this
I thank the Deputy for raising the issue. I will very quickly go through it because I think he is looking for clarification. Basically, the HSE received an application for pricing and reimbursement on 1 August 2024 for Skyclarys, for adults and adolescents aged 16 years and older. On foot of a rapid review of the application by the National Centre for Pharmacoeconomics, the HSE commissioned a full health technology assessment, HTA, on 25 September 2024. Necessary materials were submitted by Biogen Idec on 2 July 2025, ten months after the HTA was commissioned by the HSE. The agency met with Biogen Idec on 12 February. However, despite several requests, a commercial proposal from the applicant was not received until 28 May. This is the information that I have available.
That said, we need to get this decided upon as quickly as we possibly can. My understanding is it would be on the agenda for the July meeting of the HSE's drugs group, but if we can bring it forward, we will, although I do not want to make any commitments on that.
However, there are many families out there who are very worried and stressed. I acknowledge that.