The Health Service Executive (HSE) has approved the reimbursement of Skyclarys for people living with Friedreich’s Ataxia, following a significantly improved financial offer from pharmaceutical company Biogen.
The decision was made by the HSE Senior Management Team following a review of Biogen’s revised commercial proposal. The HSE said the company had moved “substantially” from its previous position and welcomed what it described as a “flexible and constructive approach”.
The HSE had previously been advised against reimbursing the drug on cost-effectiveness grounds. However, following the new offer from Biogen, the Senior Management Team decided that, on balance, reimbursement should proceed.
Friedreich’s Ataxia is a rare and progressive neuromuscular condition that can cause nerve damage, muscle weakness and a gradual loss of mobility. There are estimated to be around 200 people living with the condition in Ireland.
Skyclarys is the first approved treatment specifically for Friedreich’s Ataxia and can help slow the progression of the disease. The treatment has been approved by both the European Medicines Agency and the US Food and Drug Administration.
Minister for Health Jennifer Carroll MacNeill said she had asked the HSE to begin discussions with Biogen immediately to establish how patients can gain access to the drug.
She described the decision as an important day for people with Friedreich’s Ataxia and their families, while acknowledging the complexity of the statutory process involved in approving high-cost medicines.
HSE Chief Clinical Officer Dr Colm Henry also recognised the distress experienced by patients and families during the lengthy negotiations. He said the revised deal represented a substantial reduction in the price being sought by Biogen, although the final figure remains commercially sensitive.
Dr Henry said the decision demonstrated the importance of negotiating with pharmaceutical companies to secure medicines at prices that are more sustainable for the health service.
Biogen welcomed the decision, describing it as a “landmark moment” for people living with Friedreich’s Ataxia. The company said it would work closely with the HSE to facilitate access to the treatment as quickly as possible.
The decision has been broadly welcomed by political parties, although opposition representatives criticised the length of time it took to reach an agreement.
Sinn Féin, the Social Democrats, Labour, Aontú and Independent Ireland all welcomed the approval while highlighting concerns over the lengthy process and calling for patients to gain access without further delays.
The HSE Drugs Group had recommended earlier this month that the treatment should not be reimbursed for public patients, while the National Centre for Pharmacoeconomics had previously raised concerns about its cost-effectiveness and clinical benefit.
The approval follows a campaign lasting around two years by patients and families seeking access to Skyclarys.
Credit: RTÉ News
