THE HSE DRUGS Group has recommended that a drug to treat the rare disease Friedreich\u2019s ataxia should not be funded by the health service at this time.\u00a0<\/p>\n
The group met today to consider the application for the reimbursement of Skyclarys \u2013 reimbursement meaning it will be covered for patients who have medical cards or who are covered by another state scheme.\u00a0<\/p>\n
The recommendation will now go to a meeting of the HSE senior management team on 25 August, where a final decision will be made.\u00a0\u00a0<\/p>\n
Friedreich\u2019s ataxia is a progressive, neuromuscular disease that mainly affects the nervous system and the heart. It is a hereditary disease caused by a gene mutation.<\/p>\n
While there is no cure for the disease, Skyclarys has been found to slow the disease progression and improve neurological function.<\/p>\n
The treatment was approved by the European Medicines Agency in February 2024 and has been made available to patients in other European countries.<\/p>\n
Around 200 people have Friedreich\u2019s ataxia in Ireland, and a campaign has been underway to make the drug available by the HSE.\u00a0<\/p>\n
In a statement, the HSE said that when considering any drug for reimbursement, the drugs group looks at the benefits the drug would bring patients, the clinical evidence available for the drug and the impact that reimbursing the drug would have on overall resources available to the health service.\u00a0<\/p>\n
\u201cEveryone involved in this process is acutely aware of the impact their decisions have on the lives of patients and their families,\u201d the statement said.<\/p>\n
It said the HSE Drugs Group examined submissions and data from Friedreich\u2019s ataxia patients, their doctors and advocacy groups and discussed \u201cthe profound and devastating impact\u201d that the disease has on quality of life and life expectancy.<\/p>\n
The group considered input from the Rare Diseases Technology Review Committee (RDTRC), which was positive about the impact of the drug on the experience of patients and highlighted the substantial unmet need of those suffering from the disease.\u00a0<\/p>\n