Co Kilkenny woman diagnosed with rare disease sues HSE over access to drug

High Court Reporters

A Co Kilkenny woman diagnosed with Friedreich’s ataxia (FA) has sued over alleged delays in the HSE determination of an application seeking the approval of a drug capable of treating the rare condition.

Emily Felix (28) was 12 years old when she was diagnosed with the rare, inherited and progressive neuromuscular disease.

She is fully reliant on a wheelchair for mobility and requires assistance with “virtually all aspects of daily living” on account of her condition.

In a lawsuit, she is asking the High Court to direct the HSE to finalise its decision on the approval, reimbursement and funding of omaveloxolone, a drug capable of slowing the progression of FA. In bringing the case, she ultimately seeks access to the medicine.

On Tuesday, Judge Cian Ferriter granted permission to Helen Callinan, the woman's counsel with Conor Duff and Anthony Walsh, to pursue the judicial review challenge against the HSE and the Minister for Health.

Felix, who works for the Central Bank of Ireland and is studying to be a solicitor, was present in court for Tuesday’s hearing. In a sworn statement, she says she is “fighting for [her] survival” in bringing the case.

According to her court documents, omaveloxolone, under the trade name Skyclarys, is licensed by the European Medicines Agency for patients over 16. Biogen, the pharmaceutical company behind Skyclarys, received market authorisation from the European

Commission in February 2024, and the drug is available in 12 EU member states.

Omaveloxolone is not a cure for FA, but it is capable of slowing the progression of the condition.

In August 2024, Biogen made a pricing and reimbursement application to the HSE in respect of Skyclarys.

Medicine suppliers can apply to the HSE to have new drugs added to the executive’s list of drugs eligible for reimbursement. Approval allows for public patients to get access to the drug, under various reimbursement schemes.

In December 2025, the National Centre for Pharmacoeconomics – which considers the cost-effectiveness of reimbursing new drugs – recommended to the HSE that omaveloxolone not be considered for reimbursement.

Biogen subsequently met with the HSE’s Corporate Pharmaceutical Unit in an effort to progress the pricing and reimbursement application.

Biogen submitted a commercial proposal to the HSE in May this year.

The application remains under consideration by the HSE.

In recent years, Felix has experienced a “substantial deterioration” in her speech, mobility, fatigue levels and swallowing ability on account of her condition. FA is progressive, and deterioration is irreversible.

Felix’s lawyers submit that delaying her access to the drug has “real and irreversible consequences”.

“She fears that without access to treatment capable of slowing progression now, her condition may deteriorate to such an extent that future treatment opportunities may ultimately be of little practical benefit to her,” her lawyers submit.

It is also submitted that there are other FA sufferers in the same position as Felix.

She seeks various reliefs, including an order directing the HSE to determine “the application for approval, reimbursement, funding and/or access to Skyclarys drug treatment which has been with the HSE since August 2024”.

Felix also seeks provisions for an interim access arrangement to the drug while the HSE decision is pending.

The judge said the case could be mentioned again in September.