Skyclarys: The €288,000 Drug That 200 Irish Patients Still Cannot Get

Fine Gael members met the manufacturers of Skyclarys, a disease-modifying drug for the rare disease Friedreich’s Ataxia, on Monday. It is the latest move in a campaign to reverse an HSE decision recommending against funding a treatment that costs €288,000 per patient per year.

Why the HSE said no to Skyclarys

Skyclarys was approved by the European Medicines Agency in February 2024 and has since been made available to patients in other European countries. In Ireland it is not available to the roughly 200 patients living with Friedreich’s Ataxia, a rare neurological condition. It is the only licensed treatment for the disease.

The sticking point is the price. At €288,000 per patient per year, the cost sits at the very top end of what the State is asked to reimburse, and the HSE recommended against funding it. That arithmetic will be familiar to anyone who has followed other HSE funding decisions in Ireland, where a clinical case and a budget line pull in opposite directions.

The timeline is the part that stings. The drug cleared the European regulator two and a half years ago and patients elsewhere in Europe are being treated with it. Irish patients with the same diagnosis, and the same single licensed option, are not.

Government TDs are lining up against the decision

Last week, 47 members of the Fianna Fáil parliamentary party signed a letter to Health Minister Jennifer Carroll MacNeill, Taoiseach Micheál Martin, Tánaiste Simon Harris and HSE Chief Executive Ann O’Connor calling for the decision to be reversed — an unusually large bloc of backbenchers lining up against a call taken on their own Government’s watch.

Fine Gael has now taken the next step. TDs Micheál Carrigy, Catherine Callaghan, Seán Kyne, David Maxwell, Noel McCarthy and John Paul O’Shea, along with Senator Noel O’Donovan, met Biogen, the biotechnology company that makes the drug, and called on it to work with the HSE to give patients access.

Going to the company rather than the Minister is a shift in tactics. The letters, the demonstration outside Leinster House and the calls for political intervention were all aimed at Government; bringing Biogen into the room puts the other half of the equation on the record too.

What happens next for Irish patients

Nothing has changed for those patients yet. The HSE recommendation stands, the price is unchanged, and the treatment remains available in other European countries but not here. What has changed is the political temperature: TDs in both Government parties are now publicly on the record against the decision, and the manufacturer has been brought into the conversation.

As The Journal reported, the ask now is for Biogen and the HSE to engage directly. That is a long way from a protest outside Leinster House, but for families watching a progressive condition advance while a licensed treatment sits on the other side of a funding decision, it is the only conversation that counts.