Cork father welcomes Skyclarys approval

Cork father Craig Coady has welcomed the HSE’s decision to fund the drug Skyclarys, and thanked all those who supported the campaign.

“Great news yesterday, Skyclarys has been passed. Hopefully only a week or two until we can get it into the hands of the patients.

“There’s a lot of messages coming through and I don’t have a chance to get through them all, but I just want to say for now thank you, you’ve all been amazing, Cork people, North Cork people, thank you so much,” he said in video statement.

The HSE announced on Tuesday that it will fund the drug Skyclarys, used to treat the neurological disease Friedreich’s Ataxia.

Following engagement between the health service and the drug’s manufacturers Biogen, a deal has been reached which “substantially reduces” the cost of the drug for the HSE, according to a spokesperson.

Earlier this month, the HSE Drugs Group had recommended that the drug not be funded by the service, as it would not have been “cost-effective”.

The group said that the drug would cost €280,000 per patient, per year, with a five-year budget impact of approximately €130 million.

Speaking to Newstalk, Minister for Health Jennifer Carrol MacNeill said: “There was a substantially improved offer from the manufacturer in the last seven days.

“There have been extremely intensive negotiations between the HSE and the manufacturer, that delivers for patients, for more patients, but crucially also delivers for the taxpayers of Ireland who need that money to deliver other drugs,” she said.

Public protest

The initial refusal to fund the drug met with considerable public and political outcry.

A letter sent to An Taoiseach Micheál Martin and an Tánaiste Simon Harris saying that the HSE’s system for approving drugs was “broken and not fit for purpose” was signed by 48 Fianna Fáil TDs, senators, and MEPs.

Members of the Fine Gael parliamentary party held a number of meetings with representatives of Biogen to appeal to the company to “engage fully with the HSE on what is possible to get patients access to this drug”.

Outside of Leinster House, a large body of support has grown behind campaigners for the drug.

In Mallow, over 1,000 people attended a demonstration and vigil in support of sufferers of Friedreich’s Ataxia, which culminated in speeches from Coady and Fianna Fáil TD Pádraig O’Sullivan.

A GoFundMe started to assist Coady, whose 16 year old son Paudie suffers from the disease, and whose 13 year old son Rory died from the disease last year, raised over €172,000, over twice the goal of €85,000.

Approval welcome

The decision by the HSE has been welcomed by campaigners.

Fianna Fáil Deputy Pádraig O’Sullivan, and Fianna Fáil Senators Anne Rabbite and Teresa Costello, who directly supported the Coady, said: “This decision should never have taken as long as it did.

“Patients waited through an initial HSE Drugs Group recommendation against reimbursement, a deferral for further review, and months of uncertainty, while a progressive and life-limiting condition did not wait with them.

“Ireland's system for approving rare disease drugs needs to change. It is slower, more bureaucratic and more resistant to using its own discretion than our European neighbours. We will continue to push for reform of how Ireland assesses and approves treatments for rare conditions,” they said.

Labour Senator Laura Harmon also welcomed the announcement but said that the individual negotiations EU countries had to go through made them more difficult.

“We should look seriously at whether European countries can work together to negotiate and purchase these treatments. Working together could give countries greater negotiating strength while protecting both patients and public money,” she said.