Glimmer of hope for Skyclarys campaign
Campaigners seeking access to a drug that halts the progress of a rare generative condition have been given a glimmer of hope.
Members of Ataxia Foundation Ireland, which includes Castleshane woman Aoife Gavan, are encouraged by an eleventh hour intervention by Fianna Fáil TDs and Senators who wrote to the Taoiseach this week demanding the State reimburse patients for the Skyclarys treatment.
They are further heartened by news that the company, which produces the drug, is prepared to “continue dialogue” with the HSE on the cost - previously reported at €56M annually for the 200 sufferers in Ireland.
The news comes as campaigners plan a major protest in Dublin ahead of a crucial meeting of the HSE Leadership Team on August 25, when a final decision is due to be taken on funding for the scheme.
The demonstration was organised in response to recommendations by the HSE ‘s Drugs Group not to fund the medicine. The protest will take place on Sunday, August 23, from 12 noon, from the Garden of Remembrance.
The recommendation, issued on August 11, concluded Skyclarys was not cost-effective for patients in Ireland because of its limited efficacy, this despite the treatment getting approval from both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
Approved
Although legally available for prescription in Ireland, the drug’s estimated annual cost of €280,000 per patient places it beyond the reach of most families without State support.
Campaigners also received a further potentially encouragement this week through correspondence from Skyclarys manufacturer, Biogen, to the Ataxia Foundation Ireland.
The letter, dated August 13 and seen by The Anglo-Celt, said its submission to the HSE followed extensive engagement, and was consistent with arrangements reached in 11 comparable European countries where Skyclarys has already been reimbursed.
The company disputed figures circulating regarding the cost to the State of reimbursing the medicine: “We do not believe the numbers quoted are reflective of the offer Biogen has submitted.”
Biogen added: “We remain committed to working collaboratively with the HSE to secure access to treatment for patients in Ireland.”
FF letter
Fianna Fáil representatives. Senator Robbie Gallagher, Senator Diarmuid Wilson and Deputy Brendan Smith were among more than 60 Fianna Fáil parliamentarians and MEPs to sign an open letter calling on the Government and HSE to reject the recommendation against reimbursement.
Minister Niamh Smyth, who was away at the time the letter was issued, also fully supports its contents, and she too is also calling on the Taoiseach and Minister for Health to secure the necessary funding for Aoife and others.
The correspondence- sent to Taoiseach Micheál Martin (FF), Tánaiste Simon Harris (FG), Minister for Health Jennifer Carroll MacNeill (FG), Minister of State Seán Canney (II) and HSE Chief Executive Anne O’Connor- argues the decision exposed wider problems within the reimbursement system, describing it as “broken” and “not fit for purpose”.
“Families living with Friedreich’s Ataxia have watched this process drag on while their condition progresses, and they now face the prospect of being denied the one treatment that could make a real difference to their lives,” the letter reads.
The signatories urged that Irish patients are not “left behind their European counterparts” and denied access to the only licensed treatment currently available for the condition.
Castleshane woman Aoife (21) is watching developments closely.
While Tuesday’s Drugs Group recommendation was a setback, it’s not the final decision.
She remains deeply frustrated by the rationale underpinning the process. Speaking after reading comments made by Minister Carroll MacNeill during a visit to Monaghan Hospital on July 23, Aoife challenged suggestions that the Skyclarys decision is being determined by scientific factors.
“I was actually really angry reading that as well, because they keep saying it is a science-led decision. That is not true. If it was science-led, it would be approved today.
“The science and research are showing Skyclarys does make a significant change in the progression of the disease.”
While acknowledging the treatment is not a cure, Aoifesaid its ability to slow disease progression could be life-changing, and believes cost remains the central issue.
“For what the drug does, they don’t think it’s worth that money. But I really don’t think you can put a price on a life.”
The young student revealed she recently ordered a wheelchair following discussions with Occupational Therapy services.
“If I can’t walk, that’s it. I’m no longer an independent person.”
She also highlighted the financial realities facing people with disabilities such making their homes more accessible or purchasing an adapted vehicle.
Aoife says she has already spent countless hours researching potential treatment pathways abroad but as yet hasn’t found a way that’s achievable.
“Even if the Government said ‘We can’t provide this medication here, but we’ll help create a pathway to access it elsewhere,’ I’d take that. But they’re closing this door and they’re not opening another one.”
The HSE’s Leadership Team will consider the matter next Tuesday, August 25.
As campaigners prepare to travel to protest, Aoife intends to keep fighting. Directing an appeal to Minister Carroll MacNeill, she said people living with Friedreich’s Ataxia have already waited too long.
“They havve been dragging
this process on for over 750 days. They’re hearing us, but they’re not listening. Time is everything.”
For Aoife, the fight is about preserving opportunities many young people take for granted: completing her education, pursuing a career and being independent.
One message remains at the heart of her campaign: “You cannot put a price on life.”