THIS Saturday marks a full year of HSE “delays and dithering” since a revolutionary drug’s approval – but Donegal children are still waiting for treatment, it is claimed.
Boys like nine-year-old Aaron Langan, from Laghey, and young Ballybofey brothers Diarmuid and Nathan O’Sullivan all have severe, genetic disease Duchenne muscular dystrophy (DMD).
It is a heartbreaking, incurable condition that can lead to scoliosis and causes muscles, including the heart, to slowly stop working.
Miracle drug Givinostat was approved by the European Medicines Agency (EMA) last June – but it has not been rolled out by the HSE amid a cost-benefit analysis review.
Donegal Deputy Pearse Doherty this week accused the Government of “delays and dithering”.
He said in the Dail: “Givinostat was approved one year ago next Saturday.
“Aaron was walking around when that was happening. Today, he is in a wheelchair.
“Without access to that drug, people such as Aaron and the 150 others will not have quality of life.
“I am asking the Minister to deal with the cost of disability with no more delays in terms of euro and access to crucial medication.”
He added: “The cost is not just measured in euro and cent. It is also measured in the delays and dithering.”
Pearse Doherty speaking previously in the Dáil. Image: Oireachtas TV
Nathan was on a trial for Givinostat in Britain for the rare terminal illness and is now able to live a fulfilling life.
But younger brother Diarmuid (10) is not able to have this drug until it is provided by the HSE
Deputy Doherty said on Tuesday past: “I am thinking clearly of two young children, and they are two of 150, in my constituency of Donegal, namely, young Aaron Langan from Laghy and young Diarmuid O’Sullivan from the Finn Valley.
“I had the pleasure of spending Sunday with young Aaron. He has Duchenne muscular dystrophy (DMD).
“He was here last year, demanding that the Government allow him access to a drug that was approved by the European Commission.”
Aaron and Diarmuid’s families fears they could miss out because the HSE remains locked in commercial negotiations with the drug’s manufacturer about cost of the drug.
Givinostat is only licensed for those who are able to walk.
Aaron Langan, form Laghey, has Duchenne muscular dystrophy (DMD).
Aaron’s case was highlighted at a meeting of the Regional Health Forum West on Tuesday past.
Cllr Michael Naughton asked the HSE to confirm when Givinostat will be approved and made available in Ireland.
A HSE spokesperson responded that the service is “committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available to it”.
He stated the HSE has received an application for the pricing and reimbursement of the drug from a company called Italfarmaco Pharma.
The spokesperson added: “The application remains under consideration by the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.”
Aaron’s dad Dermot told the Donegal News: “We feel let down by the Government and the HSE. We do not have time.
“We went to Leinster House last summer and we were told, ‘Leave it with us’. They said they’d help.
“We wish we didn’t leave it with them. Aaron was still able to walk at the time. He’s now in a wheelchair.”
There are 150 children in Ireland with Duchenne muscular dystrophy (DMD).
When the EMA ruled that Givinostat is a treatment for children who are at least six years old, a parents’ group protested outside the Dail to demand that the HSE cover the cost of the miracle drug.
Figures have put the cost of Givinostat at between €92,000 and €348,000 per child, depending on the patient’s weight.
A health report the estimated that costs of the drug for the HSE could run to between €26m and €58m over five years.