Skyclarys maker disputes figures cited in HSE decision not to fund the drug 

In a letter seen by the Irish Examiner, Biogen UK and Ireland head of medical affairs Samantha Dixon wrote: 'We do not believe the numbers quoted [by the HSE] are reflective of the offer Biogen has submitted.' File picture: Steven Senne/AP

The maker of the Friedreich’s ataxia drug Skyclarys have disputed figures cited by the HSE for the public reimbursement of the drug, as a crunch decision on the drug’s availability looms.

In a letter seen by the Irish Examiner, biotech firm Biogen’s UK and Ireland head of medical affairs, Samantha Dixon, said it “does not recognise the current figures that are being reported on the budget impact of the medicine."

“We do not believe the numbers quoted [by the HSE] are reflective of the offer Biogen has submitted," Dr Dixon wrote.

Skyclarys’ availability in Ireland for the roughly 200 patients who suffer from Friedreich's ataxia has hinged on concerns over cost and efficacy.

On August 11, the HSE drugs group did not recommend the drug for reimbursement, largely based on a review by the National Centre for Pharmacoeconomics (NCPE).

The HSE drugs group said the cited figure of €280,000 per year per patient, which Biogen now disputes, raised concerns about “cost-effectiveness". 

The group also referenced “limitations and uncertainties associated with the available clinical efficacy data”. 

The drug is designed to slow down the progressive degeneration that occurs with Friedreich’s ataxia, where patients are typically bound to a terminal life sentence as their nervous systems slowly deteriorate.

Barry Rice with his wife Claire and daughters Isabelle and Ellen. He was diagnosed with Friedrich's Ataxia 13 years ago. See link above to: ‘Money can’t come into it’: Patients plead for access to life-changing Friedrich’s ataxia drug

Skyclarys was approved by the European Commission in February 2024, and is now available in 11 European countries according to Biogen.

Biogen said that the availability of the drug “shows that a sustainable approach to access the medicine is possible in Ireland.” 

 According to Friedrich’s Ataxia Research Ireland, Germany initially paid €327,000 per person per year for the medication in 2024. All negotiations in Germany and in other countries are now confidential.

The HSE said it was prioritising private communications with Biogen.

"The HSE’s priority is to explore directly with Biogen whether there is any possibility of an enhanced offering emerging from Biogen as opposed to responding to communications in the media," said a spokesperson for the service.

"Biogen placed commercial confidentiality limitations on the HSE in relation to any offer that Biogen made in advance of the HSE drugs group. The HSE has sought to respect the same and has not discussed in public the details of any offer made, nor will we before this process has been completed."

Demonstrations and vigils planned 

A series of vigils, meetings, and demonstrations is set to be held in the lead-up to the HSE senior management’s decision on whether to legalise the drug on Tuesday, August 25.

On Thursday, Independent Ireland TD for Cork South-West Michael Collins will be convening a meeting between Friedreich’s ataxia campaigners in Dublin and has invited representatives from Biogen and the HSE, following a vigil for 26-year-old Emma O’Shea in West Cork last night.

Ms O’Shea was first diagnosed with the condition when she was nine but was only informed of her condition three years later, when she was forced to undergo spinal surgery due to her condition.

In 2016, she watched her older brother Timmy pass away at 29 from the same condition.

“When my brother passed away, it was hard watching him because he was suffering, and I was fully aware that this was my future,” she told the Irish Examiner.

She said the decision from the HSE drugs group was “incredibly difficult” and has dampened hopes for a positive decision on August 25.

“We have a disease, a condition that none of us asked for, none of us were aware that we had this kind of thing over our bodies, and it's incredibly hard to be told that we're not worth the money.

“We may be physically different, but at the end of the day we're all still humans.”

Craig Coady speaking with Deirdre O’Shaughnessy for a podcast in June. A vigil of solidarity with the Coady family will take place on Friday in Cork. Picture: Chani Anderson

Another vigil of solidarity will be held for the Coady family on Friday evening in Ballinlough Park in Cork City. 

Craig Coady lost his youngest son Rory (13) to Friedreich’s ataxia while his eldest son Paudie (16) also bears the condition.

Mr Coady recently told the Irish Examiner the HSE drugs group decision was “the worst day since the passing of Rory".

A national protest is set to be held in Dublin on Sunday, organised by Ataxia Foundation Ireland and AccessForAllIreland. Protestors will meet at the Garden of Remembrance before marching towards the Custom House Quay.