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.
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."
