The Health Service Executive approved the reimbursement of the drug, Skyclarys, on
Tuesday 26 August 2026. This represents a reversal of the HSE Drugs Group initial
recommendation on 14 August, against the drug’s reimbursement.
Skyclarys is the first drug available for the treatment of Friedreich’s Ataxia – a rare
genetic condition which causes progressive damage to the nervous system, affecting
mobility, balance and coordination. Reimbursement of Skyclarys for approximately 200
people living with FA in Ireland will now be publicly funded. The total annual cost has
not yet been disclosed.
Though Skyclarys is not a cure for Friedreich’s Ataxia, it has been shown to slow down
the progression of the disease and has been approved for use in the EU since 2024.
Initial talks between the HSE and Skyclarys producer Biogen failed, with the Drugs
Group referencing the high cost and limited efficacy of Skyclarys as its reasons for
recommending against reimbursement. This considered the assessment carried out by
the National Centre of Pharmacoeconomics in December which also recommended
against reimbursement, highlighting uncertainty regarding the clinical effectiveness of
Skyclarys in FA therapeutics.
Public outcry followed the recommendation, which culminated in the HSE Senior
Management Team (SMT) re-entering talks with Biogen, emerging with what they
described as “a very different commercial offering to that which the HSE Drugs Group
considered”. Based on this improved offer, the SMT decided to approve reimbursement
of Skyclarys.
While the reversal of the initial decision was welcomed by campaigners, the delayed
decision has raised many questions regarding the evaluation process of such
reimbursement applications. Many are now calling for a re-evaluation of this process.
Speaking to RTE News, chief clinical officer with the HSE Colm Henry said that without
the second round of negotiations, the HSE would have been “significantly
disadvantaged financially, with less money to spend throughout the rest of the service”.
Labour’s health spokesperson Marie Sherlock felt that this leads to “a bigger question
about how Ireland negotiates with pharmaceutical manufacturers on high-cost
medicines”. She called for greater cooperation at an EU level with regards to prices and
access, and hoped that August’s decision could be “a catalyst for a better approach”.
The HSE and the Irish government are now under scrutiny for the length of time it will
take to procure and provide the treatment. Irish patients and their families have been
waiting over two years for access to Skyclarys – time those living with Friedreich’s Ataxia
don’t have.
The HSE has said it is working to have reimbursement for Skyclarys rolled out by 1
October. It remains to be seen if this tight deadline will be met.
