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СпутникиРНSpaceXРоскосмосNASAMeeting held with representatives from Biogen, which makes drug Skyclarys
Fine Gael TDs and Senators have asked the maker of Skyclarys to consider developing a compassionate access programme for patients with Friedreich’s ataxia.
The group met with representatives from Biogen, which makes the drug, on Monday.
Last December, the National Centre for Pharmacoeconomics (NCPE) recommended that the drug not be considered for reimbursement by the Health Service Executive as it would cost about €280,000 per patient annually.
The HSE drugs group upheld the NCPE recommendation, stating there were “limitations and uncertainties associated with the available clinical efficacy data”.
In a statement after the meeting, Fine Gael parliamentary party chairman Micheál Carrigy said the group had appealed to Biogen to engage fully with the HSE on what is possible to get patients access to the drug, and also called on the company to give consideration to developing a compassionate access programme and for this to be done in advance of the next HSE senior management meeting on August 25th.
Friedreich’s ataxia causes progressive damage to the nervous system. Individuals with the condition have a shorter-than-average life expectancy. About 200 people in Ireland have the condition.
In February 2023 the drug omaveloxolone, branded as Skyclarys, was approved in the United States for the treatment of the disease. Europe followed suit 12 months later. Skyclarys is not a cure, but patients and advocates say it has the ability to slow the progression of the condition by up to 55 per cent.
The decision not to greenlight the drug has led to significant pressure on the Coalition from backbenchers and the Opposition.
Sinn Féin leader Mary Lou McDonald has written to Taoiseach Micheál Martin asking him to intervene, while a majority of Fianna Fáil’s parliamentary party called on the HSE to reconsider its refusal to fund the drug.
Along with Longford-Westmeath TD Carrigy, TDs Catherine Callaghan, Seán Kyne, David Maxwell, Noel McCarthy, John Paul O’Shea and Senator Noel O’Donovan met the company’s representatives.
In a statement released afterwards, they said: “We are committed to continuing to represent them to all stakeholders and today’s meeting with Biogen will, we hope, assist progress between the company and the HSE.
“We understand there is a statutory process under way and we also understand that other EU countries, like Belgium, Sweden and the Netherlands have publicly acknowledged real challenges with the efficacy and impact of this drug and its very high price, while other countries have approved it.”