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The HSE has decided to provide the Skyclarys drug to those suffering from Friedreich's ataxia, a disease that causes progressive damage to the nervous system. The drug is the first treatment available which can slow the progress of the disease. The decision was reached after a substantial reduction in the asking price from drug company Biogen.
The decision by the HSE to provide the Skyclarys drug to those suffering from Friedreich's ataxia has been welcomed by everyone. The disease causes progressive damage to the nervous system and the drug is the first treatment available which can slow its progress.
The HSE had looked likely to refuse to reimburse the drug on the basis of the previous offer from the company, leading to protests and a major rally. The process underlines the difficulty in making decisions on the availability of drugs, particularly for those with rare diseases and conditions where costs tend to be much higher. The National Centre for Pharmacoeconomics is charged with the task of advising the HSE, based on a clinical and cost assessment.
The independence of this process must be protected. The Skyclarys saga also showed that change is needed in the negotiation and approval process. The drug was approved for use in Europe in 2024 and it has taken two years for it to become available here. There are questions here for the State, but also for Biogen, in relation to the drawn-out negotiations.
The pharmaceutical companies claim they are pricing drugs based on the enormous cost of developing them. However, HSE chief clinical officer Colm Henry told RTÉ that negotiations had led to a reduction in the cost of 26 drugs approved this year from €900 million over the next five years to €112 million. This raises serious questions about the basis of the initial amounts demanded by the companies - and about the whole negotiation process.
The Government and the drug companies have signed a new framework agreement this year on drug provision, which is welcome. However, its target of achieving the statutory target of making reimbursement decisions within 180 days by the first quarter of 2029 seems remarkably lacking in ambition. A consultancy study of the process is being commissioned by Government and this must aim for a system offering speed and clarity.
Not every drug can be approved, but patients deserve a transparent process that seeks, where possible, to deliver new therapies as quickly as possible
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Campaigners Push for Reimbursement of Skyclarys, a Drug for Rare ConditionCampaigners and patients marched through Dublin city centre to push for the reimbursement of Skyclarys, a drug used to treat Friedreich's Ataxia, a rare and progressive neuromuscular condition.
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