Mary Butler (Waterford, Fianna Fail) | Oireachtas source

I thank Deputy Flaherty for raising this issue and for his comprehensive explanation. It is not a condition I am overly familiar with. I will first provide some background for our colleagues and then address his question. This medicine is used to treat polyneuropathy - nerve damage - caused by hATTR. The European Medicines Agency, EMA, granted marketing authorisation for this product in September 2022. As hATTR amyloidosis is a rare disease, the EMA has also designated this an orphan medicine. The company marketing this medicine made an application for addition to the HSE’s reimbursement list in July 2023.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics. There are formal processes, which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines to be funded or reimbursed. In August 2023 the NCPE completed a rapid review of vutrisiran. Factors evaluated during rapid review include the cost of the drug relative to potential comparators, uncertainty relating to comparative clinical effectiveness, uncertainty relating to cost effectiveness and the potential drug budget impact. On this occasion, the NCPE did not recommend a full health technology assessment. Their recommendation was that this medicine not be considered for reimbursement at the price proposed by the company marketing it.

The NCPE’s recommendation is importantly only one component considered by the HSE in making a decision on the reimbursement of a medicine. The Health (Pricing and Supply of Medical Goods) Act 2013 requires that nine criteria be considered in reaching a decision. These include the health needs of the public and the clinical need for the medicine. Following engagement with the manufacturer of this drug, the HSE has decided to approve reimbursement subject to a managed access protocol. These protocols identify patients who would most benefit from the specific treatment being reimbursed. The processes necessary to implement this are currently being developed by the HSE. I reiterate that the HSE has decided to approve reimbursement subject to a managed access protocol.

The State acknowledges the importance of access to medicines and has made considerable investments in new medicines in recent years. Last year, a record of more than €3 billion of public funding was spent on medicines for patients in Ireland. This represents almost €1 of almost every €8 spent by the State on healthcare. This level of investment is unprecedented in supporting patients through the availability of the latest and wide-ranging medicines. The last three budgets have included dedicated funding for new medicines of €98 million. This has enabled the HSE to approve reimbursement for almost 150 medicines, including 61 for treating cancer and 39 for treating rare diseases. For 2024, funding of €20 million has been allocated to enable access to new medicines. The HSE has, in addition, been instructed to identify and realise a further €10 million of efficiencies. When achieved, reinvestment in new drugs will be a possibility. I am delighted that the Deputy will be able to go back and tell his constituent that the HSE has decided to approve the drug for reimbursement.

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