Kieran O'Donnell (Limerick City, Fine Gael)

I thank the Deputy for raising this issue, which I am taking on behalf of the Minister for Health, Deputy Carroll MacNeill. I will provide some background and then address the Deputy's question.

Fezolinetant, marketed under the trade name Veoza by Astellas Pharma is a medicine used to treat moderate to severe vasomotor symptoms such as hot flushes and night sweats associated with menopause. The European Medicines Agency granted marketing authorisation for this product in December 2023. The company marketing this medicine made an application for addition to the HSE reimbursement list in February 2024. 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, NCPE. Formal processes govern applications for the pricing and reimbursement of medicines and new uses of existing medicines to be funded or reimbursed, or both. In March 2024, the NCPE completed a rapid review of Veoza. Factors that are evaluated during rapid review include the cost of the drug relative to potential comparators, uncertainty in comparative clinical effectiveness, uncertainty in cost effectiveness and the potential drug budget impact. On this occasion, the NCPE recommended a full health technology assessment, HTA, of Veoza to assess its clinical effectiveness and cost effectiveness compared with the current standard of care. Subsequently, the HSE commissioned a full HTA and a pre-submission consultation took place between the NCPE and the company in April 2024. The next step in the agreed process is for the applicant to submit a full HTA dossier to the NCPE. To date, a full HTA dossier has not been received by the NCPE. Given the substantial budgetary impact of the funds sought by the applicant, the company must engage with the pricing and reimbursement process in order for the application to progress.

The State acknowledges the importance of access to medicines and has made considerable investments in new medicines in recent years. A record of more than €3 billion, almost €1 in every €8 of public funding spent on health in 2023 was spent on medicines. This is an unprecedented level of investment in supporting patients through the availability of the latest and wide range of medicines. Between budget 2021 and budget 2024, an additional €128 million was allocated for new medicines, which facilitated the introduction of 194 new drugs for reimbursement by the HSE, including 74 for treating cancer and 46 for treating rare diseases. For 2025, funding of €30 million has been allocated to enable access to new medicines. This will come directly from efficiencies to be achieved by the HSE. Throughout this year and over the coming years, we will continue to focus on investment in medicines including through the maximisation of the considerable budget available, to ensure patients can access medicines in as timely a way as possible.

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