3920. Deputy Pádraig O'Sullivan asked the Minister for Health the steps her Department has taken to give effect to Ireland's obligations under Regulation (EU) 2021/2282 on health technology assessment, including the obligation to give due consideration to Joint Clinical Assessment reports in national health technology assessments; the reason no guidance has been issued to marketing authorisation holders on how Joint Clinical Assessments will be considered in the reimbursement process (details supplied) ; whether she will direct that such guidance be published, setting out the process, timelines and the manner in which Joint Clinical Assessment reports will be factored into reimbursement recommendations by the National Centre for Pharmacoeconomics and the Health Service Executive; and if she will make a statement on the matter. [58155/26]

3921. Deputy Pádraig O'Sullivan asked the Minister for Health the arrangements her Department has put in place to implement Regulation (EU) 2021/2282 on health technology assessment, which has applied to new oncology medicines and advanced therapy medicinal products since January 2025; the body designated to represent Ireland on the Member State Coordination Group on Health Technology Assessment; the additional resources provided to the National Centre for Pharmacoeconomics and the Health Service Executive for this purpose; the number of Joint Clinical Assessment reports given consideration in Irish reimbursement evaluations to date; and if she will make a statement on the matter. [58156/26]

I propose to take Questions Nos. 3920 and 3921 together.

The National Centre for Pharmacoeconomics (NCPE) was established in 1998 with the aim of promoting expertise in Ireland for the advancement of the discipline of pharmacoeconomics through practice, research and education. The NCPE is an independent Health Technology Assessment (HTA) Agency responsible for evaluating drug treatments for use in the Irish healthcare setting. The NCPE conducts the HTA of drugs for the health service in Ireland in collaboration with the Health Service Executive's Corporate Pharmaceutical Unit. They assess comparative clinical effectiveness and cost-effectiveness of drugs compared to current standard of care, as well as the budget impact.

The NCPE is playing a leading role in international initiatives such as the European HTA Regulation. The Regulation on HTA entered into force in January 2022 and became fully applicable in January 2025. Its purpose is to strengthen the quality of HTA in the European Union and ensure efficiency in the evaluation of new medicines and technologies in a consistent way across member states.

The Regulation on HTA establishes a framework for conducting Joint Clinical Assessments (JCA) at EU level. These assessments support member states in their national HTA processes, providing a scientific analysis of clinical evidence regarding a health technology. The NCPE are committed to ensuring that JCAs are incorporated into their national HTA evaluation processes.

The Chair of the Member-State-led EU HTA Coordination Group (HTA CG) is Dr Rosin Adams (NCPE). Also, members of the NCPE represent Ireland (for Medicinal Products) in the HTA CG and in all of the HTA CG subgroups. The NCPE were lead assessors in the first ever JCA, have now completed two JCAs and are assessors in two further on-going JCAs. The NCPE will continue to lead future JCAs. The NCPE are therefore well placed to ensure that JCAs are incorporated into their national HTA Evaluation processes.

The NCPE have already built the JCA (which is an assessment of comparative effectiveness metrics and any associated uncertainties) into their national process via a completed rapid review assessment. The NCPE has been able to do this as the health technology developer (HTD) (i.e. the pharmaceutical company) have made a timely application for reimbursement. To date four JCAs have been completed at the EU level and of these one application has been submitted by one HTD.

The EU HTAR 2021/2282 will operate in a phased manner starting with oncology and ATMPs. Given the early phase of the regulation it is important for future guidance to encompass all learnings from these initial phases. The NCPE are in the process of developing guidance for HTDs and aims to have this published in the coming months. However, the NCPE continue to ensure that the JCA reports are utilised as the core comparative effectiveness assessment for the work of the NCPE. The NCPE provide advice on an individual basis to HTDs who are submitting products which have undergone a JCA.

The NCPE's commitment to ensuring that JCAs are incorporated into their national HTA Evaluation processes is dependent largely on the timely engagement of HTDs with the national process. The NCPE encourage HTDs to engage with the national processes when a JCA (of their medicinal product) is on-going or has recently been completed. A delay in national engagement may result in the clinical evidence, evaluated within the JCA, to become superseded by further evidence. In which case, it will be necessary for this further evidence to be submitted, by the HTD, to the NCPE for evaluation. Any time savings in national processes, associated with the availability of a JCA, would then be negatively impacted.