Background
Access to new cancer medicines across Europe depends on both European and national decision-making systems. While the EMA grants marketing authorisation, reimbursement in Ireland follows national HTA through the NCPE and subsequent review by the Department of Health and the HSE. Ultimately, companies decide whether and when to launch medicines, influenced by market size and wider considerations such as pricing frameworks. The EFPIA Patients W.A.I.T Indicator provides valuable access benchmarking on the time between EMA approval and reimbursement, but it does not capture when drugs actually enter national HTA systems or whether they are launched at all. Understanding these interlinked European and national processes is essential to inform Ireland’s readiness for implementation of the EU Health Technology Assessment Regulation (HTAR) and to support evidence-based policy on equitable access.
Aim and hypothesis
This project aims to investigate inequities in access to cancer medicines in Ireland by analysing the interval between EMA approval, HTA submission and reimbursement decisions. It is hypothesised that variation in submission timing, launch decisions and national policy factors contributes to delays and differences in drug access across cancer types.
Objectives
Identify oncology medicines approved by the EMA (2015–2025).
Record HTA submission, recommendation and reimbursement dates in Ireland.
Compare timelines across cancer types, with particular focus on lung cancer.
Explore how European and national policies, including the new EU HTAR and its Joint Clinical Assessment (JCA), may influence access.
Assess how data-infrastructure gaps, such as the absence of molecular-level data in NCRI datasets, limit understanding of equity.
Expected outcomes
By integrating European and national perspectives, the project will establish where delays occur in Ireland’s access pathway, how these compare with European patterns, and how data limitations affect interpretation. Expected outputs include descriptive analyses, policy interpretation and visual materials for patients and stakeholders.