Estimation of Future Patient Populations Eligible for Radioligand Therapies in the EU and the UK: A Modelling Study.

Background: The eligible patient population for radioligand therapies (RLTs) has the potential to grow rapidly in the coming years. European healthcare systems may be ill-prepared to provide the additional treatment capacity required on top of current workload. To address this challenge, data on the size of the eligible patient pool and the potential utilisation of RLTs are needed. Methods: The maximum pool of patients theoretically eligible for RLTs over the next decade was estimated for the 27 EU member states (EU-27) using incidence data, and additionally for France, Germany, Italy, Spain (EU-4) and the UK using prevalence data. Conditions for which RLT are currently authorised, potential expansions of existing authorisations to earlier disease stages, and anticipated authorisations for products in development were analysed. Findings: Between 2025 and 2035 in the EU-27, the patient pool theoretically eligible for RLTs could increase from 11,000 to 13,000 to approximately 130,000-180,000. A scenario based on preliminary utilisation data suggests that, in the EU-4, 17,000-35,000 patients from this pool could be treated in 2030, increasing to approximately 37,000 patients by 2035. Interpretation: The expected uptake of RLTs in EU healthcare systems over the coming decade may overwhelm available treatment capacity, even in countries with well-developed nuclear medicine infrastructure. Efforts across all EU countries will be required to ensure adequate patient access to RLTs and to minimise health inequalities in cancer care. Funding: Research by WifOR was funded by Novartis Pharma AG. JRC research was covered by the European Commission's Research Framework Programmes budget.