Access to novel cancer medicines in Europe: inequities across countries and their drivers

Abstract

<h3>Background</h3><p>An increasing number of cancer medicines are being developed and approved. Access to these medicines is important for improving patient outcomes and overall quality of care, yet achieving equitable access across countries in Europe is challenging.</p><h3>Method</h3><p>This study reviews inequities in access to novel cancer medicines in countries of the European Union (EU) and European Economic Area (EEA), and neighboring countries, at three critical stages: regulatory approval, reimbursement approval, and use in clinical practice. It also examines reasons contributing to these inequities. The analysis builds on published evidence from a predefined set of international stakeholders.</p><h3>Results</h3><p>Inequities vary across the three stages. At the regulatory stage, disparities are minimized within EU/EEA countries due to centralized approval by the European Medicines Agency (EMA), while worse access exists outside this region. Reimbursement of EMA-approved medicines varies significantly, with rates ranging from 0% in Malta to 96% in Germany, and timelines spanning <100 days to nearly 1000 days. Alternative access schemes enable (limited) access before and after regulatory and reimbursement approval, which may change conclusions about access in some countries. Clinical use exhibits a 10-fold difference across countries in some cases, with Central and Eastern Europe consistently lagging. Contributing factors include country-specific prioritization of pharmaceutical companies for regulatory and reimbursement applications, health technology assessment (HTA) processes and criteria, constraints in financial resources for medicines and testing infrastructure, suboptimal care processes, organization, and continuing medical education.</p><h3>Conclusion</h3><p>Patient access to novel medicines differs widely across European countries, caused by financial, organizational, administrative, and capacity reasons. Policy harmonization, as seen with mandatory regulatory approval by the EMA and the EU HTA Regulation, has the potential to reduce inequities, but it will not address underlying economic and health care system constraints. Achieving equity will require a balance between innovation, affordability, and sustainability in health care systems.</p>