Abstract
Cancer drug spending in Europe has grown at an average of 11% per year for the past decade, yet access remains highly unequal across member states. This study analyses pricing and reimbursement mechanisms across 12 EU countries, identifies the key structural drivers of inequality, and proposes a framework for more equitable access.
Background
Health technology assessment (HTA) processes vary significantly across EU member states, leading to situations where patients in some countries wait years for access to drugs already reimbursed elsewhere. The European HTA Regulation, effective from 2025, provides a partial solution — but implementation gaps remain.
Methods
We analysed reimbursement decisions for 48 oncology drugs approved by the EMA between 2018 and 2024 across 12 EU member states, supplemented by analysis of confidential pricing data obtained under freedom of information requests and through regulatory submissions.
Key findings
The median time from EMA approval to national reimbursement ranges from 147 days in Germany to over 900 days in Romania and Bulgaria. Price confidentiality agreements — used in 78% of cases — systematically disadvantage lower-income member states in negotiations. Joint clinical assessment under the new EU HTA Regulation is not, on its own, sufficient to resolve pricing inequities.
Policy recommendations
We recommend a mandatory reference pricing floor, greater transparency in managed entry agreements, and dedicated capacity support for health technology assessment bodies in lower-income member states.