The impacts of pricing and reimbursement policies on access to cell and gene therapies across Europe.

The increasing number of expensive cell- and gene-based therapies (CGT) on the market have raised concerns regarding equal patient access, regarding both affordability and timely access. Health Technology Assessments (HTA) and Managed Entry Agreements (MEA) play a pivotal role in pricing and reimbursement (P&R) decisions for expensive drugs in Europe, aiming to ensure patient access while optimizing resource allocation. However, discrepancies in HTA and P&R processes lead to delayed, unequal or lack of access in different countries, exacerbating health inequalities across Europe. Though they facilitate access, MEAs introduce additional delays in pricing and reimbursement discussions, and their lack of transparency increases administrative burden and encourages pricing inequity, negatively affecting healthcare system sustainability. Recent legislative changes under Regulation (EU) 2021/2282 have established the Health Technology Assessment Coordination Group (HTACG), which will oversee mandatory joint clinical assessments in the coming years. This new legislation aims to streamline HTA processes across the EU. To address the ethical imperative of improving access equality for CGT in Europe, we propose further policy reforms including concurrent HTA, early benefit assessment, and incorporation of additional elements of value in HTA evaluations, alongside current initiatives to increase cross-border collaboration.