What can England, the Netherlands and Spain teach us about adopting MEAs for ATMPs?

ATMPs offer promising new treatment options for patients with high unmet medical needs. Yet, despite their transformative potential, reimbursement remains challenging due to high upfront costs, uncertain long-term outcomes, administrative complexity, and implementation barriers.

To better understand these challenges and potential solutions, the study conducted semi-structured interviews with decision-makers directly involved in HTA, reimbursement, and MEA implementation across the three countries.

What did the study find?

Across jurisdictions, administrative burden, outcome measurement, and data collection consistently emerged as the most pressing challenges for MEA adoption.

Decision-makers highlighted that successful implementation requires more than innovative reimbursement contracts alone. Earlier evidence alignment, interoperable real-world data infrastructure, collaborative evidence generation, and healthcare system readiness were repeatedly identified as critical factors.

The study also showed that challenges and solutions are often context-dependent, shaped by differences in HTA systems, governance structures, funding pathways, and national policy frameworks.

Why does this matter?

MEAs are increasingly considered as a way to facilitate patient access to ATMPs while managing uncertainty and financial risk. However, the findings suggest that their success depends heavily on whether healthcare systems are prepared to operationalize them in practice.

Key message

To make MEAs work for ATMPs, coordinated action is needed across developers, HTA bodies, payers, clinicians, and policymakers. Strengthening data infrastructure, enabling earlier dialogue, and improving policy coordination will be essential to support sustainable access to innovative therapies.