MEA Adoption Challenges in Advanced Therapy Medicinal Products: Insights and Implications

MEA Adoption Challenges continue to limit the practical use of Managed Entry Agreements for Advanced Therapy Medicinal Products across Europe. The 2026 pre-proof paper by Greco et al. draws on interviews with HTA bodies and payers in England, the Netherlands, and Spain to show that hybrid agreements—blending financial and outcome-based elements—can address uncertainty around high-cost, one-time therapies such as CAR-T treatments, yet remain hampered by administrative complexity, incompatible data systems, and inflexible treasury rules.

Structural Barriers Limit Payment Flexibility

Hybrid arrangements offer a route to managing variable outcomes and long-term risks, but country-specific constraints reduce their appeal. England’s treasury regulations block deferred payments, while Spain imposes full VAT on the first installment of any spread-payment scheme. The Netherlands has no dedicated ATMP fund, compelling case-by-case negotiations once budget-impact thresholds are crossed. Across all three jurisdictions, administrative burden, outcome tracking, and data collection emerged as the highest-ranked obstacles, which explains why simple discounts still dominate negotiations.

HTA Experts Highlight Data and Governance Gaps

Semi-structured interviews conducted between July 2023 and October 2024 with representatives from NHS England, NICE, Zorginstituut Nederland, and Spanish health authorities revealed recurring difficulties in relative-effectiveness assessment, liability for post-administration events, and the absence of interoperable registries. Decentralized governance in Spain further fragments data collection, while smaller and academic developers struggle to meet evidence requirements early enough to influence appraisal. Thematic saturation confirmed that these systemic factors outweigh product-specific characteristics in shaping feasible MEA designs.

Targeted Reforms to Ease MEA Adoption Challenges

Regulatory updates to permit spread payments, creation of joint ATMP funds, and earlier dialogue between developers and HTA bodies—ideally 18 months before CHMP recommendation—would reduce friction and regional disparities. Standardized consent processes and interoperable real-world data infrastructure could simultaneously lighten patient burden and strengthen outcome tracking. These steps, drawn directly from Greco et al., provide health systems with concrete levers to improve MEA feasibility while preserving fiscal and ethical standards.