Abstract

Objectives

This study aims to (1) identify and assess challenges experienced by reimbursement authorities adopting Managed Entry Agreements (MEAs) during Health Technology Assessment (HTA), appraisal, and reimbursement of Advanced Therapy Medicinal Products (ATMPs) in The Netherlands, Spain, and England and (2) rank the most reported adoption challenges and identify potential solutions across jurisdictions.

Methods

Between July 2023 and October 2024, semistructured interviews were conducted with current or former reimbursement authorities. Transcripts were analyzed using inductive thematic content analysis. Emerging themes were grouped into 3 steps: HTA, Appraisal and Decision Making, and Implementation. During the interviews, participants completed an embedded prioritization exercise developed based on adoption challenges identified in prior literature.

Results

From thematic analysis, 6 themes emerged: Relative Effectiveness, Cost-Effectiveness Analysis and Budget Impact, Stakeholder Involvement, Routines and Practices, MEA Design, Policy Considerations, and Moving Forward. Within HTA, participants highlighted several challenges hampering MEA adoption for ATMPs, including high upfront costs, patient response variability, long-term risks, and ethical concerns. In apprais al, ATMP negotiation dynamics were described as complex due to uncertainty, delivery, administration, and product specificities. Regarding Implementation, hybrid MEAs were seen as promising yet constrained by administrative burden, fragmented data infrastructures, and rigid accounting rules. Structural changes, early dialog, and interoperable real-world data were deemed essential. Prioritization findings confirmed qualitative insights, with administrative burden, outcome measurement, and data collection consistently ranked as key challenges in all countries.

Conclusion

Drawing on decision-makers’ experiences, this study identified cross-country challenges to adopting MEAs for ATMPs. Addressing these challenges will require regulatory reform, interoperable data infrastructure, collaborative evidence generation, and ethical oversight.