Overcoming Challenges in Managed Entry Agreements for ATMPs
Decision-makers in England, the Netherlands, and Spain consistently identify administrative burden, outcome measurement, and data collection as the foremost obstacles to adopting managed entry agreements ATMPs. These challenges emerge most acutely when hybrid or outcome-based agreements are considered, because such schemes require ongoing verification of clinical performance after a one-time administration. Greco et al. (2026) document that participants across all three jurisdictions ranked these three issues at the top of a structured prioritization exercise, confirming qualitative themes derived from semi-structured interviews conducted between July 2023 and October 2024.
Administrative and Data Barriers in Practice
Thematic analysis organized around the reimbursement pathway—HTA, appraisal and decision-making, and implementation—reveals why administrative and data-related hurdles constrain hybrid managed entry agreements ATMPs in particular. Coordination and documentation costs arise from the need to track patients across multiple providers and time points, while opportunity costs divert scarce HTA and registry staff from other priorities. Fragmented registries, manual oversight requirements, and lack of interoperability between systems compound these difficulties, especially when payments must be adjusted on the basis of long-term outcomes.
Country-specific insights illustrate the shared nature of the problem. In England, all interviewed experts placed administrative burden first, citing coordination across NHS entities and the difficulty of aligning funding flows with MEA timelines. Dutch participants emphasized unclear rebates and limited contractual transparency alongside workload concerns for slower-progressing diseases. Spanish experts highlighted regional disparities in data infrastructure that hinder cohesive national implementation. Despite these nuances, the prioritization exercise showed that administrative burden, outcome measurement, and data collection remained the only challenges ranked among the top three in every jurisdiction.
Targeted Solutions from Field Experts
Participants proposed concrete, context-sensitive solutions that directly address the ranked challenges. Limiting data collection to essential endpoints routinely captured in clinical care was repeatedly advocated to reduce documentation load without sacrificing decision-relevant information. Dedicated registry personnel were viewed as necessary to ensure consistent and accurate reporting, while digital automation tools were suggested to minimize manual data entry across fragmented systems. Shifting planning from individual therapies to disease-level frameworks was proposed to improve outcome comparability and avoid duplicative data collection. Finally, improving cross-jurisdictional interoperability was seen as essential for enabling pooled analyses and reducing redundant evidence generation.
These recommendations were grounded in practical experience. English participants stressed the value of quantifying opportunity costs to inform resource allocation and called for alignment of treasury rules with implementation timelines. Dutch experts recommended early clinician engagement to identify trackable prognostic outcomes and cautioned against scaling local research-assistant models nationally without sustainable funding. Spanish participants advocated investment in interoperable digital systems and openness to automation that could harmonize records across regions and with European standards.
Policy Pathways for Sustainable Value-Based Access
The findings carry direct implications for health economics and outcomes research, market access, pricing, and reimbursement. Administrative and data burdens inflate the transaction costs of outcome-based schemes, making simple discounts the default despite growing interest in hybrid arrangements that could better align payment with value. Without regulatory reform to accommodate spread payments and interoperable real-world data infrastructure, payers will continue to favor financially based agreements that do not fully address uncertainty about durability and heterogeneity of effect. Earlier evidence alignment between developers and HTA bodies—ideally before marketing authorization—emerges as a prerequisite for feasible MEA design. Coordinated action at national and international levels, including potential joint negotiations and shared ATMP funds, could mitigate regional disparities while preserving incentives for smaller and academic developers.
