Presentation (CTI)

OBJECTIVES: The introduction of Managed Entry Agreements (MEA) was initially welcomed by the healthcare ecosystem to enable access to promising new medicines with clinical and financial uncertainties that could be resolved by further data collection. Despite the theoretical appeal of performance-based agreements (PBA) in balancing risk, enthusiasm is declining in experienced markets. This study explores the operational barriers driving this shift, and proposes a framework for future MEA adoption.
METHODS: This qualitative study used expert elicitation and thematic synthesis. In depth, semi-structured interviews (~ 60 minutes) were conducted with 10 key stakeholders, comprising industry market access experts and representatives from national HTA bodies/payers (including NICE and CDA). Eight countries were selected to represent diverse healthcare archetypes with high MEA maturity.
RESULTS: Results pinpoint three key findings. PBAs frequently fail during execution due to overwhelming administrative burden, high transaction costs, and insufficient data infrastructure. Poor systemic interoperability and real-world data (RWD) capture consistently cause incomplete outcomes reporting. Stakeholders identified “The Exit Trap”: time-bound agreements can expire or result in a treatment being decommissioned, presenting financial risks and ethical dilemmas regarding treatment continuation. Consequently, stakeholders prefer operationally feasible, financial based agreements (e.g. price-volume caps, flat discounts).
CONCLUSIONS: Informed by this research we propose that PBAs should not be the default mechanism for facilitating access to medicines. For the best chance of success they are most suited to innovations with high clinical uncertainty and low patient volumes. Based on these findings we propose a four-step Best Practice Framework for MEA design: 1) Strategic Matching (aligning agreement complexity with disease volume and uncertainty); 2) Operational Design (favouring binary, trackable metrics over complex clinical endpoints); 3) Maturity Assessment (tailoring contract complexity to local digital infrastructure); 4) System Partnership (collaborative infrastructure co-development). Ultimately, the future of MAEs relies on context-appropriate, pragmatic design ensuring broader patient access to innovative therapies.