Presentation (CTI)

OBJECTIVES: Managed-entry agreements (MEAs) are widely used in health technology assessment (HTA) submissions to enable access while addressing payer concerns related to budget impact, uptake uncertainty, clinical and durability uncertainty, and real-world utilization beyond intended populations. While MEA concepts are well established, consolidated evidence on how different MEA types are implemented across jurisdictions, and which operational conditions most strongly influence HTA acceptability, remains limited. This study aims to characterize MEA types used across HTA submissions and identify practical implementation features determining feasibility and acceptance.
METHODS: We conducted a structured cross-jurisdictional review of publicly available HTA and payer outputs and peer-reviewed literature describing MEA use in reimbursement decisions. Jurisdictions included major European HTA systems and selected non-European markets with established MEA practice. MEAs were classified into implementation archetypes: financial agreements (discounts, rebates, price-volume agreements, expenditure caps); performance-based agreements (outcome guarantees, staged payments, managed access or coverage with evidence development); hybrid agreements combining financial and outcome-linked elements; and payment-structure variants (instalment, annuity, and milestone-based payments). For each archetype, we extracted the primary risk addressed, trigger design, data requirements, reconciliation cadence, governance arrangements, and re-opener or sunset clauses.
RESULTS: Across HTA submissions, MEAs cluster into a limited number of repeatable designs. Financial MEAs are most common when concerns focus on budget shock or rapid uptake, reflecting simplicity and low administrative burden. Performance-based MEAs are applied when uncertainty is primarily clinical or durability-related, provided measurable endpoints and feasible data collection exist. Hybrid MEAs address concurrent fiscal and clinical uncertainties but depend on robust data infrastructure and clear reconciliation rules. Payment-structure variants address affordability and expenditure timing for high up-front cost therapies.
CONCLUSIONS: MEAs function as pragmatic implementation tools aligning access with payer risk tolerance. Applying a consistent taxonomy with an operational readiness perspective may support MEA selection and improve HTA acceptability by making deliverability explicit.