WHO Europe sets out new principles for managed entry agreements

WHO Europe has published a new policy framework on Managed Entry Agreements (MEAs), developed through its Access to Novel Medicines Platform. The framework aims to help countries improve equitable access to high-cost, novel medicines while managing uncertainty around their clinical value, real-world performance, and financial impact. 

Managed Entry Agreements are arrangements between a medicine developer and a payer or provider that allow access, coverage, or reimbursement of a treatment under specified conditions. In practice, they are used when there is uncertainty about a medicine’s evidence base, long-term effectiveness, appropriate use, or budget impact, but where there may still be a strong case for earlier patient access. 

The new WHO framework distinguishes between two broad types of MEAs. Financial-based agreements focus mainly on managing expenditure and may include discounts, rebates, price-volume agreements, or subscription models. Outcome-based agreements link reimbursement or continued access to evidence generated after launch, such as real-world outcomes, treatment response, or additional data collected during a managed access period. 

This matters because many novel medicines now reach the market with earlier or conditional regulatory approvals, particularly in areas of high unmet need. While this can help patients access promising treatments sooner, it also means payers may face uncertainty about long-term benefits, durability of response, and real-world effectiveness. At the same time, many new therapies come with high upfront costs, making budget planning difficult for health systems. 

The framework sets out eight principles: six general principles for all MEAs and two additional principles specifically for outcome-based agreements. These include starting from transparent HTA and reimbursement processes, keeping agreements as simple as possible, matching the type of MEA to the specific uncertainty being addressed, agreeing assessment and exit terms from the outset, ensuring collaboration between relevant stakeholders, and regularly evaluating whether agreements are working as intended. 

For outcome-based agreements, WHO Europe highlights the importance of using existing data structures where possible, such as registries, ongoing trials, and national datasets, to avoid unnecessary administrative burden. It also calls for transparency around the type of agreement and the clinical outcomes being collected, while recognising the need to protect commercially sensitive information. 

The framework is practical in design. It includes an MEA complexity scale, a flow chart, and a checklist covering four phases: selection, contracting, implementation, and managed exit. These tools are intended to help countries decide when an MEA is appropriate, what type of agreement fits the uncertainty, what data need to be collected, which stakeholders should be involved, and how reassessment or exit should be handled if the evidence does not support continued reimbursement. 

The report also stresses that MEAs should not become a default workaround for difficult pricing decisions. They are most useful when uncertainty can realistically be resolved through additional evidence generation, and when the arrangement offers a net benefit to patients, payers, and the health system. This is particularly important for complex medicines, rare disease treatments, one-time therapies, and other innovations where standard reimbursement routes may struggle to account for uncertainty and long-term value.

For psychedelic therapies which are complex interventions that combine medicines with structured psychological support and other contextual factors, these principles are highly relevant. Future access discussions will depend not only on regulatory approval, but also on how health systems manage uncertainty, collect real-world evidence, and structure reimbursement in ways that support access while safeguarding sustainability. WHO Europe’s framework offers a useful reference point for these debates as Europe continues to rethink how innovative mental health treatments move from approval to real-world availability.