Exploring Managed Entry Agreements: A Scoping Review of Approaches, Considerations, and Country-Specific Approaches

OBJECTIVES: Managed entry agreements (MEAs) are reimbursement agreements between payers and health technology developers that facilitate market access while managing costs and uncertainties. MEAs can be financial (FA), focusing on costs, or outcome-based (OA), with reimbursement tied to treatment performance. This study aims to map the types, pros, cons, and applications of MEAs across the European Economic Area (EEA).

METHODS: A scoping review of English-language scientific publications from 2013 to September 2023 was conducted. Databases searched included MedLine, Embase, and Web of Science Core Collection.

RESULTS: Out of 7,777 records identified, 92 publications were included. Six types of MEAs were identified: three for FA (discounts and rebates, volume or expenditure caps, and price-volume agreements) and three for OA (coverage with evidence development, pay-by-result, and conditional treatment continuation). FAs offer simplicity and predictability. OAs link value to reimbursement and address clinical uncertainties but encounter difficulties in implementation and monitoring due to the lengthy, expensive, and complicated processes. MEAs are utilized in 24 EEA countries, with both OAs and FAs reported in 80% of these countries, albeit with variability in implementation. Problems with MEA implementation were described in Central and Eastern European countries, which are hindered by weak negotiation power and immature HTA systems. Italy and Spain have more experience with MEAs, particularly OAs, which are supported by specific patient registry systems, though the described difficulties persist.

CONCLUSIONS: This research demonstrates the wide adoption of MEAs across the EEA but highlights difficulties in adopting OAs, even in countries with established systems. Until reliable outcomes data can be extracted from routinely used sources, the decision to implement OAs remains a delicate trade-off between transaction costs and the desire for more evidence on effectiveness. Addressing these challenges requires standardizing methods and frameworks for MEAs in general, with a further focus on the design, implementation, and assessment of OAs.