OECD Makes Recommendations for Improvement of Performance-Based Managed Entry Agreements for Medicines
The Organisation for Economic Co-operation and Development (“OECD”) published a health working paper (the “Paper”) authored by Martin Wenzl and Suzannah Chapman that offers recommendations for the use of performance-based managed entry agreements in OECD countries and EU Member States (see, attached).
The Paper reflects the results of a review of managed entry agreements (“MEAs”) carried out in 2018 and 2019. MEAs are arrangements between healthcare payers and pharmaceutical firms that provide for the reimbursement of generally new health technologies, including medicines, while controlling the financial impact of that reimbursement and keeping price concessions confidential. These financial agreements are thus tools for achieving patient access to medicines while managing uncertainty.
A further group of MEA’s, far less common than these purely financial agreements, are performance-based contracts. Both financial MEA’s and performance-based MEA’s can be assessed either at the level of individual patients or at that of a given population.
The Paper indicates that the experience with performance-based MEA’s is both limited and mixed. This is in large part due to the dearth of available information as few countries have formally assessed their experience with performance-based MEA’s. The Paper therefore relies on limited public sources and a number of expert interviews. Only Belgium and Sweden had independent evaluations conducted by third parties. The tentative conclusion of the Paper is that performance-based MEA’s have made only a limited contribution towards reducing uncertainty regarding product performance.
This is why the Paper makes recommendations for good practices that make it more likely for performance-based MEA’s to reach their objectives. These are:
- to use performance-based MEA’s strategically and in the wider context of information derived from the use of other instruments such as horizon-scanning;
- to identify uncertainties and design the performance-based MEA’s to address such uncertainties;
- to create a governance framework that ensures transparency of process and guarantees that results are actually acted upon;
- to ensure an appropriate level of transparency of content, even though some parts of the MEA’s, such as prices, may have to remain confidential.
The Paper points out that countries could benefit from sharing information but very little information is at present published or shared. Still, the Paper cites approvingly a number of collaborative initiatives of the European Medicines Agency such as the EU-wide framework on patient registries or the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.