The Use of Managed Entry Agreements (MEAs) for Accessing Innovative Health Technologies

OBJECTIVES: We aimed to understand the use of MEAs in the healthcare industry, any critique on previous financial-based submissions, and investigate potential recommendations for future MEA submissions.

METHODS: EMBASE and Medline were searched from inception until 07/06/2023. Articles of interest assessed the feasibility of financial-based MEAs, the impact of successful agreements and the time taken to the final decision outcome. Additionally, we sought information on key recommendations, good practices, critiques, and potential ways to improve MEAs.

RESULTS: We identified 21 publications related to the use of financial-based MEAs. Currently, health technology assessment bodies prefer a simple arrangement or direct discounts, however these approaches might not address outcome uncertainties. The feasibility of MEAs or combination of MEAs could lead to successful and sustainable reimbursement of expensive innovative products, and many options for combining MEAs into a reimbursement mechanism exist. However, limitations were identified with these agreements, including the lack of consistent guidelines across countries for the required evidence, submission of evidence with high level of uncertainty, and lack of transparency in the review process. To tackle some of these issues, countries are developing more robust guidelines for MEAs in combination with more transparent submission processes.

CONCLUSIONS: MEAs are showing positive impact on providing access to medicines and their reimbursement. However, a strategy for guiding the use of financial-based MEAs must be defined. This will ensure that the advantage of new evidence on product performance overcomes the cost of negotiating and implementing MEAs. Furthermore, uncertainties in each coverage selection and building MEAs must be identified. This involves that data sources and study designs are suited to meet the uncertainties at hand.