OBJECTIVES: This work created a framework and tools to support decision making about managed entry agreement (MEA) strategy and design. Only scarce guidance exists in this area, and it tends to be mainly theoretical or narrowly scoped. This research aimed for an output that is 1) comprehensive and flexible enough to address a wide range of situations, 2) internally and externally valid and 3) practical and user friendly. METHODS: Initial concepts/principles were built based on literature review and own experience of MEAs, and tools were created. These were then refined and validated through multiple rounds of discussions and testing with a varied range of pharma industry stakeholders and payers from countries worldwide. RESULTS: Feedback from the stakeholders validated a suite of tools, anchored in a conceptual framework, to 1) conduct a strategic analysis and decide whether an MEA approach is needed and for what reasons, 2) what specific MEAs are most appropriate given the product situation and country (national/local) and 3) assess the financial impact of the selected MEA solutions. Main principles for MEA selection/analysis and insight from the primary research will be presented. CONCLUSIONS: Practical tools and guidance to support decision making and business cases are very much needed in the area of MEAs, and will benefit to both industry and payers.