Enablers of decision making in an adaptive environment: managing uncertainties and disengagement (D3.03)

This report identified that the terminology surrounding disengagement from MAPPs needs further clarification as interchangeable terminology such as, ‘exit strategy’, ‘withdrawal’, or ‘disinvestment’ holds different meanings and different implications to different stakeholders. Flexibility remains important and it is not possible or even desirable to map all the potential scenarios under MAPPs where disengagement may occur. Many will be specific to a product or a therapeutic area. This report has sought to consolidate an understanding, but not seek consensus, across various ADAPT SMART deliverables on the rationale why disengagement from MAPPs might occur, how it may impact stakeholders and where gaps exists for stakeholders. Two important gaps were identified; i) the lack of established best practices to manage price adjustments based on the level of evidence (mainly for pricing and reimbursement authorities) and ii) despite the fact that there is no MAPPs designation, the lack of an established process of how to concretely disengage and how to effectively manage the impact such decision has on other stakeholders. The later could be specified in an overarching agreement that would accompany the development process and covers topics such as the binding or non-binding nature of dialogues, stakeholder duties and expectations, a mechanism for conflict resolution or arbitration, and best communication practices. This report provides a summary of discussions around these topics to stimulate further exploration as the MAPPs concept matures.