Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?

Abstract

Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life-span. These considerations are of relevance for regulatory and access pathways that strive to address the "evidence vs. access" conundrum.

Figure 1

Building blocks of MAPPs. HTA, Health Technology Assessment; P&R, Pricing and Reimbursement; RCT, Randomized Clinical Trial. Republished with permission from www.adaptsmart.eu.

Figure 2

Proposal for the core multistakeholder engagement and assessment moments enabling an adaptive pathway. Within the diagram, each product life‐span phase is symbolized by a blue cog. The separate cogs are comparatively sized to represent the characteristic duration of the phase during the lifespan of a typical medicine. The top half of the figure includes the assessment or decision moments by the stakeholder represented. Although these moments may be informed by multistakeholder inputs, in the end the designated stakeholder makes an assessment and ultimate decision based on their respective remits. Within the bottom portion of the diagram, moments of multistakeholder engagement are illustrated. Each “moment” represented may actually be a series of engagement moments. For further explanation, please refer to Ref. 10. Modified with permission from Seamless process and Decision Points of an Adaptive Pathway.10