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.
Journal article
2019-05-01T00:00:00+00:00
105
1148 - 1155
7
Drug Approval, Drugs, Investigational, Health Services Accessibility, Humans, Patient Selection, Risk Assessment, Time Factors