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

Clin Pharmacol Ther. 2019 May;105(5):1148-1155. doi: 10.1002/cpt.1121. Epub 2018 Sep 11.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Drug Approval / organization & administration*
  • Drugs, Investigational / pharmacology*
  • Health Services Accessibility
  • Humans
  • Patient Selection
  • Risk Assessment
  • Time Factors

Substances

  • Drugs, Investigational