Podcast: “The Regulatory Needs of MAPPs – What are the Evidence Requirements to Make Adaptive Pathways Work in Practice?”.

On 25 October 2017, ADAPT SMART had a discussion with François Meyer, Advisor to the President & International Affairs at the French National Authority for Health (HAS), Solange Corriol-Rohou, Senior Director Global Regulatory Affairs & Policy, Europe at AstraZeneca Global Medicines Development, Elin Haf Davies, CEO of Aparito and Stefan Lange, Deputy Director at IQWiG, moderated by Richard Barker, Director, CASMI.

This podcast was recorded at the DIA Value, Access and Regulatory Strategy Workshop in Basel, Switzerland.

This podcast tried to provide answers to the following questions:

  • What is the current opinion of the utility of MAPPs in the member states, and what could ADAPT SMART do to facilitate?
  • What is the current gap, if any, in RWE availability and quality within the member states to put MAPPs into practice
  • What are the patient’s role in the regulatory and HTA process? What tools do we have at our disposal to facilitate their participation, and what still needs to be developed?
  • There are increasing discussions on the need for new, highly active therapeutics like IO checkpoint and CAR-T cells to be introduced into practice differently; pay for performance, annuity, etc. Would MAPPs be a tool to facilitate such an approach? What tools are lacking, if any, to make this possible?