10 Dec 2020
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MAPPs provide a limited commercial marketing authorisation for a well-defined stratified population that is likely to respond based on available diagnostics for therapies with a high level of efficacy and safety.
MAPPs and its associated areas of applied research funding will be a major area of focus across the EU for the next five years. EMA has instituted a MAPPs pilot project under a "safe harbour" environment to allow the exploitation of the strengths, and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring, and utilisation pathways in a confidential manner and without commitment for either side.
The core barriers to MAPPs are:
- Key Members State stakeholders must be aligned at the design phase of a "MAPP" and agree on the evidence package for early approval and re-assessment;
- There is a need for a better understanding of patient's and payers' willingness to operate with greater uncertainty driven by the release of needed therapies with less evidence at the initial launch.
- The IT infrastructure and processes to provide the necessary evidence base using real world data do not exist in most of Europe;
- If the 28 Members States in Europe do not accept the value of MAPPs, there will be no way to ultimately pay for new medicines that are licensed by EMA to enter the marketplace;
- There must be willingness by national regulators to address a flexible pricing structure that responds both upwards and downwards based on the evolution of data and knowledge gained in the course of a MAPPs development plan.
For more information on the activities of this initiative, please contact Denis Horgan, Executive Director