IMI’s ADAPT SMART Kick-Starts 2017 by Putting Stakeholders at the Centre

(January 18, 2017 – London): ADAPT SMART’s General Assembly, held at the European Medicines Agency (EMA), agrees to focus its final year on incorporating stakeholder feedback into the development of Medicines Adaptive Pathways to Patients (MAPPs) tools and methodologies.

With growing international interest and visibility in the final year of the consortium, ADAPT SMART members have agreed to redouble their efforts to collaborate with key stakeholder groups and incorporate their feedback into the deliverables during the calendar year of 2017.

MAPPs aims to foster access to beneficial treatments for specific, well-defined, patient groups at the earliest appropriate time in the product life-span in a sustainable and affordable fashion. Under the Innovative Medicines Initiative (IMI2), the ADAPT SMART consortium (a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes)[1] enables coordination of MAPPs activities, supporting investigation of methodologies and dialogue to develop workable concepts.

“The driving force behind the need for MAPPs was the patients themselves,” said Project Director Dr Hans-Georg Eichler, Senior Medical Officer at the EMA. “We believe that through the iterative development and assessment of evidence generation over the entire life-span of the medicine, we can meet the needs of patients for faster access while addressing the realities of stratified medicines without lowering standards for safety, quality and efficacy/effectiveness.”

Addressing the need for to balance access and safety for, consortia member Yann Le Cam, CEO of EURORDIS said, “MAPPs is creating so much debate as it crystallises and catalyses the challenges of these new therapies, as well as a shift from two decades of a focus on safety. Due to the new science, there is a need for a re-evaluation on how to manage risk, and we believe that MAPPs manages risk.

To meet these challenges, ADAPT SMART set several key objectives that were successfully delivered in 2016:

  • A consolidated report on how best to define the Engagement Criteria for MAPPs, to facilitate iterative development and assessments.
  • A comprehensive Glossary of working definitions for common terms relevant for the ADAPT SMART consortium and external stakeholders
  • An overview of relevant IMI and EU project outcomes that can be used to inform ADAPT SMART – [this document is not yet public]
  • Several roundtables were held with HTA stakeholders to create a best practices overview to Managed Entry Agreements (MEAs)
  • The current EU clinical pathway stakeholder engagements was defined, and a MAPPs stakeholder Seamless Pathway was proposed based on stakeholder needs

During the course of its two day Annual Meeting held in London, The ADAPT SMART consortium reached a broad consensus that the work completed in 2016 outlines an effective response to stakeholder concerns expressed in three key areas of MAPPs feasibility. These three issues will be addressed in 2017:

  • The tools required to develop an infrastructure which supports MAPPs evidence generation
  • A set of methodologies on the use of new sources of evidence to facilitate appropriate patient access decisions in MAPPs
  • Approaches for the control of prescribing that facilitate appropriate use

By fostering dialogue and working to align the understanding of MAPPs and its impact amongst all stakeholders, ADAPT SMART hopes to address the remaining challenges and barriers to implementing MAPPs in Europe in 2017.

[1] The ADAPT SMART Coordination and Support Action (CSA) acts as a neutral collaborative framework to establish the platform that will engage with all relevant stakeholders, including patients, industry, SMEs (Small and Medium sized Enterprises), regulators, health technology assessment bodies (HTAs), payers (national and European Networks), clinicians, governments/policy makers (national authorities as well as European Commission’s DG SANTE and DG GROW, and European Networks). In addition to engaging in a dialogue with relevant stakeholders, the ADAPT-SMART consortium aims to align understanding of the impact of MAPPs, to share findings between all stakeholders, and to allow the field to actively work towards MAPPs implementation.