EFPIA General Meeting Highlights Enormous Gains Made by MAPPs and Carves a Path for the Future

17th June 2015 – by Duane Schulthess

While progress is often slow and laborious when trying to gain traction for new ideas in the ‘Brussels Bubble’, there was much to be optimistic about in the Medicine’s Adaptive Pathways to Patients (MAPPs) meeting held on Thursday June 4 in Luxembourg. Organised as part of EFPIA’s general assembly, a broad cross section of stakeholders attended the MAPPs session to hear what had been accomplished over the last twelve months and discover how the initiative is being moved forward in partnership with the second Innovative Medicines Initiative (IMI2) and the European Medicine’s Agency (EMA).

The overarching goal of MAPPs is to translate science into healthcare solutions that are available to patients earlier. To do so, diverse stakeholders, including payers, patients, practitioners, regulators, and industry, must be aligned “in a truly cross-functional, cross sector engagement” of continuous evaluation of the performance over the entire life-cycle of a new therapy, according to session moderator Jeremy Haigh.

The keynote of the session was delivered by Hans-Georg Eichler, Senior Medical Officer of the EMA. He presented the potential benefits of MAPPs defined by the IMI Coordination and Support Action stakeholders as aiming “to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion”:

Hans-Georg Eichler and Jeremy Haigh in MAPPs: Saving Time, Saving Lives 4 June 2015

Hans-Georg Eichler speaks  about the need for new ways of thinking. Click for video.

  • “for patients and providers – earlier access promising new medical products” and also, by focusing on monitoring, “MAPPs can lower realised harm.”
  • For Pharma – possibly earlier revenue streams and staggered development costs by avoiding big bet ‘mega-trials’, and de-risk the cost of late stage failures and post-market withdrawals – “a less expensive failure”
  • For regulators – continuous reduction of uncertainty through the lifetime of the product, as well as restored public confidence due to improved risk management.
  • For payers – ability to align value with price and utilisation.

Dr Eichler finished the presentation by noting that progress will require new ways of thinking and innovative approaches to implementing research.

Hans-Georg Eichler in MAPPs: Saving Time, Saving Lives 4 June 2015

Hans-Georg Eichler on the potential of MAPPs. Click for video.

EMA’s Adaptive Pathways pilot offers the possibility to design and test completely new concepts. Dr Eichler challenged the industry again on the contents of the applications calling for more ‘creative intelligence’ “Is this the best we can do intellectually? Maybe we can move a level up,” Eichler said. “If we show a smashing success rate, patients should have that drug now,” he commented, highlighting the benefits of possible earlier access.

Karin Van Baelen, Head of Global Regulatory Affairs at Janssen, J&J, and the newly appointed Chair of EFPIA’s MAPPs task force, gave an overview of the accomplishments of MAPPs in the year since the previous EFPIA General Assembly. The number of institutional and other forums that discuss MAPPs is very encouraging – so is the number of stakeholders already involved (http://www.efpiamapps.eu).

Karin van Baelen in MAPPs: Saving Time, Saving Lives 4 June 2015

Karin Van Baelen, Head of Global Regulatory Affairs, Janssen. Click for video.

Industry has embraced the adaptive pathways in other ways as well, applying the concept in a variety of environments through numerous applications to the EMA pilot, development of MAPPs principles and deliverables and launch and contribution to the IMI Coordination and Support Action on MAPPs.  Another clear landmark on the institutional side, was the establishment of the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP), made up of International Representatives from 23 Member States and the European Medicines Agency. STAMP seeks to optimise the use of existing regulatory tools to improve the safe and timely access and availability of medicines for patients.

James Anderson in MAPPs: Saving Time, Saving Lives 4 June 2015

James Anderson, Head of Corporate Government Affairs, GSK, on ‘MAPPs myths’. Click for video.

James Anderson, Head of Corporate Government Affairs, GSK, addressed several key ‘MAPPs myths’ and recurring questions around MAPPs implementation and feasibility. Key points of Anderson’s presentation were that MAPPs is not only for rare diseases; it is possible R&D investments may not be lower under MAPPs due to need to accelerate costs such as manufacturing; and that lower prices may not materialise as targeted populations may gain greater health benefits and value, even if not fully demonstrated at launch.

Luk Maes, Executive Director Regulatory Europe, BMS, gave a detailed overview of the
Coordination and Support Action (CSA) as an enabling platform for MAPPs related activities within IMI2, as well as engaging in a dialogue with relevant stakeholders.

The session was rounded off by Jeremy Haigh, the outgoing chair of the MAPPs task force, acting as the moderator of an open discussion with Dr Eichler; Sue Forda, VP-Global Regulatory Affairs-International, Eli Lilly; Sarah Garner, Associate Director Science Policy and Research, NICE; and Nathalie Seigneuret, Senior Scientific Project Manager, IMI.

Presentations from the event can be downloaded here.

The entire MAPPs session can be viewed here: