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| Newsletter September 1st, 2016 | |||
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Press Release: ADAPT SMART Welcomes European Medicines Agency Report on Adaptive Pathways Pilot
(16 August 2016 – Brussels): ADAPT SMART welcomes the European Medicines Agency (EMA) report on its adaptive pathways pilot, considering this as a positive step in the current multi-stakeholder discussions about early access to medicines via a Medicines Adaptive Pathways to Patients in the EU. READ THE FULL PRESS RELEASE |
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ADAPT SMART Progress Matrix Podcast: “MAPPs – Agreeing on Success” On 5 July, MAPPs stakeholders met to discuss the tools needed to define endpoints and success measures in MAPPs. Participants included: Richard Barker, Founding Director of the Centre for the Advancement of Sustainable Innovation (CASMI): “Although we would all like certainty, we don’t even have certainty today… The clinical data that comes in, even in today’s process, has a high degree of uncertainty. We have to square up in a very adult way, to the fact that there’s always uncertainty…” Claudine Sapede-Kniffel, Global HTA & Payment Policy Lead, F. Hoffmann-La Roche: “I think success will depend really on the ability of manufacturers and then payers in each individual country to find a mutually acceptable solution. This is country-specific, because we need to look at the healthcare system, the disease specifics, and the difference requirements in terms of evidence that payers want to see…” Anja Schiel, Senior Advisor and Statistician, NOMA (the Norwegian Medicines Agency): “We have to understand that there are patient populations that are aboslutely willing to take any risk for an active treatment, but no risk for being in the placebo arm… We have to listen to patients who say ‘fine, you want this data; but we want teatment’…” LISTEN TO THE FULL PODCAST |
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ADAPT SMART Progress Matrix ADAPT SMART consists of distinct work packages, each with an individual set of deliverables. This deliverables matrix is designed to track the concrete progress of specific deliverables for each work package. VIEW THE MATRIX |
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| NEWSLETTER – 1st July 2016 | |||
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Illustrated Article: “Early Access: Is it worth it?”
Following the stories of the characters Jane and John, this illustrated article, written by Hans-Georg Eichler (Senior Medical Officer, European Medicines Agency), explores the need for drug development to serve both current and future patients. It further explains the challenges facing MAPPs, while driving home the importance of putting patients first. Text by Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency. |
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ADAPT SMART Glossary Published
The ADAPT SMART glossary provides working definitions for common terms relevant for the consortium and includes references. The glossary is based on the input from members of the ADAPT SMART consortium representing different stakeholder groups. The definitions are based on relevant legislation or literature sources and written in the context of the ADAPT SMART project; where applicable, an EU perspective was chosen. Some definitions have been created without any direct reference source and these are shown as ‘ADAPT SMART’. This is a working document and will be updated during the lifespan of the ADAPT SMART project. |
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29 February Workshop: Preliminary Conclusions Report & Blog On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands. A full report of the event will be available in due course. A preliminary overview of conclusions was prepared for the participants in the “Innovation for the benefit of the patient” conference organized by the Dutch Ministry of Health on 1-2 March 2016. VIEW THE PRELIMINARY CONCLUSIONS Additionally, a blog was co-authored by Angelika Joos (MSD) and Mathieu Boudes (EURORDIS). In their capacity as ADAPT SMART D2.03 leaders, they also provide reflections on the workshop’s outcomes. |
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| NEWSLETTER – 12th May 2016 | ||
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ADAPT SMART Podcast from DIA Hamburg 2016: Hans-Georg Eichler of EMA, Luk Maes of Bristol-Myers Squibb, Ad Schuurman of ZIN, and Sarah Garner of NICE |
On 7 April 2016, key ADAPT SMART participants met to discuss the “evidence versus access” conundrum faced by MAPPs. Taking place at DIA Hamburg, the discussion included participation from regulators, payers and the pharmaceutical industry.
“…We have patients who need new drugs right now and their window of opportunity is closing. So we need to address this conundrum. Patients have the right to have well-tested drugs but this takes some time. So how can we square this circle?” – Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency (EMA)
“One barrier is the skepticism among half the payers in Europe. The second half do think (MAPPs) can be a promising way of working for a few diseases where immediate life-threatening issues are at stake. But payers want to see control on volume and costs and data. And, until now, the data issue has not been solved. So it’s a real challenge to see if we can do that better in the future.” – Ad Schuurman, Head of Business Contact Centre & International Affairs, National Health Care Institute of the Netherlands (ZIN)
“MAPPs is still seen by many as an attempt by the industry to create a new ultra-accelerated review process… On the contrary, the MAPPs concept will be using existing regulatory and legal tools. We aren’t creating anything new…and it’s trying to bring much more control to the process from the very beginning and with all stakeholders.” – Luk Maes, Executive Director, Regulatory Scientific Policies Europe, Bristol-Myers Squibb
“One issue is the capacity of healthcare systems to collect the data needed. It’s just not there at the moment…And then we have this conundrum of who is actually paying. And there is no opportunity in the system to have a dialogue about how we jointly do that.” – Sarah Garner, Associate Director Science Policy & Research, National Institute of Health & Care Excellence (NICE)
LISTEN TO THE FULL PODCAST
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| NEWSLETTER – 15th March 2016 | ||
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Podcast on Managed Entry: Claudine Sapede-Kniffel of F. Hoffmann-La Roche and Jacoline Bouvy of the National Institute of Health and Care Excellence
In February 2016, Jacoline Bouvy, Scientific Adviser at NICE, and Claudine Sapede-Kniffel, Global HTA & Payment Policy Lead, F. Hoffmann-La Roche, met in London to discuss managed entry in the context of ADAPT SMART. “In the context of an adaptive pathway, (managed entry) is exactly the kind of understanding we would need to move towards…” – Claudine Sapede-Kniffel “To be able to make possible recommendations on what a managed entry agreement in the context of adaptive pathways might look like, we decided that we first need to see what the actual experience of different stakeholders has been in the past years.” – Jacoline Bouvy LISTEN TO THE FULL PODCAST |
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| NEWSLETTER – 1st March 2016 | |||
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Webinar Report: Status Updates from ADAPT SMART Work Package Leads
On 8th January, ADAPT SMART Work Package Leads participated in a webinar to provide a status update on deliverables and timelines. ADAPT SMART consortium members were invited to participate in this internal webinar and had the opportunity to ask questions. A summary report of the webinar is now available for the public. “There is a need to remain fully involved, so you can expect us to be reaching out to companies – especially in areas like IP and legal ethics, where there are a lot of strong viewpoints and extensive expertise. We want to make sure those viewpoints are on the table.” – Richard Barker, WP 3 Co-Lead READ THE FULL WEBINAR REPORT |
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Powerpoint Presentations: Download the Presentations from the 8th January Webinar
Powerpoint presentations from the 8th January webinar have been compiled into one master powerpoint for the public. You can download the presentations, which include greater detailed material from all of the work package leads who participated, on the ADAPT SMART website. |
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Podcasts
On 17 February, ADAPT SMART had a discussion with Professor Hans-Georg Eichler, Senior Medical Officer EMA and ADAPT SMART project leader to find out the evolution of MAPPs in Europe and Internationally.
On 5 July, key stakeholders involved in the MAPPs conversation met to discuss the tools needed to define endpoints and success measures in MAPPs. Participants included Richard Barker, founding director, Centre for the Advancement of Sustainable Medical Innovation (CASMI); Claudine Sapede-Kniffel, Global HTA & Payment Policy Lead, F. Hoffmann-La Roche; Anja Schiel, Senior Advisor and Statistician, NOMA (The Norwegian Medicines Agency).
On 7 April, key participants associated with the IMI ADAPT SMART project met to discuss the consortia’s progress in finding ways to implement MAPPs in Europe. Participants included: Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA); Luk Maes, Executive Director, Regulatory Scientific Policies – Europe, for Bristol-Myers Squibb; Ad Schuurman, Head of the Business Contact Centre & International Affairs National Health Care Institute of the Netherlands (ZIN); and Sarah Garner, Associate Science Policy and Research, National Institute of Health and Care Excellence (NICE).
On 17th February, Jacoline Bouvy of NICE and Claudine Sapede of F. Hoffmann-La Roche met in London to discuss managed entry in the context of the ADAPT SMART initiative.
In December 2015, ADAPT SMART work package leads André Broekmans and Luk Maes met to discuss the ambitious objectives of ADAPT SMART, the impact of the diverse participants involved in the project, and what sets this initiative apart from other programmes focussed on MAPPs.
On 6 September, Nicola Bedlington from The European Patients Forum (EPF) and Yann Le Cam from Eurordis, two of Europe’s leading patient representatives, discussed adaptive pathways from the patient perspective.