EMA Official Dismisses Claims That Prescribers & Companies Won’t Play By Adaptive Pathways Rules
By Neena Brizmohun
The “glass is half full,” the European Medicines Agency’s senior medical officer says of efforts to get everyone onboard the adaptive pathways approach for accelerating the approval of drugs for high unmet needs.
Adaptive Pathways: A Solution For Worried Payers in Europe
By Neena Brizmohun
Payers often worry about where they would stand if a drug that was approved in the context of adaptive pathways should subsequently underperform. But they should not be concerned, according to the latest discussions on this relatively new concept for getting drugs to market faster.
Blogpost: “Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs”
Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs
By Paul Robinson of Merck Sharp & Dohme
One of the key factors in the future success of any MAPPs implementation will be the need for continuous monitoring, in health data registries, of how patients respond to new therapies. On January 17th, 2017, the ADAPT SMART consortia hosted a multi-stakeholder workshop to explore the ethical and legal considerations of MAPPs and the uncertainties of patients. The workshop covered several topics including the use of patient data in registries.
Podcast: The Evolution of MAPPs
On 17 February, ADAPT SMART had a discussion with Professor Hans-Georg Eichler, Senior Medical Officer EMA and ADAPT SMART project leader on what exactly are Adaptive Pathways and why they are important.
Press release: IMI’s ADAPT SMART Kick-Starts 2017 by Putting Stakeholders at the Centre
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.
ADAPT SMART in 2017 – Putting Stakeholder Opinions at the Centre of the Process
It is difficult to imagine, but the IMI’s ADAPT SMART project has been operational for eigtheen months, having launched officially at the EMA on September 4, 2015. ADAPT SMART is investigating the tools and (processes) interaction moments required for the use of Adaptive Pathways, but seeks a consensual, multi-stakeholder approach to the continuous lifespan evaluation of the evidence used in regulatory decision making for new therapies that address medical needs.
ADAPT SMART’s Webinar Discusses Positive Developments and Remaining Challenges for 2017
On December 14th, IMI’s ADAPT SMART project heads and WP1-2-3 work package leads hosted an internal year-end webinar, updating on the project’s status and next steps for members of the consortium. Some 70 consortium members were guided through the project’s delivered first-year objectives and explained what will occur over next 12 months, until the end of ADAPT-SMART in December 2017.
Report by Charles River Associates: use of managed entry agreements for products with a conditional or exceptional authorisations
The European Federation of Pharmaceutical Industries and Associations (EFPIA) asked Charles River Associates (CRA) to undertake an interview programme to understand how managed entry agreements (MEA) have been used for products with Conditional Marketing Authorisations or Market Authorisations under exceptional circumstances as a proxy for Medicines Adaptive Pathways to Patients (MAPPs).
Discussion paper on Engagement Criteria for MAPPs
An issue of divergent views became apparent early in the course of the ADAPT SMART project, namely; to what kind of novel medicines and clinical scenarios/conditions should a MAPPs approach be applied? The ADAPT SMART consortium convened discussion fora with stakeholders to elaborate MAPPs engagement criteria that may be acceptable to all concerned within the existing legislation. In this paper, we summarize viewpoints from these discussions.
Discussion paper on Engagement Criteria for MAPPs
On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands.
Podcast: ADAPT SMART & MAPPs from the Patient’s Perspective, with EPF and EURORDIS
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 the need for Adaptive Pathways (MAPPs) in Europe.
Press Release: ADAPT SMART Welcomes European Medicines Agency Report on Adaptive Pathways Pilot
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.
Podcast: MAPPs – Agreeing on Success
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 Statistian, NOMA (The Norwegian Medicines Agency).
Early access – is it worth it?
There is much debate about the need to allow patients with serious diseases early access to promising new therapies. Some concerned stakeholders argue for “the right to try any treatment option for every patient in need” while others oppose this position, saying “only thoroughly studied treatments should be allowed on the market - we need to take our time”.
ADAPT SMART Glossary
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 [...]
Preliminary Conclusions Report From 29th February Multi-Stakeholder Workshop
On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands. The programme from the event can be found here. A full report of the event [...]
Blog From D2.03 Leaders: Takeaways From the ADAPT SMART Workshop on Selection Criteria for MAPPs
On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands. Angelika Joos of MSD and Mathieu Boudes of EURORDIS attended the workshop in their capacity [...]
“MAPPs can be a promising way of working”: Podcast with HTA’s and Payers From DIA Hamburg 2016
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).
MAPPs Q&A
This Q&A aims to address some frequently addressed queries around MAPPs. MAPPs, broadly, are a multi-stakeholder approach to developing an "RCT-plus" to evaluating new medicines. In order for outcomes-based healthcare to succeed, we need [...]
Podcast on Managed Entry: Claudine Sapede-Kniffel of F. Hoffmann-La Roche and Jacoline Bouvy of 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.
Podcast: Views from André Broekmans and Luk Maes, Work Package 2 Leads
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.
Editorial Contribution: André Broekmans, Coordinator ADAPT SMART, Looks Ahead
With the first few months of the ADAPT SMART project underway, coordinator André Broekmans (Escher Platform, TI Pharma) shares his views on what is needed to continue to drive the project forward.
ADAPT SMART Round Table – Thought leaders discuss objectives and approaches for success
On 27th October, thought leaders in the field of adaptive pathways met in Washington D.C. to discuss the global objectives of IMI ADAPT SMART and what the landmark project hopes to achieve.
ADAPT SMART Kick-off Meeting – The Innovative Medicines Initiative’s ADAPT SMART: Laying the Foundations and Building Consensus to Make MAPPs Work for All
On Friday September 4th, 2015, a coalition of 90 European healthcare stakeholders from 32 organisations including patients, payers, regulators, HTAs, academic institutions, and industry took their first steps towards investigating MAPPs tools and methodologies, and engaging in a dialogue with all relevant stakeholders to prove and develop workable MAPPs concepts.
ADAPT SMART Launch in the News
On Friday September 4th, 2015, a coalition of 90 European healthcare stakeholders from 32 organisations including patients, payers, regulators, HTAs, academic institutions, and industry took their first steps towards investigating MAPPs tools and methodologies, and [...]
Press Release: Innovative Medicines Initiative Launches ‘ADAPT SMART’, an Adaptive Pathways Project with 32 International Participants
The project will establish a platform that enables the coordination of Medicines Adaptive Pathways to Patients (MAPPs) related activities within the Innovative Medicines Initiative (IMI) and engages in dialogue with all relevant stakeholders. MAPPs seek 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. The outcomes of the ADAPT SMART consortium will help inform future research agendas and discuss approaches for the implementation of MAPPs.
The European Medicines Agency on Adaptive Pathways
The adaptive pathways approach (formerly known as ‘adaptive licensing’) is part of the European Medicines Agency’s (EMA) efforts to improve timely access for patients to new medicines.
MAPPs and New Benefit Risk Models: IMI2 Leads with Patient Engagement
The Innovative Medicines Initiative (IMI) yesterday launched its 5th Call for proposals under the IMI 2 programme.
Interview with Sarah Garner of NICE: IMI’s GetReal – Using real world data for decision-making in R&D and health technology assessment
In this interview, Professor Sarah Garner, Associate Director for Science Policy and Research at NICE, speaks about The GetReal project is another IMI initiative addressing MAPPs. Real world evidence holds the potential to both increase efficiency in R&D and to bridge the gap between the proof of efficacy required to pass regulatory scrutiny and the demonstration of likely effectiveness needed to satisfy health technology assessment bodies.
MIT’s NEWDIGS Launches New Program in Healthcare Data
The inaugural meeting of the NEWDIGS Data Program was held in January 2015, and brought together international experts from academia, government, information technology, and the healthcare sector. A series of panel discussions focused on identifying the gaps and opportunities that might be addressed through better international cooperation in data system design and use.