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.
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. This is not a new route of approval for medicines, but makes use of existing approval tools, such as conditional approval, to address areas of high unmet need. Under the Initiative Medicines Initiative (IMI2) the ADAPT SMART consortium (a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes) enables coordination of MAPPs activities, supporting investigation of MAPPs methodologies and dialogue to develop workable MAPPs concepts.
ADAPT SMART believes that the findings from the EMA’s pilot can help shape the on-going discussions around MAPPs. Launched in March 2014, the EMA pilot explored practical implications of adaptive pathways by examining medicines already under development. Of 62 applications, 18 were selected for in-depth examination in Stage I; six (6) progressed to receive parallel advice by the EMA and HTA bodies in Stage 2; and one (1) was selected to receive scientific advice.
The EMA pilot has demonstrated that medicines with high potential can be identified early on in development and that, through multi-stakeholder collaboration, they can move quickly through the development phases and regulatory processes, ensuring that evidence requirements agreed upon downstream are taken into account as development plans are created.
ADAPT SMART is delighted that MAPPS will continue to have a role in the EU regulatory and access processes and believes that its work can help address challenges to implementing MAPPs as demonstrated by the EMA pilot, namely:
- Involvement from patients and healthcare professionals;
- Consensus regarding post-authorisation data gathering plans;
- Involvement from payers;
- Clarity for companies.
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.
Based on the pilot project, the EMA has revisited its guidance for companies considering applying for the adaptive pathways approach. Following the release of the report, additional discussion and practical experience is needed. Towards this end, the EMA will organise a workshop on December 8, 2016, to explore the adaptive pathways concept, gathering more views and proposals from all stakeholders.
The ADAPT SMART consortium looks forward to this continuing discussion, and further contributing to it with its own exploration of the adaptive pathways concept.
The EMA press release and its report on the adaptive pathways pilot project can be found here.
 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 learnings between all stakeholders, and to allow the field to actively work towards MAPPs implementation.