ADAPT SMART is an enabling platform for the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities that aims to foster access to beneficial for patients with unmet needs, such as rare diseases at the earliest appropriate time in the product life-span in a sustainable fashion. ADAPT SMART is a 30-month project under IMI2 – the second phase of the Innovative Medicines Initiative (IMI) – which will work towards proving and developing workable MAPPs concepts.
IMI2 is a public-private partnership of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission. The IMI is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research.
Led by the European Medicines Agency (EMA), the this first of a kind coalition will engage relevant stakeholders, bringing together patients, regulators, industry, Health Technology Assessment (HTA) bodies, payers, and academics, to foster the development of MAPPs in Europe. The EMA believes that this will encourage more efficient ways of developing and regulating medicines thus providing patients with more appropriate access to innovative medicines.
Accordingly the ADAPT SMART consortium will do the following:
- “Distribute findings, key discoveries and case studies from ongoing or completed MAPPs pilot projects, creating a MAPPs repository of knowledge and opportunities
- Identify the scientific challenges and opportunities related to the implementation of MAPPs and foster the aligned understanding of consortium members and their constituents
- Support new IMI2 research and innovation actions by facilitating the inclusion of MAPPs enablers, tools and methodologies to address its challenges and opportunities
- Conduct horizon scanning and research on key topics to produce actionable advice and recommendations for IMI and other stakeholders to further the broad implementation and adoption of MAPPs”
It will centre its initial work on four key work packages.
- Work Package 1: “Evidence generation throughout the entire product life cycle” led by National Institute for Clinical Excellence, AstraZeneca
- Work Package 2: “Designing the MAPPs pathway” led by Top Institute Pharma, Bristol-Myers Squibb
- Work Package 3: “Decision-making, sustainability and their implications” led by Centre for the Advancement of Sustainable Medical Innovation, Sanofi-Aventis Research and Development (Genzyme)
- Work Package 4: “ADAPT SMART Operational Project Management” led by Top Institute Pharma
On September 4th, 2015, a coalition of 90 European healthcare stakeholders from 32 organizations met and talked about collaborative efforts to prove and develop workable MAPPs concepts. In its kick-off session, it was pointed out that one of the key bottlenecks and points of distrust, to be addressed through ADAPT SMART, is the need to involve both patients and prescribers. Yann le Cam, CEO of EURORDIS said, “We are focusing so much on putting the patients at the center, we’re forgetting that for the products we are addressing the key relationship is between the patient and the doctor at hospital centers, where prescriptions are prescribed and the capture of real world evidence takes place. This will be key to making MAPPs a success.”