ADAPT SMART welcomes EMA report on adaptive pathways pilot
EMA pilot has demonstrated that drugs with high potential can be identified early in development
ADAPT SMART has welcomed 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 (MAPPs) 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 lifespan 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 Innovative Medicines Initiative (IMI2) the ADAPT SMART consortium (a sustainable, multi-stakeholder approach from research to treatment-outcomes) enables co-ordination 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 to shape the ongoing 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 progressed to receive parallel advice by the EMA and HTA bodies in Stage 2, and one 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.
