4 September 2015 - Called the Accelerated Development of Appropriate Patient Therapies (ADAPT SMART), and funded by the EU Innovative Medicines Initiative, the project is a collaboration between 32 international partners that includes regulators, patients, academia, and industry representatives.
The path that any new treatment takes from marketing authorisation to decisions on reimbursement and approval can take years to complete. So with new medicines being developed at pace, there is a need to make this process more efficient to allow patients to safely access treatments of potential benefit.
One strategy that aims to address this is the Medicines Adaptive Pathways to Patients (MAPPs). MAPPs allows patients with unmet medical needs to gain access to treatments as early as possible.
Through flexible pathways, MAPPS aims to increase the likelihood of a treatment's success as they are given to the patients who are most likely to respond to them.
This is done by ensuring mechanisms are in place to safely manage, access, and gather as much information as possible to inform decision making.
The strategy uses a set of objective measures, including appropriately designed real-world evidence studies, to monitor the response patients have to a new treatment over its entire lifespan. It then adjusts prescribing recommendations based on the evolving evidence base.