NICE is to partner with a number of organisations as part of a new public-private project which aims to identify activities that can make the development and regulation of medicines more efficient.
The project, called the Accelerated Development of Appropriate Patient Therapies (ADAPT SMART) is funded by the EU Innovative Medicines Initiative and is a collaboration between 32 international partners that includes regulators, patients, academia and industry representatives.
Such streamlining of the process is needed, as the journey from developing a new medicine to gaining authorisation and decisions on reimbursement and approval can take years to complete. As new medicines are being developed at pace, NICE believes 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.
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.
The new ADAPT SMART project seeks to develop a MAPPs model that is responsive to the needs of patients, regulators, healthcare professionals and members of the industry.
It aims to:
- Gain consensus among all relevant healthcare stakeholders as to the evidence that will be required
- Determine how multiple data sources can be best used to put MAPPs into action
- Identify the scientific and societal challenges that MAPPs needs to address.
Sarah Garner, Associate Director for Science Policy at NICE and co-lead for the ADAPT SMART project, said: “MAPPs represents a more considered and integrated approach to the development and assessment of new drugs – potentially accelerating access of important treatments to patients with high unmet needs.
“The coordinated approach could therefore make a real difference to patients and help make the drug development process more sustainable by increasing efficiency. The UK health system and research capability is ideally placed to enable decision making to be coordinated with the collection of necessary real-world data.
“ADAPT-SMART will act as a catalyst, and the project will explore the feasibility of alternative reimbursement models and more pragmatic trial designs, which are needed in the adaptive landscape. The activity will complement the real-world data activity NICE is undertaking as part of the IMI funded GetReal consortium.”
Hans-Georg Eichler, Senior Medical Officer at the European Medicines Association, said: “With the challenges facing healthcare in Europe, we see MAPPs as a vital tool to make the increasing number of promising new therapies available at the earliest appropriate time for patients with unmet medical needs.
“We need to do so in a way that is sustainable for all stakeholders in the healthcare ecosystem. ADAPT SMART is a vital programme to help achieve this goal."