Adaptive Pathways in Nature Reviews Drug Discovery
Earlier this month, Nature Reviews Drug Discovery (NRDD) published an article about Medicines Adaptive Pathways to Patients' (MAPPs). MAPPs seek to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span, in a sustainable fashion.
The NRDD article describes the evolution of the adaptive approach and of concepts developed by ADAPT SMART, a multi-stakeholder consortium funded by the European Innovative Medicines Initiative. The consortium (which completed its work in 2018), provided a platform to discuss bottlenecks and opportunities for making MAPPs a reality with a wider range of stakeholders, published analyses and offered advice on future research priorities.
The outcomes of ADAPT SMART do not propose a new regulatory pathway or legal framework, but a combination of ‘building blocks’, each of which are discussed in detail in the NRDD article:
- A focus on speedy access for patient (sub-)populations in urgent need
- Rapid increase of the evidence-to-uncertainty ratio
- Use of the full spectrum of study methods for evidence generation
- Adaptive pricing and reimbursement
- A focus on appropriate use
- Collaboration of all stakeholders
On a more practical note, the ADAPT SMART team also submitted an article to Clinical Pharmacology & Therapeutics. In this article, the authors summarise the MAPPs engagement process and critical questions to be asked at each milestone of the product life-span. The article was accepted for publication last month.
Are you interested in learning more? Both articles are available, open access, on the publishers’ websites:
- The evolution of adaptiveness: balancing speed and evidence, Nature Reviews Drug Discovery
- Medicines Adaptive Pathways to Patients: Why, when and how to engage?, Clinical Pharmacology & Therapeutics