Medicines adaptive pathways: A practical strategy to improve patient access to medicines?
1-2 October 2014, Heathrow, UK
This workshop built on previous CIRS workshops in which recommendations to advance this concept have been identified. In addition to providing a current overview of the different medicines adaptive pathways being discussed, designed, piloted and implemented around the world, this workshop provided perspectives on the opportunities and hurdles from the points of view of the sponsor, HTA and licensing bodies and focused on specific building blocks needed to refine and implement these paradigms.
Workshop objectives
- Discuss the new regulatory approaches to accelerating medicines availability and the role of HTA and coverage bodies in enabling access.
- Recommend how to best ensure the success of new facilitated regulatory pathways and what will be the critical success factors to manage uncertainty, ensure proper use and to interpret continuity with evidence generated during early phases of study.
- Identify the possible pathways for an integrated approach that are acceptable to all stakeholders for adaptive routes and discuss the challenges and opportunities for the regulatory and HTA agencies and the sponsor.