How do you define the value of a medicine? An acute cancer patient prizes quality of life, while a clinician emphasizes clinical efficacy. Agreement on what constitutes value would focus resources on new medicines that improve outcomes for patients and society.
To develop disease-specific value frameworks, Tapestry convened Breast Cancer and Type 2 Diabetes Working Groups consisting of leading medical experts, regulators, payers, reimbursement authorities, patients, and industry representatives. These disease areas were chosen for their high impact on patients and high costs.
In 2009, Working Group participants established a shared value framework for evaluating new medicines, thereby increasing transparency and collaboration among all stakeholders throughout the drug development process. This framework sought to provide guidance on what constitutes value in a new medicine and how to demonstrate that value across constituencies.
Recognizing the inherent limitations of a static framework, the Working Groups recommended creating a new cross-stakeholder approach for evaluating medicines early in the drug development process. This led to the multi-stakeholder pilot initiative launched in 2010, which allowed for greater specificity than the original frameworks while preserving the collaborative culture of the Working Groups.
Working Group topics:
After developing a shared value framework focused on how new medicines can be assessed and rewarded, the Breast Cancer Working Group recommended that progress in this area should continue in the form of pilots of early multi-stakeholder consultations in drug development. The Working Group suggested that the consultations would require institutional commitment across Member States and that the objectives, structure, participants, and process details of the pilots should be fully transparent.
The Working Group completed a consensus framework for measuring the value of breast cancer medicines. Additionally, participants took initial steps to design a collaborative pilot process testing the merit of earlier consultations in drug development.
Over the course of the Working Group's meetings, participants agreed unmet needs in Type 2 Diabetes and opportunities to improve patient health outcomes, and committed to working together to overcome challenges to achieving these improvements.
The Type 2 Diabetes Working Group brought together world class thought leaders and decision-makers from the ranks of medical experts, regulators, HTA, payers and advisors, patient representatives and industry. Committed to establishing a shared value framework for drug development in this area, the Working Group developed approaches to overcome barriers to innovation through more effective collaboration among all stakeholders.
European Healthcare Innovation Leadership Network, Disease-specific Working Groups
Professor of Diabetes Medicine, Newcastle University