European Healthcare Innovation Leadership Network, December 2009
The Breast Cancer Working Group convened for its third meeting on November 11, 2009 in Berlin. Initiated by the European Healthcare Innovation Leadership Network, the Working Group brings together world-class thought leaders and decision makers from the ranks of medical experts, regulators, payers and advisers, patient representatives and industry. Working together over the course of 2009, Working Group participants are committed to addressing unmet needs in breast cancer by establishing a Shared Value Framework and developing approaches to overcome barriers to innovation through more effective collaboration among all stakeholders.
The Shared Value Framework is a recommended approach arising from this collaboration to encourage changes in how the value of new medicines can be assessed, demonstrated, captured and rewarded, with the end goal of improving health outcomes. To move towards the tangible outcome of a Shared Value Framework, the Working Group has focused on generating elements of a “21st century” breast cancer drug development template. The goal of its proponents is to provide an improved process for drug development that refocuses on shared definitions of value across healthcare stakeholders and accelerates patient access to innovative medicines. The template consists of three major components:
A tiered set of value indicators and measures required to demonstrate benefit in addressing unmet needs along the drug development lifecycle
A process for early consultation with regulators, HTA and payers that includes engagement of patient and clinical perspectives
Principles and criteria for use of post-launch mechanisms to encourage innovation and value-based pricing