Abstract

The Emerging Commercial Paradigm for Personalized Medicine: Recent Developments and EU Market Access

Iain Miller, Co-Founder, Healthcare Strategies Group

Market access is a terms encompassing the process of driving adoption of new technology. In the field of Personalized Medicine, including companion diagnostics, this includes the heterogeneous processes by which new medicines and tests are reviewed by Health Technology Assessment agencies and payors across the globe. Notable amongst these is NICE in the UK, with its unique cost effectiveness review criteria. Other EU payors and agencies apply different review standards. The reviewer, who serves on NICE Technology Appraisal Committee C, and has participated in various pan-European initiatives, will consider the current market access paradigm in the EU and associated business model for companion testing. This market access paradigm will be placed in the context of key recent developments in the field, including the new class of oncology immunotherapies and their candidate biomarkers, new regulatory models, and re-imbursement pathways.