Excite – A New Collaborative Model Of Pre-Market Evaluation Of Health Technologies

Many non-drug technologies with regulatory approval fail to be recommended for reimbursement. Reasons include low quality evidence or lack of relevance Excellence in Clinical Innovation and Technology Evaluation (EXCITE) is a collaboration between industry, government and academia to develop a harmonized pre-market evaluation that mitigates risk, improves adoption, and responds to system needs EXCITE works with industry to evaluate evidence of efficacy and safety, cost effectiveness and adoption realities. It builds on Ontario’s field evaluation experience. Structure: 1) Management board representing industry, government, academia and the Ontario Health Technology Advisory Committee (OHTAC); 2) Scientific collaboration of 7 Methodological Centres (MC) and 24 Academic Health Science Centres and a Quality Assurance Committee; and 3) Chief Scientific Officer and secretariat. Process: The management board prioritizes applications based on innovation, relevance, and commercialization. MCs develop a protocol and budget for clinical evaluation, systematic review, and an economic analysis. Human factors and usability analysis, and preference studies are offered. Consideration is underway for conditions of early adoption. Studies are funded by industry through MaRS, which fosters and commercializes innovation. Of 17 applications (year 1), 3 have commenced evaluation, 3 are in protocol development, discussions ongoing in 3 and one declined. Studies are designed to satisfy regulatory and reimbursement requirements and reflect complexities of adoption while maintaining high academic standards. Lessons learnt include a better understanding of the complexities of adoption and the benefit of endorsement in mitigating risk; limited funding for evaluations; tension between needs of industry and independence and objectivity of MCs; and intricacies of contract structures. EXCITE is a potential alternative to post-market HTA in Ontario, and may improve adoption in other jurisdictions. Expansion to a national and international scale will provide global reach for evaluated technologies. This is a potentially innovative and powerful model of early HTA.