Conditionally Funded Field Evaluations: PATHs Coverage with Evidence Development Program for Ontario Ron Goeree, MA, Kiran Chandra, MSc, Jean-Eric Tarride, PhD, Daria O’Reilly, PhD, Feng Xie, PhD, James Bowen, BScPhm, MSc, Gord Blackhouse, MSc, Robert Hopkins, MA Department of Clinical Epidemiology & Biostatistics, McMaster University & Programs for Assessment ofTechnology in Health (PATH) Research Institute, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada Keywords: conditionally funded field evaluation, coverage with evidence development, evidence-based decision-making, health technology assessment, Ontario. Introduction Faced with escalating health-care costs, in 2003 the Ontario Ministry of Health and Long-Term Care (MOHLTC) decided to embark on a new evidence-based platform for decision-making around medical devices, procedures, and programs. This new venture was predicated on the belief that assessment of technolo- gies using a more systematic and rigorous process could improve efficiencies in the health-care system, potentially control rising health-care costs, and ultimately improve the overall health of Ontarians. In the case where the evidentiary base for a new technology is strong and fairly conclusive, making recommenda- tions about reimbursement, implementation, or uptake of the technology is relatively straightforward. However, what if the evidentiary base is of poor quality, conflicting, not based on “real world” effectiveness studies or there are concerns about imple- mentation and uptake of the technology for a particular jurisdic- tion? For example, economic evaluation evidence may exist, but because of known differences in unit costs, practice patterns, or patient preferences across jurisdictions, this might affect the transferability of economic evaluation data across jurisdictions. There may even be concerns about the generalizability of clinical evidence from other jurisdictions for local decision-making needs. For example, differences in patient characteristics like demographics or rates of compliance with therapies, or provider characteristics such as level of expertise or training, or health- care system characteristics like payment incentives or available infrastructure, can all affect whether, and to what extent, a technology works in a particular jurisdiction. In these cases, assessing the technology using local context-specific data collec- tion may be necessary. The Programs for Assessment of Technology in Health (PATH) Research Institute is the longest established group undertaking conditionally funded field evaluations (CFFEs) of health-care technologies in Ontario. CFFEs are safety, efficacy, effectiveness, or cost-effectiveness studies conducted in the “real world” (i.e., more pragmatic) and where funding for the technology or use of the technology is conditional on sites or professionals participat- ing in data collection for evaluation purposes. There are other groups in Ontario conducting CFFEs and each research group not only addresses slightly different levels of decision uncertainty, but each group also approaches and conducts CFFEs in slightly different ways. The CFFE process used by PATH, illustrative examples of completed CFFEs and their impact on policy and reimbursement in the province are discussed. Finally challenges for government and researchers are highlighted with some con- clusions for moving forward. Ontario’s Evidence-Based HealthTechnology Assessment (HTA) Process An overview of Ontario’s evidence-based HTA process and the role of CFFEs are provided in Figure 1. The process begins when a health-care organization, health-care facility or health-care provider requests that the MOHLTC consider purchasing or reimbursing a new technology in the province. The funding requests for surgical or diagnostic procedures, devices or prod- ucts, or new programs or services are submitted to a division of the MOHLTC called the Medical Advisory Secretariat (MAS), which conducts an initial scan of the technology and prioritizes using a standardized scoring algorithm. This initial scan and scoring is then presented to the Ontario Health Technology Advi- sory Committee (OHTAC), which meets once a month to review evidence around technologies and makes recommendations to the Deputy Minister of Health. OHTAC was formed in 2003 to create an evidence-based single point of entry for the uptake and diffusion of health technologies in the province and consists of clinical epidemiologists, clinicians, health economists, health policy analysts, health services researchers, bioethicists, senior hospital administrators, and representatives from the Ontario Hospital Association, the Ontario Medical Association, Medical Device Manufacturing Association, and community-based health-care programs. Based on the initial scan and prioritiza- tion, OHTAC may reject the request for review, request more information or may decide that MAS proceed to conduct a Health Technology Policy Analysis (HTPA) around the technol- ogy. An HTPA is completed internally by MAS within 16 weeks, where the technology’s safety, efficacy, effectiveness, and cost- effectiveness are reviewed. Guided by a rating of the technology using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE), the evidence around the technology is deliberated by OHTAC at which point OHTAC may make a policy recommendation regarding the uptake and diffusion of the technology. OHTAC may also conclude that there is not enough information to make an evidence-based decision, and recom- mend that a CFFE be undertaken. Address correspondence to: Ron Goeree, Department of Clinical Epidemi- ology & Biostatistics, McMaster University & Programs for Assessment of Technology in Health (PATH) Research Institute, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada L8P 1H1. E-mail: goereer@mcmaster.ca 10.1111/j.1524-4733.2010.00747.x Ron Goeree, Jean-Eric Tarride, Daria O’Reilly, Feng Xie, James Bowen, Gord Blackhouse, Kiran Chandra, and Robert Hopkins have no conflicts to declare. Volume 13 • Supplement 1 • 2010 VALUE IN HEALTH S8 © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 1098-3015/10/S8 S8–S11