There is no 'I' in RWE: (but there's a 'we'...): Opportunities and barriers to use of real-world evidence in Canada Presentation to: CADTH Symposiym, Saskatoon, 14, April, 2015 Don Husereau BScPharm, MSc (1) Senior Associate, Institute of Health Economics, Edmonton, Alberta (2) Adjunct Professor, Department of Epidemiology and Community Medicine, University of Ottawa (3) Senior Scientist, Institute for Public Health, Medical Decision Making and Health Technology Assessment UMIT - Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik GmbH TCU Place– Saskatoon, Apr 14, 2015

Disclosures and acknowledgements The roundtable hosted by the IHE was supported by, developed and delivered in partnership with AstraZeneca Canada. It was held in association with the Canadian Agency for Drugs and Technologies in Health 2014 Symposium. Travel and related expenses for developing this Panel supported by Janssen Inc. Some of my relevant current activities: – Senior Associate, IHE – Member, pCODR Economic Guidance Panel – Lead, International Society for Pharmacoeconomics and Outcomes Research European Patient Representatives Roundtable – Senior Scientist, Institute for Public Health, Medical Decision Making and Health Technology Assessment, UMIT – Payer and strategic advisor, some pharmaceutical and medical device companies Collaborators on this topic – IHE (PPP, Universities of Calgary, Alberta; Alberta Government (Health), Alberta innovates Health Solutions, Alberta Health Services, Alberta Innovates- Health Solutions; AstraZeneca, Eli Lilly, GSK, Merck, Pfizer); Institute of Governance (Eddy Nason), AstraZeneca

Acknowledgements Chris Henshall, Health Economics Research Group (HERG), Brunel University John Sproule, Senior Policy Director, Institute of Health Economics Lisa Marsden, VP of Market Access & Government Relations at AstraZeneca Canada Vasanthi Srinivasan, Executive Director, Ontario SPOR DSU Greg Rossi, VP Payer and Real World Evidence Tara Gomes, Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto Jaclyn Bosco, Associate Director, Epidemiology, Real-World & Late Phase Research, Quintiles Adrian R. Levy, Professor and Head, Community Health and Epidemiology, Dalhousie Anne MacFarlane, Vice President, Western Canada and Development Initiatives David Henry, University of Toronto Tara Gomes, Applied Health Research Centre, St. Michael's Hospital Cy Frank, CEO, Alberta Innovates – Health Solutions (AI-HS) Greg Zaric, Professor, Ivey Business School Elaine Campbell, President of AstraZeneca Canada Inc. Neil Corner, Director, Innovative Solutions (Real World Evidence Lead) at IMS Brogan Deborah Marshall, Associate Professor, University of Calgary Robyn Tamblyn, Director, Canadian Institutes of Health Research – Institute for Health Services and Policy Research Suzanne McGurn, ADM Ontario MOHLTC Carole McMahon, Patient representative expert, pan-Canadian Oncology Drug Review Expert Review Committee Suzanne McGurn, ADM Ontario MOHLTC Muhammad Mamdani, Director, Applied Health Research Centre, St. Michael's Hospital

Context Role of evidence to support decision-making gaining prominence Increased use of data routinely collected for the purpose of reimbursing provider services, monitoring hospital activities, or for management of individual patient care. These data can provide decision-makers with real world evidence (RWE) to inform or revisit health system decisions.

Context RWE becoming of increased importance to – Regulators – Payers – Researchers – Industry

Real world evidence roundtable In April 2014, we held the first roundtable discussion on the current and future role of real world evidence (RWE) in Canada, bringing together multiple stakeholders from across Canada and internationally. The objectives of this roundtable were to: – Discuss the current and potential state of the use of routinely collected data within health systems to improve health outcomes – Identify opportunities and barriers to incenting and organizing policy makers, health system administrators, care providers, industry, and researchers to use and apply appropriate methods. – Articulate some directions and goals for more appropriate and widespread use of routinely collected data to improve health outcomes within Canadian health systems.

Issues identified Linking real world evidence with innovation and research: – There is a need to build a culture that does not make artificial distinctions between health service delivery and research and recognizes the value and role RWE can play in fostering health care system innovation

Issues identified Aligning real world evidence with public and patient outcomes, and policy priorities: – Patients, providers and the public may be too far removed from decisions to use RWE to appreciate its potential to improve the quality and efficiency of care. – A greater understanding of the value of RWE is required. Some current RWE initiatives lack meaningful participation by all stakeholders.

Issues identified Data linkage for real world evidence: – There is still a need to use common healthcare information technology (IT) data structures and vocabularies to allow better linkage and analysis so that RWE can become a more useful tool to support decisions in the health system.

Next Steps Determining where real world evidence is most suitable and what evidence to use: – Support appropriateness of care initiatives, such as those being undertaken by the Health Care Working Group (HCWG) of the Council of the Federation. – The HCWG could also play a real role in adopting common IT data structures.

Next Steps Make (better) use of existing data and infrastructure in Canada: Build capacity for real world evidence in Canada: This includes building research, data and infrastructure, and receptor capacity for RWE: Create a ‘safe space’ for all stakeholders to continue to discuss and develop real world evidence:

Real world evidence roundtable In November 2014, we held the second roundtable discussion The objectives of this roundtable were to: – Identify situations where and when real-world evidence can be most impactful to health care policymakers in monitoring patient outcomes and health system performance. – Articulate questions or guiding principles that can be leveraged by existing real-world data programs and processes and will accelerate their capabilities and effectiveness. – Discuss critical factors for building RWE capabilities in Canada for improving the use of real-world evidence such as data success, linkage and public perception of risk.

Considerations and Future Actions Timeliness – There are barriers to timely access and analysis A collaborative approach is essential – All stakeholders in the health system (government, academia, industry, provider, and patients) is critical for success. More patient engagement is required – Lessons learned internationally suggest patient concerns about privacy must be balanced with concerns about appropriate care using the best available evidence

Considerations and Future Actions Increasing investment in data infrastructure can curb health system spending. Current efforts to build capacity in this area, such as through the Canadian Institutes for Health Research (CIHR) Strategy for Patient Oriented Research (SPOR) Decision Support Units must also be matched by investments to: Update data infrastructure so that outcomes relevant for decision (e.g., patient outcomes, cost and operational outcomes) are included Cover operational costs of data access for qualified researchers, to allow access to comprehensive health information Ultimately reduce operational costs of research, by improving accuracy of information and reducing the need to collect and analyse additional information