The document summarizes discussions from two roundtables on opportunities and barriers to using real-world evidence in Canada. Key points identified include the need to: 1) build a culture that recognizes real-world evidence can foster healthcare innovation; 2) increase understanding of real-world evidence's value to improve quality and efficiency; and 3) use common data structures and vocabularies to better link and analyze data. Next steps discussed building real-world evidence capacity in Canada through continued stakeholder discussions, leveraging existing data infrastructure, and balancing privacy concerns with the need for appropriate care.

1. 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 dhusereau@ihe.ca
(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

2. 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

3. 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

5. 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.

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

7. 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.

8. 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

9. 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.

10. 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.

11. 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.

12. 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:

13. 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.

14. 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

15. 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