This document discusses a panel on the evolving role of real-world evidence to support healthcare policy and practice. It provides an introduction to real-world evidence and its increasing importance. The panel will discuss current and future trends in the use of real-world data from electronic health records to conduct healthcare assessments and support decision making. This includes issues around frameworks for using real-world evidence, aligning with patient and policy priorities, and overcoming technical challenges. The discussion will also involve perspectives from healthcare, industry, and research on preparing for the growing role of real-world evidence.

1. The evolving role of real-world evidence to
support policy and practice
CADTH 2015

2. Content
• “Let’s get Real” Introduction
− Neil Corner, Director of Innovation and Real World Evidence, IMS Health
brogan, Canada
• Utility of RWE in creating and capturing measurable
value; a practical provider's perspective
− Peter Fenwick, Senior Provincial Director, Major Initiatives, Alberta Health
Services
• “RWE is the New Black: A Perspective from Industry”
− Julia Brown, Vice President, Government Affairs and Market Access,
Janssen Inc.
• “There is no 'I' in RWE (but there's a 'we'...)” National
requirements for better use of RWE
− Don Husereau, Senior Associate, Institute of Health Economics
• Discussion
2
90 minutes

3. Let’s Get Real
• Title: The evolving role of real-world assessment to support policy and practice
• Routinely collected data within health systems is increasingly being viewed as a means
to increase payer certainty by conducting assessments of performance in the “real
world”. There are considerable issues that arise when considering how to best use real-
world evidence: these include the need for a clear framework of priority setting; shifting
attitudes about the roles of health care research and delivery; aligning these activities
with patient preferences and political priorities; and overcoming technical challenges
related to information technology as well as applying appropriate epidemiologic
methods. The last 10 years in Canada has seen a shift toward the use of real world
evidence in some areas. As this use of real-world evidence becomes routine, it will have
a real impact on payers and the HTA bodies that support them, as well as providers,
patients and industry. This panel will discuss current and future trends and how health
care, industry, and academic leaders along with HTA bodies might best prepare for it.
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Abstract

4. 4
What is Real World Evidence in Canada?
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5. Europe
5
• The Innovative Medicines Initiative (IMI) is working to improve
health by speeding up the development of, and patient
access to, innovative medicines, particularly in areas where there is
an unmet medical or social need. It does this by facilitating
collaboration between the key players involved in healthcare research,
including universities, the pharmaceutical and other industries, small and
medium-sized enterprises (SMEs), patient organisations, and medicines
regulators. IMI is a partnership between the European Union (represented
by the European Commission) and the European pharmaceutical
industry (represented by EFPIA, the European Federation of Pharmaceutical
Industries and Associations).
• The budget
• IMI is the world's biggest public-private partnership (PPP) in the life
sciences; Through the IMI 2programme, it has a €3.3 billion budget for the
period 2014-2024.

6. Europe
GetReal is a project of the Innovative Medicines Initiative (IMI), a
public-private consortium consisting of pharmaceutical companies,
academia, HTA agencies and regulators (e.g., NICE, HAS, EMA and
ZIN), patient organisations and SMEs.
• Bringing together regulators, HTA bodies, academics, companies, patients and other
societal stakeholders;
• Assessing existing processes, methodologies, and key research issues;
• Proposing innovative (and more pragmatic) trial designs and assessing the value of
information;
• Proposing and testing innovative analytical and predictive modelling approaches;
• Assessing operational, ethical, regulatory issues and proposing and testing solutions;
• Creating new decision making frameworks, and building open tools to allow for the
evaluation of development programmes and use in the assessment of the value of new
medicines;
• Sharing and discussing deliverables with, among others, Pharmaceutical companies,
regulatory authorities, HTA / reimbursement agencies, clinicians and patient
organizations;
• Developing training activities for researchers, decision makers and societal stakeholders
in the public and private sector in order to increase knowledge about various aspects of
relative effectiveness.
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7. Examining Type 2 Diabetes through the RWE lens
1 1.OECD Health Statistics 2014 : How does Canada compare? Available at: http://www.oecd.org/els/health-systems/Briefing-Note-CANADA-2014.pdf. Accessed 6 October, 2014
2 Statistics Canada, Community Health Survey 2012. Available at http://www.statcan.gc.ca/pub/82-625-x/2013001/article/11832-eng.htm. Accessed 6 October, 2014

8. 8
Source: IMS Evidence 360: A database of
850,000 Canadian De-identified longitudinal
electronic medical records. Period: June 2013 to
May 2014

9. 9
Source: IMS Evidence 360: A database of over 800,000 Canadian
De-identified longitudinal electronic medical records
Source: IMS Evidence 360: A database of
850,000 Canadian De-identified longitudinal
electronic medical records. Period: June 2013 to
May 2014

10. 10
% of Patients taking T2D
medications with HbA1c controlled
Under 7% Equal to or Over 7%
Source: IMS Evidence 360: A database of
850,000 Canadian De-identified longitudinal
electronic medical records. Period: June 2013 to
May 2014
Level of control of type 2 diabetes in Canadians

11. Source: IMS Evidence 360: A database of
850,000 Canadian De-identified longitudinal
electronic medical records. Period: June 2013 to
May 2014
Real World Evidence suggests we are failing to
deliver results with T2D - action is required
• Newer drugs are more effective at controlling symptoms, with
fewer side effects enabling improved HbA1c control and
slowing disease progression.
• Examine the impact on early intervention with SGLTs, SGLT2s
and DPP4s on physician work load and real world outcomes.
• Align budgets within provincial governments to enable the
benefits from newer drugs which may reduce the costs of
hospitalizations and GP visits to be realized.
• Trust the evidence. It is easy to criticize the data. Big data
will drive the future of our health system.
• Are our policies progressive enough to match those in
Europe? Or are we going to be left behind in Canada?