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

Content 90 minutes “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

Let’s Get Real Abstract 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. Presentation Title [via Insert tab > Header & Footer] Fixed Date [via Insert tab > Header & Footer]

What is Real World Evidence in Canada?

Europe 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.

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.

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

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

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

Level of control of type 2 diabetes in Canadians 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? Source: IMS Evidence 360: A database of 850,000 Canadian De-identified longitudinal electronic medical records. Period: June 2013 to May 2014