REAL-WORLD CLINICAL EVIDENCE DEVELOPMENT- AN ANALYSIS OF RELEVANT INTERNATIONAL MODELS FOR THE POTENTIAL IMPLEMENTATION OF SUCH A PROGRAM IN QUEBEC

Author(s)

Bibeau J1, Savoie M2, Lachaine J1
1University of Montreal, Montreal, QC, Canada, 2Montreal InVivo, Montreal, QC, Canada

OBJECTIVES: There is a growing need for the development of real-world clinical evidences, particularly in the field of health technology assessments. The objective of this analysis was to identify and describe the key elements for the implementation of a program aiming to develop real-world clinical evidences in Quebec. METHODS: A literature review was conducted to analyze the position, progress and development of strategies fostering risk management and development of real-world clinical evidences in different provinces and countries. A literature search was performed using electronic databases including Pubmed, Medline and Embase. Additional guidelines and government policies were retrieved using Google and Google Scholar. The following keywords, were used for search, alone or in combination: risk-sharing and product listing agreements, coverage with evidence development, patient access scheme, drug reimbursement, risk management, clinical evidence development, real-world, real-life setting.   RESULTS: A total of 15 programs of risk management and development of real-world clinical evidence were analyzed. Of these programs, 6 were selected as relevant models for the province of Quebec. For 4 of these programs, ongoing in Canada, Australia and Europe, it was the manufacturer’s responsibility to develop and perform data collection. Otherwise, it was the responsibility of government agencies. For 100% of analyzed programs, a substantial financial participation from the manufacturer was required. Half of programs reported a direct participation of academic research institutions in the collection and processing of data while the other half did not mention their participation explicitly. Fifty percent of these programs were related to a reimbursement decision. CONCLUSIONS: This study indicated that the success of programs aiming to develop real-world clinical evidences involve active participation of academic research organizations as well as support from the manufacturers. These key elements should be considered in developing such a program in Quebec.

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PHP48

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways, Decision & Deliberative Processes, Health Disparities & Equity

Disease

Multiple Diseases

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