Hostname: page-component-586b7cd67f-t7czq Total loading time: 0 Render date: 2024-11-22T06:54:21.976Z Has data issue: false hasContentIssue false
  • English
  • Français

Use of Real-World Data Sources for Canadian Drug Pricing and Reimbursement Decisions: Stakeholder Views and Lessons for Other Countries

Published online by Cambridge University Press:  28 May 2019

Don Husereau ,
Edward Nason ,
Tarun Ahuja ,
Enkeleida Nikaï ,
Eva Tsakonas  and
Philip Jacobs
Don Husereau*
Affiliation:
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada
Edward Nason
Affiliation:
Ontario SPOR Support Unit, Toronto, Canada
Tarun Ahuja
Affiliation:
Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada
Enkeleida Nikaï
Affiliation:
Eli Lilly Benelux S.A., Brussels, Belgium
Eva Tsakonas
Affiliation:
Independent consultant, Montreal, Canada
Philip Jacobs
Affiliation:
University of Alberta, Edmonton, Canada
*
Author for correspondence: Don Husereau, E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Background

Canada has a long history of the use of clinical evidence to support healthcare decision making. Given improvements in data holdings and analytic capacity in Canada and stakeholder interest, the purpose of this study is to reflect on perceptions of the value of real-world evidence in pricing and reimbursement decisions, barriers to its optimal use in pricing and reimbursement, current initiatives that may lead to its increased use, and what role the pharmaceutical industry may play in this.

Methods/Results

To capture stakeholder perceptions, ninety-one participants identified as key stakeholders were identified according to background roles and geography and invited to participate in four round table discussions conducted under Chatham House rule. Important themes emerging from these discussions included: (i) the need to understand what “real world” evidence means; (ii) barriers to using real world evidence from differences in access, governance, inter-operability, system structures, expertise, and quality across Canadian health systems; (iii) differing views on industry's role.

Conclusions

The use of real-world data in Canada to inform pricing and reimbursement decisions is far from routine but nascent and slowly increasing. Barriers, including interoperability concerns, may also apply to other federated health systems that need to focus on the networking of healthcare administrative data across provincial jurisdictional boundaries. There also appears to be a desire to see better use of pragmatic trials linked to these administrative data sets. Emerging initiatives are under way to use real world evidence more broadly, and include identification of common data elements and approaches to networking data.

Keywords

DataHealthcare policyReal-world dataEvidence generation
Type
Policy
Information
International Journal of Technology Assessment in Health Care , Volume 35 , Issue 3 , 2019 , pp. 181 - 188
Copyright
Copyright © Cambridge University Press 2019 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Sackett, DL (1969) Clinical epidemiology. Am J Epidemiol 89, 125–128.Google Scholar
2.Desai, S, lsmail, SJ, Lerch, R, Warshawsky, BF, Gemmill, I (2015) Canada's National Advisory Committee on Immunization: Celebrating 50 years. Can J Infect Dis Med Microbiol 26, 126–128.Google Scholar
3.No Authors listed (1979) The periodic health examination. Canadian Task Force on the Periodic Health Examination. Can Med Assoc J 121, 1193–1254.Google Scholar
4.Battista, RN, Côté, B, Hodge, MJ, Husereau, D (2009) Health technology assessment in Canada. Int J Technol Assess Health Care 25(Suppl 1), 53–60.Google Scholar
5.Martin, J, Polisena, J, Dendukuri, N, Rhainds, M, Sampietro-Colom, L (2016) Local health technology assessment in Canada: Current state and next steps. Int J Technol Assess Health Care 32, 175–180.Google Scholar
6.Sackett, DL, Rosenberg, WMC, Gray, JAM, Haynes, RB, Richardson, WS (1996) Evidence based medicine: What it is and what it isn't. BMJ 312, 71–72.Google Scholar
7.Rocchi, A, Miller, E, Hopkins, RB, Goeree, R (2012) common drug review recommendations: An evidence base for expectations? PharmacoEconomics 30, 229–246.Google Scholar
8.Panteli, D, Arickx, F, Cleemput, I, et al. (2016) Pharmaceutical regulation in 15 European countries review. Health Syst Transit 18, 1–122.Google Scholar
9.Royle, P, Kandala, N-B, Barnard, K, Waugh, N (2013) Bibliometrics of systematic reviews: Analysis of citation rates and journal impact factors. Syst Rev 2, 74.Google Scholar
10.Jamali, A, Nedjat, S, Heidari, K, et al. (2015) Worldwide inequality in production of systematic reviews. Med J Islam Repub Iran 29, 309.Google Scholar
11.Rocchi, A, Menon, D, Verma, S, Miller, E (2008) The role of economic evidence in Canadian oncology reimbursement decision-making: To lambda and beyond. Value Health 11, 771–783.Google Scholar
12.Jacobs, P, Roos, NP (1999) Standard cost lists for healthcare in Canada. Issues in validity and inter-provincial consolidation. PharmacoEconomics 15, 551–560.Google Scholar
13.Roos, NP, Black, C, Frohlich, N, et al. (1996) Population health and health care use: An information system for policy makers. Milbank Q 74, 3–31.Google Scholar
14.Fisher, ES, Malenka, DJ, Wennberg, JE, Roos, NP (1990) Technology assessment using insurance claims. Example of prostatectomy. Int J Technol Assess Health Care 6, 194–202.Google Scholar
15.Klemp, M, Frønsdal, KB, Facey, K, HTAi Policy Forum (2011) What principles should govern the use of managed entry agreements? Int J Technol Assess Health Care 27, 77–83.Google Scholar
16.Lucyk, K, Lu, M, Sajobi, T, Quan, H (2015) Administrative health data in Canada: Lessons from history. BMC Med Inform Decis Mak 15, 69.Google Scholar
17.Morin, SN, Flegel, K (2017) A national health care data network is overdue. CMAJ 189, E951.Google Scholar
18.Chatham House (2019) Chatham House Rule. https://www.chathamhouse.org//node/44.Google Scholar
19.Institute of Health Economics (2017) Real-world evidence: What role can it play in real-world decision making? Summary Report. https://www.ihe.ca/advanced-search/real-world-evidence-what-role-can-it-play-in-real-world-decision-making-summary-report.Google Scholar
20.Institute of Health Economics (2016) About the real-world evidence into decision making roundtable. https://www.ihe.ca/events/past/conferences/rwedm/about-rwedm.Google Scholar
21.Institute of Health Economics (2014) About the Real World Evidence Roundtable. https://www.ihe.ca/events/past/conferences/real-world-evidence/about-rwe.Google Scholar
22.Scott, PJ, Rigby, M, Ammenwerth, E, et al. (2017) Evaluation considerations for secondary uses of clinical data: Principles for an evidence-based approach to policy and implementation of secondary analysis. A position paper from the IMIA Technology Assessment & Quality Development in Health Informatics Working Group. Yearb Med Inform 26, 59–67.Google Scholar
23.Council of Canadian Academies (2015) Accessing health and health-related data in Canada: The expert panel on timely access to health and social data for health research and health system innovation. Ontario: Council of CanadianAcademies.Google Scholar
24.Garrison, LP, Neumann, PJ, Erickson, P, Marshall, D, Mullins, CD (2007) Using real-world data for coverage and payment decisions: The ISPOR Real-World Data Task Force report. Value Health 10, 326–335.Google Scholar
25.McCabe, CJ, Stafinski, T, Edlin, R, Menon, D (2010) Access with evidence development schemes: A framework for description and evaluation. PharmacoEconomics 28, 143–152.Google Scholar
26.Wodchis, W, Bushmeneva, K, Nikitovic, M, McKillop, I (2013) Guidelines on person-level costing using administrative databases in Ontario. https://tspace.library.utoronto.ca/handle/1807/87373.Google Scholar
27.Elshaug, AG, Moss, JR, Littlejohns, P, et al. (2009) Identifying existing health care services that do not provide value for money. Med J Aust 190, 269–273.Google Scholar
28.Government of Alberta (2015) Government introduces new eye care program, saving millions for patients and taxpayers. https://www.alberta.ca/release.cfm?xID=386013C86CA06-B059-36C8-B0F92434C5C65946.Google Scholar
29.IC/ES (2019) Data & analytic services. https://www.ices.on.ca/DAS.Google Scholar
30.University Hospital Foundation. (2017) https://www.universityhospitalfoundation.ab.ca/jahip-competition.Google Scholar
31.Kalkman, S, van Thiel, G, Zuidgeest, MGP, Goetz, I (2017) Challenges of informed consent for pragmatic trials. J Clin Epidemiol doi:10.1016/j.jclinepi.2017.03.019Google Scholar
32.Kim, SYH, Miller, FG (2014) Informed consent for pragmatic trials--the integrated consent model. N Engl J Med 370, 769–772.Google Scholar
33.Campbell, D (1969) Reforms as experiments. Am Psychol 24, 409–429.Google Scholar
34.Canadian Institute for Health Information (2018) Pan-Canadian oncology drug data minimum data set. https://secure.cihi.ca/estore/productSeries.htm?pc=PCC1715.Google Scholar
35.Ivers, NM, Grimshaw, JM (2016) Reducing research waste with implementation laboratories. Lancet 388, 547–548.Google Scholar
36.Canadian Institutes of Health Research (2012) SPOR SUPPORT Units. http://www.cihr-irsc.gc.ca/e/45859.html.Google Scholar
37.Chan, KK. Generating real world evidence to promote sustainability of cancer drug funding. www.cqco.ca/common/pages/UserFile.aspx?fileId=365985.Google Scholar
38.Government of Canada (2017) Remarks from the Honourable Jane Philpott, Minister of Health, to the Economic Club of Canada - May 16, 2017. https://www.canada.ca/en/health-canada/news/2017/05/economic_club_ofcanada-may162017.html?wbdisable=true.Google Scholar
39.Canadian Institutes of Health Research (2018) SPOR National Data Platform Webinar - Frequently asked questions - CIHR. http://www.cihr-irsc.gc.ca/e/50891.html#;1.Google Scholar
40.European Medicines Agency - Pharmacovigilance - Patient registries. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000658.jsp&mid=WC0b01ac0580961211.Google Scholar
41.Parent. http://www.parent-ror.eu/#/.Google Scholar
42.Suissa, S, Henry, D, Caetano, P, et al. (2012) CNODES: The Canadian Network for Observational Drug Effect Studies. Open Med 6, e134–e140.Google Scholar
43.Birtwhistle, R, Keshavjee, K, Lambert-Lanning, A, et al. (2009) Building a pan-Canadian primary care sentinel surveillance network: Initial development and moving forward. J Am Board Fam Med 22, 412–422.Google Scholar
44.Hennessy, DA, Flanagan, WM, Tanuseputro, P, et al. (2015) The Population Health Model (POHEM): An overview of rationale, methods and applications. Popul Health Metr 13, 24.Google Scholar
45.Canadian Centre for Applied Research in Cancer Control. About Canadian Centre for Applied Research in Cancer Control. https://cc-arcc.ca/.Google Scholar
46.Canadian Institutes of Health Research (2010) Strategy for patient-oriented research. http://www.cihr-irsc.gc.ca/e/41204.html.Google Scholar
47.Collier, R (2011) Federal government unveils patient-oriented research strategy. CMAJ 183, E993–E994.Google Scholar
48.Canadian Research Data Centre Network (2017) About the CRDCN. https://crdcn.org/about-crdcn.Google Scholar
49.Canadian Institute for Health Information (2017) About CIHI. Information on Canada's health systems. https://www.cihi.ca/en/about-cihi.Google Scholar
50.Khan, S, Moore, JE, Gomes, T, et al. (2014) The Ontario Drug Policy Research Network: Bridging the gap between research and drug policy. Health Policy 117, 392–398.Google Scholar
51.Dolan, D, Grainger, J, MacCallum, N, et al. (2012) The Institute for Clinical Evaluative Sciences: 20 years and counting. Healthc Q 15, 19–21.Google Scholar
52.Roos, NP, Roos, LL, Freemantle, J (2011) Administrative data and the Manitoba Centre for Health Policy: Some reflections. Healthc Policy 6, 16–28.Google Scholar
53.Chamberlayne, R, Green, B, Barer, ML, et al. (1998) Creating a population-based linked health database: A new resource for health services research. Can J Public Health 89, 270–273.Google Scholar
Supplementary material: File

Husereau et al. supplementary material

Husereau et al. supplementary material 1

Download Husereau et al. supplementary material(File)
File 5.8 MB