Future Role of Health Technology Assessment for Genomic Medicine in Oncology: A Canadian Laboratory Perspective

Don Husereau¹, Yvonne Bombard^{2

3}, Tracy Stockley^{4

5}, Michael Carter⁶, Scott Davey^{7

8

9}, Diana Lemaire¹⁰, Erik Nohr^{11

12}, Paul Park¹³, Alan Spatz^{14

15

16}, Christine Williams^{7

10}, Aaron Pollett^{17

18}, Bryan Lo¹⁹, Stephen Yip²⁰, Soufiane El Hallani²¹, Harriet Feilotter^{7

10}

Affiliations

¹ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada.
² Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON M5T 3M6, Canada.
³ Genomics Health Services Research Program, Li Ka Shing Knowledge Institute, Michael's Hospital, Unity Health Toronto, Toronto, ON M5B 1T8, Canada.
⁴ Division of Clinical Laboratory Genetics, Laboratory Medicine Program, University Health Network, 200 Elizabeth Street, Toronto, ON M5G 2C4, Canada.
⁵ Department of Laboratory Medicine and Pathobiology, University of Toronto, 1 King's College Circle, Toronto, ON M5S 1A8, Canada.
⁶ Department of Pathology and Laboratory Medicine, Nova Scotia Health (Central Zone), Halifax, NS B3H 1V8, Canada.
⁷ Department of Pathology and Molecular Medicine, Queen's University, Kingston, ON K7L 3N6, Canada.
⁸ Division of Cancer Biology and Genetics, Queen's University Cancer Research Institute, Queen's University, Kingston, ON K7L 3N6, Canada.
⁹ Departments of Oncology and Biomedical and Molecular Sciences, Queen's University Cancer Research Institute, Queen's University, Kingston, ON K7L 2V7, Canada.
¹⁰ Ontario Institute for Cancer Research, 661 University Ave, Toronto, ON M5G 0A3, Canada.
¹¹ Department of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB T2N 1N4, Canada.
¹² Alberta Precision Laboratories, Foothills Medical Center, 1403 29 St NW, Calgary, AB T2N 2T9, Canada.
¹³ Department of Pathology, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB R3A 1R9, Canada.
¹⁴ Division of Pathology, McGill University Health Center, 1001 Decarie Blvd., Montreal, QC H4A 3J, Canada.
¹⁵ OPTILAB-MUHC & Department of Laboratory Medicine, 1001 Decarie Blvd., Montreal, QC H4A 3J, Canada.
¹⁶ Research Molecular Pathology Center, Lady Davis Institute, 3755 Côte Ste-Catherine Road, Montreal, QC H3T 1E2, Canada.
¹⁷ Pathology & Laboratory Medicine, Sinai Health System, Toronto, ON M5G 1X5, Canada.
¹⁸ Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON M5S 1A8, Canada.
¹⁹ The Ottawa General Hospital, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada.
²⁰ Department of Pathology & Laboratory Medicine, Faculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z7, Canada.
²¹ Alberta Precision Laboratory, Department of Laboratory Medicine and Pathology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2R7, Canada.

PMID: 37999120
PMCID: PMC10670221
DOI: 10.3390/curroncol30110700

Review

Future Role of Health Technology Assessment for Genomic Medicine in Oncology: A Canadian Laboratory Perspective

Don Husereau et al. Curr Oncol. 2023.

. 2023 Oct 31;30(11):9660-9669.

doi: 10.3390/curroncol30110700.

Authors

Affiliations

¹ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada.
² Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON M5T 3M6, Canada.
³ Genomics Health Services Research Program, Li Ka Shing Knowledge Institute, Michael's Hospital, Unity Health Toronto, Toronto, ON M5B 1T8, Canada.
⁴ Division of Clinical Laboratory Genetics, Laboratory Medicine Program, University Health Network, 200 Elizabeth Street, Toronto, ON M5G 2C4, Canada.
⁵ Department of Laboratory Medicine and Pathobiology, University of Toronto, 1 King's College Circle, Toronto, ON M5S 1A8, Canada.
⁶ Department of Pathology and Laboratory Medicine, Nova Scotia Health (Central Zone), Halifax, NS B3H 1V8, Canada.
⁷ Department of Pathology and Molecular Medicine, Queen's University, Kingston, ON K7L 3N6, Canada.
⁸ Division of Cancer Biology and Genetics, Queen's University Cancer Research Institute, Queen's University, Kingston, ON K7L 3N6, Canada.
⁹ Departments of Oncology and Biomedical and Molecular Sciences, Queen's University Cancer Research Institute, Queen's University, Kingston, ON K7L 2V7, Canada.
¹⁰ Ontario Institute for Cancer Research, 661 University Ave, Toronto, ON M5G 0A3, Canada.
¹¹ Department of Pathology and Laboratory Medicine, University of Calgary, Calgary, AB T2N 1N4, Canada.
¹² Alberta Precision Laboratories, Foothills Medical Center, 1403 29 St NW, Calgary, AB T2N 2T9, Canada.
¹³ Department of Pathology, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB R3A 1R9, Canada.
¹⁴ Division of Pathology, McGill University Health Center, 1001 Decarie Blvd., Montreal, QC H4A 3J, Canada.
¹⁵ OPTILAB-MUHC & Department of Laboratory Medicine, 1001 Decarie Blvd., Montreal, QC H4A 3J, Canada.
¹⁶ Research Molecular Pathology Center, Lady Davis Institute, 3755 Côte Ste-Catherine Road, Montreal, QC H3T 1E2, Canada.
¹⁷ Pathology & Laboratory Medicine, Sinai Health System, Toronto, ON M5G 1X5, Canada.
¹⁸ Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON M5S 1A8, Canada.
¹⁹ The Ottawa General Hospital, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada.
²⁰ Department of Pathology & Laboratory Medicine, Faculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z7, Canada.
²¹ Alberta Precision Laboratory, Department of Laboratory Medicine and Pathology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2R7, Canada.

PMID: 37999120
PMCID: PMC10670221
DOI: 10.3390/curroncol30110700

Abstract

Genome-based testing in oncology is a rapidly expanding area of health care that is the basis of the emerging area of precision medicine. The efficient and considered adoption of novel genomic medicine testing is hampered in Canada by the fragmented nature of health care oversight as well as by lack of clear and transparent processes to support rapid evaluation, assessment, and implementation of genomic tests. This article provides an overview of some key barriers and proposes approaches to addressing these challenges as a potential pathway to developing a national approach to genomic medicine in oncology.

Keywords: analytic validity; clinical utility; clinical validity; genomic biomarkers; health technology assessment.

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Conflict of interest statement

The authors declare the following conflict of interest. D.H. has received funding, outside the submitted work, from pharmaceutical and diagnostic companies with an interest in genome-based testing and precision medicine, including Amgen Canada Inc., AstraZeneca Canada, Eli Lilly Canada Inc., GlaxoSmithKline Inc. (GSK Canada), Janssen Inc./J&J, Pfizer Canada ULC, Thermo Fisher Scientific Inc., and Roche Canada. Y.B. is cofounder of Genetics Adviser. T.S. has been a consultant for Health Canada (current) Advisory boards (with honoraria) within the past 36 months, related to diagnostic genetics, from AstraZeneca, Janssen, Bayer, Pfizer, and Merck. M.C. has participated in advisory boards and/or received speaking honoraria from Amgen, Incyte, Janssen, Merck, Novartis, and Pfizer. E.N. and S.E.H. both receive funding from Alberta Precision Laboratories E.N. has received an honorarium from Bayer Pharmaceuticals and Grants/Research Support from AstraZeneca. D.L., P.P., A.S., C.W., A.P., S.Y., S.E.H., and H.F. have no conflicts to disclose that are relevant to this article.

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Future Role of Health Technology Assessment for Genomic Medicine in Oncology: A Canadian Laboratory Perspective

Affiliations

Future Role of Health Technology Assessment for Genomic Medicine in Oncology: A Canadian Laboratory Perspective

Authors

Affiliations

Abstract

Conflict of interest statement

References

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