Optimizing the delivery of genetic and advanced diagnostic testing in the province of Ontario: challenges and implications for laboratory technology assessment and management in decentralized healthcare systems

References

• Government of Canada SC. Population estimates on July 1st, by age and sex. 2021; [cited 2022 Jan 17]. Available from: https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1710000501.
   Google Scholar
• Our Story | Ontario Health. 2022; [cited 2022 Jan 10]. Available from: https://www.ontariohealth.ca/our-story.
   Google Scholar
• Sumah AM, Baatiema L, Abimbola S. The impacts of decentralisation on health-related equity: a systematic review of the evidence. Health Policy. 2016;120(10):1183–1192.
   PubMed Web of Science ®Google Scholar
• Abimbola S, Baatiema L, Bigdeli M. The impacts of decentralization on health system equity, efficiency and resilience: a realist synthesis of the evidence. Health Policy Plan. 2019;34(8):605–617.
   PubMed Web of Science ®Google Scholar
• Ramos MC, Barreto JOM, Shimizu HE, et al. Regionalization for health improvement: a systematic review. PLoS One. 2020;15(12):e0244078.
   PubMed Web of Science ®Google Scholar
• Molecular Oncology Task Force. Ensuring access to high quality molecular oncology laboratory testing and clinical cancer genetic services in Ontario- Report of the molecular oncology task force. Cancer Care Ontario. 2008; Available from: https://collections.ola.org/mon/23001/289823.pdf
   Google Scholar
• Cancer Care Ontario. Recommendations report for Ontario’s clinical genetic services. Cancer Care Ontario. 2018; Available from: https://www.cancercareontario.ca/sites/ccocancercare/files/assets/ClinicalGeneticServicesRecommendationReport.pdf
   Google Scholar
• Office of the Auditor General of Ontario. Laboratory services in the health sector. Office of the Auditor General of Ontario. 2017; Available from: https://www.auditor.on.ca/en/content/annualreports/arreports/en17/v1_307en17.pdf
   Google Scholar
• A healthy Ontario: Building a sustainable health care system: Chapter 2: The vision for health care in Ontario | Ontario.ca. 2022; [cited 2022 Jan 10]. Available from: https://www.ontario.ca/document/healthy-ontario-building-sustainable-health-care-system/chapter-2-vision-health-care-ontario.
   Google Scholar
• Sikka R, Morath JM, Leape L. The quadruple aim: care, health, cost and meaning in work. BMJ qual saf. BMJ Publishing Group Ltd. 2015;24:608–610.
   Google Scholar
• Gutiérrez-Ibarluzea I, Chiumente M, Dauben H-P. The life cycle of health technologies. Challenges and ways forward. Front Pharmacol. 2017;8(14):14.
   PubMedGoogle Scholar
• Cancer Research Investment in Canada, 2018. 2018;8.
   Google Scholar
• Strategic Priorities – Mission & Priorities [Internet]. Clinical Trials Ontario. 2022; [cited 2022 Jan 10]. Available from: https://www.ctontario.ca/who-we-are-clinical-trials-ontario/mission-and-priorities-strategic-priorities/.
   Google Scholar
• INESSS [Internet]. INESSS. 2022; [cited 2022 Jan 10]. Available from: http://www.inesss.qc.ca/.
   Google Scholar
• Mateo J, Steuten L, Aftimos P, et al. Delivering precision oncology to patients with cancer. Nat Med. 2022;28(4):658–665.
   PubMed Web of Science ®Google Scholar
• Drummond MF, Schwartz JS, Jönsson B, et al. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008;24(3):244–258. discussion 362-368.
   PubMed Web of Science ®Google Scholar
• Stewart DJ, Maziak DE, Moore SM, et al. The need for speed in advanced non‐small cell lung cancer: a population kinetics assessment. Cancer Med. 2021;10(24):9040–9046.
   PubMed Web of Science ®Google Scholar
• Augustovski F, Alfie V, Alcaraz A, et al. A value framework for the assessment of diagnostic technologies: a proposal based on a targeted systematic review and a multistakeholder deliberative process in Latin America. Value Health. 2021;24(4):486–496.
   PubMed Web of Science ®Google Scholar
• hta-methods-and-process-guide-en.pdf. 2022; [cited 2022 Jan 17]. Available from: https://www.hqontario.ca/Portals/0/documents/evidence/reports/hta-methods-and-process-guide-en.pdf.
   Google Scholar
• Melosky B, Blais N, Cheema P, et al. Standardizing biomarker testing for Canadian patients with advanced lung cancer. Curr Oncol. 2018;25(1):73–82.
   PubMed Web of Science ®Google Scholar
• Cheung CC, Smith AC, Albadine R, et al. Canadian ROS proto-oncogene 1 study (CROS) for multi-institutional implementation of ROS1 testing in non-small cell lung cancer. Lung Cancer. 2021;160:127–135.
   PubMed Web of Science ®Google Scholar
• Torlakovic E, Albadine R, Bigras G, et al. Canadian multicenter project on standardization of programmed Death-Ligand 1 immunohistochemistry 22C3 Laboratory-Developed tests for pembrolizumab therapy in NSCLC. J Thorac Oncol. 2020;15(8):1328–1337.
   PubMed Web of Science ®Google Scholar
• Cutz J-C, Craddock KJ, Torlakovic E, et al. Canadian anaplastic lymphoma kinase study: a model for multicenter standardization and optimization of ALK testing in lung cancer. J Thorac Oncol. 2014;9(9):1255–1263.
   PubMed Web of Science ®Google Scholar
• Sabatini LM, Mathews C, Ptak D, et al. Genomic sequencing procedure microcosting analysis and health economic Cost-Impact analysis: a report of the association for molecular pathology. J Mol Diagn. 2016;18(3):319–328.
   PubMed Web of Science ®Google Scholar
• Hede K. Breast cancer testing scandal shines spotlight on black box of clinical laboratory testing. J Natl Cancer Inst. 2008;100(12):836–844.
   PubMedGoogle Scholar
• Husereau D, Sullivan T, Jacobs P. Towards Optimizing the Delivery of Diagnostic Testing in Cancer Care: A proposal to change genetic testing in Ontario. 2021. Available from: https://www.dropbox.com/s/2qtion2qo0auo45/White%20paper_FINAL_CONFIDENTIALV2.pdf?dl=0.
   Google Scholar
• Comprehensive-Cancer-Testing-Announcement-Wave-1.pdf. 2022; [cited 2022 Jan 10]. Available from: https://survivornet.ca/wp-content/uploads/2021/06/Comprehensive-Cancer-Testing-Announcement-Wave-1.pdf.
   Google Scholar
• Ontario Health. 2021. Hereditary Cancer Testing Eligibility Criteria: Version 2. Ontario health; 2021; [cited 2022 Mar 1]. Available from: https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.cancercareontario.ca/en/file/62671/download%3Ftoken%3D5usSZa-S&ved=2ahUKEwiistXYr6X2AhUej4kEHYUTAjkQFnoECA0QAQ&usg=AOvVaw1ukQ6iYUlawwCZ8KORFg1a.
   Google Scholar
• Sullivan T, Gordon P, Minto S. Laboratory Services Expert Panel. 2015; Available from: http://www.health.gov.on.ca/en/common/ministry/publications/reports/lab_services/labservices.pdf.
   Google Scholar
• ClinicalGeneticServicesRecommendationReport.pdf. 2022; [cited 2022 Jan 10]. Available from: https://www.cancercareontario.ca/sites/ccocancercare/files/assets/ClinicalGeneticServicesRecommendationReport.pdf.
   Google Scholar
• Sorenson C, Drummond M, Bhuiyan KB. Medical technology as a key driver of rising health expenditure: disentangling the relationship. Clinicoecon Outcomes Res. 2013;5:223–234.
   PubMedGoogle Scholar
• Pammolli F, Riccaboni M, Oglialoro C, et al. Medical devices competitiveness and impact on public health expenditure. Germany: University Library of Munich; 2005. Report No.: 16021. Available from: http://ideas.repec.org/p/pra/mprapa/16021.html
   Google Scholar
• Wurcel V, Cicchetti A, Garrison L, et al. The value of diagnostic information in personalised healthcare: a comprehensive concept to facilitate bringing this technology into healthcare systems. Public Health Genomics. 2019;22(1–2):8–15.
   PubMed Web of Science ®Google Scholar
• Snape K, Wedderburn S, Barwell J. The new genomic medicine service and implications for patients. Clin Med. 2019;19(4):273–277.
   PubMed Web of Science ®Google Scholar
• Scotland PM. About Precision Medicine Scotland Innovation Centre. Precision Medicine Scotland. 2012; [cited 2022 Jan 10]. Available from: https://www.precisionmedicinescotland.com/about-pms/.
   Google Scholar
• Die deutsche Genom-Initiative – genomDE. 2022. [cited 2022 May 10]. Available from: https://www.bundesgesundheitsministerium.de/themen/gesundheitswesen/personalisierte-medizin/genomde-de.html.
   Google Scholar
• $185 million investment to fast-track treatments for rare and ‘untreatable’ cancers. Garvan Institute of Medical Research. 2022; [cited 2022 May 3]; Available from: https://www.garvan.org.au/news-events/news/185-million-investment-to-fast-track-treatments-for-rare-and-2018untreatable2019-cancers.
   Google Scholar
• Hogervorst MA, Vreman RA, Mantel-Teeuwisse AK, et al. Reported challenges in health technology assessment of complex health technologies. Value in Health. 2021; [cited 2022 Feb 8]. Available from: https://www.sciencedirect.com/science/article/pii/S1098301521031879
   Google Scholar
• Challenges of Health Technology Assessment (HTA) in Pluralistic Healthcare Systems: Report of an ISPOR HTA Council Working Group. Value in Health (Elsevier Science). [in press].
   Google Scholar
• Ozdemir V, Husereau D, Hyland S, et al. Personalized medicine beyond genomics: New technologies, global health diplomacy and anticipatory governance. Curr Pharmacogenomics Person Med. 2009;7(4):225–230.
   PubMedGoogle Scholar
• Greenhalgh T, Robert G, Macfarlane F, et al. Diffusion of innovations in service organizations: systematic review and recommendations. Milbank Q. 2004;82(4):581–629.
   PubMed Web of Science ®Google Scholar
• Wong J. The history of technology assessment and comparative effectiveness research for drugs and medical devices and the role of the federal government. Biotechnol Law Rep. 2014;33(6):221–248.
   PubMed Web of Science ®Google Scholar
• Ontario Health (Quality). Genome-Wide sequencing for unexplained developmental disabilities or multiple congenital anomalies: a health technology assessment. Ont Health Technol Assess Ser. 2020;20:1–178.
   Google Scholar
• Pollard S, Weymann D, Chan B, et al. Defining a core data set for the economic evaluation of precision oncology. Value Health. 2022;2022:S1098-3015(22)00055-9.
   Google Scholar
• Girling A, Lilford R, Cole A, et al. Headroom approach to device development: current and future directions. Int J Technol Assess Health Care. 2015;31(5):331–338.
   PubMed Web of Science ®Google Scholar
• Fenwick E, Claxton K, Sculpher M. The value of implementation and the value of information: Combined and uneven development. Med decis making. 2008. 28:21–32.
   PubMed Web of Science ®Google Scholar
• Trosman JR, Weldon CB, Gradishar WJ, et al. From the past to the present: Insurer coverage frameworks for Next-Generation tumor sequencing. Value Health. 2018;21(9):1062–1068.
   PubMed Web of Science ®Google Scholar
• Pruneri G, De Braud F, Sapino A, et al. Next-Generation sequencing in clinical practice: is it a cost-saving alternative to a single-gene testing approach? Pharmacoecon Open. 2021;5(2):285–298.
   PubMed Web of Science ®Google Scholar
• Yip S, Christofides A, Banerji S, et al. A Canadian guideline on the use of next-generation sequencing in oncology. Current Oncology. 2019;26(2):241–254.
   Web of Science ®Google Scholar
• Baltussen R, Jansen M, Oortwijn W. Evidence-informed deliberative processes for legitimate health benefit package design – Part I: Conceptual framework. Int J Health Policy Manag. 2021;2021:158.
   Google Scholar
• Norris S, Belcher A, Howard K, et al. Evaluating genetic and genomic tests for heritable conditions in Australia: lessons learnt from health technology assessments. J Community Genet. 2021;2021:2.
   Google Scholar
• Tricco AC, Antony J, Zarin W, et al. A scoping review of rapid review methods. BMC Med. BioMed Central. 2015;13:1–15.
   Google Scholar
• Speckemeier C, Niemann A, Wasem J, et al. Methodological guidance for rapid reviews in healthcare: a scoping review. Res Synthe Methods. 2022;13(4):394–404.
   PubMed Web of Science ®Google Scholar
• Elliott JH, Turner T, Clavisi O, et al. Living systematic reviews: an emerging opportunity to narrow the Evidence-Practice gap. PLoS Med. 2014;11(2):e1001603.
   PubMed Web of Science ®Google Scholar
• Ramsey SD, Sullivan SD. A new model for reimbursing genome-based cancer care. Oncologist. 2014;19(1):1–4.
   PubMed Web of Science ®Google Scholar
• Kirwin E, Round J, Bond K, et al. A conceptual framework for life-cycle health technology assessment. Value in Health [Internet]. 2022; [cited 2022 May 10]; Available from: https://www.sciencedirect.com/science/article/pii/S1098301522000018.
   Google Scholar
• Sweetman K. U of A precision health and entrepreneurship platforms get a boost to accelerate innovation. 2022; [cited 2022 Feb 8]. Available from: https://www.ualberta.ca/folio/2021/05/u-of-a-precision-health-and-entrepreneurship-platforms-get-a-boost-to-accelerate-innovation.html.
   Google Scholar
• OICR – Maximizing the benefits of cancer research for Ontarians. Ontario Institute for Cancer Research. 2022; [cited 2022 Feb 25]. Available from: https://oicr.on.ca/.
   Google Scholar
• Goldberg RB. Managing the pharmacy benefit: the formulary system. Academy of Managed Care Pharmacy. 2020;26:341–349.
   PubMedGoogle Scholar
• Law Document English View [Internet]. Ontario.ca. 2014.;[cited 2022 Feb 8]. Available from: https://www.ontario.ca/laws/view.
   Google Scholar
• Kitto S. Opening up the CPD imagination. J Contin Educ Health Prof. 2019;39(3):159–160.
   PubMed Web of Science ®Google Scholar
• Cheema PK, Gomes M, Banerji S, et al. Consensus recommendations for optimizing biomarker testing to identify and treat advanced EGFR-mutated non-small-cell lung cancer. Curr Oncol. 2020;27(6):321–329.
   PubMed Web of Science ®Google Scholar
• Bergethon K, Shaw AT, Ignatius Ou SH, et al. ROS1 rearrangements define a unique molecular class of lung cancers. JCO. 2012;30(8):863–870.
   PubMed Web of Science ®Google Scholar
• Provincial Funding Summary – Crizotinib (Xalkori) for Non-Small Cell Lung Cancer, first-line (pCODR10054). [cited 2022 Feb 25]. Available from: https://www.cadth.ca/sites/default/files/pcodr/pcodr-provfund_xalkorire-nsclc.pdf
   Google Scholar
• Government of Canada HC. Medical Devices Active Licence Listing. 2012 [cited 2022 Feb 25]. Available from: https://health-products.canada.ca/mdall-limh/information.do?deviceId_idInstrument=590957&deviceName_nomInstrument=VYSIS+LSI+ROS1+%28TEL%29+SPECTRUMORANGE+PROBE&lang=eng&licenceId=91493
   Google Scholar
• Shaw AT, Ou SHI, Bang YJ, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014;371(21):1963–1971.
   PubMed Web of Science ®Google Scholar
• Wu YL, Yang JCH, Kim DW, et al. Phase II study of crizotinib in East Asian patients with ROS1-positive advanced non-small-cell lung cancer. J Clin Oncol. 2018;36(14):1405–1411.
   PubMed Web of Science ®Google Scholar
• Inc PC. XALKORI® Approved by health Canada for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer. [cited 2022 Feb 25]. Available from: https://www.newswire.ca/news-releases/xalkori-approved-by-health-canada-for-the-treatment-of-patients-with-ros1-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer-657435843.html
   Google Scholar
• Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the study of lung cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321–346.
   PubMed Web of Science ®Google Scholar
• pCODR Expert Review Committee (pERC). Final Recommendation. [cited 2022 Feb 25]. Available from: https://www.cadth.ca/sites/default/files/pcodr/Reviews2019/10151CrizotinibNSCLC_fnRec_EC_approvedbyChair_Post_23May2019_final_cleaned.pdf
   Google Scholar
• Cancer Care Ontario. Comprehensive cancer testing at diagnosis as of February 1, 2022. [cited 2022 Aug 2]. Available from: https://www.cancercareontario.ca/sites/ccocancercare/files/assets/ComprehensiveCancerTestingIndications.pdf
   Google Scholar