701
Views
25
CrossRef citations to date
0
Altmetric
SPECIAL FOCUS: In Vitro Companion Diagnostics - Review

Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist

, , &

References

  • Schilsky RL. Personalized medicine in oncology: the future is now. Nat Rev Drug Discov 2010;9(5):363-6
  • Ong FS, Das K, Wang J, et al. Personalized medicine and pharmacogenetic biomarkers: progress in molecular oncology testing. Expert Rev Mol Diagn 2012;12(6):593-602
  • Spackman E, Rice S, Norman G, et al. Trastuzumab for the treatment of HER2-positive metastatic gastric cancer : a NICE single technology appraisal. Pharmacoeconomics 2013;31(3):185-94
  • Weinstein MC, Toy EL, Sandberg EA, et al. Modeling for health care and other policy decisions: uses, roles, and validity. Value Health 2001;4(5):348-61
  • Shih YC, Halpern MT. Economic evaluations of medical care interventions for cancer patients: how, why, and what does it mean? CA Cancer J Clin 2008;58(4):231-44
  • Sanghera S, Orlando R, Roberts T. Economic evaluations and diagnostic testing: an illustrative case study approach. Int J Technol Assess Health Care 2013;29(1):53-60
  • Ferrusi IL, Marshall DA, Kulin NA, et al. Looking back at 10 years of trastuzumab therapy: what is the role of HER2 testing? A systematic review of health economic analyses. Pers Med 2009;6(2):193-215
  • Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361(10):947-57
  • Zweig MH, Campbell G. Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine. Clin Chem 1993;39(4):561-77
  • Flowers CR, Veenstra D. The role of cost-effectiveness analysis in the era of pharmacogenomics. Pharmacoeconomics 2004;22(8):481-93
  • Annemans L, Redekop K, Payne K. Current methodological issues in the economic assessment of personalized medicine. Value Health 2013;16(6 Suppl):S20-6
  • Companion diagnostic devices: in vitro and imaging tools. Silver Spring, MD: United States Food and Drug Administration, 2014. Available from: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm [Last accessed 17 March 2014]
  • Chiou CF, Hay JW, Wallace JF, et al. Development and validation of a grading system for the quality of cost-effectiveness studies. Med Care 2003;41(1):32-44
  • Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009;6(7):e1000097
  • Health Technology Assessment. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health, 2011. Available from: www.cadth.ca/en/products/health-technology-assessment?q [Last accessed 27 February 2014]
  • Rapid Response. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health, 2014. Available from: www.cadth.ca/en/products/rapid-response [Last accessed 27 February 2014]
  • Pharmaceutical Benefits Advisory Committee Public Summary Documents. Canberra, ACT: Australian Government, Department of Health, 2013. Available from: www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd [Last accessed 27 February 2014]
  • Medical Services Advisory Committee Completed Assessments and Reviews. Canberra, ACT: Australian Government, Department of Health, 2013. Available from: www.msac.gov.au/internet/msac/publishing.nsf/Content/completed-assessments [Last accessed 27 February 2014]
  • Technology Assessments. Rockville, MD: agency for Healthcare Research and Quality, 2014. Available from: www.ahrq.gov/research/findings/ta/index.html [Last accessed 27 February 2014]
  • Published technology appraisals. London, UK: national Institute for Health and Care Excellence, 2013. Available from: http://guidance.nice.org.uk/TA/Published [Last accessed 27 February 2014]
  • Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med 2005;37(5):360-3
  • Shemilt I, Thomas J, Morciano M. A web-based tool for adjusting costs to a specific target currency and price year. Evid Policy 2010;6(1):51-9
  • Wong WB, Carlson JJ, Thariani R, Veenstra DL. Cost effectiveness of pharmacogenomics: a critical and systematic review. Pharmacoeconomics 2010;28(11):1001-13
  • Djalalov S, Musa Z, Mendelson M, et al. A review of economic evaluations of genetic testing services and interventions (2004-2009). Genet Med 2011;13(2):89-94
  • Yang M, Patel DS, Tufail W, Issa AM. The quality of economic studies of cancer pharmacogenomics: a quantitative appraisal of the evidence. Expert Rev Pharmacoecon Outcomes Res 2013;13(5):597-611
  • Blank PR, Moch H, Szucs TD, Schwenkglenks M. KRAS and BRAF mutation analysis in metastatic colorectal cancer: a cost-effectiveness analysis from a Swiss perspective. Clin Cancer Res 2011;17(19):6338-46
  • Vijayaraghavan A, Efrusy MB, Goke B, et al. Cost-effectiveness of KRAS testing in metastatic colorectal cancer patients in the United States and Germany. Int J Cancer 2012;131(2):438-45
  • Atherly AJ, Camidge DR. The cost-effectiveness of screening lung cancer patients for targeted drug sensitivity markers. Br J Cancer 2012;106(6):1100-6
  • Lee JA, Bubendorf L, Stahel R, Peters P. Testing for anaplastic lymphoma kinase rearrangement to target crizotinib therapy: oncolgy, pathology and health economic perspectives. Expert Rev Anticancer Ther 2013;13(5):625-36
  • Djalalov S, Beca J, Hoch JS, et al. Cost effectiveness of EML4-ALK fusion testing and first-line crizotinib treatment for patients with advanced ALK-Positive non-small-cell lung cancer. J Clin Oncol 2014;32(10):1012-19
  • Lieberthal RD, Dudash K, Axelrod R, Goldfarb NI. An economic model to value companion diagnostics in non-small-cell lung cancer. Pers Med 2013;10(2):139-47
  • Elkin EB, Weinstein MC, Winer EP, et al. HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. J Clin Oncol 2004;22(5):854-63
  • Lidgren M, Jonsson B, Rehnberg C, et al. Cost-effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer. Ann Oncol 2008;19(3):487-95
  • Lidgren M, Wilking N, Jonsson B, Rehnberg C. Cost-effectiveness of HER2 testing and trastuzumab therapy for metastatic breast cancer. Acta Oncol 2008;47(6):1018-28
  • Blank PR, Schwenkglenks M, Moch H, Szucs TD. Human epidermal growth factor receptor 2 expression in early breast cancer patients: a Swiss cost-effectiveness analysis of different predictive assay strategies. Breast Cancer Res Treat 2010;124(2):497-507
  • Lee JA, Shaheen M, Walke T, Daly M. Clinical and health economic outcomes of alternative HER2 testing strategies for guiding adjuvant trastuzumab therapy. Expert Rev. Pharmacoeconomics Outcomes Res 2011;11(3):325-41
  • Garrison LPJr, Lalla D, Brammer M, et al. Assessing the potential cost-effectiveness of retesting IHC0, IHC1+, or FISH-negative early stage breast cancer patients for HER2 status. Cancer 2013;119(17):3113-22
  • Grosse SD. Assessing cost-effectiveness in healthcare: history of the $50,000 per QALY threshold. Expert Rev Pharmacoecon Outcomes Res 2008;8(2):165-78
  • Meads C, Round J, Tubeuf S, et al. Cetuximab for the first-line treatment of metastatic colorectal cancer: A Single Technology Appraisal. West Midlands Health Technology Assessment Collaboration; 2008
  • Medical Advisory Secretariat. KRAS testing for anti-EGFR therapy in advanced colorectal cancer: an evidence-based and economic analysis. Ont Health Technol Assess Ser 2010;10(25):1-49
  • Shiroiwa T, Motoo Y, Tsutani K. Cost-effectiveness analysis of KRAS testing and cetuximab as last-line therapy for colorectal cancer. Mol Diagn Ther 2010;14(6):375-84
  • Behl AS, Goddard KAB, Flottemesch TJ, et al. Cost-effectiveness analysis of screening for KRAS and BRAF mutations in metastatic colorectal cancer. J Natl Cancer Inst 2012;104(23):1785-95
  • Hoyle M, Peters J, Crathorne L, et al. Cost-effectiveness of cetuximab, cetuximab plus irinotecan, and panitumumab for third and further lines of treatment for KRAS wild-type patients with metastatic colorectal cancer. Value Health 2013;16(2):288-96
  • Barone C, Pinto C, Normanno N, et al. KRAS early testing: consensus initiative and cost-effectiveness evaluation for metastatic colorectal patients in an Italian setting. PLoS One 2014;9(1):e85897
  • Duarte A, Burch J, Smith A, et al. Crizotinib for the treatment of previously treated non-small-cell lung cancer associated with an anaplastic lymphoma kinase (ALK) fusion gene: a single technology appraisal. Centre for Reviews and Dissemination (CRD) and Centre for Health Economics (CHE); 2013
  • Carlson JJ, Garrison LP, Ramsey SD, Veenstra DL. The potential clinical and economic outcomes of pharmacogenomic approaches to EGFR-tyrosine kinase inhibitor therapy in non-small-cell lung cancer. Value Health 2009;12(1):20-7
  • Borget I, Cadranel J, Pignon JP, et al. Cost-effectiveness of three strategies for second-line erlotinib initiation in nonsmall-cell lung cancer: the ERMETIC study part 3. Eur Respir J 2012;39(1):172-9
  • Handorf EA, McElligott S, Vachani A, et al. Cost effectiveness of personalized therapy for first-line treatment of stage IV and recurrent incurable adenocarcinoma of the lung. J Oncol Pract 2012;8(5):267-74
  • Norum J, Risberg T, Olsen JA. A monoclonal antibody against HER-2 (trastuzumab) for metastatic breast cancer: a model-based cost-effectiveness analysis. Ann Oncol 2005;16(6):909-14
  • Neyt MJ, Albrecht JA, Clarysse B, Cocquyt VF. Cost-effectiveness of Herceptin: a standard cost model for breast-cancer treatment in a Belgian university hospital. Int J Technol Assess Health Care 2005;21(1):132-7
  • Neyt M, Albrecht J, Cocquyt V. An economic evaluation of Herceptin((R)) in adjuvant setting: the Breast Cancer International Research Group 006 trial. Ann Oncol 2006;17(3):381-90
  • Garrison LP, Lubeck D, Lalla D, et al. Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer 2007;110:489-98
  • Dedes KJ, Szucs TD, Imesch P, et al. Cost-effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a model-based analysis of the HERA and FinHer trial. Ann Oncol 2007;18(9):1493-9
  • Neyt M, Huybrechts M, Hulstaert F, et al. Trastuzumab in early stage breast cancer: a cost-effectiveness analysis for Belgium. Health Policy 2008;87(2):146-59
  • Skedgel C, Rayson D, Younis T. The cost-utility of sequential adjuvant trastuzumab in women with Her2/Neu-positive breast cancer: an analysis based on updated results from the HERA trial. Value Health 2009;12(5):641-8
  • Van Vlaenderen I, Canon JL, Cocquyt V, et al. Trastuzumab treatment of early stage breast cancer is cost-effective from the perspective of the Belgian Health Care Authorities. Acta Clin Belg 2009;64(2):100-12
  • Hoyle M, Crathorne L, Peters J, et al. The clinical effectiveness and cost-effectiveness of cetuximab (mono- or combination chemotherapy), bevacizumab (combination with non-oxaliplatin chemotherapy) and panitumumab (monotherapy) for the treatment of metastatic colorectal cancer after first-line chemotherapy (review of technology appraisal No.150 and part review of technology appraisal No. 118): a systematic review and economic model. Health Technol Assess 2013;17(14):1-237
  • Statistical Methods in Diagnostic Medicine using SAS Software. Rochester, MN: Mandrekar JN, Mandrekar SJ, 2005. Available from: www2.sas.com/proceedings/sugi30/211-30.pdf [Last accessed 12 May 2014]
  • Phelps CE, Mushlin AI. Focusing technology assessment using medical decision theory. Med Decis Making 1988;8(4):279-89
  • Laking G, Lord J, Fischer A. The economics of diagnosis. Health Econ 2006;15(10):1109-20
  • Vegter S, Boersma C, Rozenbaum M, et al. Pharmacoeconomic evaluations of pharmacogenetic and genomic screening programmes: a systematic review on content and adherence to guidelines. Pharmacoeconomics 2008;26(7):569-87
  • Vegter S, Jansen E, Postma MJ, Boersma C. Economic evaluations of pharmacogenetic and genomic screening programs: update of the literature. Drug Dev Res 2010;71:492-501
  • Beaulieu M, de Denus S, Lachaine J. Systematic review of pharmacoeconomic studies of pharmacogenomic tests. Pharmacogenomics 2010;11(11):1573-90
  • Phillips KA, Van Bebber SL. A systematic review of cost-effectiveness analyses of pharmacogenomic interventions. Pharmacogenomics 2004;5(8):1139-49
  • Higashi MK, Veenstra DL. Managed care in the genomics era: assessing the cost effectiveness of genetic tests. Am J Manag Care 2003;9(7):493-500
  • Frank M, Mittendorf T. Influence of Pharmacogenomic Profiling Prior to Pharmaceutical Treatment in Metastatic Colorectal Cancer on Cost Effectiveness A Systematic Review. Pharmacoeconomics 2013;31(3):215-28
  • Shim HS, Lee DH, Park EJ, Kim SH. Histopathologic Characteristics of Lung Adenocarcinomas With Epidermal Growth Factor Receptor Mutations in the International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society Lung Adenocarcinoma Classification. Arch Pathol Lab Med 2011;135(10):1329-34
  • Chan M, Lee CW, Wu M. Integrating next-generation sequencing into clinical cancer diagnostics. Expert Rev Mol Diagn 2013;13(7):647-50
  • Garau M, Towse A, Garrison L, et al. Can and should value-based pricing be applied to molecular diagnostics? Pers Med 2013;10(1):61-72
  • Doble B, Harris A, Thomas DM, et al. Multiomics medicine in oncology: assessing effectiveness, cost-effectiveness and future research priorities for the molecularly unique individual. Pharmacogenomics 2013;14(12):1405-17
  • Buchanan J, Wordsworth S, Schuh A. Issues surrounding the health economic evaluation of genomic technologies. Pharmacogenomics 2013;14(15):1833-47
  • Blair ED, Stratton EK, Kaufmann M. The economic value of companion diagnostics and stratified medicines. Expert Rev Mol Diagn 2012;12(8):791-4
  • Novielli N, Cooper NJ, Sutton AJ. Evaluating the cost-effectiveness of diagnostic tests in combination: is it important to allow for performance dependency? Value Health 2013;16(4):536-41
  • Longo R, Baxter P, Hall P, et al. Methods for Identifying the Cost-effective Case Definition Cut-Off for Sequential Monitoring Tests: an Extension of Phelps and Mushlin. Pharmacoeconomics 2014;32(4):327-34
  • Baird RD, Caldas C. Genetic heterogeneity in breast cancer: the road to personalized medicine? BMC Med 2013;11:151
  • Gerlinger M, Rowan AJ, Horswell S, et al. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 2012;366(10):883-92
  • Simonds NI, Khoury MJ, Schully SD, et al. Comparative effectiveness research in cancer genomics and precision medicine: current landscape and future prospects. J Natl Cancer Inst 2013;105(13):929-36
  • Veenstra DL, Roth JA, Garrison LPJr, et al. A formal risk-benefit framework for genomic tests: facilitating the appropriate translation of genomics into clinical practice. Genet Med 2010;12(11):686-93
  • Berg JS, Khoury MJ, Evans JP. Deploying whole genome sequencing in clinical practice and public health: meeting the challenge one bin at a time. Genet Med 2011;13(6):499-504
  • Hornberger J. Assigning value to medical algorithms: implications for personalized medicine. Pers Med 2013;10(6):577-88

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.