Special Report

Looking back at 10 years of trastuzumab therapy: what is the role of HER2 testing? A systematic review of health economic analyses

McMaster University, Hamilton, ON, Canada

† Author for correspondence

Centre for Evaluation of Medicines, Department of Clinical Epidemiology & Biostatistics, McMaster University, 105 Main St. E, Level P1, Hamilton, ON L8N 1G6, Canada.

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Email the corresponding author at ferrusil@mcmaster.ca

Nathalie A Kulin

St Joseph’s Hospital, Hamilton, ON, Canada

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Natasha B Leighl

Princess Margaret Hospital, Toronto, ON, Canada

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Kathryn A Phillips

5UCSF Institute for Health Policy Studies & UCSF Comprehensive Cancer Center, CA, USA

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Published Online:13 Mar 2009https://doi.org/10.2217/17410541.6.2.193

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Abstract

Trastuzumab is a targeted therapy for human EGF receptor-2 (HER2)-positive breast cancer. The effectiveness and cost–effectiveness of trastuzumab hinges not only on its clinical efficacy in responding patients, but on the ability to accurately identify appropriate therapeutic candidates. We sought to systematically review the cost–effectiveness of trastuzumab with a focus on the impact of the test(s) used for HER2 diagnosis. Our review included 17 economic evaluations or health technology assessments of trastuzumab therapy or HER2 testing. Trastuzumab was considered cost-effective in all early-stage disease studies, while one author concluded that trastuzumab was not cost-effective for metastatic disease. Only two papers considered the joint effects of test accuracy and sequencing with trastuzumab therapy. These demonstrated that trastuzumab cost–effectiveness is sensitive to HER2-test properties.

Keywords:

Papers of special note have been highlighted as: ▪ of interest ▪▪ of considerable interest

Bibliography

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MedlineGoogle Scholar
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MedlineGoogle Scholar
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Medline CASGoogle Scholar
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MedlineGoogle Scholar
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MedlineGoogle Scholar
11 Metcalfe S, Evans J, Priest G: PHARMAC funding of 9-week concurrent trastuzumab (Herceptin) for HER2-positive early breast cancer. N. Z. Med. J.120(1256),U2593 (2007).
MedlineGoogle Scholar
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MedlineGoogle Scholar
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MedlineGoogle Scholar
16 Drummond MF, Sculpher MJ, Torrance GW, O’Brian BJ, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. Oxford University Press, Oxford, UK (2005).
Google Scholar
17 Perik PJ, de Korte MA, van Veldhuisen DJ, Gietema JA, Sleijfer DT, de Vries EGE: Cardiotoxicity associated with the use of trastuzumab in breast cancer patients. Expert Rev. Anticancer Ther.7(12),1763–1771 (2007).
Medline CASGoogle Scholar
18 Fleiss JL: The statistical basis of meta-analysis. Stat. Methods Med. Res.2,121–145 (1993).
Medline CASGoogle Scholar
19 Vernaglia PR, Cunha FM, Correa M et al.: Cost–effectiveness analysis of trastuzumab therapy in patients with early HER-2 positive breast cancer in Brazil. Breast Cancer Res.Treat.106(Suppl. 1) S106 (2007) (Abstract).
Google Scholar
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Google Scholar
21 Hornberger J, Kerrigan M, Foutel V: Cost–effectiveness of trastuzmab (Herceptin^®) for treatment of metastatic breast cancer. Ann. Oncol.13,52 (2002)
MedlineGoogle Scholar
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Google Scholar
23 Millar JA, Millward MJ: Cost–effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a lifetime model. Pharmacoeconomics25,429–442 (2007).
Medline CASGoogle Scholar
24 Neyt M, Huybrechts M, Hulstaert F, Vrijens F, Ramaekers D: Trastuzumab in early stage breast cancer: a cost–effectiveness analysis for Belgium. Health Policy87(2),146–159 (2008).
MedlineGoogle Scholar
25 Elkin EB, Weinstein MC, Winer EP, Kuntz KM, Schnitt SJ, Weeks JC: HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost–effectiveness analysis. J. Clin. Oncol.22,854–863 (2004).▪▪ Demonstrates how test accuracy and sequencing can be modeled in conjunction with treatment; it focuses on the metastatic setting.
MedlineGoogle Scholar
26 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.16,909–914 (2005).
Medline CASGoogle Scholar
27 Poncet B, Bachelot T, Colin C et al.: Use of the monoclonal antibody anti-HER2 trastuzumab in the treatment of metastatic breast cancer: a cost–effectiveness analysis. Am. J. Clin. Oncol.31(4),363–368 (2008).
Medline CASGoogle Scholar
28 National Institute for Clinical Excellence: Guidance on the use of trastuzumab for the treatment of advanced breast cancer. 34,1–14 (2002).
Google Scholar
29 Slamon DJ, Leyland-Jones BSS, Fuchs H et al.: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that over expresses HER2. N. Engl. J. Med.344,783–792 (2001).
Medline CASGoogle Scholar
30 Dedes KJ, Szucs TD, Imesch P, Fedier A, Fehr MK, Fink D: Cost–effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a model-based analysis of the HERA and FinHer trial. Ann. Oncol.18,1493–1499 (2007).
Medline CASGoogle Scholar
31 Lidgren M, Jonsson B, Rehnberg C, Willking N, Bergh J: Cost–effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer. Ann. Oncol.19,487–495 (2008).▪ Illustrates the consequences of inappropriate diagnosis in the early-stage setting by modeling HER2 test accuracy and sequencing to direct trastuzumab treatment.
Medline CASGoogle Scholar
32 Garrison LP, Lubeck D, Lalla D, Paton V, Dueck A, Perez EA: Cost–effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer110(3),489–498 (2007).
Medline CASGoogle Scholar
33 Kurian AW, Thompson RN, Gaw AF, Arai S, Ortiz R, Garber AM: A cost–effectiveness analysis of adjuvant trastuzumab regimens in early HER2/neu-positive breast cancer. J. Clin. Oncol.25,634–641 (2007).
Medline CASGoogle Scholar
34 Liberato NL, Marchetti M, Barosi G: Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer. J. Clin. Oncol.25,625–633 (2007).
MedlineGoogle Scholar
35 National Institute for Health and Clinical Excellence: Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer. 107 (2006).
Google Scholar
36 Morelle M, Haslé E, Treilleux I, Michot JP, Bachelot T: Cost–effectiveness analysis of strategies for HER2 testing of breast cancer patients in France. Int. J. Technol. Assess. Health Care22,396–401 (2006).
MedlineGoogle Scholar
37 Dranitsaris G, Norris B, Hanna W, O’Malley F, Gelmon K: Identifying the optimal testing of HER2 testing in patients with breast cancer: a Canadian economic evaluation. Curr. Oncol.10,36–44 (2003).
Google Scholar
38 Alvarez R, Albarracin C, Valero V, Sahin A, Johnson M, Hortobagyi G: Discordance rates of HER-2 expression between breast primary tumors and paired metastatic tumor specimens. 2008 American Society of Clinical Oncology Breast Cancer Symposium (2008) (Abstract 121).
Google Scholar
39 Simmons C, Miller N, Geddie W, Gianfelice D, Dranitsaris G, Oldfield M, Clemons M: Changes in breast tumor receptor status with time: a prospective study assessing the impact of obtaining confirmatory biopsy at metastatic recurrence on patient management. 2008 American Society of Clinical Oncology Breast Cancer Symposium (2008) (Abstract 124).
Google Scholar
40 McKeage K, Lyseng-Williamson KA: Trastuzumab: a pharmacoeconomic review of its use in early breast cancer. Pharmacoeconomics6(8),699–719 (2008).▪▪ Presents an alternative systematic review of cost–effectiveness analyses of trastuzumab in breast cancer.
Google Scholar
41 Younis T, Skedgel C: Is trastuzumab a cost-effective treatment for breast cancer. Expert Rev. Pharmacoeconomics Outcomes Res.8(5),433–442 (2008).
MedlineGoogle Scholar
42 Hofmann M, Stoss O, Gaiser T et al.: Central HER2 IHC and FISH analysis in a trastuzumab (Herceptin) Phase II monotherapy study: assessment of test sensitivity and impact of chromosome 17 polysomy. J. Clin. Pathol.61(1),89–94 (2008).
Medline CASGoogle Scholar
43 Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al.: Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N. Engl. J. Med.353,1659–1672 (2005).
Medline CASGoogle Scholar
44 Shiroiwa T, Fukuda T, Shimozuma K, Ohashi Y, Kiichiro T: The model-based cost–effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res.Treat.109,559–566 (2008).
Medline CASGoogle Scholar
45 Norum J, Olsen JA, Wist EA, Lonnin PE: Trastuzumab in adjuvant breast cancer therapy: a model based cost–effectiveness analysis. Acta Oncol.46,153–164 (2007).
Medline CASGoogle Scholar
101 Doherty D: Roche sales fall 4% on lower demand for Tamiflu (2008) www.bloomberg.com/apps/news?pid=20670001&refer=home&sid=aIW.jE9ReeJU
Google Scholar
102 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (1999) www.federalreserve.gov/releases/g5a/19990104/
Google Scholar
103 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (2007) www.federalreserve.gov/releases/g5a/20070103/
Google Scholar
104 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (2008) www.federalreserve.gov/releases/g5a/20030106/
Google Scholar
105 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (2008) www.federalreserve.gov/releases/g5a/current/
Google Scholar
106 US Bureau of Labor Statistics: Consumer price index – all urban consumers, medical care. Series ID: CUUR0000SAM (2008) www.bls.gov/cpi/#data 52
Google Scholar
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Google Scholar

Papers of special note have been highlighted as: ▪ of interest ▪▪ of considerable interest

Bibliography

1 Joensuu H, Kellokumpu-Lehtinen PL, Bono P et al.: Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N. Engl. J. Med.354,809–820 (2006).
Medline CASGoogle Scholar
2 McKeage K, Perry CM: Trastuzumab: a review of its use in the treatment of metastatic breast cancer overexpressing HER2. Drugs62,209–243 (2002).
Medline CASGoogle Scholar
3 De Laurentiis M, Cancello G, Zinno L et al.: Targeting HER2 as a therapeutic strategy for breast cancer: a paradigmatic shift of drug development in oncology. Ann. Oncol.16(Suppl. 4),IV7–IV13 (2005).
MedlineGoogle Scholar
4 Dendukuri N, Khetani K, McIsaac M, Brophy J: Testing for HER2-positive breast cancer: a systematic review and cost–effectiveness analysis. Can. Med. Assoc. J.176,1429–1434 (2007).▪ Presents one methodology for the synthesis of human EGF receptor-2 (HER2) test accuracy data and the integration of this information into cost–effectiveness analysis.
MedlineGoogle Scholar
5 Wolff AC, Hammond ME, Schwartz JN et al.: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J. Clin. Oncol.25,118–145 (2007).
Medline CASGoogle Scholar
6 Dahabreh IJ, Linardou H, Siannis F, Fountzilas G, Murray S: Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials. Oncologist13(6),620–630 (2008).
Medline CASGoogle Scholar
7 Minhas R: How much will herceptin really cost? The money is already there. BMJ333(7580),1219–1220 (2006).
MedlineGoogle Scholar
8 Dillon A, Littlejohns P: How much will herceptin really cost? Balancing local and national priorities is not new. BMJ333(7580),1219–1220 (2006).
MedlineGoogle Scholar
9 Kondro W, Sibbald B: Patient demand and politics push Herceptin forward. Can. Med. Assoc. J.173(4),347–348 (2005).
Google Scholar
10 Metcalfe S, Evans J: PHARMAC responds on Herceptin assumptions and decisions. N. Z. Med. J.120(1260),U2692 (2007).
MedlineGoogle Scholar
11 Metcalfe S, Evans J, Priest G: PHARMAC funding of 9-week concurrent trastuzumab (Herceptin) for HER2-positive early breast cancer. N. Z. Med. J.120(1256),U2593 (2007).
MedlineGoogle Scholar
12 Rosevear M: PHARMAC and Herceptin for early-stage breast cancer in New Zealand: Herceptin or deception? N. Z. Med. J.119(1235),U2014 (2006).
MedlineGoogle Scholar
13 Petersen S: Roche responds to the ‘Herceptin or deception’ article. N. Z. Med. J.119(1237),U2069 (2006).
MedlineGoogle Scholar
14 Breast Cancer Advocacy Coalition; Burgess EP: Breast Cancer Advocacy Coalition responds to the ‘Herceptin or deception’ article. N. Z. Med. J.119(1237),U2065 (2006).
MedlineGoogle Scholar
15 Hillner BE, Smith TJ: Do the large benefits justify the large costs of adjuvant breast cancer trastuzumab? J. Clin. Oncol.25,611–613 (2007).
MedlineGoogle Scholar
16 Drummond MF, Sculpher MJ, Torrance GW, O’Brian BJ, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. Oxford University Press, Oxford, UK (2005).
Google Scholar
17 Perik PJ, de Korte MA, van Veldhuisen DJ, Gietema JA, Sleijfer DT, de Vries EGE: Cardiotoxicity associated with the use of trastuzumab in breast cancer patients. Expert Rev. Anticancer Ther.7(12),1763–1771 (2007).
Medline CASGoogle Scholar
18 Fleiss JL: The statistical basis of meta-analysis. Stat. Methods Med. Res.2,121–145 (1993).
Medline CASGoogle Scholar
19 Vernaglia PR, Cunha FM, Correa M et al.: Cost–effectiveness analysis of trastuzumab therapy in patients with early HER-2 positive breast cancer in Brazil. Breast Cancer Res.Treat.106(Suppl. 1) S106 (2007) (Abstract).
Google Scholar
20 Hillner BE: [5040] Clinical and cost–effectiveness implications of the adjuvant transtuzumab in HER2⁺ breast cancer trials. San Antonio Breast Cancer Symposium 2005. San Antonio, TX, USA, 8–11 December (2005).
Google Scholar
21 Hornberger J, Kerrigan M, Foutel V: Cost–effectiveness of trastuzmab (Herceptin^®) for treatment of metastatic breast cancer. Ann. Oncol.13,52 (2002)
MedlineGoogle Scholar
22 Ragaz J, Spinelli JJ: [2029] Cost–benefit estimates of adjuvant (Adj) trastuzumab (herceptin, H) for early breast cancer (BrCa). San Antonio Breast Cancer Symposium 2005. San Antonio, TX, USA, 8–11 December (2005).
Google Scholar
23 Millar JA, Millward MJ: Cost–effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a lifetime model. Pharmacoeconomics25,429–442 (2007).
Medline CASGoogle Scholar
24 Neyt M, Huybrechts M, Hulstaert F, Vrijens F, Ramaekers D: Trastuzumab in early stage breast cancer: a cost–effectiveness analysis for Belgium. Health Policy87(2),146–159 (2008).
MedlineGoogle Scholar
25 Elkin EB, Weinstein MC, Winer EP, Kuntz KM, Schnitt SJ, Weeks JC: HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost–effectiveness analysis. J. Clin. Oncol.22,854–863 (2004).▪▪ Demonstrates how test accuracy and sequencing can be modeled in conjunction with treatment; it focuses on the metastatic setting.
MedlineGoogle Scholar
26 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.16,909–914 (2005).
Medline CASGoogle Scholar
27 Poncet B, Bachelot T, Colin C et al.: Use of the monoclonal antibody anti-HER2 trastuzumab in the treatment of metastatic breast cancer: a cost–effectiveness analysis. Am. J. Clin. Oncol.31(4),363–368 (2008).
Medline CASGoogle Scholar
28 National Institute for Clinical Excellence: Guidance on the use of trastuzumab for the treatment of advanced breast cancer. 34,1–14 (2002).
Google Scholar
29 Slamon DJ, Leyland-Jones BSS, Fuchs H et al.: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that over expresses HER2. N. Engl. J. Med.344,783–792 (2001).
Medline CASGoogle Scholar
30 Dedes KJ, Szucs TD, Imesch P, Fedier A, Fehr MK, Fink D: Cost–effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a model-based analysis of the HERA and FinHer trial. Ann. Oncol.18,1493–1499 (2007).
Medline CASGoogle Scholar
31 Lidgren M, Jonsson B, Rehnberg C, Willking N, Bergh J: Cost–effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer. Ann. Oncol.19,487–495 (2008).▪ Illustrates the consequences of inappropriate diagnosis in the early-stage setting by modeling HER2 test accuracy and sequencing to direct trastuzumab treatment.
Medline CASGoogle Scholar
32 Garrison LP, Lubeck D, Lalla D, Paton V, Dueck A, Perez EA: Cost–effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer110(3),489–498 (2007).
Medline CASGoogle Scholar
33 Kurian AW, Thompson RN, Gaw AF, Arai S, Ortiz R, Garber AM: A cost–effectiveness analysis of adjuvant trastuzumab regimens in early HER2/neu-positive breast cancer. J. Clin. Oncol.25,634–641 (2007).
Medline CASGoogle Scholar
34 Liberato NL, Marchetti M, Barosi G: Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer. J. Clin. Oncol.25,625–633 (2007).
MedlineGoogle Scholar
35 National Institute for Health and Clinical Excellence: Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer. 107 (2006).
Google Scholar
36 Morelle M, Haslé E, Treilleux I, Michot JP, Bachelot T: Cost–effectiveness analysis of strategies for HER2 testing of breast cancer patients in France. Int. J. Technol. Assess. Health Care22,396–401 (2006).
MedlineGoogle Scholar
37 Dranitsaris G, Norris B, Hanna W, O’Malley F, Gelmon K: Identifying the optimal testing of HER2 testing in patients with breast cancer: a Canadian economic evaluation. Curr. Oncol.10,36–44 (2003).
Google Scholar
38 Alvarez R, Albarracin C, Valero V, Sahin A, Johnson M, Hortobagyi G: Discordance rates of HER-2 expression between breast primary tumors and paired metastatic tumor specimens. 2008 American Society of Clinical Oncology Breast Cancer Symposium (2008) (Abstract 121).
Google Scholar
39 Simmons C, Miller N, Geddie W, Gianfelice D, Dranitsaris G, Oldfield M, Clemons M: Changes in breast tumor receptor status with time: a prospective study assessing the impact of obtaining confirmatory biopsy at metastatic recurrence on patient management. 2008 American Society of Clinical Oncology Breast Cancer Symposium (2008) (Abstract 124).
Google Scholar
40 McKeage K, Lyseng-Williamson KA: Trastuzumab: a pharmacoeconomic review of its use in early breast cancer. Pharmacoeconomics6(8),699–719 (2008).▪▪ Presents an alternative systematic review of cost–effectiveness analyses of trastuzumab in breast cancer.
Google Scholar
41 Younis T, Skedgel C: Is trastuzumab a cost-effective treatment for breast cancer. Expert Rev. Pharmacoeconomics Outcomes Res.8(5),433–442 (2008).
MedlineGoogle Scholar
42 Hofmann M, Stoss O, Gaiser T et al.: Central HER2 IHC and FISH analysis in a trastuzumab (Herceptin) Phase II monotherapy study: assessment of test sensitivity and impact of chromosome 17 polysomy. J. Clin. Pathol.61(1),89–94 (2008).
Medline CASGoogle Scholar
43 Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al.: Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N. Engl. J. Med.353,1659–1672 (2005).
Medline CASGoogle Scholar
44 Shiroiwa T, Fukuda T, Shimozuma K, Ohashi Y, Kiichiro T: The model-based cost–effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res.Treat.109,559–566 (2008).
Medline CASGoogle Scholar
45 Norum J, Olsen JA, Wist EA, Lonnin PE: Trastuzumab in adjuvant breast cancer therapy: a model based cost–effectiveness analysis. Acta Oncol.46,153–164 (2007).
Medline CASGoogle Scholar
101 Doherty D: Roche sales fall 4% on lower demand for Tamiflu (2008) www.bloomberg.com/apps/news?pid=20670001&refer=home&sid=aIW.jE9ReeJU
Google Scholar
102 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (1999) www.federalreserve.gov/releases/g5a/19990104/
Google Scholar
103 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (2007) www.federalreserve.gov/releases/g5a/20070103/
Google Scholar
104 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (2008) www.federalreserve.gov/releases/g5a/20030106/
Google Scholar
105 US Federal Reserve: Foreign exchange rates (annual). G5A(405) (2008) www.federalreserve.gov/releases/g5a/current/
Google Scholar
106 US Bureau of Labor Statistics: Consumer price index – all urban consumers, medical care. Series ID: CUUR0000SAM (2008) www.bls.gov/cpi/#data 52
Google Scholar
107 US Food and Drug Administration: New device approval: invitrogen SPOT-Light^® HER2 CISH™ Kit – P050040 (2009) www.fda.gov/cdrh/mda/docs/p050040.html
Google Scholar

Vol. 6, No. 2

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Financial & competing interests disclosure

This research was funded in part by an award from the Ontario Council on Graduate Studies; it was also funded by two grants from the National Cancer Institute (R01CA101849 and P01CA130818). Deborah Marshall provides ad hoc consulting for i3 Innovus, a global health economics and outcomes research company. Natasha Leighl has previously received honoraria from Hoffmann-La Roche within the last 2 years for continuing medical education lectures that were not related to this project or herceptin. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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