Top

PharmacoEconomics

Published in:

01-02-2014 | Original Research Article

Cost Effectiveness of a 21-Gene Recurrence Score Assay Versus Canadian Clinical Practice in Post-Menopausal Women with Early-Stage Estrogen or Progesterone-Receptor-Positive, Axillary Lymph-Node Positive Breast Cancer

Authors: Malek B. Hannouf, Bin Xie, Muriel Brackstone, Gregory S. Zaric

Published in: PharmacoEconomics | Issue 2/2014

Abstract

Background

A 21-gene recurrence score (RS) assay provides a method of guiding treatment decisions in women with early-stage breast cancer (ESBC). We investigated the cost effectiveness of using the RS assay versus current clinical practice (CCP) in post-menopausal women with estrogen- or progesterone-receptor-positive, one to three positive axillary lymph-node ESBC from the perspective of the Canadian public healthcare system.

Methods

We developed a decision analytic model to project the lifetime clinical and economic consequences of ESBC. We assumed that the RS assay would classify patients among risk levels (low, intermediate and high) and corresponding adjuvant treatment regimens. The model was parameterized using 7-year follow-up data from the Manitoba Cancer Registry, cost data from Manitoba Health administrative databases and secondary sources. Costs are presented in 2012 Canadian dollars, and future costs and benefits were discounted at 5 %.

Results

In the base case analysis, the RS assay compared with CCP led to an increase of 0.08 quality-adjusted life-year (QALY) and an increase in cost of Can$36.2 per person, resulting in an incremental cost-effectiveness ratio (ICER) of Can$464/QALY gained. The ICER was most sensitive to the proportion of women classified to intermediate risk by the RS assay who received adjuvant chemotherapy, and absolute risk of relapse among patients receiving the RS assay.

Conclusions

The RS assay is likely to be cost effective in the Canadian healthcare system. Field evaluations of the assay in this patient population will help reduce uncertainty in clinical guidelines for intermediate-range RS-assay values and specific disease outcomes by the RS assay, which are important drivers of ICER.

Levine M. Clinical practice guidelines for the care and treatment of breast cancer: adjuvant systemic therapy for node-positive breast cancer (summary of the 2001 update). The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. CMAJ. 2001;164(5):644–6.PubMedCentralPubMed

Mook S, Schmidt MK, Viale G, Pruneri G, Eekhout I, Floore A, et al. The 70-gene prognosis-signature predicts disease outcome in breast cancer patients with 1–3 positive lymph nodes in an independent validation study. Breast Cancer Res Treat. 2009;116(2):295–302. doi:10.1007/s10549-008-0130-2.PubMedCrossRef

Hannouf MB, Brackstone M, Xie B, Zaric GS. Evaluating the efficacy of current clinical practice of adjuvant chemotherapy in postmenopausal women with early-stage, estrogen or progesterone receptor-positive, one-to-three positive axillary lymph node, breast cancer. Curr Oncol. 2012;19(5):e319–28. doi:10.3747/co.19.1038 PubMedCentralPubMedCrossRef

Albain KS, Barlow WE, Shak S, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 11(1):55–65. doi:10.1016/S1470-2045(09)70314-6.

Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817–26. doi:10.1056/NEJMoa041588.PubMedCrossRef

Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24(23):3726–34. doi:10.1200/JCO.2005.04.7985.PubMedCrossRef

Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP, et al. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol. 2010;28(10):1677–83. doi:10.1200/JCO.2009.23.7610.PubMedCrossRef

Zujewski JA, Kamin L. Trial assessing individualized options for treatment for breast cancer: the TAILORx trial. Future Oncol. 2008;4(5):603–10. doi:10.2217/14796694.4.5.603.PubMedCrossRef

Cobleigh MA, Tabesh B, Bitterman P, Baker J, Cronin M, Liu ML, et al. Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res. 2005;11(24 Pt 1):8623–31. doi:10.1158/1078-0432.CCR-05-0735.PubMedCrossRef

10.

Goldstein LJ, Gray R, Badve S, Childs BH, Yoshizawa C, Rowley S, et al. Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features. J Clin Oncol. 2008;26(25):4063–71. doi:10.1200/JCO.2007.14.4501.PubMedCrossRef

11.

Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, et al. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010;28(11):1829–34. doi:10.1200/JCO.2009.24.4798.PubMedCrossRef

12.

Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst. 2009;101(21):1446–52. doi:10.1093/jnci/djp335.PubMedCrossRef

13.

Tsoi DT, Inoue M, Kelly CM, Verma S, Pritchard KI. Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer. Oncologist. 2010;15(5):457–65. doi:10.1634/theoncologist.2009-0275.PubMedCrossRef

14.

Lamond NW, Skedgel C, Rayson D, Lethbridge L, Younis T. Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer. Breast Cancer Res Treat. 2012;133(3):1115–23. doi:10.1007/s10549-012-1989-5.PubMedCrossRef

15.

Hannouf MB, Xie B, Brackstone M, Zaric GS. Cost-effectiveness of a 21-gene recurrence score assay versus Canadian clinical practice in women with early-stage estrogen- or progesterone-receptor-positive, axillary lymph-node negative breast cancer. BMC Cancer. 2012;12(1):447. doi:10.1186/1471-2407-12-447.PubMedCentralPubMedCrossRef

16.

Hornberger J, Cosler LE, Lyman GH. Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer. Am J Manag Care. 2005;11(5):313–24 pii: 2843.PubMed

17.

Lyman GH, Cosler LE, Kuderer NM, Hornberger J. Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies. Cancer. 2007;109(6):1011–8. doi:10.1002/cncr.22506.PubMedCrossRef

18.

Kondo M, Hoshi SL, Ishiguro H, Yoshibayashi H, Toi M. Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan. Breast Cancer Res Treat. 2008;112(1):175–87. doi:10.1007/s10549-007-9842-y.PubMedCrossRef

19.

Kondo M, Hoshi SL, Yamanaka T, Ishiguro H, Toi M. Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03). Breast Cancer Res Treat. 2011;127(3):739–49. doi:10.1007/s10549-010-1243-y.PubMedCrossRef

20.

Klang SH, Hammerman A, Liebermann N, et al. Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-Managed Health-Care Organization. Value Health. 2010;13:381–87. doi:10.1111/j.1524-4733.2010.00724.x.

21.

Vanderlaan BF, Broder MS, Chang EY, Oratz R, Bentley TG. Cost-effectiveness of 21-gene assay in node-positive, early-stage breast cancer. Am J Manag Care. 2011;17(7):455–64 (pii: 50186).PubMed

22.

Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making. 1993;13(4):322–38.PubMedCrossRef

23.

Lo SS, Mumby PB, Norton J, et al. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol. 2008;28(10):1671–6. doi:10.1200/JCO.2008.20.2119.

24.

Oratz R, et al. Physician survey of the effect of the 21-gene recurrence score assay results on treatment recommendations for patients with lymph node-positive, estrogen receptor-positive breast cancer. JOP. 2011;7(2):94–9.PubMed

25.

Wolowacz SE, Cameron DA, Tate HC, Bagust A. Docetaxel in combination with doxorubicin and cyclophosphamide as adjuvant treatment for early node-positive breast cancer: a cost-effectiveness and cost-utility analysis. J Clin Oncol. 2008;26(6):925–33. doi:10.1200/JCO.2006.10.4190.PubMedCrossRef

26.

Statistics Canada/Health Statistics Division: Life Tables, Canada and the Provinces, 2000–2002. Ottawa: Minister of Industry, publication 84-537-XIE; 2006.

27.

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chron Dis. 1987;40(5):373–83.PubMedCrossRef

28.

Ragaz J. The 21-gene assay: impact on breast cancer in Canada. In: Report Card on Cancer in Canada. (Emerson D, Major P, Co-Chairs): Cancer Advocacy Coalition of Canada, vol. 12; Winter 2009–2010.

29.

Bank of Canada. Home > Rates and Statistics > Related Information > Inflation Calculator [Web resource]. Ottawa: Bank of Canada; n.d. http://www.bankofcanada.ca/en/rates/inflation_calc.html (Accessed 20 June 2013).

30.

Hanmer J, Lawrence WF, Anderson JP, Kaplan RM, Fryback DG. Report of nationally representative values for the noninstitutionalized US adult population for 7 health-related quality-of-life scores. Med Decis Making. 2006;26(4):391–400. doi:10.1177/0272989X06290497.PubMedCrossRef

31.

Smith TJ, Hillner BE. The efficacy and cost-effectiveness of adjuvant therapy of early breast cancer in premenopausal women. J Clin Oncol. 1993;11(4):771–6.PubMed

32.

Earle CC, Chapman RH, Baker CS, Bell CM, Stone PW, Sandberg EA, et al. Systematic overview of cost-utility assessments in oncology. J Clin Oncol. 2000;18(18):3302–17.PubMed

33.

Thornton AA, Madlensky L, Flatt SW, Kaplan RM, Pierce JP. The impact of a second breast cancer diagnosis on health related quality of life. Breast Cancer Res Treat. 2005;92(1):25–33. doi:10.1007/s10549-005-1411-7.PubMedCrossRef

34.

Fryback DG, Lawrence WF Jr. Dollars may not buy as many QALYs as we think: a problem with defining quality-of-life adjustments. Med Decis Making. 1997;17(3):276–84.PubMedCrossRef

35.

Kornblith AB, Herndon JE 2nd, Weiss RB, Zhang C, Zuckerman EL, Rosenberg S, et al. Long-term adjustment of survivors of early-stage breast carcinoma, 20 years after adjuvant chemotherapy. Cancer. 2003;98(4):679–89. doi:10.1002/cncr.11531.PubMedCrossRef

36.

McKenna C, Claxton K. Addressing adoption and research design decisions simultaneously: the role of value of sample information analysis. Med Decis Making. 2011;31(6):853–65. doi:10.1177/0272989X11399921.PubMedCrossRef

37.

Laupacis A, Feeny D, Detsky AS, Tugwell PX. How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ. 1992;146(4):473–81.PubMedCentralPubMed

38.

Goeree R, Levin L, Chandra K, Bowen JM, Blackhouse G, Tarride JE, et al. Health technology assessment and primary data collection for reducing uncertainty in decision making. J Am Coll Radiol. 2009;6(5):332–42. doi:10.1016/j.jacr.2009.01.012.PubMedCrossRef

39.

Muszbek N, Shah S, Carroll S, McDonald H, Dale P, Maroun J, et al. Economic evaluation of sorafenib in the treatment of hepatocellular carcinoma in Canada. Curr Med Res Opin. 2008;24(12):3559–69. doi:10.1185/03007990802563706.PubMedCrossRef

40.

Chabot I, Rocchi A. How do cost-effectiveness analyses inform reimbursement decisions for oncology medicines in Canada? The example of sunitinib for first-line treatment of metastatic renal cell carcinoma. Value Health. 2010;13(6):837–45. doi:10.1111/j.1524-4733.2010.00738.x.

41.

Ontario Health Technology Advisory Committee (OHTAC) recommendation: multi-gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer; 2010. http://www.health.gov.on.ca/english/providers/program/ohtac/tech/recommend/rec_gep_20101213.pdf (Accessed 5 May 2012).

42.

Ragaz J. The 21-gene assay, part 2. Canada’s uneven response. Report Card on Cancer in Canada. 2010–2011;13:41–3.

43.

Gonzalez-Angulo AM, Barlow, WE, et al. SWOG S1007: a phase III randomized clinical trial of standard adjuvant endocrine therapy with or without chemotherapy in patients with one to three positive nodes, hormone receptor (HR)-positive, and HER2-negative breast cancer with recurrence score (RS) of 25 or less. http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=76547.

44.

How to estimate physician/patient responses to personalized medicine technologies in real-world Canadian setting? The Health Canada and Canadian Institutes of Health Research Personalized Medicine in Canada: a multi-stakeholder workshop to examine the Canadian perspective, Ottawa; 2012. http://www.ihe.ca/documents/Personalized%20Medicine%20Final%20Report.pdf (Accessed 20 Oct 2013).

45.

Hannouf MB, Zaric GS. Cost-effectiveness analysis using registry and administrative data. In: Zaric GS, editor. Operations research and health care policy. International series in operations research & management science. vol 190. New York: Springer; 2013. p. 341–61.

46.

Carriere KC, Jin Y, Marrie TJ, Predy G, Johnson DH. Outcomes and costs among seniors requiring hospitalization for community-acquired pneumonia in Alberta. J Am Geriatr Soc. 2004;52(1):31–8 52007 (pii: 52007).PubMedCrossRef

47.

Baunemann Ott CL, Ratna N, Prayag R, Nugent Z, Badiani K, Navaratnam S. Survival and treatment patterns in elderly patients with advanced non-small-cell lung cancer in Manitoba. Curr Oncol. 2011;18(5):e238–42.PubMedCentralPubMedCrossRef

48.

Cooke AL, Appell R, Suderman K, Fradette K, Latosinsky S. Radiation treatment waiting times for breast cancer patients in Manitoba, 2001 and 2005. Curr Oncol. 2009;16(5):58–64.PubMedCentralPubMedCrossRef

49.

Erb C, Fox KR, Patel M, et al. Evaluation of practice patterns in the treatment of node-negative, hormone-receptor positive breast cancer patients with the use of the oncotype DX assay at the University of Pennsylvania. Presentation at the 30th annual San Antonio breast cancer symposium, San Antonio; 2007 (Abstract 3082).

50.

Oratz R, Chao C, Skrzypezak S, et al. Effect of a 21-gene reverse-transcriptase polymerase chain reaction assay on treatment recommendations for patients with lymph node-positive and estrogen receptor-positive breast cancer. Cancer Res. 2009;69(24 Suppl):abstract 2031.CrossRef

Title: Cost Effectiveness of a 21-Gene Recurrence Score Assay Versus Canadian Clinical Practice in Post-Menopausal Women with Early-Stage Estrogen or Progesterone-Receptor-Positive, Axillary Lymph-Node Positive Breast Cancer
Authors: Malek B. Hannouf
Bin Xie
Muriel Brackstone
Gregory S. Zaric
Publication date: 01-02-2014
Publisher: Springer International Publishing
Published in: PharmacoEconomics / Issue 2/2014
Print ISSN: 1170-7690
Electronic ISSN: 1179-2027
DOI: https://doi.org/10.1007/s40273-013-0115-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Cost Effectiveness of a 21-Gene Recurrence Score Assay Versus Canadian Clinical Practice in Post-Menopausal Women with Early-Stage Estrogen or Progesterone-Receptor-Positive, Axillary Lymph-Node Positive Breast Cancer

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 2/2014

Eliciting Preferences to Inform Patient-Centred Policies: the Case of Psoriasis

Modelling the Cost Effectiveness of Rituximab in Chronic Lymphocytic Leukaemia in First-Line Therapy and Following Relapse

The Cost Effectiveness of Dry Powder Antibiotics for the Treatment of Pseudomonas aeruginosa in Patients with Cystic Fibrosis

On the Use and Interpretation of Quantile Regression in Quality-of-Life Research

Clinical and Economic Impact of Substituting Dexmedetomidine for Propofol due to a US Drug Shortage: Examination of Coronary Artery Bypass Graft Patients at an Urban Medical Centre

Survival Modeling for the Estimation of Transition Probabilities in Model-Based Economic Evaluations in the Absence of Individual Patient Data: A Tutorial