Journal Article
. 2013 Nov;32(2).
doi: 10.1007/s40273-013-0115-9.

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

Malek B Hannouf 1 Bin Xie  Muriel Brackstone  Gregory S Zaric  
Affiliations
  • PMID: 24288208
  •     40 References
  •     6 citations

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.

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.
Malek B Hannouf, Bin Xie, Muriel Brackstone, Gregory S Zaric.
BMC Cancer, 2012 Oct 04; 12. PMID: 23031196    Free PMC article.
Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer.
John Hornberger, Leon E Cosler, Gary H Lyman.
Am J Manag Care, 2005 May 19; 11(5). PMID: 15898220
Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer.
Daphne T Tsoi, Miho Inoue, +2 authors, Kathleen I Pritchard.
Oncologist, 2010 Apr 28; 15(5). PMID: 20421264    Free PMC article.
Cost-effectiveness of 21-gene assay in node-positive, early-stage breast cancer.
Burton F Vanderlaan, Michael S Broder, +2 authors, Tanya G K Bentley.
Am J Manag Care, 2011 Aug 09; 17(7). PMID: 21819166
The 70-gene prognosis-signature predicts disease outcome in breast cancer patients with 1-3 positive lymph nodes in an independent validation study.
Stella Mook, Marjanka K Schmidt, +10 authors, TRANSBIG Consortium.
Breast Cancer Res Treat, 2008 Jul 29; 116(2). PMID: 18661261
Dollars may not buy as many QALYs as we think: a problem with defining quality-of-life adjustments.
D G Fryback, W F Lawrence.
Med Decis Making, 1997 Jul 01; 17(3). PMID: 9219187
Addressing adoption and research design decisions simultaneously: the role of value of sample information analysis.
Claire McKenna, Karl Claxton.
Med Decis Making, 2011 Mar 12; 31(6). PMID: 21393558
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.
Isabelle Chabot, Angela Rocchi.
Value Health, 2010 Jun 22; 13(6). PMID: 20561332
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.
Mitch Dowsett, Jack Cuzick, +11 authors, Steven Shak.
J Clin Oncol, 2010 Mar 10; 28(11). PMID: 20212256
Highly Cited.
Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection.
Shelly S Lo, Patricia B Mumby, +8 authors, Kathy S Albain.
J Clin Oncol, 2010 Jan 13; 28(10). PMID: 20065191
Highly Cited.
A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.
M E Charlson, P Pompei, K L Ales, C R MacKenzie.
J Chronic Dis, 1987 Jan 01; 40(5). PMID: 3558716
Highly Cited.
Docetaxel in combination with doxorubicin and cyclophosphamide as adjuvant treatment for early node-positive breast cancer: a cost-effectiveness and cost-utility analysis.
Sorrel E Wolowacz, David A Cameron, Helen C Tate, Adrian Bagust.
J Clin Oncol, 2008 Feb 19; 26(6). PMID: 18281666
Survival and treatment patterns in elderly patients with advanced non-small-cell lung cancer in Manitoba.
C L Baunemann Ott, N Ratna, +3 authors, S Navaratnam.
Curr Oncol, 2011 Oct 08; 18(5). PMID: 21980255    Free PMC article.
Use of archived specimens in evaluation of prognostic and predictive biomarkers.
Richard M Simon, Soonmyung Paik, Daniel F Hayes.
J Natl Cancer Inst, 2009 Oct 10; 101(21). PMID: 19815849    Free PMC article.
Highly Cited.
Trial assessing individualized options for treatment for breast cancer: the TAILORx trial.
Jo Anne Zujewski, Leah Kamin.
Future Oncol, 2008 Oct 17; 4(5). PMID: 18922117
Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan.
Masahide Kondo, Shu Ling Hoshi, +2 authors, Masakazu Toi.
Breast Cancer Res Treat, 2007 Dec 14; 112(1). PMID: 18075786
Health technology assessment and primary data collection for reducing uncertainty in decision making.
Ron Goeree, Les Levin, +7 authors, Daria O'Reilly.
J Am Coll Radiol, 2009 Apr 28; 6(5). PMID: 19394574
Radiation treatment waiting times for breast cancer patients in Manitoba, 2001 and 2005.
A L Cooke, R Appell, +2 authors, S Latosinsky.
Curr Oncol, 2009 Oct 29; 16(5). PMID: 19862362    Free PMC article.
Markov models in medical decision making: a practical guide.
F A Sonnenberg, J R Beck.
Med Decis Making, 1993 Oct 01; 13(4). PMID: 8246705
Highly Cited.
Long-term adjustment of survivors of early-stage breast carcinoma, 20 years after adjuvant chemotherapy.
Alice B Kornblith, James E Herndon, +10 authors, Jimmie C Holland.
Cancer, 2003 Aug 12; 98(4). PMID: 12910510
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
Soonmyung Paik, Gong Tang, +11 authors, Norman Wolmark.
J Clin Oncol, 2006 May 25; 24(23). PMID: 16720680
Highly Cited.
Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes.
Melody A Cobleigh, Bita Tabesh, +7 authors, Steven Shak.
Clin Cancer Res, 2005 Dec 20; 11(24 Pt 1). PMID: 16361546
A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
Soonmyung Paik, Steven Shak, +12 authors, Norman Wolmark.
N Engl J Med, 2004 Dec 14; 351(27). PMID: 15591335
Highly Cited.
Outcomes and costs among seniors requiring hospitalization for community-acquired pneumonia in Alberta.
Keumhee C Carriere, Yan Jin, +2 authors, David H Johnson.
J Am Geriatr Soc, 2003 Dec 23; 52(1). PMID: 14687312
The efficacy and cost-effectiveness of adjuvant therapy of early breast cancer in premenopausal women.
T J Smith, B E Hillner.
J Clin Oncol, 1993 Apr 01; 11(4). PMID: 8478670
How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations.
A Laupacis, D Feeny, A S Detsky, P X Tugwell.
CMAJ, 1992 Feb 15; 146(4). PMID: 1306034    Free PMC article.
Highly Cited.
The impact of a second breast cancer diagnosis on health related quality of life.
Andrea A Thornton, Lisa Madlensky, +2 authors, John P Pierce.
Breast Cancer Res Treat, 2005 Jun 28; 92(1). PMID: 15980988
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.
Gary H Lyman, Leon E Cosler, Nicole M Kuderer, John Hornberger.
Cancer, 2007 Feb 22; 109(6). PMID: 17311307
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.
M Levine, Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer.
CMAJ, 2001 Mar 22; 164(5). PMID: 11258212    Free PMC article.
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.
Ruth Oratz, Benjamin Kim, +4 authors, Michael Broder.
J Oncol Pract, 2011 Jul 07; 7(2). PMID: 21731516    Free PMC article.
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.
M B Hannouf, M Brackstone, B Xie, G S Zaric.
Curr Oncol, 2012 Nov 13; 19(5). PMID: 23144580    Free PMC article.
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.
Eleftherios P Mamounas, Gong Tang, +7 authors, Norman Wolmark.
J Clin Oncol, 2010 Jan 13; 28(10). PMID: 20065188    Free PMC article.
Highly Cited.
Economic evaluation of sorafenib in the treatment of hepatocellular carcinoma in Canada.
Noemi Muszbek, Sonalee Shah, +4 authors, Jennifer Knox.
Curr Med Res Opin, 2008 Nov 27; 24(12). PMID: 19032137
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.
Kathy S Albain, William E Barlow, +20 authors, Breast Cancer Intergroup of North America.
Lancet Oncol, 2009 Dec 17; 11(1). PMID: 20005174    Free PMC article.
Highly Cited.
Systematic overview of cost-utility assessments in oncology.
C C Earle, R H Chapman, +4 authors, P J Neumann.
J Clin Oncol, 2000 Sep 14; 18(18). PMID: 10986064
Review.
Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer.
Nathan W D Lamond, Chris Skedgel, +2 authors, Tallal Younis.
Breast Cancer Res Treat, 2012 Mar 01; 133(3). PMID: 22361999
Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization.
Shmuel H Klang, Ariel Hammerman, +3 authors, John Hornberger.
Value Health, 2010 Apr 24; 13(4). PMID: 20412544
Report of nationally representative values for the noninstitutionalized US adult population for 7 health-related quality-of-life scores.
Janel Hanmer, William F Lawrence, +2 authors, Dennis G Fryback.
Med Decis Making, 2006 Jul 21; 26(4). PMID: 16855127
Highly Cited.
Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features.
Lori J Goldstein, Robert Gray, +12 authors, Joseph A Sparano.
J Clin Oncol, 2008 Aug 06; 26(25). PMID: 18678838    Free PMC article.
Highly Cited.
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).
Masahide Kondo, Shu-Ling Hoshi, +2 authors, Masakazu Toi.
Breast Cancer Res Treat, 2010 Nov 18; 127(3). PMID: 21082239
The Clinical Significance of Occult Gastrointestinal Primary Tumours in Metastatic Cancer: A Population Retrospective Cohort Study.
Malek B Hannouf, Eric Winquist, +6 authors, Gregory S Zaric.
Cancer Res Treat, 2017 Mar 23; 50(1). PMID: 28324922    Free PMC article.
21-Gene recurrence score testing among Medicare beneficiaries with breast cancer in 2010-2013.
Julie A Lynch, Brygida Berse, Nicole Coomer, John Kautter.
Genet Med, 2017 Mar 24; 19(10). PMID: 28333918
The clinical significance of occult gynecologic primary tumours in metastatic cancer.
M B Hannouf, E Winquist, +6 authors, G S Zaric.
Curr Oncol, 2017 Nov 02; 24(5). PMID: 29089807    Free PMC article.
The Potential Clinical and Economic Value of Primary Tumour Identification in Metastatic Cancer of Unknown Primary Tumour: A Population-Based Retrospective Matched Cohort Study.
Malek B Hannouf, Eric Winquist, +6 authors, Gregory S Zaric.
Pharmacoecon Open, 2018 Apr 07; 2(3). PMID: 29623630    Free PMC article.
Cost-utility analysis of 21-gene assay for node-positive early breast cancer.
L Masucci, S Torres, +5 authors, W Isaranuwatchai.
Curr Oncol, 2019 Nov 12; 26(5). PMID: 31708649    Free PMC article.
Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment.
Ontario Health (Quality).
Ont Health Technol Assess Ser, 2020 Apr 15; 20(10). PMID: 32284770    Free PMC article.