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© 2000 American Society for Clinical Oncology Tamoxifen Should be Cost-Effective in Reducing Breast Cancer Risk in High-Risk WomenFrom the Department of Medicine, Massey Cancer Center, Virginia Commonwealth University, Richmond, VA. Address reprint requests to Thomas J. Smith, MD, Division of Hematology/Oncology, 1101 East Marshall St, PO Box 980230, Richmond, VA 23298-0230; email tsmith{at}mcc1.mcc.vcu.edu
PURPOSE: To estimate the cost-effectiveness of tamoxifen in the prevention of breast cancer. PATIENTS AND METHODS: Clinical trial results of National Surgical Adjuvant Breast Program P-1 compared tamoxifen versus placebo in the prevention of breast cancer, and direct medical care costs were estimated from the Agency for Health Care Policy and Research and local sources. The base estimate of effectiveness included all women on the trial. RESULTS: For every 100 women treated for 5 years, 1.665 expected cancers would not be detected. If breast cancer death is fully prevented by this strategy, then the cost-effectiveness of tamoxifen compared with no intervention is $8,479 per additional year of life gained. If lifetime prevention of the risk of death from breast cancer exceeded 17%, then the cost-effectiveness ratio would be less than $50,000 per year of life gained (a common benchmark). CONCLUSIONS: Tamoxifen for breast cancer prevention should be cost-effective under nearly all circumstances. Its use will require additional resources because it is not cost saving, but it fits within accepted guidelines.
THE NATIONAL SURGICAL Adjuvant Breast Program recently reported the use of tamoxifen to reduce the risk of breast cancer in women at high risk.1 This welcome means to delay, suppress, or possibly even prevent invasive breast cancer was accompanied by a small excess risk of thrombotic events and uterine cancer. As a result, the decision to use tamoxifen outside a clinical trial has been problematic because of competing benefits, risks, and cost. Health care dollars are limited, and decisions must be made implicitly or explicitly.2 We attempted to estimate the direct health care cost of reducing breast cancer risk with tamoxifen.
To determine the cost-effectiveness of tamoxifen, we used the clinical trial results of P-11 and costs from the Agency for Health Care Policy and Research Web site [http://www.ahcpr.gov/data/94drgb.htm]. The cost estimates were similar to others reported.3 We converted all the risks and benefits of reported major health events to those that would accrue to 100 women on tamoxifen compared with 100 women not on the drug. We used the base estimate of all women on the trial, regardless of age, as the most general case. Only direct medical care costs for the 5 years on trial were estimated, as the true benefit (risk reduction, prevention, delay, suppression of estrogen receptor-positive cancers, or some combination) cannot be estimated at present. No discounting of either costs or benefits was done for the 5-year period. Costs are presented in a spreadsheet format so that each center can apply its own costs. The analysis is performed from the perspective of a health service payer, ie, an integrated health care system that includes prevention services, primary care, and specialty care.2,4
For every 100 women, 1.665 expected cancers would not be detected, which is defined as risk reduction (annual rate of 6.76 expected cancers per 1,000 women reduced to 3.43 per 1,000 women, or 0.333 per 100 women a year times 5 years). The competing adverse and beneficial events and economic consequences are listed in Table 1. The cost to reduce the risk of invasive breast cancer for one woman would be approximately $292,523.
If death from breast cancer could be 100% prevented by 5 years of tamoxifen (100% protection against loss of life), then a woman in her early forties would gain 34.5 years of life, with 3% discounting. This would lead to a cost-effectiveness ratio of $292,523/34.5 years = $8,479 per additional year of life gained (Table 1). Anything greater than 17% protection against breast cancer death would be less than a benchmark of $50,000 per year of life gained,2 as listed in Table 2, and meet guidelines for adoption.5 Even if we used the lifetime cost of ischemic stroke6 to emphasize the long-term cost of rare side effects, $90,981 per person instead of $11,500, the cost-effectiveness does not change by more than 1%.
How should this data be used? We performed this simple analysis to investigate the costs, not to decide about reimbursement. To assess if tamoxifen is an acceptable use of societal dollars2,4 would require more knowledge about long-term efficacy, long-term direct medical costs, and better estimates of indirect costs, such as wages. However, there are some important points to be gained from this preliminary analysis. First, the risk reduction is significant; 1.655 expected cancers would not be detected per 100 women over 5 years. This is the same as 6.76 expected cancers reduced to 3.43 per 1,000 women, expressed in the preferred method of absolute risk reduction per 100 women.7 This preventive benefit from tamoxifen is far more than the estimated reduction of breast cancer death of seven per 10,000 women (0.007 per 100 women) for annual screening mammography between the ages of 40 and 50 years.8 Second, it will not be possible to calculate the cost per additional year of life from the available data for many years, so some method of estimation must be used. Whether the risk reduction from tamoxifen translates into a reduction of breast cancer death is not known. For one woman to have a reduced risk of breast cancer, the total health dollars spent would be about $292,523. This breast cancer may be truly prevented, suppressed, or delayed. If the cancer is truly 100% prevented, and the woman gains 34.5 additional years of life, the cost-effectiveness would be $8,479 per year of life. This group of women would be under standard surveillance with screening mammography and physician examinations, so their risk of breast cancer death would be low already. Under almost all conditions, however, the cost-effectiveness of tamoxifen should be less than a threshold of $50,000 per additional life year gained (Table 2). For example, if only 17% of cases of breast cancer are truly prevented and become years of life saved, the cost per additional life year gained would still be less than $50,000. Third, the cost-effectiveness fits within guidelines, but the ratio would be better if the drug cost less. Although the cost-effectiveness is reasonable, tamoxifen prevention will still require additional funds. The cost does argue for careful consideration of tamoxifen use versus alternative uses of the same health care dollar. The average wholesale price of raloxifene, a possible alternative with risk reduction in the same range,9,10 is only slightly less at $55 per month. A complete analysis will require more information about nonmedical costs as well as medical costs.11 For some women who are buying the drug out of pocket or for those in charge of making purchasing decisions for a health care system, the additional expense will require additional resources. Finally, cost-effectiveness is determined by effectiveness. If tamoxifen does not work in women with different baseline risks or who use estrogen concurrently,12,13 then the cost will not be important.
1. Fisher B, Costantino JP, Wickerham DL, et al: Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1. J Natl Cancer Inst 90:1371-1388, 1998
2.
Smith TJ, Hillner BE, Desch CE: Efficacy and cost-effectiveness of cancer treatment: Rational allocation of resources based on decision analysis. J Natl Cancer Inst 85:1460-1474, 1993 3. Johnell O: The socioeconomic burden of fractures: Today and in the 21st century. Am J Med 130:20S-25S, 1997 4. Brown ML, Glick HA, Harrell FE, et al: Integrating economic analysis into cancer clinical trials: The NCI-ASCO economics workbook. J Natl Cancer Inst Monogr 24:1-28, 1998 5. Laupacis A, Feeny D, Detsky AS, et al: How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluation. Can Med Assoc J 146:473-481, 1992[Abstract]
6.
Taylor TN, Davis PH, Torner JC, et al: Lifetime cost of stroke in the United States. Stroke 27:1459-1466, 1996
7.
Staytor EK, Ward JE: How risks of breast cancer and benefits of screening are communicated to women: Analysis of 58 pamphlets. BMJ 317:263-264, 1998
8.
Berry DA: Benefits and risks of screening mammography for women in their forties: A statistical appraisal. J Natl Cancer Inst 90:1431-1439, 1998
9.
Cummings SR, Norton L, Eckhardt S, et al: Raloxifene reduces the risk of breast cancer and may decrease the risk of endometrial cancer in post-menopausal women: Two-year findings from the Multiple Outcomes of Raloxifene Evaluation (More) Trial. JAMA 281:2189-2196, 1999 10. Jordan VC, Glusman JE, Eckhert S, et al: Incident primary breast cancers are reduced by raloxifene: Integrated data from multicenter, double-blind, randomized trials in 12,000 postmenopausal women. Proc Am Soc Clin Oncol 17:122a 1998 (abstr 466) 11. Gold MR, Russell LB, Siegel JE, et al: Cost-Effectiveness in Health and Medicine. New York, NY, Oxford University Press, 1996 12. Powles T, Eeles R, Ashley S, et al: Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial. Lancet 352:98-101, 1998[Medline] 13. Veronesi U, Maisonneuve P, Costa A, et al: Prevention of breast cancer with tamoxifen: Preliminary findings from the Italian randomised trial among hysterectomised women—Italian Tamoxifen Prevention Study. Lancet 352:93-97, 1998[Medline] Submitted April 30, 1999; accepted August 17, 1999.
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Copyright © 2000 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
