Chemoprevention: Drug pricing and mortality - The case of tamoxifen

Cancer

Volumn 107, Issue 5, 2006, Pages 950-958

  Melnikow, Joy ^a,e   Kuenneth, Christina ^a   Helms, L Jay ^a   Barnato, Amber ^b   Kuppermann, Miriam ^c   Birch, Stephen ^d   Nouvo, James ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d MCMASTER UNIVERSITY   (Canada)

^e UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Breast cancer; Cost effectiveness; Prevention; Tamoxifen

Indexed keywords

ESTROGEN RECEPTOR; TAMOXIFEN;

ARTICLE; BREAST CANCER; CANADA; CANCER INCIDENCE; CANCER MORTALITY; CANCER REGISTRY; CANCER RISK; CARCINOMA IN SITU; CATARACT; CHEMOPROPHYLAXIS; COST EFFECTIVENESS ANALYSIS; DEEP VEIN THROMBOSIS; DIAGNOSIS RELATED GROUP; DRUG COST; DRUG EFFICACY; DRUG PRICING; ENDOMETRIUM CANCER; FRAGILITY FRACTURE; HUMAN; LUNG EMBOLISM; MEDICARE; MONTE CARLO METHOD; PRIORITY JOURNAL; PROBABILITY; REIMBURSEMENT; RISK REDUCTION; SENSITIVITY ANALYSIS; UNITED STATES;

ANTICARCINOGENIC AGENTS; ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; CANADA; COST-BENEFIT ANALYSIS; ENDOMETRIAL NEOPLASMS; FEMALE; HUMANS; MARKOV CHAINS; MIDDLE AGED; MONTE CARLO METHOD; NEOPLASMS, HORMONE-DEPENDENT; RISK; TAMOXIFEN; TIME FACTORS; UNITED STATES;

EID: 33747886042     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.22075     Document Type: Article

References (51)

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 Study. J Natl Cancer Inst 1998;90:1371-1388.
2. U.S. Preventative Services Task Force. Chemoprevention of breast cancer: recommendations and rationale. Ann Intern Med. 2002;137:56-58.
3. Levine M, Moutquin JM, Walton R, et al. Chemoprevention of breast cancer. A joint guideline from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative's Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. CMAJ. 2001;164:1681-1690.
4. Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003;53:5-26.
5. Veronesi U, Maisonneuvre P, Costa A, et al. Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomized trial among hysterectomised women. Italian Tamoxifen Prevention Study. Lancet. 1998;352:93-97.
6. Powles T, Eeles R, Ashley S, et al. Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomized Chemoprevention trial. Lancet. 1998;352:98-101.
7. IBIS Investigators. First results from the International Breast Cancer Intervention Study (IBIS-1): a randomized prevention trial. Lancet. 2002;360:817-824.
8. Cuzick J, Powles T, Veronesi U, et al. Overview of the main outcomes in breast-cancer prevention trials. Lancet. 2003;361:296-300.
9. Platet N, Cathiard AM, Gleizes M, Garcia M. Estrogens and their receptors in breast cancer progression: a dual role in cancer proliferation and invasion. Crit Rev Oncol Hematol. 2004;51:55-67.
10. Bugden S. Rx: Canadian drugs [comment]. N Engl J Med. 2004;350:1155.
11. Moynihan R. Drug spending in North America rose by 11% in 2003. BMJ. 2004;328:727.
12. Kennedy EM, Thomas B. Dramatic improvement or death spiral-two members of Congress assess the Medicare bill [news]. N Engl J Med. 2004;350:747-751.
13. Mantone MM, Tieman J. Seniors finally get help. Drug support limited by 'doughnut hole,' costs. Mod Health. 2003;33:30-31.
14. Medi-Span. Database online. Indianapolis: Wolters Kluwer Health, 2004. Available at URL: http://www.medi-span.com/ Accessed July 27, 2005.
15. Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press; 1996.
16. Food and Drug Administration. Novaldex (tamoxifen citrate) final approved labeling text. Available at: URL: http://www.fda.gov/cder/news/tamoxifen/ Accessed July 27, 2005.
17. Beck JR, Pauker SG. The Markov process in medical prognosis. Med Decis Making. 1983;3:419-458.
18. Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making. 1993;13:322-338.
19. Lilienfeld DE. Foundations of Epidemiology. New York: Oxford University Press; 1980.
20. Surveillance, Epidemiology, and End Results (SEER) Program (available at URL: www.seer.cancer.gov). SEER Stat Database: incidence-SEER 9 Regs Public-Use 2003 (released April 2004, based on the November 2003 submission). Bethesda: National Cancer Institute, DCCPS, Surveillance Research Program, Cancer Statistics Branch, 2004.
21. White RH, Zhou H, Murin S, Harvey D. Effect of ethnicity and gender on the incidence of venous thromboembolism in a diverse population in California in 1996. Thromb Haemost. 2005;93:298-305.
22. Melton LJ, Therneau TM, Larson DR. Long-term trends in hip fracture prevalence: the influence of hip fracture incidence and survival. Osteoporosis Int. 1998;8:68-74.
23. Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA. 2001;286:2815-2822.
24. Leske MC, Sperduto RD. The epidemiology of senile cataracts: a review. Am J Epidemiol. 1983;118:152-165.
25. Braithwaite RS, Col NF, Wong JB. Estimating hip fracture morbidity, mortality and costs. J Am Geriatr Soc. 2003;51:364-370.
26. Fransen M, Wooward M, Norton R, Robinson E, Butler M, Campbell AJ. Excess mortality or institutionalization after hip fracture: men are at greater risk than women. J Am Geriatr Soc. 2002;50:685-690.
27. Hannan EL, Magaziner J, Wang JJ, et al. Mortality and locomotion 6 months after hospitalization for hip fracture. Risk factors and risk-adjusted hospital outcomes. JAMA. 2001;285:2736-2742.
28. Heikkinen T, Parker M, Jalovaara P. Hip fractures in Finland and Great Britain-a comparison of patient characteristics and outcomes. Int Orthop. 2001;25:349-354.
29. Wolinsky FD, Fitzgerald JF Stump TE. The effect of hip fracture on mortality, hospitalization, and functional status: a prospective study. Am J Public Health. 1997;87:398-403.
30. Parker MJ, Pryon GA, Myles J. Eleven-year results in 2846 patients of the Peterborough Hip Fracture Project. Acta Orthop Scand. 2000;71:34-38.
31. Carson JL, Kelley MA, Duff A, et al. The clinical course of pulmonary embolism. N Engl J Med. 1992;326:1240-1245.
32. Janke RM, McGovern PG, Folsom AR. Mortality, hospital discharges, and case fatality for pulmonary embolism in the Twin Cites: 1980-1995. J Clin Epidemiol. 2000;53:103-109.
33. Kniffin WE, Barron JA, Barrett J, Birkmeyer JD, Anderson FA Jr. The epidemiology of diagnosed pulmonary embolism and deep venous thrombosis in the elderly. Arch Intern Med. 1994;154:861-866.
34. Anderson FA Jr., Wheeler HB, Goldberg RJ, et al. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991;151:933-938.
35. Arias E. United States life tables, 2000. National vital statistics report no. 51(3). Hyattsville: National Center for Health Statistics; 2002.
36. Center for Medicare and Medicaid Services. 100% Medicare Provider Analysis and Review (MEDPAR) Inpatient Hospital Fiscal Year 2000, June 2001 update. Available at URL: http://www.cms.hhs.gov/statistics/medpar Accessed June 2, 2005.
37. Center for Medicare and Medicaid Services. Clinical Diagnostic Laboratory Fee Schedule, November 18, 1999. Available at URL: http://www.cms.hhs.gov/ providers/pufdownload Accessed June 2, 2005.
38. Association of American Medical Colleges. Physician Fee Schedule Updates and Policy Changes for Calendar Year 2000, Association of American Medical Colleges, November 17, 1999. Available at URL: http://www.aamc.org/advocacy/ library/teachphys/phys0006.htm Accessed June 2, 2005.
39. Center for Medicare and Medicaid Services. Revised 2000 National Physician Fee Schedule Relative Value File, February 10, 2000. Available at URL: http://www.cms.hhs.gov/providers/pufdownload/rvudown.asp Accessed June 2, 2005.
40. Hoover DR, Crystal S, Kumar R, Sambamoorthi U, Kantor JC. Medical expenditures during the last year of life: findings from the 1992-1996 Medicare Current Beneficiary Survey. Health Serv Res. 2002;37:1625-1642.
41. Doubilet P, Begg CB, Weinstein MC, Braun P, McNeil BJ. Probabilistic sensitivity analysis using Monte Carlo simulation. A practical approach. Med Decis Making. 1985;5:157-177.
42. Ministry of Health, Ontario. Drug benefit formulary/comparative drug index no. 38. Toronto: Queen's Printer for Ontario; 2003.
43. Grady D, Ettinger B, Moscarelli E, et al. Multiple Outcomes of Raloxifene Evaluation Investigators. Safety and adverse effects associated with reloxifene: multiple outcomes of raloxifene evaluation. Obstet Gynecol. 2004;104:837-844.
44. Vogel VG, Costantino JP, Wickerham DL, et al. The effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes. JAMA. 2006;295:2727-2741.
45. Genencarelli DM. Average wholesale price for prescription drugs: is there a more appropriate pricing mechanism' NHPF Issue Brief. 2002;775:1-19.
46. Will BP, Berthelot JM, Nobrega KM, et al. Canada's Population Health Model (POHEM): a tool for performing economic evaluations of cancer control interventions. Eur J Cancer. 2001;37:1797-1804.
47. Gail M, Costantino J, Bryant J, et al. Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J Natl Cancer Inst. 1999;91:1829-1846.
48. Col NF, Goldberg RJ, Orr RK, et al. Survival impact of tamoxifen use for breast cancer risk reduction: projections from a patient-specific Markov model. Med Decis Making. 2002;22:386-393.
49. Cykert S, Phifer N, Hansen C. Tamoxifen for breast cancer prevention: a framework for clinical decisions. Obstet Gynecol. 2004;104:433-442.
50. Grann VR, Sundararajan V, Jacobson JS, et al. Decision analysis of tamoxifen for the prevention of invasive breast cancer. Cancer J. 2000;6:169-178.
51. Freedman AN, Graubard BI, Rao SR, McCaskill-Stevens W, Ballard-Barbash R, Gail MH. Estimates of the number of US women who could benefit from tamoxifen for breast cancer chemoprevention. J Natl Cancer Inst. 2003;95:526-532.