PharmacoEconomics Italian Research Articles

, Volume 9, Issue 1, pp 31–43 | Cite as

Analisi costo-utilità di anastrozolo versus tamoxifene nel trattamento adiuvante del carcinoma mammario precoce post-menopausale


Cost-utility analysis of anastrozole versus tamoxifen for adjuvant treatment in postmenopausal women with early breast cancer


Objectives: To evaluate and compare healthcare-related costs and results on patients’ health state of anastrozole 1mg per os per diem and tamoxifen 20 mg per os per diem for adjuvant treatment in postmenopausal women with early breast cancer.

Methods: On the grounds of the results of an international, multicenter, randomized clinical trial (anastrozole: 3,125 patients; tamoxifen: 3,116 patients), the 68-month disease-free survival (anastrozole: 81.2%; tamoxifen: 78.3%; difference: 2.9%; 95% CI 0.5–4.5%; p<0.05) was considered for an intention-to-treat cost-utility analysis performed following the Italian National Health Service perspective. Healthcare-related costs of drugs, 68-month median follow-up, first events and prespecified adverse events were taken into account. Costs were expressed in Euros 2005. Whenever necessary, costs and effectiveness were discounted at a social rate of 3%.

Results: Patients treated with anastrozole gained 3.784 QALYs instead of 3.670 QALYs with tamoxifen (difference: 0.114 QALYs; 95% CI: 0.109–0.120; p<0.001). Cost for anastrozole patient was € 31,638.15, whereas cost for tamoxifen patient reached € 26,201.48 (difference: € 5,436.67; 95% CI: 5,436.66–5,436.68; p<0.001). The incremental cost-utility ratio amounted to € 47,555.55 (non-parametric bootstrap percentile method 95% CI: 46,091.60–49,683.59). Sensitivity analysis confirmed the robustness of the base case findings.

Conclusions: Anastrozole seems advisable even from an economic point of view, since its incremental cost-utility ratio falls well within the usual acceptability standards for incremental year of life saved (€ 12,000–60,000; US$ 50,000).


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    FONCaM-Forza Operativa Nazionale sul Carcinoma della Mammella. I tumori della mammella. Linee-guida sulla diagnosi, il trattamento e la riabilitazione. 2003Google Scholar
  2. 2.
    Early Breast Cancer Trialists’ Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998; 351: 1451–67CrossRefGoogle Scholar
  3. 3.
    Love RR, Barden HS, Mazess RB, et al. Effect of tamoxifen on lumbar spine bone mineral density in postmenopausal women after 5 years. Arch Intern Med 1994; 154: 2585–8PubMedCrossRefGoogle Scholar
  4. 4.
    The American College of Obstetricians and Gynecologists. Tamoxifen and endometrial cancer. Obstet Gynecol 2000; 95: 1C–3CCrossRefGoogle Scholar
  5. 5.
    Cutuli B, Petit JC, Fricker JP, et al. Adjuvant tamoxifen in breast cancer treatment in postmenopausal women: occurrence of thromboembolic complications. Oncol Rep 1994; 1: 59–63PubMedGoogle Scholar
  6. 6.
    Meier CR, Jick H. Tamoxifen and risk of idiopathic venous thromboembolism. Br J Clin Pharmacol 1998; 45: 608–12PubMedCrossRefGoogle Scholar
  7. 7.
    Geisler J, King N, Dowsett M, et al. Influence of anastrozole (Arimidex), a selective, non-steroidal aromatase inhibitor, on in vivo aromatisation and plasma oestrogen levels in post-menopausal women with breast cancer. Br J Cancer 1996; 74: 1286–91PubMedCrossRefGoogle Scholar
  8. 8.
    Masson. REFI-Repertorio Farmaceutico Italiano 2006. Milano: Masson, 2006Google Scholar
  9. 9.
    Nabholtz JM, Buzdar A, Pollack M, et al. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North America multicenter randomized trial. J Clin Oncol 2000; 18: 3758–76PubMedGoogle Scholar
  10. 10.
    Bonneterre J, Buzdar A, Nabholtz JMA, et al. Anastrozole versus tamoxifene as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the tamoxifen or Arimidex randomized group efficacy and tolerability study. J Clin Oncol 2000; 18: 3748–57PubMedGoogle Scholar
  11. 11.
    Winer EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer: status report 2004. J Clin Oncol 2005; 23: 619–29PubMedCrossRefGoogle Scholar
  12. 12.
    Ministero della Salute. Prontuario Farmaceutico Nazionale 2005. Roma: Ministero della Salute, 15 dicembre 2004 [Consultato il 6 giugno 2005]Google Scholar
  13. 13.
    Masson-OEMF. L’Informatore Farmaceutico 2005. Milano: Masson-OEMF, 2005Google Scholar
  14. 14.
    Drummond MF, O’Brien BJ, Stoddart GL, Torrance GW Methods for the economic evaluation of health care programmes. 2nd ed. New York: Oxford University Press, 1997Google Scholar
  15. 15.
    The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists’ Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet 2002; 359: 2131–9PubMedCrossRefGoogle Scholar
  16. 16.
    The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists’ Group. Results of the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer., 8 dicembre 2004: 1–2 [Consultato il 6 giugno 2005]
  17. 17.
    Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996Google Scholar
  18. 18.
    Delea TE, Karnon J, Smith RE, et al. Cost-effectiveness of extended adjuvant letrozole therapy after 5 years of adjuvant tamoxifen therapy in postmenopausal women with early-stage breast cancer. Am J Manag Care 2006; 12: 374–86PubMedGoogle Scholar
  19. 19.
    Sorensen S, Brown R, Benedict A, et al. Patient-rated utilities in postmenopausal early breast cancer (EBC): a cross-country comparison: Contributed Podium Presentations. Value Health 2004; 7: 637–57Google Scholar
  20. 20.
    Leibson CL, Tosteson AN, Gabriel SE, et al. Mortality, disability, and nursing home use for persons with and without hip fracture: a population-based study. J Am Geriatr Soc 2002; 50: 1644–50PubMedCrossRefGoogle Scholar
  21. 21.
    Vanara F. Il nuovo sistema di finanziamento nel servizio sanitario nazionale. Roma: Aracne, 1995Google Scholar
  22. 22.
    Grassi C, Casali L, Curti E, et al. Efficacy and safety of short course (5-day) moxifloxacin vs 7-day ceftriaxone in the treatment of acute exacerbations of chronic bronchitis (AECB). J Chemother 2002; 14: 543–54Google Scholar
  23. 23.
    AstraZeneca S.p.A. Data on file studio ATAC oggetto di comunicazione ufficiale al Ministero della Salute nel giugno 2005. AstraZeneca SpA, 2005Google Scholar
  24. 24.
    Ministero della Sanità. Decreto ministeriale n. 150 del 22 luglio 1996. Prestazioni di assistenza specialistica ambulatoriale erogabili nell’ambito del Servizio sanitario nazionale e relative tariffe. Supplemento ordinario alla Gazzetta Ufficiale n. 216 del 14 settembre 1996, Serie generaleGoogle Scholar
  25. 25.
    The Italian Group for Antiemetic Research. Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med 2000; 342: 1554–9CrossRefGoogle Scholar
  26. 26.
    Ministero della Sanità. Decreto ministeriale n. 178 del 30 giugno 1997. Aggiornamento delle tariffe delle prestazioni di assistenza ospedaliera, di cui al decreto ministeriale 14 dicembre 1994. Supplemento ordinario alla Gazzetta Ufficiale n. 209 dell’8 settembre 1997, Serie generaleGoogle Scholar
  27. 27.
    Ministero della Salute. AIFA-Agenzia Italiana del Farmaco. Bollettino d’informazione sui farmaci 2005; 3-4: 150–51. Roma: Ministero della Salute, maggio-agosto 2004 [Consultato il 10 giugno 2005]Google Scholar
  28. 28.
    Francis RM, Baillie SP, Chuck AJ, et al. Acute and long-term management of patients with vertebral fractures. QJM 2004; 97: 63–74PubMedCrossRefGoogle Scholar
  29. 29.
    Randelli P Le fratture., 2000 [Consultato il 19 giugno 2005]
  30. 30.
    EVEREST-European Vertebroplasty Research Team. Vertebro-plastica., 2005 [Consultato il 19 giugno 2005]Google Scholar
  31. 31.
    Lazzaro C. Health and economic consequences of smoking (ECOS) model. WHO European Partnership Project to reduce tobacco dependence. Appendix 1. Copenhagen-Geneva: WHO,, 1999 [Consultato il 6 aprile 2001]Google Scholar
  32. 32.
    Ministero della Salute. Sistema Informativo Sanitario. SDO. Idati delle S.D.O. File dati delle S.D.O. 2003. Roma:, 2005 [Consultato il 22 giugno 2005]Google Scholar
  33. 33.
    Hyers TM, Agnelli G, Hull RD, et al. Antithrombotic therapy for venous thromboembolic disease. Chest 2001; 119: 176S–93PubMedCrossRefGoogle Scholar
  34. 34.
    SICVE-Società Italiana di Chirurgia Vascolare ed Endovascolare. Flebologia. Milano: SICVE, 2005 [Consultato il 24 giugno 2005]Google Scholar
  35. 35.
    Roscoe JA, Morrow GR, Hickok JT, et al. Effect of paroxetine hydrochloride (Paxil) on fatigue and depression in breast cancer patients receiving chemotherapy. Breast Cancer Res Treat 2005; 89: 243–9PubMedCrossRefGoogle Scholar
  36. 36.
    G.L.I.C.O.-Gruppo di Lavoro Interaziendale Coordinamento Oncologico. Linee Guida Clinico-Organizzative per la Diagnosi ed il Trattamento del Carcinoma Mammario per la Provincia di Modena. Ia edizione. Modena 2000Google Scholar
  37. 37.
    Jones L, Hawkins N, Westwood M, et al. Systematic review of the clinical effectiveness and cost-effectiveness of capecitabine (Xeloda®) for locally advanced and/or metastatic breast cancer. Health Technol Assess 2004; 8: 1–143Google Scholar
  38. 38.
    Attanasio E, Bruzzi P, Capri S, et al. Raccomandazioni per la conduzione degli studi di farmacoeconomia: la Guida GISF. Mecosan 1999; 29: 65–72Google Scholar
  39. 39.
    Regione Lombardia. Prestazioni di assistenza specialistica ambulatoriale erogabili nell’ambito del Servizio Sanitario Regionale e relative tariffe in vigore dal 1∘ settembre 2004. Milano: Regione Lombardia, settembre2004 [Consultato il 24 giugno 2005]Google Scholar
  40. 40.
    Regione Lombardia. Tariffe delle prestazioni ospedaliere in regime di ricovero in vigore dalle dimissioni del 1/1/2004 (CMS-DRG Grouper V19.0) — DGR VII/15324 del 28/11/2003. Milano: Regione Lombardia, novembre 2004 [Consultato il 24 giugno 2005]Google Scholar
  41. 41.
    Regione Toscana. Delibera n. 372 del 15/04/2002. Dipartimento della Salute e delle Politiche della Solidarietà. Revisione dei criteri di attribuzione delle tariffe ai presidi di ricovero per acuti (livelli tariffari). Individuazione dei DRG di alta specialità e loro remunerazione. Firenze: Regione Toscana,, aprile 2002 [Consultato il 24 giugno 2005]Google Scholar
  42. 42.
    Regione Toscana. Nomenclatore tariffario delle prestazioni specialistiche ambulatoriali. DGR n. 229 del 03/03/1997 e successive modificazioni e integrazioni (aggiornato al 10/06/2002) Firenze: Regione Toscana,, giugno 2002 [Consultato il 24 giugno 2005]Google Scholar
  43. 43.
    Regione Sicilia. Assessorato della Sanità. Decreto 28 gennaio 2002. Conversione in euro delle tariffe per le prestazioni di assistenza specialistica ambulatoriale erogate dalle strutture sanitarie pubbliche e private del Servizio sanitario regionale di cui al decreto 11 dicembre 1997 e successive modifiche. Supplemento ordinario alla Gazzetta Ufficiale della Regione Siciliana n. 11 dell’8 marzo 2002Google Scholar
  44. 44.
    Regione Sicilia. Assessorato della Sanità. Decreto 21 giugno 2002. Modifica del decreto 12 giugno 2002, concernente classificazione delle strutture sanitarie pubbliche e private e rideterminazione delle tariffe delle prestazioni di assistenza ospedaliera. Gazzetta Ufficiale della Regione Siciliana n. 30 del 1∘ luglio 2002Google Scholar
  45. 45.
    Efron B, Tibshirani RJ. An Introduction to the Bootstrap. Chapman and Hall: New York, 1993Google Scholar
  46. 46.
    Desgagné A, Castilloux AM, Angers JF, LeLorier J. The use of bootstrap statistical method for the pharmacoeconomic cost analysis of skewed data. PharmacoEconomics 1998; 13: 487–97PubMedCrossRefGoogle Scholar
  47. 47.
    Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med 2000; 19: 3219–36PubMedCrossRefGoogle Scholar
  48. 48.
    Briggs A, Fenn P. Confidence intervals or surfaces? Uncertainty on the cost-effectiveness plane. Health Econ 1998; 7: 723–40PubMedCrossRefGoogle Scholar
  49. 49.
    Briggs A, Clarke P, Polsky D, Glick H. Modelling the cost of health care interventions. Paper prepared for DEEM III: Costing Methods for Economic Evaluation. University of Aberdeen, 15–16th April 2003Google Scholar
  50. 50.
    Locker GY, on behalf of the ATAC Trialists’ Group. Cost-utility analysis of anastrozole versus tamoxifen as primary adjuvant therapy in postmenopausal women with early breast cancer from a US healthcare system perspective: the 5-year completed treatment analysis of the ATAC (“Arimidex”, Tamoxifen Alone or in Combination) Trial. Poster presented at the 27th Annual San Antonio Breast Cancer Symposium. San Antonio (TX), USA: 8-11 December 2004.Google Scholar
  51. 51.
    Mark DB, Hlatky MA, Califf RM, et al. Cost-effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction, N Engl J Med 1995; 332: 1418–24PubMedCrossRefGoogle Scholar
  52. 52.
    Messori A, Santarlasci B, Trippoli S, Vaiani M. Controvalore economico del farmaco e beneficio clinico: stato dell’arte della metodologia e applicazione di un algoritmo farmacoeconomico. PharmacoEconomics-Italian Research Articles 2003; 5: 53–67Google Scholar
  53. 53.
    Johanneson M, Meltzer D. Some reflections on cost-effectiveness analysis. Health Econ 1998; 7: 1–7CrossRefGoogle Scholar
  54. 54.
    Trueman P, Drummond M, Hutton J. Developing guidance for budget impact analysis. PharmacoEconomics 2001; 19: 609–21PubMedCrossRefGoogle Scholar
  55. 54.
    Lucioni C. Budget Impact: strumento di valutazione per il decisore pubblico. Economia & Politica del Farmaco 2005; 6: 42–6Google Scholar

Copyright information

© Adis Data Information 2007

Authors and Affiliations

  1. 1.Economista sanitarioMilanoItalia
  2. 2.Studio di economia sanitariaMilanoItalia

Personalised recommendations