An exploratory analysis of the factors leading to delays in cancer drug reimbursement in the European Union: The trastuzumab case

European Journal of Cancer

Volumn 50, Issue 18, 2014, Pages 3089-3097

  Ades, Felipe ^a   Senterre, Chistelle ^b   Zardavas, Dimitrios ^d   De Azambuja, Evandro ^a   Popescu, Razvan ^c   Parent, Florence ^b   Piccart, Martine ^a  

^a JULES BORDET INSTITUTE   (Belgium)

^b UNIVERSITÉ LIBRE DE BRUXELLES   (Belgium)

^c KLINIK HIRSLANDEN   (Switzerland)

^d Breast International Group (BIG)   (Belgium)

Author keywords

Breast cancer; Drug reimbursement; European Union; Health expenditure; Health policy; Trastuzumab

Indexed keywords

TRASTUZUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ARTICLE; BREAST CANCER; CANCER INCIDENCE; CANCER MORTALITY; CANCER THERAPY; COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG COST; DRUG MARKETING; EUROPEAN UNION; EXPLORATORY RESEARCH; HEALTH CARE POLICY; HUMAN; PRIORITY JOURNAL; REIMBURSEMENT; ADJUVANT CHEMOTHERAPY; BREAST NEOPLASMS; COST BENEFIT ANALYSIS; ECONOMICS; FEMALE; HEALTH CARE COST; METASTASIS; STATISTICS AND NUMERICAL DATA; TIME;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COST-BENEFIT ANALYSIS; DRUG APPROVAL; EUROPEAN UNION; FEMALE; HEALTH EXPENDITURES; HEALTH POLICY; HUMANS; NEOPLASM METASTASIS; REIMBURSEMENT MECHANISMS; TIME FACTORS;

EID: 84925225626     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2014.09.011     Document Type: Article

References (45)

1. wcr-2008.pdf. Available at: http://www.iarc.fr/en/publications/pdfs-online/wcr/2008/wcr-2008.pdf.
2. ee-2012-2-en.pdf. Available at: http://ec.europa.eu/economy-finance/publications/european-economy/2012/pdf/ee-2012-2-en.pdf.
3. A. Verdecchia, S. Francisci, H. Brenner, G. Gatta, A. Micheli, and L. Mangone Recent cancer survival in Europe: a 2000-02 period analysis of EUROCARE-4 data Lancet Oncol 8 2007 784 796
4. M. Kalager, M. Zelen, F. Langmark, and H.-O. Adami Effect of screening mammography on breast-cancer mortality in Norway N Engl J Med 363 2010 1203 1210
5. F.R. Lichtenberg The impact of new drug launches on longevity: evidence from longitudinal, disease-level data from 52 countries, 1982-2001 Int J Health Care Finance Econ 5 2005 47 73
6. 2004000089en1-32 1.1 - LexUriServ.do. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF.
7. The Centralised Procedure. Available at: http://ec.europa.eu/health/authorisation-procedures-centralised-en.htm.
8. Extent and causes of international variations in drug usage - Publications - Inside Government - GOV.UK. Available at: https://www.gov.uk/government/publications/extent-and-causes-of-international-variations-in-drug-usage.
9. Comparator report on patient access to cancer drugs in Europe Jan 15 09.pdf.
10. J.P. Mackenbach, M. Karanikolos, and M. McKee The unequal health of Europeans: successes and failures of policies Lancet 381 2013 1125 1134
11. Mackenbach J. Successes and failures of health policy in Europe: four decades of divergent trends and converging challenges. Availabel at: http://www.euro.who.int/en/about-us/partners/observatory/news/news/2013/04/just-published-successes-and-failures-of-health-policy-in-europe-four-decades-of-divergent-trends-and-converging-challenges.
12. R. Luengo-Fernandez, J. Leal, A. Gray, and R. Sullivan Economic burden of cancer across the European Union: a population-based cost analysis Lancet Oncol 14 2013 1165 1174
13. F. Ades, C. Senterre, E. de Azambuja, R. Sullivan, R. Popescu, and F. Parent Discrepancies in cancer incidence and mortality and its relationship to health expenditure in the 27 European Union member states Ann Oncol 24 2013 2897 2902
14. P. Autier, M. Boniol, C. La Vecchia, C. LaVecchia, L. Vatten, and A. Gavin Disparities in breast cancer mortality trends between 30 European countries: retrospective trend analysis of WHO mortality database BMJ 341 2010 c3620
15. C.M. Perou, T. Sørlie, M.B. Eisen, M. van de Rijn, S.S. Jeffrey, and C.A. Rees Molecular portraits of human breast tumours Nature 406 2000 747 752
16. S. Dawood, K. Broglio, A.U. Buzdar, G.N. Hortobagyi, and S.H. Giordano Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review J Clin Oncol 28 2010 92 98
17. M.J. Piccart-Gebhart, M. Procter, B. Leyland-Jones, A. Goldhirsch, M. Untch, and I. Smith Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer N Engl J Med 353 2005 1659 1672
18. E.H. Romond, E.A. Perez, J. Bryant, V.J. Suman, C.E. Geyer Jr., and N.E. Davidson Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer N Engl J Med 353 2005 1673 1684
19. H. Joensuu, P. Bono, V. Kataja, T. Alanko, R. Kokko, and R. Asola Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial J Clin Oncol 27 2009 5685 5692
20. M. Spielmann, H. Roché, T. Delozier, J.-L. Canon, G. Romieu, and H. Bourgeois Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial J Clin Oncol 27 2009 6129 6134
21. D. Slamon, W. Eiermann, N. Robert, T. Pienkowski, M. Martin, and M. Press Adjuvant trastuzumab in HER2-positive breast cancer N Engl J Med 365 2011 1273 1283
22. World Bank Group. Available at: http://www.worldbank.org/.
23. GLOBOCAN 2008. Availabel at: http://globocan.iarc.fr/.
24. F. Asadzadeh Vostakolaei, H.E. Karim-Kos, M.L.G. Janssen-Heijnen, O. Visser, A.L.M. Verbeek, and L.A.L.M. Kiemeney The validity of the mortality to incidence ratio as a proxy for site-specific cancer survival Eur J Public Health 21 2011 573 577
25. J.P. Mackenbach, and M. McKee A comparative analysis of health policy performance in 43 European countries Eur J Public Health 23 2013 195 201
26. European Medicines Agency - Find medicine - Herceptin. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000278/human-med-000818.jsp&mid=WC0b01ac058001d124.
27. EUR-Lex - 31989L0105 - EN. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31989L0105:EN:HTML.
28. F. Fagnani, X. Colin, P. Arveux, B. Coudert, and J.-L. Misset Cost/effectiveness analysis of adjuvant therapy with trastuzumab in patients with HER2 positive early breast cancer Bull Cancer 94 2007 711 720
29. P. Dinh, E. de Azambuja, F. Cardoso, and M.J. Piccart-Gebhart Facts and controversies in the use of trastuzumab in the adjuvant setting Nat Clin Pract Oncol 5 2008 645 654
30. I. Van Vlaenderen, J.L. Canon, V. Cocquyt, G. Jerusalem, J.P. Machiels, and P. Neven Trastuzumab treatment of early stage breast cancer is cost-effective from the perspective of the Belgian health care authorities Acta Clin Belg 64 2009 100 112
31. P.S. Hall, C. Hulme, C. McCabe, Y. Oluboyede, J. Round, and D.A. Cameron Updated cost-effectiveness analysis of trastuzumab for early breast cancer: a UK perspective considering duration of benefit, long-term toxicity and pattern of recurrence Pharmacoeconomics 29 2011 415 432
32. A. Macedo, I. Monteiro, S. Andrade, A. Cirrincione, and J. Ray Cost/effectiveness analysis of adjuvant therapy with trastuzumab in patients with HER2 positive early breast cancer Acta Med Port 23 2010 475 482
33. T.T. Purmonen, E. Pänkäläinen, J.H.O. Turunen, C. Asseburg, and J.A. Martikainen Short-course adjuvant trastuzumab therapy in early stage breast cancer in Finland: cost-effectiveness and value of information analysis based on the 5-year follow-up results of the FinHer Trial Acta Oncol 50 2011 344 352
34. M. Lidgren, B. Jönsson, C. Rehnberg, N. Willking, and J. Bergh Cost-effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer Ann Oncol 19 2008 487 495
35. N.L. Liberato, M. Marchetti, and G. Barosi Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer J Clin Oncol 25 2007 625 633
36. B.A.B. Essers, S.C. Seferina, V.C.G. Tjan-Heijnen, J.L. Severens, A. Novák, and M. Pompen Transferability of model-based economic evaluations: the case of trastuzumab for the adjuvant treatment of HER2-positive early breast cancer in the Netherlands Value Health 13 2010 375 380
37. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials Lancet 365 2005 1687 1717
38. D. Zardavas, L. Pugliano, F. Ades, I. Bozovic-Spasojevic, M. Capelan, and E. de Azambuja Targeted treatments of HER2-positive metastatic breast cancer: trastuzumab and beyond Breast Cancer Manag 1 2012 217 233
39. D. Zardavas, J. Baselga, and M. Piccart Emerging targeted agents in metastatic breast cancer Nat Rev Clin Oncol 10 2013 191 210
40. C. Leopold, S. Vogler, C. Habl, A.K. Mantel-Teeuwisse, and J. Espin Personalised medicine as a challenge for public pricing and reimbursement authorities - a survey among 27 European countries on the example of trastuzumab Health Policy 113 2013 313 322
41. 16-year mortality from breast cancer in the UK Trial of Early Detection of Breast Cancer Lancet 353 1999 1909 1914
42. L. Nyström, I. Andersson, N. Bjurstam, J. Frisell, B. Nordenskjöld, and L.E. Rutqvist Long-term effects of mammography screening: updated overview of the Swedish randomised trials Lancet 359 2002 909 919
43. J.A. Van Dijck, R. Holland, A.L. Verbeek, J.H. Hendriks, and M. Mravunac Efficacy of mammographic screening of the elderly: a case-referent study in the Nijmegen program in The Netherlands J Natl Cancer Inst 86 1994 934 938
44. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) S. Darby, P. McGale, C. Correa, C. Taylor, and R. Arriagada Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials Lancet 378 2011 1707 1716
45. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) R. Peto, C. Davies, J. Godwin, R. Gray, and H.C. Pan Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials Lancet 379 2012 432 444