Cost-consequences evaluation between bivalent and quadrivalent HPV vaccines in Italy: The potential impact of different cross-protection profiles

Gynecologic Oncology

Volumn 121, Issue 3, 2011, Pages 514-521

  Capri, S ^a   Gasparini, R ^b   Panatto, D ^b   Demarteau, N ^c  

^a CREMS Centre for Research on Health Economics Social and Health Care Management Carlo Cattaneo University LIUC   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

^c GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

Cervical cancer; Cost consequences analysis; Cross protection; Human papillomavirus; Italy; Vaccination

Indexed keywords

WART VIRUS VACCINE;

ABNORMAL LABORATORY RESULT; ARTICLE; CANCER PREVENTION; CONDYLOMA ACUMINATUM; CONTROLLED STUDY; CROSS PROTECTION; DRUG COST; DRUG EFFICACY; ECONOMIC EVALUATION; FEMALE; HUMAN; INFECTION PREVENTION; ITALY; PAPANICOLAOU TEST; PRIORITY JOURNAL; UTERINE CERVIX CANCER; UTERINE CERVIX CARCINOMA IN SITU; VACCINATION;

ALPHAPAPILLOMAVIRUS; CERVICAL INTRAEPITHELIAL NEOPLASIA; CROSS REACTIONS; FEMALE; HUMAN PAPILLOMAVIRUS 11; HUMAN PAPILLOMAVIRUS 16; HUMAN PAPILLOMAVIRUS 18; HUMAN PAPILLOMAVIRUS 6; HUMANS; MODELS, STATISTICAL; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; UTERINE CERVICAL NEOPLASMS; VAGINAL NEOPLASMS; VULVAR NEOPLASMS;

EID: 79957486779     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2011.01.029     Document Type: Article

References (74)

1. J. Ferlay, H.R. Shin, F. Bray, D. Forman, C. Mathers, and D.M. Parkin GLOBOCAN 2008: cancer incidence and mortality worldwide http://globocan.iarc.fr 2010 [cited 2010 Jun 22];(IARC CancerBase No 10)
2. A. Ricciardi, N. Largeron, R.P. Giorgi, M. Raffaele, C. Cohet, and A. Federici Incidence of invasive cervical cancer and direct costs associated with its management in Italy Tumori 95 2 Mar 2009 146 152
3. N. Munoz Human papillomavirus and cancer: the epidemiological evidence J Clin Virol 19 1-2 Oct 2000 1 5
4. F.X. Bosch, A.N. Burchell, M. Schiffman, A.R. Giuliano, S. de Sanjose, and L. Bruni Epidemiology and natural history of human papillomavirus infections and type-specific implications in cervical neoplasia Vaccine 26 Supplement 10 Aug 19 2008 K1 K16
5. G.M. Clifford, R.K. Rana, S. Franceschi, J.S. Smith, G. Gough, and J.M. Pimenta Human papillomavirus genotype distribution in low-grade cervical lesions: comparison by geographic region and with cervical cancer Cancer Epidemiol Biomark Prev 14 5 May 2005 1157 1164 (Pubitemid 40656461)
6. J.S. Smith, L. Lindsay, B. Hoots, J. Keys, S. Franceschi, and R. Winer Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update Int J Cancer 121 3 Apr 2 2007 621 632 (Pubitemid 46986496)
7. J.M. Walboomers, M.V. Jacobs, M.M. Manos, F.X. Bosch, J.A. Kummer, and K.V. Shah Human papillomavirus is a necessary cause of invasive cervical cancer worldwide J Pathol 189 1 1999 12 19 (Pubitemid 29406813)
8. D.R. Brown, J.M. Schroeder, J.T. Bryan, M.H. Stoler, and K.H. Fife Detection of multiple human papillomavirus types in condylomata acuminata lesions from otherwise healthy and immunosuppressed patients J Clin Microbiol 37 10 Oct 1999 3316 3322 (Pubitemid 29455226)
9. P. Vandepapeliere, R. Barrasso, C.J. Meijer, J.M. Walboomers, M. Wettendorff, and L.R. Stanberry Randomized controlled trial of an adjuvanted human papillomavirus (HPV) type 6 L2E7 vaccine: infection of external anogenital warts with multiple HPV types and failure of therapeutic vaccination J Infect Dis 192 12 Dec 15 2005 2099 2107 (Pubitemid 41779207)
10. L. Minelli, F. Stracci, S. Prandini, I.F. Moffa, and R.F. La Gynaecological cancers in Umbria (Italy): trends of incidence, mortality and survival, 1978-1998 Eur J Obstet Gynecol Reprod Biol 115 1 Jul 15 2004 59 65 (Pubitemid 38844220)
11. M. Quinn, P. Babb, J. Jones, and E. Allen Effect of screening on incidence of and mortality from cancer of cervix in England: evaluation based on routinely collected statistics BMJ 318 7188 Apr 3 1999 904 908 (Pubitemid 29191925)
12. F. Bray, A.H. Loos, P. McCarron, E. Weiderpass, M. Arbyn, and H. Moller Trends in cervical squamous cell carcinoma incidence in 13 European countries: changing risk and the effects of screening Cancer Epidemiol Biomark Prev 14 3 Mar 2005 677 686 (Pubitemid 40489214)
13. Ministero della Sanita Linee-guida elaborate dalla Commissione oncologica nazionale, in applicazione di quanto previsto dal Piano sanitario nazionale per il triennio 1994-1996, relativo all'azione programmata "Prevenzione e cura delle malattie oncologiche", concernenti l'organizzazione della prevenzione e dell'assistenza in oncologia Gazz Ufficiale 127 Jun 1 1996 Available from: http://www.guritel.it/free-sum/ARTI/1996-06/01/sommario.html
14. G. Ronco, P. Giubilato, C. Naldoni, M. Zorzi, E. Anghinoni, and A. Scalisi Activity level and process indicators of organised programmes for cervical cancer screening in Italy Epidemiol Prev 30 1 Suppl 3 Jan 2006 27 40
15. Il sistema di sorveglianza sui Progressi delle Aziende Sanitarie per la Salute in Italia (Passi) dall'ascolto dei cittadini alle azioni di prevenzione: Rapporto Nazionale 2008 Sep 2009 Progressi delle Aziende Sanitarie per la Salute in Italia (PASSI) Pavona
16. S.L. Giannini, E. Hanon, P. Moris, M. Van Mechelen, S. Morel, and F. Dessy Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only Vaccine 24 33-34 2006 5937 5949 (Pubitemid 44080367)
17. V. Bouvard, R. Baan, K. Straif, Y. Grosse, B. Secretan, and G.F. El A review of human carcinogens-Part B: Biological agents Lancet Oncol 10 4 Apr 2009 321 322
18. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans Human Papillomaviruses Dec 2007 World Health Organization International Agency for Research on Cancer Lyon Report No.: Volume 90
19. M. Deschuyteneer, A. Elouahabi, D. Plainchamp, M. Plisnier, D. Soete, and Y. Corazza Molecular and structural characterization of the L1 virus-like particles that are used as vaccine antigens in Cervarix, the AS04-adjuvanted HPV-16 and -18 cervical cancer vaccine Hum Vaccin 6 5 May 2010 407 419
20. EMEA EPARs for authorised medicinal products for human use: Cervarix H-C-721 03/10/07 [cited 2008 May 23];Available from: URL: http://www.emea. europa.eu/humandocs/PDFs/EPAR/cervarix/H-721-en6.pdf October 3 2007
21. H. Mach, D.B. Volkin, R.D. Troutman, B. Wang, Z. Luo, and K.U. Jansen Disassembly and reassembly of yeast-derived recombinant human papillomavirus virus-like particles (HPV VLPs) J Pharm Sci 95 10 Oct 2006 2195 2206 (Pubitemid 44568530)
22. J. Paavonen, P. Naud, J. Salmerón, C.M. Wheeler, S.N. Chow, and D. Apter Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women Lancet 374 9686 Jul 25 2009 301 314
23. L.L. Villa, R.L. Costa, C.A. Petta, R.P. Andrade, J. Paavonen, and O.E. Iversen High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up Br J Cancer 95 11 Dec 4 2006 1459 1466 (Pubitemid 44863348)
24. D.R. Brown, S.K. Kjaer, K. Sigurdsson, O.E. Iversen, M. Hernandez-Avila, and C.M. Wheeler The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years J Infect Dis 199 7 Apr 1 2009 926 935
25. M.H. Einstein, M. Baron, M.J. Levin, A. Chatterjee, R.P. Edwards, and F. Zepp Comparison of the immunogenicity and safety of Cervarix(TM) and Gardasil(R) human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years Hum Vaccin 5 10 Oct 14 2009 702 716
26. D.M. Harper Currently approved prophylactic HPV vaccines Expert Rev Vaccin 8 12 Dec 2009 1663 1679
27. F. Song, Y.K. Loke, T. Walsh, A.M. Glenny, A.J. Eastwood, and D.G. Altman Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews BMJ 338 2009 b1147
28. D. Jenkins A review of cross-protection against oncogenic HPV by an HPV-16/18 AS04-adjuvanted cervical cancer vaccine: importance of virological and clinical endpoints and implications for mass vaccination in cervical cancer prevention Gynecol Oncol 110 3 Suppl. 1 2008 S18 S25
29. R. Skinner, D. Apter, S.N. Chow, C. Wheeler, and G. Dubin Cross-protection efficacy of Cervarix(tm) against oncogenic HPV types beyond HPV-16/18 Abstract n° O-29.01 Presented at the 25th International Papillomavirus Conference, May 8-14, Malmö, Sweden 2009
30. A. Szarewski HPV vaccine: Cervarix Expert Opin Biol Ther 10 3 Mar 2010 477 487
31. E.A. Joura, S. Leodolter, M. Hernandez-Avila, C.M. Wheeler, G. Perez, and L.A. Koutsky Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials Lancet 369 9574 May 19 2007 1693 1702 (Pubitemid 46783792)
32. F.X. Bosch, Sd Sanjose, and X. Castellsague Evaluating the potential benefits of universal worldwide human papillomavirus vaccination Therapy 5 3 May 1 2008 305
33. L. Annemans, V. Remy, E. Lamure, E. Spaepen, M. Lamotte, and J.P. Muchada Economic burden associated with the management of cervical cancer, cervical dysplasia and genital warts in Belgium J Med Econ 11 1 2008 135 150 (Pubitemid 351613819)
34. P. Hillemanns, G. Breugelmans, F. Gieseking, S. Benard, E. Lamure, and K. Littlewood Estimation of the incidence of genital warts and the cost of illness in Germany: a cross-sectional study BMC Infect Dis 8 Jun 2 2008 75
35. E. Lukasiewicz, S. Aractingi, and A. Flahault Incidence and management of condylomata acuminata by French general physicians Ann Dermatol Vénéréol 129 8-9 Aug 2002 991 996 (Pubitemid 35230579)
36. J. Monsonego, J.G. Breugelmans, S. Bouee, A. Lafuma, S. Benard, and V. Remy Anogenital warts incidence, medical management and costs in women consulting gynaecologists in France Gynécol Obstét Fertil 35 2 Feb 2007 107 113
37. WHO/ICO Information centre on HPV and cervical cancer http://www.who.int/hpvcentre/statistics/dynamic/ico/DataQuerySelect.cfm 2010 [cited 2010 Feb 20]
38. The FUTURE II Study Group Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions N Engl J Med 356 19 May 10 2007 1915 1927
39. S.M. Garland, M. Hernandez-Avila, C.M. Wheeler, G. Perez, D.M. Harper, and S. Leodolter Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases N Engl J Med 356 19 May 10 2007 1928 1943 (Pubitemid 46740303)
40. D.M. Harper, E.L. Franco, C. Wheeler, D.G. Ferris, D. Jenkins, and A. Schuind Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial Lancet 364 9447 Nov 13 2004 1757 1765 (Pubitemid 39488060)
41. N. Munoz, S.K. Kjaer, K. Sigurdsson, O.E. Iversen, M. Hernandez-Avila, and C.M. Wheeler Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women J Natl Cancer Inst 102 5 Feb 5 2010 325 339
42. W.K. Huh Quadrivalent HPV Vaccine Phase IIb/III Investigators Impact of quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle vaccine on the incidence of abnormal pap tests and cervical procedures. (Abstract n° 20 presented at the 48th Annual ICAAC/IDSA 46th Annual meeting, 25-28 Oct., Washington, USA) Gynecol Oncol 108 3 Suppl.1 2008 S10
43. W. Tjalma, J. Paavonen, P. Naud, C.M. Wheeler, S.N. Chow, and D. Apter Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against abnormal cytology and low-grade histopathological lesions in an oncogenic HPV-naïve population Abstract n° A-171-0004-01446 Presented at the 16th International Meeting of the European Society for Gynaecological Oncology (ESGO), 11-14 Oct, Belgrade, Serbia 2009
44. S. Capri, F. Bamfi, A. Marocco, and N. Demarteau Capitolo 6: Impatto clinico ed economico della vaccinazione anti-HPV Ital J Public Health 4 2 Suppl.1 2007 55 81
45. A. Marocco, A. Mannocci, S. Capri, and G. La Torre Capitolo 3: Analisi dei costi del ricorso alle risorse sanitaire pe rla prevenzione e il trattamento del carcinoma della cervice uterina Ital J Public Health 4 2 Suppl.1 2007 22 29
46. L'Istituto nazionale di statistica Istat it 2010 http://istat.it/prezzi/ precon/rivalutazioni 2010
47. M. Merito, N. Largeron, C. Cohet, L. Timelli, F. Boselli, and A. Matteelli Treatment patterns and associated costs for genital warts in Italy Curr Med Res Opin 24 11 Oct 10 2008 3175 3183
48. F. Bamfi, A. Marocco, S. Capri, and M.G. Sideri Epidemiologia e costi dei condilomi ano-genitali in Italia: revisione delle evidenze disponibili Farmeconomia Percorsi Terapeut 9 4 2008 183 189
49. G. Vittori, A. Matterellil, F. Borselli, L. Naldi, and L.A. Emberti Gialloreti A new approach to estimate genital warts incidence and prevalence in the Italian general population Int J Gynaecol Obstet 20 1 2008 33 42 (Pubitemid 351802376)
50. H. De Vuyst, G.M. Clifford, M.C. Nascimento, M.M. Madeleine, and S. Franceschi Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva, vagina and anus: a meta-analysis Int J Cancer 124 7 Apr 1 2009 1626 1636
51. M.L. Gillison, A.K. Chaturvedi, and D.R. Lowy HPV prophylactic vaccines and the potential prevention of noncervical cancers in both men and women Cancer 113 10 Suppl Nov 15 2008 3036 3046
52. M. Hampl, H. Sarajuuri, N. Wentzensen, H.G. Bender, and V. Kueppers Effect of human papillomavirus vaccines on vulvar, vaginal, and anal intraepithelial lesions and vulvar cancer Obstet Gynecol 108 6 Dec 1 2006 1361 1368 (Pubitemid 44901008)
53. M. Watson, M. Saraiya, F. Ahmed, C.J. Cardinez, M.E. Reichman, and H.K. Weir Using population-based cancer registry data to assess the burden of human papillomavirus-associated cancers in the United States: overview of methods Cancer 113 10 Suppl Nov 15 2008 2841 2854
54. R.P. Insinga, K.L. Liaw, L.G. Johnson, and M.M. Madeleine A systematic review of the prevalence and attribution of human papillomavirus types among cervical, vaginal, and vulvar precancers and cancers in the United States Cancer Epidemiol Biomark Prev 17 7 Jul 2008 1611 1622
55. N.F. Schlecht, R.W. Platt, E. Duarte-Franco, M.C. Costa, J.P. Sobrinho, and J.C. Prado Human papillomavirus infection and time to progression and regression of cervical intraepithelial neoplasia J Natl Cancer Inst 95 17 Sep 3 2003 1336 1343 (Pubitemid 37160867)
56. J. Berkhof, M.C. de Bruijne, G.D. Zielinski, and C.J. Meijer Natural history and screening model for high-risk human papillomavirus infection, neoplasia and cervical cancer in the Netherlands Int J Cancer 115 2 Jun 10 2005 268 275 (Pubitemid 40586736)
57. A.R. Chang Carcinoma in situ of the cervix and its malignant potential. A lesson from New Zealand Cytopathology 1 6 1990 321 328
58. I. Kalliala, A. Anttila, E. Pukkala, and P. Nieminen Risk of cervical and other cancers after treatment of cervical intraepithelial neoplasia: retrospective cohort study BMJ 331 7526 Nov 19 2005 1183 1185 (Pubitemid 41689433)
59. M.J. Khan, P.E. Castle, A.T. Lorincz, S. Wacholder, M. Sherman, and D.R. Scott The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice J Natl Cancer Inst 97 14 Jul 20 2005 1072 1079 (Pubitemid 41417924)
60. N. Kiviat Natural history of cervical neoplasia: overview and update Am J Obstet Gynecol 175 4 Pt 2 Oct 1996 1099 1104 (Pubitemid 26357925)
61. C.J. Meijer, P.J. Snijders, and A.J. van den Brule Screening for cervical cancer: should we test for infection with high-risk HPV? CMAJ 163 5 Sep 5 2000 535 538
62. A.G. Ostor Natural history of cervical intraepithelial neoplasia: a critical review Int J Gynecol Pathol 12 2 Apr 1993 186 192 (Pubitemid 23095196)
63. M. Schiffman, and S.K. Kjaer Chapter 2: Natural history of anogenital human papillomavirus infection and neoplasia J Natl Cancer Inst Monogr 31 2003 14 19
64. P.J. Snijders, R.D. Steenbergen, D.A. Heideman, and C.J. Meijer HPV-mediated cervical carcinogenesis: concepts and clinical implications J Pathol 208 2 Jan 2006 152 164 (Pubitemid 43126109)
65. N. Ylitalo, P. Sorensen, A.M. Josefsson, P.K. Magnusson, P.K. Andersen, and J. Ponten Consistent high viral load of human papillomavirus 16 and risk of cervical carcinoma in situ: a nested case-control study Lancet 355 9222 Jun 24 2000 2194 2198 (Pubitemid 30394326)
66. K.M. Stone Human papillomavirus infection and genital warts: update on epidemiology and treatment Clin Infect Dis 20 Suppl 1 Apr 1995 S91 S97
67. R.L. Winer, N.B. Kiviat, J.P. Hughes, D.E. Adam, S.K. Lee, and J.M. Kuypers Development and duration of human papillomavirus lesions, after initial infection J Infect Dis 191 5 Mar 1 2005 731 738 (Pubitemid 40271061)
68. B. Romanowski, P.C. de Borba, P.S. Naud, C.M. Roteli-Martins, N.S. De Carvalho, and J.C. Teixeira Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years Lancet 374 9706 Dec 12 2009 1975 1985
69. S.E. Olsson, L.L. Villa, R.L. Costa, C.A. Petta, R.P. Andrade, and C. Malm Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine Vaccine 25 26 Jun 21 2007 4931 4939 (Pubitemid 46843434)
70. C.M. Roteli-Martins, P. Naud, P. Borba, J. Teixeira, N. De Carvalho, and T. Zahaf Sustained immunogenicity and efficacy of the HPV-16/18 AS04 adjuvanted vaccine: follow-up to 8.4 years Abstract Presented at 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), May 4-8, Nice, France 2010
71. C. Fraser, J.E. Tomassini, L. Xi, G. Golm, M. Watson, and A.R. Giuliano Modeling the long-term antibody response of a human papillomavirus (HPV) virus-like particle (VLP) type 16 prophylactic vaccine Vaccine 25 21 May 22 2007 4324 4333 (Pubitemid 46635934)
72. M.P. David, K. Van Herck, K. Hardt, F. Tibaldi, G. Dubin, and D. Descamps Long-term persistence of anti-HPV-16 and -18 antibodies induced by vaccination with the AS04-adjuvanted cervical cancer vaccine: modeling of sustained antibody responses Gynecol Oncol 115 3 Suppl 1 Feb 2009 S1 S6
73. S.M. Garland, M. Steben, H.L. Sings, M. James, S. Lu, and R. Railkar Natural History of Genital Warts: Analysis of the Placebo Arm of 2 Randomized Phase III Trials of a Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine J Infect Dis Jan 26 2009
74. P. Giorgi Rossi, A. Ricciardi, C. Cohet, F. Palazzo, G. Furnari, and S. Valle Epidemiology and costs of cervical cancer screening and cervical dysplasia in Italy BMC Public Health 9 2009 71