The Health Technology Assessment of bivalent HPV vaccine Cervarix® in Italy

Vaccine

Volumn 28, Issue 19, 2010, Pages 3379-3384

  La Torre, Giuseppe ^a,b   de Waure, Chiara ^a   Chiaradia, Giacomina ^a   Mannocci, Alice ^a   Capri, Stefano ^c   Ricciardi, Walter ^a  

^a CATHOLIC UNIVERSITY   (Italy)

^b SAPIENZA UNIVERSITY OF ROME   (Italy)

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

Author keywords

Health Technology Assessment; HPV vaccine; Italy

Indexed keywords

WART VIRUS VACCINE;

ARTICLE; CLINICAL TRIAL; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; DRUG EFFICACY; ECONOMIC ASPECT; HOSPITALIZATION; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; ITALY; META ANALYSIS; MORTALITY; PREVALENCE; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; SCREENING; SYSTEMATIC REVIEW; UTERINE CERVICITIS; UTERINE CERVIX CARCINOMA; VACCINATION;

ADOLESCENT; ADULT; ANIMALS; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; ITALY; MIDDLE AGED; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; UTERINE CERVICAL NEOPLASMS; YOUNG ADULT;

EID: 77950520426     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.02.080     Document Type: Article

References (50)

1. WHO, UNICEF, GIVS. Global immunization vision and strategy. Available online from: http://www.who.int/vaccines-documents/DocsPDF05/GIVS_Final_EN.pdf; 2006-2015 [accessed on July 2009].
2. Peny J.M., Gleizes O., and Covilard J.P. Financial requirements of immunisation programmes in developing countries: a 2004-2014 perspective. Vaccine 23 37 (2005) 4610-4618
3. La Torre G., Chiaradia G., de Waure C., Mannocci A., Capri S., Bruno S., et al. Health Technology Assessment and vaccine: new needs and opportunities?. Ital J Public Health 5 4 (2007) 81-88
4. La Torre G., de Waure C., Chiaradia G., Mannocci A., Specchia M.L., Nicolotti N., et al. The future of best investing in vaccines: the Health Technology Assessment approach. Vaccine 26 13 (2008) 1609-1610
5. La Torre G., Chiaradia G., Mannocci A., de Waure C., Ricciardi W., Capri S., et al. Health Technology Assessment della vaccinazione anti-HPV (Health Technology Assessment of HPV vaccination). Ital J Public Health 4 2S (2007) 1-60
6. National Institute of Statistics. Health for all - Italy. Available online from: http://www.istat.it/sanita/Health/ [accessed on July 2009].
7. Associazione Italiana Registri Tumori (Italian Association Cancer Registers). Available online from: http://www.registri-tumori.it/cms/ [accessed on July 2009].
8. Ministero della Salute. Direzione Generale della Prevenzione. Raccomandazioni per la pianificazione e l'esecuzione degli screening di popolazione per la prevenzione del cancro della mammella, del cancro della cervice uterina e del cancro del colon retto (Ministry of Health. Recommendation for the planning and the carrying out of screening to prevent cervical, breast and colon cancer). Available online from: http://www.epicentro.iss.it/focus/screening/pdf/Screeningraccom.pdf [accessed on February 2009].
9. Osservatorio Nazionale Screening (National Screening Observatory). Available online from: http://win.osservatorionazionalescreening.it/ [accessed on July 2009].
10. Istituto Nazionale di Statistica. La prevenzione dei tumori femminili in Italia: il ricorso a pap test e mammografia. Anni 2004-2005 (National Institute of Statistics. Prevention of cancer in Italian women: the recourse to Pap test and mammography. Years 2004-2005); 4 dicembre 2006.
11. Gallo T, Binkin N, Baldissera S, Bertozzi N, Bietta C, De Giacomi GV, et al. La diffusione dell'attività di diagnosi precoce in Italia per lo screening cervicale, mammografico e colorettale (studio PASSI, 2005). Osservatorio Nazionale Screening. Quinto rapporto (The diffusion of early diagnosis activities in Italy for cervical, breast and colorectal screening (PASSI study, 2005). National Screening Observatory. Fifth Report.
12. Tariffario delle prestazioni di assistenza specialistica ambulatoriale (22 Luglio 1996). (Outpatient specialist services fares, July 22nd 1996). Available online from: http://www.ministerosalute.it/programmazione/normativa/sezNormativa.jsp?label=tar [accessed on July 2009].
13. Società italiana di Colposcopia e Patologia Cervico-Vaginale. Gestione della paziente con PAP test Anormale. Linee guida Edizione 2006. (Italian society of colposcopy and cervical-vaginal diseases. The management of abnormal Pap test. Guideline 2006). La Colposcopia in Italia 2006;21:2-26. Available online from: http://www.sigo.it/Documenti/LineeGuida/LineeGuidaColposcopia06.pdf [accessed on July 2009].
14. Tariffe delle prestazioni di assistenza ospedaliera per acuti erogate in regime di ricovero ordinario e diurno ex D.M. 30.06.1997 espresse in Euro (Acute inpatient services fares, Ministerial Decree June 30th 1997). Available online from: http://www.ministerosalute.it/programmazione/normativa/sezNormativa.jsp?label=tar [accessed on July 2009].
15. Jadad A.R., Moore A., Carroll D., Jenkinson C., Reynolds D.J., Gavaghan D.J., et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 17 (1996) 1-12
16. Goldie S.J., Kohli M., Grima D., Weinstein M., Wright T.C., and Bosch F.X. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16/18 vaccine. J Natl Cancer Inst 96 (2004) 604-615
17. Harper D.M., Franco E.L., Wheeler C.M., Moscicki A.B., Romanowski B., Roteli-Martins C.M., et al. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 367 9518 (2006) 1247-1255
18. Paavonen J., Jenkins D., Bosch F.X., Naud P., Salmerón J., Wheeler C.M., et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet 369 9580 (2007) 2161-2170
19. Gold M.R., Franks P., McCoy K.I., and Fryback D.G. Toward consistency in cost-utility analyses: using national measures to create condition-specific values. Med Care 36 (1998) 778-792
20. In: Stratton K.R., Durch J.S., and Lawrence R.S. (Eds). Vaccines for the 21st century: a tool for decision-making (1999), Institute of Medicine, National Academy Press, Washington, DC
21. Insinga R, Glass A, Rush B. Health state transitions following an abnormal pap smear: implications for health utility assessment in cost-effectiveness analyses. Abstract W-02 presented at 22nd International Papillomavirus Conference & Clinical Workshop 2005, Vancouver, BC, Canada; April 30-May 6, 2005.
22. Myers E.R., Green S., and Lipkus I. Patient preferences for health states related to HPV infection: visual analog scale versus time trade-off elicitation. Twenty-First International Papillomavirus Conference. México City, México. February 20-27 (2004)
23. Dunne E.F., Unger E.R., Sternberg M., McQuillan G., Swan D.C., Patel S.S., et al. Prevalence of HPV infection among females in the United States. J Am Med Assoc 297 8 (2007) 813-819
24. Ronco G., Ghisetti V., Segnan N., Snijders P.J., Gillio-Tos A., Meijer C.J., et al. Prevalence of human papillomavirus infection in women in Turin, Italy. Eur J Cancer 41 (2005) 297-305
25. Ammatuna P., Giovannelli L., Matranga D., Ciriminna S., and Perino A. Prevalence of genital human papilloma virus infection and genotypes among young women in Sicily, south Italy. Cancer Epidemiol Biomarkers Prev 17 8 (2008) 2002-2006
26. Epicentro. Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della Salute. Available at http://www.epicentro.iss.it/ [accessed on July 2009].
27. Ferlay J., Bray F., Pisani P., and Parkin D.M. GLOBOCAN 2002: Cancer incidence, mortality and prevalence worldwide. IARC Cancer Base No. 5, version 2.0 (2004), Lyon, France, IARC Press
28. AIRT Working Group. Registri tumori in Italia: il rapporto 2006. Epidemiol Prev 1S (2006) 64-65
29. Ronco G, Giubilato P, Naldoni P, Zorzi M, Anghinoni E, Scalisi A, et al. Livello di attivazione e indicatori di processo dei programmi organizzati di screening dei tumori del collo dell'utero in Italia. In: Osservatorio Nazionale Screening. Quinto rapporto (Activity level and process indicators of organised cervical screening programs in Italy. In: Screening National Observatory, fifth report). Available online from: http://www.osservatorionazionalescreening.it/ons/pubblicazioni/rapporto5/indicatori_cervice.pdf [accessed on July 2009].
30. La Torre G., de Waure C., Chiaradia G., Mannocci A., and Ricciardi W. HPV vaccine efficacy in preventing persistent cervical HPV infection: a systematic review and meta-analysis. Vaccine 25 50 (2007) 8352-8358
31. Brown D.R., Fife K.H., Wheeler C.M., Koutsky L.A., Lupinacci L.M., Railkar R., et al. Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine. Vaccine 22 21-22 (2004) 2936-2942
32. Mao C., Koutsky L.A., Ault K.A., Wheeler C.M., Brown D.R., Wiley D.J., et al. Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial. Obstet Gynecol 107 1 (2006) 18-27
33. Villa L.L., Costa R.L., Petta C.A., Andrade R.P., Paavonen J., Iversen O.E., et al. 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 (2006) 1459-1466
34. National Board of Health Reduction in the risk of cervical cancer by vaccination against human papillomavirus (HPV) - a Health Technology Assessment. Copenhagen: National Board of Health, Danish Centre for Health Technology Assessment, 2007. Series Name 2007;9(1). http://www.sst.dk/publ/Publ2007/MTV/HPV/HPV_vaccination_smfatn_en.pdf [accessed on July 2009].
35. Kulasingam S.L., and Myers E.R. Potential health and economic impact of adding a human papillomavirus vaccine to screening programs. J Am Med Assoc 290 6 (2003) 781-789
36. Sanders G.D., and Taira A.V. Cost-effectiveness of a potential vaccine for human papillomavirus. Emerg Infect Dis 9 1 (2003) 37-48
37. Taira A.V., Neukermans C.P., and Sanders G.D. Evaluating human papillomavirus vaccination programs. Emerg Infect Dis 10 11 (2004) 1915-1923
38. Health Protection Agency. Press release. Available from http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070919_hpv_cost.htm; 2007 [accessed on July 2009].
39. OECD Health Data 2004, 1st edition.
40. Colombo G.L., Serra G., Morlotti L., and Fara G.M. The role of economic evaluation for the implementation of vaccination strategies. Ann Ig 17 6 (2005) 479-490
41. Russo P. La valutazione farmacoeconomica nel contesto regolatorio italiano. Analisi quali-quantitativa dei dossier di richiesta del prezzo e della rimborsabilità[Pharmacoeconomic evaluations in the Italian regulatory context: a quali-quantitative analysis of pricing and reimbursement dossiers. PharmacoEconomics - Ital Res Articles 10 (2008) 59-75
42. La Torre G., Chiaradia G., de Waure C., Nicolotti N., Monteduro A., and Ricciardi W. Report HTA del vaccino quadrivalente anti-HPV Gardasil (HTA report on quadrivalent HPV vaccine). Ital J Public Health 6 Suppl. 2 (2009) 1-66
43. Centro di Ricerca in Ingegneria Sanitaria Ambientale e Valutazione delle Tecnologie Sanitarie. La valutazione dell'impatto clinico, economico, organizzativo, etico e sociale di lapatinib in Italia: risultati del gruppo di lavoro HTA (Research Center on Environmental Health Engineering and Health Technology Assessment. The evaluation of clinical, economic, organisational, ethical and social impact of lapatinib use in Italy: results from HTA work group). Ital J Public Health 2009;6(Suppl. 1).
44. Centro di Ricerca in Ingegneria Sanitaria Ambientale e Valutazione delle Tecnologie Sanitarie. Health Technology Assessment di Lucentis nel trattamento della degenerazione maculare senile (Research Center on Environmental Health Engineering and Health Technology Assessment. Health Technology Assessment of Lucentis in the treatment of age related macular degeneration). Ital J Public Health 2009;6(Suppl. 3).
45. Paavonen J., Naud P., Salmerón J., Wheeler C.M., Chow S.N., Apter D., et al. 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 (2009) 301-314
46. European Center for Disease Control. Guidance for the introduction of HPV vaccines in EU Countries. Stockholm; January 2008.
47. Health Information and Quality Authority. The role of human papillomavirus vaccines in reducing the risk of cervical cancer in Ireland. A Health Technology Assessment; 25th February 2008.
48. Health Council of the Netherlands. Vaccination against cervical cancer. The Hague: Health Council of the Netherlands; 2008 [publication no. 2008/08E].
49. Socialstyrelsen. Background to a vaccination programme for the human papilloma virus in Sweden 2007. Article nr. 2008-132-2.
50. Institut National de Santé Publique du Québec. Advice of the Institut National de Santé Publique du Québec on Human Papillomavirus vaccines; February 2008.