Modeling the impact of the difference in cross-protection data between a human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and a human papillomavirus (HPV)-6/11/16/18 vaccine in Canada

BMC Public Health

Nadia Demarteau¹  Andrea Anonychuk¹  Jennifer Haig²  Donna Lawrence²  Michele Kohli² 

[1] GlaxoSmithKline Biologicals, Global Vaccines Development, Avenue Fleming, 20, 1300, Wavre, Belgium;OptumInsight, Health Economics and Outcomes Research, 5500 North Service Rd, Burlington, ON, L7L 6W6, Canada

关键词: Canada;    Markov model;    Cost-effectiveness;    Vaccine;    Cervical cancer;    Human papillomavirus;   

Others  :  1162974
DOI  :  10.1186/1471-2458-12-872

 received in 2012-02-24, accepted in 2012-10-08,  发布年份 2012

【 授权许可】

   
2012 Kohli et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Canadian Immunization Committee: Recommendations on a Human papillomavirus vaccination program. 2007. http://www5.statcan.gc.ca/cansim/a05?id=1030550&pattern=&stByVal=3&paSer=&lang=eng webcite.
• [2]Al-Daraji WI, Smith JH: Infection and cervical neoplasia: facts and fiction. Int J Clin Exp Pathol 2009, 2:48-64.
• [3]Parkin DM, Bray F, Ferlay J, Pisani P: Global cancer statistics, 2002. CA Cancer J Clin 2005, 55:74-108.
• [4]Clifford G, Franceschi S, Diaz M, Muñoz N, Villa LL: Chapter 3: HPV type-distribution in women with and without cervical neoplastic diseases. Vaccine 2006, 24:S26-S34.
• [5]Muñoz N, Bosch FX, De Sanjose S, Herrero R, Castellsagué X, Shah KV, et al.: Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003, 348:518-527.
• [6]Muñoz N, Bosch FX, Castellsagué X, Díaz M, De Sanjose S, Hammouda D, et al.: Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int J Cancer 2004, 111:278-285.
• [7]Bosch FX, Burchell AN, Schiffman M, Giuliano AR, De Sanjose S, Bruni L, et al.: Epidemiology and Natural History of Human Papillomavirus Infections and Type-Specific Implications in Cervical Neoplasia. Vaccine 2008, 26:K1-K16.
• [8]Bouvard V, Baan R, Straif K, Grosse Y, Secretan B, El GF, et al.: A review of human carcinogens–Part B: biological agents. Lancet Oncol 2009, 10:321-322.
• [9]Insight on Cancer: News and Information on Cervical Cancer. Toronto: Canadian Cancer Society (Ontario Division). Cancer Care Ontario; 2005.
• [10]Canadian Cancer Society/National Cancer Institute of Canada: Canadian cancer statistics 2010 Toronto, Canada; 2010. http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/~/media/CCS/Canada%20wide/Files%20List/English%20files%20heading/pdf%20not%20in%20publications%20section/Canadian20Cancer20Statistics2020102020English.ashx webcite.
• [11]Immunization Schedule. HealthLinkBC 2010. http://www.healthlinkbc.ca/immunization.stm webcite.
• [12]Ogilvie GS, Remple VP, Marra F, McNeil SA, Naus M, Pielak KL, et al.: Parental intention to have daughters receive the human papillomavirus vaccine. Can Med Assoc J 2007, 177:1506-1512.
• [13]Government of Alberta: Routine Immunization Schedule. 2011. www.health.alberta.ca/health-info/imm-routine-schedule.html webcite.
• [14]Saskatchewan: Immunization Schedule. 2010. http://www.health.gov.sk.ca/immunization-schedule webcite.
• [15]Manitoba. Immunization Schedule 2010. http://www.gov.mb.ca/health/publichealth/cdc/schedule.html webcite.
• [16]Publicly funded immunisation schedules for Ontario - January 2009 2010. http://www.health.gov.on.ca/english/providers/program/immun/pdf/schedule.pdf webcite.
• [17]Colucci R, Hryniuk W, Savage C: HPV Vaccination Programs in Canada: Are we hitting the mark?. Report card on cancer in Canada; 2008.
• [18]Sante et services sociaux Quebec: HPV Vaccine Program. 2010. http://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?programme-de-vaccination-contre-le-vph-en webcite.
• [19]Sante et services sociaux Quebec. FlashVigie Bulletin quebecois de vigie et d’intervention en maladie infectieuses 2010. http://msssa4.msss.gouv.qc.ca/fr/document/publication.nsf/4b1768b3f849519c852568fd0061480d/30bc6f2f39299a32852572720070cc98?OpenDocument5[3] webcite.
• [20]Newfoundland and Labrador. Immunization Schedule 2010. http://www.health.gov.nl.ca/health/publichealth/cdc/immunizations_sched.html webcite.
• [21]New Brunswick. Routine Immunization Schedule 2010. http://www.gov.ns.ca/hpp/publications/13153_CDPC_SchoolImmunizationSchedule.pdf webcite.
• [22]Nova Scotia. Immunization Schedule 2010. http://www.gov.ns.ca/hpp/publications/13153_CDPC_SchoolImmunizationSchedule.pdf webcite.
• [23]Prince Edward Island. Immunisation Schedule 2010. http://www.gov.pe.ca/health/index.php3?number=1021131&lang=E webcite.
• [24]Giannini SL, Hanon E, Moris P, Van Mechelen M, Morel S, Dessy F, et al.: 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 2006, 24:5937-5949.
• [25]Skinner R, Apter D, Chow SN WCDG for the HPV PATRICIA Study Group: Cross-protection efficacy of Cervarix against oncogenic HPV types beyond HPV-16/18: Final analysis of cross-protection- PATRICIA STUDY. Malmö, Sweden: 25th International Papillomavirus Conference and Clinical Workshops; 2009.
• [26]Paavonen J, Naud P, Salmerón J, Wheeler CM, 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 2009, 374:301-314.
• [27]Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Mauricio HA, Wheeler CM, et al.: 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 2009, 199:926-935.
• [28]Merck Canada Inc: GARDASIL® (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine). Health Canada: Product Monograph.Submission Control: 147972; 2011.
• [29]GlaxoSmithKline: Cervarix™ (Human papillomavirus (types 16, 18) recombinant adjuvanted, adsorbed vaccine) product monograph. Submission Control: 141721. Health Canada; 8-16-2011. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php webcite.
• [30]Anonychuk A, Bauch C, Merid MF, Van Kriekinge G, Demarteau N: A cost-utility analysis of cervical cancer vaccination in preadolescent Canadian females. BMC Publ Health 2009, 9:401. BioMed Central Full Text
• [31]Rogoza RM, Ferko N, Bentley J, Meijer CJLM, Berkhof J, Wang KL, et al.: Optimization of primary and secondary cervical cancer prevention strategies in an era of cervical cancer vaccination: A multi-regional health economic analysis. Vaccine 2008, 26:F46-F58.
• [32]Debicki D, Ferko N, Demarteau N, Gallivan S, Bauch C, Anonychuk A, et al.: Comparison of detailed and succinct cohort modelling approaches in a multi-regional evaluation of cervical cancer vaccination. Vaccine 2008, 26:F16-F28.
• [33]Brisson M, van de Velde , De Wals P, Boily M-C: The potential cost-effectiveness of prophylactic human papillomavirus vaccines in Canada. Vaccine 2007, 25:5399-5408.
• [34]Dee A, Howell F: A cost-utility analysis of adding a bivalent or quadrivalent HPV vaccine to the Irish cervical screening programme. Eur J Public Health 2010, 20:213-219.
• [35]Ezat SW, Aljunid S: Comparative cost-effectiveness of HPV vaccines in the prevention of cervical cancer in Malaysia. Asian Pac J Cancer Prev 2010, 11:943-951.
• [36]Mennini FS, Costa S, Favato G, Picardo M: Anti-HPV vaccination: a review of recent economic data for Italy. Vaccine 2009, 27(Suppl 1):A54-A61.
• [37]Jit M, Choi YH, Edmunds WJ: Economic evaluation of human papillomavirus vaccination in the United Kingdom. BMJ 2008, 337:a769.
• [38]Aljunid S, Zafar A, Saperi S, Amrizal M: Burden of disease associated with cervical cancer in malaysia and potential costs and consequences of HPV vaccination. Asian Pac J Cancer Prev 2010, 11:1551-1559.
• [39]Capri S, Gasparini R, Panatto D, Demarteau N: Cost-consequences evaluation between bivalent and quadrivalent HPV vaccines in Italy: The potential impact of different cross-protection profiles. Gynecol Oncol 2011, 121:514-521.
• [40]Demarteau N, Standaert B: Modelling the economic value of cross- and sustained-protection in vaccines against cervical cancer. J Med Econ 2010, 13:324-338.
• [41]Jit M, Chapman R, Hughes O, Choi YH: Comparing bivalent and quadrivalent human papillomavirus vaccines: economic evaluation based on transmission model. BMJ 2011, 343:d5775.
• [42]Mauskopf JA, Earnshaw S, Mullins CD: Budget impact analysis: review of the state of the art. Expert Rev Pharmacoecon Outcomes Res 2005, 5:65-79.
• [43]Statistics Canada. CANSIM Table 103–0550. New cases for ICD-O-3 primary sites of cancer (based on the July 2011 CCR tabulation file), by age group and sex, Canada, provinces and terriitories, annual (194880 series) 2011. http://www5.statcan.gc.ca/cansim/a05?id=1030550&pattern=&stByVal=3&paSer=&lang=eng webcite.
• [44]Marra F, Ogilvie G, Colley L, Kliewer E, Marra CA: Epidemiology and costs associated with genital warts in Canada. Sex Transm Infect 2009, 85:111-115.
• [45]WHO/ICO Information Centre of HPV and Cervical Cancer (HPV Information Centre): Human Papillomavirus and Related Cancer in Canada. 2010. www.who.int/hpvcentre webcite.
• [46]Paavonen J, Jenkins D, Bosch FX, Naud P, Salmerón J, Wheeler CM, 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 2007, 369:2161-2170.
• [47]Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, 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 2006, 367:1247-1255.
• [48]Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, et al.: 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 2004, 364:1757-1765.
• [49]Villa LL, Costa RLR, Petta CA, Andrade RP, 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 2006, 95:1459-1466.
• [50]Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, et al.: Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007, 356:1928-1943.
• [51]Tjalma W, Paavonen J, Naud P, Wheeler CM, Chow SN, et al.: Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against abnormal cytology and low-grade histopathological lesions in an oncogenic HPV-naïve population. Belgrade, Serbia: 16th International meeting of the European Society of Gynaecological Oncology (ESGO); 2009.
• [52]Statistics Canada. Pap smear, by age group, women aged 18 to 69, Canada, provinces, territories, health regions and peer groups, 2003 2003. http://www.statcan.gc.ca/pub/82-221-x/2005002/t/html/4063576-eng.htm webcite.
• [53]Bergeron C, Cartier I, Guldner L, Lassalle M, Savignoni A, Asselain B: Lesion precancereuses et cancers du col de l’uterus diagnostiques par le frottis cervical, Ile-de-France, enquete Crisap, 2002. Bulletin epidemiologique hebdomadaire 2005, 2:5-6.
• [54]Krahn M, McLachlin M, Pham B, Rosen B, Sander B, Grootendorst P, et al.: Liquid-based techniques for cervical cancer screening: a systematic review and cost-effectiveness analysis. Ottawa, Canada: Canadian Agency for Drugs and Technologies in Health; 2008.
• [55]Suarez E, Smith JS, Bosch FX, Nieminen P, Chen CJ, Torvinen S, et al.: Cost-effectiveness of vaccination against cervical cancer: A multi-regional analysis assessing the impact of vaccine characteristics and alternative vaccination scenarios. Vaccine 2008, 26:F29-F45.
• [56]Cardiff Research Consortium: Health outcomes data repository. 2007. https://www.crc-limited.co.uk webcite.
• [57]Insinga R, Glass A, Rush B: Health state transitions following an abnormal pap smear: implications for health utility assessment in cost-effectiveness analyses. Vancouver, Canada: 22nd International Papillomavirus Conference & Clinical Workshops; 2005.
• [58]Myers ER, Green S, Lipkus I: Patient preferences for health states related to HPV infection: visual analog scale versus time trade-off elicitation. Mexico City, Mexico: 21st International Papillomavirus Conference; 2004.
• [59]Institute Of Medicine: Financing vaccines in the 21st century: assuring access and availability. Washington DC: The National Academies Press; 2003.
• [60]WHO/ICO Information Centre of HPV and Cervical Cancer (HPV Information Centre): Human Papillomavirus and Related Cancer in North America. 2010. www.who.int/hpvcentre webcite.
• [61]Aubin F, Prétet JL, Jacquard AC, Saunier M, Carcopino X, Jaroud F, et al.: Human papillomavirus genotype distribution in external acuminata condylomata: A large French national study (EDiTH IV). Clin Infect Dis 2008, 47:610-615.
• [62]Keam SJ, Harper DM: Human papillomavirus types 16 and 18 vaccine (recombinant, AS04 adjuvanted, adsorbed) [CervarixTM]. Drugs 2008, 68:359-372.
• [63]Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, et al.: 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 sexually active women aged 16–26 years. J Infect Dis 2009, 199:936-944.
• [64]Munoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, et al.: Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst 2010, 102:325-339.
• [65]Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, et al.: Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol 2012, 13:100-110.
• [66]Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsague X, et al.: Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol 2012, 13:89-99.
• [67]Guay M, ClouaÌtre A-M, Blackburn M, Baron G, De Wals P, Roy C, et al.: Effectiveness and cost comparison of two strategies for hepatitis B vaccination of schoolchildren. Can J Public Health 2003, 94:64-67.
• [68]World Health Organization: Preparing for the introduction of HPV vaccines: Policy and programme guidance for countries. Geneva: World Health Organization Press; 2006.
• [69]World Health Organization: Report of the consultation on human papillomavirus vaccines. Geneva: World Health Organization Press; 2005.
• [70]Woodhall S, Eriksson T, Nykanen AM, Huhtala H, Rissanen P, Apter D, et al.: Impact of HPV vaccination on young women’s quality of life - a five year follow-up study. Eur J Contracept Reprod Health Care 2011, 16:3-8.
• [71]Drolet M, Brisson M, Maunsell E, Franco EL, Coutlee F, Ferenczy A, et al.: The impact of anogenital warts on health-related quality of life: a 6-month prospective study. Sex Transm Dis 2011, 38:949-956.
• [72]Brisson M, van d V , Franco EL, Drolet M, Boily MC: Incremental impact of adding boys to current human papillomavirus vaccination programs: role of herd immunity. J Infect Dis 2011, 204:372-376.
• [73]Donovan B, Franklin N, Guy R, Grulich AE, Regan DG, Ali H, et al.: Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of national sentinel surveillance data. Lancet Infect Dis 2011, 11:39-44.
• [74]Leval A, Herweijer E, Arnheim-Dahlstrom L, Walum H, Frans E, Sparen P, et al.: Incidence of Genital Warts in Sweden Before and After Quadrivalent Human Papillomavirus Vaccine Availability. J Infect Dis 2012.
• [75]Moscicki AB, Hills N, Shiboski S, Powell K, Jay N, Hanson E, et al.: Risks for incident human papillomavirus infection and low-grade squamous intraepithelial lesion development in young females. JAMA 2001, 285:2995-3002.
• [76]Sanders GD, Taira AV: Cost effectiveness of a potential vaccine for human papillomavirus. Emerg Infect Dis 2003, 9:37-48.
• [77]Van de Velde N, Brisson M, Boily M-C: Modeling human papillomavirus vaccine effectiveness: Quantifying the impact of parameter uncertainty. Am J Epidemiol 2007, 165:762-775.
• [78]Nobbenhuis MA, Meijer CJ, van den Brule AJ, Rozendaal L, Voorhorst FJ, Risse EK, et al.: Addition of high-risk HPV testing improves the current guidelines on follow-up after treatment for cervical intraepithelial neoplasia. Br J Cancer 2001, 84:796-801.
• [79]Sellors JW, Karwalajtys TL, Kaczorowski J, Mahony JB, Lytwyn A, Chong S, et al.: Incidence, clearance and predictors of human papillomavirus infection in women. Can Med Assoc J 2003, 168:421-425.
• [80]Monsonego J, Breugelmans JG, Bouee S, Lafuma A, Benard S, Remy V: [Anogenital warts incidence, medical management and costs in women consulting gynaecologists in France]. Gynecol Obstet Fertil 2007, 35:107-113.
• [81]Fahey MT, Irwig L, Macaskill P: Meta-analysis of Pap test accuracy. Am J Epidemiol 1995, 141:680-689.
• [82]Gold MR, Franks P, McCoy KI, Fryback DG: Toward Consistency in Cost - Utility Analyses Using National Measures to Create Condition-Specific Values. Med Care 1998, 36:778-792.
• [83]Villa LL, Perez G, Kjaer SK, Paavonen J, Lehtinen M, Muñoz N, et al.: Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007, 356:1915-1927.
• [84]WHO/ICO Information Centre of HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancer 2010. www.who.int/hpvcentre webcite.
• [85]Statistics Canada: Table 051–0001. Estimates of population, by age group and sex for July 1, Canada, provinces and territories, annual, CANSIM (database). 2010.
• [86]Desai S, Wetten S, Woodhall SC, Peters L, Hughes G, Soldan K: Genital warts and cost of care in England. Sex Transm Infect 2011, 87:464-468.
• [87]World Health Organization guide for the standardization of immunisation programmes: final version: Geneva. Switzerland: World Health Organization; 2008.
• [88]Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, Zepp F, et al.: Comparison of the immunogenicity and safety of Cervarix® and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18–45 years. Hum Vaccin 2009, 5:705-719.
• [89]Einstein MH, Baron M, Levin MJ, Chatterjee A, Fox B, Scholar S, et al.: Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 vaccine and HPV-6/11/16/18 vaccine: Follow-up from Months 12–24 in a Phase III randomized study of healthy women aged 18–45 years. Hum Vaccin 2011, 7:1343-1358.