Cost-effectiveness analysis of AS04-adjuvanted human papillomavirus 16/18 vaccine compared with human papillomavirus 6/11/16/18 vaccine in the Philippines, with the new 2-dose schedule

References

• Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. GLOBOCAN 2012 v1.0, Cancer incidence and mortality worldwide. Lyon, France: International Agency for Research on Cancer; 2013. [cited 2014 Jan 31]; Available from: http://globocan.iarc.fr
   Google Scholar
• Domingo EJ, Dy Echo AV. Epidemiology, prevention and treatment of cervical cancer in the Philippines. J Gynecol Oncol 2009; 20:11-6; PMID:19471671; http://dx.doi.org/10.3802/jgo.2009.20.1.11
   PubMed Web of Science ®Google Scholar
• Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999; 189:12-9; PMID:10451482; http://dx.doi.org/10.1002/(SICI)1096-9896(199909)189:1%3c12::AID-PATH431%3e3.0.CO;2-F
   PubMed Web of Science ®Google Scholar
• Almonte M, Albero G, Molano Mn, Carcamo C, García PJ, Pθrez G. Risk factors for Human Papillomavirus Exposure and Co-factors for Cervical Cancer in Latin America and the Caribbean. Vaccine 2008; 26:L16-L36; PMID:18945400; http://dx.doi.org/10.1016/j.vaccine.2008.06.008
   PubMed Web of Science ®Google Scholar
• de Villiers EM. Cross-roads in the classification of papillomaviruses. Virology 2013; 445:2-10; PMID:23683837; http://dx.doi.org/10.1016/j.virol.2013.04.023
   PubMed Web of Science ®Google Scholar
• Fernandes JV, Araujo JMG, Fernandes TAAM. Biology and natural history of human papillomavirus infection. Open Access J Clin Trials 2013; 5:1-12; http://dx.doi.org/10.2147/OAJCT.S37741
   Google Scholar
• de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol 2010; 11:1048-56; PMID:20952254; http://dx.doi.org/10.1016/S1470-2045(10)70230-8
   PubMed Web of Science ®Google Scholar
• Paavonen J, Naud P, Salmeron J, Wheeler C, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira J, Skinner S, 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; 374:301-14; PMID:19586656; http://dx.doi.org/10.1016/S0140-6736(09)61248-4
   PubMed Web of Science ®Google Scholar
• The FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007; 356:1915-27; PMID:17494925; http://dx.doi.org/10.1056/NEJMoa061741
   PubMed Web of Science ®Google Scholar
• Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, 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; 13:100-10; PMID:22075170; http://dx.doi.org/10.1016/S1470-2045(11)70287-X
   PubMed Web of Science ®Google Scholar
• Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsague X, Skinner SR, Apter D, Naud P, Salmeron J, 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; PMID:22075171; http://dx.doi.org/10.1016/S1470-2045(11)70286-8
   PubMed Web of Science ®Google Scholar
• Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, 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; 199:926-35; PMID:19236279; http://dx.doi.org/10.1086/597307
   PubMed Web of Science ®Google Scholar
• Munoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Brown DR, Koutsky LA, Tay EH, 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; 102:325-39; PMID:20139221; http://dx.doi.org/10.1093/jnci/djp534
   PubMed Web of Science ®Google Scholar
• Lazcano-Ponce E, Stanley M, Munoz N, Torres L, Cruz-Valdez A, Salmeron J, Rojas R, Herrero R, Hernandez-Avila M. Overcoming barriers to HPV vaccination: Non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a 2-dose vs. a 3-dose schedule at 21 months. Vaccine 2014; 32:725-32; PMID:24355090; http://dx.doi.org/10.1016/j.vaccine.2013.11.059
   PubMed Web of Science ®Google Scholar
• Puthanakit T, Huang LM, Chiu CH, Tang RB, Schwarz TF, Esposito S, Frenette L, Giaquinto C, McNeil S, Rheault P, et al. Randomized open trial comparing 2-dose regimens of the human papillomavirus 16/18 AS04-adjuvanted vaccine in girls aged 9–14 years versus a 3-dose regimen in women aged 15–25 years. J Infect Dis 2016; 214(4):525-36[ Epub ahead of print]; PMID:26908726
   PubMed Web of Science ®Google Scholar
• Romanowski B, Schwarz TF, Ferguson LM, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Catteau G, Dobbelaere K, et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccin 2011; 7:1374-86; PMID:22048171; http://dx.doi.org/10.4161/hv.7.12.18322
   PubMed Web of Science ®Google Scholar
• Romanowski B, Schwarz TF, Ferguson LM, Ferguson M, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Behre U, et al. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: Results from a randomized study. Hum Vaccin Immunother 2014; 10:1155-65
   PubMed Web of Science ®Google Scholar
• Romanowski B, Schwarz TF, Ferguson L, Peters K, Dionne M, Behre U, Schulze K, Hillemanns P, Suryakiran P, Thomas F, et al. Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study. Hum Vaccin Immunother 2016; 12:20-9. 10.1080/21645515.2015.1065363 [doi]; PMID:26176261; http://dx.doi.org/10.1080/21645515.2015.1065363
   PubMed Web of Science ®Google Scholar
• World Health Organization (WHO). Human papillomavirus vaccines: WHO position paper, October 2014. Wkly Epidemiol Rec 2014; 89:465-91; PMID:25346960
   PubMedGoogle Scholar
• Santiago ML, Republic of the Philippines-Department of Health-Food and Drug Administration, letter to: Gatchalian, S. R. 2014 Jan 28.
   Google Scholar
• European Medicines Agency (EMA). Cervarix: EPAR - Product Information - EMA/694197/2014. London, UK: European Medicines Agency. [cited 2016 Mar 17]; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000721/WC500024634.pdf
   Google Scholar
• Recto CS, Merck Sharp & Dohm (I.A.) Corporation Philippines, letter to: 2014 May 6.
   Google Scholar
• Tjalma W, Paavonen J, Naud P, Wheeler C, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira J, Skinner R, 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. Int J Gynecol Cancer 2009; 19:1008.
   Google Scholar
• Skinner R, Apter D, Chow SN, Wheeler C, Dubin G. Cross-protective efficacy of Cervarix against oncogenic HPV types beyond HPV 16/18: Final analysis of cross-protection - PATRICIA study [Abstract]. 25th International Papillomavirus Conference; 2009 May 8; Malmö, Sweden. International Papillomavirus Society; 2009. p. 469 Available from: http://www.hpv2009.org/Abstractbok_hela%20webb%20low%5B1%5D.pdf
   Google Scholar
• Demarteau N, Tang CH, Chen HC, Chen CJ, Van Kriekinge G. Cost-effectiveness analysis of the bivalent compared with the quadrivalent human papillomavirus vaccines in Taiwan. Value Health 2012; 15:622-31; PMID:22867770; http://dx.doi.org/10.1016/j.jval.2012.02.012
   PubMed Web of Science ®Google Scholar
• Suárez E, Smith JS, Bosch FX, Nieminen P, Chen CJ, Torvinen S, Demarteau N, Standaert B. 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; http://dx.doi.org/10.1016/j.vaccine.2008.05.069
   PubMed Web of Science ®Google Scholar
• Demarteau N, Standaert B. Modelling the economic value of cross- and sustained-protection in vaccines against cervical cancer. J Med Econ 2010; 13:324-38; PMID:20504110; http://dx.doi.org/10.3111/13696998.2010.490481
   PubMedGoogle Scholar
• Philippine Statistic Authorithy. Statistics - Population projections. Republic of the Philippines. [cited 2016 Mar 14]; Available from: http://www.nscb.gov.ph/secstat/d_popnProj.asp
   Google Scholar
• World Health Organization. Life tables Philippines. [cited 2013 Aug 1]; Available from: http://apps.who.int/healthinfo/statistics/mortality/whodpms/
   Google Scholar
• Institut Català d'Oncologia. ICO (Institut Català d'Oncologia) Information Centre on HPV and Cancer (HPV Information Centre). [cited 2014 Feb 10]; Available from: http://www.hpvcentre.net/dataquery.php
   Google Scholar
• Fahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol 1995; 141:680-9; PMID:7702044
   PubMed Web of Science ®Google Scholar
• Goldie SJ, Kohli M, Grima D, Weinstein MC, Wright TC, Bosch FX, Franco E. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16/18 vaccine. J Natl Cancer Inst 2004; 96:604-15; PMID:15100338; http://dx.doi.org/10.1093/jnci/djh104
   PubMed Web of Science ®Google Scholar
• Woodhall SC, Jit M, Soldan K, Kinghorn G, Gilson R, Nathan M, Ross JD, Lacey CJ. The impact of genital warts: loss of quality of life and cost of treatment in 8 sexual health clinics in the UK. Sex Transm Infect 2011; 87:458-63; PMID:21636616; http://dx.doi.org/10.1136/sextrans-2011-050073
   PubMed Web of Science ®Google Scholar
• 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; 36:778-92; PMID:9630120; http://dx.doi.org/10.1097/00005650-199806000-00002
   PubMed Web of Science ®Google Scholar
• Stratton K, Durch J, Lawrence S. Vaccines for the 21st century: a tool for decisionmaking; Appendix 11: Human Papillomavirus. Washington, DC: National Academy Press; 2000.
   Google Scholar
• 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]. 22nd International Papillomavirus Conference & Clinical Workshop; 2005; Vancouver, BC, Canada. 2005.
   Google Scholar
• Myers ER, Green S, Lipkus I. Patient preferences for health states related to HPV infection: visual analog scale versus time trade-off elicitation. (Abstract n° 542 presented at the Twenty-First International Papillomavirus Conference, México City, México. February 20 – 27). 2004.
   Google Scholar
• Redaniel MTM, Laudico AV, Lumague MRM, Mapua CA, Patama T, Pukkala E. Cancer in the Philippines: Vol. IV Part 1 - Cancer incidence 1998–2002. Manilla: Philippine Cancer Society; 2008.
   Google Scholar
• Kumamoto Y, Tsukamoto J, Sugiyama T, Akaza H, Noguchi M, Naya A, Kamidono S, Usui T, Kagawa S, Tanaka M, et al. National surveillance of sexually transmitted diseases of Japan in 2002 (Article in Japanese). Japanese J Sexually Trans Dis 2004; 15:17-45.
   Google Scholar
• Haasis MA, Ceria JA. Cost-utility analysis of 10- and 13-valent pneumococcal conjugate vaccines in the Philippines [Abstract n° PIN26]. International Society for Pharmacoeconomics and Outcomes Research (ISPOR); Beijing, China. 2014.
   Google Scholar
• Walker DG, Hutubessy R, Beutels P. WHO Guide for standardisation of economic evaluations of immunization programmes. Vaccine 2010; 28:2356-9; PMID:19567247; http://dx.doi.org/10.1016/j.vaccine.2009.06.035
   PubMed Web of Science ®Google Scholar
• World Bank. GDP per capita [cited 2013 Aug 3]. Available from: http://data.worldbank.org/indicator/NY.GDP.PCAP.CD
   Google Scholar
• National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal 2013. [cited 2016 Mar 14]; Available from: https://www.nice.org.uk/process/pmg9/chapter/foreword
   Google Scholar
• Moscicki AB, Hills N, Shiboski S, Powell K, Jay N, Hanson E, Miller S, Clayton L, Farhat S, Broering J, et al. Risks for incident human papillomavirus infection and low-grade squamous intraepithelial lesion development in young females. JAMA 2001; 285:2995-3002; PMID:11410098; http://dx.doi.org/10.1001/jama.285.23.2995
   PubMed Web of Science ®Google Scholar
• Melnikow J, Nuovo J, Willan AR, Chan BK, Howell LP. Natural history of cervical squamous intraepithelial lesions: a meta-analysis. Obstet Gynecol 1998; 92:727-35; PMID:9764690
   PubMed Web of Science ®Google Scholar
• Schlecht NF, Platt RW, Duarte-Franco E, Costa MC, Sobrinho JP, Prado JC, Ferenczy A, Rohan TE, Villa LL, Franco EL. Human papillomavirus infection and time to progression and regression of cervical intraepithelial neoplasia. J Natl Cancer Inst 2003; 95:1336-43; PMID:12953088; http://dx.doi.org/10.1093/jnci/djg037
   PubMedGoogle Scholar
• Van de Velde N, Brisson M, Boily MC. Modeling human papillomavirus vaccine effectiveness: quantifying the impact of parameter uncertainty. Am J Epidemiol 2007; 165:762-75; PMID:17276976; http://dx.doi.org/10.1093/aje/kwk059
   PubMed Web of Science ®Google Scholar
• Sanders GD, Taira AV. Cost-effectiveness of a potential vaccine for human papillomavirus. Emerg Infect Dis 2003; 9:37-48; PMID:12533280; http://dx.doi.org/10.3201/eid0901.020168
   PubMed Web of Science ®Google Scholar
• Laudico AV, Medina V, Lumague MRM, Mapua CA, Redaniel MTM, Valenzuela FG, Pukkula E. Philippines Cancer Facts and Estimates. [cited 2016 Mar 14]; Available from: http://philcancerorgph.ipage.com/wp-content/uploads/2014/04/2010-Philippine-Cancer-Facts-Estimates.pdf
   Google Scholar
• Richardson H, Kelsall G, Tellier P, Voyer H, Abrahamowicz M, Ferenczy A, Coutlee F, Franco EL. The natural history of type-specific human papillomavirus infections in female university students. Cancer Epidemiol Biomarkers Prev 2003; 12:485-90; PMID:12814991
   PubMed Web of Science ®Google Scholar
• Aubin F, Pretet JL, Jacquard AC, Saunier M, Carcopino X, Jaroud F, Pradat P, Soubeyrand B, Leocmach Y, Mougin C, et al. Human papillomavirus genotype distribution in external acuminata condylomata: a Large French National Study (EDiTH IV). Clin Infect Dis 2008; 47:610-5; PMID:18637758; http://dx.doi.org/10.1086/590560
   PubMed Web of Science ®Google Scholar
• Sturegard E, Johansson H, Ekstrom J, Hansson BG, Johnsson A, Gustafsson E, Dillner J, Forslund O. Human papillomavirus typing in reporting of condyloma. Sex Transm Dis 2013; 40:123-9; PMID:23324975
   PubMed Web of Science ®Google Scholar
• Garland SM, Steben M, Sings HL, James M, Lu S, Railkar R, Barr E, Haupt RM, Joura EA. 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 2009; 199:805-14; PMID:19199546; http://dx.doi.org/10.1086/597071
   PubMed Web of Science ®Google Scholar