4,229
Views
14
CrossRef citations to date
0
Altmetric
Research Paper

Estimating the epidemiological impact and cost-effectiveness profile of a nonavalent HPV vaccine in Spain

, , , , &
Pages 1949-1961 | Received 06 Sep 2018, Accepted 09 Dec 2018, Published online: 20 Feb 2019

References

  • Forman D, de Martel C, Lacey CJ, Soerjomataram I, Lortet-Tieulent J, Bruni L, Vignat J, Ferlay J, Bray F, Plummer M, et al. Global burden of human papillomavirus and related diseases. Vaccine. 2012;30:F12–23. doi:10.1016/j.vaccine.2012.07.055.
  • Doorbar J, Quint W, Banks L, Ig B, Stoler M, Tr B, Ma S. The biology and life-cycle of human papillomaviruses. Vaccine. 2012;30:F55–70. doi:10.1016/j.vaccine.2012.06.083.
  • Hartwig S, Baldauf J, Dominiak-Felden G, Simondon F, Alemany L, de Sanjosé S, Castellsagué X. Estimation of the epidemiological burden of HPV-related anogenital cancers, precancerous lesions, and genital warts in women and men in Europe: potential additional benefit of a nine-valent second generation HPV vaccine compared to first generation HPV vaccines. Papillomavirus Res. 2015;1:90–100. doi:10.1016/j.pvr.2015.06.003.
  • European Centre for Disease Prevention and Control. Introduction of HPV vaccines in EU countries – an update. Stockholm: ECDC; 2012 [ accessed 2018 Jun 26]. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/20120905_GUI_HPV_vaccine_update.pdf.
  • Cervarix. Summary of Product Characteristics. European Medicines Agency. London, UK: European Medicines Agency; 2015 [ Accessed 8 Mar 2017]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000721/WC500024632.pdf.
  • Gardasil. Summary of Product Characteristics. European Medicines Agency. London, UK: European Medicines Agency; 2017 [ Accessed 8 Mar 2017]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000703/WC500021142.pdf.
  • Romanowski B. Long term protection against cervical infection with the human papillomavirus: review of currently available vaccines. Hum Vaccin. 2011;7:161–169. doi:10.4161/hv.7.2.13690.
  • GSK Cervarix® two-dose schedule receives European marketing authorisation: glaxoSmithKline. 2013 [ accessed 2017 Mar 9]. http://us.gsk.com/en-us/media/press-releases/2013/gsk-cervarix-two-dose-schedule-receives-european-marketing-authorisation/.
  • Gardasil EPAR Summary Updated Final. [ accessed 2017 Mar 9]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000703/WC500021146.pdf.
  • Gardasil 9. Summary of Product Characteristics. European Medicines Agency. London, UK: European Medicines Agency; 2016 [ Accessed 8 Mar 2017]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003852/WC500189111.pdf.
  • Joura EA, Giuliano AR, Iversen O-E, Bouchard C, Mao C, J M, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, et al. A 9-Valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372:711–723. doi:10.1056/NEJMoa1405044.
  • Huh WK, Joura EA, Giuliano AR, Iversen O-E, Andrade RP, Ault KA, Bartholomew D, Cestero RM, Fedrizzi E, Hirschberg AL, et al. Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomized, double-blind trial. Lancet. 2017;390:2143–2159. doi:10.1016/S0140-6736(17)31821-4.
  • Food and Drug Administration. Summary Basis of Regulatory Action (SBRA). 2014 [ accessed 2017 Mar 10]. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM428239.pdf.
  • Summary of opinion Gardasil 9 human papillomavirus 9-valent vaccine (recombinant, adsorbed). European Medicine Agency, Committee for Medicinal Products for Human Use. London, UK: Committee for Medicinal Products for Human Use, European Medicines Agency; 2015 [ Accessed 9 Mar 2017]. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003852/WC500184904.pdf.
  • Gardasil 9. EPAR - Procedural steps taken and scientific information after the authorisation. 2016 [ accessed 2017 Mar 9]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/003852/WC500202890.pdf.
  • [Immunization schedule. spanish pediatric association and vaccine advisory committee]. [ accessed 2017 Mar 10]. http://vacunasaep.org/profesionales/calendario-de-vacunaciones-de-la-aep-2016.
  • Spanish Ministry of Health, Social Services and Equality. HPV vaccination coverage. 2015 [ accessed 2017 Mar 10]. https://www.msssi.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/docs/CoberturasVacunacion/Tabla3.pdf.
  • Fiol G, Hernández-Aguado J, Torné A [Estimation of HPV vaccination coverage in women 15–45 years old in Spain]. XXVII Meeting of the Spanish Association of Cervical Pathology and Colposcopy (AEPCC); 2015 Nov 26–28; Córdoba, Spain.
  • Torné Bladé A, Del Pino Saladrigues M, Cusidó Gimferrer M, Alameda Quitllet F, Andia Ortiz D, Castellsagué Piqué X, Cortés Bordoy J, Granados Carreño R, Guarch Troyas RM, LLoveras Rubio B, et al. [Guidelines for cervical cancer screening in Spain, 2014]. Prog Obs Ginecol. 2014;57(Suppl 1):1–53.
  • Sacristán JA, Oliva J, Del Llano J, Prieto L, Pinto JL. [What is an efficient health technology in Spain?]. Gac Sanit. 2002;16:334–343. doi:10.1016/S0213-9111(02)71933-X.
  • Stanley M. HPV vaccination in boys and men. Hum Vaccin Immunother. 2014;10:2109–2111. doi:10.4161/hv.29137.
  • López N, Á G-D-M, Pascual-García R, Gil-Prieto R. Hospitalizations associated with malignant neoplasia and in situ carcinoma in the anus and penis in men and women during a 5-year period (2009–2013) in Spain: an epidemiological study. Hum Vaccin Immunother. 2017;13:2292–2299. doi:10.1080/21645515.2017.1348443.
  • ICO Information Centre on HPV and Cancer. Human papillomavirus and related diseases report: Spain. 2016 [ accessed 2017 Mar 15]. http://www.hpvcentre.net/statistics/reports/ESP.pdf.
  • Statement on HPV vaccination – joint committee on vaccination and immunisation. [ accessed 2018 Jul]. https://www.gov.uk/government/publications/jcvi-statement-extending-the-hpv-vaccination-programme-conclusions
  • Weiss T, Pillsbury M, Dasbach E Potential health and economic impact of the investigational 9-valent HPV vaccine in the United States. 29th Int Papillomavirus Conf Clin Work; 2014 Aug 21–25; Seattle, Washington.
  • Brisson M, Laprise J-F, Chesson HW, Drolet M, Malagón T, Boily M-C, Markowitz LE. Health and Economic Impact of Switching from a 4-Valent to a 9-Valent HPV Vaccination Program in the United States. J Natl Cancer Inst. 2016; 4;108(1). doi:10.1093/jnci/djv282.
  • Chesson HW, Markowitz LE, Hariri S, Ekwueme DU, Saraiya M. The impact and cost-effectiveness of nonavalent HPV vaccination in the United States: estimates from a simplified transmission model. Hum Vaccin Immunother. 2016;12:1363–1372. doi:10.1080/21645515.2016.
  • Durham DP, Ndeffo-Mbah ML, Skrip LA, Jones FK, Bauch CT, Galvani AP. National- and state-level impact and cost-effectiveness of nonavalent HPV vaccination in the United States. Proc Natl Acad Sci U S A. 2016;113:5107–5112. doi:10.1073/pnas.1515528113.
  • Boiron L, Joura E, Largeron N, Prager B, Uhart M. Estimating the cost-effectiveness profile of a universal vaccination programme with a nine-valent HPV vaccine in Austria. BMC Infect Dis. 2016;16:153. doi:10.1186/s12879-016-1483-5.
  • Largeron N, Petry KU, Jacob J, Bianic F, Anger D, Uhart M. An estimate of the public health impact and cost-effectiveness of universal vaccination with a 9-valent HPV vaccine in Germany. Expert Rev Pharmacoecon Outcomes Res. 2016:1–14. doi:10.1080/14737167.2016.1208087.
  • Mennini FS, Bonanni P, Bianic F, de Waure C, Baio G, Plazzotta G, Uhart M, Rinaldi A, Largeron N. Cost-effectiveness analysis of the nine-valent HPV vaccine in Italy. Cost Eff Resour Alloc. 2017;15:11. doi:10.1186/s12962-017-0073-8.
  • Malagón T, Drolet M, Boily M-C, Franco EL, Jit M, Brisson J. Cross-protective efficacy of two human papillomavirus vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12:781–789. doi:10.1016/S1473-3099(12)70187-1.
  • Soergel P, Makowski L, Schippert C, Staboulidou I, Hille U, Hillemanns P. The cost efficiency of HPV vaccines is significantly underestimated due to omission of conisation-associated prematurity with neonatal mortality and morbidity. Hum Vaccin Immunother. 2012;8:243–251. doi:10.4161/hv.18519.
  • Lerner D, Parsons SK, Justicia-Linde F, Chelmow D, Chang H, Rogers WH, Greenhill AM, Perch K, Kruzikas D. The impact of precancerous cervical lesions on functioning at work and work productivity. J Occup Environ Med. 2010;52:926–933. doi:10.1097/JOM.0b013e3181f12fb0.
  • Gil-Prieto R, Ester PV, Álvaro-Meca A, Msm R, De Miguel ÁG. The burden of hospitalizations for anus and penis neoplasm in Spain (1997–2008). Hum Vaccin Immunother. 2012;8:201–207. doi:10.4161/hv.18388.
  • Gil-Prieto R, Viguera-Ester P, Álvaro-Meca A, San-Martín-Rodriguez M, Gil de Miguel Á. The burden of hospitalizations for head and neck neoplasm in Spain (1997–2008): an epidemiologic study. Hum Vaccin Immunother. 2012;8:788–798. doi:10.4161/hv.19819.
  • Joura EA, Ault KA, Bosch FX, Brown D, Cuzick J, Ferris D, Garland SM, Giuliano AR, Hernandez-Avila M, Huh W, et al. Attribution of 12 high-risk human papillomavirus genotypes to infection and cervical disease. Cancer Epidemiol Biomarkers Prev. 2014;23:1997–2008. doi:10.1158/1055-9965.EPI-14-0410.
  • Elbasha EH, Dasbach EJ, Insinga RP. Model for assessing human papillomavirus vaccination strategies. Emerg Infect Dis. 2007;13:28–41. doi:10.3201/eid1301.060438.
  • Ultsch B, Damm O, Beutels P, Bilcke J, Brüggenjürgen B, Gerber-Grote A, Greiner W, Hanquet G, Hutubessy R, Jit M, et al. Methods for health economic evaluation of vaccines and immunization decision frameworks: A consensus framework from a european vaccine economics community. Pharmacoeconomics. 2016;34:227–244. doi:10.1007/s40273-015-0335-2.
  • Elbasha EH, Dasbach EJ. Impact of vaccinating boys and men against HPV in the United States. Vaccine. 2010;28:6858–6867. doi:10.1016/j.vaccine.2010.08.030.
  • Chesson HW. Overview of cost-effectiveness of 9-valent HPV vaccination. Atlanta (GA, United States): Meet Advis Comm Immun Pract (ACIP). 2015 Feb 26.
  • Instituto Nacional de Estadistica (INE). Demographic phenomena 2014. 2016 Jun [accessed 2017 Mar 12]. http://www.ine.es/en.
  • Instituto Nacional de Estadística. Health and Sexual Habits Survey 2003. General Report. Madrid (Spain); 2005 [ accessed 2017Mar 12]. http://www.ine.es/en.
  • Mercer CH, Tanton C, Prah P, Erens B, Sonnenberg P, Clifton S, Macdowall W, Lewis R, Field N, Datta J, et al. Changes in sexual attitudes and lifestyles in Britain through the life course and over time: findings from the national surveys of sexual attitudes and lifestyles (Natsal). Lancet. 2013;382:1781–1794. doi:10.1016/S0140-6736(13)62035-8.
  • Instituto Nacional de Estadística. European survey of Health in Spain 2014. Madrid (Spain); 2015 [ accessed 2017 Mar 12]. http://www.ine.es/en.
  • Bergeron C, Breugelmans J-G, Bouée S, Lorans C, Bénard S, Rémy V. [Cervical cancer screening and associated treatment costs in France]. Gynecol Obstet Fertil. 2006;34:1036–1042. doi:10.1016/j.gyobfe.2006.09.005.
  • Bergeron C, Largeron N, McAllister R, Mathevet P, Remy V. Cost-effectiveness analysis of the introduction of a quadrivalent human papillomavirus vaccine in France. Int J Technol Assess Health Care. 2008;24:10–19. doi:10.1017/S0266462307080026.
  • Marqués Espí J, Peiró I Gregori S, Mendrano Heredia J. València: Subsecretaria per a l’Agència Valenciana de la Salut [Variations in standardized rates of surgery in Alicante], Valencia, Spain. 2003.
  • De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, Trama A, Visser O, Brenner H, Ardanaz E, et al. Cancer survival in Europe 1999–2007 by country and age: results of EUROCARE-5–a population-based study. Lancet Oncol. 2014;15:23–34. doi:10.1016/S1470-2045(13)70546-1.
  • Cancer Research UK. Cervical cancer survival statistics. 2014 [ accessed 2017 Mar 1]. http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/cervical-cancer/survival.
  • Ault KA. Future II study group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007;369:1861–1868. doi:10.1016/S0140-6736(07)60852-6.
  • Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GWK, Ferris DG, Steben M, Bryan J, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007;356:1928–1943. doi:10.1056/NEJMoa061760.
  • Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, et al. 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. 2007;369:1693–1702. doi:10.1016/S0140-6736(07)60777-6.
  • Palefsky JM, Giuliano AR, Goldstone S, Moreira ED, Aranda C, Jessen H, Hillman R, Ferris D, Coutlee F, Stoler MH, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011;365:1576–1585. doi:10.1056/NEJMoa1010971.
  • Giuliano AR, Palefsky JM, Goldstone S, Moreira ED, Penny ME, Aranda C, Vardas E, Moi H, Jessen H, Hillman R, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med. 2011;364:401–411. doi:10.1056/NEJMoa0909537.
  • Ministerio de Sanidad. [Vaccine coverages. Statistical data]. 2015 [ accessed 2017 Mar 10]. http://www.msssi.gob.es/en/profesionales/saludPublica/prevPromocion/vacunaciones/coberturas.htm.
  • Instituto Nacional de Estadistica (INE). Harmonised index of consumer prices 2016. [accessed 2017 Mar 10, 15]. http://www.ine.es/en.
  • Consejo General de Colegios Oficiales de Farmacéuticos. [accessed 2017 Oct 31]. https://botplusweb.portalfarma.com/botplus.aspx.
  • Diaz M, de Sanjose S, Ortendahl J, O’Shea M, Goldie SJ, Bosch FX, Kim JJ. Cost-effectiveness of human papillomavirus vaccination and screening in Spain. Eur J Cancer. 2010;46:2973–2985. doi:10.1016/j.ejca.2010.06.016.
  • Castellsagué X, Rémy V, Puig-Tintoré LM, de la Cuesta RS, Gonzalez-Rojas N, Cohet C. Epidemiology and costs of screening and management of precancerous lesions of the cervix in Spain. J Low Genit Tract Dis. 2009;13:38–45. doi:10.1097/LGT.0b013e318182cd89.
  • Morano R, Torné A, Castellsagué X. [Healthcare and economic impact of vaccination against cervical cancer and precursor lesions in Spain]. Progr Obstet Ginecol. 2012;55:299–303. doi:10.1016/j.pog.2012.02.004.
  • Georgalis L, de Sanjosé S, Esnaola M, Bosch FX, Diaz M. Present and future of cervical cancer prevention in Spain: a cost-effectiveness analysis. Eur J Cancer Prev. 2016;25:430–439. doi:10.1097/CEJ.0000000000000202.
  • Cortés J, Hurtado P, Castellsagué X. M356. Burden of disease due to vulvar and vaginal cancers in Spain. Int J Gynecol Obstet. 2012;119:S644–5. doi:10.1016/S0020-7292(12)61547-1.
  • Castellsagué X, Cohet C, Puig-Tintoré LM, Acebes LO, Salinas J, San Martin M, Breitscheidel L, Rémy V. Epidemiology and cost of treatment of genital warts in Spain. Eur J Public Health. 2009;19:106–110. doi:10.1093/eurpub/ckn127.
  • Hughes O, Tsikoudas A, Auerbach R, Barr G, Bateman N, Blaney S, Bosman D, Bridger M, Clarke P, Clement A, et al. The burden of recurrent respiratory papillomatosis in the United Kingdom: results from the BAPO and ENT-UK National Survey. In: ORS Spring Meeting, London 18th March 2011. Clin Otolaryngol. 2011;36:409.
  • Trapero-Bertran M, Acera Pérez A, de Sanjosé S, Manresa Domínguez JM, Rodríguez Capriles D, Rodriguez Martinez A, Bonet Simó JM, Sanchez Sanchez N, Hidalgo Valls P, Díaz Sanchis M. Cost-effectiveness of strategies to increase screening coverage for cervical cancer in Spain: the CRIVERVA study. BMC Public Health. 2017 Feb 14;17(1):194. doi:10.1186/s12889-017-4115-0.
  • Esalud. 2017 rate for colposcopy in Andalusia (Spain). [accessed 2018 Jun 4]. http://esalud.oblikue.com/.
  • Esalud. 2017 rate for biopsy in Basque Country (Spain). [accessed 2018 Jun 4]. http://esalud.oblikue.com/.
  • Pecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet. 2009;105:103–104. doi:10.1016/j.ijgo.2009.02.012.
  • Szende A, Janssen B, Cabases J, editors. Self-reported population health: an international perspective based on EQ-5D. Dordrecht (The Netherlands): Springer Netherlands; 2014.
  • Elbasha EH, Dasbach EJ. An integrated economic evaluation and HPV disease transmission models - Technical report accompanying the manuscript “Impact on vaccinating boys and men against HPV in the United States”. Vaccine. 2010;28(42):6858–6867.
  • Sullivan PW, Slejko JF, Sculpher MJ, Ghushchyan V. Catalogue of EQ-5D scores for the United Kingdom. Med Decis Mak. 2011;31:800–804. doi:10.1177/0272989X11401031.
  • Hu D, Goldie S. The economic burden of noncervical human papilomavirus disease in the United States. Am J Obstet Gynecol. 2008;198:500–507. doi:10.1016/j.ajog.2008.03.064.
  • International Agency for Research on Cancer (IARC). GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. [accessed 2017 Mar 15]. http://globocan.iarc.fr/Pages/summary_table_pop_sel.aspx.
  • Instituto Nacional de Estadística. [Mortality by cause of death]. [ Accessed 2017 Mar 15]. http://msssi.gob.es/gl/estadEstudios/estadisticas/estadisticas/estMinisterio/mortalidad/home.htm.
  • Hartwig S, Syrjänen S, Dominiak-Felden G, Brotons M, Castellsagué X. Estimation of the epidemiological burden of human papillomavirus-related cancers and non-malignant diseases in men in Europe: a review. BMC Cancer. 2012;12:30. doi:10.1186/1471-2407-12-30.