Cost-effectiveness of human papillomavirus vaccination and screening in Spain

Unit of Infections and Cancer, Cancer Epidemiology Research Program, Catalan Institute of Oncology, IDIBELL, Av. Gran Via 199-203, 08907 L'Hospitalet de Llobregat, Barcelona, Spain.
European journal of cancer (Oxford, England: 1990) (Impact Factor: 4.82). 11/2010; 46(16):2973-85. DOI: 10.1016/j.ejca.2010.06.016
Source: PubMed

ABSTRACT In Spain, prophylactic vaccination against human papillomavirus (HPV) types 16 and 18 is being offered free-of-charge to one birth cohort of girls aged 11-14. Screening is opportunistic (annual/biannual) contributing to social and geographical disparities.
A multi-HPV-type microsimulation model was calibrated to epidemiologic data from Spain utilising likelihood-based methods to assess the health and economic impact of adding HPV vaccination to cervical cancer screening. Strategies included (1) screening alone of women over age 25, varying frequency (every 1-5 years) and test (cytology, HPV DNA testing); (2) HPV vaccination of 11-year-old girls combined with screening. Outcomes included lifetime cancer risk, life expectancy, lifetime costs, number of clinical procedures and incremental cost-effectiveness ratios.
After the introduction of HPV vaccination, screening will need to continue, and strategies that incorporated HPV testing are more effective and cost-effective than those with cytology alone. For vaccinated girls, 5-year organised cytology with HPV testing as triage from ages 30 to 65 costs 24,350€ per year of life saved (YLS), assuming life-long vaccine immunity against HPV-16/18 by 3 doses with 90% coverage. Unvaccinated girls would benefit from organised cytology screening with HPV testing as triage; 5-year screening from ages 30 to 65 costs 16,060€/YLS and 4-year screening from ages 30 to 85 costs 38,250€/YLS. Interventions would be cost-effective depending on the cost-effectiveness threshold and the vaccine price.
In Spain, inequitable coverage and overuse of cytology make screening programmes inefficient. If high vaccination coverage among pre-adolescent girls is achieved, organised cytology screening with HPV triage starting at ages 30 to at least 65 every 4-5 years represents the best balance between costs and benefits.

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    • "Health outcomes were reported as a mean and range of results, while incremental cost-effectiveness ratios were reported as the ratio of the difference in mean costs divided by the difference in mean effects across the good-fitting parameter sets for one strategy compared with the next best alternative. The calibration process has been previously described [30] [31] [32] [33] [34] [35] [36] and details of the calibration data, methods, and results for all three countries are provided in the Appendix. Strategies that were evaluated in this analysis include: (1) HPV16/18 vaccination of pre-adolescent girls (by age 12); (2) screening alone; and (3) combined pre-adolescent HPV16/18 vaccination and screening. "
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    ABSTRACT: To date, no studies have evaluated the cost-effectiveness of human papillomavirus (HPV) vaccination in countries in the Extended Middle East and North Africa (EMENA) region. We synthesized population and epidemiologic data for 20 EMENA countries using a model-based approach to estimate averted cervical cancer cases and deaths, disability-adjusted life years (DALYs) and cost-effectiveness ratios (I$ [international dollars] per DALY averted) associated with HPV vaccination of pre-adolescent girls. We utilized additional epidemiologic data from Algeria, Lebanon, and Turkey to evaluate select cervical cancer screening strategies either alone or in combination with vaccination. Results showed that pre-adolescent vaccination of five consecutive birth cohorts at 70% coverage has the potential to prevent over 180,000 cervical cancer cases. Cases averted varied by country, largely due to differences in cancer burden and population size; 69% of cases averted occurred in the three GAVI-eligible countries in EMENA. Despite the low cervical cancer incidence in EMENA, we found that HPV vaccination was cost-effective using a threshold of each country's gross domestic product per capita (a common metric for evaluating cost-effectiveness) in all but five countries at a cost per vaccinated girl of I$25 ($5 per dose). However, cost-effectiveness diminished with increasing vaccine cost; at a cost of I$200 per vaccinated girl, HPV vaccination was cost-effective in only five countries. When the cost per vaccinated girl exceeded I$50 in Lebanon and Turkey and I$150 in Algeria, screening alone was most attractive. We identified opportunities to improve upon current national screening guidelines, involving less frequent screening every 3-5 years. While pre-adolescent HPV vaccination promises to be a cost-effective strategy in most EMENA countries at low costs, decision makers will need to consider many other factors, such as affordability, acceptability, feasibility, and competing health priorities, when making decisions about cervical cancer prevention. This article forms part of a regional report entitled "Comprehensive Control of HPV Infections and Related Diseases in the Extended Middle East and North Africa Region" Vaccine Volume 31, Supplement 6, 2013. Updates of the progress in the field are presented in a separate monograph entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012.
    Vaccine 12/2013; 31S6:G65-G77. DOI:10.1016/j.vaccine.2012.06.096 · 3.49 Impact Factor
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    • "Our findings show that a 3 year screening interval is safe although based on a small sample of women. hrHPV triage is likely to result in a cost-effective strategy if screening intervals are kept and diverts women from colposcopy in hrHPV negative women [10,22]. However, although the sensitivity of hrHC2 was very high, specificity was relatively low increasing unnecessarily the number of women referred to colposcopy because of a positive test. "
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    ABSTRACT: A protocol for cervical cancer screening among sexually active women 25 to 65 years of age was introduced in 2006 in Catalonia, Spain to increase coverage and to recommend a 3-year-interval between screening cytology. In addition, Human Papillomavirus (HPV) was offered as a triage test for women with a diagnosis of atypical squamous cells of undetermined significance (ASC-US). HPV testing was recommended within 3 months of ASC-US diagnosis. According to protocol, HPV negative women were referred to regular screening including a cytological exam every 3 years while HPV positive women were referred to colposcopy and closer follow-up. We evaluated the implementation of the protocol and the prediction of HPV testing as a triage tool for cervical intraepithelial lesions grade two or worse (CIN2+) in women with a cytological diagnosis of ASC-US. During 2007-08 a total of 611 women from five reference laboratories in Catalonia with a novel diagnosis of ASC-US were referred for high risk HPV (hrHPV) triage using high risk Hybrid Capture version 2. Using routine record linkage data, women were followed for 3 years to evaluate hrHPV testing efficacy for predicting CIN2+ cases. Logistic regression analysis was used to estimate the odds ratio for CIN2 +. Among the 611 women diagnosed with ASC-US, 493 (80.7%) had at least one follow-up visit during the study period. hrHPV was detected in 48.3% of the women at study entry (mean age 35.2 years). hrHPV positivity decreased with increasing age from 72.6% among women younger than 25 years to 31.6% in women older than 54 years (p < 0.01). At the end of the 3 years follow-up period, 37 women with a diagnosis of CIN2+ (18 CIN2, 16 CIN3, 2 cancers, and 1 with high squamous intraepithelial lesions--HSIL) were identified and all but one had a hrHPV positive test at study entry. Sensitivity to detect CIN2+ of hrHPV was 97.2% (95%confidence interval (CI) = 85.5-99.9) and specificity was 68.3% (95%CI = 63.1-73.2). The odds ratio for CIN2+ was 45.3 (95% CI: 6.2-333.0), when among ASC-US hrHPV positive women were compared to ASC-US hrHPV negative women. Triage of ASC-US with hrHPV testing showed a high sensitivity for the detection of CIN2+ and a high negative predictive value after 3 years of follow-up. The results of this study are in line with the current guidelines for triage of women with ASC-US in the target age range of 25-65. Non adherence to guidelines will lead to unnecessary medical interventions. Further investigation is needed to improve specificity of ASC-US triage.
    BMC Infectious Diseases 01/2012; 12:25. DOI:10.1186/1471-2334-12-25 · 2.61 Impact Factor
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    ABSTRACT: The AS04-adjuvanted human papillomavirus (HPV) 16/18 vaccine (Cervarix®) is a noninfectious recombinant vaccine produced using purified virus-like particles (VLPs) that induce a strong immunogenic response eliciting high levels of anti-L1 VLP antibodies that persist at levels markedly greater than those observed with natural infection. The vaccine adjuvant (AS04) is composed of monophosphoryl-lipid A, which enhances cellular and humoral immune response, adsorbed to aluminum hydroxide. The vaccine is indicated for the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic HPV types in females aged ≥10 years. The AS04-adjuvanted HPV 16/18 vaccine, administered via an intramuscular injection in a three-dose schedule over 6 months, elicits a high immunogenic response and is highly protective against cervical intraepithelial neoplasia and infection causally related to high-risk oncogenic HPV types. In well designed clinical trials in young women aged 15-25 years who were HPV 16/18 seronegative and DNA negative to 14 HPV high-risk types, high levels of immunogenicity and protection were sustained for follow-up periods of up to 8.4 years. High and persistent immunogenicity against infection with HPV 16/18 has also been demonstrated in older and younger females (aged 10-55 years) who were seronegative for vaccine HPV types. The AS04-adjuvanted HPV 16/18 vaccine elicited a greater immunogenic response than the quadrivalent HPV vaccine in women aged 18-45 years who were seronegative and DNA negative for HPV 16/18. The AS04-adjuvanted HPV 16/18 vaccine confers cross protection against certain non-vaccine, high-risk HPV types. A rapid and strong anamnestic humoral immune response was elicited following a fourth dose of the vaccine. The AS04-adjuvanted HPV 16/18 vaccine is generally well tolerated, and pharmacoeconomic analyses have demonstrated the potential for public health benefits and cost effectiveness when vaccination programs are run in conjunction with screening programs. Thus, the AS04-adjuvanted HPV 16/18 vaccine prevents cervical disease associated with certain oncogenic HPV types, thereby reducing the burden of premalignant cervical lesions and, very likely, cervical cancer.
    BioDrugs 08/2011; 25(4):265-9. DOI:10.2165/11206830-000000000-00000 · 2.12 Impact Factor
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