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

Human papillomavirus (HPV) is one of the main causes of infection-related cancer. The bivalent vaccine (2vHPV) (16/18) and quadrivalent (6/11/16/18) HPV vaccine (4vHPV) have been included in the Spanish vaccination calendar since 2007. The new nonavalent HPV vaccine (9vHPV), approved in Europe in 2015, includes nine HPV types 6/11/16/18/31/33/45/52/58 and has been available in Spain since May 2017. Our study aims to estimate the epidemiological impact and the cost-effectiveness of a girls-only and a gender-neutral vaccination program with 9vHPV compared to the current vaccination program in Spain. A dynamic transmission model simulating the natural history of HPV infections was calibrated to the Spanish setting and applied to estimate costs and quality-adjusted life years (QALYs) associated with vaccination strategies using a payer perspective and a 100-year time horizon. A girls-only vaccination strategy at age 12 years with 9vHPV was found to be a cost-effective strategy compared with 4vHPV (incremental cost-effectiveness ratio (ICER) of €7,718 per QALY). Compared with girls-only vaccination with 4vHPV, gender-neutral vaccination with 9vHPV was associated with further reductions of up to 28.5% in the incidence of cervical intraepithelial neoplasia (CIN) 2/3 and 17.1% in the incidence of cervical cancer, as well as with a 14.0% reduction in cervical cancer mortality. Furthermore, a gender-neutral vaccination program with 9vHPV could potentially be cost-effective considering some parameters as head and neck protection or discount rates, leading to a reduction in the burden of HPV-related diseases in both sexes in the Spanish population.

Epidemiologic and economic burden of HPV diseases in Spain: implication of additional 5 types from the 9-valent vaccine.

BACKGROUND: A new nonavalent human papillomavirus (HPV) vaccine that includes genotypes 6/11/16/18/31/33/45/52/58 has been recently approved in Spain. A previous study has shown that attributable fraction of HPV related diseases in Spain is consistent with that reported in European and global studies. The aim of the present study was to estimate the annual direct costs associated to the following HPV-related diseases: genital warts, high grade precancerous lesions and cancer of cervix, vulva, vagina, anus and penis and head and neck cancer, caused by genotypes included in the nonavalent (9vHPV) and quadrivalent vaccines (4vHPV), in Spanish men and women. METHODS: Cancer registries and epidemiological studies were used to estimate the number of new annual cases of genital warts, anogenital precancerous lesions and cancer of cervix, vulva, vagina, anus, penis and head and neck, as well as the fraction attributable to HPV infection and to genotypes targeted by both vaccines in Spain. Costs per patient for each disease were obtained from the literature. In addition, 142 specialists were surveyed to estimate cost per patient of vulvar, vaginal, anal and penile precancerous lesions. The annual burden of diseases attributable to types targeted by both vaccines was estimated and compared. All results were validated by a panel of experts. RESULTS: In 2016, new genital warts, precancerous lesions and cancers attributable to types targeted by the 9vHPV were estimated at 49,251, 29,405 and 3381, respectively. Among them, 12,597 new precancerous lesions and 530 new cancers were related to the 5 additional types covered by the 9vHPV. Annual cost of new cases of these diseases associated to types targeted by the 4vHPV and 9vHPV were estimated at 116.7 and 150.9 million € for the Spanish National Health Service (NHS), respectively (2017 €). CONCLUSIONS: HPV-related diseases represent a major burden for the Spanish NHS. Annual new cases and costs related to the 5 additional types from the 9vHPV represent a significant burden compared with that associated to types included in the 4vHPV.

Hospitalization burden associated with malignant neoplasia and in situ carcinoma in vulva and vagina during a 5-year period (2009-2013) in Spain: An epidemiological study.

BACKGROUND: Vulvar and vaginal cancers are considered rare cancers in women. Human Papillomavirus is responsible for 30-76% of them. The aim of this study was to describe the burden of hospital admissions by malignant neoplasia (MN) and in situ carcinoma (ISC) of vulva and vagina from 2009 to 2013, in Spain METHODS: This observational, descriptive study used discharge information obtained from the national surveillance system for hospital data, Conjunto Mínimo Básico de Datos, CMBD, provided by the Ministry of Health. RESULTS: From 2009-2013, we found 9,896 hospitalizations coded as MN or ISC of vulva and vagina. Mean age of hospitalization was 69.94 ±â€¯15.16 years; average length of hospital stay (ALOS) was 10.02 ±â€¯12.40 days, and mean hospitalization costs were 5,140.31 ±â€¯3,220.61 euros. Mean hospitalization rate was 9.874 per 100,000 women aged >14 years old (95% CI: 9.689-10.058); mean mortality rate was 0.932 per 100,000 women aged >14 years old (95% CI: 0.872-0.991) and mean case fatality rate was 9.438% (95% CI: 8.862-10.014). CONCLUSION: MN and ISC of vulva and vagina are responsible for a considerable hospitalization burden. Information about these hospitalizations could be useful for cost effectiveness analysis and monitoring of HPV vaccination effectiveness.

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.

BACKGROUND: Approximately 40,000 new cases of anal cancer and 26,000 new cases of penile cancer occurred in 2012 worldwide. Human Papillomavirus (HPV) infection is responsible for 88.3% and 33.0% of these cancers, respectively. The aim of this study was to describe the hospital burden associated with malignant neoplasm (MN) and in situ carcinoma (ISC) in the anus and penis in Spain from 2009 to 2013. METHODS: This observational, retrospective study used discharge information obtained from the national surveillance system for hospital data, Conjunto Mínimo Básico de Datos, provided by the Ministry of Health. RESULTS: We found 3,668 hospitalizations due to MN and ISC in the anus for both genders, and more than 55% of these hospitalizations occurred in men and were associated with a lower median age of hospitalization (p < 0.001), higher average length of hospital stay (ALOS) (p = 0.0032), higher hospitalization costs (p < 0.001) and higher hospitalization rate (2.141 per 100,000 males aged > 14 y old and 1.604 per 100,000 women aged > 14 y old, p < 0.001) than in women. During the same period, 4,156 hospitalizations due to MN and ISC of the penis were registered. The hospitalization rate was 4.320 per 100,000 males aged > 14 y old. The hospitalization rate due to MN and ISC in the anus in males increased significantly during this period (p = 0.048). CONCLUSION: Our study provides relevant information about the hospital burden of anal and penile MN and ISC in Spain. This information could be useful for cost effectiveness analysis of universal HPV vaccination and for future HPV vaccination impact monitoring in Spain, and for other countries of similar socioeconomic status.