Clinical effectiveness and cost-effectiveness of quadrivalent human papillomavirus vaccination in HIV-negative men who have sex with men to prevent recurrent high-grade anal intraepithelial neoplasia |
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Institution: | 1. Laboratório Interdisciplinar de Pesquisas Médicas, IOC, Fiocruz, Rio de Janeiro, Brasil;2. Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira - Fundação Oswaldo Cruz;3. Instituto de Saúde Coletiva, Universidade Federal do Oeste do Pará and Post-graduate Student at Medicina Tropical – IOC - Fiocruz – Rio de Janeiro, Brasil;4. Center for Technology Development in Health (CDTS)/(INCT-IDPN)-Fiocruz, Brazil;5. Ohio State University Comprehensive Cancer Center, Columbus, OH, USA |
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Abstract: | We examined the long-term clinical and economic benefits of quadrivalent human papillomavirus (qHPV) vaccine as a secondary/adjunct prevention strategy in the prevention of recurrent high-grade intraepithelial neoplasia (HGAIN) in HIV-negative men who have sex with men (MSM) and are 27 years or older. We constructed a Markov model to evaluate the clinical effectiveness and cost-effectiveness of two strategies: (1) no qHPV vaccine after treatment for HGAIN versus (2) qHPV vaccine after treatment for HGAIN. Model parameters, including natural history of anal cancer, vaccine efficacy measured in terms of hazard ratio (HR) (decrease in the risk of recurrent HGAIN), HGAIN treatment efficacy, utilities, and costs, were obtained from the literature. The outcomes were measured in terms of lifetime risk of anal cancer, lifetime cost, quality-adjusted life years, and incremental cost-effectiveness ratios (ICERs). Sensitivity analysis was conducted on all model parameters. We found that vaccinating HIV-negative MSM reduced the lifetime risk of anal cancer by 60.77% at an ICER of US$87,240 per quality-adjusted life-year. The results were highly sensitive to vaccine efficacy, transition of HGAIN to anal cancer, cost of treatment for HGAIN, vaccine degree of protection over time, and the vaccine duration of protection and less sensitive to HPV clearance, cost of qHPV vaccine, and the transitions from normal to low-grade anal intraepithelial neoplasia (LGAIN) and normal to HGAIN. With an HR of 0.3, the ICER was well below a $50,000 willingness-to-pay threshold; with an HR of 0.5, the ICER was still below a threshold of $100,000. The most critical disease-related factor influencing the cost-effectiveness was the progression of HGAIN to anal cancer. At an annual transition probability below 0.001, the ICER was below $50,000. Vaccinating HIV-negative MSM treated for HGAIN decreases the lifetime risk of anal cancer and is likely to be a cost-effective intervention. |
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Keywords: | Human papillomavirus Cost-effectiveness analysis Quadrivalent human papillomavirus vaccine Secondary/adjunct prevention Anal neoplasia High-grade intraepithelial neoplasia |
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