a Unit of Lower Genital Tract Pathology, Department of Obstetrics and Gynecology, Hospital Universitario Infanta Leonor , Madrid , Spain.
b Medical Department, MSD Spain , Madrid , Spain.
Hum Vaccin Immunother. 2019;15(7-8):1949-1961. doi: 10.1080/21645515.2018.1560770. Epub 2019 Feb 20.
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.
人乳头瘤病毒（HPV）是感染相关癌症的主要病因之一。二价疫苗（2vHPV）（16/18）和四价疫苗（6/11/16/18）HPV 疫苗（4vHPV）自 2007 年以来已被纳入西班牙免疫接种计划。新的九价 HPV 疫苗（9vHPV）于 2015 年在欧洲获得批准，包含九种 HPV 类型 6/11/16/18/31/33/45/52/58，自 2017 年 5 月以来已在西班牙上市。我们的研究旨在评估与西班牙目前的免疫接种计划相比，仅对女孩和性别中立的 9vHPV 接种计划的流行病学影响和成本效益。一个动态传播模型模拟了 HPV 感染的自然史，并根据西班牙的情况进行了校准，并应用于从支付者的角度和 100 年的时间范围来估计与疫苗接种策略相关的成本和质量调整生命年（QALY）。与 4vHPV 相比，在 12 岁时对女孩进行 9vHPV 单一疫苗接种被认为是一种具有成本效益的策略（每 QALY 的增量成本效益比（ICER）为 7718 欧元）。与仅对女孩接种 4vHPV 相比，对女孩和男孩进行 9vHPV 接种还与宫颈上皮内瘤变（CIN）2/3 的发病率降低 28.5%和宫颈癌发病率降低 17.1%有关，以及宫颈癌死亡率降低 14.0%。此外，考虑到某些参数，如头颈部保护或贴现率，对男孩和女孩进行 9vHPV 接种可能具有成本效益，从而降低西班牙人群中 HPV 相关疾病的负担。
