Brisson Marc, Laprise Jean-François, Chesson Harrell W, Drolet Mélanie, Malagón Talía, Boily Marie-Claude, Markowitz Lauri E
Centre de recherche du CHU de Québec, Axe Santé des populations et pratiques optimales en santé, Québec, Canada (MB, JFL, MD, TM); Département de médecine sociale et préventive, Université Laval, Québec, Canada (MB, MD, TM); Department of Infectious Disease Epidemiology, Imperial College, London, UK (MB, MCB); National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, GA (HWC, LEM).
J Natl Cancer Inst. 2015 Oct 4;108(1). doi: 10.1093/jnci/djv282. Print 2016 Jan.
Randomized clinical trials have shown the 9-valent human papillomavirus (HPV) vaccine to be highly effective against types 31/33/45/52/58 compared with the 4-valent. Evidence on the added health and economic benefit of the 9-valent is required for policy decisions. We compare population-level effectiveness and cost-effectiveness of 9- and 4-valent HPV vaccination in the United States.
We used a multitype individual-based transmission-dynamic model of HPV infection and disease (anogenital warts and cervical, anogenital, and oropharyngeal cancers), 3% discount rate, and societal perspective. The model was calibrated to sexual behavior and epidemiologic data from the United States. In our base-case, we assumed 95% vaccine-type efficacy, lifelong protection, and a cost/dose of $145 and $158 for the 4- and 9-valent vaccine, respectively. Predictions are presented using the mean (80% uncertainty interval [UI] = 10(th)-90(th) percentiles) of simulations.
Under base-case assumptions, the 4-valent gender-neutral vaccination program is estimated to cost $5500 (80% UI = 2400-9400) and $7300 (80% UI = 4300-11 000)/quality-adjusted life-year (QALY) gained with and without cross-protection, respectively. Switching to a 9-valent gender-neutral program is estimated to be cost-saving irrespective of cross-protection assumptions. Finally, the incremental cost/QALY gained of switching to a 9-valent gender-neutral program (vs 9-valent girls/4-valent boys) is estimated to be $140 200 (80% UI = 4200->1 million) and $31 100 (80% UI = 2100->1 million) with and without cross-protection, respectively. Results are robust to assumptions about HPV natural history, screening methods, duration of protection, and healthcare costs.
Switching to a 9-valent gender-neutral HPV vaccination program is likely to be cost-saving if the additional cost/dose of the 9-valent is less than $13. Giving females the 9-valent vaccine provides the majority of benefits of a gender-neutral strategy.
随机临床试验表明，与四价人乳头瘤病毒（HPV）疫苗相比，九价HPV疫苗对31/33/45/52/58型HPV具有更高的有效性。政策决策需要九价疫苗在健康和经济方面额外获益的证据。我们比较了美国九价和四价HPV疫苗接种在人群层面的有效性和成本效益。
我们使用了一个基于个体的HPV感染和疾病（肛门生殖器疣、宫颈癌、肛门生殖器癌和口咽癌）的多类型传播动力学模型，贴现率为3%，采用社会视角。该模型根据美国的性行为和流行病学数据进行校准。在我们的基础案例中，我们假设四价和九价疫苗的疫苗型效力均为95%，具有终身保护作用，四价和九价疫苗的成本/剂量分别为145美元和158美元。预测结果以模拟的均值（80%不确定区间[UI]=第10百分位数-第90百分位数）呈现。
在基础案例假设下，四价性别中立的疫苗接种计划估计成本为5500美元（80% UI=2400-9400美元），在有和没有交叉保护的情况下，每获得一个质量调整生命年（QALY）分别为7300美元（80% UI=4300-11000美元）。无论交叉保护假设如何，改用九价性别中立计划估计都能节省成本。最后，改用九价性别中立计划（与九价女孩/四价男孩相比）每获得一个QALY的增量成本估计在有和没有交叉保护的情况下分别为140200美元（80% UI=4200美元->100万美元）和31100美元（80% UI=2100美元->100万美元）。结果对于HPV自然史、筛查方法、保护持续时间和医疗成本的假设具有稳健性。
如果九价疫苗的额外成本/剂量低于13美元，改用九价性别中立的HPV疫苗接种计划可能会节省成本。给女性接种九价疫苗可提供性别中立策略的大部分益处。
