我国城市女性乳腺癌筛查方案的流行病学效果预测与成本效果分析

Breast cancer remains an important health problem among women in mainland China, the number of new cancer cases will be substantially increasing along with the urbanization and population aging. Most women in urban areas in this setting do not have access to breast cancer screening. Comprehensive evaluation of the cost-effectiveness of breast cancer screening in urban populations in China has not previously been performed. The aim of the study is to evaluate epidemiologic outcomes and cost-effectiveness of various breast cancer screening strategies in urban populations in China using detailed models by incorporating the findings from field studies and review of the evidence. The study will include three components: (1) The field studies will be conducted in Hunan Province (central south China) and Gansu Province (northwest China). Using a micro-costing approach, aggregated costs associated with breast cancer screening, diagnosis and treatment will be estimated at province and prefecture level. (2) Using a systematic review approach, data associated with specific screening test accuracy will be reviewed and the natural history of breast cancer and its precancerous lesions will be characterized, including regression, persistence and progression between difference health states; based on the findings, several meta-analyses or narrative reviews will be performed. (3) Informed by data collected from the field studies (Component 1) and literature search (Component 2), we will develop and calibrate Markov models of breast cancer natural history and screening interventions; based on the validated models, we will predict lifetime reduction in breast cancer incidence and mortality for various strategies and associated cost-effectiveness from a societal perspective; we will also perform budget impact analyses from a beget holder’s perspective. The study is expected to assist the local policy decision-making for proper breast cancer screening strategies and scale-up intervention program in urban populations in mainland China.

乳腺癌位居我国女性恶性肿瘤发病首位，随着城镇化和老龄化加速，城市女性人群的乳腺癌疾病负担将日益加重。目前国内筛查项目间的筛查方案存在较大差异，究竟哪些筛查方案最经济有效尚不得知，针对中国人群乳腺癌筛查的经济有效性证据仍然有限，而进行人群特异性的研究非常必要。本项目将采取现场结合模型的方法，对在我国城市人群中开展多种乳腺癌筛查的方法进行综合的流行病学效果预测和卫生经济学评价。项目将在湖南和甘肃现场，开展乳腺癌筛查诊治相关的微观法医疗成本核算；同时用系统性文献查阅的方法对乳腺癌疾病自然史、干预和预后及筛查技术准确度等参数进行系统量化；然后整合现场和文献所获信息，构建和调试乳腺癌疾病自然史和筛查诊治的高效度模型，最终运基于模型对系列乳腺癌筛查方案进行流行病学效果预测、成本效果分析和预算影响分析。预期研究结果可为将来在我国城市人群中开展扩大范围的乳腺癌筛查的卫生决策提供重要的科学依据。

目前我国乳腺癌筛查项目间的筛查方案存在较大差异，针对中国人群乳腺癌筛查的经济有效性证据仍然有限。本课题采取现场结合模型的方法，对在我国城市人群中开展多种乳腺癌筛查的方法进行综合的流行病学效果预测和卫生经济学评价，课题主要包括三部分研究内容。1）成本核算：项目在湖南和甘肃现场，结合临床路径方法，开展乳腺癌筛查诊治相关的微观法医疗成本核算，该研究内容获得了调查现场乳腺癌筛查诊治微观成本数据集，其中省级机构成本较高的现场也提示乳腺癌筛查工作“重心下移”可能会经济有效；此外也开发了可推广到其他癌种的微观成本核算工具包，也探索了成本/费用比方法用于推算全国其他地区（有费用信息而无成本数据）的成本的可行性。2）参数系统评价：用文献综述法、系统评价和Meta分析的方法分别对基于RCT的疾病自然史研究、乳腺癌自然史模型研究、预后参数、筛查技术准确性、当地乳腺癌相关疾病负担、健康效用值测量、经济负担等参数或专题进行系统量化；兼顾证据全面性和人群特异性，课题共完成了4项全球证据和5项中国人群特异性数据的系统评价；其中卫生经济学评价进展的系统评价结果初步提示，在我国人群中开展乳腺癌筛查经济有效，但整体最优方案待深入。3）模型构建与分析：整合以上信息，构建了乳腺癌疾病自然史和筛查诊治干预模型，基于模型针对21项国内外开展的乳腺癌筛查方案进行流行病学效果和卫生经济学评价，评价指标包括每挽救1个生命年和每增加1个质量调整生命年的成本，目前已完成模型架构调试及初步结果分析。因本课题现场工作基础部分为国家重大公共卫生服务项目城市癌症早诊早治项目，产出预期会对相关决策和指南制定有一定影响；谨慎起见，模型结果将在开展多方研讨论证后以政策简报和公开发表论文等形式全面推出呈现。