不同价格场景下二线抗结核药品疗程费用及总费用测算

Estimation of Course Cost and Total Cost of Second-line Antituberculosis Drugs under Different Price Scenarios

目的从宏观层面,测算不同价格场景下二线抗结核药品的全疗程总费用,以期为相关药物保障政策制定提供依据。方法基于我国《耐多药肺结核临床路径(2012年版)》指南(简称2012版)和2018年WHO耐药结核治疗指南(简称WHO2018版)推荐的治疗方案,参考中国大陆现有药品价格、全球药物基金组织(GDF)采购价格及预测谈判价格,分别测算不同采购方案及报销水平下,二线抗结核药品疗程费用及全国总费用。结果根据2012版及现有药品价格测算药品全疗程费用为1.95万~12.7万元/人,自付0.53万~7.84万元,部分方案构成灾难性卫生支出。根据WHO 2018版,在现有药品价格下疗程费用为56.17万~63.42万元/人;GDF采购价格下疗程费用1.74万~3.41万元/人;中国大陆疗程费用相当于GDF采购价格的20倍,相当于灾难性医疗支出的3.4倍,其中贝达喹啉及利奈唑胺价格对总费用影响较大。按中国大陆耐药结核患者7.3万人/年测算,如果接受全疗程治疗,药品总费用为14.2亿~92.9亿元。结论与GDF采购价格比较,国内二线抗结核药物价格较为昂贵,国家财政负担沉重。亟需使用谈判集中采购、加快仿制药品研发上市等措施,降低药品价格,以满足患者用药需求。

Objectives This study measures the total cost of full-course treatment of second-line anti-tuberculosis drugs in different scenarios from a macro level,in order to provide a basis for the formulation of relevant drug protection policies.Methods Based on the Guidelines of China’s Multidrug-Resistant Tuberculosis Clinical Pathway(2012 Edition)and 2018'WHO Treatment Guidelines For Multidrug-And Rifampicin-Resistant Tuberculosis'(WHO 2018),referring to the current drug prices in China's Mainland,the purchase prices of Global Fund to Fight AIDS,TB and Malaria(GDF)and forecasted negotiation prices,this paper measures the cost of second-line anti-tuberculosis drugs and the total national cost under different procurement plans and reimbursement levels respectively.Results Based on the 2012 Edition and the present drug prices,the total drug cost is estimated to be 19.5 to127 thousand yuan/person,and 5.3 to 78.4 thousand yuan is paid out of pocket.Some therapeutic courses will form catastrophic health expenditure.Based on the WHO 2018 edition,the cost of treatment with the present drug price is 561.7 to 634.2 thousand yuan/person,while that with the GDF purchase,the price is 17.4 to 44.1 thousand yuan/person;which means the former one is equivalent to 20 times of the latter one,and 3.4 times of catastrophic medical expenditure.The prices of Bedaquiline and Linezolid have great impact on the total cost.If the full treatment course is accepted by the 73 thousand patients with drug resistant tuberculosis per year in China's Mainland,the total cost of the medicines is between 1.4 to 9.23 billion yuan.Conclusion Compared with the purchase prices of GDF,domestic second-line anti-tuberculosis drugs are more expensive and pose a heavy financial burden on the country.It is urgent to use centralized negotiations and speed up the development and listing of generic drugs to reduce drugs prices and meet the needs of patients.