药物经济学在医保药品谈判中的角色--以丙型肝炎直接抗病毒药物为例

目的:以参加2019年国家医保药品谈判的丙型肝炎治疗药物为例,探讨药物经济学在医保药品谈判中的作用,为医保药品目录调整和同类药品谈判提供参考。方法:通过成本效用分析和阈值分析,测算丙肝治疗药物的降价幅度并与实际降价幅度进行对比,结合具体谈判方式探讨相关影响因素。结果:2019年丙肝药品谈判采用了竞争性谈判和比价磋商谈判两种方式。竞争性谈判纳入的基因1b型药品艾尔巴韦格拉瑞韦和来迪派韦索磷布韦测算降价幅度(50.7%和32.8%)低于实际降价幅度(89.0%和89.9%),比价磋商谈判纳入的非基因1b型药品索磷布韦维帕他韦测算降价幅度(36.7%)也低于实际降价幅度(81.2%),竞争性谈判降价幅度高于比价磋商谈判。结论:药物经济学、预算影响、国际参考价格和疾病市场特征等可为谈判提供依据,优化参照选择和成本计算可提高药物经济学证据的决策利用度,但谈判起决定性作用的还是支付者意愿。竞争性谈判不宜针对创新药物,易打击企业研发积极性。

The role of pharmacoeconomics in national reimbursement drug negotiation: Taking direct-acting antiviral drugs for hepatitis C virus infection as an example

Objective:To explore the role of pharmacoeconomics in national negotiation taking direct-acting antivirals(DAAs)for hepatitis C virus infection as an example based on data from 2019,so as to provide references for adjustment of national reimbursement drug list and the negotiation of similar drugs.Methods:Through cost-utility analysis and threshold analysis,the DAAs price reduction was calculated and compared with the actual price reduction,and relevant factors of influence were analyzed in combination with specific negotiation methods.Results:Competitive negotiation and price comparison negotiation were adopted in the negotiation of DAAs for Hepatitis C in 2019.The estimated price reduction for genotype 1b DAAs elbasvir/grazoprevir and ledipasvir/sofosbuvir included by competitive negotiation,i.e.50.7%and 32.8%,respectively,were lower than actual price reduction(89.0%and 89.9%).The estimated price reduction of non-genotype 1b DAAs sofosbuvir/velpatasvir included in the price comparison negotiation(36.7%)was also lower than the actual price reduction(81.2%).However,the price reduction of competitive negotiation was higher than the actual price reduction in the price comparison negotiation.Conclusions:Pharmacoeconomics,budget impact,international reference prices,and disease market characteristics can provide evidence for negotiation.Optimizing reference selection and cost calculation can improve the decision-making utilization of pharmacoeconomics evidence,but it is the payer’s willingness that plays a decisive role in the negotiation.Competitive negotiation is not suitable when innovative drugs are to be targeted in the negotiation,and this can easily discourage the enthusiasm of research and development(R&D)enterprises.