日本成本-效用评估制度对我国医保目录药品准入定价的启示

Insights from Japan’s cost-effectiveness analysis policy on pricing for China’s NRDL access

日本于2019年开始正式对药品施行成本-效用评估政策,实现了不同品种的价格定量化调整。在评估品种上,日本采用分级分类手段遴选预计年销售额较大的品种,并根据预先设定的增量成本-效果比(ICER)阈值对现有价格构成中的溢价部分和利润部分进行调整,从而解决了由主观差异导致的调整标准和幅度不一致的问题;同时,该政策对部分药品进行了特殊考量,给予评估豁免或提高ICER阈值的激励措施。在价格调整机制上,日本针对药品价格加算部分和营业利润部分,结合阶梯式ICER阈值和量化公式,构建了有升有降的价格调整机制。我国在医保目录准入环节,仍存在部分药品价格形成的量化机制不够明确、价格修正措施不完善、沟通环节滞后等问题。建议我国可在医保准入阶段提高特殊人群用药的ICER阈值,量化调增、调减的标准和幅度,对提交高质量疗效证据的企业给予价格激励,前置企业沟通环节,就降价幅度过大的准入品种探索建立价格兜底机制,以进一步提升我国医保目录准入过程中药品定价的科学性和公平性。

The cost-effectiveness analysis policy for drugs was institutionalized in Japan since 2019,realizing quantitative adjustment of price across varieties.A hierarchical categorization approach was adopted to select medicines with high expected annual sales.For selected medicines,adjustments were made to the premium and profit components within the existing price structure based on a pre-defined incremental cost-effectiveness ratio(ICER)threshold,effectively resolving the issue of inconsistent criteria and magnitudes caused by subjective judgment.Meanwhile,incentive measures like evaluation exemption or threshold enhancement were granted for specific medicines.Besides,a price adjustment mechanism,which was allowed for upward and downward adjustments,involving tiered ICER threshold and quantified formulas,had been established for the premium and profit components of drug price.In China’s National Reimbursement Drug List(NRDL)access,certain issues remained to be addressed:insufficient clarity in the quantitative mechanism of price formation,incomplete price adjustment measures,and lagging in the communication channels.It is recommended that the following measures could be referred to when further improving the scientificity and fairness of drug pricing during China’s NRDL access,such as enhancing the ICER threshold for medicines catering to special populations,quantifying criteria and extents for price adjustment,granting preferential pricing policies to pharmaceutical companies that present high-quality evidence of effectiveness,preceding communication channels with pharmaceutical companies,as well as exploring a price floor mechanism for the drugs with excessive price reduction.