评估在韩国提交的药物经济学评价报告。
Assessment of pharmacoeconomic evaluations submitted for reimbursement in Korea.
机构信息
Drug Listing Division, Health Insurance Review and Assessment Services, Seoul, Republic of Korea.
出版信息
Value Health. 2012 Jan-Feb;15(1 Suppl):S104-10. doi: 10.1016/j.jval.2011.11.026.
OBJECTIVE
To assess the quality of pharmacoeconomic evaluations (PEs) submitted with new drug applications for reimbursement and to investigate the role of PEs for coverage decisions in Korea.
METHODS
Forty-seven PEs that were submitted by pharmaceutical companies for coverage decisions between June 2005 and December 2009 were included in this study. To assess their appropriateness with regard to the PE guidelines, we used the Health Insurance Review and Assessment services (HIRA) checklist consisting of 20 items based on the PE guidelines. We also evaluated the results for coverage decisions, as "recommended," "recommended with restricted use," or "not recommended," based on the incremental cost-effectiveness ratio and the range of uncertainty.
RESULTS
On average, 14 of the 20 items on the HIRA checklist were fulfilled (70.9%, range 35.0%-100%). The compliance rate for the following items was above 70%: presentation of perspectives and evaluation methods, a sufficient time horizon, and appropriateness of comparators and health outcomes. The compliance rate for the following items was below 70%: omission of objectives for the study, inappropriate target population, unclear selection process for effectiveness and cost, inappropriate cost estimation, insufficient justification of generalizability, and description of study limitations. The range of incremental cost-effectiveness ratios per quality-adjusted life-years of PEs from a societal perspective varied from dominant to 59K USD (n = 13): it consisted of dominant to 28K USD for "recommended" submissions (n = 6), 8K to 20K USD for "recommended with restricted use" submissions (n = 4), and 13K to 59K for "not recommended" ones (n = 3).
CONCLUSIONS
Our study showed that most PEs in this study have reached an adequate level for coverage decisions. Overall barriers associated with a lack of relevant evidence could account for the low compliance rate with specific items in the PE guidelines. PEs with good quality submitted for coverage decisions have played an important role for selecting cost-effective drugs.
目的
评估新药申请报销中提交的药物经济学评价（PE）的质量，并研究其在韩国覆盖决策中的作用。
方法
本研究纳入了 2005 年 6 月至 2009 年 12 月期间制药公司为覆盖决策提交的 47 项 PE。为了根据 PE 指南评估其适当性，我们使用了由 HIRA 组成的检查表，检查表由 20 项基于 PE 指南的项目组成。我们还根据增量成本效益比和不确定性范围，将覆盖决策的结果评估为“推荐”、“推荐但限制使用”或“不推荐”。
结果
HIRA 检查表上的 20 个项目平均有 14 项得到满足（70.9%，范围 35.0%-100%）。以下项目的符合率超过 70%：展示观点和评价方法、足够的时间范围、以及比较器和健康结果的适当性。以下项目的符合率低于 70%：研究目标缺失、目标人群不合适、有效性和成本选择过程不明确、成本估算不适当、推广性的理由不充分、以及研究局限性的描述。从社会角度来看，PE 每质量调整生命年的增量成本效益比的范围从占优势到 59 千美元（n = 13）：其中，“推荐”提交的范围从占优势到 28 千美元（n = 6），“推荐但限制使用”提交的范围从 8 千到 20 千美元（n = 4），“不推荐”提交的范围从 13 千到 59 千美元（n = 3）。
结论
本研究表明，该研究中的大多数 PE 已达到覆盖决策的适当水平。与缺乏相关证据相关的总体障碍可能是 PE 指南中特定项目符合率低的原因。为覆盖决策提交的高质量 PE 在选择具有成本效益的药物方面发挥了重要作用。
Zotero 插件