Liu Wenbin, Shi Lizheng, Sawhney Monika, Gu Xiaoli, Chen Yingyao
Department of Health Management, School of Public Health, Fujian Medical University, Fuzhou, Fujian, China.
School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.
BMC Health Serv Res. 2019 Feb 11;19(1):112. doi: 10.1186/s12913-019-3937-0.
Evidence-based decision on drug list or formulary has been applied worldwide. Although the importance of scientific evidence was emphasized, the decision-making procedures for including medicines into the national reimbursement drug list were often challenged by their process opacity and relying on subjective expert opinion. This study aimed to explore and assess the evidence for the effectiveness of anti-hypertensive medicines included on the Chinese National Reimbursement Drug List (NRDL), and to provide recommendations for further improvement.
Three international evidence-based guidelines were selected to serve as reference criteria. The antihypertensive medicines included in NRDL of Urban Employee Basic Medical Insurance (UEBMI) were compared with recommended drugs in three international guidelines. Medicines recommended by at least two guidelines were considered to have sound evidence support for the effectiveness. Otherwise, published literature with high evidence grade, namely systematic review, meta-analysis and randomized controlled trial (RCT), were searched for further assessment. Medicines reported as fairly good effectiveness by literature with high evidence grade can be also considered having sound evidence for the effectiveness. Methodological quality of systematic review or meta-analysis was evaluated by AMSTAR scale and PRISMA statement. Literature quality of RCTs was assessed by Jadad scale.
For the 97 antihypertensive medicines in NRDL, there were sound evidence supports for the effectiveness of 56 kinds of medicines. Specifically, twenty-six of them were supported by international evidence-based guidelines, twenty were supported by systematic review or meta-analysis and the other ten by RCT. However, for the rest 41 medicines, there is insufficient evidence for their effectiveness.
Some antihypertensive medicines in NRDL did not have sufficient evidence for their effectiveness. Further evaluation and revision were required. It is also recommended to standardize decision-making procedures for inclusion of medicines, set up high quality evidence database to timely provide sound evidence, and so on.
基于证据的药品目录或处方集决策已在全球范围内得到应用。尽管强调了科学证据的重要性，但将药品纳入国家医保药品目录的决策程序往往因其过程不透明且依赖主观专家意见而受到质疑。本研究旨在探索和评估中国国家医保药品目录（NRDL）中抗高血压药物有效性的证据，并为进一步改进提供建议。
选择三项国际循证指南作为参考标准。将城镇职工基本医疗保险（UEBMI）的NRDL中包含的抗高血压药物与三项国际指南中推荐的药物进行比较。至少两项指南推荐的药物被认为具有充分的有效性证据支持。否则，检索具有高证据等级的已发表文献，即系统评价、荟萃分析和随机对照试验（RCT），进行进一步评估。具有高证据等级的文献报道有效性较好的药物也可被认为具有充分的有效性证据。系统评价或荟萃分析的方法学质量通过AMSTAR量表和PRISMA声明进行评估。RCT的文献质量通过Jadad量表进行评估。
对于NRDL中的97种抗高血压药物，有56种药物具有充分的有效性证据支持。具体而言，其中26种得到国际循证指南的支持，20种得到系统评价或荟萃分析的支持，另外10种得到RCT的支持。然而，其余41种药物的有效性证据不足。
NRDL中的一些抗高血压药物缺乏充分的有效性证据。需要进一步评估和修订。还建议规范药品纳入的决策程序，建立高质量证据数据库以及时提供充分证据等。
