Abstract

BackgroundEvidence-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.MethodsThree 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.ResultsFor 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.ConclusionsSome 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.

Highlights

  • Evidence-based decision on drug list or formulary has been applied worldwide

  • General information There are 97 antihypertensive medicines included in National Reimbursement Drug List (NRDL) of Urban Employee Basic Medical Insurance (UEBMI), which were divided into Class A and Class B

  • Based on the mechanism of action, the 97 antihypertensive medicines can be divided into seven categories, such as calcium antagonist, β-blockers, diuretics, angiotensin converting enzyme inhibitors (ACEIs), Angiotensin II receptor antagonist, vasodilators and others, respectively accounting for 24.7, 14.4, 11.4, 15.5, 12.4, 7.2 and 14.4% of all the 97 kinds of medicines

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Summary

Introduction

Evidence-based decision on drug list or formulary has been applied worldwide. 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 antihypertensive medicines included on the Chinese National Reimbursement Drug List (NRDL), and to provide recommendations for further improvement. In 2009, WHO explicitly recommended to apply GRADE in evidence-based evaluation and selection of essential medicines, as well as submit the evidence of medicine efficacy and safety in the form of GRADE tables [2, 3]. The medicines in this list are categorized into Class A and Class B. The provincial bureaus have no right in adjusting medicines in Class A, but they have the right to adjust not more than 15% of the medicines in Class B in accordance to local socio-economic level, health demand and medication habits [5]

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