Axia Research, Burlington, ON, Canada.
Pharmacoeconomics. 2012 Mar;30(3):229-46. doi: 10.2165/11593030-000000000-00000.
The Common Drug Review (CDR) was created to provide a single process to review the comparative clinical efficacy and cost effectiveness of new drugs, and then to make formulary listing recommendations to Canadian publicly funded drug benefit plans.
The objective was to conduct an in-depth analysis of Canadian Expert Drug Advisory Committee (CEDAC) recommendations to date, to explore predictors and possible explanatory factors associated with negative recommendations.
Final recommendations were identified from inception (September 2003) to 31 December 2009. Using only publicly available information, recommendations were analysed under the following categories: submission specifics, drug characteristics, clinical factors and economic factors. Descriptive analyses were conducted, followed by statistical analyses, to determine which factors independently predicted a 'do not list' (DNL) recommendation.
The database consisted of 138 unique final recommendations. The overall DNL rate was 48%. Significant differences in DNL rates were observed between therapeutic areas, ranging from 0% for HIV antivirals up to 88% for analgesic drugs. In the univariate analysis, several factors were significantly associated with a DNL recommendation, including first-in-class drugs and use of clinical scales as an outcome. In the multivariate regression, four factors were significantly predictive of a DNL recommendation: clinical uncertainty (odds ratio [OR] 14), price higher than comparators (OR 9), request for reconsideration (OR 10) and price as the only economic evidence used (OR 18). Incremental cost-effectiveness thresholds were not predictive of recommendations. The hypothesis that economic factors did not impact recommendations when clinical factors were included first was supported by the analysis.
This analysis documented an evidence-driven process that simultaneously weighted multiple factors. Clinical uncertainty and price considerations, but not economic results, had a strong impact on the recommendations. Insufficiency of clinical evidence may have resulted from the gap in evidence available at the time of product launch and the absence of demonstrated benefits to support innovative drugs.
创建通用药物评审（CDR）是为了提供一个单一的流程，以审查新药的临床疗效和成本效益的比较，并对加拿大公共资助的药物福利计划提出列入药品目录的建议。
对加拿大专家药物咨询委员会（CEDAC）迄今为止的建议进行深入分析，探讨与负面建议相关的预测因素和可能的解释因素。
从成立（2003 年 9 月）到 2009 年 12 月 31 日，确定最终建议。仅使用公开可得的信息，根据以下类别对建议进行分析：提交具体情况、药物特性、临床因素和经济因素。进行描述性分析，然后进行统计分析，以确定哪些因素独立预测“不列入”（DNL）建议。
数据库包含 138 个独特的最终建议。DNL 总体发生率为 48%。不同治疗领域的 DNL 发生率存在显著差异，从 HIV 抗病毒药物的 0%到镇痛药的 88%不等。在单变量分析中，几个因素与 DNL 建议显著相关，包括首创新药和使用临床量表作为结局。在多变量回归中，有四个因素对 DNL 建议有显著预测作用：临床不确定性（比值比[OR]14）、价格高于对照药物（OR9）、要求重新审议（OR10）和仅使用价格作为经济证据（OR18）。增量成本效益阈值与建议无关。当首先纳入临床因素时，经济因素不会影响建议的假设得到了分析的支持。
本分析记录了一个同时权衡多个因素的循证过程。临床不确定性和价格考虑因素，但不是经济结果，对建议有很大影响。临床证据不足可能是由于产品上市时可用证据的差距以及缺乏支持创新药物的收益证据造成的。
