Data from: Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis

Objectives
Investigate if the recommendations by the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR) to provincial, territorial and federal drug plans about whether to list non-oncology and oncology drug-indication combinations on their formularies are associated with whether the drug-indication combination was approved via the standard evidence pathway or the Notice of Compliance with conditions (NOC/c – limited evidence) pathway.
Design
Cohort study.
Data sources
Web sites of the CDR and pCODR up to the end of March 31, 2017; journal articles evaluating drugs approved through the NOC/c pathway, the Notice of Compliance database, the Notice of Compliance with conditions web site and the Summary Basis of Decision website.
Interventions
Recommendations by the CDR and pCODR.
Primary and secondary outcome measures
Analysis of the percent of drugs receiving positive listing recommendations from CDR and pCODR depending on the pathway used to approve the drug.
Results
There were 310 recommendations for drug-indication combinations from the CDR and 79 from the pCODR. There was a statistically significant difference in the number of drug-indication combinations that received a list versus do not list recommendation from the CDR for those approved through the standard pathway compared to those approved through the NOC/c pathway (p = 0.0407). A similar analysis for recommendations from the pCODR was not statistically significant.
Conclusion
For non-oncology drug-indication combinations, the type of review appears to influence the recommendation regarding listing on public formularies. This difference may reflect the level of evidence about the efficacy and safety of the drug-indication at the time the recommendation was made.

研究目标
探讨加拿大普通药品评审（Common Drug Review, CDR）与泛加拿大肿瘤药品评审（pan-Canadian Oncology Drug Review, pCODR）向省、地区及联邦药品计划提出的关于非肿瘤与肿瘤药品-适应症组合是否纳入处方集的评审建议，是否与该药品-适应症组合通过标准证据路径还是附带条件上市许可（Notice of Compliance with conditions, NOC/c – 有限证据路径）获批存在关联。
研究设计
队列研究。
数据来源
截至2017年3月31日的CDR与pCODR官方网站；评估通过NOC/c路径获批药品的期刊文献、上市许可数据库、附带条件上市许可官方网站及决策依据摘要网站。
干预措施
CDR与pCODR的评审建议。
主要与次要结局指标
分析依据药品获批路径不同，CDR与pCODR给出阳性纳入处方集建议的药品占比。
研究结果
CDR共提出310项药品-适应症组合评审建议，pCODR共提出79项。对于通过标准路径获批的药品-适应症组合与通过NOC/c路径获批的组合，CDR给出纳入与不纳入处方集建议的数量存在统计学显著差异（p = 0.0407）。而针对pCODR建议的同类分析未显示统计学显著性。
研究结论
对于非肿瘤药品-适应症组合，评审类型似乎会影响公共处方集的纳入建议。该差异可能反映了评审作出时，该药品-适应症的有效性与安全性证据水平。