Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.
Pharmacoeconomics. 2013 Mar;31(3):229-36. doi: 10.1007/s40273-012-0022-5.
Cost-effectiveness evidence is increasingly considered in the reimbursement decisions of pharmaceuticals. In some jurisdictions such as the UK and Canada, pharmaceutical manufacturers are required to submit economic evaluations when seeking reimbursement.
Our objectives were to describe the role of economic evidence in the cancer drug review process in Canada, and to investigate the nature of problems encountered in the review and interpretation of economic evidence used in the process.
We conducted a retrospective review of cancer drug review meeting minutes and reviewers' comments on pharmacoeconomic studies submitted to the oncology drug review process in Canada.
We used pharmacoeconomic reviewers' reports and relevant cancer drug review expert advisory committee meeting minutes during the first year of the review process (April 2007 to March 2008).
Fifteen economic submissions were reviewed. One-third of the studies had flaws significant enough that the advisory committee could not determine the cost effectiveness of the drugs from the results. The common issues outlined by the reviewers and committee were related to the uncertainty of comparative clinical benefits, quality of life and costs. The reviewers felt that few analyses provided sufficient sensitivity analyses around key variables to assess the robustness of results. Most problems identified by reviewers are simple to fix and do not involve advanced methods.
Canada has a separate review process for making cancer drug funding recommendations, and this process uses both clinical and economic evidence. The committee could not determine the value for money of the drugs from several of the submitted pharmacoeconomic analyses. Transparent analyses and detailed critique of evidence are crucial to the use of economic evidence in reimbursement decisions. Rigorous evaluation is resource intensive and may benefit from a shared drug review process among several jurisdictions.
成本效益证据在药品报销决策中越来越受到重视。在一些司法管辖区,如英国和加拿大,制药商在寻求报销时必须提交经济评估。
我们的目的是描述经济证据在加拿大癌症药物审查过程中的作用,并调查在审查和解释用于该过程的经济证据时遇到的问题的性质。
我们对提交给加拿大肿瘤药物审查过程的药物经济学研究的癌症药物审查会议记录和审查员评论进行了回顾性审查。
我们使用了药物经济学审查员的报告以及相关的癌症药物审查专家咨询委员会会议记录,这些记录是在审查过程的第一年(2007 年 4 月至 2008 年 3 月)收集的。
审查了 15 份经济报告。三分之一的研究存在严重缺陷,以至于咨询委员会无法从结果中确定药物的成本效益。审查员和委员会概述的常见问题与比较临床效益、生活质量和成本的不确定性有关。审查员认为,很少有分析对关键变量进行了足够的敏感性分析,以评估结果的稳健性。审查员发现的大多数问题都很容易解决,不涉及复杂的方法。
加拿大有一个单独的审查程序来制定癌症药物资金建议,该程序同时使用临床和经济证据。委员会无法从提交的几个药物经济学分析中确定这些药物的性价比。透明的分析和对证据的详细评估对于在报销决策中使用经济证据至关重要。严格的评估需要大量的资源,并且可能受益于几个司法管辖区之间的共享药物审查程序。