Laupacis Andreas
Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.
Pharmacoeconomics. 2006;24(11):1157-62. doi: 10.2165/00019053-200624110-00011.
The Canadian Common Drug Review (CDR) was established in 2003 to provide a single process for making formulary recommendations to most Canadian publicly funded drug plans. This paper considers the most common challenges faced by the CDR: (a) determining the effectiveness of a drug (particularly interpreting the importance of surrogate markers and changes in QOL measures); (b) the massive rise in the cost of new drugs, which, in general, does not seem to accompanied by a massive increase in effectiveness; (c) interpreting complex pharmacoeconomic evaluations which often do not provide straightforward answers about the cost effectiveness of a drug; (d) prescription creep (the tendency for drugs in the real world to be used in patients who were not studied in clinical trials, thus raising concerns about a drug's real-world cost effectiveness; and (e) ethical and societal issues, particularly the reimbursement of expensive drugs for rare diseases.
加拿大药品通用审查（CDR）成立于2003年，旨在为大多数加拿大公共资助的药品计划提供单一的药品目录推荐流程。本文探讨了CDR面临的最常见挑战：（a）确定药物的有效性（特别是解释替代指标的重要性和生活质量测量的变化）；（b）新药成本大幅上升，而总体而言，其有效性似乎并未随之大幅提高；（c）解读复杂的药物经济学评估，这些评估往往无法直接给出药物成本效益的答案；（d）处方蔓延（现实中药物用于未在临床试验中研究的患者的趋势，从而引发对药物实际成本效益的担忧）；以及（e）伦理和社会问题，尤其是罕见病昂贵药物的报销问题。
