Allen Nicola, Walker Stuart R, Liberti Lawrence, Sehgal Chander, Salek M Sam
School of Pharmacy and Pharmaceutical Sciences (Allen, Walker), Cardiff University, Cardiff, UK; Centre for Innovation in Regulatory Science (Allen, Walker), London, UK; Centre for Innovation in Regulatory Science (Liberti), Hatton Garden, London, UK; Canadian Agency for Drugs and Technologies in Health (Sehgal), Ottawa, Ont.; Department of Pharmacy, Pharmacology and Postgraduate Medicine (Salek), School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK; Institute for Medicines Development (Salek), Cardiff, UK.
CMAJ Open. 2016 Nov 3;4(4):E674-E678. doi: 10.9778/cmajo.20160006. eCollection 2016 Oct-Dec.
BACKGROUND: The CADTH Common Drug Review was established in 2002 to prepare national health technology assessment reports to guide listing decisions for 18 participating drug plans. The aim of this study was to compare the nonmandatory recommendations from the Common Drug Review in Canada with the listing decisions of provincial payers to determine alignment. METHODS: We identified the recommendations issued by the Common Drug Review from Jan. 1, 2009, to Jan. 1, 2015, and compared these with the listing decisions of 3 provincial public payers (Alberta, British Columbia and Ontario) that participate in the Common Drug Review and the recommendations from Quebec. RESULTS: We identified 174 medicine-indication pairs in CADTH Common Drug Review reports issued from Jan. 1, 2009, to Jan. 1, 2015; 110 of these met the inclusion criterion. Among the 110 medicine-indication pairs, listing decisions were available for 95 in Alberta, 102 in Quebec, 104 in Ontario and 106 in BC. There was moderate to substantial agreement between provincial listing decisions and Common Drug Review recommendations: 74.5% (κ = 0.47, 95% confidence interval [CI] 0.31-0.64) for Quebec, 78.8% (κ = 0.56, 95% CI 0.41-0.72) for Ontario, 78.9% (κ = 0.58, 95% CI 0.42-0.74) for Alberta and 81.1% (κ = 0.62, 95% CI 0.47-0.77) for BC. INTERPRETATION: Our study showed moderate to substantial agreement between Common Drug Review recommendations and provincial listing decisions. Future studies can build on this research by evaluating the concordance between Common Drug Review recommendations and listing decisions of all participating federal, provincial and territorial drug plans.
背景：加拿大药品和卫生技术署通用药品审查于2002年设立，旨在编写国家卫生技术评估报告，以指导18个参与药品计划的上市决策。本研究的目的是比较加拿大通用药品审查的非强制性建议与省级支付方的上市决策，以确定一致性。 方法：我们确定了2009年1月1日至2015年1月1日期间通用药品审查发布的建议，并将其与参与通用药品审查的3个省级公共支付方（艾伯塔省、不列颠哥伦比亚省和安大略省）的上市决策以及魁北克省的建议进行比较。 结果：我们在2009年1月1日至2015年1月1日发布的加拿大药品和卫生技术署通用药品审查报告中确定了174种药物-适应症对；其中110种符合纳入标准。在这110种药物-适应症对中，艾伯塔省有95种、魁北克省有102种、安大略省有104种、不列颠哥伦比亚省有106种有上市决策。省级上市决策与通用药品审查建议之间存在中度至高度一致性：魁北克省为74.5%（κ = 0.47，95%置信区间[CI] 0.31 - 0.64），安大略省为78.8%（κ = 0.56，95% CI 0.41 - 0.72），艾伯塔省为78.9%（κ = 0.58，95% CI 0.42 - 0.74），不列颠哥伦比亚省为81.1%（κ = 0.62，95% CI 0.47 - 0.77）。 解读：我们的研究表明通用药品审查建议与省级上市决策之间存在中度至高度一致性。未来的研究可以在此基础上，通过评估通用药品审查建议与所有参与的联邦、省级和地区药品计划的上市决策之间的一致性来开展。
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