Green Carolyn J, Maclure Malcolm, Fortin Patricia M, Ramsay Craig R, Aaserud Morten, Bardal Stan
Division of Medical Sciences, University of Victoria, PO Box 3040 STN CSC, Victoria, British Columbia, Canada, V8W 3N7.
Cochrane Database Syst Rev. 2010 Aug 4;2010(8):CD008654. doi: 10.1002/14651858.CD008654.
Public policy makers and benefit plan managers need to restrain rising pharmaceutical drug costs while preserving access and optimizing health benefits.
To determine the effects of a pharmaceutical policy restricting the reimbursement of selected medications on drug use, health care utilization, health outcomes and costs (expenditures).
We searched the 14 major bibliographic databases and websites (to January 2009).
Included were studies of pharmaceutical policies that restrict coverage and reimbursement of selected drugs or drug classes, often using additional patient specific information related to health status or need. We included randomised controlled trials, non-randomised controlled trials, interrupted time series (ITS) analyses, repeated measures studies and controlled before-after studies set in large care systems or jurisdictions.
Two authors independently extracted data and assessed study limitations. Quantitative re-analysis of time series data was undertaken for studies with sufficient data.
We included 29 ITS analyses (12 were controlled) investigating policies targeting 11 drug classes for restriction. Participants were most often senior citizens or low income adult populations, or both, in publically subsidized or administered pharmaceutical benefit plans. Impact of policies varied by drug class and whether restrictions were implemented or relaxed. When policies targeted gastric-acid suppressant and non-steroidal anti-inflammatory drug classes, decreased drug use and substantial savings on drugs occurred immediately and for up to two years afterwards, with no increase in the use of other health services (6 studies). Targeting second generation antipsychotic drugs increased treatment discontinuity and the use of other health services without reducing overall drug expenditures (2 studies). Relaxing restrictions for reimbursement of antihypertensives and statins increased appropriate use and decreased overall drug expenditures. Two studies which measured health outcomes directly were inconclusive.
AUTHORS' CONCLUSIONS: Implementing restrictions to coverage and reimbursement of selected medications can decrease third-party drug spending without increasing the use of other health services (6 studies). Relaxing reimbursement rules for drugs used for secondary prevention can also remove barriers to access. Policy design, however, needs to be based on research quantifying the harm and benefit profiles of target and alternative drugs to avoid unwanted health system and health effects. Health impact evaluation should be conducted where drugs are not interchangeable. Impacts on health equity, relating to the fair and just distribution of health benefits in society (sustainable access to publically financed drug benefits for seniors and low income populations, for example), also require explicit measurement.
公共政策制定者和福利计划管理者需要在控制药品成本不断上涨的同时,确保民众能够获得药品并优化健康效益。
确定一项限制特定药物报销的药品政策对药物使用、医疗保健利用、健康结果及成本(支出)的影响。
我们检索了14个主要的文献数据库和网站(截至2009年1月)。
纳入的研究为关于限制特定药物或药物类别的覆盖范围和报销的药品政策,通常会使用与健康状况或需求相关的其他特定患者信息。我们纳入了大型医疗系统或辖区内开展的随机对照试验、非随机对照试验、中断时间序列(ITS)分析、重复测量研究以及前后对照研究。
两位作者独立提取数据并评估研究局限性。对有足够数据的研究进行时间序列数据的定量再分析。
我们纳入了29项ITS分析(12项为对照研究),这些研究调查了针对11类药物进行限制的政策。参与研究的对象大多是公共补贴或管理的药品福利计划中的老年人或低收入成年人群体,或二者皆是。政策的影响因药物类别以及限制是实施还是放宽而有所不同。当政策针对胃酸抑制剂和非甾体抗炎药类别时,药物使用立即减少,且在之后长达两年的时间里药品费用大幅节省,同时其他医疗服务的使用并未增加(6项研究)。针对第二代抗精神病药物的政策增加了治疗中断和其他医疗服务的使用,但并未降低总体药品支出(2项研究)。放宽抗高血压药和他汀类药物的报销限制增加了合理使用并降低了总体药品支出。两项直接测量健康结果的研究结果尚无定论。
对特定药物的覆盖范围和报销实施限制可降低第三方药品支出,且不会增加其他医疗服务的使用(6项研究)。放宽用于二级预防药物的报销规则也可消除获取障碍。然而,政策设计需要基于对目标药物和替代药物的危害和益处进行量化的研究,以避免对卫生系统和健康产生不良影响。在药物不可互换的情况下应进行健康影响评估。对健康公平性的影响,即社会中健康效益的公平公正分配(例如,老年人和低收入人群可持续获得公共资助的药品福利),也需要进行明确衡量。