Luiza Vera Lucia, Chaves Luisa A, Silva Rondineli M, Emmerick Isabel Cristina M, Chaves Gabriela C, Fonseca de Araújo Silvia Cristina, Moraes Elaine L, Oxman Andrew D
Nucleus for Pharmaceutical Policies, Sergio Arouca National School of Public Health, Rua Leopoldo Bulhões, 1480 - Manguinhos, Rio de Janeiro, Brazil, 21041 210.
Cochrane Database Syst Rev. 2015 May 8;2015(5):CD007017. doi: 10.1002/14651858.CD007017.pub2.
Growing expenditures on prescription medicines represent a major challenge to many health systems. Cap and co-payment policies are intended as an incentive to deter unnecessary or marginal utilisation, and to reduce third-party payer expenditures by shifting parts of the financial burden from insurers to patients, thus increasing their financial responsibility for prescription medicines. Direct patient payment policies include caps (maximum numbers of prescriptions or medicines that are reimbursed), fixed co-payments (patients pay a fixed amount per prescription or medicine), co-insurance (patients pay a percentage of the price), ceilings (patients pay the full price or part of the cost up to a ceiling, after which medicines are free or are available at reduced cost) and tier co-payments (differential co-payments usually assigned to generic and brand medicines). This is the first update of the original review.
To determine the effects of cap and co-payment (cost-sharing) policies on use of medicines, healthcare utilisation, health outcomes and costs (expenditures).
For this update, we searched the following databases and websites: The Cochrane Central Register of Controlled Trials (CENTRAL) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, Cochrane Library; MEDLINE, Ovid; EMBASE, Ovid; IPSA, EBSCO; EconLit, ProQuest; Worldwide Political Science Abstracts, ProQuest; PAIS International, ProQuest; INRUD Bibliography; WHOLIS, WHO; LILACS), VHL; Global Health Library WHO; PubMed, NHL; SCOPUS; SciELO, BIREME; OpenGrey; JOLIS Library Network; OECD Library; World Bank e-Library; World Health Organization, WHO; World Bank Documents & Reports; International Clinical Trials Registry Platform (ICTRP), WHO; ClinicalTrials.gov, NIH. We searched all databases during January and February 2013, apart from SciELO, which we searched in January 2012, and ICTRP and ClinicalTrials.gov, which we searched in March 2014.
We defined policies in this review as laws, rules or financial or administrative orders made by governments, non-government organisations or private insurers. We included randomised controlled trials, non-randomised controlled trials, interrupted time series studies, repeated measures studies and controlled before-after studies of cap or co-payment policies for a large jurisdiction or system of care. To be included, a study had to include an objective measure of at least one of the following outcomes: medicine use, healthcare utilisation, health outcomes or costs (expenditures).
Two review authors independently extracted data and assessed study limitations. We reanalysed time series data for studies with sufficient data, if appropriate analyses were not reported.
We included 32 full-text articles (17 new) reporting evaluations of 39 different interventions (one study - Newhouse 1993 - comprises five papers). We excluded from this update eight controlled before-after studies included in the previous version of this review, because they included only one site in their intervention or control groups. Five papers evaluated caps, and six evaluated a cap with co-insurance and a ceiling. Six evaluated fixed co-payment, two evaluated tiered fixed co-payment, 10 evaluated a ceiling with fixed co-payment and 10 evaluated a ceiling with co-insurance. Only one evaluation was a randomised trial. The certainty of the evidence was found to be generally low to very low.Increasing the amount of money that people pay for medicines may reduce insurers' medicine expenditures and may reduce patients' medicine use. This may include reductions in the use of life-sustaining medicines as well as medicines that are important in treating chronic conditions and medicines for asymptomatic conditions. These types of interventions may lead to small decreases in or uncertain effects on healthcare utilisation. We found no studies that reliably reported the effects of these types of interventions on health outcomes.
AUTHORS' CONCLUSIONS: The diversity of interventions and outcomes addressed across studies and differences in settings, populations and comparisons made it difficult to summarise results across studies. Cap and co-payment polices may reduce the use of medicines and reduce medicine expenditures for health insurers. However, they may also reduce the use of life-sustaining medicines or medicines that are important in treating chronic, including symptomatic, conditions and, consequently, could increase the use of healthcare services. Fixed co-payment with a ceiling and tiered fixed co-payment may be less likely to reduce the use of essential medicines or to increase the use of healthcare services.
处方药支出不断增长对许多卫生系统构成重大挑战。限额和共付政策旨在激励措施，以阻止不必要或边际性的使用，并通过将部分经济负担从保险公司转移到患者身上来减少第三方支付者的支出，从而增加患者对处方药的经济责任。直接患者支付政策包括限额（可报销的处方或药品的最大数量）、固定共付额（患者为每张处方或每种药品支付固定金额）、共保（患者支付价格的一定百分比）、上限（患者支付全额价格或直至上限的部分费用，之后药品免费或以降低的成本提供）以及分级共付额（通常分配给仿制药和品牌药的差异化共付额）。这是对原始综述的首次更新。
确定限额和共付（费用分摊）政策对药品使用、医疗保健利用、健康结果和成本（支出）的影响。
对于本次更新，我们检索了以下数据库和网站：Cochrane对照试验中心注册库（CENTRAL）（包括Cochrane有效实践与护理组织（EPOC）小组专业注册库，Cochrane图书馆）；MEDLINE，Ovid；EMBASE，Ovid；IPSA，EBSCO；EconLit，ProQuest；全球政治学文摘，ProQuest；PAIS国际，ProQuest；INRUD文献目录；WHOLIS，世界卫生组织（WHO）；LILACS，VHL；全球卫生图书馆WHO；PubMed，NHL；SCOPUS；SciELO，BIREME；OpenGrey；JOLIS图书馆网络；经合组织图书馆；世界银行电子图书馆；世界卫生组织，WHO；世界银行文件与报告；国际临床试验注册平台（ICTRP），WHO；ClinicalTrials.gov，美国国立卫生研究院（NIH）。我们于2013年1月和2月检索了所有数据库，但SciELO于2012年1月检索，ICTRP和ClinicalTrials.gov于2014年3月检索。
我们将本综述中的政策定义为政府、非政府组织或私人保险公司制定的法律、规则或财务或行政命令。我们纳入了针对大型管辖区或护理系统的限额或共付政策的随机对照试验、非随机对照试验、中断时间序列研究、重复测量研究和前后对照研究。要纳入研究，必须包括对以下至少一项结果的客观测量：药品使用、医疗保健利用、健康结果或成本（支出）。
两位综述作者独立提取数据并评估研究局限性。对于有足够数据的研究，如果未报告适当的分析，我们重新分析了时间序列数据。
我们纳入了32篇全文文章（17篇新文章），报告了对39种不同干预措施的评估（一项研究 - Newhouse 1993 - 包括五篇论文）。我们从本次更新中排除了本综述上一版本中纳入的八项前后对照研究，因为它们在干预组或对照组中仅包括一个地点。五篇论文评估了限额，六篇评估了限额与共保及上限。六篇评估了固定共付额，两篇评估了分级固定共付额，十篇评估了固定共付额与上限，十篇评估了共保与上限。只有一项评估是随机试验。证据的确定性总体上被发现为低到非常低。增加人们为药品支付的金额可能会减少保险公司的药品支出，并可能减少患者的药品使用。这可能包括维持生命药品以及对治疗慢性病重要的药品和无症状疾病药品的使用减少。这些类型的干预措施可能导致医疗保健利用略有下降或影响不确定。我们未发现可靠报告这些类型干预措施对健康结果影响的研究。
各研究中干预措施和结果的多样性以及设置、人群和比较的差异使得难以汇总各研究的结果。限额和共付政策可能会减少药品使用并降低健康保险公司的药品支出。然而，它们也可能减少维持生命药品或对治疗慢性病（包括有症状疾病）重要的药品的使用，因此可能会增加医疗保健服务的使用。固定共付额与上限以及分级固定共付额可能不太可能减少基本药品的使用或增加医疗保健服务的使用。
