Acosta Angela, Ciapponi Agustín, Aaserud Morten, Vietto Valeria, Austvoll-Dahlgren Astrid, Kösters Jan Peter, Vacca Claudia, Machado Manuel, Diaz Ayala Diana Hazbeydy, Oxman Andrew D
School of Pharmacy, Universidad Nacional de Colombia, Avenida Carrera 30 # 45, Bogotá, Cundinamarca, Edificio Farmacia, Bogota, Bogota DC, Colombia, 111321.
Cochrane Database Syst Rev. 2014 Oct 16;2014(10):CD005979. doi: 10.1002/14651858.CD005979.pub2.
Pharmaceuticals are important interventions that could improve people's health. Pharmaceutical pricing and purchasing policies are used as cost-containment measures to determine or affect the prices that are paid for drugs. Internal reference pricing establishes a benchmark or reference price within a country which is the maximum level of reimbursement for a group of drugs. Other policies include price controls, maximum prices, index pricing, price negotiations and volume-based pricing.
To determine the effects of pharmaceutical pricing and purchasing policies on health outcomes, healthcare utilisation, drug expenditures and drug use.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library (including the Effective Practice and Organisation of Care Group Register) (searched 22/10/2012); MEDLINE In-Process & Other Non-Indexed Citations and MEDLINE, Ovid (searched 22/10/2012); EconLit, ProQuest (searched 22/10/2012); PAIS International, ProQuest (searched 22/10/2012); World Wide Political Science Abstracts, ProQuest (searched 22/10/2012); INRUD Bibliography (searched 22/10/2012); Embase, Ovid (searched 14/12/2010); NHSEED, part of The Cochrane Library (searched 08/12/2010); LILACS, VHL (searched 14/12/2010); International Political Science Abstracts (IPSA), Ebsco (searched (17/12/2010); OpenSIGLE (searched 21/12/10); WHOLIS, WHO (searched 17/12/2010); World Bank (Documents and Reports) (searched 21/12/2010); Jolis (searched 09/10/2011); Global Jolis (searched 09/10/2011) ; OECD (searched 30/08/2005); OECD iLibrary (searched 30/08/2005); World Bank eLibrary (searched 21/12/2010); WHO - The Essential Drugs and Medicines web site (browsed 21/12/2010).
Policies in this review were defined as laws; rules; financial and administrative orders made by governments, non-government organisations or private insurers. To be included a study had to include an objective measure of at least one of the following outcomes: drug use, healthcare utilisation and health outcomes or costs (expenditures); the study had to be a randomised trial, non-randomised trial, interrupted time series (ITS), repeated measures (RM) study or a controlled before-after study of a pharmaceutical pricing or purchasing policy for a large jurisdiction or system of care.
Two review authors independently extracted data and assessed the risk of bias. Results were summarised in tables. There were too few comparisons with similar outcomes across studies to allow for meta-analysis or meaningful exploration of heterogeneity.
We included 18 studies (seven identified in the update): 17 of reference pricing, one of which also assessed maximum prices, and one of index pricing. None of the studies were trials. All included studies used ITS or RM analyses. The quality of the evidence was low or very low for all outcomes. Three reference pricing studies reported cumulative drug expenditures at one year after the transition period. Two studies reported the median relative insurer's cumulative expenditures, on both reference drugs and cost share drugs, of -18%, ranging from -36% to 3%. The third study reported relative insurer's cumulative expenditures on total market of -1.5%. Four reference pricing studies reported median relative insurer's expenditures on both reference drugs and cost share drugs of -10%, ranging from -53% to 4% at one year after the transition period. Four reference pricing studies reported a median relative change of 15% in reference drugs prescriptions at one year (range -14% to 166%). Three reference pricing studies reported a median relative change of -39% in cost share drugs prescriptions at one year (range -87% to -17%). One study of index pricing reported a relative change of 55% (95% CI 11% to 98%) in the use of generic drugs and -43% relative change (95% CI -67% to -18%) in brand drugs at six months after the transition period. The same study reported a price change of -5.3% and -1.1% for generic and brand drugs respectively six months after the start of the policy. One study of maximum prices reported a relative change in monthly sales volume of all statins of 21% (95% CI 19% to 24%) after one year of the introduction of this policy. Four studies reported effects on mortality and healthcare utilisation, however they were excluded because of study design limitations.
AUTHORS' CONCLUSIONS: The majority of the studies of pricing and purchasing policies that met our inclusion criteria evaluated reference pricing. We found that internal reference pricing may reduce expenditures in the short term by shifting drug use from cost share drugs to reference drugs. Reference pricing may reduce related expenditures with effects on reference drugs but the effect on expenditures of cost share drugs is uncertain. Reference pricing may increase the use of reference drugs and may reduce the use of cost share drugs. The analysis and reporting of the effects on patients' drug expenditures were limited in the included studies and administration costs were not reported. Reference pricing effects on health are uncertain due to lack of evidence. The effects of other purchasing and pricing policies are until now uncertain due to sparse evidence. However, index pricing may reduce the use of brand drugs, increase the use of generic drugs, and may also slightly reduce the price of the generic drug when compared with no intervention.
药物是能够改善人们健康状况的重要干预措施。药品定价和采购政策被用作成本控制措施，以确定或影响药品的支付价格。内部参考定价在一个国家内设定一个基准或参考价格，这是一组药物的最高报销水平。其他政策包括价格管制、最高价格、指数定价、价格谈判和基于数量的定价。
确定药品定价和采购政策对健康结果、医疗保健利用、药品支出和药物使用的影响。
我们检索了Cochrane对照试验中心注册库（CENTRAL），它是Cochrane图书馆的一部分（包括有效实践和护理组织组注册库）（检索日期为2012年10月22日）；MEDLINE在研及其他未索引引文和MEDLINE，Ovid（检索日期为2012年10月22日）；EconLit，ProQuest（检索日期为2012年10月22日）；PAIS国际，ProQuest（检索日期为2012年10月22日）；世界政治科学文摘，ProQuest（检索日期为2012年10月22日）；INRUD文献目录（检索日期为2012年10月22日）；Embase，Ovid（检索日期为2010年12月14日）；NHSEED，Cochrane图书馆的一部分（检索日期为2010年12月8日）；LILACS，VHL（检索日期为2010年12月14日）；国际政治科学文摘（IPSA），Ebsco（检索日期为2010年12月17日）；OpenSIGLE（检索日期为2010年12月21日）；WHOLIS，世界卫生组织（检索日期为2010年12月17日）；世界银行（文件和报告）（检索日期为2010年12月21日）；Jolis（检索日期为2011年10月9日）；全球Jolis（检索日期为2011年10月9日）；经合组织（检索日期为2005年8月30日）；经合组织iLibrary（检索日期为2005年8月30日）；世界银行电子图书馆（检索日期为2010年12月21日）；世界卫生组织 - 基本药物和药品网站（浏览日期为2010年12月21日）。
本综述中的政策被定义为法律、规则、政府、非政府组织或私人保险公司发布的财务和行政命令。要纳入一项研究，必须包括对以下至少一项结果的客观测量：药物使用、医疗保健利用、健康结果或成本（支出）；该研究必须是一项随机试验、非随机试验、中断时间序列（ITS）、重复测量（RM）研究或对一个大辖区或护理系统的药品定价或采购政策进行的前后对照研究。
两位综述作者独立提取数据并评估偏倚风险。结果以表格形式汇总。各研究中具有相似结果的比较太少，无法进行荟萃分析或有意义地探讨异质性。
我们纳入了18项研究（7项在更新中确定）：17项关于参考定价的研究，其中1项还评估了最高价格，1项关于指数定价的研究。没有一项研究是试验性研究。所有纳入的研究都使用了ITS或RM分析。所有结果的证据质量都很低或非常低。三项参考定价研究报告了过渡期后一年的累计药品支出。两项研究报告了参考药物和成本分担药物的相对保险人累计支出中位数为 -18%，范围从 -36% 到3%。第三项研究报告了相对保险人在整个市场的累计支出为 -1.5%。四项参考定价研究报告了过渡期后一年参考药物和成本分担药物的相对保险人支出中位数为 -10%，范围从 -53% 到4%。四项参考定价研究报告了一年后参考药物处方的相对中位数变化为15%（范围 -14% 至166%）。三项参考定价研究报告了一年后成本分担药物处方的相对中位数变化为 -39%（范围 -87% 至 -17%）。一项指数定价研究报告了过渡期后六个月通用药物使用的相对变化为55%（95% CI 11% 至98%），品牌药物的相对变化为 -43%（95% CI -67% 至 -18%）。同一研究报告了政策开始后六个月通用药物和品牌药物的价格变化分别为 -5.3% 和 -1.1%。一项关于最高价格的研究报告了引入该政策一年后所有他汀类药物月销售量的相对变化为21%（95% CI 19% 至24%）。四项研究报告了对死亡率和医疗保健利用的影响，但由于研究设计限制而被排除。
符合我们纳入标准的大多数定价和采购政策研究评估了参考定价。我们发现内部参考定价可能通过将药物使用从成本分担药物转向参考药物来在短期内降低支出。参考定价可能会降低与参考药物相关的支出，但对成本分担药物支出的影响尚不确定。参考定价可能会增加参考药物的使用，并可能减少成本分担药物的使用。纳入研究中对患者药品支出影响的分析和报告有限，且未报告管理成本。由于缺乏证据，参考定价对健康的影响尚不确定。由于证据稀少，其他采购和定价政策的影响目前尚不确定。然而，与无干预相比，指数定价可能会减少品牌药物的使用，增加通用药物的使用，并且可能还会略微降低通用药物的价格。
