Dranitsaris George, Jacobs Ira, Kirchhoff Carol, Popovian Robert, Shane Lesley G
Augmentium Pharma Consulting Inc., Toronto, ON, Canada.
Global Medical Affairs, Pfizer Inc, New York, NY.
Clinicoecon Outcomes Res. 2017 Sep 29;9:573-584. doi: 10.2147/CEOR.S140063. eCollection 2017.
Due to the continued increase in global spending on health care, payers have introduced a number of programs, policies, and agreements on pharmaceutical pricing in order to control costs. While incentives to increase generic drug use have achieved significant savings, other cost-containment measures are required. Tendering is a formal procedure to purchase medications using competitive bidding for a particular contract. Although useful for cost containment, tendering can lead to decreased competition in a given market. Consequently, drug shortages can occur, resulting in changes to treatment plans to products that may have lower efficacy and/or an increased risk of adverse effects. Therefore, care must be taken to ensure that tendering does not negatively impact patient care or the health care system. A large and expanding portion of total pharmaceutical expenditure is for biologic therapies. These agents have revolutionized the treatment of many diseases, including cancer and inflammatory conditions; however, patient access to biologic drugs can be limited due to availability, insurance coverage, and cost. As branded biologic therapies reach the end of patent- and data-protection periods, biosimilars are being approved as lower-cost alternatives. Biosimilars are products that are highly similar to the originator product with no clinically meaningful differences in terms of safety, purity, or potency. As more biosimilars receive regulatory approval and adoption increases, these therapies are expected to have an impact on global health care spending and should result in overall savings. However, the use of tendering to maximize the potential benefits of biosimilars has varied across the world. Therefore, the objectives of this review are to examine the drug-tendering process and its implications on drug supply and drug shortages, as well as to describe biosimilars and how tendering may influence their uptake.
由于全球医疗保健支出持续增加，支付方出台了一系列有关药品定价的计划、政策和协议，以控制成本。虽然鼓励增加仿制药使用已实现了大幅节约，但还需要其他成本控制措施。招标是通过对特定合同进行竞争性投标来采购药品的正式程序。尽管招标有助于控制成本，但在特定市场中可能会导致竞争减少。因此，可能会出现药品短缺，从而导致治疗方案改为使用疗效可能较低和/或不良反应风险增加的产品。因此，必须谨慎确保招标不会对患者护理或医疗保健系统产生负面影响。药品总支出中很大且不断扩大的一部分用于生物疗法。这些药物彻底改变了包括癌症和炎症性疾病在内的许多疾病的治疗方法；然而，由于可得性、保险覆盖范围和成本等因素，患者获得生物药物的机会可能有限。随着品牌生物疗法专利和数据保护期到期，生物类似药作为低成本替代品正在获得批准。生物类似药是与原研产品高度相似，在安全性、纯度或效力方面没有临床意义差异的产品。随着越来越多的生物类似药获得监管批准且采用率上升，这些疗法预计将对全球医疗保健支出产生影响，并应带来总体节约。然而，在全球范围内，利用招标来最大化生物类似药潜在效益的情况各不相同。因此，本综述的目的是研究药品招标过程及其对药品供应和药品短缺的影响，以及描述生物类似药以及招标可能如何影响其采用情况。
