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生物类似药采用的障碍及可能的解决方案:一项比利时案例研究。

Barriers to the uptake of biosimilars and possible solutions: a Belgian case study.

作者信息

Dylst Pieter, Vulto Arnold, Simoens Steven

机构信息

KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, O&N 2, P.O. Box 521, 3000, Leuven, Belgium,

出版信息

Pharmacoeconomics. 2014 Jul;32(7):681-91. doi: 10.1007/s40273-014-0163-9.

Abstract

BACKGROUND

Biosimilars are medicinal products that are similar to a biopharmaceutical that has already been authorised. As biopharmaceuticals are expected to dominate the best-selling pharmaceuticals worldwide by 2016, the emergence of biosimilars imposes an important challenge for governments. At this moment, the uptake of biosimilars in Belgium is limited, with market shares close to 0%.

OBJECTIVE

This study aimed to identify the barriers that impede the uptake of biosimilars in Belgium.

METHODS

Semi-structured interviews were conducted to investigate in depth the barriers to the uptake of biosimilars in Belgium. Respondents were selected through selective sampling so that all different stakeholders were represented (authorities, physicians, pharmacists, patients, academics and industry). Respondents were contacted by e-mail and letter with a request for participation. A thematic framework was used to analyze the data.

RESULTS

Three main barriers to the uptake of biosimilars in the Belgian market were identified: a lack of confidence towards biosimilars by some stakeholders; uncertainty about the interchangeability and substitution of biosimilars; and a hospital financing system that discourages the use of them. Providing all stakeholders with objective information on the concept of biosimilars, reforming the financing of hospitals, developing and implementing prescription quota in hospitals, setting up patient registries for biosimilars and speeding up the pricing and reimbursement process of biosimilars are suggested solutions to increase the uptake of biosimilars in Belgium.

CONCLUSIONS

To fully capture the potential savings of biosimilars, governments should take measures to increase their uptake. The Belgian government, and also the manufacturers of biosimilars, should take measures to reduce the uncertainties related to biosimilars and raise confidence among prescribers. In addition, the financing of hospitals should be reformed and incentives should be developed to stimulate physicians to prescribe biosimilars.

摘要

背景

生物类似药是与已获批准的生物制药相似的医药产品。鉴于预计到2016年生物制药将在全球最畅销药品中占据主导地位,生物类似药的出现给各国政府带来了重大挑战。目前,比利时生物类似药的使用情况有限,市场份额接近0%。

目的

本研究旨在确定阻碍比利时生物类似药使用的障碍。

方法

进行了半结构化访谈,以深入调查比利时生物类似药使用的障碍。通过选择性抽样选择受访者,以便涵盖所有不同的利益相关者(当局、医生、药剂师、患者、学者和行业)。通过电子邮件和信件联系受访者,邀请他们参与。采用主题框架对数据进行分析。

结果

确定了比利时市场上生物类似药使用的三个主要障碍:一些利益相关者对生物类似药缺乏信心;生物类似药的可互换性和可替代性存在不确定性;以及医院融资系统不利于生物类似药的使用。建议的解决方案包括向所有利益相关者提供有关生物类似药概念的客观信息、改革医院融资、在医院制定和实施处方配额、建立生物类似药患者登记册以及加快生物类似药的定价和报销流程,以增加比利时生物类似药的使用。

结论

为了充分实现生物类似药的潜在节省,政府应采取措施增加其使用。比利时政府以及生物类似药制造商应采取措施减少与生物类似药相关的不确定性,并提高开处方者的信心。此外,应改革医院融资并制定激励措施,以刺激医生开处方使用生物类似药。

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