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利妥昔单抗生物类似药上市的真实世界预算影响

Real-World Budget Impact of Listing a Biosimilar of Rituximab.

作者信息

Boidart Arnaud, Darveau Martin, Déry Nicole, Racine Marie-Claude

机构信息

, MPharm, MBA, is with the Faculty of Pharmacy of Amiens, Amiens, France.

, BPharm, MSc, is with the Pharmacy Department, Centre hospitalier universitaire de Québec-Université Laval, Québec, Quebec.

出版信息

Can J Hosp Pharm. 2020 Jan-Feb;73(1):13-18. Epub 2020 Feb 1.

Abstract

BACKGROUND

The approval of new biosimilars by national health agencies is expected to generate significant cost savings for health care systems. This is particularly the case with the biosimilar of rituximab approved for the Canadian market in 2019. However, several uncertainties remain regarding utilization of this agent.

OBJECTIVES

To determine the proportion of total annual drug expenses for each indication for rituximab in the hospital setting and to determine potential savings related to introduction of a biosimilar.

METHODS

A budget impact analysis was performed through 3 real-world scenarios, based on data obtained from a large university teaching hospital for a 12-month period.

RESULTS

This study involved data for 420 patients. Annual expenses for rituximab for all indications represented 7.7% of total annual drug spending for the hospital, of which 5.0% was related specifically to indications approved by Health Canada. More than 6% of the annual drug expenses was attributable to the use of rituximab for oncologic indications, including 1.8% for uses not approved by Health Canada. Overall, each 10% reduction in the price of a biosimilar of rituximab (relative to the reference rituximab) would result in annual savings of about 0.8% of total drug expenses in the hospital if a biosimilar was used for all real-world indications, whether approved by Health Canada or not.

CONCLUSIONS

The introduction of a biosimilar of rituximab to the Canadian market would generate significant savings. To properly assess the potential savings that this agent could generate in the limited budget environment of a hospital, it seems important to consider all of the indications for which it could be used.

摘要

背景

国家卫生机构批准新的生物类似药有望为医疗保健系统大幅节省成本。2019年在加拿大市场获批的利妥昔单抗生物类似药尤其如此。然而,关于该药物的使用仍存在一些不确定性。

目的

确定医院环境中利妥昔单抗各适应症的年度药物总费用比例,并确定引入生物类似药相关的潜在节省。

方法

基于从一家大型大学教学医院获取的12个月期间的数据,通过3种真实世界情景进行预算影响分析。

结果

本研究纳入了420例患者的数据。利妥昔单抗所有适应症的年度费用占医院年度药物总支出的7.7%,其中5.0% specifically与加拿大卫生部批准的适应症相关。超过6%的年度药物费用归因于利妥昔单抗在肿瘤适应症中的使用,包括1.8%用于加拿大卫生部未批准的用途。总体而言,如果利妥昔单抗生物类似药用于所有真实世界适应症(无论是否经加拿大卫生部批准),其价格每降低10%(相对于参比利妥昔单抗),将使医院年度药物总费用节省约0.8%。

结论

利妥昔单抗生物类似药进入加拿大市场将带来显著节省。为了在医院有限的预算环境中正确评估该药物可能产生的潜在节省,考虑其所有可能的使用适应症似乎很重要。

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