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爱尔兰最佳价值生物医学倡议实施后,肿瘤坏死因子-α抑制剂阿达木单抗和依那西普的生物类似药的应用情况。

Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value biological medicine initiative in Ireland.

机构信息

Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland.

Health Services Executive (HSE) Medicines Management Programme, Trinity Centre for Health Sciences, St James's Hospital, Dublin 8, Ireland.

出版信息

Int J Clin Pharm. 2021 Oct;43(5):1251-1256. doi: 10.1007/s11096-021-01243-0. Epub 2021 Feb 9.

DOI:10.1007/s11096-021-01243-0
PMID:33560486
Abstract

Background There is over 10 years of clinical experience and evidence to show that biosimilar medicines can be used as safely and effectively in approved therapeutic indications as their originator biological medicines. In Ireland, biosimilar medicine uptake has been very slow, and savings to the health service will only be realised through fostering a competitive biological medicine market. Objective The objective of this study was to investigate the utilisation of biosimilars following a 'best-value biological' medicine initiative for adalimumab and etanercept in the Irish healthcare setting. Methods Data was extracted from the National High Tech claims database and High Tech ordering and management hub for the following drugs; adalimumab (Humira®, Amgevita®, Hulio®, Idacio®, and Imraldi®) and etanercept (Enbrel® and Benepali®). Main outcome measure: uptake of the best-value biological medicines. Results In June 2019, just over 90 patients had been initiated on, or switched to a best-value biological for adalimumab or etanercept. Over the next 12 months this increased to over 8500 patients. With the best-value biologicals accounting for approximately 50 % of market share in June 2020, the combined estimated savings and avoided costs are €22.7 million to date. The gain-share prescribing incentive has raised over €3.6 million for the specialties to invest back into patient care. Conclusion Against the background of a finite healthcare budget, this study shows that increasing use of biosimilars can create the financial savings and space to invest in new innovative therapies for the benefit of many patients.

摘要

背景

有超过 10 年的临床经验和证据表明,生物类似药在已批准的治疗适应症中可以与原研生物药一样安全有效地使用。在爱尔兰,生物类似药的使用非常缓慢,只有通过培育有竞争力的生物药市场,才能为医疗服务节省费用。目的:本研究旨在调查在爱尔兰医疗保健环境中针对阿达木单抗和依那西普实施“最佳价值生物”药物倡议后生物类似药的使用情况。方法:从国家高值药品索赔数据库和高值药品订购和管理中心提取以下药品的数据:阿达木单抗(修美乐®、Amgevita®、Hulio®、Idacio®和 Imraldi®)和依那西普(恩利®和 Benepali®)。主要结局指标:最佳价值生物药物的使用情况。结果:2019 年 6 月,仅有 90 多名患者开始使用或转换为阿达木单抗或依那西普的最佳价值生物药物。在接下来的 12 个月中,这一数字增加到 8500 多名患者。到 2020 年 6 月,最佳价值生物药物占据了约 50%的市场份额,迄今为止,累计节省和避免的费用为 2270 万欧元。收益共享处方激励措施为专科医生带来了超过 360 万欧元的收入,用于投资于患者护理。结论:在医疗保健预算有限的背景下,本研究表明,增加生物类似药的使用可以节省资金并为新的创新疗法腾出空间,使许多患者受益。

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To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry.
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Ophthalmol Ther. 2025 Apr;14(4):621-641. doi: 10.1007/s40123-025-01104-3. Epub 2025 Feb 26.
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Appl Health Econ Health Policy. 2024 Nov;22(6):771-781. doi: 10.1007/s40258-024-00904-1. Epub 2024 Aug 12.
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