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沙特阿拉伯治疗炎症性肠病的皮下注射英夫利昔单抗(CT-P13 SC)的预算影响分析:支付方视角的分析。

Budget impact analysis of subcutaneous infliximab (CT-P13 SC) for treating inflammatory bowel disease in Saudi Arabia: Analysis from payer perspective.

机构信息

Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.

Path Economics, LLC, Amman, Jordan.

出版信息

PLoS One. 2024 Nov 12;19(11):e0312603. doi: 10.1371/journal.pone.0312603. eCollection 2024.

Abstract

BACKGROUND

The Saudi Food and Drug Authority (SFDA) has approved the subcutaneous (SC) administration of infliximab, presenting a more convenient alternative with reduced outpatient visits and diminished expenses compared to the intravenous (IV) administration. However, the financial implications of this formulation have not been examined from the perspective of Saudi payers.

METHODS AND MATERIALS

A prevalence-based budget impact model was developed to evaluate the financial effects of introducing "environment without" versus "with infliximab SC." The model's time horizon spanned over 2 years (2021-2023), aligning with the biennial national pharmaceutical procurement cycle. The comparison focused on infliximab SC versus all available formulations of infliximab IV in the Saudi market for two inflammatory bowel diseases (IBD): Ulcerative Colitis (UC) and Crohn's Disease (CD). Treatment comparators' comparability and dose escalations were substantiated by published studies, utilizing dosing information from the summary of product characteristics. Drug acquisition costs were derived from SFDA registered prices, with IV formulation administration costs included. Scenario analysis assessed the budget impact of infliximab SC introduction at uptake rates ranging from 0% to 100%.

RESULTS

Introducing infliximab SC demonstrated cost-saving potential in the treatment of IBD. At 100% uptake with UC patients for 2 years, infliximab SC resulted in savings of -SAR-31.9 million (-SAR29,145 per patient). Similarly, for CD, introducing infliximab SC at 100% uptake over 2 years yielded savings of -SAR106.2 million (-SAR36,585 per patient).

CONCLUSION

This study reveals that infliximab SC is associated with cost-saving potential when compared to infliximab IV formulations available in Saudi Arabia. Future research should address uncertainties related to real-world comparative effectiveness, the convenience of administration, patient tolerability, and physician acceptance of the SC formulation of infliximab, alongside comparisons with other TNF-alpha inhibitors.

摘要

背景

沙特食品和药物管理局(SFDA)已批准英夫利昔单抗的皮下(SC)给药,与静脉内(IV)给药相比,这种给药方式更方便,减少了门诊就诊次数,降低了费用。然而,从沙特支付者的角度来看,尚未对这种制剂的经济影响进行研究。

方法和材料

采用基于流行率的预算影响模型来评估引入“无环境”与“有英夫利昔单抗 SC”的经济影响。模型的时间范围为 2 年(2021-2023 年),与两年一次的国家药品采购周期一致。该比较集中在沙特市场上两种炎症性肠病(IBD)的英夫利昔单抗 SC 与所有可用的英夫利昔单抗 IV 制剂上:溃疡性结肠炎(UC)和克罗恩病(CD)。治疗比较剂的可比性和剂量递增通过已发表的研究得到证实,使用产品特性摘要中的剂量信息。药物获取成本来自 SFDA 注册价格,包括 IV 制剂的管理成本。方案分析评估了英夫利昔单抗 SC 引入的预算影响,其吸收率范围从 0%到 100%。

结果

在治疗 IBD 方面,引入英夫利昔单抗 SC 具有节省成本的潜力。在 2 年内,UC 患者的吸收率达到 100%,英夫利昔单抗 SC 可节省 3190 万沙特里亚尔(SAR)(每位患者 29145SAR)。同样,对于 CD,在 2 年内将英夫利昔单抗 SC 的吸收率提高到 100%,可节省 1.062 亿沙特里亚尔(SAR)(每位患者 36585SAR)。

结论

与沙特阿拉伯现有的英夫利昔单抗 IV 制剂相比,本研究表明英夫利昔单抗 SC 具有节省成本的潜力。未来的研究应解决与现实世界比较疗效、管理便利性、患者耐受性和医生对英夫利昔单抗 SC 制剂的接受程度相关的不确定性,以及与其他 TNF-α抑制剂的比较。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b38b/11556681/4a913d2e3a5c/pone.0312603.g001.jpg

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