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从德国社会视角比较奥法妥木单抗与富马酸二甲酯及醋酸格拉替雷在复发型多发性硬化症患者中的长期临床和经济影响:一项成本后果分析

Comparing the long-term clinical and economic impact of ofatumumab versus dimethyl fumarate and glatiramer acetate in patients with relapsing multiple sclerosis: A cost-consequence analysis from a societal perspective in Germany.

作者信息

Koeditz Dominik, Frensch Juergen, Bierbaum Martin, Ness Nils-Henning, Ettle Benjamin, Vudumula Umakanth, Gudala Kapil, Adlard Nicholas, Tiwari Santosh, Ziemssen Tjalf

机构信息

Novartis Pharma GmbH, Nuremberg, Germany.

Hexal AG, Holzkirchen, Germany.

出版信息

Mult Scler J Exp Transl Clin. 2022 Mar 29;8(1):20552173221085741. doi: 10.1177/20552173221085741. eCollection 2022 Jan-Mar.

Abstract

BACKGROUND

Evidence suggests that early highly efficacious therapy in relapsing multiple sclerosis is superior to escalation strategies.

OBJECTIVE

A cost-consequence analysis simulated different treatment scenarios with ofatumumab (OMB), dimethyl fumarate (DMF) and glatiramer acetate (GA): immediate OMB initiation as first treatment, early switch to OMB after 1 year on DMF/GA, late switch after 5 years or no switch.

METHODS

An EDSS-based Markov model with a 10-year time horizon was applied. Cycle transitions included EDSS progression, improvement or stabilization, treatment discontinuation, relapse or death. Input data were extracted from OMB trials, a network meta-analysis, published literature, and publicly available sources.

RESULTS

The late switch compared to the immediate OMB scenario resulted in a lower proportion of patients with EDSS 0-3 (Δ - 7.5% DMF; Δ - 10.3% GA), more relapses (Δ + 0.72 DMF; Δ + 1.23 GA) and lower employment rates (Δ - 4.0% DMF; Δ - 5.6% GA). The same applies to late versus early switches. No switch scenarios resulted in worse outcomes. Higher drug acquisition costs in the immediate OMB and early switch scenarios were almost compensated by lower costs for patient care and productivity loss.

CONCLUSION

Immediate OMB treatment and an early switch improves clinical and productivity outcomes while remaining almost cost neutral compared to late or no switches.

摘要

背景

有证据表明,复发型多发性硬化症的早期高效治疗优于逐步升级策略。

目的

一项成本效益分析模拟了使用奥法木单抗(OMB)、富马酸二甲酯(DMF)和醋酸格拉替雷(GA)的不同治疗方案:立即开始使用OMB作为初始治疗,在使用DMF/GA 1年后早期换用OMB,5年后晚期换用或不换用。

方法

应用了基于扩展残疾状态量表(EDSS)的马尔可夫模型,时间跨度为10年。周期转换包括EDSS进展、改善或稳定、治疗中断、复发或死亡。输入数据来自OMB试验、网络荟萃分析、已发表的文献以及公开可用的来源。

结果

与立即使用OMB的方案相比,晚期换用方案导致EDSS评分为0 - 3的患者比例更低(DMF降低7.5%;GA降低10.3%),复发更多(DMF增加0.72;GA增加1.23),就业率更低(DMF降低4.0%;GA降低5.6%)。晚期换用与早期换用相比也是如此。不换用方案的结果更差。立即使用OMB和早期换用方案中较高的药物采购成本几乎被较低的患者护理成本和生产力损失所抵消。

结论

与晚期或不换用相比,立即使用OMB治疗和早期换用可改善临床和生产力结果,同时几乎保持成本中性。

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