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长效棕榈酸帕利哌酮三月剂型与一月剂型治疗法国精神分裂症的临床和经济影响:一项成本-效用研究。

The clinical and economic impact of three-monthly long-acting formulation of paliperidone palmitate versus the one-monthly formulation in the treatment of schizophrenia in France: A cost-utility study.

机构信息

IQVIA, Corporate Village, Davos Building, Da Vincilaan 7, 1930 Zaventem, Belgium.

Department of Psychiatry, University Hospital of Saint-Etienne, TAPE Laboratory, EA7423, Jean Monnet University, 42100 Saint-Étienne, France.

出版信息

Encephale. 2019 Dec;45(6):459-467. doi: 10.1016/j.encep.2019.03.001. Epub 2019 Sep 18.

DOI:10.1016/j.encep.2019.03.001
PMID:31542210
Abstract

OBJECTIVES

Schizophrenia entails a considerable humanistic and economic burden. Improved treatment continuity to antipsychotic therapy is paramount to reduce the risk of relapse. The novel three-monthly paliperidone palmitate treatment (PP3M) offers the longest dosing interval currently available in France. This study assesses its cost-effectiveness, versus the currently available one-monthly long-acting treatment (PP1M) in French schizophrenic patients.

METHODS

A Markov model with monthly cycles was developed and adapted. It encompassed [a] administration of PP3M or PP1M in first-line, [b] a period where the patient does not receive any active treatment, and [c] a follow-up treatment line consisting of a treatment mix reflecting French clinical practice. Relapse rates in first-line were based on a pivotal non-inferiority head-to-head trial, and treatment discontinuation rates were based on French real-world data. Accounting for differences in drug exposure, time-dependent monthly relapse rates were applied following discontinuation to first line. The impact of a less frequent injection schedule for PP3M in QoL was accounted for through the application of a utility differential. The collective perspective was adopted throughout a 5-year time horizon. Four percent discount rates were applied on costs and outcomes.

RESULTS

PP3M was dominant when compared to PP1M, featuring an incremental QALY of 0.123 and a cost saving effect (-669€) resulting from reduced therapy costs (drug acquisition, administration and monitoring) and relapse-related costs. Sensitivity analysis supported the robustness of the results.

CONCLUSION

With slightly better QALY outcomes and a cost-saving effect when compared to PP1M, introducing PP3M is an improvement to the current treatment in France.

摘要

目的

精神分裂症带来了巨大的人文和经济负担。改善抗精神病药物治疗的连续性对于降低复发风险至关重要。新型三个月帕利哌酮棕榈酸酯治疗(PP3M)提供了目前在法国可用的最长给药间隔。本研究评估了其与目前可用的每月长效治疗(PP1M)相比在法国精神分裂症患者中的成本效益。

方法

开发并改编了一个每月周期的马尔可夫模型。它包括 [a] 在一线使用 PP3M 或 PP1M,[b] 患者不接受任何积极治疗的时期,以及 [c] 由反映法国临床实践的治疗组合组成的后续治疗线。一线治疗的复发率基于一项关键性非劣效性头对头试验,停药率基于法国真实世界数据。考虑到药物暴露的差异,停药后根据每月复发率进行时间依赖性应用。PP3M 较少的注射方案对 QoL 的影响通过应用效用差异来考虑。整个 5 年时间范围内采用集体观点。对成本和结果应用 4%的贴现率。

结果

与 PP1M 相比,PP3M 具有优势,其增量 QALY 为 0.123,并且由于治疗成本(药物获取、管理和监测)和与复发相关的成本降低,具有成本节约效果(节省 669 欧元)。敏感性分析支持结果的稳健性。

结论

与 PP1M 相比,PP3M 具有稍好的 QALY 结果和成本节约效果,在法国引入 PP3M 是对当前治疗的改进。

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