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在意大利,莫苏奈妥珠单抗与替沙格赛定用于治疗三线或更高线(3L+)复发或难治性(R/R)滤泡性淋巴瘤(FL)的成本效益分析。

A Cost-Effectiveness Analysis of Mosunetuzumab vs Tisagenlecleucel for Treatment of Third- or Higher-Line (3L+) Relapsed or Refractory (R/R) Follicular Lymphoma (FL) in Italy.

作者信息

Luminari Stefano, Pinto Antonio, Puccini Benedetta, D'Arpino Alessandro, Omodeo Salè Emanuela, Bellone Marco, Pradelli Lorenzo, Sabinot Alice

机构信息

Hematology, Azienda USL IRCCS of Reggio Emilia, Reggio Emilia, Italy.

CHIMOMO Department, University of Modena and Reggio Emilia, Modena, Italy.

出版信息

Clinicoecon Outcomes Res. 2025 Apr 16;17:335-348. doi: 10.2147/CEOR.S509907. eCollection 2025.

Abstract

PURPOSE

To compare the cost-effectiveness of mosunetuzumab with tisagenlecleucel for treating patients with relapsed or refractory follicular lymphoma (R/R FL 3L+) from the perspective of the Italian National Health Service (NHS).

PATIENTS AND METHODS

The analysis employs a weekly cycle partitioned survival model (PSM) with a lifetime horizon. The PSM model tracks patient outcomes based on time-to-event data, including progression-free survival (PFS) and post-progression survival (PPS). A matching-adjusted indirect treatment comparison (MAIC) approach was used to account for differences in trial population characteristics on the relative efficacy of mosunetuzumab to tisagenlecleucel. PFS and overall survival (OS) were extrapolated beyond the trial period by applying the hazard ratios from the MAIC to mosunetuzumab's parametric survival curves. Utility values and patient data are retrieved from the GO29781 trial. Economic inputs, from the perspective of the Italian NHS, include direct medical costs such as drugs, administration, monitoring, adverse event (AE) management, therapy following FL progression. Discontinuation and terminal care costs were also considered. Probabilistic sensitivity (PSA) and scenario analyses were conducted.

RESULTS

Mosunetuzumab was found to be dominant compared to tisagenlecleucel, resulting in an increase of 0.98 life years (LYs) and 0.70 quality-adjusted life years (QALYs), while also being associated with lower overall costs. The sensitivity analysis consistently favored mosunetuzumab, with 94% of simulations demonstrating its cost-effectiveness based on the Italian WTP threshold of €40,000/QALY. Even in a scenario where tisagenlecleucel maintained a PFS advantage with assumed equivalence in OS, mosunetuzumab still showed a favorable cost-saving profile due to its lower incremental costs.

CONCLUSION

In the Italian setting, mosunetuzumab is a cost-effective treatment option compared to tisagenlecleucel for adult patients with R/R 3L+ FL, presenting favourable outcomes from the perspective of the NHS. Future research and data collection efforts are crucial to validate these findings and reduce uncertainties regarding long-term clinical and economic implications.

摘要

目的

从意大利国家医疗服务体系(NHS)的角度,比较莫苏奈妥单抗与替沙格韦单抗治疗复发或难治性滤泡性淋巴瘤(R/R FL 3L+)患者的成本效益。

患者与方法

分析采用每周周期划分生存模型(PSM),生存期为终身。PSM模型根据事件发生时间数据跟踪患者结局,包括无进展生存期(PFS)和进展后生存期(PPS)。采用匹配调整间接治疗比较(MAIC)方法,以考虑试验人群特征对莫苏奈妥单抗与替沙格韦单抗相对疗效的影响。通过将MAIC得出的风险比应用于莫苏奈妥单抗的参数生存曲线,将PFS和总生存期(OS)外推至试验期之后。效用值和患者数据取自GO29781试验。从意大利NHS的角度来看,经济投入包括直接医疗成本,如药物、给药、监测、不良事件(AE)管理、滤泡性淋巴瘤进展后的治疗。还考虑了停药和终末期护理成本。进行了概率敏感性(PSA)和情景分析。

结果

发现莫苏奈妥单抗与替沙格韦单抗相比具有优势,可增加0.98个生命年(LYs)和0.70个质量调整生命年(QALYs),同时总成本也较低。敏感性分析始终支持莫苏奈妥单抗,94%的模拟显示,基于意大利40,000欧元/QALY的意愿支付阈值,其具有成本效益。即使在替沙格韦单抗在假设OS等效的情况下保持PFS优势的情景中,莫苏奈妥单抗由于其较低的增量成本,仍显示出有利的成本节约情况。

结论

在意大利的情况下,与替沙格韦单抗相比,莫苏奈妥单抗是治疗成年R/R 3L+ FL患者的一种具有成本效益的治疗选择,从NHS的角度来看具有良好的结局。未来的研究和数据收集工作对于验证这些发现以及减少关于长期临床和经济影响的不确定性至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63b2/12009579/8a17b03e0b28/CEOR-17-335-g0001.jpg

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