不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel:ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题: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.
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.
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在意大利背景下,对于成人 R/R 3L+ FL 患者,与 tisagenlecleucel 相比,mosunetuzumab 是一种具有成本效益的治疗选择,从 NHS 角度呈现出有利的结果。未来的研究和数据收集工作对于验证这些发现并减少长期临床和经济影响方面的不确定性至关重要。
从意大利国家卫生服务(NHS)的角度,比较mosunetuzumab与tisagenlecleucel用于治疗复发/难治性滤泡性淋巴瘤(R/R FL 3L+)患者的成本效果。
该分析采用周循环分区生存模型(PSM),时间跨度为终生。PSM模型基于时间-事件数据追踪患者结局,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)方法来校正试验人群特征差异对mosunetuzumab相对于tisagenlecleucel相对疗效的影响。通过将MAIC得出的风险比应用于mosunetuzumab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角度出发的经济学输入包括直接医疗成本,如药物、给药、监测、不良事件(AE)管理、FL进展后的治疗。还考虑了停药成本和终末期照护成本。进行了概率敏感性分析(PSA)和情景分析。
与tisagenlecleucel相比,mosunetuzumab具有优势,使生命年(LYs)增加0.98年,质量调整生命年(QALYs)增加0.70年,同时总体费用更低。敏感性分析一致倾向于mosunetuzumab,基于意大利€40,000/QALY的WTP阈值,94%的模拟显示其具有成本效果。即使在tisagenlecleucel保持PFS优势且假设OS等效的情景下,mosunetuzumab仍因其较低的增量成本而显示出有利的成本节约特征。
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).
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.
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.
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.
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