van Oostrum I, Russell-Smith T A, Jakobsson M, Torup Østby J, Heeg B
Ingress-Health, Weena 316-318, 3012 NJ, Rotterdam, The Netherlands.
Pfizer Inc, New York, USA.
Pharmacoecon Open. 2022 Jan;6(1):47-62. doi: 10.1007/s41669-021-00287-2. Epub 2021 Jul 26.
The aim was to estimate the cost-effectiveness of inotuzumab ozogamicin (InO) versus standard of care chemotherapy (SoC) for adults with relapsed or refractory B cell acute lymphoblastic leukaemia (R/R ALL) in Sweden and Norway, and compare this to evaluations made by the health technology assessment (HTA) authorities Tandvårds- och läkemedelsförmånsverket (TLV) and the Norwegian Medicines Agency (NoMA).
A partitioned survival model was developed to determine incremental cost-effectiveness ratios (ICERs) for InO versus SoC. Parametric survival models were fit to overall survival and progression-free survival Kaplan-Meier data from the INO-VATE ALL phase III trial. Two base cases were run using (1) Swedish and (2) Norwegian inputs (costs and discount rates). Core clinical inputs and utilities did not differ between countries. Analyses were then conducted to reflect the preferred assumptions of TLV and NoMA. Univariate and multivariate sensitivity analyses were performed.
The base case deterministic ICERs for InO versus SoC were €16,219/quality-adjusted life years (QALY) in Sweden (probabilistic €19,415) and €44,405/QALY in Norway (probabilistic €47,305). The ICERs using our model but applying the preferred assumptions of TLV or NoMA were €74,061/QALY (probabilistic €77,484) and €59,391/QALY (probabilistic €63,632), respectively. Differences between our base cases and the ICERs with TLV and NoMA settings were mainly explained by the exclusion of productivity costs and use of pooled post-haematopoietic stem-cell transplant (post-HSCT) survival in Sweden and use of higher HSCT costs in Norway. All ICERs remained below the approximated willingness-to-pay thresholds. The probability of InO being cost-effective ranged from 77 to 99% versus SoC.
InO can likely be considered cost-effective versus SoC under our and the HTA-preferred settings.
旨在评估在瑞典和挪威,对于复发或难治性B细胞急性淋巴细胞白血病(R/R ALL)成人患者,与标准护理化疗(SoC)相比,奥英妥珠单抗(InO)的成本效益,并将其与卫生技术评估(HTA)机构瑞典药品福利管理局(TLV)和挪威药品管理局(NoMA)所做的评估进行比较。
建立一个分区生存模型,以确定InO与SoC相比的增量成本效益比(ICER)。参数生存模型适用于INO-VATE ALL III期试验的总生存和无进展生存的Kaplan-Meier数据。使用(1)瑞典和(2)挪威的输入数据(成本和贴现率)进行了两个基础案例分析。各国的核心临床输入数据和效用数据没有差异。然后进行分析以反映TLV和NoMA的首选假设。进行了单因素和多因素敏感性分析。
InO与SoC相比,基础案例确定性ICER在瑞典为16,219欧元/质量调整生命年(QALY)(概率性为19,415欧元),在挪威为44,405欧元/QALY(概率性为47,305欧元)。使用我们的模型但应用TLV或NoMA的首选假设的ICER分别为74,061欧元/QALY(概率性为77,484欧元)和59,391欧元/QALY(概率性为63,632欧元)。我们的基础案例与TLV和NoMA设定下的ICER之间的差异主要是由于在瑞典排除了生产力成本并使用了造血干细胞移植(HSCT)后合并生存数据,以及在挪威使用了更高的HSCT成本。所有ICER均低于近似的支付意愿阈值。与SoC相比,InO具有成本效益的概率范围为77%至99%。
在我们以及HTA首选的设定下,与SoC相比,InO可能被认为具有成本效益。