Akpo Esse I H, Jansen Irshaad R, Maes Edith, Simoens Steven
Market Access Strategy and Health EconomicsDeloitte (Belgium), Zaventem, Belgium.
Department of Pharmaceutical and Pharmacological SciencesKU Leuven, Leuven, Belgium.
Front Pharmacol. 2017 Sep 13;8:614. doi: 10.3389/fphar.2017.00614. eCollection 2017.
Lipegfilgrastim (Lonquex®) has demonstrated to be non-inferior to pegfilgrastim (Neulasta®) in reducing the duration of severe neutropenia (SN) in patients with stage II-IV breast cancer. Compared to pegfilgrastim, lipegfilgrastim also demonstrated statistically significant lower time to ANC recovery in cycles 1-3, lower incidence of SN in cycle 2 and lower depth of absolute neutrophil count (ANC) nadir in cycles 2 and 3. The aim of this study was to quantify the cost utility of lipegfilgrastim compared to pegfilgrastim in stage II-IV breast cancer patients, taking the perspective of the Belgian payer over a lifetime horizon. Two Markov models were developed to track on- and post-chemotherapy related complications, including SN, febrile neutropenia (FN), chemotherapy dose delay, chemotherapy relative dose intensity of less than 85%, infection, death rates, and quality-adjusted life years (QALYs). Data on costs (2015 value) and effects were obtained from literature, national references, and complemented by a survey of clinical experts using a modified Delphi method. Both deterministic and probabilistic sensitivity analyses were carried out. Outcomes measures included costs, QALYs and life-years (LY). At current equivalent price of €1,169, treatment with lipegfilgrastim was associated with overall costs of €9,845 vs. €10,208 for pegfilgrastim and overall QALYs of 13.977 vs. 13.925 for pegfilgrastim. Life expectancy was increased by 21 days (or 0.058 LY gained). The difference in costs stem from avoided infection, SN and FN cases in the lipegfilgrastim compared to the pegfilgrastim group. Similarly, the difference in QALYs was explained by the difference in the number of patients in the chemotherapy/G-CSF Markov state followed by infection and FN between lipegfilgrastim and pegfilgrastim. The probability of lipegfilgrastim to be cost-effective compared to pegfilgrastim was 68, 79, and 83% at the willingness-to-pay thresholds (WTP) of €10,000, €30,000 and €50,000 per QALY gained, respectively. At a WTP threshold of €30,000 per QALY gained, lipegfilgrastim was cost-effective up to €1,500 across all age bands and cancer stages, compared to the current price. Lipegfilgrastim is a cost-effective use of health care resources in patients with stage II-IV breast cancer.
聚乙二醇非格司亭(Lonquex®)已证明在降低II-IV期乳腺癌患者严重中性粒细胞减少症(SN)持续时间方面不劣于聚乙二醇化重组人粒细胞刺激因子(Neulasta®)。与聚乙二醇化重组人粒细胞刺激因子相比,聚乙二醇非格司亭在第1-3周期中还显示出至中性粒细胞绝对值计数(ANC)恢复的时间在统计学上显著更短,第2周期中SN的发生率更低,以及第2和第3周期中ANC最低点的深度更低。本研究的目的是从比利时医保支付方的终身视角出发,量化聚乙二醇非格司亭与聚乙二醇化重组人粒细胞刺激因子相比在II-IV期乳腺癌患者中的成本效益。开发了两个马尔可夫模型来跟踪化疗期间及化疗后相关并发症,包括SN、发热性中性粒细胞减少症(FN)、化疗剂量延迟、化疗相对剂量强度低于85%、感染、死亡率以及质量调整生命年(QALY)。成本(2015年价值)和效果数据来自文献、国家参考资料,并通过使用改良德尔菲法对临床专家进行的一项调查加以补充。进行了确定性和概率性敏感性分析。结果指标包括成本、QALY和生命年(LY)。按照当前1169欧元的等效价格,使用聚乙二醇非格司亭治疗的总体成本为9845欧元,而聚乙二醇化重组人粒细胞刺激因子为10208欧元;聚乙二醇非格司亭的总体QALY为13.977,而聚乙二醇化重组人粒细胞刺激因子为13.925。预期寿命增加了21天(或获得了0.058 LY)。成本差异源于与聚乙二醇化重组人粒细胞刺激因子组相比,聚乙二醇非格司亭组避免了感染、SN和FN病例。同样,QALY的差异是由聚乙二醇非格司亭和聚乙二醇化重组人粒细胞刺激因子在化疗/粒细胞集落刺激因子马尔可夫状态下随后发生感染和FN的患者数量差异所解释的。与聚乙二醇化重组人粒细胞刺激因子相比,聚乙二醇非格司亭在每获得一个QALY支付意愿阈值(WTP)分别为10000欧元、30000欧元和50000欧元时具有成本效益的概率分别为68%、79%和83%。在每获得一个QALY支付意愿阈值为30000欧元时,与当前价格相比,聚乙二醇非格司亭在所有年龄组和癌症分期中高达1500欧元时具有成本效益。聚乙二醇非格司亭在II-IV期乳腺癌患者中是一种具有成本效益的医疗资源利用方式。