Bektur Carina, Nurgozhin Talgat
Center for Life Sciences, Nazarbayev University, Astana, Kazakhstan.
Cent Asian J Glob Health. 2014 Dec 12;3(Suppl):154. doi: 10.5195/cajgh.2014.154. eCollection 2014.
Bone mass loss (BML) is one of the adverse effects of oncological chemotherapy, especially in cases of hormonal types of cancer, such as a prostate cancer (PC). BML is strongly associated with skeletal-related events (SREs), therefore decreasing the quality of patient's life. Denosumab shows an advantage over zoledronic acid (ZA) in delaying the first onset of SREs and subsequent SREs in adults with PC in several phase III clinical trials. Since generic ZA recently became available, the purpose of the present study was to assess the cost-effectiveness of denosumab vs. brand or generic ZA in the prevention of SREs in Kazakhstani patients with PC.
A Markov model was constructed in Tree-Age Pro 2013 software program with 4-week model cycles to analyze the cost-effectiveness of the treatments from the perspective of Ministry of Health (MoH) over a 10-year PC cohort. Direct costs (in Kazakhstani monetary units "tenge" in 2014) included costs of drug, SRE (pathologic fracture, surgery to bone, radiation to bone, spinal cord compression), and adverse events treatment. All costs were discounted for 3% per year. Effectiveness was appraised based on the number of SREs. Health states were defined according to SRE occurrence, SRE history, and death. The model assumed that a maximum of 1 SRE could occur in each cycle. Transition probabilities were derived from the relevant phase III trials. Results were present in the incremental total cost per SRE avoided. One-way sensitivity analyses were performed to examine the robustness of the model.
Over the 10-year period, denosumab incurred 103,091 tenge higher costs than brand ZA, 677,133 tenge higher costs than generic ZA, and 0.58 fewer SREs per patient with PC. The estimated incremental total direct costs per SRE avoided with the use of denosumab were 177,743 tenge (instead of brand ZA) and 1,167,470 tenge (instead of generic ZA). Results were robust to one-way sensitivity analyses.
With the assumption that brand and generic ZAs are equally effective in the prevention of SREs in PC patients, denosumab seems to be a cost-effective alternative for brand ZA (insignificant difference in costs - less than 5%) and a costly alternative for generic ZA from the perspective of MoH of Kazakhstan.
骨量丢失(BML)是肿瘤化疗的不良反应之一,尤其是在激素类型癌症的病例中,如前列腺癌(PC)。BML与骨相关事件(SREs)密切相关,因此会降低患者的生活质量。在多项III期临床试验中,地诺单抗在延迟PC成年患者首次发生SREs及后续SREs方面显示出优于唑来膦酸(ZA)的优势。由于通用型ZA最近已上市,本研究的目的是评估地诺单抗与品牌或通用型ZA在哈萨克斯坦PC患者预防SREs方面的成本效益。
在Tree-Age Pro 2013软件程序中构建了一个马尔可夫模型,模型周期为4周,从哈萨克斯坦卫生部(MoH)的角度分析10年PC队列中各治疗方法的成本效益。直接成本(以2014年哈萨克斯坦货币“坚戈”为单位)包括药物成本、SRE(病理性骨折、骨手术、骨放疗、脊髓压迫)以及不良事件治疗成本。所有成本均按每年3%进行贴现。根据SREs的数量评估有效性。根据SRE的发生情况、SRE病史和死亡情况定义健康状态。该模型假设每个周期最多发生1次SRE。转移概率来自相关的III期试验。结果以避免每例SRE的增量总成本表示。进行单向敏感性分析以检验模型的稳健性。
在10年期间,地诺单抗的成本比品牌ZA高103,091坚戈,比通用型ZA高677,133坚戈,每例PC患者的SREs减少0.58例。使用地诺单抗避免每例SRE的估计增量总直接成本分别为177,743坚戈(相对于品牌ZA)和1,167,470坚戈(相对于通用型ZA)。结果对单向敏感性分析具有稳健性。
假设品牌和通用型ZA在预防PC患者SREs方面同样有效,从哈萨克斯坦卫生部的角度来看,地诺单抗似乎是品牌ZA具有成本效益的替代方案(成本差异不显著——小于5%),而对于通用型ZA则是成本较高的替代方案。