Department of Cardiovascular Epidemiology and Research, The Danish Heart Foundation, Copenhagen, Denmark.
Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark.
JAMA Cardiol. 2019 Feb 1;4(2):128-135. doi: 10.1001/jamacardio.2018.4566.
In the Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) trial, the anti-inflammatory monoclonal antibody canakinumab significantly reduced the risk of recurrent cardiovascular events in patients with previous myocardial infarction (MI) and high-sensitivity C-reactive protein (hs-CRP) levels of 2 mg/L or greater.
To estimate the cost-effectiveness of adding canakinumab to standard of care for the secondary prevention of major cardiovascular events over a range of potential prices.
DESIGN, SETTING, AND PARTICIPANTS: A state-transition Markov model was constructed to estimate costs and outcomes over a lifetime horizon by projecting rates of recurrent MI, coronary revascularization, infection, and lung cancer with and without canakinumab treatment. We used a US health care sector perspective, and the base case used the current US market price of canakinumab of $73 000 per year. A hypothetical cohort of patients after MI aged 61 years with an hs-CRP level of 2 mg/L or greater was constructed.
Canakinumab, 150 mg, administered every 3 months plus standard of care compared with standard of care alone.
Lifetime costs and quality-adjusted life-years (QALYs), discounted at 3% annually.
Adding canakinumab to standard of care increased life expectancy from 11.31 to 11.36 years, QALYs from 9.37 to 9.50, and costs from $242 000 to $1 074 000, yielding an incremental cost-effectiveness ratio of $6.4 million per QALY gained. The price would have to be reduced by more than 98% (to $1150 per year or less) to meet the $100 000 per QALY willingness-to-pay threshold. These results were generally robust across alternative assumptions, eg, substantially lower health-related quality of life after recurrent cardiovascular events, lower infection rates while receiving canakinumab, and reduced all-cause mortality while receiving canakinumab. Including a potential beneficial effect of canakinumab on lung cancer incidence improved the incremental cost-effectiveness ratio to $3.5 million per QALY gained. A strategy of continuing canakinumab selectively in patients with reduction in hs-CRP levels to less than 2 mg/L would have a cost-effectiveness ratio of $819 000 per QALY gained.
Canakinumab is not cost-effective at current US prices for prevention of recurrent cardiovascular events in patients with a prior MI. Substantial price reductions would be needed for canakinumab to be considered cost-effective.
在 Canakinumab 抗炎性血栓结局研究（CANTOS）试验中，抗炎性单克隆抗体卡那单抗可显著降低 hs-CRP 水平为 2mg/L 或更高且有过心肌梗死（MI）病史的患者发生心血管不良事件复发的风险。
为了评估在一系列潜在价格下，将卡那单抗添加到标准护理中用于二级预防主要心血管事件的成本效益。
设计、环境和参与者：构建了一个状态转移马尔可夫模型，通过预测伴有和不伴有卡那单抗治疗的 MI 复发、冠状动脉血运重建、感染和肺癌的复发率，来估算终生的成本和结果。我们采用了美国医疗保健部门的视角，基础情况使用了卡那单抗目前在美国市场的价格 73000 美元/年。构建了一个 hs-CRP 水平为 2mg/L 或更高且年龄为 61 岁的 MI 后患者的假设队列。
卡那单抗，150mg，每 3 个月给药一次，联合标准护理，与单独标准护理相比。
终生成本和质量调整生命年（QALYs），贴现率为每年 3%。
与单独的标准护理相比，将卡那单抗添加到标准护理中可使预期寿命从 11.31 年增加到 11.36 年，QALYs 从 9.37 年增加到 9.50 年，成本从 242000 美元增加到 1074000 美元，增量成本效益比为每获得一个质量调整生命年需花费 640 万美元。价格必须降低 98%以上（每年 1150 美元或更低），才能达到 10 万美元/QALY 的意愿支付阈值。在替代假设下，这些结果通常具有稳健性，例如，心血管不良事件复发后的健康相关生活质量大幅下降、接受卡那单抗治疗时感染率降低以及接受卡那单抗治疗时全因死亡率降低。纳入卡那单抗对肺癌发病率的潜在有益影响可将增量成本效益比提高到每获得一个质量调整生命年需花费 350 万美元。在 hs-CRP 水平降低至 2mg/L 以下的患者中继续使用卡那单抗的策略，其增量成本效益比为每获得一个质量调整生命年需花费 81.9 万美元。
对于有既往 MI 的患者，卡那单抗预防心血管不良事件复发的成本效益在当前的美国价格下并不理想。需要大幅降低卡那单抗的价格，才能使其具有成本效益。
