Department of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria.
Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.
Bipolar Disord. 2018 Dec;20(8):733-745. doi: 10.1111/bdi.12713. Epub 2018 Dec 17.
Although not licensed for acute bipolar depression, lamotrigine has evidence for efficacy in trials and its use is recommended in guidelines. So far there had been no prospective health economic evaluation of its use.
Cost-utility analysis of the CEQUEL trial comparing quetiapine plus lamotrigine vs quetiapine monotherapy (and folic acid vs placebo in an add-on factorial design) for patients with bipolar depression (n = 201) from the health and social care perspective. Differences in costs together with quality-adjusted life years (QALYs) between the groups were assessed over 52 weeks using a regression-based approach.
Health-related quality of life improved substantially for all randomization groups during follow-up with no significant difference in QALYs between any of the comparisons (mean adjusted QALY difference: lamotrigine vs placebo -0.001 (95% CI: -0.05 to 0.05), folic acid vs placebo 0.002 (95% CI: -0.05 to 0.05)). While medication costs in the lamotrigine group were higher than in the placebo group (£647, P < 0.001), mental health community/outpatient costs were significantly lower (-£670, P < 0.001). Mean total costs were similar in the groups (-£180, P = 0.913).
Lamotrigine improved clinical ratings in bipolar depression compared with placebo. This differential effect was not detected using the EQ-5D-3L. The additional cost of lamotrigine was balanced by significant savings in some other medical costs which made its use cost neutral to the health service. Compared to placebo, folic acid produced neither clinical nor significant health economic benefits. The study supports the use of lamotrigine in combination with other drugs to treat bipolar depression.
尽管拉莫三嗪未获得治疗急性双相抑郁的适应证，但多项试验证实其具有疗效，因此指南推荐该药用于治疗双相抑郁。但迄今为止，尚未有前瞻性卫生经济学评价其应用价值。
采用成本效用分析方法，对 CEQUEL 试验进行分析，该试验比较了喹硫平联合拉莫三嗪与喹硫平单药治疗（附加因子设计中添加叶酸或安慰剂）双相抑郁患者（n=201）的疗效，从卫生保健和社会护理角度评估 52 周时两组的成本和质量调整生命年（QALY）。采用回归方法评估组间成本和 QALY 差异。
所有随机分组患者的健康相关生活质量在随访期间均显著改善，任何比较组之间的 QALY 均无显著差异（拉莫三嗪与安慰剂校正 QALY 差异：0.001（95%CI：-0.05 至 0.05），叶酸与安慰剂 0.002（95%CI：-0.05 至 0.05））。拉莫三嗪组的药物治疗费用高于安慰剂组（£647，P<0.001），但精神卫生社区/门诊费用明显较低（-£670，P<0.001）。两组的平均总费用相似（-£180，P=0.913）。
与安慰剂相比，拉莫三嗪可改善双相抑郁患者的临床评分。使用 EQ-5D-3L 无法检测到这种差异效应。拉莫三嗪的额外成本与其他一些医疗成本的显著节省相平衡，使该药的使用对卫生服务而言无成本差异。与安慰剂相比，叶酸既没有带来临床获益，也没有带来显著的健康经济效益。该研究支持拉莫三嗪与其他药物联合用于治疗双相抑郁。
