Centre for Health Economics and Medicines Evaluation, Bangor University, Wales.
Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Rheumatology (Oxford). 2017 Oct 1;56(10):1729-1739. doi: 10.1093/rheumatology/kex253.
To determine whether prospective testing for HLA-B*58:01, as a strategy to prevent serious adverse reactions to allopurinol in patients with gout, is cost-effective from the perspective of the National Health Service in the UK.
A systematic review and meta-analysis for the association of HLA-B*58:01 with cutaneous and hypersensitivity adverse drug reactions informed a decision analytic and Markov model to estimate lifetime costs and outcomes associated with testing vs standard care (with febuxostat prescribed for patients who test positive). Scenario analyses assessed alternative treatment assumptions and patient populations.
The number of patients needed to test to prevent one case of adverse drug reaction was 11 286 (95% central range (CR): 2573, 53 594). Cost and quality-adjusted life-year (QALY) gains were small, £103 (95% CR: £98, £106) and 0.0023 (95% CR: -0.0006, 0.0055), respectively, resulting in an incremental cost-effectiveness ratio (ICER) of £44 954 per QALY gained. The probability of testing being cost-effective at a threshold of £30 000 per QALY was 0.25. Reduced costs of testing or febuxostat resulted in an ICER below £30 000 per QALY gained. The ICER for patients with chronic renal insufficiency was £38 478 per QALY gained.
Routine testing for HLA-B*58:01 in order to reduce the incidence of adverse drug reactions in patients being prescribed allopurinol for gout is unlikely to be cost-effective in the UK; however testing is expected to become cost-effective with reductions in the cost of genotyping, and with the future availability of cheaper, generic febuxostat.
从英国国家医疗服务体系的角度出发，确定 HLA-B*58:01 前瞻性检测是否可作为预防痛风患者使用别嘌醇时发生严重不良反应的一种策略。
对 HLA-B*58:01 与皮肤和过敏药物不良反应之间的关联进行系统回顾和荟萃分析，为决策分析和马尔可夫模型提供信息，以估计与检测相比，标准护理（对检测呈阳性的患者开具非布司他）相关的终生成本和结果。情景分析评估了替代治疗假设和患者人群。
需要检测的患者人数为 11286 人，以预防一例药物不良反应（95%置信区间（CR）范围为 2573 人至 53594 人）。成本和质量调整生命年（QALY）收益较小，分别为 103 英镑（95%CR：98 英镑，106 英镑）和 0.0023（95%CR：-0.0006，0.0055），导致增量成本效益比（ICER）为每获得一个 QALY 增加 44954 英镑。在 30000 英镑/QALY 的阈值下，检测具有成本效益的概率为 0.25。检测或非布司他成本降低会使 ICER 低于每获得一个 QALY 增加 30000 英镑的水平。慢性肾功能不全患者的 ICER 为每获得一个 QALY 增加 38478 英镑。
为了降低痛风患者使用别嘌醇时不良反应的发生率，常规检测 HLA-B*58:01 在英国不太可能具有成本效益；然而，随着基因分型成本的降低，以及未来更便宜、通用的非布司他的出现，检测有望变得具有成本效益。
