Dr Baker & Partners, Morriston, Great Britain.
Clin Drug Investig. 2010;30(2):71-87. doi: 10.2165/11533310-000000000-00000.
Published analyses have demonstrated that the lidocaine (lignocaine) plaster is a cost-effective treatment for postherpetic neuralgia (PHN) relative to gabapentin or pregabalin. However, these analyses have been based on indirect comparisons from placebo-controlled trials, and there is evidence of a discrepancy between the outcomes of direct and indirect analyses. Fortunately, recent publication of the results of a head-to-head trial comparing the lidocaine plaster and pregabalin in patients with PHN or diabetic polyneuropathy allows customization of the existing model to more accurately reflect the relative cost effectiveness of these two products.
To assess the cost-effectiveness of the lidocaine 5% medicated plaster compared with pregabalin for the treatment of PHN in the UK primary-care setting.
A Markov model has been developed to assess the costs and benefits of the lidocaine plaster and pregabalin over a 6-month time horizon for the treatment of patients with PHN who are intolerant to tricyclic antidepressants and in whom analgesics are ineffective or contraindicated. The model structure allows for differences in costs, utilities (derived from published data and from the head-to-head trial) and transition probabilities between the initial 30-day run-in period and maintenance therapy, and also takes account of add-in medication and drugs received by patients discontinuing therapy. The calculation was based on data from the recent head-to-head trial described above. Additional data sources included published literature, discussions with a Delphi panel, official price/tariff lists and national population statistics. The study was conducted from the perspective of the UK National Health Service (NHS).
The base-case analysis (1.71 lidocaine plasters per day used in the head-to-head trial for the PHN population) indicated that the total cost of treating PHN patients for 6 months with the lidocaine plaster was pound 980 per patient treated, compared with pound 784 for pregabalin (year of costing 2009). Costs for 1 month without pain and intolerable adverse events (AEs) (modified TWIST analysis) were pound 126 for the lidocaine plaster relative to pregabalin. The average patient treated with the lidocaine plaster experienced 0.321 quality-adjusted life-years (QALYs) over the 6-month period modelled compared with 0.254 QALYs for pregabalin. Quality-of-life benefits were attributed to the favourable AE profile of the lidocaine plaster. Subsequently, the lidocaine plaster cost pound 2925 per QALY gained relative to pregabalin. However, patient level longitudinal data have shown that the actual clinical usage of the lidocaine plaster is 1.1 plasters per day. If this more realistic assumption is used in the model, the total cost for a 6-month treatment period was pound 756 for the lidocaine plaster, which dominated treatment with pregabalin. Scenario analyses and sensitivity analyses had minimal impact on the results, confirming the robustness of the study. The incremental cost-effectiveness ratios for the lidocaine plaster remained well below pound 35,000 per QALY gained in all analyses.
This analysis showed that the lidocaine 5% medicated plaster is a cost-effective method for obtaining sustained relief of localized neuropathic pain associated with PHN compared with pregabalin in a UK setting, in terms of both the cost per QALY gained and the cost per additional month without symptoms, when used for patients who do not experience sufficient pain relief from standard analgesics.
已发表的分析表明，与加巴喷丁或普瑞巴林相比，利多卡因（利诺卡因）贴剂治疗疱疹后神经痛（PHN）具有成本效益。然而，这些分析是基于安慰剂对照试验的间接比较，并且直接和间接分析的结果之间存在差异的证据。幸运的是，最近发表了一项头对头试验的结果，该试验比较了利多卡因贴剂和普瑞巴林在 PHN 或糖尿病性多发性神经病患者中的疗效，这使得可以定制现有模型，以更准确地反映这两种产品的相对成本效益。
评估利多卡因 5%贴剂与普瑞巴林在英国初级保健环境中治疗 PHN 的成本效益。
开发了一个 Markov 模型，以评估在 6 个月的时间内，对于不能耐受三环类抗抑郁药且镇痛药无效或禁忌的 PHN 患者，使用利多卡因贴剂和普瑞巴林治疗的成本和效益。该模型结构允许在初始 30 天的运行期和维持治疗之间的成本、效用（源自已发表的数据和头对头试验）和转移概率存在差异，并且还考虑了加用药物和因治疗中断而接受的药物。计算基于上述最近的头对头试验的数据。其他数据源包括已发表的文献、与德尔斐小组的讨论、官方价格/关税清单和国家人口统计数据。该研究从英国国家卫生服务局（NHS）的角度进行。
基础案例分析（头对头试验中用于 PHN 人群的利多卡因贴剂每天使用 1.71 片）表明，使用利多卡因贴剂治疗 PHN 患者 6 个月的总成本为每位治疗患者 980 英镑，而普瑞巴林为 784 英镑（2009 年的成本年）。无疼痛和无法耐受的不良事件（AE）的 1 个月成本（改良 TWIST 分析）相对于普瑞巴林，利多卡因贴剂为 126 英镑。与普瑞巴林相比，模型中接受利多卡因贴剂治疗的患者在 6 个月的治疗期间平均经历 0.321 个质量调整生命年（QALY）。生活质量获益归因于利多卡因贴剂有利的 AE 特征。随后，利多卡因贴剂的成本效益比为每获得 1 个 QALY 花费 2925 英镑，而普瑞巴林为 254 英镑。然而，患者水平的纵向数据表明，利多卡因贴剂的实际临床使用率为每天 1.1 贴。如果在模型中使用更现实的假设，6 个月治疗期的总成本为利多卡因贴剂 756 英镑，这比普瑞巴林治疗具有优势。情景分析和敏感性分析对结果的影响很小，证实了研究的稳健性。在所有分析中，利多卡因贴剂的增量成本效益比均保持在每获得 1 个 QALY 低于 35000 英镑以下。
本分析表明，与普瑞巴林相比，在英国环境中，对于不能从标准镇痛药中获得足够疼痛缓解的患者，利多卡因 5%贴剂是一种具有成本效益的方法，可获得与 PHN 相关的局部神经性疼痛的持续缓解，无论是从获得的每个 QALY 的成本还是从没有症状的每个额外月的成本来看，当用于不能从标准镇痛药中获得足够疼痛缓解的患者时。
