Freitas Rita, van Keep Marjolijn, Kandaswamy Prashanth, Prüfert Anja, Ager Miranda, Eerdekens Marielle
Grünenthal S.A., Alameda Fernão Lopes 12 8ºA, 1495-190, Algés, Portugal.
RJW & Partners, The Old Sawmills, Filleigh, EX32 0RN, UK.
Pain Ther. 2025 Aug 31. doi: 10.1007/s40122-025-00769-9.
INTRODUCTION: Peripheral neuropathic pain (PNP) is a chronic condition often inadequately controlled by oral pharmacologic treatments. High-concentration capsaicin patch (HCCP) is a topical neurolytic treatment for PNP. This study assessed the cost-effectiveness of HCCP as an add-on to standard of care (SoC) in patients with PNP in Scotland. METHODS: A cost-utility analysis was conducted using a Markov model with 3-month cycles and a lifetime horizon to determine the cost-effectiveness of HCCP added-on to SoC compared to SoC alone, in adult patients with PNP. The model included five health states (no pain, mild, moderate, severe pain, and death) and was developed according to Scottish Medicines Consortium (SMC) guidance from a National Health Service (NHS) Scotland perspective. Clinical inputs were derived from HCCP trials (e.g., PACE), and health-related quality of life was based on EQ-5D values from HCCP trials. Analyses were conducted for an adult PNP population, and diabetic and non-diabetic etiologies. Costs included drug acquisition, administration, drug and disease monitoring, adverse events, and-in a scenario analysis-societal costs. RESULTS: For the adult PNP population, HCCP + SoC resulted in an incremental gain of 1.00 quality-adjusted life-years (QALYs) at an additional cost of £13,479, yielding an incremental cost-effectiveness ratio (ICER) of £13,516 per QALY. ICERs for specific etiologies were £11,383 for non-diabetic and £16,442 for diabetic PNP populations. Deterministic and probabilistic sensitivity analyses (PSA) confirmed robustness of the model, with 89% of PSA iterations falling below a £20,000/QALY threshold. Scenario analysis using a societal perspective further improved cost-effectiveness (ICER: £7475). CONCLUSIONS: HCCP is a cost-effective add-on therapy for the treatment of adults with PNP in Scotland, with consistent findings across diabetic and non-diabetic populations. These results support the benefits of integrating HCCP in healthcare systems and clinical practice, both in terms of patient outcomes and economic benefits for the system.
引言：外周神经性疼痛（PNP）是一种慢性疾病，口服药物治疗往往难以有效控制。高浓度辣椒素贴剂（HCCP）是一种用于治疗PNP的局部神经溶解疗法。本研究评估了在苏格兰，HCCP作为成人PNP患者标准治疗（SoC）的附加治疗的成本效益。 方法：采用马尔可夫模型进行成本效用分析，周期为3个月，时间跨度为终身，以确定与单独使用SoC相比，HCCP附加于SoC在成人PNP患者中的成本效益。该模型包括五种健康状态（无疼痛、轻度、中度、重度疼痛和死亡），并根据苏格兰药品联盟（SMC）的指导，从苏格兰国民保健服务（NHS）的角度开发。临床数据来自HCCP试验（如PACE），健康相关生活质量基于HCCP试验中的EQ-5D值。对成人PNP人群以及糖尿病和非糖尿病病因进行了分析。成本包括药物采购、给药、药物和疾病监测、不良事件，以及在情景分析中的社会成本。 结果：对于成人PNP人群，HCCP + SoC导致质量调整生命年（QALY）增加1.00，额外成本为13479英镑，每QALY的增量成本效益比（ICER）为13516英镑。特定病因的ICER，非糖尿病PNP人群为11383英镑，糖尿病PNP人群为16442英镑。确定性和概率敏感性分析（PSA）证实了模型的稳健性，89%的PSA迭代低于20000英镑/QALY的阈值。从社会角度进行的情景分析进一步提高了成本效益（ICER：7475英镑）。 结论：在苏格兰，HCCP是治疗成人PNP的一种具有成本效益的附加疗法，在糖尿病和非糖尿病人群中结果一致。这些结果支持将HCCP纳入医疗保健系统和临床实践的益处，无论是在患者结局还是系统的经济效益方面。
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