Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Japan Access & Value, Pfizer Japan Inc., Tokyo, Japan.
J Dermatol. 2024 Jun;51(6):759-771. doi: 10.1111/1346-8138.17234. Epub 2024 Apr 22.
Atopic dermatitis (AD) is a chronic inflammatory skin disease with a significant clinical, economic, and human burden. The JAK1 Atopic Dermatitis Efficacy and Safety (JADE) program's Phase 3 trials demonstrated that as a treatment for moderate-to-severe AD in adults with previous exposure to immunotherapy, abrocitinib showed superior efficacy and safety compared with standard of care (SoC), consisting of topical corticosteroids. This study assessed the cost-effectiveness of abrocitinib with SoC versus SoC alone for this patient population in Japan from a societal perspective. A hybrid decision tree and Markov model were used to capture the initial treatment and long-term maintenance phases. Clinical inputs at 16 weeks were obtained through a Bayesian network meta-analysis of four pivotal trials from the JADE program. Clinical inputs at 52 weeks were derived from the JADE EXTEND trial. Response-specific utility inputs were obtained from published literature. Resource use, costs, and productivity inputs were gathered from Japanese claims analysis, literature, public documents, and expert opinion. Costs and quality-adjusted life years (QALYs) were discounted at 2.0% per year and incremental cost-effectiveness ratios (ICERs) were calculated. Sensitivity and scenario analyses were performed to validate the base case results and explore a payer perspective. Over a lifetime horizon and with the base-case societal perspective, abrocitinib produced a mean gain of 0.75 QALYs, incremental costs of JPY (¥) 2 270 386 (USD [$] 17 265.6), and a resulting ICER of ¥3 034 514 ($23 076.5) per QALY compared with SoC. From a payer perspective, the incremental costs increased to ¥4 476 777 ($34 044.4), with an ICER of ¥5 983 495 ($45 502.6) per QALY. The results were most sensitive to treatment-specific, response-based utility weights, drug costs, and productivity-related inputs. From a Japanese societal perspective, abrocitinib demonstrated superior QALYs and with a willingness-to-pay threshold of ¥5 000 000 ($38 023.4) per QALY, can be considered cost-effective compared with SoC as a treatment for moderate-to-severe AD in adult patients with previous immunosuppressant exposure.
特应性皮炎(AD)是一种慢性炎症性皮肤病,具有显著的临床、经济和人类负担。JAK1 特应性皮炎疗效和安全性(JADE)计划的 3 期试验表明,作为一种治疗成人中重度 AD 的药物,与包括局部皮质类固醇在内的标准治疗(SoC)相比,阿布昔替尼具有更好的疗效和安全性。本研究从社会角度评估了阿布昔替尼联合 SoC 与单独 SoC 治疗日本患者的成本效益。使用混合决策树和 Markov 模型来捕捉初始治疗和长期维持阶段。16 周的临床数据通过来自 JADE 计划的四项关键试验的贝叶斯网络荟萃分析获得。52 周的临床数据来自 JADE EXTEND 试验。基于反应的效用数据来自已发表的文献。资源使用、成本和生产力数据来自日本索赔分析、文献、公共文件和专家意见。成本和质量调整生命年(QALY)以每年 2.0%贴现,增量成本效益比(ICER)计算。进行敏感性和情景分析以验证基础案例结果并探讨支付者视角。在终身范围内,基于社会视角,阿布昔替尼产生了 0.75 个 QALY 的平均收益,JPY(日元)2270386 日元(美元)17265.6 美元)的增量成本,以及与 SoC 相比,每 QALY 的 ICER 为 3034514 日元(美元)23076.5 美元)。从支付者的角度来看,增量成本增加到 4476777 日元(美元)34044.4 美元),每 QALY 的 ICER 为 5983495 日元(美元)45502.6 美元)。结果对治疗特异性、基于反应的效用权重、药物成本和生产力相关投入最为敏感。从日本社会的角度来看,阿布昔替尼具有更高的 QALY,并且在支付意愿阈值为 5000000 日元(美元)38023.4 美元)/QALY 的情况下,与 SoC 相比,作为治疗成人中重度 AD 的药物,在既往免疫抑制剂治疗的患者中具有成本效益。