Abstract：
Onychomycosis, a fungal nail infection, is a common dermatological condition in Japan, with a prevalence of approximately 5%-10%. Despite the introduction of new antifungal medications and updated treatment guidelines published in 2019, data on real-world prescription trends and the associated medical costs are limited. This study aimed to investigate the prescription patterns and medical costs of topical and oral antifungal medications for onychomycosis in Japan from fiscal years 2014 to 2021 using the National Database of Health Insurance Claims and Specific Health Checkups of Japan Open Data. We analyzed the annual prescription volumes and medical costs of four antifungal medications: efinaconazole, luliconazole, fosravuconazole, and terbinafine. The prescription volume of efinaconazole, a topical medication launched in 2014, rapidly increased and dominated the market share. Fosravuconazole, an oral medication introduced in 2018, showed an increasing trend, coinciding with a decline in efinaconazole prescriptions. Terbinafine, a well-established oral medication, experienced a substantial decrease in prescription volume. The sex- and age-adjusted prescription volume per 100 000 population was higher among older adults, particularly for efinaconazole. The total medical costs for onychomycosis treatment more than doubled in fiscal year 2015 compared with that for 2014, mainly driven by efinaconazole prescriptions, and exceeded 30 billion Japanese yen in fiscal years 2019-2021. The costs slightly decreased in fiscal years 2020 and 2021, possibly due to the introduction of fosravuconazole. The predominance of topical prescriptions, especially in older adults, raises concerns regarding adherence to the Japanese guidelines that recommend oral antifungals as the first-line treatment for onychomycosis. The substantial increase in medical costs also highlights the economic burden of onychomycosis and the need for cost-effective treatment strategies. This study provides valuable insights into the real-world prescription trends and medical costs of onychomycosis treatment in Japan, suggesting an opportunity to assess potential gaps between guideline recommendations and clinical practice.
摘要：
甲癣,真菌指甲感染,是日本常见的皮肤病，患病率约为5%-10%。尽管2019年推出了新的抗真菌药物和更新的治疗指南，但实际处方趋势和相关医疗费用的数据有限。本研究旨在使用日本开放数据的国家健康保险索赔和特定健康检查数据库，调查2014财年至2021财年日本甲癣局部和口服抗真菌药物的处方模式和医疗费用。我们分析了四种抗真菌药物的年度处方量和医疗费用：艾氟康唑，卢立康唑,福鲁康唑,还有特比萘芬.艾菲康唑的处方量，2014年推出的一种局部用药，迅速增加并占据市场份额。福瑞康唑,2018年推出的口服药物呈增长趋势，与艾菲康唑处方的下降相吻合。特比萘芬,一种成熟的口服药物，经历了处方量的大幅减少。在老年人中，每10万人的性别和年龄调整处方量较高，特别是艾菲康唑。与2014年相比，2015财年甲癣治疗的总医疗费用增加了一倍以上，主要是由依菲康唑处方推动的，2019-2021财年超过300亿日元。在2020财年和2021财年，成本略有下降，可能是由于引入了福沙康唑。局部处方的优势，尤其是老年人，对于遵循推荐口服抗真菌药物作为甲癣一线治疗的日本指南,人们感到担忧.医疗费用的大幅增加也凸显了甲癣的经济负担和需要具有成本效益的治疗策略。这项研究为日本甲癣治疗的现实世界处方趋势和医疗费用提供了有价值的见解，建议有机会评估指南建议和临床实践之间的潜在差距。
