Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Dermatology, Venerology and Allergology, Division of Evidence based Medicine (dEBM).
Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Dermatology, Venerology and Allergology.
J Dtsch Dermatol Ges. 2017 Nov;15(11):1103-1109. doi: 10.1111/ddg.13345. Epub 2017 Oct 24.
"Off-label use" is defined as the prescription of pharmaceutical products outside their approved indications. Rare diseases frequently lack "on-label" treatment options. In order to avoid reimbursement claims following the prescription of off-label drugs, physicians in Germany can - on a case-by-case basis - file an application for cost coverage with the competent health insurance prior to treatment initiation.
We conducted a chart review for cost coverage requests submitted by two outpatient clinics at a university-affiliated dermatology department between 2010 and 2012 (clinic for autoimmune diseases and urticaria clinic). Insurance providers, acceptance rates, reasons for rejection, and processing times were analyzed.
The analysis showed that 56.8 % of applications for off-label use (n = 44) were approved during the first round. The rate increased to 75.0 % when including approvals granted after up to two rejections. The time between initial application and the response of health insurers was 49 days (median). In case of cost coverage approval, treatments were initiated 92 days (median) after the initial request.
The present case series shows that, in the majority of cases, health insurers in Germany have agreed to reimburse the costs of proposed off-label therapies. A prospective study is required in order to evaluate whether current changes to legal regulations (GKV-Versorgungsstrukturgesetz, Patientenrechtegesetz) adequately address the problems identified.
“超适应证用药”是指在药品批准的适应证之外开具处方。罕见病通常缺乏“适应证内”的治疗选择。为了避免在开具超适应证药物后提出报销申请，德国的医生可以在治疗开始前针对个别病例向负责的健康保险公司提出费用补偿申请。
我们对 2010 年至 2012 年期间（自身免疫性疾病诊所和荨麻疹诊所）在一家大学附属皮肤科的两个门诊诊所提交的费用补偿申请进行了图表回顾。分析了保险公司、接受率、拒绝原因和处理时间。
分析显示，44 份超适应证用药申请（n=44）中的 56.8%在第一轮就获得批准。如果包括最多两次拒绝后的批准，批准率增加到 75.0%。从最初申请到健康保险公司做出回应的时间为 49 天（中位数）。在获得费用补偿批准的情况下，在最初申请后 92 天（中位数）开始治疗。
本病例系列表明，在大多数情况下，德国的健康保险公司已同意报销拟议的超适应证治疗费用。需要进行前瞻性研究，以评估当前对法律规定（GKV-Versorgungsstrukturgesetz、Patientenrechtegesetz）的修改是否充分解决了所确定的问题。
