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首页> 外文期刊>Der Hautarzt; Zeitschrift fuer Dermatologie, Venerologie, und verwandte Gebiete >Off-label use and G-BA: Legal framework for off-label use [Off-label-Use und G-BA: Rechtliche Rahmenbedingungen für Off-label-Use]
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Off-label use and G-BA: Legal framework for off-label use [Off-label-Use und G-BA: Rechtliche Rahmenbedingungen für Off-label-Use]

机译：标签外使用和G-BA：标签外使用的法律框架[标签外使用和G-BA：标签外使用的法律框架]

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Off-label use of medicinal products, i.e. beyond their submitted, tested and approved indications, lies between 30 and 90%-depending on the indication. In dermatology, off-label use is of special importance, for even guideline-endorsed standard therapeutic approaches for common dermatological diseases like atopic eczema, psoriasis, or malignant melanoma are to some extent not licensed for these indications. In addition, many of the approximately 5000 dermatological diseases have a low prevalence. For many such orphan diseases, there are no approved drugs, and it is not feasible that licensing studies will be performed for these indications within a foreseeable time. A reliable legal framework for the reimbursement of medicinal products that are used off-label is essential both for patients and to allow physicians to choose the most adequate therapy. Therefore, off-label use expert groups have been convened by the Federal Ministry of Health (BMG) in order to improve patient care. So far this new and innovative approach has not provided any reasonable improvement for many patients with dermatological diseases whose treatment can only be off-label since a comprehensive evaluation of all off-label indications is not possible. The following statement of the former Federal Minister of Health, U. Schmidt, is particularly true for dermatological therapy: "Good oncologic care also requires a good drug treatment-especially in the outpatient setting. The use of drugs which are not or not yet approved for this indication is often required here". Federal Minister of Health, Ulla Schmidt, 25th German Cancer Congress, 10 March 2002, Berlin.
机译：药物的标签外使用，即超出其提交，测试和批准的适应症范围，取决于适应症在30％到90％之间。在皮肤病学中，标签外使用尤为重要，因为即使是针对指南指南认可的常见皮肤病（如特应性湿疹，牛皮癣或恶性黑色素瘤）的标准治疗方法在某种程度上也未获得这些适应症的许可。此外，大约5000种皮肤病中的许多疾病患病率较低。对于许多此类孤儿疾病，没有批准的药物，并且在可预见的时间内针对这些适应症进行许可研究也不可行。对于患者而言，以及为医生选择最适当的治疗方法，必须提供可靠的法律框架，以补偿标签外使用的药品。因此，联邦卫生部（BMG）召集了标签外使用专家小组，以改善患者护理。到目前为止，对于许多皮肤病患者而言，这种新的创新方法尚未对他们的治疗提供任何合理的改善，这些患者的治疗只能在标签外进行，因为不可能对所有标签外适应症进行全面评估。前联邦卫生大臣施密特（U. Schmidt）的以下声明对皮肤科治疗尤为正确：“良好的肿瘤治疗也需要良好的药物治疗，尤其是在门诊患者中。使用尚未批准或尚未批准的药物通常在这里需要此指示”。联邦卫生部长Ulla Schmidt，第25届德国癌症大会，2002年3月10日，柏林。

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