Article
The assessment guide “Drug therapy: Notes on off-label use”: an update by the Medizinischen Dienst (Medical Service)
Der Begutachtungsleitfaden „Arzneimittelversorgung: Hinweise zum Off-Label-Use“ des Medizinischen Dienstes: ein Update
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Authors
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Thomas Grimmsmann
- Medizinischer Dienst Mecklenburg-Vorpommern, Schwerin, Germany
| Published: | November 13, 2024 |
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Outline
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Background: In general, the German statutory health insurance (SHI) covers the costs of medicines only if the medicines are prescribed according to the marketing authorisation (“in-label use”). However, it can be necessary to prescribe medicines for an unapproved indication or in an unapproved age group, dosage, or route of administration (“off-label use”). According to decisions of the Federal Social Court, the costs for an off-label use must be covered by the SHI under certain conditions. To assess whether these conditions are fulfilled, is one of the most common tasks of the Medical Service in the area of drug therapy.
Materials and Methods: Important principles of the assessment guide, created by the Sociomedical Expert Group for Drug Therapy (Sozialmedizinische Expertengruppe “Arzneimittelversorgung”), supplemented by comments of several medical associations in Germany, will be presented at the conference, with a special focus on its most recent update.
Results: The sociomedical assessment of an off-label use is essentially based on the criteria defined by the case law of the Federal Social Court (including Az.: B 1 KR 37/00 R of 19.03.2002, B 1 KR 1/06 R of 26.09.2006). Accordingly, the costs of an off-label use are only covered by the SHI if (i) a serious illness is present, (ii) no other therapy is available and if (iii) there is a reasonable prospect, based on the data available, that treatment success can be achieved with the preparation in question. This means a data situation ready for authorisation is required.
In case of an acute life-threatening or regularly fatal illness for which no other therapy is available, § 2 Abs 1a Social Code Book (SGB) V is applied. Then it is sufficient that the data available suggest at least a noticeably positive effect on the course of the disease, based on circumstantial evidence.
Conclusion: With the revised assessment guide, a document is available that is initially aimed at medical service assessors and is intended to lead to a standardized assessment. The document is available online so that the principles of the assessment are transparent for doctors working in the community or in hospitals. To simplify the application process, doctors will be guided in the future by a structured questionnaire to precisely present the relevant aspects of the off-label; a summary for patients to make decisions transparent for laypersons, too, is also in preparation.
