Off-label use

Off-label use refers to the prescription of a finished drug outside the use approved by the drug authorities. The use may deviate from the marketing authorisation in the area of application or the type of application. In German, this is referred to as off-label use.

Marketing authorisation applications for new medicinal products are often very narrowly defined for various reasons. In addition, applications from pharmaceutical companies for marketing authorisation extensions to the drug authorities are rare. The reason for this is often the high cost of the required clinical studies. Legislators in Germany and Europe are currently trying to counteract this development - e.g. through simplified approval regulations or economic incentives such as an extended protection period for approvals for children (benefits for approvals for children).

Application areas

In many medical fields, a large proportion of drugs are used off-label, especially in paediatrics and oncology. An example from gynaecology is the induction of labour with misoprostol, which is only approved under drug law for the treatment of gastric and duodenal ulcers. For many rare diseases there are no approved drugs available.

Reimbursement by health insurance companies

The reimbursability of off-label prescribed drugs by the statutory health insurers (SHI) has repeatedly been the subject of legal disputes. In a landmark decision of the Federal Social Court (BSG) of 19 March 2002 (B 1 KR 37/00 R), the criteria for reimbursement of drugs outside the approved indication (off-label use) by the statutory health insurers were therefore defined: There must be

1. the treatment of a serious illness for which the patient is not
2. no other treatment is available and
3. there is a reasonable prospect of successful treatment based on the available data.

In its ruling of 4 April 2006 (B 1 KR 7/05 R), the Federal Social Court further refined the criteria for off-label use.

In its decision of 13 June 2006, the Bavarian Regional Social Court further distinguished between off-label use and a claim for a constitutional ^[evidence?] extension of benefits in the sense of a beyond-label use. It held that, in order to establish a claim for extension of benefits for the continued use of a drug for the same patient, the same drug and the same treatment, concrete evidence of a severe form of a disease could be sufficient in special cases. However, in the specific case of the continued treatment of an ADHD patient after reaching the age of 18, the Regional Social Court did not consider the conditions for a claim for reimbursement to be met.