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Off-Label Use

When a medicinal product is licensed, this marketing authorisation refers both to a specific indication and to a specific group of patients. However, under certain circumstances the medicinal product can also be used for diseases or persons for which it has not been authorised. Such cases are called "off-label use".

Time and again, the eligibility for reimbursement of medicinal products prescribed for such off-label use by the statutory health insurance was the subject of legal disputes. Finally, the landmark verdict of the Federal Social Court of 19 March 2002 (case number B 1 KR 37/00 R) specified the criteria to be fulfilled in order for a reimbursement of medicinal products prescribed for off-label use by the statutory health insurance to be considered. The medicinal product must be prescribed in order to treat a serious disease for which no other treatment is available and for which current data provides reasonable grounds to suspect successful treatment.