Abstract
In 2002, with its "Off-label verdict", the German Federal Social Court (Bundessozialgericht; BSG) issued a fundamental decision to the effect that in certain circumstances an off-label prescription might be payable by health insurance firms, these circumstances being: severe illness with no prospect of a cure being brought about by any therapy approved for this illness and an evidence-based chance that an off-label treatment could yield a cure. Subsequently, the former German Federal Ministry of Health and Social Security (BMGS) appointed its "expert group on off-label use of treatments". This panel's task was to formulate professional comments and expert recommendations to the Federal Joint Committee (G-BA) on scientific evidence relating to selected medications used for off-label treatment. The group was found not to be sufficiently efficient and was laid down in August 2005. Meanwhile, it has been replaced by other work groups. However, the constant increase in the amount of medical evidence available means that off-label use is a continuing process that cannot easily be regulated by expert committees. It would be preferable for reimbursement for off-label prescriptions to be linked to the qualifications of the attendant physician. One suggestion might be that only specifically authorised physicians with special additional skills be permitted to apply and be reimbursed for off-label prescriptions.
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