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Off-label use in oncological therapy. Therapeutic, economic and medico-legal aspects in Germany Stenzinger A, Faculty of Medicine, Justus-Liebig-University. Giessen, Germany. Introduction The term off-label use describes the prescription and subsequent use of a licensed therapeutic agent in ways not approved by the regulatory bodies; that is outside the limits of its approved indication, dosage and route of administration. It is estimated that about 60% of drugs in oncology are being used off-label in Germany. Evidently, off-label prescribing and subsequent treatment without the formal and legal protection of the label are essential pillars in the treatment of malignant diseases with a huge economic impact on the financial resources of public health care systems throughout the world. Objectives 1) to highlight the current situation of oncological off-label treatment in Germany; 2) to unravel arising medico-legal and economic problems. Method On- and off-line research was performed using the relevant medical and legal literature as well as the major judgements of the courts. Results * New oncological drugs entering the market are labelled for a very specific indication, which is based on the results of multi-centric phase III studies. * Prescription of a drug being used for an indication but not labelled yet is permissible, if it is appropriate, economical and in accordance with the acknowledged medical standard. * According to a judgement of the German Federal Social Welfare Court health insurance institutions have to bear the costs of off-label therapy, if - the disease is life-threatening; - no other therapy is available; - recent well-founded research shows a curative or palliative effect on the patient’s disease. * One of the current medico-legal problems: Trastuzumab (Herceptin) in adjuvant treatment of breast cancer. Summary Off-label use of approved drugs is not illegal but insufficiently regulated in Germany. Although prescription of drugs being used off-label is permissible by law, the coverage of costs resulting from the therapy often remains an open question. In the long term it is the task of the legislative assemblies in Germany to introduce a bill that clarifies the current medico-legal situation. Meanwhile, it is important to define some criteria that are essential to guarantee an economically and medically responsible use of off-label drugs. Some literature * Boos J. Off label use - label off use? Annals of Oncol. 2003;14:1-5. * Kocs D, Fendrick AM. Effect of off-label use of oncology drugs on pharmaceutical costs: the rituximab experience. Am J Manag Care. 2003;9:393-400. * Poole SG, Dooley MJ. Off-label prescribing in oncology. Support Care Cancer. 2004;12:302-305 * Seeber S, Braun AH. Phase III trials in oncology: setting standards of care? Nat Clin Pract Oncol. 2005;2:426-7. Acknowledgements I am indebted to my father Werner Stenzinger for fruitful discussions and to Monika Wimmer for her generous support. Summer School Participant Albrecht Stenzinger [email protected]