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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.
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.
1) to highlight the current situation of oncological off-label treatment in Germany;
2) to unravel arising medico-legal and economic problems.
On- and off-line research was performed using the relevant medical and legal literature as
well as the major judgements of the courts.
* 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
* 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
* One of the current medico-legal problems: Trastuzumab (Herceptin) in adjuvant
treatment of breast cancer.
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.
I am indebted to my father Werner
Stenzinger for fruitful discussions and to
Monika Wimmer for her generous
Summer School Participant
Albrecht Stenzinger
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