Off-label use

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This article or paragraph presents the situation in Germany . Help us to describe the situation in other countries.

Off-label use refers to the prescription of a finished drug outside of theuse approvedby the drug authorities. The use maydifferfrom the approval in the area of application or the type of application. In German this is referred to as cross- approval application.

Approval applications for new drugs are often very narrow for various reasons. In addition, applications from pharmaceutical companies for extensions to the drug authorities are rare. The reason for this is often the high cost of the required clinical studies . The legislators in Germany and Europe are currently trying to counteract this development - z. B. through simplified admission regulations or economic incentives such as an extended protection period for admission for children ( concessions for admission for children ).

application areas

A large number of drugs are used off-label in many medical fields, especially in paediatrics and oncology . An example from the Gynecology is the induction of labor with misoprostol , which is only used to treat stomach - and duodenal ulcers approved drug legally. Approved drugs are not available for many rare diseases.

liability

In the case of off-label use, the treating physicians are liable for the medical correctness and for any side effects . The medical societies recommend that off-label prescriptions only be carried out on the basis of valid guidelines , recommendations or recognized scientific literature . To the patient education additional requirements are also provided.

Even in the case of off-label use , however, a legal liability for the pharmaceutical companies exist. According to Section 84 (1) No. 1 AMG , the pharmaceutical company is liable if damage occurs during “intended use”. The "intended use" is not limited to the use in the sense of the approval. According to Section 28 (3a), the pharmaceutical manufacturer can, for example, be obliged to monitor use after approval . A company is also liable if it had known about the regular application outside the approval and could have taken appropriate risk minimization measures.

Reimbursement by health insurance companies

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

  1. the treatment of a serious medical condition for which
  2. no other treatment is available and
  3. There is a reasonable prospect of a successful treatment based on the data.

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

With the judgment of June 13, 2006, the Bavarian State Social Court also differentiated between off-label use and a right to constitutionally compliant [proof?] Service expansion in the sense of beyond label use . It found that, in special cases, specific indications of a severe form of illness might be sufficient to justify a right to extended benefits for the continued use of a drug for the same patient, the same drug and the same treatment. In the specific case of further treatment of an ADHD patient after reaching the age of 18 , however, the regional social court did not consider the requirements for a claim to reimbursement to be met.

See also

Web links

Individual evidence

  1. ↑ Federal Social Court refines criteria for off-label use ( Memento from September 30, 2007 in the Internet Archive )
  2. ↑ LSG Bayern, judgment of June 13, 2006, L 5 KR 93/06 (ASR 2007, 126). Full text , Sozialgerichtsbarkeit.de.