Zeitschrift für Rheumatologie
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For rheumatoid arthritis (RA) and diseases of the spondyloarthritis group (SpA) a large number of approved medications are available. Nevertheless, in Germany even for these diseases several off-label risks exist for the rheumatologist prescribing antirheumatic drugs which have recently led to a series of recourses or threats of recourse. In RA as well as SpA first of all biologicals are the target of recourse imposed mainly by health insurances. ⋯ The same applies to early AS not fulfilling the 1984 New York criteria which still lacks labeled use of TNF inhibitors. In these cases, however, based on successful randomized controlled trials and changed diagnostic criteria a label extension is expected in the near future. Until then it seems suitable to apply for permission for this treatment from insurers in each case.
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The assessment of off-label medications is one of the most common reasons for assessment of drugs for individual patients in the German medical services. Tension is not uncommon because of great expectations of patients and doctors on the one hand and the requirements of the law on the other. ⋯ The jurisdiction has approved criteria for reimbursement by the statutory health insurance only in clearly defined exception and one requirement is that there are no alternative forms of treatment. For serious diseases this is based on the evidence of drug approval; however, for immediately life-threatening situations a very low evidence level is sufficient.
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The off-label use of approved pharmaceuticals outside the authorized status is implemented in pharmacotherapy of many diseases, especially for rare diseases and in cases of therapy resistance. The German regulations are presented and analyzed and the relative literature is discussed.