title: [Off-label therapy from the perspective of the medical insurance service].
abstract: 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. They often do not match. Even if there is a medically justified off-label use the road to drug approval is principally via the authorities with tested efficacy and safety in order not to deprive the patient of the protection of the Pharmaceuticals Act. 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.
authors.affiliation: Medizinischer Dienst der Krankenversicherung Westfalen-Lippe, Paderborn, Deutschland. LGrell@mdk-wl.de
authors.forename: L
authors.initials: L
authors.lastname: Grell
authors.forename: M
authors.initials: M
authors.lastname: Rieger
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D019317:Evidence-Based Medicine / Q000191:economics / Q000331:legislation & jurisprudence; D005104:Expert Testimony / Q000331:legislation & jurisprudence*; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006801:Humans; D007356:Insurance, Pharmaceutical Services / Q000191:economics* / Q000331:legislation & jurisprudence*; D009313:National Health Programs / Q000191:economics* / Q000331:legislation & jurisprudence*; D056687:Off-Label Use / Q000191:economics* / Q000331:legislation & jurisprudence*; D012051:Reimbursement Mechanisms / Q000191:economics / Q000331:legislation & jurisprudence