["Be right" vs. "get one's rights" : Practice-oriented recommendations from a legal viewpoint]

When is off-label use permitted by law in the statutory health insurance? Which approach is recommended for medical professionals to avoid recourse?

The statutory health insurance in Germany is characterized among others by the precepts of efficiency and quality. Thus medicinal products may only be prescribed after an examination of quality, safety and efficacy. For using medicinal products off label, i. e. without applicable authorization or outside the authorized indications, these requirements are slightly reduced. Prerequisites for an off-label use are 1) a severe disease, 2) the absence of approved treatment alternatives and 3) scientific data that makes treatment success sufficiently probable. The clinical trials must be: placebo-controlled, randomized and double blind. Indications of lower evidential value are sufficient for life-threatening diseases.

For an off-label use reference is often made to scientifically insufficient studies; however, it is always important to have the most careful possible reasoning for the specific case, especially for the absence of an approved treatment alternative. This also includes having an answer to all possible objections from critics.