Co author: My Anh Cao 

In a ruling dated 25 September 2023 (Ref.: 1 BvR 1790/23), the Federal Constitutional Court dealt with the statutory health insurance's obligation to provide benefits for off-label therapy in cases of life-threatening or regularly fatal illnesses.

The complainant, who was born in 2020, suffers from GM2 gangliosidosis/Morbus Tay-Sachs, a rare congenital metabolic disease that can lead to severe disability and a shortened life expectancy. There is no recognised causal therapy. The complainant has been receiving off-label therapy with the drug N-acetyl-L-leucine since spring 2022. In November 2022, the complainant applied to his health insurance fund for reimbursement of the costs of therapy with the medicinal substance Miglustat, which was rejected by the health insurance fund after obtaining an expert opinion from the Medical Service (MD). According to the MD's report, no positive clinically relevant effect of Miglustat on the course of Tay-Sachs disease could be suggested. The complainant considers his fundamental rights to have been violated by the refusal to cover the costs.

In its decision, the Federal Constitutional Court found that the complainant's constitutional complaint was inadmissible as it did not fulfil the presentation requirements of Sec. 23 para. 1 sentence 2, Sec. 92 BVerfGG. A violation of fundamental rights due to the denial of the right to the requested provision of Miglustat was not sufficiently demonstrated. No constitutional claim against the health insurance funds for the provision of specific and specialised health care services is generally derived from Art. 2 para. 2 sentence 1 GG. In special cases, however, the courts could be obliged to interpret the relevant provisions of health insurance law in a way that is orientated towards fundamental rights. This applies in particular to the treatment of a life-threatening or regularly fatal illness. To this end, the other treatment method chosen by the insured person must promise a not entirely remote prospect of cure or a noticeable positive effect on the course of the illness, based on circumstantial evidence. These indications must be sufficiently demonstrated in the proceedings. The indications could result from the insured person's state of health compared to other non-treated persons treated with this treatment method and the assessment of the effectiveness by the patient's doctors. Purely experimental treatment methods that are not sufficiently supported by evidence are not covered by the statutory health insurance's obligation to provide benefits. In principle, studies are not necessarily required to demonstrate efficacy, as a minimum level of scientific data can also be obtained from other sources of knowledge. If the treating doctor's assessment is used to demonstrate the effectiveness of the treatment method, high demands must be placed on this. It is necessary for the doctor to have carried out a case-by-case assessment of whether there are serious indications of significant efficacy.