RESUMO
BACKGROUND: On March 10th 2017, the law amending narcotic and other regulations was expanded, thereby allowing physicians, irrespective of their specialization, to prescribe cannabis-derived medicines as magistral formulas or proprietary medicinal products at the expense of the German statutory health insurance (GKV). First prescription requires approval from the respective health insurance, which in turn commissions the Medical Advisory Board of the Statutory Health Insurance Funds (MDK) to prepare a medico-legal report. OBJECTIVES: Since § 31 Para. 6 of the German Social Code, Book V (SGB V) came into effect, a multitude of imponderables have been reported regarding reimbursement. Based on the experience of the MDK Nord, problems within the fields of patients, physicians and cannabis-derived medicines are illustrated. MATERIAL AND METHODS: Considering current literature, a retrospective review was conducted including approximately 2200 applications for reimbursement received in 2018 from patients residing in Hamburg and Schleswig-Holstein. RESULTS: A relevant problem within the field of patients resulted from the lack of a specific definition of the term "severe (chronic) disease". Although this term is mentioned several times in SGB V, it is not put into concrete terms. Circumstances like multimorbidity are not taken into account. Another problem consisted in an irreproducible anticipation of treatment with cannabis-derived medicines. Within the field of physicians, a major problem was caused by missing, fragmentary or inconsistent information regarding disease and/or therapy. Hence, initially, almost one-third of all applications could not be appraised. Amongst various cannabis-derived medicines, dried flowers were found to be the most problematic regarding doses and effective levels. Notably, a marked increase in numbers of applications for reimbursement of therapy with pure cannabidiol was noted. DISCUSSION: Numerous problems reported elsewhere and relating to prescription of cannabis-derived medicines were also observed by the MDK Nord. Many prescriptions reflected an uncertainty regarding therapeutic use of cannabis-derived medicines. Thus, one should consider restricting the prescription of cannabis-derived medicines to selected specialists. It should be noted that, in individual cases, e.g., patients suffering from neuropathic pain, treatment with cannabis-derived medicines seems to be a reasonable therapeutic option taking into account the risks and benefits.