Analyse der medikamentösen Versorgung von Patienten mit Multipler Sklerose anhand von Routinedaten der gesetzlichen Krankenversicherung

Abstract

Multiple sclerosis (MS) is the most common chronic inflammatory autoimmune disease of the central nervous system (CNS). While the use of MS drugs in routine care is well studied quantitatively, current data on the implementation of the requirements within the Summary of Product Characteristics (SmPC) and the consideration of guideline recommendations are insufficient. In addition, little is known about the implementation of a cost-effective drug therapy. Therefore, the aim of this thesis is to answer these open questions about drug use in MS. A routine data analysis was conducted on the use of drugs for MS between 2017 and 2020 using claims data from around 10 million insured members of the Techniker Krankenkasse (TK). This data was used to determine the outpatient prescription prevalence of various MS drugs. Overall, 54.95 % of MS patients were prescribed disease-modifying therapies (DMTs) for immunotherapy. Only 0.37 % of MS patients received rituximab off-label. Glatiramer acetate was prescribed to 13.04 % of MS patients. Of these only a small proportion were generic prescriptions. 23.15 % of MS patients were treated with glucocorticoids for acute relapse therapy without having previously received DMTs. Prescriptions for symptom-related drugs were given to a total of 51.38 % of patients. This included fampridine prescriptions for 11.29 % of patients, of whom 57.91 % received the drug for a continuous period of at least seven months. The observed proportion of 45.05 % of MS patients without a DMT prescription suggests that at least some of these patients may be undersupplied with DMTs. The low relevance of rituximab in MS therapy despite its designation as a recognised alternative treatment in the guidelines could be attributed to the barriers to off-label use in Germany. The low relevance of generic glatiramer acetate compared to the originator product is striking. The observation that 57.91 % of fampridine treatments continued for at least seven months raises questions as the SmPC requires the initial therapy attempt in non-responders to be limited to two to four weeks whilst the literature assumes a responder rate of less than 40 %. It is possible that the time-limit for treatment of non-responders is not adequately considered by physicians. Further research is needed to verify the assumptions made.