OBJECTIVES: Cladribine has been approved in the EU for the treatment of patients with highly active relapsing multiple sclerosis in 2017. Cladribine tablets are administered during two treatment weeks in year 1 and 2, no additional treatment is required in year 3 and 4. This retrospective analysis aims to assess persistence and switch rates of patients receiving cladribine tablets using real-world claims data.

METHODS: The analyses are based on German statutory health insurance records from BARMER, representing 8.9 million insured persons. Adult patients with an MS diagnosis (ICD-10 G35.x) and an initial prescription of cladribine from September 2017 - June 2021 were included. Patients with an exclusive coding PPMS (ICD-10 G35.2), non-active SPMS (ICD-10 G35.30) or non-specific MS (ICD-10 G35.9) were excluded. Prior therapy was recorded within the 12 months before initial prescription of cladribine tablets.

RESULTS: 358 patients prescribed cladribine tablets were identified. 57.7% of these received treatment prior to initiating cladribine tablets. The overall persistence rate was 95.5%. 16 patients switched therapy, 4 of those patients switched in their first treatment year, 3/7/2 patients in years 2/3/4 respectively.

CONCLUSIONS: More than 95% of incident cladribine patients continued their therapy as directed beyond year 2. Under cladribine, there was a low overall switch rate of 4.5%. In the therapy-free years 3 and 4, only 2.5% of patients required further active therapy for RMS.