(PO-4712) Utilization Of Rotigotine Transdermal Patch In Germany: Results From A Claims Database Study

Lars Joeres, Stephan Luca, Guilhem Pietri and Lisa Zimmermann

Background: Rotigotine (RTG), a dopamine agonist, is authorized in EU as a transdermal patch for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS) with a recommended dose ranging from 4 to 16mg/24h for PD and 1-3mg/24h for RLS. Data on real-life usage of RTG in Germany are not available.

Objectives: To assess utilization and persistence (overall and dose-dependent) of RTG for RLS and PD in real-world practice in Germany.

Methods: Utilization and persistence of RTG among prevalent PD and RLS patients were assessed between 2013 and 2017 using the Deutsche Analysedatenbank, a collection of claims data from German sick funds, according to ICD-10 and ATC codes. Annual prevalence rates were calculated for PD and RLS and extrapolated to the German social health insured (SHI) population. RTG utilization in prevalent PD and RLS patients was assessed as number of treated patients, mean and median dosage per indication; persistence was assessed as mean treatment duration (in days) overall and per dosage. Summary descriptive statistics were calculated.

Results: Approx. 2 million insured persons could be evaluated. Among those, 9,876 (PD) and 16,617 (RLS) patients could be identified using G20.0, G20.1, G20.2, G20.9 ICD-10 codes for PD and G25.80, G25.81 and G25.88 for RLS (extrapolated to 291,026 PD and 489,669 RLS patients in the SHI population). Of those, 543 PD patients and 699 RLS patients claimed at least one prescription of RTG (ATC code N04BC09; extrapolated to 16,001 PD and 20,598 RLS patients). A mean dose of 4.88mg/24h in PD and 2.58mg/24h in RLS was calculated. Dosages of 2, 4, 6, and 8mg/24h in PD and 1, 2, 3mg/24h in RLS were mainly used (29.7%, 33.7%, 23.6%, and 23.6% of PD patients were treated with RTG 2mg, 4mg, 6mg, and 8mg, respectively; 34.8%, 42.6% and 28.5% of RLS patients were treated with RTG 1mg, 2mg and 3mg, respectively), reflecting the commercially available patch sizes. Persistence overall was calculated as 218.3 days in PD and 391.1 days in RLS. The persistence in PD for stable doses of 4 - 6mg/24h ranged from 136.1 to 122.2 days; the highest persistence was observed in PD at 8mg/24h with 322.5 days. In RLS, persistence ranged from 522.0 to 343.1 days within approved dose range of 1-3mg/24h.

Conclusions: The analysis suggests that RTG is prescribed according to prescribing recommendations but using a lower recommended dose range for PD. Mean dose for RTG in PD was in a lower dose range. Persistence is higher for RLS and equally distributed among approved dosages but for PD persistence appears to be dose-dependent, with highest persistence at 8mg/24h. Further research needs to be conducted to corroborate the findings.