Author Of 2 Presentations
P0707 - Costs and health-related quality of life in patients with neuromyelitis optica spectrum disorder and MOG-antibody associated disease (CHANCENMO-Study) (ID 1015)
- M. Hümmert
- L. Schöppe
- J. Bellmann-Strobl
- N. Siebert
- F. Paul
- A. Duchow
- H. Pellkofer
- T. Kuempfel
- J. Havla
- S. Jarius
- B. Wildemann
- F. Then Bergh
- M. Pawlitzki
- L. Klotz
- I. Kleiter
- M. Stangel
- S. Gingele
- M. Weber
- J. Faiss
- R. Pul
- A. Walter
- U. Zettl
- M. Senel
- J. Stellmann
- V. Häußler
- K. Hellwig
- I. Ayzenberg
- O. Aktas
- M. Ringelstein
- O. Schreiber-Katz
- C. Trebst
Neuromyelitis optica spectrum disorder (NMOSD) and myelin oligodendrocyte glycoprotein-antibody associated disease (MOG-AD) are orphan diseases with high impact on quality of life and to date unknown socio-economic burden.
The aim of this study was to evaluate costs and health-related quality of life of NMOSD and MOG-AD from the societal perspective.
In a multicenter cross-sectional study throughout Germany between 04/2017 and 04/2019, the primary data on retrospective consumption of medical and non-medical resources and work ability related to NMOSD and MOG-AD were assessed via standardized and pre-tested paper-based patient questionnaires. Health-related quality of life was captured by the EuroQoL Group EQ-5D-5L questionnaire. Clinical data were retrieved from the Neuromyelitis Optica Study Group (NEMOS) database. Patient recruitment took place at 17 German NEMOS centers. Costs were analyzed in EUR for 2018.
During the recruitment period, 218 of 275 adult patients were screened for eligibility. 212 patients (80.2% women; mean age 49 ± SD 15 years; mean disease duration 9 ± SD 8.5 years; Expanded Disability Status Scale (EDSS) 3.7 ± SD 2.1) were analyzed. The mean total annual per capita cost of illness accounted for EUR 59 576 and the mean index value of the EQ-5D-5L was 0.693. Given an estimated prevalence of NMOSD in Germany of 1.3/100 000, the annual burden from the societal perspective adds to EUR 64.3 Mio for Germany. The most important cost drivers were informal care costs (27.6% of total costs), indirect costs (23.3%; particularly loss of salary) and drugs, especially immunotherapeutics (16.4%). Costs showed a significant positive correlation with disease severity (p<0.0001); in the EDSS 6.5-8.5 subgroup the annual costs were EUR 129 436. Moreover, the health-related quality of life revealed a negative correlation with disease severity (p<0.0001); in the EDSS 6.5-8.5 subgroup the mean index value was 0.195.
These German data from the era without approved standard medications show enormous effects of the disease on costs and quality of life and might be helpful for estimating the impact and cost-effectiveness of new therapeutic approaches.
P0849 - CLADQoL (CLADribine Tablets – evaluation of Quality of Life) study: evaluating Qol 12 months after treatment initiation with cladribine tablets (ID 771)
CLADQoL is a non-interventional study (NIS) in patients with RMS treated with cladribine tablets, focusing on quality of life. This is the first publication on the change in quality of life (examined by MSQoL-54) of patients treated with cladribine tablets in real world conditions at baseline and after 12 months. The recruitment period has ended in April 2020. Patient follow-up will continue and is planned for four years.
Describing the patient population including pre-treatment and relapse rate and evaluating changes in patients’ quality of life (MSQoL-54 physical health and mental health composite scores) under therapy with cladribine tablets 12 months after treatment initiation.
Quality of life (QoL) was evaluated from the patient subset where MSQoL-54 was available both at baseline and month 12. Cut-Off date for analysis was January 31st 2020.
87 of 254 recruited patients were evaluated so far (mean age 37 years; 78.2% female; 93.1% RRMS). Most frequent last previous therapy for treated patients was fingolimod, dimethyl fumarate, glatiramer acetate and daclizumab.
For the subsets with valid MSQoL-54 at baseline and month 12 the physical health composite score showed a decrease -0.942 ±14.08 whereas the mental health composite score revealed an increase 0.711 ±17.33 (Change 12 months vs. baseline). None of the differences reached significance.
The number of relapses decreased from 1.0 ±1.09 (Mean ±SD) at baseline to 0.2 ±0.58 (Mean ±SD) at month 12.
Regarding safety, evaluation was performed for the overall study population (N=254). 82 patients experienced at least one AE and 15 patients at least one SAE.
Within the first year of treatment with cladribine tablets in patients with RRMS or SPMS with superimposed relapses there were minimal changes in QoL scores.
We observed a decrease in relapses and the safety results were in line with known safety profile of cladribine tablets.
The NIS is ongoing and patient subset is being followed up.