COMPARING CHARACTERISTICS OF HUNGARIAN “REAL LIFE” PATIENTS WITH PARTICIPANTS OF RCTS- FIRST-LINE DISEASE MODIFYING THERAPIES IN MULTIPLE SCLEROSIS
Author(s)
Foldesi C1, Penzes M2, Szabo M2
1National Institute of Quality and Organizational Development in Healthcare and Medicines, Budapest, Hungary, 2National Health Insurance Fund, Budapest, Hungary
OBJECTIVES Health technology assessment and decision making process lean on evidences provided by RCTs. Our aim was to compare the characteristics of Hungarian patients with multiple sclerosis to the participants enrolled in pivotal trials of first-line DMTs. METHODS The database of the National Health Insurance Fund was used for analyze the attributes of all MS patients starting first-line DMTs between 2008 and 2013. We investigated the following characteristics: 1. age, 2. gender ratio, 3. time since first MS symptoms, 4. time since first MS diagnosis, 5. number of relapses in 2 years prior to therapy. For the comparison we summarized phase III RCTs of interferon beta-1a and 1b, glatiramer-acetate, teriflunomide and dimethyl-fumarate. RESULTS A total of 3877 Hungarian MS patients were involved and 1670 were selected for analysis after excluding the population of the year of DMT inclusion. The mean age was 36.18±9.96 years which resembles to the participants of old immunomodulatory drugs (≈36 years) and slightly younger than the patients of the trials with new therapies (≈38 years). There was no difference in gender ratio (≈70% female). While in the RCTs the mean time since first symptoms was longer than the mean time since first diagnosis (≈7–8 vs ≈5.5 years), in the Hungarian patients these two values did not differ significantly (3.30±3.80 vs 3.17±3.77 years). We suspect that the reason for this unexpected difference can be explained by the imprecise use of ICD codes in Hungarian clinical practice. The relapse rate per 2 years seemed to decline in trials of the last two decades from 3 to 2-2.5 which is equal to the Hungarian patients. CONCLUSIONS The population of RCTs represents the Hungarian MS patients in certain aspects but not completely. Our analysis can help the adaptation of international models to local circumstances in HTA of forthcoming MS therapies.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PND78
Topic
Health Technology Assessment, Study Approaches
Topic Subcategory
Decision & Deliberative Processes, Registries
Disease
Neurological Disorders