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New HTA Decisions in Germany
December 2020
Drug name
ZEPOSIA (ozanimod)
Company
Celgene GmbH
Decision date
15/10/2020
Therapeutic area
Neurological conditions
Therapeutic sub area
Multiple sclerosis
G-BA decision date
01/01/2021
Orphan Drug?
No
Decision
Considerable additional benefit
Indication
Treatment-naïve and pre-treated patients with not highly active relapse-remitting multiple sclerosis. Main comparator: interferon-beta 1a.
Decision
Additional benefit not quantifiable
Indication
Pre-treated patients with highly active relapse-remitting multiple sclerosis. Main comparator: interferon-beta 1a.
Decision Detail
Main studies: RADIANCE B and SUNBEAM Main driver of decision: Results of these studies suggest a positive impact of ozanimod in patients with not highly active relapse-remitting multiple sclerosis in terms of health-related quality of life, with no difference observed for other outcomes such as adverse events and morbidity. For patients with highly active relapse-remitting multiple sclerosis, data shows that there is only one positive effect of ozanimod compared to the comparator, with the benefit due to subgroup analysis based on gender.
Summary
IQWiG concluded that there was considerable added benefit of ozanimod in patients with not highly active relapse-remitting multiple sclerosis, but that additional benefit was not measurable in patients with highly active relapse-remitting multiple sclerosis.