Cannabidiol (6) – Epidyolex®
Dravet syndrome, ≥ 2 years, combination with clobazam
Characteristics
| Start date | 01.12.2023 – Marketing authorisation: 19.09.2019 |
|---|---|
| Resolution | 16.05.2024 |
| INN | Cannabidiol |
| Brand name | Epidyolex® |
| Pharm. company | Jazz Pharmaceuticals Germany GmbH |
| G-BA Procedure ID | D-1015 |
| ATC code | N03AX24 Other antiepileptics (N03AX) |
| Therapeutic area | Nervous system diseases Orphan (turnover limit) |
| Reason for procedure |
Reassessment: Orphan turnover exceeded
Original resolution: Cannabidiol (3) (15.04.2021) |
| Specialty | Bundling ACT change |
Studies and Results
- Clinical trials
- These were two randomised, controlled, double-blind trials in which cannabidiol was compared with placebo, in each case in addition to ongoing anti-epileptic treatment.
Patients aged 2 years and over with seizures associated with Dravet syndrome
- For patients aged 2 years and over with seizures associated with Dravet syndrome, the additional benefit is not proven.
- The additional benefit of cannabidiol compared with the appropriate comparator therapy for patients aged 2 years and over with seizures associated with Dravet syndrome is therefore not proven.
- Overall assessment
- In the overall review, there are no suitable data available for comparing cannabidiol with the appropriate comparator therapy. Consequently, the additional benefit of cannabidiol for patients aged 2 years and over with seizures associated with Dravet syndrome is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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