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| Resolution | 16.05.2024 repealed |
| INN | Cannabidiol |
| Brand name | Epidyolex® |
| Pharm. company |
Dossier: Jazz Pharmaceuticals Germany GmbH
New distributor: JAZZ PHARMACEUTICALS IRELAND LIMITED |
| G-BA Procedure ID | D-1015 |
| ATC code | N03AX24 Other antiepileptics (N03AX) |
| ICD-10 codes (AIS) | G40.4Epilepsy with grand mal seizures on awakening |
| Alpha-ID codes (AIS) | I128083Dravet syndrome |
| ORPHAcodes (AIS) | 33069Dravet syndrome |
| Therapeutic area | Nervous system diseases Epilepsy, Epilepsy in children (Dravet syndrome / Lennox-Gastaut syndrome) Orphan (turnover limit) |
| Reason for procedure |
Reassessment: Orphan turnover exceeded
Original resolution: Cannabidiol (3) (15.04.2021) |
| Specialty | Bundling ACT change Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Epidyolex is used as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in combination with clobazam in patients aged 2 years and older. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients aged 2 years and older with seizures associated with Dravet syndrome | Patient-specific therapy, taking into account the type of seizure occurring, the basic therapy and previous therapy(s) as well as any associated side effects, selecting brivaracetam, bromide, clobazam, fenfluramine, levetiracetam, stiripentol, topiramate, valproic acid |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| ACT change | 03.04.2024 – Stellungnahme der Fachgesellschaften |
- 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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