Cannabidiol (7) – Epidyolex®
Lennox-Gastaut 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 |
Dossier: Jazz Pharmaceuticals Germany GmbH
New distributor: JAZZ PHARMACEUTICALS IRELAND LIMITED |
| G-BA Procedure ID | D-1016 |
| ATC code | N03AX24 Other antiepileptics (N03AX) |
| ICD-10 codes (AIS) | G40.4Epilepsy with grand mal seizures on awakening |
| Alpha-ID codes (AIS) | I81840Lennox-Gastaut syndrome |
| ORPHAcodes (AIS) | 2382Lennox-Gastaut 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 (4) (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 Lennox-Gastaut syndrome | Patient-specific therapy, taking into account the type of seizure occurring, the basic and previous therapy(ies) and any associated side effects, with selection of brivaracetam, bromide, carbamazepine, cenobamate, clobazam, clonazepam, eslicarbazepine, ethosuximide, felbamate, fenfluramine, gabapentin, lacosamide, lamotrigine, levetiracetam, mesuximide, oxcarbazepine, perampanel, phenobarbital, phenytoin, pregabalin, primidone, rufinamide, topiramate, valproic acid, vigabatrin, zonisamide |
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 Fachgesellschaften |
- Clinical trials
- To assess the additional benefit, the pharmaceutical manufacturer has submitted analyses of studies GWEP1414 and GWEP1423.
- These are two randomised, controlled, double-blind studies 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 Lennox-Gastaut syndrome
- For patients aged 2 years and over with seizures associated with Lennox-Gastaut 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 Lennox-Gastaut syndrome is therefore not proven.
- In the studies relevant to this benefit assessment, no optimisation of antiepileptic treatment was planned for patients in the comparator arm.
- Although the included patients experienced regular epileptic seizures, the existing anti-epileptic medication in the comparator arm was supplemented only by placebo and was therefore continued unchanged.
- The appropriate comparator therapy was therefore not implemented in the studies submitted for the benefit assessment.
- Overall review
- In the overall review, there are no suitable data available for comparing cannabidiol with the appropriate comparator therapy. Consequently, additional benefit from cannabidiol is not proven for patients aged 2 years and over with seizures associated with Lennox-Gastaut syndrome.
Courtesy translation only, please refer to the German original.
Associated procedures
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