Cannabidiol (8) – Epidyolex®
Seizures associated with tuberous sclerosis, ≥ 2 years
Characteristics
| Start date | 01.12.2023 – Marketing authorisation: 16.04.2021 |
|---|---|
| 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-1017 |
| ATC code | N03AX24 Other antiepileptics (N03AX) |
| ICD-10 codes (AIS) | Q85.1Bourneville´s disease |
| Alpha-ID codes (AIS) | I16625Tuberous sclerosis |
| ORPHAcodes (AIS) | 805Tuberous sclerosis |
| Therapeutic area | Other diseases Epilepsy, Seizures Orphan (turnover limit) |
| Reason for procedure |
Reassessment: Orphan turnover exceeded
Original resolution: Cannabidiol (5) (04.11.2021) |
| Specialty | Bundling ACT change Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Epidyolex is used as an add-on therapy for seizures associated with tuberous sclerosis (TSC) in patients aged 2 years and older. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients aged 2 years and older with seizures associated with tuberous sclerosis | Patient-specific therapy, taking into account the type of seizure occurring, the basic and previous therapy(s) and any associated side effects, with selection of brivaracetam, carbamazepine, cenobamate, eslicarbazepine, everolimus, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, phenobarbital, phenytoin, pregabalin, 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
- This was a randomised, controlled, double-blind trial 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 tuberous sclerosis
- For patients aged 2 years and over with seizures associated with tuberous sclerosis, 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 tuberous sclerosis is not proven.
- In the study 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 with placebo and was therefore continued unchanged.
- The appropriate comparator therapy was therefore not implemented in the study submitted for the benefit assessment.
- Overall review
- Overall, there are no suitable data available for comparing cannabidiol with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
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