Vigabatrin (2) – Kigabeq®
Epilepsy, West syndrome, < 7 years
Characteristics
| Start date | 01.07.2019 – Marketing authorisation: 20.09.2018 |
|---|---|
| Resolution | 19.12.2019 repealed |
| INN | Vigabatrin |
| Brand name | Kigabeq® |
| Pharm. company |
Dossier: Desitin Arzneimittel GmbH
New distributor: Orphalan SA |
| G-BA Procedure ID | D-472 |
| ATC code | N03AG04 Fatty acid derivatives (N03AG) |
| ICD-10 codes (AIS) | G40.4Epilepsy with grand mal seizures on awakening |
| Alpha-ID codes (AIS) | I79443West syndrome |
| DDD | 2 g O |
| Therapeutic area | Nervous system diseases Epilepsy, Epilepsy in children (Dravet syndrome / Lennox-Gastaut syndrome), West syndrome epilepsy |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Regulatory status | PUMA |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Kigabeq is used in children aged from 1 month to under 7 years: – for the treatment as monotherapy of infantile spasms (West syndrome). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Children aged 1 month to less than 7 years suffering from infantile spasms (West syndrome) | Tetracosactide or glucocorticoids (prednisone, prednisolone) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
Children aged from 1 month to under 7 years who suffer from infantile spasms (West syndrome)
- As the necessary evidence has not been submitted, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
- No dossier was submitted by the pharmaceutical manufacturer at the relevant time.
- Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment is made as to whether, or to what extent, the active ingredient (INN) vigabatrin offers added benefit compared with the appropriate comparator therapy in the therapeutic indication ‘children aged from 1 month to under 7 years suffering from infantile spasms (West syndrome)’, there is additional benefit compared with the appropriate comparator therapy.
- Appropriate comparator therapy
- The appropriate comparator therapy was defined as follows: children aged from 1 month to under 7 years who suffer from infantile spasms (West syndrome)
- Appropriate comparator therapy: tetracosactide or glucocorticoids (prednisone, prednisolone)
Courtesy translation only, please refer to the German original.
Associated procedures
| Vigabatrin (2) | Kigabeq® | Desitin Arzneimittel GmbH | Epilepsy, West syndrome, < 7 years |
0
1,000–2,400 |
100% additional benefit not proven repealed | |
| Vigabatrin (1) | Kigabeq® | Desitin Arzneimittel GmbH | Epilepsy, focal seizures, < 7 years |
0
7,300–14,500 |
100% additional benefit not proven repealed |
<< List of all resolutions