Brivaracetam (2) – Briviact®
Epilepsy, focal seizures, add-on therapy, 4 to < 16 years
Characteristics
| Start date | 01.08.2018 – Marketing authorisation: 11.07.2018 |
|---|---|
| Resolution | 17.01.2019 |
| INN | Brivaracetam |
| Brand name | Briviact® |
| Pharm. company | UCB Pharma GmbH |
| G-BA Procedure ID | D-371 |
| ATC code | N03AX23 Other antiepileptics (N03AX) |
| ICD-10 codes (AIS) | G40.08, G40.09, G40.1Attacks without alteration of consciousness, G40.2Attacks with alteration of consciousness, often with automatisms, G40.8Epilepsies and epileptic syndromes undetermined as to whether they are focal or generalized |
| Alpha-ID codes (AIS) | I3557Focal epilepsy, I85633Epilepsy, undetermined whether focal or generalized, I90702Focal onset of epileptic seizure, I91470Epilepsy with complex focal seizure, I91514Idiopathic localization-related epilepsy |
| DDD | 0.1 g O |
| Therapeutic area | Nervous system diseases Epilepsy, Epilepsy in children (Dravet syndrome / Lennox-Gastaut syndrome) |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children and adolescents aged 4 to < 16 years with focal epileptic seizures with and without secondary generalisation (add-on therapy). | Patient-specific antiepileptic add-on therapy, if medically indicated and if no pharmacoresistance (in the sense of an insufficient response), intolerance and contraindications are known, with one of the following agents: Eslicarbazepine¹, Gabapentin², Lacosamide, Lamotrigine, Levetiracetam, Oxcarbazepine², Perampanel³, Topiramate, Valproic acid⁴, Zonisamide². The therapy should be chosen by the doctor depending on the basic and previous therapy(ies) and taking into account the reason for the change in therapy and any associated side effects. The respective marketing authorisation of the medicinal products must be taken into account. ¹Approval for children over 6 years of age ²Approval for children 6 years and older Approval for adolescents from 12 years of age ⁴Valproic acid is used for the adjunctive treatment of focal seizures with or without secondary generalisation in children and adolescents aged 4 to |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (N01263, N01266) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The N01263 trial investigated children and adolescents with epilepsy aged ≥1 month to <16 years who had focal, generalised or unspecified (unclear whether focal or generalised) seizures and who were being treated with at least one and up to a maximum of three anticonvulsants.
- The Phase III study N01266 is an ongoing long-term study.
Children and adolescents aged 4 to <16 years with focal epileptic seizures, with or without secondary generalisation, as adjunctive therapy
- For children and adolescents aged 4 to <16 years with focal epileptic seizures, with or without secondary generalisation, as adjunctive therapy, the additional benefit is not proven.
- Consequently, no comparative data against the appropriate comparator therapy were presented. An additional benefit of brivaracetam over the appropriate comparator therapy is therefore not proven.
- Summary of the assessment
- As part of the benefit assessment, two single-arm studies on brivaracetam were submitted.
- Consequently, there are no comparative data available for brivaracetam as adjunctive therapy for children and adolescents aged 4 to <16 years with focal epileptic seizures, with or without secondary generalisation, compared with the appropriate comparator therapy (individualised adjunctive antiepileptic therapy). An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Brivaracetam (3) | Briviact® | UCB Pharma GmbH | Focal seizures in epilepsy, additional therapy, 2 to < 4 years | 300–1,800 | 100% additional benefit not proven | |
| Brivaracetam (2) | Briviact® | UCB Pharma GmbH | Epilepsy, focal seizures, add-on therapy, 4 to < 16 years | 5,000–10,000 | 100% additional benefit not proven | |
| Brivaracetam (1) | Briviact® | UCB Pharma GmbH | Epilepsy, focal seizures, ≥ 16 years | 86,000–200,000 | 100% additional benefit not proven |
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