Brivaracetam (1) – Briviact®
Epilepsy, focal seizures, ≥ 16 years
Characteristics
| Start date | 15.02.2016 – Marketing authorisation: 13.01.2016 |
|---|---|
| Resolution | 04.08.2016 |
| INN | Brivaracetam |
| Brand name | Briviact® |
| Pharm. company | UCB Pharma GmbH |
| G-BA Procedure ID | D-208 |
| 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 |
| Reason for procedure | Initial assessment |
| 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 and adolescents from 16 years of age with epilepsy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults and adolescents Patients aged 16 years and over with focal epileptic seizures with or without secondary generalisation (add-on therapy) | Individualised add-on antiepileptic therapy, if medically indicated and if no pharmacoresistance / intolerance and contraindications are yet known, with one of the following agents: Eslicarbazepine or Gabapentin or Lacosamide or Lamotrigine or Levetiracetam or Oxcarbazepine or Pregabalin or Topiramate or Valproic acid or Zonisamide. The therapy should be chosen by the physician depending on the baseline and previous therapy(s) and taking into account the reason for the change in therapy and any associated side effects. The respective marketing authorisation of the preparations must be observed. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (N01254) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (MTC) |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The follow-up assessment by the IQWiG (Addendum A16-38) included studies EP0008 and SP755 (in each case, the study arms receiving 400 mg of lacosamide daily) and the brivaracetam study N01254 were included in the indirect comparison.
- All three studies were placebo-controlled, randomised, double-blind trials.
a) Adjunctive treatment of focal seizures with or without secondary generalisation in adults and adolescents aged 16 years and over with epilepsy
- An additional benefit of brivaracetam is not proven.
- The pharmaceutical manufacturer has not submitted any directly comparative study for the assessment of the additional benefit of brivaracetam compared with the G-BA’s appropriate comparator therapy (individualised adjunctive antiepileptic therapy), as the G-BA’s appropriate comparator therapy was not implemented in any of the studies.
- Taking all the aspects cited into account, the G-BA concludes that the evidence submitted, in particular the indirect comparison, is not suitable for assessing any additional benefit.
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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