Cenobamat (1) – Ontozry®
Epilepsy, focal seizures, after at least 2 previous therapies
Characteristics
| Start date | 01.06.2021 – Marketing authorisation: 26.03.2021 |
|---|---|
| Resolution | 19.11.2021 |
| INN | Cenobamat |
| Brand name | Ontozry® |
| Pharm. company | Angelini Pharma Deutschland GmbH |
| G-BA Procedure ID | D-694 |
| ATC code | N03AX25 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 | 0.2 g O |
| Therapeutic area | Nervous system diseases Epilepsy |
| Reason for procedure | Initial assessment |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Ontozry is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with epilepsy and focal seizures with or without secondary generalization,who are not adequately controlled despite previous treatment with at least two antiepileptic drugs. | Patient-specific antiepileptic add-on therapy, as far as medically indicated and if no pharmacoresistance (in the sense of an insufficient response), intolerance or contraindication is response), intolerance or contraindication is known, under selection of: Brivaracetam, eslicarbazepine, gabapentin, lacosamide, lamotrigine, levetiracetam, Oxcarbazepine, perampanel, pregabalin, topiramate, valproic acid, and zonisamide. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (Studie C017) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (Bucher) |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- Study C017 is a four-arm, blinded, randomised Phase II trial conducted to support marketing authorisation.
Adults with epilepsy and focal seizures, with or without secondary generalisation, whose condition is not adequately controlled despite prior treatment with at least two anti-epileptic medicinal products
- For adults with epilepsy and focal seizures, with or without secondary generalisation, whose condition is not adequately controlled despite prior treatment with at least two antiepileptic medicinal products, the additional benefit is not proven.
- Consequently, there are no data relevant to the benefit assessment of cenobamate, meaning that additional benefit is not proven.
- Conclusion
- Overall, the adjusted indirect comparison presented is considered unsuitable for assessing the additional benefit of cenobamate compared with the appropriate comparator therapy.
- In the only study included for cenobamate (C017), the titration regimen deviates significantly from the marketing authorisation recommendations, meaning that there is no suitable study on the intervention side for the indirect comparison.
- Furthermore, based on the data provided, it is not possible to assess whether study C017 shows sufficient similarity to the comparator studies, particularly with regard to seizure frequency at the start of the study and the potentially strong effect modifier ‘number of prior treatments’.
- Furthermore, neither study C017 nor some of the comparative studies adequately reflect the indication, as they also included patients with fewer than two previous treatments.
Courtesy translation only, please refer to the German original.
Associated procedures
| Cenobamat (1) | Ontozry® | Angelini Pharma Deutschland GmbH | Epilepsy, focal seizures, after at least 2 previous therapies | 52,910–167,470 | 100% additional benefit not proven |
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