Reason for request
Favourable opinion for reimbursement as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
The objective of medicinal treatment is the absence of seizures combined with good tolerability of treatment, where possible. Where this is not possible, medicinal treatment aims to reduce the number of seizures, with the best possible quality of life. The therapeutic strategy should be tailored individually, in liaison with patients and/or their families and/or legal representatives, based on the patient’s characteristics (sex, age, etc.), seizure type, syndrome diagnosis, existing medicinal products and treatments, comorbidities and lifestyle.
Anti-epileptic monotherapy should be used as first-line treatment. When the first-line treatment is not sufficiently effective at the maximum dose or is poorly tolerated, monotherapy using another drug (which may be a first or second-line alternative) should be initiated. The anti-epileptic drug replacement period should be carefully monitored. In the majority of cases, it is recommended to use an anti-epileptic dual therapy when two successive monotherapies, appropriate to the diagnosis of the seizures or syndrome and at optimal doses, have not enabled complete control of seizures.
Role of the medicinal product in the care pathway
VIMPAT (lacosamide) is an additional treatment option in the management of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
The potential benefit of treatment with lacosamide in primary generalised tonic-clonic seizures should be weighed up, taking into account the product’s tolerability, the effects on other generalised seizures, such as absence and myoclonic seizures, as well as the effects observed in patients with a specific diagnosis. Considering the risk of exacerbation of myoclonic seizures and the lack of efficacy on absence seizures, the patients most likely to benefit from lacosamide treatment are patients presenting isolated primary generalised tonic-clonic seizures.
The Committee deems that the clinical benefit of VIMPAT (lacosamide) is substantial as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
Clinical Added Value
|no clinical added value||
but in view of:
the Committee considers that VIMPAT (lacosamide) provides no clinical added value (CAV V) in the therapeutic strategy for the treatment of primary generalised tonic-clonic seizures.