ONTOZRY

Key points                         

Favourable opinion for reimbursement in the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-epileptic medicinal products.

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. Epilepsy does not systematically require the prescription of a long-term treatment.

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 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. If dual therapy does not stop seizures completely or is poorly tolerated, the anti-epileptic therapy (monotherapy or dual therapy) having achieved the best level of seizure control, along with a satisfactory efficacy/safety balance, should be chosen.

Patients should be referred to an expert centre in the event of drug resistance, epilepsy liable to be eligible for surgical treatment or epilepsy associated with a known or suspected rare disease.

At present, in the treatment of focal-onset seizures, meta-analyses and marketing authorisations do not enable any particular medicinal product to be prioritised in the treatment of focal-onset seizures in adults.

Role of ONTOZRY (cenobamate) in the care pathway:

ONTOZRY (cenobamate) is an additional treatment option in the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-epileptic medicinal products (drug resistant).

The potential benefit of cenobamate in focal-onset seizures with or without secondary generalisation should take into account the efficacy and safety of the product, as well as

the effects observed in patients with a specific diagnosis.  

The Summary of Product Characteristics (SPC) and the Risk Management Plan (RMP) must be complied with. The use of this medicinal product in pregnant or breast-feeding women must comply with the SPC.