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eslicarbazepine (Zebinix) Resubmission

Advice

following a re-submission

eslicarbazepine acetate (Zebinix) is accepted for restricted use within NHS Scotland.

Indication under review: as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

SMC restriction: patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs.

Eslicarbazepine acetate reduces seizure frequency compared to placebo over a 12-week maintenance period.  Direct comparative data versus other anti-epileptic drugs are unavailable, particularly comparisons with other cheaper agents with a very similar mode of action.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of eslicarbazepine acetate. This SMC advice is contingent upon the continuing availability of the PAS in Scotland.

Drug Details

Drug Name: eslicarbazepine (Zebinix) Resubmission
SMC Drug ID: 592/09
Manufacturer: Eisai Ltd
Indication: for the treatment of adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
BNF Category:
Sub Category: 4.8 Antiepileptic drugs
Submission Type: Resubmission
Status: Restricted
Date Advice Published: 8 November 2010

Archived Advice

Full submission 18 January 2010

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