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.
Download detailed advice126KB (PDF)
Medicine details
- Medicine name:
- eslicarbazepine (Zebinix) Resubmission
- SMC ID:
- 592/09
- Indication:
- for the treatment of adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
- Pharmaceutical company
- Eisai Ltd
- BNF chapter
- Central nervous system
- Submission type
- Resubmission
- Status
- Restricted
- Date advice published
- 08 November 2010
NOTE: Eisai has withdrawn the Patient Access Scheme for eslicarbazepine acetate (Zebinix) following a reduction to the list price of the product on 1 May, 2012. However, the SMC advice remains valid as the reduced list price is lower than the price SMC made its decision on.