levodopa / carbidopa / entacapone (Lecigon)

following a resubmission:

levodopa 20mg/mL + carbidopa monohydrate 5mg/mL + entacapone 20mg/mL intestinal gel (Lecigon®) is accepted for restricted use within NHSScotland.

Indication under review: treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results.

SMC restriction: for use in patients not eligible for deep brain stimulation (DBS).

Evidence from a phase I pharmacokinetic study showed that the dose-adjusted levodopa exposure was significantly higher with Lecigon® treatment, when compared with levodopa + carbidopa monohydrate intestinal gel (Duodopa®); the relevant comparator for this submission. Supportive evidence from a real-world study and an indirect comparison provided by the company suggest comparable efficacy and safety between these two treatments.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.