Advice

following a full submission assessed under orphan equivalent process:

mexiletine (Namuscla®) is not recommended for use within NHSScotland.

Indication under review: for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

In a short-term, phase III, crossover study, mexiletine significantly improved muscle stiffness compared with placebo when measured on a visual analogue scale.

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
mexiletine hydrochloride (Namuscla)
SMC ID:
SMC2241
Indication:

For the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders (NDM).

Pharmaceutical company
Lupin Healthcare
BNF chapter
Central nervous system
Submission type
Full
Status
Not recommended
Date advice published
09 March 2020