Resource impact statement

No significant resource impact is anticipated

NICE has recommended mexiletine, within its marketing authorisation, as an option for treating the symptoms of myotonia in adults with non-dystrophic myotonic disorders. It is recommended only if the company provides mexiletine (Namuscla) according to the commercial arrangement.

We do not expect this guidance to have a significant impact on resources; that is, the resource impact of implementing the recommendations in England will be less than £5 million per year (or approximately £9,000 per 100,000 population, based on a population for England of 56.3 million people).

This is because the number of people eligible for treatment is small (around 250 people) and we do not think practice will change substantially as a result of this guidance. Clinical experts on the committee stated mexiletine is already established in clinical practice with off-label use, and that people would be offered other off-label sodium channel blockers if mexiletine was not suitable. This results in a low overall incremental cost of treatment.

Mexiletine has a commercial arrangement (simple discount patient access scheme). This makes mexiletine (Namuscla) available to the NHS with a discount. The size of the discount is commercial in confidence. For details of the patient access scheme, contact information@lupin.com.

Mexiletine is commissioned by NHS England. Providers are NHS hospital trusts.

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