GVS advice mexiletine (Namuscla®)

Zorginstituut Nederland has completed its assessment whether the product mexiletine (Namuscla®) is interchangeable with another product that is included in the Medication Reimbursement System (GVS). 

Due to its unnecessarily high price, and from the point of view of solidarity which is the basic principle of our healthcare system, the Zorginstituut advises the Minister of Medical Care not to include mexiletine (Namuscla®) in List 1B of the GVS. To continue to guarantee the patient's access to mexiletine, we recommend the pharmacy preparations be included in List 3 of the Health Insurance Scheme.

Registered indication

Mexiletine (Namuscla®) is indicated for the symptomatic treatment of myotony in adult patients with non-dystrophic myotonic disorders. Each capsule of Namuscla® contains 200 mg of mexiletine hydrochloride, corresponding to 167 mg (166.62 mg) of mexiletine.

Typically, mexiletine is used in the treatment of ventricular tachycardia and ventricular fibrillation as the last treatment option for cardiac patients for whom no other treatment is available.

Therapeutic value

For the evaluation of therapeutic value, the Zorginstituut has compared mexiletine (Namuscla®) to a placebo. In addition, we compared the clinical effects of mexiletine (Namuscla®) with 2 other mexiletine preparations.

The Zorginstituut concluded that in the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders, mexiletine has added value compared to placebo. The clinical effects of mexiletine (Namuscla®) are similar to those of the other mexiletine preparations.

High price

The Zorginstituut has reservations about the high price of this product. The main reason for this is that mexiletine was previously available in the Netherlands at a significantly lower price (for a different indication and under a different brand name). Besides, mexiletine is currently also available in the Netherlands in the form of imported mexiletine and as a pharmacy preparation, at a price much lower than the registered mexiletine (Namuscla®).

The market authorisation holder has indicated that the requested price is based on the significant costs associated with marketing and making mexiletine (Namuscla®) available in accordance with current European standards. However, the Zorginstituut notes that the pricing is not in proportion to the efforts to register mexiletine (Namuscla®).

A much higher price of a product already available (via import or pharmacy preparation) will take up a much larger and unnecessary part of the insured budget. This is at the expense of treatments for other patients or the premium payer. It is the opinion of Zorginstituut Nederland that this high price is irresponsible and incompatible with the social values of health insurance. Such unnecessarily high pricing threatens our system that is based on solidarity.

Zorginstituut's advice

The Zorginstituut has concluded that mexiletine (Namuscla®) has a therapeutic added value compared to a placebo, and that there are no differences in clinical effects between mexiletine (Namuscla®) and already available mexiletine preparations.

Due to the high price and from the point of view of solidarity, which is the basic principle of our healthcare system, the Zorginstituut advises the Minister of Medical Care not to include mexiletine (Namuscla®) in List 1B of the GVS.

To continue to guarantee patient access to mexiletine, we recommend that the pharmacy preparations should be included in List 3 of the Health Insurance Scheme.