Recently, patient access to mexiletine for the prevention of ventricular tachycardia (VT) and ventricular fibrillation (VF) has become critically endangered. This follows from the marketing authorization by the European Medicines Agency (EMA) in December 2018 of mexiletine hydrochloride, now sold as ‘Namuscla’ by Lupin Europe GmbH, as an orphan drug for non-dystrophic myotonias.1 As such, the price of mexiletine has skyrocketed to about €65 000 per patient per year in European countries (price varying with dose and geographic location from €17 000 to €85 000), not only for patients with non-dystrophic myotonia but also for cardiology patients who, since the 1970s,2 use mexiletine to prevent VT/VF. As a consequence, our social healthcare systems are suddenly burdened with another tremendous increase in healthcare costs for a drug previously priced at about €450–4400 per patient per year (either import or production). Noteworthy, this case only adds to our continuing troubles with drugs to prevent VT/VF (e.g. quinidine3).

Continued misuse of orphan drug legislation: a life-threatening risk for mexiletine

Schwartz P. J.;Priori S. G.;
2020-01-01

Abstract

Recently, patient access to mexiletine for the prevention of ventricular tachycardia (VT) and ventricular fibrillation (VF) has become critically endangered. This follows from the marketing authorization by the European Medicines Agency (EMA) in December 2018 of mexiletine hydrochloride, now sold as ‘Namuscla’ by Lupin Europe GmbH, as an orphan drug for non-dystrophic myotonias.1 As such, the price of mexiletine has skyrocketed to about €65 000 per patient per year in European countries (price varying with dose and geographic location from €17 000 to €85 000), not only for patients with non-dystrophic myotonia but also for cardiology patients who, since the 1970s,2 use mexiletine to prevent VT/VF. As a consequence, our social healthcare systems are suddenly burdened with another tremendous increase in healthcare costs for a drug previously priced at about €450–4400 per patient per year (either import or production). Noteworthy, this case only adds to our continuing troubles with drugs to prevent VT/VF (e.g. quinidine3).
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11571/1314126
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