Abstract
ObjectivesMexiletine is a long-known drug used for the treatment of arrhythmias and repurposed in the 1980s for patients with nondystrophic myotonia (NDM). Recently, the price of mexiletine in Europe increased significantly after registration as an orphan drug for NDM. This led to international discussions on affordability and willingness to reimburse mexiletine in the absence of background information that would justify such a price. Our objective was to calculate a cost-based price for mexiletine for adult patients with NDM based on detailed information on development costs. MethodsWe calculated a fair price based on a cost-based pricing model for commercial mexiletine to treat adults with NDM using a recent European drug-pricing model as a framework to include actual costs incurred. Three scenarios were applied: 1 with minimum estimated costs, 1 with maximum estimated costs, and 1 with costs as if mexiletine was innovative. ResultsThe calculated fair price of mexiletine per patient per year (PPPY) is €452 for the minimum scenario and €1996 for the maximum scenario. By using hypothetical R&D costs used for innovative drugs, the price would be €6685 PPPY. In Europe, the list price of mexiletine ranges from €30 707-60 730 PPPY, based on 600 mg daily. ConclusionsThe current list price for mexiletine in Europe is manifold higher than any scenario of the cost-based models. Accounting for the reduced costs for clinical development in a repurposing scenario, the cost-based pricing model provides a fair commercial price range, which can be used as benchmark for pricing negotiations and/or reimbursement decisions.
Highlights
Nondystrophic myotonia (NDM) is a rare neuromuscular disorder in which the main symptom is delayed relaxation after voluntary contraction, resulting in muscle stiffness.[1]
Mexiletine, a sodium channel blocker, was originally developed in the 1960s and ever since has been used in cardiology to treat ventricular arrhythmias associated with sudden cardiac death.[2,3]
It is a case of obtaining market authorization for a repurposed drug, which gives reason to using a cost-based pricing model to calculate a fair price for mexiletine for NDM in Europe from an industry perspective instead of a value-based pricing model
Summary
In the 2000s, mexiletine and most of its generic versions were taken off the European market. Mexiletine had to be imported, which increased the price to V1777 to V4643 PPPY
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