No conclusions can be drawn from the open arm of the first trial, using glatiramer, since the comparison with placebo or dimethyl fumarate was not a primary endpoint.
#Dimethyl fumarate copay assistance trial
1.1 in the first study), which raises the question whether the exacerbation rate in the year preceding the trial may have been overestimated. A remarkable reduction of the number of exacerbations was seen in the placebo group, largely corresponding to the findings in the dimethyl fumarate group (1.0 vs. The results of the two randomised double-blind trials of dimethyl fumarate to treat patients with multiple sclerosis that have been published so far showed that, over the study period of approximately two years, the agent produced a statistically significant reduction of the number of exacerbations in patients with relapsing-remitting multiple sclerosis, compared to placebo. This means that doctors are allowed to prescribe dimethyl fumarate using the generic name, and pharmacists are allowed to supply a magistral prepation. 5 European drugs legislation allows pharmacists to prepare the drug magistrally, which means that no manufacturing authorisation or marketing authorisation is required, provided it concerns a drug that is prepared by the pharmacist at the pharmacy, on a doctor’s prescription. In response to questions by Dutch parliamentarians in November 2014 about the cost of dimethyl fumarate, the Minister of Health, Welfare and Sports (VWS) stated that Tecfidera® was a special case, in view of the availability of an alternative in the form of the magistral preparation, which is still covered by Dutch basic healthcare insurance. Serious side-effects have been found when the drug is used for the treatment of psoriasis vulgaris, such as progressive multifocal leuko-encephalopathy (PML) (Gebu 2014 48: 3).
#Dimethyl fumarate copay assistance registration
In fact, Germany’s own registration authority does not regard Tecfidera® as an NCE. This method of obtaining a patent is a rarity and can be added to the list of profit-maximising tips for manufacturers published in Gebu 2012 46: 148-150.
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Based on this ‘dossier protection’ of an agent that has for many years been used as a magistral preparation for the treatment of psoriasis vulgaris, the manufacturer has raised its cost tenfold, resulting in extra costs of over € 1000 a month (see the table). The trials performed by the manufacturer have obtained it a market authorisation for Tecfidera® and market exclusivity for this drug for the next ten years. As reported in our German sister publication Arznei-Telegramm (AT 2014 45: 28-29), the manufacturer has managed to get dimethyl fumarate, one of the components of Fumaderm® (which also contains monoethyl fumarate) classified by the European Medicines Agency as a New Chemical Entity (NCE) in the Tecfidera® preparation. Until recently, fumarates were only available as magistral preparations, and in Germany also as a proprietary product, Fumaderm®. Dimethyl fumarate is a derivative of fumaric acid used in the systemic treatment of psoriasis vulgaris (Gebu 2011 45: 121-132).