Dimethyl fumarate (trade name: Tecfidera) has been approved since January 2014 for adults with relapsing remitting multiple sclerosis (RRMS). In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether this new drug for MS offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). However, no added benefit can be determined, as no suitable data are available, neither for the direct nor for the indirect comparison.
Multiple Sclerosis: New Therapeutic Indication for an Old Drug
MS is a chronic and incurable inflammatory disease of the central nervous system, which often has a relapsing course. If the symptoms disappear completely or at least largely after a relapse, the disease is referred to as "relapsing remitting" (RRMS).
Dimethyl fumarate is taken as a tablet. The exact mode of action in MS is not yet known. Fumaric acid (including dimethyl fumarate) has long been used for the treatment of moderately severe to severe types of psoriasis in patients who do not respond sufficiently to topical treatment.
Drug Manufacturer Restricts Comparator Therapy
The G-BA specified beta-interferon (1a or 1b) or glatiramer acetate as the appropriate comparator therapy. The manufacturer chose beta-interferon 1a as the comparator therapy; however, this was restricted to a specific compound with this active agent (Rebif). But according to the G-BA, all available beta-interferon 1a compounds and thus a further compound (Avonex) should have been considered for the comparison with dimethyl fumarate.
This has no consequences for the direct comparison with the appropriate comparator therapy, as no studies were available here anyway. However, this has far-ranging consequences for the indirect comparison, which is now incomp
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care