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Added benefit of fampridine is not proven
Date:8/29/2012

Fampridine (trade name Fampyra) has been approved in Germany since July 2011 for adult patients suffering from a higher grade walking disability (grades 4 to 7 on the EDSS disability status scale), as a result of multiple sclerosis (MS). The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, there is no proof of added benefit, as the manufacturer's dossier contains no evaluable study data for the comparison between fampridine and the appropriate comparator therapy.

G-BA specifies physiotherapy as the appropriate comparator therapy

MS is a chronic incurable inflammatory disease, in which the patient's own immune system damages nerve tracts in the brain and spinal cord. In some patients, some muscles are in permanent spasm or are paralysed. If the disease is more advanced, patients may develop a walking disability.

The Federal Joint Committee (G-BA) has specified physiotherapy as the appropriate comparator therapy for the benefit assessment. This treatment must fulfil the requirements of the German Guideline on Remedies (Heilmittelrichtlinie). In addition, the patients must receive optimized standard therapy for MS.

Requirements for an indirect comparison not fulfilled

There are no studies that directly compare fampridine with physiotherapy. Instead, the pharmaceutical company presented data on an indirect comparison. These data originate from studies in which fampridine was compared with a placebo or in which physiotherapy was compared with "no treatment".

The legal ordinance on AMNOG explicitly specifies that it is possible to prove added benefit using indirect comparisons too. However, specific methodological conditions apply, which were not fulfilled by the manufacturer in the fampridine dossier.

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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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