Drug manufacturer did not present evaluable study data on the appropriate comparator therapy
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 optimised standard therapy for MS.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1310
Prior to starting Fampyra I had been on Tysabri for almost 5 years with no adverse effects while on it and no rebound when I came off it.
I have tried both Fampyra and compounded 4-AP. I do not notice a speed increase in walking, I do note that my control of movements and balance are improved while on 4-AP (ie Fampyra).gymbuff wrote: I was never really interested in an increase in walking speed just in walking ability.
Just to correct my original post. I have been taking Fampyra since last December - which is closer to 6 months than 3 months.
Anyway as I noted in my last post my walking had dis-improved even though my overall energy levels are good. My walking further dis-improved this week and the level of stiffness became so great yesterday that I had difficulty standing up. I made the decision to go back taking Fampyra and took my first tablet last night. I remember my neurology telling me that I would notice the difference within 2 weeks of starting, if it was to have a positive effect, and she was correct. Yesterday was 15 days since I stopped the treatment so rapid improvement and rapid dis-improvement.
As you are all aware MS affects everyone differently so my story may not be your story but as of now I am sticking with Fampyra.
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