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Hi!

We recently received information from our hospital here in Sweden that Tysabri only will be administered to those patients that have a severe version of RRMS. I am very interested in knowing what the strategy for administering tysabri in the US is? Is it for all RRMS sufferers or do they make a disticntion in the deegree of severity?

I guess I am looking for arguments to influence those in charge of the policy decision here.

Kind regards,

Martin

It probably all depends on how close the DR decisions will be monitored. Here in US, I believe it will all come down to what the DR puts on your record.

Martin,

As is the case for almost every kind of MS medication, there is going to be a fair amount of debate on who should use Tysabri.

Originally, the drug was tested on and was going to be used for initial, mild cases of RRMS. The subsequent problems with Tysabri now have it likely to be used on those patients who have done poorly on the CRAB drugs or have a very aggressive form of MS. Tysabri has not been tested on more severe types of MS and there is still a lot of concern about long term safety usage.

I think that many government health organizations around the world are likely going to wait to see how patients react to Tysabri during the first year and then perhaps begin to make some decisions when more data is available.

Also, unless the patients' insurance companies approve the use of the drug, it's terribly high cost will prevent most from trying it on their own.

Harry

Here in the US, Tysabri is only for "relapsing" forms of MS, which include RRMS, PRMS and SPMS with relapses. Furthermore, Tysabri can be used as First Line (as in needle phobic MS patients) and/or Second Line, as indicated by Dr. Richard Katz of the FDA in a C/C. See the FDA statement: "Tysabri is a monoclonal antibody used to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations (flare-ups). Tysabri is indicated for... patients who have not responded adequately to, or cannot tolerate, other treatments for MS."
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html

In addition:
See Tysabri Label: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations." http://www.biogenidec.com/site/TYSABRI-PI-MedGuide.pdf

You can also argue that you have a highly active/aggressive form of RRMS to the Swedish infusion center!

Best wishes Martin, and again - Welcome!

It was approved and can be gotten as a first line of therapy without having to go through other medications first. With its history, it may be difficult to find a doctor who will prescribe it without having tried one of the other medications first. I thought I'd have to go through a series of tests and endless paperwork to get it but that was not the case. I was prescribed it and started receiving it within one month. I was on one of the other medications but it started losing its effectiveness. I thought I'd have to go through the cycle of being on the other treatments first.

According to the "guidelines" here in Germany it can be prescribed as first medication, when the RRMS is highly active. I don't know how many doctors really do that or wait till the other stuff, IFN beta or Cop, fail... In fact, one of the reasons I'm on Rebif is that I hope it's easier to get Tysabri afterwards if its necessary...

Sandrine