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 Post subject: Tysabri in the UK :{
PostPosted: Mon Nov 29, 2004 12:07 pm 
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Well maybe :( depends on your point of view - see other threads!

NICE's web site tells us this about this treatment.

Quote:
Natalizumab for the treatment of multiple sclerosis

Scope Draft scope for consultation: October 2005
Appraisal Status Pending
Final Scope published 21 November 2005
Information meeting for consultees W/C 30 January 2006
Closing date for invited submissions 29 March 2006
First Appraisal Committee Meeting 6 September 2006
Second Appraisal Committee Meeting 1 November 2006
Expected Date of Issue April 2007

To e-mail NICE on this topic Sarah.Cumbers@nice.nhs.uk
Technology Appraisal Project Manager Dr Sarah Cumbers
Executive Lead Andrew Dillon
Technical Lead To be confirmed
Communications Manager To be confirmed
Assessment Group Southampton Health Technology Assessment Centre (SHTAC), University of Southampton

Project History 17 August 2004 Topic summary published.
My emphasis. Guess there'll be some jolly good data by then :)
I have emailled Dr Cumbers asking if there is any change given the FDA fasttrack approval. I'll post her reply here. http://www.nice.org.uk/page.aspx?o=207025

There is no current statement from UKMSSoc this one is from the Chief Executive Mike O’Donovan responding to the leaked stories earlier this month:
Quote:
It is highly encouraging to see such a marked effect on reducing relapses and we are keenly looking forward to the full results of the trial, which is also looking at the potential for the drug to slow the progress of disability.
I look forward to his statement saying that the Society will press for an immediate advancement of the NICE programme. There's a longer article but saying nothing new http://www.mssociety.org.uk/news_events/news/research/antegrenresults.html

A search of the European Medicines Agency's web site showed nothing for Tysabri nor Antegren nor Natalizumab. UKMSSoc suggest that it is this body that approves a drug for use in the EU (hence UK). Anyone know if this is so? http://www.emea.eu.int/

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PostPosted: Mon Nov 29, 2004 12:18 pm 
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John,
2 months ago I spoke with a professor of clinical neuroscience about Antegren (Tysabri). I was told that as soon as FDA approval was granted, he would be able to prescribe in the UK. I guess that whether you will be able to get a prescription within the UK will depend upon the old postcode lottery until NICE comes up with a definitive statement.

I have another appointment with him in January. I will put the question to him directly at that time and try to get a complete answer.

Robin


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PostPosted: Tue Jan 25, 2005 11:04 pm 
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It seems that once again burreocracy -and not MS- is the issue. I don't know if this has anything to do with a European drug makers' sales and their useles, ineffective, expensive and full-of-side-effects treatment. (Their advertising slogan should be: Imagine a side effect, we have it!)

Anyway, what are they waiting for? Are all these stupid meetings needed? I understand that they have responsibility about the safety of a new medicine, but, wait a minute! The same people gave their approval for Rebif! Who sane person would do such a thing! (Only one that does not have to take it, of course!). And what a patient may suffer by MS is far more than what Tysabri may cause. (but far far far less by what Rebif may cause!)

But it seems that nobody in EMEA has MS, so who cares? "Let Serono, doctors and wheelchair makers earn some more money and some day in the distant future, we will approve Tysabri. But first, we have to eliminate the People Front of Judea! Splitters!"


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