health canada approves tysabri
 

A friend got her dose last week. It been approved.
http://biz.yahoo.com/cnw/061004/tysa...oved.html?.v=1

WOW, Dayle.

That's amazing to see Canada getting on the bandwagon so quickly in the game. What a surprise!

Thanks for letting us know.

Cherie

Cherie,

It's not really surprising that Health Canada has approved Tysabri. They have been looking at this drug for months and months and in most cases when the FDA approves a medication, it normally gets approved here within 6 months afterwards.

Dr. O'Connor, who works at the St. Michael's MS Clinic in Toronto, is an aggressive prescriber of MS drugs and it's not surprising that he is the one endorsing its use.

Harry

It's only started to be actively rx'd in the US though, Harry. I've only heard of some people having as many as two treatments so far.

It may take some time to set up the TOUCH protocol in various location too, so it may be several months yet before most here have the opportunity to get on it. Then there's the issue of approval with the various insurance companies too . . .

It's good to have other options available for people, but I don't think this is is one I personally intend to consider in the near future.

Cherie

Congratulations, I think? I hope it proves to work for you all.

I wonder what the setup is for doling it out. Do you need an MRI before to provide a baseline in order to compare to a later one to look for PML? Any kind of monitoring requirements?

Does anyone know what other countries are doing, whether they've approved it too? Is there some kind of international monitoring system so that all countries can have access to information on suspected PML cases?

Does anyone know what happened to the price during the safety review period? Did it go up or down when it was re-released here?

Thanks dayle!

Although Health Canada has approved it here, I would imagine it's going to take at least a few months before anyone has general access to it. I can remember when Sativex got approved here last year, it took a few months before you could actually get it at the pharmacy.

Will be interesting here to see just what kind of MS patient will use the drug. I can remember before Tysabri got approved the first time around by the FDA, I spoke to my wife's neuro who actually was invovled in running trials on Tysabri. He told me at the time that it would be used for initial, mild cases of MS and that in their trial data, there was no improvement in the EDSS scale for the patients on the drug. If hear anything else, I'l let the forum know.

Harry

Dayle,

When Tysabri was being reviewed for those approx 18 months, readers on other forums stated that the CRAB drug makers raised the price of their drugs. I can't confirm this but perhaps someone else may be able to.

I do know that Biogen raised the wholesale cost of Tysabri by 22% during this period!!! That means the cost to the clinics would be about $ 2200.00 per infusion..and that's just their cost of buying it from Biogen. I suspect the cost per infusion is going to be around $3000.00 - $ 4500.00 based on what patients were charged the first time around. The large variance is due to the different charges for administering the Tysabri at each clinic.

It certainly won't be cheap...I'm guessing that the yearly cost will average out at around $ 40,000.00!

Harry

HArry, somehow you managed to quote someone else and attributed it to me?:confused: I think you were maybe trying to address wanabe's post?

Anyhow, I know they have restarted infusions At St Mikes, because a friend had one last week. Fortunately the drug , because it is an IV infusion is covered as a medical procedure and is covered under OHIP. My neuro told me it is for relapsing froms only-rrms and relapsing progressive and spms who have relapses.

I wonder if there's any way that regular people (like us!) can keep up on a database or something of side effects, suspected PML cases, etc. I want to follow this closely but don't know how or whether the pharma co. has an obligation to report publically all reported side FX or suspected infections and things.

Now with alot more people taking it, I want to see how the med stands up to a large number of users and what happens in terms of side effects and the like from using it in a much larger population.

Does anyone know if there's any access to this kind of info available to regular consumers?

You could start a Tysabri Check In thread here. You could do it once a month or ask for a sticky.

BT1 had a Navatrone Check in, that was quite good.

Dayle,

Hmmm...I took the quote from a message that looks like Wanabe originated but was signed with your name!!

Do you know if the current infusions at St. Mikes are being done under the trial umbrella or if they are part of the new approval by Health Canada?

Although the drug has always been used for RRMS or SPMS patients who experience relapses, there appears to be some who are trying to get their neuros to use it on them who have a more advanced level of the disease. From what I have read so far, Tysabri does not do much if anything for advanced MS.

Harry

It has not yet "proven" to be successful on non-relapsing MS, but that seems fairly typical for any new disease modifying drug. The trials target the biggest (and coincidentally most variable) population of MS'ers initially.

As I recall, it's mechanisms are said to be most suited to relapsing MS anyway (reducing attacks is it's 'claim to fame'), but . . . it might end up being like many of our drugs whereby once they have it on the market, it's really up to the individual Neuro to decide if they are going to rx it on a patient by patient basis.

I've definitely heard of several non-qualifying people who intend to FIGHT for it, even to the point of switching Neuros because they feel that is their right! There is still much to consider with the use of this drug, including prior use of immunosuppressants, etc., I'd rather see people trusting their 'usual' Neuro to help make this decision.

People will ultimately find a way to do what they feel is right for them though.

Cherie