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At greater ease? No, Harry, I respectfully disagree with you. It is scaring the hell out of a lot of them unneccessarily. Across the board, doctors and patients are getting an unbalanced view of Tysabri. That subject was discussed in great detail at this conference. And not just about Tysabri either, about drugs under RiskMAPs in general. But more so about Tysabri. If you read the Med Guide, there is no beneficial information about it in there. Nothing. It is all about risk. All the information the patient receives about Tysabri is about the risks and not the benefits.
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Perhaps using the word "ease" was not correct in this situation as I didn't mean to infer that MS patients would feel comfortable.
But who is to blame about the "unbalanced view" about Tysabri? You only need to look at Biogen/Elan for causing this entire mess in the first place. That's all they had to do was follow their original plans for the trials and subsequent approval process for Tysabri. But no, they rushed everything by a full year and got caught when PML showed up and that forced them to withdraw the drug.
Even after all the subsequent studies, nobody knows for sure just how and why the two MS patients contracted PML and of course that has caused a tremendous amount of caution by the docs. And the docs will always error on the side of caution and thus many won't prescribe Tysabri at this time.
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The cost of the drug went up 21%, but was that due to inflation and anticipated manufacturing costs?
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Certainly not inflation which is around 2-3% per year. And Biogen knew exactly what it was going to cost them to manufacture Tysabri. Heck, they had their entire marketing plan for the drug outlined on the internet before the drug even got approved the first time around. They had block-buster numbers for this medication which they anticipated would take over a huge chunk of the MS drug world.
No, this huge increase was to cover the extra costs of getting the drug re-approved and that took a lot of money to do so.
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One thing I can tell you is that there is no consistent cost associated with the infusions across the country. During my survey I found infusion costs from $3500 to $7500. That's just not right.
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You can say that again!!! Those infusion costs along with the cost of the drug make Tysabri by far the most expensive drug ever for MS. That leads to a cost/benefit situation that insurance companies and government health organizations must look at and it certainly doesn't make choosing Tysabri and easy task.
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Elan/Biogen, Idec lost a lot of money when they took Tysabri off the market February 2005 and there is still one (known) pending lawsuit. Is that a factor? I have no idea about these things, but I do know that this is the cost of doing business.
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Of course it cost them a ton of money to pull the drug....why do you think we saw the 21% price increase?
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Harry, bottomline, Tysabri is still a controversial medication for the treatment of MS. Its associated RiskMAP and TOUCH protocol was discussed by several of the presenters at this conference. It's a good RiskMAP/protocol. There are kinks and holes in it that must be addressed and fixed and that was what I pointed out to Biogen through my survey of patients who are in the "system." They spoke and they spoke loudly. Let's hope Biogen heard them.
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I will go back to my previous statement that Biogen/Elan are totally responsible for making Tysabri the controversial drug it is today. Can you imagine the different course that would have been taken if approval submission had been made AFTER the full two years of the Phase III trials? The PML cases which showed up in February 2005, before the FDA would have obtained the submission data, could have been handled differently at this point. I'm sure the fear that currently surrounds this drug would have been far less.
Harry