Philadelphia Tysabri Conf.

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby JoanCT » Thu Feb 03, 2005 4:40 pm

Hello All-

After "lurking" here for many months this thread has caused me to join and participate. I am the mother of a really wonderful young man, in his early twenties, diagnosed over a year ago with RR MS. He has been on Betaseron since diagnosis. His neuro, possibly the same one that Flora68 goes to, was a participating physician in the Tysabri trials and feels that our son is a good candidate for Tysabri. We were informed, on about the same date that Flora posted, that the cost submitted to the insurance company would be $4,000 per dose. As this was a lot higher than this office had initially indicated, I spoke at some length with the infusion nurse and later called the Tysabri line.

First, its starting to appear that the $4,000 figure for submission to the insurance company is probably not way out of the ballpark based on other postings that I have seen here and elsewhere. The $1809 amount is the WAC - Wholesale Acquisition Cost - I don't know that a neuro would be able to purchase at that price. I once worked for Pfizer and the wholesale price was not the purchase price - there was always a supplier taking a cut. I've talked to some friends who work in hospital settings in major cities, and looked back at the bills for my parents' chemotherapy and infusion fees around here can be over $1000 without considering the additional hour of monitoring which we all understand and want given the possible reactions.

It was explained to me that the insurance company will then reply with the "customary" amount that they are willing to cover - that's the operative number. In our case 70% of this customary amount will be covered by the Major Medical portion, not the pharma portion, of our medical coverage. We pay the balance up to the annual deductible and then the insurance company kicks in with the balance for the rest of the year. That left me still not knowing how much the drug would cost us out of pocket. I also went back to research some of the bills that our insurance pays and realized that I ought to pay more attention - in fact the allowed charges (in network) are typically not much over 50% of the office invoiced charges. Xrays tend to be reimbursed at about 33% and some tests at only about 25%. But since we never get billed for anything over our deductable we had the luxury of ignorance at least in terms of cost. The $1242 for Betaseron has been covered completely. I take one prescription that costs me $10 but has a price to the uninsured of $125. So who doesn't think that this is a mess that has to be addressed?

My next move was to call the Tysabri line early this week with 2 questions: one about the price and the other about the reports on this site of deaths.
First, there are a number of people on that line who work with potential patients and their insurance companies to get hard and fast numbers as to the out of pocket costs prior to infusion - each insurance company and policy is different and they are understandably more than willing to help a patient through the maze once they have signed the request form at their doctor's office.

Second topic: I've worked in the software business for way longer than I like to admit and I don't believe much that I read on the internet, particularly when it's already hearsay so I initially dismissed the rumors of deaths. I did some research on the web and came upon numerous trials that were stopped after a death occurred, or even after specific risks were increased. But some of the people on this forum seem to believe that this could be a reliable report -though it is second or third hand - so I set out to find an answer and frankly I didn't. The Tysabri line is pretty tightly controlled. I talked to two different people - both told me that they are very tightly controlled by the FDA under the terms of the early release and that all calls are recorded and that they cannot say anything positive or negative about the data that is not released yet - ie the Phase III data. BTW, each conversation began with a reading of the warnings about Tysabri. Both were extremely pleasant and seemed to be sincere is their desire to be helpful.
I then called the FDA - not easy to reach a person there when you call in. Interestingly I left a relatively generic message and within an hour had a callback on my cell phone! I described my concerns and was again told that even a request under the FOIA would not budge any information, positive or negative, about a trial that was ongoing. I switched tactics and asked what specifically would cause a trial to be stopped. I was initially told that a death from a drug in a trial would stop the trial although its really not that cut and dried - the word "situational" was used - they would investigate the situation and determine if the (hypothetical) death was caused by the drug, or perhaps the way it was infused or other aspects of the situation. I was told that any death which occurs during a trial is investigated and weighed against the perceived benefits of the drug - ie we all know that chemotherapy can kill people.

I don't really want to fuel the debate re the reliability of the quote - unless someone is willing to make their own statement clearly including dates and places, its hearsay as far as I am concerned. There is no doubt that Tysabri can cause some nasty reactions and I am certain we will hear about them as people have their second and subsequent infusions. I hope that others will attempt to get some definitive answers and continue to share them here. I think it would be great if we could put enough pressure on Elan or the FDA to make a statement but I am thinking it is unlikely. I hope others do call requesting more info and post their information here.

I just want to say thanks for the time and energy that so many of you devote to this forum. It has become a great source of information for me and always helps me to think in alternative ways about fighting this lousy disease.

Joan
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Postby HarryZ » Thu Feb 03, 2005 6:56 pm

Joan,

Thank you for your very well written and informative note. With all the thought that you obviously put into your message, your posts I'm sure would be welcomed by all the readers.

It certainly does appear to be a bit of a maze when it comes to the cost of a Tysabri infusion. It's unfortunate that the $1800.00 wholesale cost of the drug that Biogen made public has been taken by many as the cost of the infusion. As we are finding out this doesn't appear to be the case and many readers are becoming quite shocked at the high price. Hopefully as more and more people start this treatment, we'll get an average cost.

I too am trying to find out just how accurate the information is about the two deaths that allegedly happened with Tysabri. It doesn't surprise me that the people at the Tysabri hotline can't say anything about this or any other data. The FDA is quite strict about giving out this kind of information outside of their jurisdiction, especially when Tysabri was more or less conditionally approved pending the two year trial data. I have a friend who has some connections and will try see what they can come up with.

For the time being, I consider the original source of this information to be very reliable which really has me wondering. But like you said, until it is positively confirmed, it is a rumor. If it does prove to be true, there are obviously going to be a lot of questions being asked.

Again, thanks for your excellent post.

Harry
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Welcome Joan

Postby flora68 » Fri Feb 04, 2005 9:12 am

Glad to have you aboard, Joan :)
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Biogen info

Postby better2gether » Fri Feb 04, 2005 1:43 pm

.
I found this on another message board.

"I called the Biogen Tysabri info number and after 30 minutes on the line with them was able to get the following information.

1. There was one death during the trials, but it was unrelated to the drug. These things do happen, people die.

2. Biogen is not countering misinformation from any sources and has no apparent plans to do so in the future."

Regards
.
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Re: Biogen info

Postby HarryZ » Fri Feb 04, 2005 2:31 pm

Better,

Interesting that the Biogen Info person per that conversation gave the person who called some detail on the death of a trial participant. Per Joan, the people at this number would not give her any information whatsoever, stating FDA regulations.

At least we are now getting some kind of information about this situation.

Harry
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Link to replay of Philadelphia Tysabri Conference

Postby optimist » Thu Feb 17, 2005 12:24 pm

Last edited by optimist on Thu Feb 17, 2005 3:09 pm, edited 1 time in total.
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Postby Arron » Thu Feb 17, 2005 1:07 pm

For those wondering, optimist's link is to a Tysabri video (i did not watch it yet, though)
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby amelia » Mon Feb 21, 2005 4:59 pm

On the subject of allergic reactions:
Gary's neuro told us in Nov appt. before FDA approval that she would not give him a full dose the first time. It would be a little and she would watch him to make sure there was not an allergic reaction. I don't know if this is standard procedure, but if you are going to have a reaction, it would be better to have a small amount in you rather than the whole kit and kaboodle. Just my opinion. Has any other neuros said this?
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Postby Arron » Mon Feb 21, 2005 6:57 pm

by the way, Hello and Welcome Joan :)
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby optimist » Tue Feb 22, 2005 12:47 pm

Hi Harry,

I don't know if you ever took the time (1 1/2 hrs) to look and listen to the video that I linked to in my post of 2/17/05, but it is a video of the ENTIRE live Philadelphia teleconference including Q & A. I listened carefully, but I did not hear the answer that you quoted as a reply to the audience question cited in your original post (1/29/05) on this topic.

FYI, the Q & A portion starts about 1:14 in the video, but the entire video is quite interesting as a number of patient case studies are presented along with a discussion of possible treatments by neurologists.


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Last edited by optimist on Tue Feb 22, 2005 2:25 pm, edited 1 time in total.
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Postby HarryZ » Tue Feb 22, 2005 1:09 pm

Optimist,

I don't know if you ever took the time (1 1/2 hrs) to look and listen to the video that I linked to in my post of 2/17/05, but it is a video of the ENTIRE live Philadelphia teleconference including Q & A. I listened carefully, but I did not hear the answer that you quoted as a reply to the audience question cited in your original post (1/29/05) on this topic.


The info and question that I posted on that first message of this thread was sent to me and others from a person who works with MS. She actually took part in the original live teleconference and sent a brief summary of the conference to several on her email list. I copied and pasted that one particular question and answer that I got in my e-mail.

I have no way of verifying the info and have only listened to part of that conference. It's 1 1/2 hours long and every time I try to listen for any period of time, I get interrupted. I'll try and listen to the entire conference and see if I come up with the same conclusion as you did.

Harry
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Postby HarryZ » Tue Feb 22, 2005 7:38 pm

Optimist,


Well I was finally able to listen to the entire teleconference.....took me about 6 hours, again always being interrupted by something!

The first mention of the placebo data suspicions came from Dr. Kachuk when he stated that the data from the Affirm and Sentinel trials was very similar. That was during the patient case study discussion.

The second mention of strange data came at the very end when they discussed the relapse rates being quite different as compared to the CRAB studies and explained this due to different criteria being used to determine what exactly a relapse was.

The info I was given certainly didn't reflect what was said I am going to write the person involved and ask for a clarification. I'll get back to you when I hopefully get an answer.

It was also interesting to hear the docs on the panel mention the 54% reduced exacerbation rates that one of the CRAB pharma's had published recently. They pretty much dismissed this data, stating that it was not compared to placebo but instead obtained from people using the drug post clinical trial. This supposedly "skewed" the data for a number of reasons with one being that patients who stopped using the drug did not have their data counted in the final results.That meant that the data used made the final figure much more attractive. The fact that the CRAB efficacy rates were from 30-33% was repeated more than once. Yet how many times have we heard from messages posted on the net that the CRABs have a much higher beneficial rate than what we have read in the past?

I got the impression that the panel and presenter were very gently trying to state that the CRAB drugs were more or less past their prime and that the new drug of choice was now Tysabri. The MS professionals in the audience continued to show this support as well with their mini surveys. Yet, the data presented at the beginning of the trial was from the one year data from 2 of 99 world wide 2-year Phase III trials. Surprisingly, this limited data did not influence the MS professionals in the audience.

Harry
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Postby HarryZ » Thu Feb 24, 2005 6:57 am

Optimist,

I received a reply back from the person who wrote the original info about the Philadelphia web-cast and she stands by her original comments!!

Hmmm....I'm not sure what to say at this point. Web-casts can be edited before being made available on the net but that would be a serious accusation to infer on the producers.

Let's just say that I have a lot of question marks at the moment!!!

Harry
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