As I posted on the MS forum, Yabbit and I attended a seminar sponsored by Biogen/ MSActiveSource. This is going to be a long post!
I was specifically interested in the Tysabri questions people asked. I also got to speak to the two Biogen reps about my concerns and get some answers to some questions.
I took some rough notes on questions and this is what I got:
They admitted that the monotherapy rate of PML is 2:35K+ at this point.
There is some thought that Pt. #1 back in September may not have had PML at all!! He was the one who had no JCV showing in his CSF after first LP and an extremely low level after LP # 2. His MRI was reviewed by a number of neurologists and radiologists and most of them feel that it wasn't PML. This was the patient who was treatment naive and is recovering at home. He had some IRIS problems after treatment with PLEX and mefloquine and more info. would be forthcoming as it is known.
Pt.#2 definitely had PML. He was the one whose neuro continued Tysabri and administered steroids before finally testing for PML and he is still in a rehab, with major disability. He was just brought out of a drug induced coma last month. He is suffering from IRIS and they are not sure what will happen with his case. This is the patient who had been on Imuran for years, along with CRABs. It is not known when he had his last dose of Imuran.
Pt#3 ( US patient) is recovering at home. There is still no information at this time due to HIPAA laws. This patient was 14 infusions, had methotrexate prior to Tysabri and had her last dose of metho 4 months prior to first Ty infusion.
I asked about Ty as first line therapy. Answer was every person with MS is different and what would be prescribed for one may not be done for another. If a pt. presented with a lesion load of 20 and 2 severe relapses within a short span of time, doc would be more likely to prescribe Tysabri, than for one with severe relapse and only two lesions. It depends on case and amount of risk patient and doc were willing to assume, but that Ty IS being prescribed for first line.
I asked why Ty is not prescribed BEFORE Novantrone, Imuran, Methotrexate, Cellcept, etc. They said it will come as neuros become more comfortable with Tysabri. It was also stated that Ty will be prescribed more for first line therapy as neuros become more comfortable with it.
For both of the above questions, the example was given: Remember the early 90s when there was a lottery for Betaseron? Some people couldn't wait to get on it and some crapped all over it for whatever reason. As it became more accepted, more people were treated. As each new drug came out, the same thing happened. There's no one perfect choice. Every patient is different and every doc is different and every treatment will be different!
I asked about washout times for patients who are on heavy duty treatments. Doc responded that he would not be prescribing for anyone who has been on those treatments until more info was available. He felt that some of them ( Novantrone was used as example) stay with the patient for a year or more and that more information is needed.
The cost of Tysabri is now 2295.16 per dose. Previous price was 2228.31
Biogen and Elan can help with the cost of the drug, but NOT with infusion center costs. I stressed the need for more information to be available for people who call and ask about this. I asked them if a system could be set up to direct people to places where they COULD get help with costs, such as NORD, and other organizations. The rep stated that they are not allowed to help with actual infusion costs as it could be construed as "enticement" to go on the drug, but agreed that something could be done to direct people.
I spoke to the reps about MSAS specifically. I have NEVER heard from my case worker since I got the first call to welcome me and the second call with my appointment information and insurance information. I admitted that I may have scared the girl when she called to "welcome me" as I had waited three weeks for that call and she had nothing for me except the "welcome". I told them that when you are on Copaxone, the SS people are right up your butt with info, mailings, calls, etc. Not sure if that happens with the other CRABs but it sure doesn't happen with MSAS.
I spoke with her about the MSAS site and how Tysabri was NOT EVER mentioned by name ie: "Biogen- Makers of Avonex and another MS therapy" and that the Tysabri.com site directs you to call the number and you get an Avonex rep and that it is VERY confusing for some folks! I told her I would have brought in my laptop to pull up the sites but that both of them were down when I went to them to get a screen shot to bring up earlier while I was waiting for the seminar to start! Their reply was that they are required to clear everything before it is put on either site, every word of the advertising and packaging for the free stuff they passout has to be approved, every word they say through MSAS has to be cleared, etc etc etc. They admitted that they are as frustrated as many out here are, and that it is getting better slowly, and a lot more activity has been seen since another drug company has come up with a generic for Avonex ( now tied up in court) I had more to say about all that but since it's more about protecting a cash cow I will hold it back from this thread...
I also brought up the problem some people have had when signing up for these seminars and they ask you what treatment you are on and there's no check off for Tysabri. It's not like that on every seminar listed but it is like that for a few of them!
A lot of the attendees asked Ty questions. It was good to hear some of the misunderstandings about Tysabri and hear them officially corrected!
Good seminar. If you get the invite, take advantage of it and go!