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Gary is in the VERY SLOW process of getting in the TOUCH program to receive Tysabri. He was required to have a MRI of the brain within the past 6 months. The Neuro nurse stated that the DR would look at the MRI and see if he was a canidate for Tysabri. Other than the obvious PML, what are they looking for?

Amelia,
I would think the key thing to the MRI that the TOUCH program requires is not to rule out PML but to have a benchmark in case something goes wrong once the infusions start. As for 6 months they must have loosened the MRI requirement because just 60 days ago it was 3 months. Lastly I got my TOUCH approval in minutes once I had the MRI. Maybe Gary is getting a run around that didn't come from TOUCH.

Lee

The nurse we are dealing with has never met Gary. Our Neuro changed to another group since all of this has begun. MRI was done closer to home with affliate hospital. We are suppose to hear something today about his appointment to get enrolled in TOUCH.
That being said:
I have had to call the nurse back at each level to "see what we are going to do next". When I spoke with her Fri afternoon, she was hesitant about Gary getting Tysabri. Her words " when she (the neuro) looks at the MRI, then we will know if he is eligible for Tysabri. The reason I said that the nurse had never met Gary is that his last MRI show 5 OLD lesions. But Gary is of the MSer's that has much disability with little lesions.
I'm guessing that she was making her own interpretation of the MRI. ( I knew she was looking at it as we spoke)
Anyway, maybe something today.

Here we go again!
Gary spoke to his Neuro this morning. He had nothing new on his brain MRI. (had 5 OLD lesions in little more than a year ago)
Neuro (she) wasn't keen on putting him on Tysabri. Said he wasn't showing "progress" with his MRI. (Gary's MS has never shown well on MRI and has affected spine mainly) So he tells her that his has been mainly in the spine. She says he isn't relapsing and is Progressive. He has never been labled progressive and does have small set backs with improvements. We just don't see running to the DR everytime he has a minor set back the improves on its own.
Now she is going to run MRI of the spine and then sit down and discuss everything with him. She started in about the possiblity of dying. Gary said he had been reading up on Tysabri for a while.
Doesn't look like it is the patient's choice, does it. I know the DR has input, but what about the patient!
the saga continues.
Will let you know how it all goes.

Does anyone have a Tysabri update from Kaiser

Amelia,

It's certainly strange that they are looking at MRI's to determine if a MS patient gets to use Tysabri. It is well known that not all lesions show up on an MRI and that there is little correlation between these lesions and symptoms. You can also have just a couple of lesions and severe symptoms and many lesions and minor disability problems.

And now it may appear that the docs are going to be very hesitant about approving some patients going on the medication. Just one more obstacle for MS patients to overcome....that's all you need, more roadblocks!!

Harry

hi Devner, Amelia, Ronnie (wherever you are ) as most of you know, I've been fighting with Kaiser Permanente So. Calif. re: their roadblocks to Tysabri..well goooood news! These are a few of my posts from my Blog: http://lauren-livingwithms-aolcomlglbgl ... gspot.com/ (If I copy and paste, it will be much easier on my hands, and should only take 2-3 posts here to bring you all up to date):
Sunday, August 27, 2006
Patient demand for Tysabri, and update on the Kaiser So. Ca Saga....

Ok, now to start off, I believe patient demand for Tysabri initially will be fairly high. Why you ask?? Because 50% of the MS population is no longer RRMS, they have progressed to SPMS with a majoriy falling into the "with relapses" category (like me)...and we do not want to get worse - progressing to SPMS w/o relapses - making us ineligible for Tysabri and only making us eligible for incurring further disabilities! The patient is the one suffering these risks, not their neuro that either refuses to rx Tysabri through the TOUCH program or is taking a 'wait and see' attitude...patients educated in their disease process, educated in the true & correct facts regarding Tysabri, and who fall into the above category (even newbies with a needle phobia) will NOT wait...as they can plainly see their future with disabilities without Tysabri.

As for my own Tysabri saga with Kaiser So. Calif. not getting on board with No. Calif. Kaiser, my neuro called me late Thursday and advised me of the following: her boss - the Chief of Neurology - in her home office in the S.F.V. (HUGE offices in P.C. with an adjoining Kaiser hospital and every single med. specialty you can think of) got involved a few weeks ago as I believe the patients were screaming for action re: Tysabri and the TOUCH program to be instituted, in addition to the demands that we be referred outside the network for evaluation and the complaints & grievances were piling up. Further, she told me she has 5 other patients (among her many MS patients) that are also demanding Tysabri as they too are on the verge of becoming SPMS w/o relapses.

Could all of the above been due to other outside activities forcing Kaiser's hand? I really don't know...

The good news is she has been in contact with my Kaiser member services rep, MSactivesource, the Biogen rep servicing their area, and they are working on coordinating the ''in-servicing/training".

The bad news is that she told me that this will 'probably' not be completed until mid-October as all of the neuros, and all of the infusion centers (along with their personnel) have to be scheduled together, thus the delay. But she also said IF it's completed sooner than mid-October, I will be immediately advised.

At least it's a start, I just pray I can hold on to my dx of SPMS with relapses until then, and that she does not upgrade my dx when she evaluates me in October and we go over all the enrollment forms.

I still don't know if they have changed the current status of denying authorization for Tysabri as being 'experimental' under the Sr. Advantage Plan (Medicare HMO), and I'll be following up with Kaiser tomorrow.

On a side note, I received an 'approval letter' from Kaiser yesterday to see an outside-of-the-network neuro that can prescribe Ty for me once evaluated and eval of my recent MRI (which according to my neuro had "changes", well duuuh), after the Chief of Neurology at Kaiser reviewed my medical records. The earliest appt. I could get with the MS specialist outside of Kaiser was 10/31! I refuse to cancel that appt even though Kaiser is "starting" to come around, as I'm on a waiting/cancellation list for an earlier appt.

10/31......and people are wondering about patients and Tysabri therapy??? I have never before waited over 2 months to see a neurologist due to him/her being booked solid in advance........ does that give all of you any idea regarding patient demand?

Helllllllloooo????

Lauren

Monday, August 28, 2006
Kaiser Permanente So. Calif./Tysabri Saga continues.......,


Whoa, more good news from Kaiser... I got off the phone earlier today with the members services rep from Kaiser who's been helping me through their gawd-awful maze. She told me that Tysabri will be covered under Part B of the Sr. Advantage Plan! (Medicare HMO Plan, Note: I was originally advised that Tysabri would not be covered under Kaiser's Senior Advantage Plan either under Part B or D as it was excluded as experimental!!!)

This is a classic example of patients being their own advocate (do you guys think by me calling Medicare originally to find out if it was covered under their Part B [yes it is!] had anything to do with stressing this fact to my member services rep before she called Kaiser's Head Oakland Pharmacist to inquire why Tysabri was originally not covered under the Sr. Advantage Plan - Medicare HMO Plan as being "experimental"?????).

Only 2 remaining hurdles to overcome: 1) remaining SPMS with relapses and 2) getting Kaiser So. Calif. to speed up their in-servicing of the neuros and infusion centers!!!

Lauren

Saturday, September 16. 2005
Just a short update tonight.....

I'm truly overwhelmed at each of your concerns for me. I just got home tonight and online after being admitted to the hospital for 4 days. My choices given to me by the attending neuro, after filling me with 3 days of IV Solumedrol, were 1) hire a caregiver 24/7 to assist you with your chair transfers (which is what landed me in the hospital Wednesday night after I took 2 bad falls - as I can no longer stand) and help you with your daily chores, or 2) you have to go to a nursing home for the next 6 weeks.

Well, option #2 was out of the question, so I hired a caregiver to live with me (I'm sooooooooo NOT happy about that because now I have no privacy to speak of, plus it's costing me a small fortune as Kaiser Sr. Advantage doesn't cover live-in care, etc.) BUT it's better than the alternative.

Now do all of you understand the phrase "TIME IS BRAIN"??? All this time without Tysabri, MS is creating MORE lesions on my brain, and this time, it's taken away my ability to even stand. I don't even know if I'll still be eligible for it now, and the neuros in So. Calif Kaiser won't be "TOUCH" Certified until mid-October.

I can't type long as this is my first night home, and I'm not feeling all that great...more disappointed than anyone, at the system.

Thank you one and all for your concern. I have a TON of emails to answer, and I probably won't get to half, but once again, thank you all. I'm not giving up, and neither should any of you!

(((hugs)))
Love, Lauren

Friday, September 22, 2005


My Tysabri Diary... eeeeeeeeeeee!!!!!!! My neuro's secretary just called me...

and told me my neuro wanted to see me (discharge from hospital follow up)...when I asked if she had completed the 'TOUCH' certification training yet as I didn't want to make two trips to see her (I was prev. told mid-oct), her nurse said hold on......when she came back on the line, she said "yes, and she wants to see you asap...now she's booked solid again, but can you come in on 10/2 and she'll see you in between patient appts if you don't mind waiting a bit when you're here?"

I said, "Not at all...of course, I'll be there with bells on my chair!" (I'm thinking, I've waited since 3/1/05 until 6/5/06--plus through 10/2 it will be 19 months without Tysabri...wait a bit in between patient appts...helllllllllooooooo?)

One last hurdle to go: keeping my dx of SPMS with relapses to stay eligible for Tysabri.

(((hugs)))
Love, Lauren

leeeway:

I would think the key thing to the MRI that the TOUCH program requires is not to rule out PML but to have a benchmark in case something goes wrong once the infusions start. ... Lastly I got my TOUCH approval in minutes once I had the MRI. Maybe Gary is getting a run around that didn't come from TOUCH

"Tysabri will only be administered to patients who are enrolled in the program. Prior to initiating the therapy, health care professionals are to obtain the patient's Magnetic Resonance Imaging (MRI) scan to help differentiate potential future multiple sclerosis symptoms from PML. "
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html

As for 6 months they must have loosened the MRI requirement because just 60 days ago it was 3 months.

This is not in reference to MRIs...it is in reference to re-evals by neuro..."Patients on Tysabri are to be evaluated at 3 and 6 months after the first infusion and every 6 months after that, and their status will be reported regularly to Biogen Idec. More information, including a detailed product history, is available at www.fda.gov/cder/drug/infopage/natalizumab/default.htm."

Amelia:

Neuro (she) wasn't keen on putting him on Tysabri. Said he wasn't showing "progress" with his MRI. (Gary's MS has never shown well on MRI and has affected spine mainly) So he tells her that his has been mainly in the spine. She says he isn't relapsing and is Progressive. He has never been labled progressive and does have small set backs with improvements

It sounds like Gary needs a new neuro, as she does not want to get involved with the "TOUCH" program or is an idiot (sorry)especially with your statement:

He has never been labled progressive and does have small set backs with improvements

Those are relapses!!! Just guessing here, but it sounds like he is SPMS with relapses, perhaps?

Doesn't look like it is the patient's choice, does it. I know the DR has input, but what about the patient!

No, Amelia...GARY has the final choice, it is his body, his disease, and the neuro works for him! Gary must take charge of his own health and be his own patient advocate.

Furthermore honey, print these 2 links out for your neuro: "Tysabri is a monoclonal antibody used to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations (flare-ups). Tysabri is indicated for use as a monotherapy, meaning it should not be used in combination with other immune system modifying drugs, and is for patients who have not responded adequately to, or cannot tolerate, other treatments for MS." http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html

Tysabri label: "INDICATIONS AND USAGE TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."
http://www.biogenidec.com/site/TYSABRI-PI-MedGuide.pdf

Imho Amelia, for her not to prescribe Tysabri for Gary, or at the very least refer Gary to a "TOUCH" certified MS specialist asap, she is doing a dis-service to her patients.

If Gary is adamant he wants the opportunity to have the MS medication that shows a proven 2/3rd's efficacy of a 68% reduction of clinical relapses, an 83% reduction in the development of new or newly enlarging MRI-detected brain lesions, reduced the mean number of enhancing (active) MRI lesions by 92% after the first and second year and improves the patient's QoL, call MSActivesource at 1-800-456-2255 and request the names and phone #'s of 3 TOUCH certified neuros near you and pick up Gary's newest "brain" MRI when he sees his female neuro.

Best wishes always honey...,

Those are relapses!!! Just guessing here, but it sounds like he is SPMS with relapses, perhaps?

Yeah, I do believe he is SP w/ relapses. He does have a "spell" of worsening for a couple of days and then improves completely from that. The problem comes in where the neuro has NO record of this because he does not run to the DR every time he has a problem. With Medicare, you simply stay with the big problems. He has had MS for over 25 years that we know of. He is in the stage of the disease to cross over. And yes, we know the huge importance of getting some better medicine. He has been off Copaxon for several months. Really no difference than on it. He is scheduled for a spinal MRI Oct 2 and an appt with neuro on Oct 9th. She wanted to tell him about the TOUCH program and all the side effects of Tysabri. Well DUH!!! He told her that we were VERY updated on the Tysabri via the internet. I think once we sit down and talk, she will be AMAZED at what we do know. THANKS TO ALL HERE ON THIS FORUM!!
Her statement was:
You know that you could DIE from Tysabri?
Yeah, and steroids kill TOO!

Amelia,

Her statement was
You know that you could DIE from Tysabri?
Yeah, and steroids kill TOO!

As harsh as that statement may sound, it is something that the doc has to make simply for liability reasons. While you are extremely well-informed about Tysabri, there are many MS patients who don't have the opportunity of searching out this info on the net. This kind of patient has to be told everything about the drug prior to trying it.

I hope it works out well for Gary.....he has waited long enough!

Harry

The main thing is if the Tysabri doesn't work like we want it to or for whatever reason Gary chooses not to take it, I doubt he will go back on the CRABs. There are TOO many options out there that we did not know about. We have a friend that is spoon fed his info by the DR. I'm afraid most people are. I know through this site there are so much options to see what works best. NONE of it is a cure yet, but we already know the CRABs are not the answer.

amelia wrote:The main thing is if the Tysabri doesn't work like we want it to or for whatever reason Gary chooses not to take it, I doubt he will go back on the CRABs. There are TOO many options out there that we did not know about. We have a friend that is spoon fed his info by the DR. I'm afraid most people are. I know through this site there are so much options to see what works best. NONE of it is a cure yet, but we already know the CRABs are not the answer.

I'm going to guess that the vast majority of MS patients obtain most if not all of their info from their doc. When we moved here to London ON from Toronto over 4 years ago, we met several new friends who had MS. In almost all of our conversations with them, very few participated on MS internet forums but got their info from their doc and MS Society publications.

I know what you mean about options that are out there. Marg started using Prokarin over 6 years ago for her SPMS. It has helped reduce most of her MS symptoms and given her some quality of life. Of course, sitting in a wheel-chair 16 hours a day isn't very conducive to good health and that in itself causes several other related medical problems.

I can really appreciate what you are going through in trying to help Gary with this lousy disease. The frustration level for the care-giver is often over-looked but very, very real.

Whatever you and Gary eventually end up trying, I hope it helps give him some relief.

Harry