Hey Joe? You there?

Read this post from sheena http://neurotalk.psychcentral.com/sh...ysabri&page=36

then look for her latest posts. You can search on her posts by clicking under her pic on the left side of her posts and then click on "find more posts by sheena"

She went through some stuff too, but it all turned out ok. You can ask her too, cause she is still here and still on Tysabri!

Me too Vic!

I have Anthem BCBS of Maine. I am under an OLD plan where I have Major Medical and basic insurance, you know, the OLD insurance. Everything associated with my infusion costs is picked up by my major medical.

As I posted the other day, the cost of the drug being charged by the infusion center FAR outweighs what the infusion center charges for the actual infusion. I'm scrolling back here in the Tysabri forum to find out what the last increase in Tysabri cost was. If I have to hand carry my own Tysabri in I will, just to cut the infusion center's rip off.

I haven't heard from the specialist at BCBS after my talk with her the other day, but she is looking into what they are charging and how much it will cost by getting it through the ins. co. specialty pharm as opposed to the infusion center's supplier.

I forgot to tell you that the refund I am expecting is directly related to the "balance billing" thing you posted. They are going back to 1992 and they are going to refund me all the money I paid to any provider over what they paid after my deductible.

She said they would take it directly from the providers and refund it to me and deal with them on the overcharging. She said it was due to an error in how my plan was listed and that they were charging me as if every provider was out of network provider instead of a network provider, even though I don't have a network ( if they accept BCBS they are in network!)

I should be seeing a good chunk of change from this one!!:) I told her I want an itemized list of every overcharge to compare to my own records.

I am going to go to bat here for the Tysabri users out there. The charges some of you are being charged for infusion itself are outrageous! I'll start making some noise and see what comes of it. If I need some voices I will let you all know!!

"Elan to decide on $300m new plant as revenue rises

By John Mulligan

Friday October 24 2008

Irish pharmaceutical firm Elan will make a decision before Christmas on the proposed location in Dublin for a $300m manufacturing plant, according to chief executive Kelly Martin.

Speaking yesterday as the company announced a 53pc year-on-year rise in revenue during the third quarter to $270.1m, Mr Martin confirmed that the planned sale of the company's drug delivery unit has been postponed "for the foreseeable future".

Elan's shares tumbled more than 9pc in Dublin yesterday to close at €5.64.

It had been expected that the drug technology unit could attract a purchase price of up to $1.4bn.

Chief financial officer Shane Cooke said there had been "considerable interest" in the unit, but that a decision had been made to pull the sale. He said structures would be put in place to fuel growth at the drug delivery division.

Private Equity

Private equity giants including Texas Pacific, Bain Capital and Warburg Pincus had all expressed an interest in the business. Kohlberg Kravis Roberts and Cinven had already pulled out of the bidding process.

Mr Martin added that the planned sale "wasn't a balance sheet reason; it was a strategic reason" when asked how the postponement might affect its ability to repay $1.1bn of debt that matures in November 2011.

He added that it would be premature to say what options the company would explore in relation to the debt.

Elan said that its adjusted earnings before interest, tax, depreciation and amortisation were now close to break-even, and that the break-even position should be achieved by year-end.

It posted a net loss of $84m for the period, down from $87m a year ago, beating estimates.

Patient enrolment for use of Elan's Tysabri multiple sclerosis treatment declined after two new cases of the life-threatening brain disease PML were discovered during the summer. One of those patients has almost recovered, while the other was "not in good shape", according to Mr Martin.

CFO Shane Cooke added that extrapolating patient enrolments since the summer, Elan would have 60,000 people using the drug by the end of 2010. That's below the 100,000 target the company hopes to reach. For every 10,000 patients that sign up to use Tysabri, Elan generates an extra $100m in annual profits.

Moderation

"There was a moderation in subscribing habits," conceded Mr Cooke, who added that it was too early to determine whether the slower take-up since the summer would continue. He added that the 100,000 target remained appropriate.

Analyst Ian Hunter with Goodbody Stockbrokers also said that the fact Tysabri subscriptions had not fallen as much as expected was a "positive riposte" to those who believed the enrolment numbers would shrink more significantly.

- John Mulligan"

http://www.independent.ie/business/i...s-1508045.html

Cherie

Not sure why the above business article was posted.

It has to do with a manufacturing plant for Elan's drug delivery unit. Elan manufactures drugs that are developed by other companies, that use Elan's proprietary nanotechnology drug system, where they are able to reconstitute a drug by making it into nanosized particles that are more easily delivered into the body (think very small molecule) thereby using less of a drug to gain more benefit.

Tysabri scripts declined less than 1% overall, most notably during vacation time. It is thought that the PML cases did not have an effect on people who were on Tysabri and that most people who were on Tysabri chose to stay on Tysabri, with some people who were considering Tysabri either going ahead with it or choosing to wait until more investigation was done.

Elan does not manufacture Tysabri. Biogen Idec does. Although Elan invented Tysabri, their agreement with Biogen Idec provides that Biogen manufactures and controls Tysabri in the US, and Elan controls ROW, with Biogen manufacturing Tysabri for worlwide use.

As for the generation of profits, there are agreements in place where for every certain number of patients on Tysabri, Biogen must pay Elan a royalty above the normal profit share.

I could elaborate on this but this thread is for Tysabri users for information and questions about using Tysabri, not a business thread, so I will refrain.

The reason this matters to Vic (and others), is that he no longer able to take this med because of COST, and the continuously growing cost of the med and/or infusion center charges is very relevant for many people who are on or are wanting this drug.

Most of the “news” in that article was very good (at least that’s the way I saw it), but it was COST factor that I was posting to. Vic had brought up that 43 out of the 48 patients had to stop taking this drug because of infusion costs, and this article suggests that for every 10,000 people on Tysabri, the company generates 100,000 million in profit (NOTE: not revenue, but PROFIT).

I didn’t realize that this was something we shouldn’t be talking about here, so I will seek more clearly defined parameters for this thread with the administration.

Cherie

talking about and debating are different things vic.

BTW...I thought I asked rather nicely that if anyone wanted to dicsuss this they do so by PM. :rolleyes:

Vic - I thought you figured out the incorrect billing going on and that you might/would return to Ty.

In looking at my bills for the two Ty treatments I had...the med itself was around $2500 and the rest of the charges were less than $500. The center billed Blue Shield (of CA) for $2,956.00, and BS "approved" $2,624.66 - meaning that was the allowable amount. And from that, I have a 20% copay - leaving me with around $500 to pay.

What I have never understand from your experience is HOW and WHY the infusion center was charging you exorbitant amounts.....and why you weren't able to check other infusion locations. It is definitely concerning to me.

I also have wondered....and I hope I'm not being TOO nosey....is does your insurance policy have an Out of Pocket Maximum for the year? My policy has a $4,000 out of pocket max. Once I hit that - then all of my copays are covered and I pay nothing. This is different than a deductible (of which mine is currently also $4000). I have a PPO plan.

The biggest "bummer" about my plan is that injectibles - like all the CRABs are covered under PRESCRIPTION benefits - which do not fall into the out of pocket maximum limit. So all of my meds, I have to pay, though the negotiated rate. But now that I'm back on Copaxone - my copay is close to $600 for that alone :eek:....but I'm VERY fortunate to be receiving assistance from the Chronic Disease Fund.

However, between now and December 31st, I plan on getting as much medical care as possible.......since it won't cost me anything (as long as I'm in network - which with Blue Shield PPO, it pretty much covers anything).

Through the years when I watched my mother chronically and terminally ill....I learned alot about insurance....and I own my own business, so I got to choose our plans.

I guess I should be thankful - BS has been VERY good to me. They approved the HiCy treatment within 5 minutes of receiving the request. When I had gastric bypass surgery 4.5 yrs ago, they approved that within an hour. My MRIs have always been covered. When I needed provigil or other off-label meds, they've approved.

And most interesting is that a nurse case manager has been calling me to follow up on my recent hospital stay/chemotherapy treatment (the HiCy)! Can you believe that?! Totally shocked me.

Oh, and any claims I file when I use an out of network provider....I get my reimbursement check within 10 days or so!

Vic - if you need any help with this stuff - let me know... Plus, I'm a New Yorker....and I've been known to go "NY on people" :)

Be well,

~Keri

ps/I still think you should look into HiCy!

I just spoke with my neuro-team and although they agree that the absence of IVSM would provide valuable data, the delay in treatment could cause nerve damage. Hence, they have a plan...and so do I.

With an incredible amount of help from Lauren, Biogen & Elan have done something with my insurance about the infusions (and I do not know the details yet...but the result is expected to be certain this time).

On November 3 I see my neuro-team to start Tysabri again!

What a rollercoaster ~~~~~~~~ Just up and down and up and down! LOL

Well, it looks like I may have missed the first Tysabri train pulling out of Riverside, but I have a free ticket to the next one, and it boards on November 4.

-Vic

Lauren,

I do not know who you called or what you did, but THANK YOU !!!!

I see my neurologist on November 3 and will be back on Tysabri on November 4 !!!

Some way or another there seems to have been a deal negotiated between Biogen, Elan, Anthem Blue Cross and the infusion center to make this all work out in a fair manner.

Thanks again for all of your help !!!

-Vic

Holy Cow, Vic! Good for you!:)

How's your stress level with all this back and forth stuff??? :rolleyes: It'll be interesting to see the graphs after all you have been through!

I am glad to hear the problem is solved!

Thanks!

The good news is that I have not been stressed by this entire process since it became clear that there was an opportunity to monitor the physical response to being off of Tysabri. And, in an odd way the loss of that evaluation is kind of a bummer (as I must be nuts).

-Vic

You're just a scientist through and through Vic! :) I hope it's true, that you'll be back on Ty and the problems will be over. I'm glad you're looking at it in a positive way though. :hug:

Wow, Vic. I've been off the board (too busy right now) and checking in now and then. What a ride you've had!! I am so happy that things worked out in your favor and that you will be going back on Tysabri. Whoohoo! :yahoo: I know that you may have been excited about charting what happened off the drug but I'm glad to know you are back in the club with us!

Biogen reports another case of PML.

http://www.247wallst.com/2008/10/biogen-finds-mo.html

Unconfirmed reports state that the case of PML was caught early and that the patient has already received plasmapheresis treatments and mefloquine, and is under treatment as an outpatient. The patient had a prior history of treatment with interferons, glatiramir acetate and methotrexate. It is unknown at this time how long the patient was off those other drugs.

More forthcoming as it becomes available.

I think the reason this case was announced was because it is the first case in the US since Ty was off market, and the first under the TOUCH program.

Patient was previously treated with methotrexate for a "rheumatic condition" with last dose 4 months previous to start of Tysabri.

Patient is a 59 yr old female with history of 14 infusions.

Patient is under home treatment by her doctor. She went to the ER with aphasia and nausea. An MRI was done and PML was suspected. Treatment with plasmapheresis and mefloquine was started immediately.

Info is slowly trickling in, but I don't expect to hear much as far as ongoing news due to HIPPA, more than likely just general updates.

Hi all :)! Sorry I haven't been around for a while. I'm remaining stable (no relapses) since I started Ty in February. No improvement. I'm having an mri next week because my cognitive sx are getting worse. I saw neuro this morning and the first thing he said to me was 'there's been another case of pml'. He also told me that the woman appears to be responding well to treatment, not saying that there won't be lasting damage but it doesn't look like it will be fatal. That's great to hear! Hopefully there won't be many more cases, but if there are it seems that doctor's, will be able to test and treat quickly.

I had my 19th infusion yesterday and my six month MRI. The infusion went well, and I have the CD of the MRI. I had the MRI after the infusion though, so unless the doctor sees something bad on it when he gets it emailed to him from the radiologist, I expect to hear his opinion a month from now. I checked it out and it looked good to me for what that's worth, lol.

There was some issue with my eyes yesterday when he examined me and he wants my records from the eye doctor. When he had me follow his finger left to right, there was some double vision (sort of) to the left. I doubt it's anything though.

I'm tired today but it's slow at work so that's a good thing.

Glad to hear # 19 went well Wiz!:hug:

I'm also glad to hear he is keeping up with the eye thing. It may be nothing, but it's docs like yours who are catching PML early enough so that there have been no more deaths and minimal disability in some of the cases.

How things stand right now:
(1) Tysabri infusions, the Tysabri co-pay and associated tests have cost me more than most people make in two years.

(2) Anthem Blue Cross will only cover the remaining 2 months of Tysabri this year, wherein they cover the entire medication cost, but not the infusion cost. The subsequent ten months of 2009 will result in costs similar to 2008 (though slightly higher).

(3) The decline in QOL was noticable after 12 months on Tysabri...and that in my opnion was a direct result of the stress caused by the costs.

My Plan:
(1) After Thanksgiving I am on Rebif for certain. The cost will be $25 per month.

(2) IVSM starting tomorrow.

(3) Ophthologist this week.

(4) An AFO next week.

So the plan is final. Tysabri is done.

I am going to just relax for the rest of the day and pay bills & wash clothes in the morning.

My Tysabri Log will continue until I begin Rebif soon. Post-Tysabri data are valuable.;)

-Vic:)

Hi Vic, Wow. Sounds like way too many ups and downs with this Tysbari business. You sound good, though. I guess all you can do is just be as zen as possible. I'm optimistic about new meds on the horizon. I've been reading a lot about them lately. I know your neuro is on top of this.

Anyhow, sorry you had to deal with the "one minute this, the next minute that..." bull#&%*$. I've been having my own Tysabri problems lately but nothing like yours.

There is something to be said for eliminating the stress of money, though!! :)

Good luck with the IVSM.

Natalie :hug: :hug: :hug: :hug:

Vic,
I am just so sorry to hear this. I've been working on this problem with no solid answers.

The problem lies with infusion centers and their costs, whether they are private infusion centers or run by a public health organization or a nurologist in house; insurance issues and differences in policies, whether they are self pay or employer sponsored, public or private, etc etc etc.

It's a vicious circle and there seems to be no end.

I am sorry to hear you will lose because of this issue. It just sucks.

Actually I loooove adventures and data-crunching, so this turn of events will be fun! Some say I am nuts, and maybe I am, but documenting the end of the Tysabri adventure has value and is neat to me.

Rebif will be a new adventure and I am looking forward to the process.

All in all, it could be so much worse: I could be in a third world country dehydrating, starving and trying to avoid military strife.:eek:

I am one lucky SOB!:D

-Vic

I had my 5th infusion yesterday. It was relaxing and quiet (unlike past times). This time I had a different nurse who actually read the questions the TOUCH protocol requires (unlike the first 4 times). It's a long complicated story. Needless to say, I've drafted a 2 page letter to the director/neurologist of the clinic complaining about all the problems with their administration of Tysabri and the failure to follow the TOUCH protocol.

I feel wiped out from the infusion and now have a low grade fever, which I have gotten a couple of times after other Ty. infusions. :( But other than that things are fine and dandy! Glad the election is over too.

Glad to hear it all went well for # 5, Natalie!

How long does the fever usually last? What does your neuro say about it?
Do you treat it with tylenol or what?:confused: Enquiring minds want to know...:D

I go for # 20 tomorrow and see the neuro afterwards, after working all night!

Hi RW,

The fever lasts no more than 2 days and it is very low grade (99.1 or 99.2). Out of 5 infusions I have gotten it 4 times. But my normal temp is usually 98.2 so I notice I feel crappier when it's a degree higher. I just take naproxen. Actually, I haven't told the neuro about it. I probably should. I haven't mentioned it I guess because it doesn't last that long and I had problems with low grade fevers for so long in the 1 1/2 years before I got diagnosed with MS and even after getting diagnosed. I had a bad case of mono for almost 9 months a year before the MS and I'm not sure I really recovered. So the neuro knew all about the fever problem -- I had been seeing a rheumatologist in the beginning too. But ironically, the continuing fevers (for days at a time and a higher temp) have actually gone away since I went on Tysabri!!! This has made me so happy because without the fevers I have felt a million times better. And it is a complete mystery to me why the Tysabri would make those annoying lingering fevers go away (they call it "fever of unknown origin").

Good luck with #20. I imagine you must take a nap in the infusion chair if you go in after working all night! :)

YUCK on the mono and being sick for so long!

I know I have something about this (fevers) in the studies and when I come across it in my files I will send it over.

I actually don't usually get a nap in the chair! Once I am awake, I am AWAKE, and just driving there and being exposed to actual daylight revs me up!:cool:

(i should be in bed right now!)

RW Yes, please send me anything you have regarding fevers and Tysabri. I am VERY curious.

Vic Sorry to hear it Vic. Are you going to do graphs with the Rebif? That would be interesting too.

Absolutely, Natalie.

I have had time to refine my analysis and collect the data necessary for a reasonable evaluation.

The graphs and analysis will be posted in a Rebif Log here at NT.

-Vic

# 20 DONE!

As usual, no problems, no concerns, scheduled infusions for the next 6 months.

Saw the doc afterwards and had a great discussion after my appt.

#1- my bloodwork showed elevated WBCs. He said this is normal with Tysabri due to the mechanism of action and that if you have inflammation, you will run a fever even if you don't notice it, and MS has inflammation associated with it (lesions!) and that it shows the Ty is doing it's work.
( For Natalie)

#2- ordered an MRI and had to have bloodwork because the MRI peeps are checking everyone before they will do a contrast study (NSF-nephrogenic systemic fibrosis associated with gadolinium). Also ordered the usual liver panel.

#3-talked about the new case (US) of PML and he says he is not prescribing Tysabri for anyone who has been on chemo, novantrone, cellcept, methotrexate, etc. Too big of a risk, drugs stay in system too long, thinks that there will be more neuros prescribing Ty as first line therapy because immune systems are intact and no exposure to strong immunosuppressants, etc.

#4-talked about the EU pts and specifically #2 pt who was in very bad shape with IRIS after the plasmapheresis treatments and mefloquine (antiviral used primarily for malaria)
http://en.wikipedia.org/wiki/Immune_...atory_syndrome


He'd had a look at the MRI from this pt and said the MRI of the PML was a walk in the park compared to the IRIS MRI and that we'd be hearing a lot more about IRIS in the future.

He said that there are studies going on right now with pre-treatment with Remeron http://www.drugs.com/remeron.html and Cyproheptadine http://www.drugs.com/pro/cyproheptadine.html because both of these drugs are 5HT2a blockers and inhibit the movement of JCV into the cells. In addition they are relatively cheap and very effective since they close the door on the JC virus.

All in all a very good (and informative!) appt, although long!

I'm off to bed! LONG LONG DAY! :cool:

RW
Thanks so much for all of this extremely useful information. It sounds like your neuro is really on top of things. So he was saying that inflammation in the brain from MS can cause fever? And that the Tysabri takes the inflammation away, along with fever? Very interesting.

What is NSF-nephrogenic systemic fibrosis?? What is the bloodwork test they are doing?

The treatment with Remeron would be given if you showed signs of the JVC virus?

Again, awesome information!! Sleep well!

That's the way I read it too . . . but you said that you are getting an increased fever only AFTER the infusion . . .

If that is what Tysabri is doing, why wouldn't the infusion reduce the inflammation/fever rather then increase it? :confused:

Cherie

I went into detail in your PM about the WBC and the BBB Natalie.

NSF is a disease that has been noted in some folks with kidney problems after use of gadolinium. You may see some commercials on TV from ambulance chaser lawyers about this. Evidently a lot of MRI companies are now testing for kidney problems before using gad now. I think the testing is like shutting the barn door after the fact for those of us who have had numerous MRIs with contrast.:rolleyes:

The Remeron, cyproheptadine and mefloquine are very inexpensive antivirals or in the case of Remeron, used to treat depression but has anti viral qualities.

The BBB is supposed to be impermeable. Rogue T cells and WBCs are what gets by when the BBB loses that impermeability. Tysabri acts to block the T cells and the WBCs from crossing the BBB, restoring the BBB to impermeability. WBCs are the signal that there is inflammation. The body sends them out to fight it. That's why lesions are created, the WBCs are fighting the rogue T cell damage. We don't know why those T cells go rogue or why they are able to get into the brain or why the BBB opens. Tysabri doesn't block them all but it stops a lot of them. That is why some people still have relapses and lesions. There is still damage going on in many cases.

I am looking forward to seeing my new MRI when it's done. I had a really good one at 6 months. I am hoping that after 20 infusions I see more improvement. My last one showed no new lesions, no enhancing lesions and many of the large lesions were gone or greatly reduced in size.

I haven't had a relapse since I started and that for me, is the greatest benefit! I was cycling through every three months or so and to be able to see straight and clear, to be able to walk in a straight line without balance problems and dizziness, to be able to do most of what I did before MS is truly a benefit. It may not be a cure, but it works for me.:)

(now if I could only get rid of the spasticity and stiffness...That damage is IMO, directly related to NOT being able to have Tysabri when it was off the market, causing damage that has not repaired. I still have hope for that problem, when I look at the data on famipridine (4-AP))

The way I've read it explained before (but it was in reference to how they thought PML was occurring with the use of Tysabri) . . . Tysabri's mechanisms are based on the belief that Multiple Sclerosis is caused when T-cells (which are the soldiers in the immune system), "mistakenly attack the lining of nerves in the brain. Without this lining, cells stop functioning and die. Tysabri works by preventing the T-cells from entering the brain. (But those same T-cells normally keep the virus that causes PML in check. If that virus, which is dormant in most people, is allowed to run rampant, it damages or destroys the brain)."

So, I see where you are coming from with the explanation on Tysabri managing new lesions/inflammation, etc. and how it could be effective for that purpose.

The part I'm still confused about though is how an infusion would seem to be CAUSING a fever for Natalie. While I can see how Tysabri might be controlling the inflammation from causing more inflammatory lesions (which is perhaps why she had so many fevers before Tysabri, and isn't now), I still don't understand why is it that every time she has an infusion she seems to get a fever for a few days? :confused:

Cherie

Idunno... my brain isn't focusing.

Maybe a mild tooth infection? Maybe it's why they often prescribe tylenol along with benadryl before infusion? Maybe there's something else going on? Maybe it's all those WBCs signaling the body that fever is associated with immune response?

Maybe you can find the answer? I'm just too tired and I have to work a ten hour OT shift tonight. I'm going to bed...again :p

Yes, I see what you are saying about the use of Tylenol, perhaps because Tysabri would "appear" to cause fever for many people (not just Natalie).

If that's the case (it's "normal" to get a fever), I guess it doesn't really matter what the mechanism is that "causes" it. Everyone is still doing well . . . so it's all good. ;)

Sleep tight. :)

Cherie

Hi Cherie,

I was having continual low grade fevers from the time I had mono until I was diagnosed with MS (about 1 year and 8 months). There was a break in between at one point. My theory is that the mono may have tripped the MS switch and then the lingering fevers became just a symptom of the MS. No one could figure out what they were coming from--my rheumatologist at the time of the MS diagnosis consulted with a well known MS specialist and he said he had seen some patients with low grade fever. Even so, I just assumed it wasn't from the MS but some sort of left over chronic fatigue syndrome or post-viral syndrome from the mono. But then I went on Tysabri and a few times I would get a fever for 2 days after the infusion but the general long term fevers (usually weeks at a time, and a little higher) completely went away. It was so strange. My temp went down to below normal -- 98-98.2. It was heaven because I felt a SO MUCH better. :) So the little and low 2 day fever after the Ty. infusion is very different than what I had before. I have no idea what it means but it doesn't phase me since most of the time I no longer have fevers which is a godsend! I will ask my neuro next month about why I get the little fever afterward. Maybe it because of a mild over suppression of the immune system the first couple of days (higher amount of Ty. in the blood)??? But that doesn't explain much. Although, I've only had 5 infusions and I've heard you don't reach steady state medication in the body until after 6 months.

Natalie