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**JerryD** · 01-14-2016, 11:08 AM

Hooray kw202 ! You won the lottery ! I think its great that you have Tysabri JCV negative. If you are able to do that drug, I think it's a great option. I know nothing about the stats on Tysabri, but I know that my MS specialist has some of his patients on that drug. I have met and spoken to them. Good luck

**Mamabug** · 01-14-2016, 12:02 PM

Welcome to MSWorld. You look to be fairly new; I just read your introduction.

I don't know much about Tysabri, but here are the questions that I have a response to.

Originally posted by kw202 View Post

Second, I've seen some suggestions that Tysabri is a pretty high-powered drug that most people seem to be put on after failing other therapies. I didn't think to ask this at the visit because there was just so much information coming at me, but what would the purpose be for recommending such a drug the first time out? Aggressiveness? Lesion load? Any thoughts welcome. (I suspect lesion load will be it in my case, even though prior to this incident I've had no real reason to believe anything was wrong with me).

I wondered about that too. Tysabri is not usually an option given until other MS meds have failed. I would certainly ask that question prior to consenting to Tysabri. Many of us had had success with the injectables. Tysabri's risks scare me.

Originally posted by kw202 View Post

Third, I do have insurance, but I'm curious about out-of-pocket costs. I realize these can vary across the board, but I'm trying to prepare myself for how this could impact my wallet. What are peoples' typical out of pocket costs with private employer-based insurance, to the extent that can be generalized?

My insurance company has a $30 co-pay for Copaxone 20 (which I used to be on) and Copaxone 40, which I'm on now. Both are considered "specialty drugs" and I have to go through a Specialty Pharmacy to get them. I believe specialty drugs are those that cost over $1500 per month. Since switching to Copaxone 40, Shared Solutions, Teva's patient support, offers to cover the $30 co-pay, so I currently pay nothing for my monthly Copaxone.

Originally posted by kw202 View Post

**Myoak** · 01-14-2016, 05:01 PM

KW202,

Since your neuro doesn�t prescribe injectables there is little to comment on regarding them but to say the older drugs were approved when there was nothing else available. There is a legitimate question� if they came to market today would they get FDA approval? Certainly questionable.

You asked a good question... how long people are recommended to stay on Tysabri, if JCV negative? Biogen doesn�t make treatment recommendations, those decisions are doctor-patient domain and will vary with individual circumstances. One of the popular but false internet rumors was, �Biogen doesn�t recommend staying on Tysabri beyond two years�. I called Biogen and they told me Biogen does not make treatment recommendations. So that rumor is false.

You asked how long people stay on Tysabri if JCV negative� there is no standard length of time. The JC virus causes PML. If you do not have JC virus you cannot and will not get PML. BUT you can have a false negative test, and that does happen. In other words, the JCV antibody titer can be below .2 (the threshold for negative is below .2; the range between .2 and .4 is indeterminate of being positive or negative, btw) but even below .2 (negative) some people were found who did have JC viremia present.

And, there have been a couple people who tested as JCV negative who did get PML, I believe. Obviously, these were positive (remember the JC virus alone causes PML) but they tested negative, a false negative. Please ask your neuro about this, ok? Out of approx. 140,000 the chance of testing negative for JCV and getting PML is quite small.

Keep in mind that you get tested every few months on Tysabri so the chances of having a fluke test (testing negative but actually being positive) is diminished. To me, a test may be off once but unlikely to be off in all subsequent consecutive tests. A negative test several times in a row would be sufficient proof for me that I was negative.

Fall of 2015 the stats were about 140,000 people who had taken Tysabri and about 600 developed PML; about 150 of those (about 25%) died as a result of PML. Again, check with your doctor.

Does risk change if over time you are JCV negative? Interesting question because over time, as an element of aging and exposure people can change from JCV- to JCV+. Nothing unusual about it; as you get older you have more exposure possibility to infections (JCV is of unknown origin) of every type, not just JCV. But you cannot get PML if you are JCV- and remain so.

Second you asked about Tysabri being a med MSers are put on after failing other therapies. Yes, often that is the case but not always. Treatment philosophy comes into play here. Some neuros want to be aggressive right away and stop MS in its tracks as soon as possible.

Other neuros, prefer to wait and see if MS gets bad before going to a higher risk � higher reward DMT like Tysabri. Obviously, the patient�s personal risk profile has to be factored in. Can you sleep with the decision you make? It has got to pass your sleep test, not your neuro's!

Perhaps, your neuro sees or suspects your MS is highly active and wants to treat it aggressively. Be sure to ask and talk about why she leans toward Tysabri.

Third, out-of�pocket cost� Biogen has a co-pay assistance program. Almost everyone qualifies for $100 toward the medicine and another $100 for the infusion. It used to be that you had to make less than 100K per year but it is even higher now, I�m sure.

Just call Biogen and they can fill you in; then you will have it straight. With our insurance, our co-pay is $110. Biogen pays $100 of that. They also assist with $100 toward infusion cost. Be sure to call Biogen and ask about their assistance program, most states allow it but I�ve heard a couple do not.

Fourth, can coming off Tysabri trigger relapse? Yes, it can and does in some (but not all by any means!) instances. But techniques to mitigate or eliminate that are being developed. It used to be that a long washout was standard before going on another medicine. However, it has been found that the shorter the wash out period, the less likely relapse will occur.

Lastly, I would say that Tysabri is tremendously effective in slowing disease progression. My wife has been on Tysabri since 2002 except for a period in 2005-2006 when it was off market due to PML concerns. She is in remarkably good health and has been JCV positive since the first test for JCV was developed a few years ago.

The major technique to de-risk for PML since she is JCV+ is to extend time between doses. The theory is that Tysabri diminishes in saturation over time which allows more immune surveillance against the JC virus. So far, as of last fall there were zero cases of PML in about 900 MSers going 5,6,7, or 8 weeks between infusions and there were 4 cases of PML in the control group (about the same number) on standard dosing of 4 weeks. So, it appears as though extending time between doses is beneficial but the trial is ongoing and some neuros will not change clinical practice until the data is published, peer-reviewed and adopted.

Possibly, people with highly active MS may not be able to go beyond 4 weeks. Also, there is little need to go beyond 4 weeks in the first two years on Tysabri whether you are JCV+ or negative because the PML risk is very low during the first two years of treatment.

I�m sure you have seen charts on estimated PML risk. If not, you might want to Google �Bart�s MS research blog� and find the PML risk chart there. If you do go to that site, also please check out the �Charcot 2� project. They are seeking a viral cause for MS and need our consideration of support.

Tysabri has risk of PML but MS, also, has huge risk if it is not treated effectively. Treatment is a decision each doctor-patient should make together.

Those opting out of the all FDA approved meds should be educating themselves about LDN (low-dose naltrexone), IMO.

Last thought� Ocrelizumab is a new, very impressive med that has been through Phase 3 trials and is likely to get FDA approval late 2016 or thereabouts. Some neuros may choose a med like Tysabri knowing it presents little risk of PML during the first two years and plan to switch to ocrelizumab when it becomes available; or, they may want to stick with Tysabri which has a proven and superb track record of effectiveness with little PML risk if a patient remains JCV-.

In patients I�ve seen and spoken with regularly for more than 10 years at the infusion center side effects on Tysabri are largely non-existent. That is only my personal observation, please discuss side effects with your doctor.

Others on Tysabri will hopefully offer their experiences in this thread, also.

Many MSers who are JCV+ choose to remain on Tysabri accepting the risk of PML because Tysabri has halted disease progression for them.

Just my thoughts. Best!

**sexygatubela** · 01-14-2016, 09:40 PM

kw202,

I'll share with you my experience with Tysabri...

Originally posted by kw202 View Post

First, are there any statistics about how long people are recommended to (or typically stay on) Tysabri if they are JC negative?
I've seen the PML risk factors laid out for 1-2+ years on Tysabri and how it changes geometrically over time if you are JCV+, but I haven't seen such a thing for JCV-. Is there such a thing? Are there quantified risk factors for JCV-? I realize, of course, that my JCV-/+ status could change and that will still require monitoring.

I'm JC-. My neuro suggested switching meds when I see him for my 6-month check-up because he's not comfortable leaving me on the med for this long. I started Ty overseas and he has treated me the last 2 years, so perhaps he hasn't had a patient this long on Ty, but that's something I'll have to ask him. As long as you're JC-, there's no PML risk. And, even if I test positive at some point, I would like to stay on it because it's the only thing that has managed my MS the best.

Originally posted by kw202 View Post

Second, I've seen some suggestions that Tysabri is a pretty high-powered drug that most people seem to be put on after failing other therapies. I didn't think to ask this at the visit because there was just so much information coming at me, but what would the purpose be for recommending such a drug the first time out? Aggressiveness? Lesion load? Any thoughts welcome. (I suspect lesion load will be it in my case, even though prior to this incident I've had no real reason to believe anything was wrong with me).

Yes, Tysabri is usually not given as a first line MS therapy, but it varies from neuro to neuro; some are more conservatives; others more aggressive. In my journey, I've been on this MS meds in chronological order: Copaxone, Gilenya, Rebif, and Tysabri. The first three either didn't work or had liver problems on them. I'm currently on my 36th consecutive month on Ty. I was relapsing every three months (confirmed with MRI), then on Ty every six, then once a year.

Originally posted by kw202 View Post

Third, I do have insurance, but I'm curious about out-of-pocket costs. I realize these can vary across the board, but I'm trying to prepare myself for how this could impact my wallet. What are peoples' typical out of pocket costs with private employer-based insurance, to the extent that can be generalized?

When I was overseas, I paid 10% of the total cost of around �3500 ($4500) for med and infusion. Here in the States I can use my insurance and Medicare, so Medicare covers my co-payment with the primary insurance. And yes, Tysabri in the States its outrageously more expensive. Monthly, my med and infusion is around $20,000 per month. Of course, the insurance has an agreed upper limit with the hospitals in their network, so they cover up to around $13,000. Still, it's pretty expensive on this side of the ocean.

Originally posted by kw202 View Post

Fourth, is there any hard data to suggest that coming off Tysabri itself can trigger serious relapses? I've seen some scare stories, but I'm not sure what to think.

Yes! Plasma exchange over a few days will get the medicine out of your body quicker so you can start on another medicine and minimize the risk of this happening.

Originally posted by kw202 View Post

Last, has anyone JCV- gotten PML while on Tysabri?

No, you have to be JC+ for the possibility of contracting PML.

Ultimately, kw202, weigh your pros and cons. For me, it was a chance to have less relapses, and hopefully, have enough strength to be there as much as possible for my kids, see them graduate high school, and send them on their way to college or any other pursuit they may have for their future. I was scared to death about the possibility of PML, but truly, I rather be dead (if that is the case) than being eaten away my this disease and not give myself to my children and my family. So far, so good.

Good luck with your decision.

**frosty123** · 01-14-2016, 11:24 PM

My doc

started me 1st with Tysabri, I had my sixth infusion in December. I am JCV positive 1.51, both before starting and after 6 months. So far, so good, when I look back at some of my older posts I was definitely feeling much worse a year ago.

I was very scared starting my first DMD and I got a lot of good support and suggestions here. I do drink more water on infusion day and got some pretty bad headaches around 3 months but those resolved so who knows if that had anything to do with the drug.

I wish you good luck whatever decision you and your Doc decide to pursue. Peace and welcome to MSworld.

**Myoak** · 01-15-2016, 04:30 AM

Those were very good posts by sexgatubela and frosty, I'm sure some others will contribute their experiences, also.

One thing that has always surprised me is the difference in cost that people pay. I know it is true but I don't know why. For example, our insurance uses Accredo for specialty meds, I checked a few months ago (by calling them) and the cost of Tysabri was about $5200 per dose. Our co-pay is $110 and Biogen's co-pay assistance is $100 leaving us with $10.

The infusion center's charge is about $350. Insurance knocks that down a bit and pays less. After Biogen's assistance of $100, we are left with a bill of about $30 for the infusion.

I know people sometimes pay an extraordinary amount more but I have no idea why that situation exists. I always suggest finding a MS Center because the expertise will be superior with neurologists who specialize in MS, IMO. I can't imagine why one center would charge what we pay and another would charge so much more but I have no doubt that people are paying what they say they are paying.

We are located in the midwest, that may explain some difference in cost, compared to New York, I suppose. But why or how a hospital (these seem to be the culprits with the highest prices) can charge 2, 3 or 4 times the $5200 we pay for Tysabri is just a mystery to me. I think I would be making some phone calls to reduce cost more in line with what most others are paying for the med and the infusion, but that's just me.

kw202, I definitely recommend calling your insurance company about Tysabri specifically to find out your exact coverage for the med. And, I would ask your neurologist about the infusion cost, assuming it is done at her facility. If the infusion isn't done there you still should find out the cost where ever it is to be done. You may be able to save a bundle by arming yourself with such knowledge ahead of time.

Don't stress about it. Just try to set aside a couple hours for phone calls. It may take less time but you will gain the comfort of knowing your cost.

Best wishes for your every success! Best of health to you!

**kw202** · 01-15-2016, 03:23 PM

Originally posted by Myoak View Post

You asked how long people stay on Tysabri if JCV negative� there is no standard length of time. The JC virus causes PML. If you do not have JC virus you cannot and will not get PML. BUT you can have a false negative test, and that does happen. In other words, the JCV antibody titer can be below .2 (the threshold for negative is below .2; the range between .2 and .4 is indeterminate of being positive or negative, btw) but even below .2 (negative) some people were found who did have JC viremia present.

And, there have been a couple people who tested as JCV negative who did get PML, I believe. Obviously, these were positive (remember the JC virus alone causes PML) but they tested negative, a false negative. Please ask your neuro about this, ok? Out of approx. 140,000 the chance of testing negative for JCV and getting PML is quite small.

That pretty much answers my question - the mysterious JCV- person(s) that suddenly got PML likely were false negative to start with, or contracted JCV suddenly I guess. My next question related to this is, I've seen a lot about a ratio of JCV antibodies and the level at which you are considered negative (in other words, you can have some antibodies and be considered negative). My understanding is that my specialist ordered the ratio test, but I'm sitting here looking at my result and it just says "negative." Is there just a binary test that doesn't return a ratio? Here's exactly what it says:

STRATIFY JCV AB: NEGATIVE

NEGATIVE

Obviously I'll ask her about it when I get all my questions together, but this returning a binary yes/no rather than a ratio threw me a little bit, and if I'm "negative" but -1.5 that's different than "negative" but -0.0 if such a thing exists, in terms of my risk. Maybe my understanding here is off somehow though.

Thank you also for the other post about infusion centers, Biogen and costs. My specialist operates a MS center that has an infusion suite so I imagine I will go that route, should I choose Tysabri. I'm approaching my choice I think. Thank you for your help.

**Myoak** · 01-15-2016, 06:50 PM

kw202,

There were some great posts which address your concerns about JCV titer number.

I will cut and paste them.

On 8-8-15 ru4cats posted this in the �JCV Negative� thread:

�Teekybird, I spent two years working with Quest diagnostics to get my titer number. I finally succeeded this past April. Your number is available, and I found out that the results DO include the titer number; it all revolves around the coding number for the test, and for Quest it is 91665. 90257- No titer number. 91665- titer number. There is no price difference on the test.

However, if your are negative, you need to "push" for that number. Mine is .12, and I pushed because I want to be able to watch to see if it elevates. I'm not sure why they just don't report everyone's number.

I signed up with MyQuest online, and my results are now sent directly to my computer as soon as they are available. I had them in less than one week. I go to Quest because the test is paid for by Biogen.�

On 8-9-15 ru4cats posted this in the �JCV Negative� thread: �Unfortunately, the test must have the correct code to get the titer--that was my problem. Your doctor MUST put the correct number on the script in order to get the results you want. At my last appt, she use a Quest script, and crossed out the incorrect number and wrote in 91665.

I ended up calling quest and they called the lab where I go to let them know they could use 91665. MyQuest is great!

Since this is the first titer number I've gotten in 11(?) tests, I won't know until October how consistent my number is. I only go every 6 months. I do know I've always been negative.

My neurologist thought it was great that I now have my titer number, and the people at Quest said they wanted everyone to have their number.

Negative is anything under .20.� End Quotes

kw, In our own experience we have always gotten the titer number with every test. Apparently, the coding must be correct to receive the number.

It is important to remember that titers normally vary with each test. Once you test positive you are considered positive from then on regardless of your titer numbers by most neuros.

kw, I think it is wonderful that you are educating yourself on these issues! Knowledge is power; your education cannot but help to achieve the best health possible.

Forgive me for going off topic but I believe an effective, safe treatment will someday come from this area... please Google, "Help us find out if we can treat multiple sclerosis with antiviral drugs" and consider supporting the project. I have followed these researchers for years and vouch for their validity.

Also, their daily blog (Bart's MS blog) has been a great source for finding the latest research in MS. Just Google if inquisitive.

**ru4cats** · 01-16-2016, 01:26 PM

kw202,

Welcome to the Tysabri cheering squad. Some bullet points....

1. If you are JC-, Tysabri has the strongest efficacy according to the researchers at the Rocky Mountain MS Center and others. They now consider it a first line treatment. The MS center on YouTube has some great videos that offer further explanations.

2. You don't mention your age or how long you've had symptoms, but the younger you are and the shorter the length of time you have had symptoms, the better your chance of experiencing true healing. Tysabri stops the majority of the white cells from crossing the blood/brain barrier, allowing brain reserves to heal damage that has already occurred. I wish you could see the younger Tysabri patients (I am 64) at my infusion center. You would never know they had MS.

3. If you are JC-, your chance of getting PML is 1/10,000, notwithstanding the case that Marco added recently. Biogen, through Quest Diagnostics, will pay for JC virus tests ( a test that costs in excess of $1400) because it is in their best interest to prevent PML. I go every 6 months. Myoak described my adventure in getting my JC titer that consumed most of a year. My first titer was .12 and my 2nd was .11. The diagnosis code is the key. With the code, you will get your titer.

4. Infusion sites definitely vary by site, with hospitals being the most expensive. My current cost is $6000, but at the hospital one mile away, the cost is in excess of $24,000! The price charged for Tysabri is 99% of the difference.

5. I stayed on my employer's insurance when I retired. My yearly total out-of-pocket is $3000, and I reach that in less than 2 months. I don't get any help with Tysabri just because I've never asked. I do get help with a copay on Ampyra.

6. IMHO, I wouldn't recommend switching to any new drug that hits the market until there is at least a year of "real life" experience behind it. I remember when BG-12 (now Tecfidera) was being hyped as the end all/be all for the future of MS. "85% of neurologists will prescribe this drug once it hits the market." A year later....not so much. The side effects were far more severe than mentioned in the studies, and many have moved on to another drug. My neurologist will only prescribe Lemtrada as a last resort due to medical problems that can occur long term.

7. I agree with JerryD. You definitely won the lottery in being JC-. I just had my 75th infusion, I've had at least 10 JC tests (still negative), and my last brain MRI (yes, you have to have at least one a year) showed I have "normal brain volume for someone my age". Whoo hoo! Brain volume is the key factor in determining your future with MS.

Good luck! You've received ton of great information in these posts that will help you make the decision that is best for you and your family.

**kw202** · 01-19-2016, 01:43 PM

Thank you first of all to everyone who's replied here. You've all helped me and I really can't thank you enough.

To answer a few points:

Originally posted by ru4cats View Post

2. You don't mention your age or how long you've had symptoms, but the younger you are and the shorter the length of time you have had symptoms, the better your chance of experiencing true healing. Tysabri stops the majority of the white cells from crossing the blood/brain barrier, allowing brain reserves to heal damage that has already occurred. I wish you could see the younger Tysabri patients (I am 64) at my infusion center. You would never know they had MS.

I've just turned 43, and though I still can't believe that's the actual age that is attached to me, I suppose compared to some other people I could be considered "younger" (but "old" for the "newly-diagnosed" cohort...). I walk and talk and work and get around as normal so I doubt anyone looking at me would guess there's anything wrong with me, much less an incurable neurodegenerative disease.

I've only had symptoms since about mid November, or at least symptoms that I recognized as something of concern. My story is a bit strange I guess, I went into some more detail about it in my intro post here - but in a nutshell, I was just recently diagnosed after experiencing numbness and some balance and neuroconductive fatigue issues with distance walking in my legs starting in about mid-November, a lot of which have resolved after a course of IV steroids last week.

What's odd is when I went in to see my specialist, she looked at my MRIs and said all my lesions are old. Which is surprising, because she said I had "significant involvement" of lesions on my spinal cord (not so much in my brain - some, but few and small). So, I guess the bottom line here is I've had lesions forming for who knows how long (years?) that I just wasn't much affected by, until now.

My specialist told me she would never have expected me to be doing as well as I am doing, with relatively little disability, with the MRIs she has seen of me. And that most people would have had some clue that something was terribly wrong long before I did, looking at them. Which I did not, I suppose looking back maybe there are one or two things I could identify as odd in retrospect, but nothing that was even concerning enough to seek treatment for -- so -- apparently my body's just been sort of handling it on its own, until it wasn't. So I'm not sure how you'd judge that in terms of how much Tysabri could help me heal what I've accumulated already.

I've asked about the coding issue and titer levels, testing schedules, concerns about rebound effects, costs and some other things. I'll see what she has to say.

Thank you again,

kw

**Myoak** · 01-19-2016, 06:32 PM

[QUOTE=kw202;1488231] "so -- apparently my body's just been sort of handling it on its own, until it wasn't. So I'm not sure how you'd judge that in terms of how much Tysabri could help me heal what I've accumulated already."

One of the concepts to become familiar with is neurological reserve. The idea is that your brain uses reserve capacity to figure work-arounds of damaged areas. However, when that capacity gets exhausted then restoration of function becomes much less likely and damage or disability from it can become permanent.

Presently, the treatments in MS are to slow or halt disease progression. If MS just stopped progressing that would be a great victory for many.

Tysabri or other DMTs would not help you heal from neurological damage already accumulated. The best that could be expected is to halt progression and give your body the best chance possible to keep doing what it has done so far, apparently, and that is figure work-arounds that have kept you relatively well in spite of considerable damage seen on MRI or prevent more damage from occurring.

No lesion is good but some can be worse than others. You really want to avoid spinal lesions if at all possible. Others may comment but it seems that the location of spinal lesions can sometimes cause a lot of disability. Perhaps, that is how your doctor is thinking and why Tysabri is on the table; it's worth talking about with her.

I think we all do much the same with treatment decisions... gather all the info we can and make our best guess.

Good luck to you, you will do well. And, keep learning!

**kw202** · 01-21-2016, 12:51 PM

Originally posted by Myoak View Post

One of the concepts to become familiar with is neurological reserve. The idea is that your brain uses reserve capacity to figure work-arounds of damaged areas. However, when that capacity gets exhausted then restoration of function becomes much less likely and damage or disability from it can become permanent.

Yeah, when I asked my specialist what she attributed it to, she called me a "weirdo miracle in a good way" and said it was probably some unknowable combination of general good health and more spinal reserves/resiliency than most have. I guess that's comforting?

BTW, I asked about my titer number and apparently they got it, but it just wasn't reflected somehow on my labs online. It's .14 - I confess I'd like for it to be lower than that, that's a little close to .19 for my taste - but, I'm still grateful that it's not .2+

So, I've gotten all my questions answered at this point, and they have started all the paperwork/approval process for Tysabri.

**ru4cats** · 01-21-2016, 09:17 PM

Originally posted by kw202 View Post

Yeah, when I asked my specialist what she attributed it to, she called me a "weirdo miracle in a good way" and said it was probably some unknowable combination of general good health and more spinal reserves/resiliency than most have. I guess that's comforting?

BTW, I asked about my titer number and apparently they got it, but it just wasn't reflected somehow on my labs online. It's .14 - I confess I'd like for it to be lower than that, that's a little close to .19 for my taste - but, I'm still grateful that it's not .2+

So, I've gotten all my questions answered at this point, and they have started all the paperwork/approval process for Tysabri.

.14 is a great number! Glad you are going ahead with Ty. I believe you'll be pleased. 👍

**ru4cats** · 01-21-2016, 09:24 PM

Myoak,

Good catch on my response to "healing". The brain's ability to rewire allows lost function to hopefully return. The lesion remains.

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Newly dx - recommended Tysabri - questions...

Newly dx - recommended Tysabri - questions...

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