Extremely Restless

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

Re: Hi Harry...

Postby HarryZ » Mon Aug 28, 2006 5:32 pm

Hi Lauren,

we have been waiting over a decade for an efficious therapy, Ty is 68% efficious or 2/3's superior over the "possible" efficiacy of the ABCR's,



First, there have been no 'head to head' comparisons of Tysabri vs. the CRABs...and I never indicated that...therefore your friend's "absolute" comparison is meaningless to me (no disrespect Harry, but if it's not published in the opinions of the NEJM, for me personally, the 'comparison' holds no water).


I took the liberty of quoting the part of your message that indicated that Tysabri was possibly 68% more efficious than the CRAB's. The 68% number that was in the NMSS FAQ had nothing to do with the CRAB's but was the relative comparison of relapses to placebo patients during the trials. You simply can't come out and state that Tysabri has this kind of possible efficacy over any other drug for the same reason you quoted above!

The person who I mentioned on Brain Talk was very aware that Tysabri and the CRABs have never been compared head-to-head in any trial.He took the long standing disease progression efficacy of the CRABs from the many trials that have been done with them vs placebo and compared the "risk of progression" efficacy of Tysabri in the same manner vs placebo. That's how he came up with only a 12% improvement which in reality is the only way one can even attempt to compare the two without head-to-head trials. Not NEJM publishable by any means but certainly a perspective of bringing Tysabri down to earth.


I am certainly not trying to curtail any enthusiasm for you or anyone else who wants to use this drug but at the same time, one has to take these numbers and place them in the proper context.

Take care.

Harry
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The effect of all this on me is...

Postby Ronnie » Wed Aug 30, 2006 8:53 am

Dear Harry and Lauren:
I am still waiting on my HMO. This morning, I tried calling a number which was sent to me in January, to speak with my "Case Manager", a nurse who sent me a letter in January and told me to contact her with any questions about my "health plan's covered services and limitations". This was a "service that Community First Health Plans provides for its members." Evidently, they don't provide it anymore.

Anyway, I spoke with a person named Joseph in the Authorizations department, who informs me that a nurse named Cindy has sent my paperwork on to the Medical Director for review, and that I will probably get a call this afternoon or in the next few days when a determination has been reached.

Yeeha! I am overjoyed.

In any case, the effect of all of this is to make me more determined to get Tysabri. I no longer am in "considering the data" mode, I am in "why are they doing this to me and how can I make them do what I want them to" mode. I don't know if they realize this.

He took the long standing disease progression efficacy of the CRABs from the many trials that have been done with them vs placebo and compared the "risk of progression" efficacy of Tysabri in the same manner vs placebo. That's how he came up with only a 12% improvement which in reality is the only way one can even attempt to compare the two without head-to-head trials.


Sounds good to me. If I could be 12% better off in a few years than I would have been just using Copaxone, plus have fewer potholes in my injection site regions, plus not have to worry about having that nasty post-injection sensation in my chest and the inability to breathe (which has only happened once so far this year, but happened about a dozen times during the last Copaxone era in my life), I will take it. Fine. Done deal. And if I suddenly get PML and keel over like a stricken gull? Well, that won't be pleasant. I'll risk it.

Hope to return with happy news.
Love,
Ronnie
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Postby bromley » Wed Aug 30, 2006 10:02 am

Dear all,

I've been in contact with several of the UK's MS specialists in the last few months and pretty much all of them are excited about Tysabri being used in the UK sometime in the not too distant future. The issues over %s could go on forever, but the evidence to date shows that the CRAB drugs reduce relapses by about a third - roughly 30%. Tysabri, on the basis of the trials undertaken to date, reduced relapses by 67% or so (I've seen 68% and 67%). That tells me that Tysabri is at least twice as good as the CRABs at reducing relapse rates. I'm not clear why head to head trials would make any difference to this figure - would the CRABs suddenly start working in a more effective manner if they know they are competing against Tysabri? In simpler terms, my Ferrari's top speed is 150 mph and your Nissan is 70 mph - the Ferrari is over twice as quick.

Of course the jury is still out about what reducing relapse rates means in terms of how the disease progresses. But some on the Tysabri trials reported improvements in walking, fatigue, vision. And for patients it's all about hope - Tysabri could be the stop gap until the next breakthrough treatment. What surprises me about the CRABs is that they do not appear to have been refined since they were introduced. There appears to have been a cosy agreement not to rock the cradle by introducing a CRAB which improved upon the others in terms of reducing relapse rates. We never saw a CRAB show a 40% efficacy at reducing relapses. Love them or loathe them, Biogen have raised the bar. Lets hope that Tysabri proves safe and delivers the hoped for benefits.

Ian
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Postby amelia » Wed Aug 30, 2006 10:03 am

Sounds good to me. If I could be 12% better off in a few years than I would have been just using Copaxone, plus have fewer potholes in my injection site regions, plus not have to worry about having that nasty post-injection sensation in my chest and the inability to breathe (which has only happened once so far this year, but happened about a dozen times during the last Copaxone era in my life), I will take it. Fine. Done deal. And if I suddenly get PML and keel over like a stricken gull? Well, that won't be pleasant. I'll risk it.

Amen Ronnie!
I really don't put much into DATA. I listen. If it is placebo effect that makes some get out of a WC or spasticity isn't as bad, etc., then more power. Gary has only gotten worse on Copaxon. His disease has still progressed. As quick as without, who knows. Will it be as fast on Tysabri. Once again, who knows. But it is new. It is different. And we are going for the MRI Wed of this next week. One more obstacle down. Probably a million to go.
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Postby amelia » Wed Aug 30, 2006 10:06 am

Ian,
How's it going overseas with the Tysabri? Where are you all on actually getting set up to take it?
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HUGE changes happening at Kaiser in So. Ca., YAY!!!!

Postby msladyinca » Wed Aug 30, 2006 10:08 am

Hi Ronnie, Harry, everyone.......wowsers, NEW developments in my ongoing Tysabri/Kaiser saga, changes for the GOOD!

Okay, now here's the update: on Monday 8/28, Whoa, more good news from Kaiser... I spoke 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!!!) :P

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"?????). :P

Myy 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 MS 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. :P :P :P

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". :P

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.

I'm keeping the appt. with the out-of-network neuro (also approved by Kaiser! for 10/31, as I am on a cancellation list for an earlier appt)

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.

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!!!

Hang on Ronnie, the obstacles to Tysabri are slowly, but surely, being removed....YAAAAAAAAAY!!!!!! :P

Lauren
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Postby HarryZ » Wed Aug 30, 2006 11:08 am

Hi Ian,

We live in a world of semantics when it comes to almost everything and clinical trial data is no exception....just look at how the pharmas use this to promote their drugs.

The CRAB's name to fame is a reduction in "progression" by 30%. Tysabri states "a reduction in the risk of progression" by 42%. (What was that I said about semantics?) Trying to compare those two different drugs you end up with approx a 12% improvement for Tysabri. So if you compare apples to apples, which is difficult in this kind of situation, Tysabri is not twice as good but supposedly better. Also don't forget that the CRABs have been used on MS patients who had been sicker than those in the Tysabri trials.

Again, I'm not trying to curb enthusiasm for potential Tysabri users but trying to make some sense out of all the numbers that are being bantered about.

I also wouldn't place too much emphasis yet on the fact that some Tysabri patients improved in their walking, fatigue and vision problems. CRAB trial users experienced this as well...in fact Prokarin users, my wife included, enjoyed significant improvements in this area in a relatively short period of time.

Love them or loathe them, Biogen have raised the bar. Lets hope that Tysabri proves safe and delivers the hoped for benefits.


Biogen neither developed Tysabri nor invented it..that credit would have to go to Elan who took over the drug that was discovered by scientists, one being Dr. Lawrence Steinman. Dr. Steinman had several less than complimentary comments to make towards Biogen when they started to market the drug before FDA approval was granted. Elan needed an American drug company to stick-handle the FDA approval and chose Biogen. BTW, Biogen only gets 50% of the Tysabri sales revenue with Elan getting the other 50%.

As for the CRAB makers improving on their original drugs...why would they? Three of those drugs were protected by Orphan Drug Status, nothing else was available to the public and why increase costs when your revenues continue to be in the billions with little or no challenges to that. Why do you think now that Teva, Serona and Berlex have been aiming their sights on Biogen/Elan in an effort to protect their very lucrative market share? Unfortunately it's all about the money, Ian and always will be!!

Take care.

Harry
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Tysabri equals Hope....

Postby msladyinca » Wed Aug 30, 2006 11:36 am

Hi Ian, hi Harry:

So if you compare apples to apples, which is difficult in this kind of situation, Tysabri is not twice as good but supposedly better. Also don't forget that the CRABs have been used on MS patients who had been sicker than those in the Tysabri trials.


Harry, the NEJM indicated 2/3rds efficacy of Tysabri over existing therapies of possible 1/3 efficacy....That is Twice as effective.

I also wouldn't place too much emphasis yet on the fact that some Tysabri patients improved in their walking, fatigue and vision problems


I respectfully disagree Harry, I would place a HUGE emphasis on the fact that: see <shortened url>

The primary end points were the rate of clinical relapse at one year and the rate of sustained progression of disability, as measured by the Expanded Disability Status Scale, at two years. RESULTS: Natalizumab reduced the risk of sustained progression of disability by 42 percent over two years (hazard ratio, 0.58; 95 percent confidence interval, 0.43 to 0.77; P<0.001). The cumulative probability of progression (on the basis of Kaplan-Meier analysis) was 17 percent in the natalizumab group and 29 percent in the placebo group. Natalizumab reduced the rate of clinical relapse at one year by 68 percent (P<0.001) and led to an 83 percent reduction in the accumulation of new or enlarging hyperintense lesions, as detected by T2-weighted magnetic resonance imaging (MRI), over two years (mean numbers of lesions, 1.9 with natalizumab and 11.0 with placebo; P<0.001). There were 92 percent fewer lesions (as detected by gadolinium-enhanced MRI) in the natalizumab group than in the placebo group at both one and two years (P<0.001)...CONCLUSIONS: Natalizumab reduced the risk of the sustained progression of disability and the rate of clinical relapse in patients with relapsing multiple sclerosis

Furthermore, Tysabri improves the Quality of Life in MS patients. See data submitted to the annual AAN: http://www.elan.com/News/full.asp?ID=840112

Biogen neither developed Tysabri nor invented it..that credit would have to go to Elan who took over the drug that was discovered by scientists, one being Dr. Lawrence Steinman. Dr. Steinman had several less than complimentary comments to make towards Biogen when they started to market the drug before FDA approval was granted. Elan needed an American drug company to stick-handle the FDA approval and chose Biogen. BTW, Biogen only gets 50% of the Tysabri sales revenue with Elan getting the other 50%.


That is correct! ;)

Gotta run for now, take care all.

Lauren
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Re: Tysabri equals Hope....

Postby HarryZ » Wed Aug 30, 2006 12:51 pm

Hi Lauren,

Harry, the NEJM indicated 2/3rds efficacy of Tysabri over existing therapies of possible 1/3 efficacy....That is Twice as effective.


If that's how you want to interpret the numbers with Tysabri over the CRABs then by all means do so :)


I respectfully disagree Harry, I would place a HUGE emphasis on the fact that: see <shortened url>


Like I said, other drugs used in clinical trials in the past have shown this kind of result. I'm not saying that having improved walking, vision etc is not important because for an MS patient it is tremendously important! But Tysabri has not been used outside the clinical trial situation other than for that 2 month period and we'll have to wait for at least a year before any kind of real answers on more than mild MS cases can be determined.

The cumulative probability of progression (on the basis of Kaplan-Meier analysis) was 17 percent in the natalizumab group and 29 percent in the placebo group.


Again, this is a "relative" number. Take 100 mild MS patents...17 of them on Tysabri have progression....29 of them on Tysabri do not. So out of 100 patients, 12 more progressed. Improvement yes....tremendously improved numbers...no.

Furthermore, Tysabri improves the Quality of Life in MS patients. See data submitted to the annual AAN: http://www.elan.com/News/full.asp?ID=840112


No doubt it does for those who gain benefit from it. And you can read similar comments from some CRAB users and also from Prokarin users. Just today I read a note from a Copaxone user who stabilized their MS and regained some quality of their life back. Like I've said, it will take a good year before Tysabri's overall performance can be determined. Hopefully the trial data we've been given will translate to the same benefit for other MS patients. If it does not, then there will be a lot of very upset people!

Take care.

Harry
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Tysabri equals Hope....

Postby msladyinca » Thu Aug 31, 2006 8:49 pm

Hi Harry...,

But Tysabri has not been used outside the clinical trial situation other than for that 2 month period and we'll have to wait for at least a year before any kind of real answers on more than mild MS cases can be determined.


If you want to get technical, Tysabri was available to the general public for four months 11/04-2/28/05, not 2 months and it was prescribed at that time for a wide range of MS, not just mild.

Quote:
"The cumulative probability of progression (on the basis of Kaplan-Meier analysis) was 17 percent in the natalizumab group and 29 percent in the placebo group. "

Again, this is a "relative" number. Take 100 mild MS patents...17 of them on Tysabri have progression....29 of them on Tysabri do not. So out of 100 patients, 12 more progressed. Improvement yes....tremendously improved numbers...no.


I provided actual data and you are rebutting said data with "relative theories"...sorry Harry, your argument doesn't fly against proven data...it flies only to you.

Quote:
"Furthermore, Tysabri improves the Quality of Life in MS patients. See data submitted to the annual AAN: http://www.elan.com/News/full.asp?ID=840112"

No doubt it does for those who gain benefit from it. And you can read similar comments from some CRAB users and also from Prokarin users. Just today I read a note from a Copaxone user who stabilized their MS and regained some quality of their life back.


Again, I quoted proven data presented to the American Academy of Neurologists, and you are rebutting proven data with an 'undocumented note from a Copaxone user...this argument only flies with/for you Harry.

Like I've said, it will take a good year before Tysabri's overall performance can be determined. Hopefully the trial data we've been given will translate to the same benefit for other MS patients. If it does not, then there will be a lot of very upset people!


Like I have said before, there is already 2 year + 2 months data and an add'l 7 months monotherapy in the trials alone, plus infusions taking place as we speak..When, not if, the data being collected up through the next 6 months or less = to one year in the phase III monotherapy trials is complete and the spectuclar data is released not only from the trials, but from the general population, there will be a lot of upset MS'ers who chose to not switch to Tysabri, endured horrible side effects therefrom needlessley, and they will be very upset with their neuros too!

In closing Harry, with all due respect, as to your other arguments re: Tysabri's price and the financial assistance needed by MS patients, please note: About Tysabri pricing, I believe there is data to support that the other MS drugs on the market have gone up similarly while Tysabri was off the market. While Tysabri was away, the competitors raised their prices. As I recall Elan's price increase was in line with other price increases.

Also, the value of Tysabri is selling a drug that has demonstrated less relapses. Less relapses mean less money spent by the medical system and insurance companies recovering from relapses. And for the patient it means less relapses, less side effects and a better quality of life. That is why Tysabri has value. It has little to do with what the consumer can afford, and it seems to me it is more about the value of a drug that saves money by working better. Saves the system money and provides a better quality of life for patients. Just like anything else, you get what you pay for. Across the board. Based on price, Tysabri is the best thing going for some.

Should you want to explore the entire health care system, that's a different story. Tons of problems, but that doesn't mean that the free market won't drive price. All houses don't cost the same, nor cars, boats, apartments, waters, or wines. Why shouldn't all drugs be free? Being an individual is not where it's at. Group insurance has better rates and better coverage because it is better business. The larger the group the more predictable the costs and more stable the costs. So, does anyone want to let the government, or private sector solve the national health insurance plan? There is your large group.

A tangled mess, with a new effective drug called Tysabri. And as discussed previously, there are support structures to try and catch those not able to afford every medication available. If you feel stongly about Tysabri availability costs, you should lobby the different companies to show strong support for all MS medications. Apparently as posted earlier such a fund exists (NORDS). If you, Harry are proactive as indicated above, then perhaps you can help affect change for large numbers of MS patients by approaching all the MS drug companies. Perhaps requesting a percentage of their net income from their MS drugs go into the NORDS fund. I don't know, it's not my battle. I wish you luck.

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Postby amelia » Fri Sep 01, 2006 5:18 am

:?: I'm confused!
What's the difference if you took Tysabri in the trials or outside of the trials? Did the drug resond differently when given in the trials? I think not.
\Lauren, you really are up on your stuff and we appreciate it. Thanks for what you do.
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Re: Tysabri equals Hope....

Postby HarryZ » Fri Sep 01, 2006 7:09 am

Hi Lauren,

I thought that we could spare any more of this back and forth sparring but I guess you insist on continuing!

If you want to get technical, Tysabri was available to the general public for four months 11/04-2/28/05, not 2 months and it was prescribed at that time for a wide range of MS, not just mild.


It was "technically available" but infusions did not start until January because the infusion centers didn't have the drug until then.

I provided actual data and you are rebutting said data with "relative theories"...sorry Harry, your argument doesn't fly against proven data...it flies only to you.


It's how you want to view the data...from a marketing/sales point of view or reality!

Again, I quoted proven data presented to the American Academy of Neurologists, and you are rebutting proven data with an 'undocumented note from a Copaxone user...this argument only flies with/for you Harry.


I'm not rebutting anything, Lauren... please read carefully what I stated. I said info from a Tysabri point of view has also been presented for other drugs that have been used to treat MS..quality of life improvement isn't unique for Tysabri.

complete and the spectuclar data is released not only from the trials, but from the general population, there will be a lot of upset MS'ers who chose to not switch to Tysabri, endured horrible side effects therefrom needlessley, and they will be very upset with their neuros too!


90% of the data released for Tysabri has been from within the clinical trial setting where mild cases of MS patients took part. This kind of market/sales hype took place with the CRAB drugs as well but when those drugs started to get used in the general population, we discovered after a couple of years that the CRABs really weren't all that great.

How can you possibly say that MS patients wll be upset with their neuros for not changing to Tysabri immediately?!! If you want to be a Tysabri Poster Girl for Biogen/Elan that's fine but please don't try and suggest how or how not MS patients are going to feel about their medications. That kind of comment is a bit irresponsible.

In closing Harry, with all due respect, as to your other arguments re: Tysabri's price and the financial assistance needed by MS patients, please note: About Tysabri pricing, I believe there is data to support that the other MS drugs on the market have gone up similarly while Tysabri was off the market. While Tysabri was away, the competitors raised their prices. As I recall Elan's price increase was in line with other price increases.


So what you are saying is that the cost of an MS drug shouldn't be based on what it cost to develop and sell at a reasonable profit but instead on how much we can "squeeze" from MS patients and insurance companies! I don't like for one minute how the CRAB makers have raised their prices either but it all proves that these MS pharmas don't give a hoot about MS patients but how much money they can gouge from them!

That is why Tysabri has value. It has little to do with what the consumer can afford, and it seems to me it is more about the value of a drug that saves money by working better. Saves the system money and provides a better quality of life for patients. Just like anything else, you get what you pay for. Across the board. Based on price, Tysabri is the best thing going for some.


Holy smokes, Lauren, with all the rationale you are giving for the cost of MS drugs within the health system, you really are a Tysabri Poster Girl! I'm sure that Biogen/Elan just love ya :)

Harry
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Tysabri equals Hope....

Postby msladyinca » Fri Sep 01, 2006 10:36 am

Hi Harry, all....,

I will stand by my post in it's entirety, and let the data speak for Tysabri....,

Holy smokes, Lauren, with all the rationale you are giving for the cost of MS drugs within the health system, you really are a Tysabri Poster Girl! I'm sure that Biogen/Elan just love ya


Btw Harry, thank you for the "compliment" ... LOL

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Still waiting, still restless...

Postby Ronnie » Tue Sep 05, 2006 7:09 am

Dear folks:
C'est moi. I am still waiting for the HMO/neurologist's office/TOUCH program to get me an infusion!

Last week, on Weds pm, after my doctor's office had closed for the day, a nurse from the HMO called and told me to ask the people in the Neuro's office to fax them documents proving that we are all signed up for the TOUCH program. The next morning, the nurse told me that the price was "still being negotiated" and that I wasn't signed up for the TOUCH program nor was any other patient being infused by their office, until a price had been agreed on, and that the nurse "should know that".

She also told me that it wasn't my job to call about this, and that the HMO should be taking care of all of this.

I decided that I am weary of this bickering, and I am taking a few days to myself. Maybe I will call someone again on Wednesday.

Good luck, everyone!
Ronnie :|
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Re: Still waiting, still restless...

Postby HarryZ » Tue Sep 05, 2006 8:42 am

Ronnie,

She also told me that it wasn't my job to call about this, and that the HMO should be taking care of all of this.


I can assure you that if you don't continually keep on everyone's backs, it will take twice the time to get done. What HMO and the medical community are putting MS patients who want to use Tysabri through is disgusting.

I sure hope that this administrative mess gets cleared up sooner rather than later. MS patients don't need extra aggravation in their lives.

Keep us posted.

Harry
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