Report on FDA RiskMAP Conference
 

Thank you to those of you who answered the survey I sent out. The data collected was valuable. It helped with my presentation in ways that will help shape the future of the TOUCH program for those already enrolled and those who will be enrolled.

Many of the problems are associated with not only the enrollment process, but the drug delivery system, the insurance coverage problems, infusion appointments but the biggest problem of all, education. Education of neurologists, education of infusion site staff and education of patients. Education of the enrollment process, but most importantly, education about TOUCH, why it is important, and the reason behind why there is a RiskMAP (Risk Minimization Action Plan) attached to Tysabri. It is a safety precaution and tracking system.

One of the most common threads that we heard was the lack of positive information about Tysabri. The Medication Guide and associated educational tools are slanted towards risk. We recommended that these materials be more balanced.

Let's see if these changes are made and the promises made for better communication to the patients are kept.

Thanks Cheryl, for your report. I'm glad it went well for you and I hope, right along with you that the Touch program runs a little more smoothly, in the future.

BTW, what are the positive reports. How does Tysabri seem to be working for PwMS. Are they reporting good results or not?

Good work, FG, it's great to have representation from someone who isn't busy organizing their own raises in pay.:mad:

Sal, most, I'd guess 90% of those I've heard from on Ty have had a lot of positive experiences with it. I can think of only two out of about 25 who feel it's not working. I haven't heard any directly negative reactions to it. Mind you, this is just from a small handful of patients with whom I communicate.

Sally

This wasn't that kind of conference. It was a conference to discuss RiskMAPs in general. So, I cannot really comment on that.

Kudo's to you FG!!!! I shouldn't be surprised that you went to the conference.... Just like you to always be a front runner on trying to help others... I take my hat off to you! :Bow:

Hey, who took my hat???? Hugs to ya Cheryl! :hug:

Well done!!!!! So proud of you!!!!

Cheryl,

I think one of the main reasons that The Medication Guide and associated educational tools are slanted towards risk is the fact that some drug companies do a very poor job in pointing out these risks to prospective patients. After all, highlighting a risk as opposed to mentioning it in the fine print, doesn't help potential sales!

Leaving Tysabri for a moment, Teva, the makers of Copaxone, spend very little effort or time to mention the dangers of Lipoatrohpy to prospective Copaxone users. Yet this problem can occur in up to 45% of Copaxone users!
Teva has said only about 1% of the users may have this problem. Hmmm.

The Touch program has certainly put a lot of doctors and MS patients at greater ease when it comes to making a decision as whether to use Tysabri or not. While Biogen can be commended for establishing this program, I sometimes wonder if they would be running it if it wasn't connected to the FDA's re-approval of the drug. The cost must be significant and in almost every case, this cost is passed on to the patient and/or insurance company.

Keep up the good work with your efforts.....you are certainly to be congratulated.

Harry

Here's the link to the conference with all the presentations.

http://www.fda.gov/cder/meeting/riskMAPs.htm



I agree with you wholeheartedly on this about Teva. There have been many complaints about getting information about Lipoatrophy from them. I was on C for a very short time and had to quit because of severe fatigue caused by the drug. It is one of the little known side effects. Could I get them to fess up to it? Nope. Even when I spoke to the Teva Rep, nada! Each drug company is protective of their territory.

At greater ease? No, Harry, I respectfully disagree with you. It is scaring the hell out of a lot of them unneccessarily. Across the board, doctors and patients are getting an unbalanced view of Tysabri. That subject was discussed in great detail at this conference. And not just about Tysabri either, about drugs under RiskMAPs in general. But more so about Tysabri. If you read the Med Guide, there is no beneficial information about it in there. Nothing. It is all about risk. All the information the patient receives about Tysabri is about the risks and not the benefits.

Biogen was forced to put this program in place. I have been involved in it from the very beginning. The RiskMAP and subsequent TOUCH protocol was a result of the March 2006 FDA hearings for the re-application to bring Tysabri back into the market. I was one of the 46 patients who testified and have not received one infusion of Tysabri since its reintroduction. So, you cannot call me biased towards Tysabri!

The cost of the drug went up 21%, but was that due to inflation and anticipated manufacturing costs? I heard comments from other companies that implementing RiskMAPs improves safety but not costs. One thing I can tell you is that there is no consistent cost associated with the infusions across the country. During my survey I found infusion costs from $3500 to $7500. That's just not right. I tried to get some answers from the Blue Cross Blue Shield rep at the conference but she was unable to answer any insurance questions. It wasn't her field - that befuddled several of us. :confused:

Elan/Biogen, Idec lost a lot of money when they took Tysabri off the market February 2005 and there is still one (known) pending lawsuit. Is that a factor? I have no idea about these things, but I do know that this is the cost of doing business.

Harry, bottomline, Tysabri is still a controversial medication for the treatment of MS. Its associated RiskMAP and TOUCH protocol was discussed by several of the presenters at this conference. It's a good RiskMAP/protocol. There are kinks and holes in it that must be addressed and fixed and that was what I pointed out to Biogen through my survey of patients who are in the "system." They spoke and they spoke loudly. Let's hope Biogen heard them.

Cheryl,

What is a RiskMAP? How does the actual RiskMAP actually aid in reducing risks to patients? I thought it was only some kind of thing where side effects are required to be reported, etc. or is that the TOUCH protocol which is different and is the reporting arm of this? But I've heard stories about people on T who appear to be having serious side effects aren't going through any special process. In fact, some are just continuing on with tx in spite of what sound like dangerous circumstances! :eek: From what I've gathered about the whole thing, it's not stringent or formal, it's pretty loosy-goosy.

If people testified at the FDA hearing (in support of the reintroduction of Ty), then they DO have an obvious bias. Why would they be involved, I assume regular every day consumers, in the development or monitoring of this RiskMAP? Wouldn't the FDA or Biogen be required to have its own PROFESSIONAL independent group responsible for overseeing this? It seems strange to me that laypeople such as yourself who only became known in any way because of their testimony at an FDA hearing to support Ty's return, are somehow involved in this process. That makes me uncomfortable. Are you being paid by someone?

I'm thinking about going on Ty. Is this RiskMAP something that would better help me make an information decision? I don't really understand your point about it highlighting the risks... obviously any doctor can access the study that shows Ty's efficacy. Isn't the whole point of this RiskMAP thing to properly characterize and delineate ALL the side effects to better gauge the risks? They are trying to make sure that people dying from Ty don't slip through the cracks like it did during the clinical trial. Aren't they?

I guess I'm a little confused by it all. And I take issue with the statement that "Biogen lost money because it was pulled". On the contrary, Biogen MADE money because it fast-tracked its little product so it could hit the market a year earlier. So it actually made money by doing so, just not as much because it had to be pulled for a while. I am annoyed that the cost of it has apparently gone up too... it already was outrageous. To think they are passing along these additional costs to the customer really irks me. They should have dropped the price to encourage customers to come back even though they forgot to properly evaluate its safety before putting it on the market to begin with. THEY should absorb these costs, not the consumers! (ok, wishful thinking I know!)

Amen Pantos.

Dear Pantos

RiskMAP = Risk Minimization Action Plan. There are many drugs that are under these types of plans, not just Tysabri. A RiskMAP is a guide whereby these drugs are watched carefully by several agencies on how they are dispensed, tracked, prescribed, alert/warnings issued, stored, and several other factors. Each RiskMAP is different and individual for each drug. There is no standardized RiskMAP or boiler plate form that can be pulled up from the internet to look at when writing one for a new drug, or for writing one for a drug that has been on the market that has been determined now to need one. Each one is specialized for that drug.

Lotronex, Accutane, Bactrim/Warfarin, Thalomid (Thalidomide), Dofetilide, Clozapine, just to name a few, but currently there are at least 30 and probably more, all have RiskMAPs. Some more stringent than others. Some with associated protocols such as stickers, black box warnings, some have stops, and some with mandatory testing before you can receive the prescription.

TOUCH is the distribution program designed to assess the risk of PML, to track any potential cases of PML and any other adverse events, and to promote informed benefit/risks associated with the decision making process for the use of Tysabri. It also contains the educational program for the training of the mandatory enrollment of patients, neurologists, pharmacists, and infusions centers.

DISCLAIMER: I am not paid by anyone. I do not receive Tysabri. I am in a clinical trial for Tovaxin which is in phase IIb trials by Opexa.

Some of the patients with MS who testified back in March 2006 were there to let the FDA know that we wanted a choice of drugs to treat MS. That was the sum and substance of my testimony. Be careful of making assumptions.

If you are considering Tysabri, I think you would be more informed about the drug. If you were, you would know the answers to the questions you are asking.

Yes, every doctor CAN access the latest efficacy information about Tysabri. The problem is that some don't. The lastest article came out in this week's NEJM. Ask your neuro if s/he has read it.

This conference pointed out that the med guide and TOUCH protocol for Tysabri DID IN FACT, only give the risks. It did not contain the benefit information for the patient to read. That is a fact. Not something I made up just to put words in a post. It is not something I said, it was something that others brought up at this conference.

Read the link I posted, you might find it interesting. ;)

I take exception to this as well. I also included Elan in this, not just Biogen. Elan is the original holder of the patent on this drug. Biogen/Idec holds the US sBLA on the drug. Yes, they all lost money. The stock dropped a significant amount. But that wasn't my point. If you think it is, then you are missing my point completely. Wishful thinking? You bet. It irks me as well. (And Elan/Biogen voluntarily pulled the drug.)

All drugs are expensive. Why is provigil so expensive? Tell me that? I take it every day and cannot for the life me understand why this drug is so damn expensive.

Thanks, Cindy. I appreciate your answer. I just haven't heard too much since Tysabri started back up. I heard wonderful stories, when it was first out and now...not much.

I assumed that the hype was bigger than the bite. In other words, Tysabri is just another MS Modifying Med. and not any closer to a cure than the rest of them.

Considering all this, the expense is rediculous and sinful. They should be ashamed.:mad: I hope that in the near future, a cure or at least something to stop MS in its tracks, will be found.

I've given up, for it to happen in my lifetime, but I hope it will happen in yours.:grouphug:

Perhaps using the word "ease" was not correct in this situation as I didn't mean to infer that MS patients would feel comfortable.

But who is to blame about the "unbalanced view" about Tysabri? You only need to look at Biogen/Elan for causing this entire mess in the first place. That's all they had to do was follow their original plans for the trials and subsequent approval process for Tysabri. But no, they rushed everything by a full year and got caught when PML showed up and that forced them to withdraw the drug.

Even after all the subsequent studies, nobody knows for sure just how and why the two MS patients contracted PML and of course that has caused a tremendous amount of caution by the docs. And the docs will always error on the side of caution and thus many won't prescribe Tysabri at this time.

Certainly not inflation which is around 2-3% per year. And Biogen knew exactly what it was going to cost them to manufacture Tysabri. Heck, they had their entire marketing plan for the drug outlined on the internet before the drug even got approved the first time around. They had block-buster numbers for this medication which they anticipated would take over a huge chunk of the MS drug world.

No, this huge increase was to cover the extra costs of getting the drug re-approved and that took a lot of money to do so.

You can say that again!!! Those infusion costs along with the cost of the drug make Tysabri by far the most expensive drug ever for MS. That leads to a cost/benefit situation that insurance companies and government health organizations must look at and it certainly doesn't make choosing Tysabri and easy task.

Of course it cost them a ton of money to pull the drug....why do you think we saw the 21% price increase?

I will go back to my previous statement that Biogen/Elan are totally responsible for making Tysabri the controversial drug it is today. Can you imagine the different course that would have been taken if approval submission had been made AFTER the full two years of the Phase III trials? The PML cases which showed up in February 2005, before the FDA would have obtained the submission data, could have been handled differently at this point. I'm sure the fear that currently surrounds this drug would have been far less.

Harry

Harry, you seem to want to discuss the issues of Biogen and Tysabri and its fast-tracking. That I respectfully refuse to do. Thank you for your input, but my purpose was not to discuss history with regard to those issues. :)

The purpose of this conference was to have an open forum/workshop to discuss RiskMAPs in general and my function was as a Patient Advocate for the TOUCH protocol for Tysabri. I put up a link to the conference, feel free to comment.

If you want to discuss history regarding who did what to whom and when, that is not what I wish to do. Been there, done that. ;)

I realize that this thread is to discuss the RiskMaps in general and of course this pertains to Tysabri's situation. You mentioned that there was unfair fear associated with Tysabri's RiskMap and I wasn't surprised to hear that.

I was merely trying to indicate why this perception exists. What's the old saying...if you want to know what is going to happen in the future, just examine the past and you'll get a pretty good idea! How appropriate if you apply this to Tysabri's current status.

Having said that, I'll refrain from taking any more shots at Biogen :wink:

Harry

Update
 

http://www.fda.gov/cder/meeting/riskMAPs/bozic.pdf

Here is Biogen's presentation.