Gilenya -- fingolimod
 

Just saw on the CNN medical news site that the FDA has approved finglimod -- the first oral MS drug. They are calling it gilenya. I have mixed feelings about this. I am glad that it has been approved, but nervous about trying a new treatment given my past history with the CRAB's and tysabri. I know the last time I saw my neuro he had mixed feelings about putting me on any new treatment considering my history and the fact that I have been relatively stable.

So who is considering trying it?

My neuro said it would be approved by the 21st...he was close.

It is good that it's oral...there are side effects, but I know the neuros will watch carefully for anything that pops up...
I might think those on Tysabri would go for it...I have a feeling that once more oral meds are on the market Tysabri will fade away...

Not sure about trying it. I don't have a prob. with Copaxone, and the costs for fingolimod are rumored to be around $30K/year:eek::eek:

Newsbot reported this too.

Here's a copy: http://news.yahoo.com/s/ap/20100922/...d_novartis_ms_...

From what I can see the main side effects appear to be macular edema (swelling of the retina), and bradycardia (slow heart rate). I'd like to know a lot more about the side effects, especially what it does to the eyes, before I made a decision.

I also heard that it can cause melanomas. I wish I could remember where I read that.

Why do all these new meds have to have such dire side effects?

I'm going to pass on this one, too.
Liver enzymes need to be monitored as well.

http://www.webmd.com/multiple-sclero...g-gets-fda-nod

Exactly! Why gives us a medication that is going to make us sicker? It's not a cure, so why market it as a solution?

I'm probably going to try it in a few months once I hit the Tysabri 24 dose mark. PML seems a lot scarier to me then this. I can't tolerate copaxone or interferons. There have been cases of skin cancer on Gilenya -- not melanoma but basal cell carcinoma (which incidentally is not as dire as melanoma which can spread throughout your body). I think on this drug you will just have to watch your skin very closely and get regular full body scans from the dermatologist AND see an eye doctor for regular check ups. As far as damage to the liver can't the interferons and Tysabri also do a serious number on the liver? I've been on Tysabri for 2 years and my liver enzymes haven't changed one bit. They are the same numbers as when I started. I'm hoping I have a strong liver that can process this drug too. If I go on it, I will report back. Honestly I am more worried about the daily side effects which they list as headache, fatigue, flu, and diarrhea. I can't take any kind of flu like side effects--that just depresses me.

People have been looking for an oral DMD for many years. Some can't take the injectables anymore, so they get infused with Tysabri or try Novantrone or Cytoxan, etc.

So an oral drug may tempt a lot of people. Not me, but many will be switching to this oral pill. Biogen has a lot to lose in this market.

Many Big Pharma companies will try to copy an oral pill, but the cost seems to be the same as the injectables.:confused: Not fair to so many people. I heard it will be available around March 2011. I don't remember where I read that.

All drugs have some side effects. Some worse than others. Death is more than a side effect, IMO. They need a safe oral pill with no side effects, one that will be much more effective than those made so far. JMO

Thanks for sharing this information. Neuros can now add another DMD to their medical bag. :rolleyes:

Anyone on this forum that is on this drug from the Clinical trials? Has it helped?

I just read that it will be available in early Oct. and most are guessing the price will be $30,000 a year. That comes out to $84.26 PER pill!!!!!! :eek: Better not drop any on the floor or lose any!

Do you have an article we can read that mentions the cost Natalie?

Here is where I found reference to the cost of the drug. Two different people offer the estimate including a health care analyst. This article also states it will be available Oct. 4 according to Novartis, the company producing fingolimod.

http://www.npr.org/blogs/health/2010...t-at-what-cost

It was just on the news, so I'm bracing for the helpful phone calls and emails from my friends who suppose I've never heard of it.

Will call Biogen when I get to it and ask if I can take it with Ty if I chose.

Just spoke with someone about it. It blocks/reduces the white cells that make up your immune system by 70-80%. Effects production in lymph nodes. Also has heart, lung? and other neg. possible receptor effects(I forget). It was a long phonecall and was 1st thing we covered so the above info isn't spot on but it's close. Sounds like something I'd take at say 1/4 dose along with Ty if possible. If I could lower my white count by say 25%, I'd try that. Am I totally off saying it sounds like a chemo drug?

If that's correct Eddie, then reducing our white cell count by 70-80% sounds pretty scary to me. :eek:

White cells are our body's main means of fighting infection, and with a reduction that large, the medication would be inducing leukemia in the person taking it, leaving them open to potentially life threatening infections.

For me, the negatives for this medication are piling up fast.

I heard its approved for dispensing on OCt 4. The cost is to be determined by the research value of the drug. strong rumors have it that it will be about 30k per year.

I will not be taking this med, or probably any other DMD in the short term. After my break from Copaxone I am feeling so much better. I just cant/wont go backwards to the land of resting in bed most of the day. If the disease takes me, so be it.

I pray all those who chose it will be out dancing in the streets.

I am confused regarding your comment about taking the new drug with tysabri. I seriously doubt that this drug is supposed to be combined with another MS treatment.

Nope, no way, heck it's not for spms anyway, only rrms. Lowering the wbc's is NOT a good idea for those who are prone to infections. Jim is one of those. Oh well, hope it works for those who try it.

Since it lowers the WBC, it will be not be allowed with Tysabri. Same as any type of Chemo.

It is being clinically tested on PPMSers at Johns Hopkins, my neuro is doing trial. I've always wanted to try it (maybe it's the old name - Fingolimod I like) My ex old neuro who moved away was in charge of trial until he moved and tried to get me in it. Now my new neuro is in charge but rejected me quickly (I am 6.5, you had to be 6.0. I really liked my ex-neuro, he was out of the box if you know what I mean. The new one is younger and a rule follower.

I'd love to try it at 1/4 dose on Ty. My white count is always 15 give or take. Could be caused by frequent urine infections so lowering my count might make things worse but i'd still love to try it a month or two. I'll ask my neuro next month. I know Ampyra at 1/2 dose has been doing good for me past few months so let's try this at a 1/4. Don't chemo drugs also lower white count? Novantrone?

Yep, that is what caused Jim to go into kidney failure. His immune system couldn't fight it after only one dose. That's why he wont be placed on any medication that would do the same.

Pricing just came out over the wire. $4,000.00 a month. That is $48,000.00 a year...for 30 pills. OUCH! :eek:

They said it was more than the injectables a month. You think?:rolleyes:

Better not drop one or more on the floor, or let kids and pets get to the bottle or blister pack. That stuff is lethal to some. I'm still shell shocked at the price.

Anyone here on/tried Gilenya yet? if not, next appt I'll be the 1st.

Good luck, keep us posted. My Neuro is a little skittish about me trying it. He says to wait until its been on the market for a while to see what the true side effects might be. Besides I doubt I will be able to afford.

Good luck, Eddie..:hug:

I saw my neuro this morning. We discussed Gilenya. He said of all his patients I was the one he thought of because I have not been able to tolerate the other treatments. I got the feeling that he would be willing to prescribe it if I want to try it. He also mentioned the $4000.00 monthly cost. I told him that I wanted to wait until more people are on it since I tend to have so many reactions to these meds. He agreed and then said he did not really want to prescribe it yet. But then he also cautioned me that I could have a major flare at any time and that I probably really should try something. "It is my job to give you information -- not advise you. But on the other hand, you do appear to be stable. Let's do another MRI in June and talk about it again." He also told me that I do have MS. I was shocked! For some reason, he tells me that during every appointment. Does he have patients that do not believe him??? I really think it is time for him to retire. He spends most of my appointments trying to figure out what my computer chart says and going over my meds.

I saw an announcement that the cost is going to be $48,000 a year. its MORE expensive than the biologic injections. They say its cost is based on its "research value" and not on its production costs. its just scary to think that ANY medicine can cost that much. Whether is chemo or an asprin...eeek!

Hey if Novantrone does the same thing, how much is Novantrone?

Barb, I thought I read that the drug company that makes Gilenya was going to assist patients the way Amprya's maker did...
anyway, you need to go to an MS center and find a new specialist.:hug:
As If I'm telling you something you don't know...;)

Maybe I will be able to find a ms specialist if I move to Austin in 2012. At this point, I do not want to drive hours to go to the doctor. I assume that if they do have financial assistance, I would not be eligible or they would require a huge co pay. But I am not ready to try this one yet. I may be making a mistake, but I know how my body has reacted to all of these **** treatments.

Hi
 

Hi, I am new to this site and have only posted on the newbie thread. Still trying to figure out how to navigate!

I am going to go on the new drug Gilenya as soon as my neuro says it's ok. I have had the body scan, eye check, ekg, blood tests. Just waiting for the blood test results and instructions on what to do next.

Very nervous about the side effects. I rarely get sick (other than my MS) so I am not looking forward to the possibility of picking up every virus that comes along.

I will post back after I get started.

Lisa

Hi Lisa.:) Welcome home and much luck with your new Med. I hope it works for you with only good sides.:hug:

Hi Barb,

Good luck making your decision about Gilenya. Here is some useful information about the drug and the assistance program. I'm like you--trying to decide if I should try it now or wait it out and see how people do with it.

http://mscare.org/cmsc/Informs-Novar...-Programs.html

The assistance program by Novartis is not based on income--mostly you just have to have commercial health insurance and not be on Medicaid/Medicare.

Here is what I picked out of the link above.

# The Gilenya Prescription Co-Pay Support Program, which will cover a significant portion of prescription out-of-pocket costs for eligible patients with commercial health insurance.*
# The Gilenya Medical Co-Pay Support Program, which will reduce the out-of pocket costs associated with Gilenya initiation for eligible patients who require certain tests before starting treatment.**

*Government program beneficiaries and residents of Massachusetts are excluded.
**Government program beneficiaries and residents of Massachusetts, Michigan, Rhode Island and Minnesota are excluded by law and are not eligible.

I just read on some blogs that Gilenya is paying everyones co-pays until 12/31/11. So that's a year+ of free meds.

If you move to Austin (Texas I assume?) I've heard this MS specialist is the guy to see. He is in a suburb of Austin.

http://austin.citysearch.com/profile...is_clinic.html

Thanks Natalie for the information. I am going to copy your post so I remember the name of the doctor. I still plan on waiting until June when I have my next MRI before I make a decision.

If Gilenya’s ingredient (fingolimod) costs $14 a month, why is Novartis wanting $4,000 a month for it? Check it out. Google "buy fingolimod" and you will find several companies that sell fingolimod for non-human research (so more applications can be found). At one company it costs $42.00 for 50mg. The Gilenya website says that the pills would be 0.05mg each day. That's about 15mg a month. Simple math shows that we could all get fingolimod for about $14 a month if we were allowed to buy it that way. Based on their projected price of $4,000 a month, that’s a 285 times markup!
Gilenya is a cheap fungal metabolite that has been used in Chinese herbal medicine. Read the research: The Immune Modulator FTY720 Targets Sphingosine 1-Phosphate Receptors9, The Journal of Biological Chemistry, Vol. 277, No. 24, Issue of June 14, pp. 21453-21457, 2002. You'll find it online in pdf form. Novartis is the sponsor of the study at the college.
It is also my opinion that the $4,000 a month was figured by adding a thousand to the average $3,000 a month of the other therapies. They figure that no needles are worth $1,000 a month. The company line is that they are offering co-pay assistance. Of course they are! At $4,000 a month they can give out half-price coupons and still make a hefty profit. Another company line is that insurance will cover most of the cost. With 40% of Americans not insured, I wonder how many people with MS aren’t able to afford any therapy at all. My co-pay for Copaxone WITH my insurance is 25% or $777.10.
As much as I hate needles and as good as the product predicts to be, I suggest we all boycott Novartis’ Gilenya until they lower their price to at least $1,000 a month. That's still exorbitant but they do have the clinical trials and their research to pay for. If half of the people with MS bought it for $1,000 they would recoup their money fast at over $166 million a month (175,000 people X ($1,000 -$50 costs)). Of course, all of the other MS therapy companies would be upset but if all of them have been setting their prices based on what the others are getting, it’s called price fixing. They call it marketing. For us it’s called crippling.
Gilenya is not an expensive biologic like Betaseron. I did use Betaseron and got drug-induced Lupus and had to change to Copaxone. At least Betaseron uses the overies of Guniea pigs (in China) and that requires high manufacturing costs (and yuk!). I can almost see the large manufacturing cost for Betaseron and other biologics but it looks like all of the other therapies base their price on Betaseron’s high price. I think the drug companies are really taking advantage of the fact that there is no cure and they’ve got us over a barrel.

Man, I did Rebif for years 2000-2004 which I hear came from Chinese Hamsters (?)and think it was $1500 a month. I had good insurance then, paid nothing. When a compounding pharmacy made my generic fampridine, it was $31 a month. Hear it's in the thousands now.

What can I say,,,,,BIG Pharma improved it:rolleyes: and they want their money back..:mad:

They say they are asking for the "research value" of this drug, and not the actual production value. Based on studies of how expensive it was to get this drug to market, they want to be reimbursed for the cost it took to get it there. isnt it sad?

They will make BILLIONS of $$$ off of us this year, whether its an injectable or a pill or a cream or an IV infusion. They WILL be allowed to get away with it, and those with great insurance will get it, and some without insurance will get a limited supply and many will simply go without. They are NOT interested in curing or halting MS, they ARE interested in making money off of it. Sad, just sad.