The FDA approval of the first oral drug for relapsing remitting multiple sclerosis (RRMS) in the US went pretty much as expected, especially in light of the unanimous June 10th recommendation from an independent committee to the US Food and Drug Administration (FDA) on June 10th of this year (see Oral MS Drug Moves Ahead at FDA).
Although it has changed names and spellings a couple of times, it looks like Gilenya, which is manufactured by Novartis, is going to stick (although there will be some of us who have a hard time breaking the "fingolimod" or "FTY720" association in our minds).
I know that most of you (even those not necessarily ready to make the switch to an oral drug) want to know two things: "When?" and "How much?"
As to when Gilenya will be available... I have seen statements ranging from "on October 4" to "by the end of this year." That kind of narrows it down to within the next two months, I guess.
Although Novartis won't yet say how much they will charge for Gilenya, this article Novartis Pill for Multiple Sclerosis Wins Approval, But at What Cost? contains statements from a couple of experts who predict that the drug will cost between $30,000 and $35,000 a year.
I don't know. I'm just not that excited at the moment. Maybe I'll have a delayed reaction and be jubilant, but I wanted to scream "WOW!"
My current enthusiasm is tempered, not only by the potential cost, but also by the side effect profile (slowing of heart rate and shortness of breath in some patients, potential macular edema, increased susceptibility to infections and possible liver damage), although none of these seem to be too serious.
Don't get me wrong, the data looks pretty good for reducing relapses (although not amazing) - in a one-year study 52% fewer relapses than in people taking Avonex. Another two-year study showed a 54% reduction in annual relapses compared to placebo.
I'll be putting together a longer, more in-depth examination of Gilenya in coming weeks. Until then, what are your thoughts? Are you ready to throw your syringes away forever and start Gilenya immediately? Are you disappointed about the predicted cost? Did you expect something else? Let out your feelings here, folks. Tell me I'm a downer and this is the best news ever, or tell me you'll be waiting on the sidelines with me for a little while to see what happens with this drug. After all, we are all in this together.
Read more about the oral drugs for MS:
Neuros More Aware of Cladribine than Fingolimod (FTY720)
Russia First to Approve Oral MS Drug
Oral MS Drug Moves Forward at FDA
What's Up With Oral Drugs for Multiple Sclerosis?
Will You Switch to an Oral MS Drug?
Oral Multiple Sclerosis Drug More Effective, According to Trial Results
$30000 to $35000 per year???
Not much of a discount from our cost for Tysabri which has statistically greater efficacy.
We’re having CCSVI liberation next week – and hopefully no more overpriced drugs.
$30000 to $35000 per year???
Not much of a discount from our cost for Tysabri which has statistically greater efficacy.
CCSVI liberation next week – and hopefully no more overpriced drugs.
My neurologist told me that with the first dose of Gilenya-the patient needs to be observed for 6 hours. He also stated that insurances dont pay for observations of this kind-at least mine do not. One more thing he said that bothered meand that it would be just a matter of time before PML is associated with this drug as well… Lots to chew on with this drug. I currently am on Tysabri and want off of it badly. This is the drug of choice for me, but at what cost? There’s not a drug out there that doesn’t have some side effects, but these are scarey too. I need to know the percentages of occurrances of these side effects… do you have any idea? Thank you!
I’ve been following Fingolimod and Me’s blog for several months now. She’s been part of the Phase III trial. Some worthy reading if you are interested in a first hand experience with it:
http://fty720.blogspot.com/
cheers
My therapy is copaxone. After 10 years, going on 11, I have gotten to the point where there are days I just can not inject. I’ve talked to my doctor about it and said it happens.
I have the immediate skin reaction and there are times it is the red face, feeling like a heart attack and at the toilet with both ends. I think my fear of the last reaction is stuck in my brain and the fear takes over.
I’ve become quite ritualistic, sit a certain way, do this, do that, thinking all will go well. Sometimes the needle just won’t go in the rough/hardened skin. So, I say maybe tomorrow.
Learning more about this oral drug is of great interest to me. But as we are all saying….at what cost to the pocket book as well as the body/liver/heart.
I have a neighbor who is a pharmacy tech for a nationwide organization. Novartis quoted them a price of $2,200/month (28 pills). After their pharmacy mark-up I would imagine we’re looking at $3,000/month.
Not to mention, last time I looked, February was the only 28-day month. I find it interesting that Novartis didn’t quote my neighbor a price for 30 pills.
As a fingolimod/Gilenya lab rat I have to say I am so very disappointed in the way Novartis is [so far] bringing this to market.
Not much difference in price from the Rebif I pay for now… well, not much difference for me that is depending on copay.
Insurance pays $2500 a month for me… copay $25…
I’m not convinced that 30-35k for this medication is going to be tolerated by the market. At least it won’t be by me.
I’m already choking on the 28k per year that is billed to my insurance for the Rebif that I take now. Granted, I only pay 10% of that cost, but it seems to the “retail” price is greatly and artificially inflated.
I’m still concerned with some of the listed side effects also.
Well, Julie, I’m passing on it. Don’t like the sounds of the side effects plus what you have to do to get on it. My doctor said why go off of Avonex when you are doing so well with it and risk not responding as well to the oral drug. I will stay on Avonex, I hate needles but I will put up with it so that I can stay well. I’ve been on Avonex for 4 years and have had no relapses. Love reading your articles, so does my neurologist. Keep up the good work!
THAT IS A LOT OF MONEY!!!!
I am in Canada and was awaiting oral therapy because my white blood cell count goes down too much to use the injectibles. Copaxone does not affect wbcc; however, my body was getting covered in “dents”…i think having low body fat (but fit) for my skin too handle it…cannot pinch an inch on arms and barely get an inch on legs, so gave that up.
Now, i read side effect of vulnerable to infections…probably cannot go on this either, as my white blood cell still fluctuates regardless of not being on the injectables.
My biggest concern is a rather complicated issue. I am currently 10 months post treatment for stage 4 head and neck cancer. To date, all scans are showing normal and the docs say they can’t yet see any sign of the cancer returning. It’s looking more and more like between the neck dissection surgery and chemo/radiation they got it all.
How does this relate to MS treatment? Well, all of the CRABs suppress the body’s production of Tumor Necrosis Factor (TNF). TNF is a hormone the body uses to try and fight the growth of tumors. It causes tumor cells to die. While I was on chemo, all of my doctors agreed that I should stop the MS treatment (Rebif) because the chemo would suppress my immune system enough that a MS relapse was extremely unlikely and taking the MS drugs while on chemo might push my immune system too far down. Anyway, my immune system has recovered. My white cell counts are approaching normal now and it’ll soon be time to consider going back on treatment.
I do NOT want to do anything that might increase my already substantial risk of the cancer returning. That leaves two options. Tysabri, which according to one article I’ve read actually increases TNF production so might actually reduce the likelihood of the cancer returning, or this new oral drug. My question is, what effect does Gilenya have on TNF production? If it suppresses TNF then Gilenya will definitely be off the list.
Tysabri scares me with its link to PML. However, I think I’d rather take that risk than accept the increased risk of a cancer recurrence that would come with one of the CRABs.
Anyway, that’s the quandary I’m in now. Trying to do the risk-benefit analysis.
I’ve been in a fingolimod trial for the last three years. I hope it’s going to help some people living with MS…especially those who can’t tolerate the injectables.
But, like lab rat said, I am disappointed in the way Novartis seems to be bringing Gilenya to market. I read the June 10 briefing memo and supplementing documents from the FDA advisory committee, and the FDA has more safety concerns regarding pulmonary function that Novartis has glossed over as “shortness of breath.” Maybe others didn’t focus on that, but I did because I’m one of the people that had pulmonary function issues within the last six months.
I thought Novartis was going to have to include some black box warnings on the label, but I haven’t seen indications of that. I’m holding out hope and praying that Novartis will do the right thing and voluntarily educate patients/health care providers about the risks/benefits of Gilenya.
If anyone wants to find out more about the trial and the FDA findings, you can search “fingolimod” on the FDA website (www.fda.gov/).
With the listed side affects I don’t think this will be the drug choice for me. I’m on Tysabri and I hope by the time that I need to think about another therapy (1-1/2 years from now) there will be a better oral drug on the market or this one will provide better results from continued studies. This drug is just too scary for me. I think your “enthusiam” is well placed to be on hold.
I just moved to Cottonwood CA. CAN you suggest one. I think the meds are to much for me.Bonnie
Well, I just stopped taking Copaxone after my fifth IPIR. This was worse than the other reactions – my skin started itching, and I had some swelling. I’ve heard that Copaxone users sometimes experience anaphylactic shock, and this seemed like an allergic reaction to me, so I figured better safe than sorry.
So now I’m starting Betaseron. If the flu-like reactions are too much for me, or if I have too much trouble mixing the stuff, then I’ll have to go to Rebif or Tysabri. If it wasn’t for financial assistance, I wouldn’t be taking Betaseron! Can’t afford it.
What I really want is a pill I can take and stay compliant with. Having to inject myself is very difficult, and it gets harder and harder to push the button on the autoject. Despite the side effects, I’m seriously considering it – can’t be any worse than the Copaxone IPIR!
I’ve been in the TRANSFORMS 3-arm clinical trial for 3 years now and working on my 4th. I have had no relapses during that time and was relapsing every 3 months for years prior to the study.
Copaxone was the only other therapy I’d ever been on (8 years) and it quit working for me.
I decided to join the trial because I was probably going to try Avonex anyhow and with no placebo in this trial (FTY720 – 1.25mg vs FTY720 – 0.5mg vs Avonex) I would be guaranteed to be on some form of treatment.
The informed consent, with all the listed side effects, scared the pants off me and I almost backed out. It was explained to me that most of the known issues with adverse events had come up in the transplant trials where FTY720 had been tested as a possible anti-rejection medication. That was at a higher dose.
I personally have been one of the lucky ones who (I found out after being unblinded in Dec 09) was on the 0.5mg dose since the very first day, and have not had any serious adverse events.
My side effects have included a steep increase in urinary tract infections and upper respiratory infections during the fist six months of treatment which later leveled off to my pre-trial normal, initial drop in heart rate on randomization day which recovered after 6 hours, and mild dizziness that could be just my MS, but might be a side effect.
While I have experienced great results with minimal side effects, I think it would be wise for anyone on MS who is currently on a therapy that is working for them to just sit back and wait.
Once this has been on the market for a while anything that might not yet be known about long term effects may come to light. This is a powerful immunomodulator that should not be taken lightly.
There are risks with any medication, however, andI have faith that it will play out, over the next couple years, to be a widely accepted and well tolerated therapy choice for MS.
Best of luck to all who try it!
Jeri
I have been on Tysabri for 2 years now. I used Avonex and Rebif before being put on Tysabri. Since I am at the 2nd year mark, my neuro had me take the new blood test for the JCVirus and it came back positive for the blood marker. I now have to come off this and really don’t have any other options. I’m in I guess….
I’ve been in the Fingolimod/Gilenya Freedoms trial for almost 3 years. When I first started out, it was placebo/1.5mg/.5mg. After a year I developed some mild pulmonary issues with no symptoms (showed up on my Pulmonary Function Tests monitored by Novartis). Novartis took me off the drug immediately and then redosed me on the .5 dose. I’m assuming I was on the higher dose (which has now been done away with) because my pulmonary tests have returned to normal. So far this drug has done wonders for me. My tremors are better, mobility issues have improved and even my fatigue isn’t near as bad, as well as spasticity and pain in my legs.
I know it is risky, but I couldn’t tolerate any of the injectables currently on the market. I had a terrible ongoing reaction so I had few choices left (basically this trial or no therapy). I personally feel that my side effects have been tolerable compared to other drugs and I am very drug-sensitive. I believe Gilenya is a huge breakthrough for MS sufferers!
Jensequitur: It’s true…I had an IPIR that turned into anaphylactic shock. Needless to say, I don’t take Copaxone anymore….
Julie, keep saying it the way it is. Great to read honest down to earth literature about this ms. Been on Copaxone for 2 1/2 years. Don’t know if it is working but am not ready to be a guinea pig yet. Hang in there everyone.
It’s been great reading everyone’s comments, since I’ve had the same “maybe. . . maybe not” reaction to Gilenya’s approval. I’ve especially appreciated the comments from folks who’ve been in the trials. I liked the guy’s blog too, and understood his feeling attacked and misunderstood by sounding so cheerful. I’ve been using Copaxone with good results for 10+ years. Only had one episode with the heart-racing early on. Do get site reactions at times; all sites are lumpy from fat necrosis; have had to quit using my arms for awhile because of bad site reactions. I’m in the camp of waiting to see how things go for others. If I were newly diagnosed, I would be delighted about Gilenya (but then, I have insurance).
Another reason not to rock the boat–I was recently diagnosed with another autoimmune disease, probably lupus–bummer. Actually, the rheumatologist called it undifferentiated connective tissue disease, which means we’ll wait and see what else develops. Am on a “benign” oral med to start. If that doesn’t work then I move into the immunomodulators like Enbrel. I have no idea how this will be managed along with the MS, and I’m not looking forward to learning.
Julie,
I called Novartis two days ago to inquire about financial support options for Gilenya. The nice person on the phone informed me that the drug will become available for prescription on October 4, as they needed production time following FDA approval.
Barbie
I was only diagnosed in July and I’m eagerly awaiting the release of Fingolimod/Gilenya. I have read the trials and the posts and I am still convinced that this is the way forward for MS suffers. In my opinion it appears far superior to the CRAB drugs and the positive effect far outweighs the risks. Unfortunately I cant hold off till spring and my neurologist has recommended Rebif as a stop gap. I’m not a big needles fan and don’t fancy injecting myself 3 times a week but what choice have I.
@Bryan, I believe leukopenia was documented in the 1.25mg dose during Fingolimod/Gilenya trials. However that, among other things, prompted Novartis to stop testing that strength (in December ‘09) and only submit 0.5mg for approval. The benefits were virtually identical between the two doses, with adverse events being pretty significantly higher with the 1.25 dose. I’ve not yet taken the time to read the FDA submission documents in detail to know about leukopenia events reported in the lower dose.
My Uncle had MS in the 40’s, the Mayo Clinic treated him with HEAT! He passed away 3 months later. My Mom had MS, she refused to believe she had it and when she relapsed she would say it was her heart making her weak (I think because she saw what her brother went through), she was diagnosed in 1967 and passed away in 1999 unable to talk, walk or eat. There weren’t to many drug therapies available other than strong steroid treatments and we all know how those work.
I was diagnosed in 2000 after being mis-diagnosed for 10 years because MS is not “suppose” to be hereditary, I beg to differ, but, knowing my family history and seeing the advancement in drug therapy over the years, I AM ALL FOR IT!! I saw how my Mother went through her life with no treatment and I REFUSE TO LET IT BEAT ME!!!
Any side effect is better than DYING from the complications of MS, believe me, I’ve seen it first hand. My poor Mom, who was the life of the party and the energetic mother of 9 children and an artist, ended up only being able to blink her answers: once for yes, twice for no. NOT ME…. MOVE OVER NEEDLES…BRING ON THE PILLS
If you can afford it, try it, if it doesn’t work, go back to what you were doing before, BUT PLEASE, take some kind of therapy. Not taking any drug therapy for MS doesn’t cause you to die sooner, it only reduces your quality of life and increases the regrets of not excepting therapy sooner. Once the damage is done, there’s no reversal, but, stop the progression of MS and we can all live with the quality of life we all deserve. Walking, talking and eating our way to the grave, like all 90 year olds are suppose to do. ok that’s my 2 cents.
Julie,
I’m with you. I read the news and instead of feeling exalted I was depressed. I would love to be off an injectable as I am down to a 50% dose of betaseron and still get large, hot, red welts with most of my injections- that last for months. And as several others have mentioned- sometimes I just don’t do them. really really tired of needles and reactions but already know that my neuro considers me stable and will not change to Gilenya until she has seen at least 12 months of post release data.
So I’m meh about it. I hope it will be reasonably priced but even that seems a stretch.
Need we wonder why insurance premiums are so high?
Gilenya cost predictions for a year is more than a year’s wages for me. Medical costs way over and above the ’supply and demand’ theory. The greed and that fact that is legally allowed is astonishing, shameful and says something about the state of society we live in. The taking advantage of those that need health CARE is astonishing. It doens’t matter if it’s out of pocket or by insurance companies. We still pay for that greed.
Suntreemom, I’m a bit confused by what your neuro told you. My neuro explained that testing positive for JCV does not put me at greater risk for PML. Had the result been negative, I might be considered at lower risk for PML, but at this time, the relationship between the positive test result and its impact on PML risk is unknown.
Julie, if you could shed any light on this issue, I would greatly appreciate it. Thanks.
I have been waiting for this for A LONG time!
I am on Tysabri and it is amazing but it is way way to expensive!
Well, let me retract that – I only pay $50 a month for the actual medicine but the center who infuses it, bills my ins $10k a month!!! After my ins (BCBS) denies a lot of it, they still bill at around $4,000 every month. So, once I have met my deductible and have to pay my 10% its $400 + $50 for the actual medicine. $450 is a bit steep every month for one medicine and 3 hrs of my time.
I’m a stay at home mom after the birth of our son last valentines day and its very hard on one income….
Nomoreneedles – this is a little off topic but did you continue with tysabri through your pregnancy? I was on it for 2 years with no hint of a relapse but have been advised to come off the drug to fall pregnant. I’m considering fingolimod for this reason but would much rather stay on tysabri!
I’ve read a lot about the pill. I’ll definitely switch as long as I can afford it. The pill looks to be more effective. I’ll deal with the side effects when they come. I’m sick of the shots and site reactions. A few months ago I went to the emergency room for what the doctor thought was an injection into my nerve… 1300 dollar bill for Vicodin which bcbs didn’t pay a dime for. My thigh has been numb with random daily shooting pains ever since.
Considering the official cost of Rebif is about $30,000 a year it’s not shocking to me that this med can cost that amount too.
Would we like to save money, HECK YES (pay $60 a month out of pocket for Rebif) but with the issues that my husband has been having the small risks of a new drug are very likely worth it for him.
Everyone needs to do their own reading/deciding with their neurologist for what is the best bet for them.
He’s terrified of Tsybari because of the brain infection potential, he already does liver enzyme monitoring with Rebif so it isn’t as big of a deal.
He was on Copaxone for 2 years and been on Rebif for 3 years. Neither has really helped keep him stable (Rebif was better though) but something has to change.
I started on Gilenya 5 days ago. Slow heart rate and maybe a tad bit of fatigue (but who knows if it’s the pill or the MS causing fatigue). The Novartis support program is picking up the entire bill, even my portion of the copay, so whoever is interested in it should talk to their doctor before deciding based on cost alone. So far I am feeling really good on it. Avonex and Rebif were horrible as far as side effects and both can be hard on your liver. IVIG I had to watch for renal effects. They all have goods and bads to them. All you can do is hope for the best and the least relapses.
I am currently taking this drug. I have been on this study from the start…7 years. I have not had a relapse in 7 years. I have remmiting relapsing ms.
Judy from Pembroke Ontario