disease-modifying drugs

Gilenya (fingolimod), first MS oral drug, will be available in US with financial help from Novartis

Lisa Emrich Health Guide October 05, 2010
  • Even before I was diagnosed with MS in 2005, I researched the different treatment options.  I learned about the ABC’s (Avonex, Betaseron, Copaxone), which soon became known as the CRAB’s with the addition of Rebif.  I learned that each of these medications were administered by s...

17 Comments
  • Vicki
    Health Guide
    Oct. 06, 2010

    Oh Lisa, you have a way of getting to the point.


    I have thought for years there should be an oral option for treatment. Now we need a treatment for our pocketbooks.


    Good job, Lisa. Very informative.

    • Lisa Emrich
      Health Guide
      Oct. 22, 2010

      Thanks, Vicki. 

       

      I do hope that having a new choice in medication will help many folks, especially the ones reluctant to do the shots.  Even better, I hope that we hear lots of good stories of patients who are doing well because of the medication.  I'm also including thoughts of future oral drugs as well, not just Gilenya.

  • Karen
    Mar. 26, 2011

    I will be starting the drug this coming Friday, April 1, 2011. I have not been on any type of disease modifiying drug in 2yrs because I couldn't tolerate the shots.

    I am going to start blogging about my experience with it because of it being a new drug and like to help others (former medical assistant) and I feel like it will be informative for others to follow....

    RHMLucky777

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    I will be starting the drug this coming Friday, April 1, 2011. I have not been on any type of disease modifiying drug in 2yrs because I couldn't tolerate the shots.

    I am going to start blogging about my experience with it because of it being a new drug and like to help others (former medical assistant) and I feel like it will be informative for others to follow.

    I was 35 when I was diagnosed in Jan 2007 and haven't had any major relapses since diagnoses. I was at first on Betaseron and then Copaxone and really didn't feel like either were helping, not to mention the awful side effects of Betaseron.

    I have had annual MRI's done since I went med free and have had only 1 new lesion in that time, which was shortly after I went med free. Nothing new last year and it's quickly coming up to have my yearly done again. So I'm praying that there will again, be nothing new.

    Thank you for the info on Gilenya and Novartis. It was very well laid out and understandable.

    • Lisa Emrich
      Health Guide
      Mar. 26, 2011

      Hi Karen,

       

      I hope that Gilenya goes really well for you!!  Hey, do I know about your blog yet?  If not, please send me a quick note so that I can include you in the big list of MS blogs.  :)

       

      Lisa

    • Karen
      Mar. 26, 2011

      Hi Lisa,

       

      No, I haven't started it yet. I will send you a link when I get everything set up.

      Thanks

  • eileenkq
    Oct. 22, 2010

    Last week I googled "buy fingolimod" and got several wholesale outlets 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...

    RHMLucky777

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    Last week I googled "buy fingolimod" and got several wholesale outlets 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!

    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 there is assistance available. Sure there is - if your family income is less than $30,000.  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. I have a co-pay with my insurance of 25%.  

    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 to pay for - an estimated $25 million from what I've heard. There's also the research money they paid out in advance to recoup.

    In case you're wondering, I use Copaxone and I have a $777.10  a month co-pay (25% of their "negotiated"cost). I did use Betaseron and got drug-induced Lupus and had to change. At least Betaseron uses the overies of Guniea pigs (in China) and that requires mfg. cost (and yuk!). I can almost see the large manufacturing cost for Betaseron but it looks like all of the other therapies base their price on Betaseron's high price. I was infuriated with Copaxone ‘s price (soon to go generic) and really hoped that the new oral medication would be cheaper. When I found out the price I nearly stroked out. A cure that took maybe 12 months of treatment would be worth that, maybe, but the drug companies are really taking advantage of the fact that there is no cure and they've got us over a barrel.

    Yes, I'm posting everywhere but y'all do the same and spread the word. Let's show Novartis' Gilenya that people with MS are tougher than they think!

    • Lisa Emrich
      Health Guide
      Oct. 22, 2010

      Hi Eileen,

       

      Yes, I've seen your message which has been left on a number of MS-related forums and message boards.  What you have done is in effect spammed our board as well.  However, rather than ask for this comment to be removed (because it is a legitimate concern of an actual MS patient, not somebody trying to sell something other than an...

      RHMLucky777

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      Hi Eileen,

       

      Yes, I've seen your message which has been left on a number of MS-related forums and message boards.  What you have done is in effect spammed our board as well.  However, rather than ask for this comment to be removed (because it is a legitimate concern of an actual MS patient, not somebody trying to sell something other than an idea), I would like to point out some information.

       

      Please, please, come back and read the posting.  You will find details which address some of your financial concerns regarding Gilenya/fingolimod.

       

      I can't speak to the set wholesale price and again that it is outrageously high, especially in comparison with the other available MS therapies.  That said, there are programs detailed which will cover a wider portion of the population than you might be aware of right now.

       

      For patients who are uninsured and earn less than 500% Federal Poverty Level (FPL), Novartis will cover full treatment costs. For a single individual, 500% FPL currently is an adjusted gross income of $54,150. For a family of four, 500% FPL is $110,250.

       

      For patients who have a copay, regardless of income, Novartis will pay up to $800/month for Gilenya.  So if your copay is 25% and your insurance allows the full $4000 cost for Gilenya, your monthly copay would be $1000.  However, Novartis would cover $800 of that cost, leaving you with a copay in effect of $200/month.

       

      Also, Novartis will pay up to $600 for the pre-testing necessary before starting Gilenya.  That's an interesting twist to their offering.

       

      I know that this information doesn't really take away the outrage of the set price.  But I do hope that it helps others in becoming more educated about the programs which will be available.  Now, I hope that Novartis has done everything they can to make sure that the process goes smoothly for patients.

       

      Good luck, and I hope that you are doing well. 

      Lisa

       

    • eileenkq
      Oct. 22, 2010

      No, I am not spamming. I am informing. I still think Novaris is taking advantage of us. Gilenya is not a biologic like Betaseron (which is made from Guniea pig ovaries). It is a cheap fungal metabolite that has been used in Chinese herbal medicine. I know because I read the research. The name of the report is: The Immune Modulator FTY720 Targets Sphingosine...

      RHMLucky777

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      No, I am not spamming. I am informing. I still think Novaris is taking advantage of us. Gilenya is not a biologic like Betaseron (which is made from Guniea pig ovaries). It is a cheap fungal metabolite that has been used in Chinese herbal medicine. I know because I read the research. The name of the report is: 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. Novaris is the sponsor of the study at the college.

       

      Now some simple math. Assuming there are 175,000 people (half of MS patients) wanting to use Gilenya (fingolimod) at $1,000 a month Novaris would net ($1,000 - $50 for mfg. costs) $950 X 175,000 = $166,250,000 a month! After a FEW MONTHS all of their costs would be paid back. If they proceed with the current plan of $4,000 price, they would have an income of $3,950 X 175,000 = $691,250,000 a month. That's $691 MILLION A MONTH PROFIT.

       

      Don't forget to Google the words "buy" and "fingolimod." You'll find the companies that sell fingolimod cheap for research. I have made up nothing. I am simply providing the research. Think again about Novaris and Gilenya. Now you have all of the information I found before I "spammed" everyone.

       

      I already know that anyone with an income over $30,000 is out of luck with most programs. Over $50,000 and forget it. So I really doubt if Novaris is going to help everyone.

       

       

  • schultzy
    Oct. 18, 2010

    Thanks for the great info Lisa.  I have been on Avonex 30 mcg once a week injections + prednisone 10 mg daily since 1997.  I have been very fortunate with this regimen, and have had hardly any reoccurence of symptoms.  It is very tempting to try the oral med, after giving myself shots for so many years.  Then there is the fear...

    RHMLucky777

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    Thanks for the great info Lisa.  I have been on Avonex 30 mcg once a week injections + prednisone 10 mg daily since 1997.  I have been very fortunate with this regimen, and have had hardly any reoccurence of symptoms.  It is very tempting to try the oral med, after giving myself shots for so many years.  Then there is the fear of something else occuring, especially with the eyes.  I will have to talk to my neuro next time I see.  I appreciate any other advice or words of wisdom.

    Thanks again.

    • Lisa Emrich
      Health Guide
      Oct. 22, 2010

      Hi Schultzy,

       

      Wow.  So many years without much disease activity going on.  Awesome!! 

       

      Sounds like you do have a regimen which is working out well for you.  I'd personally be reluctant to change anything unless my doctor thought I would do even better on something different.

       

      It's really nice to hear stories of folks who...

      RHMLucky777

      Read More

      Hi Schultzy,

       

      Wow.  So many years without much disease activity going on.  Awesome!! 

       

      Sounds like you do have a regimen which is working out well for you.  I'd personally be reluctant to change anything unless my doctor thought I would do even better on something different.

       

      It's really nice to hear stories of folks who have found success with either medication or with their disease not progressing much over time.  Very encouraging for younger folks.

       

      Definitely talk to your neurologist about Gilenya (or any of the other oral meds which should be coming soon, such as Cladribine).  It can't hurt to gather more information and opinions.  But sounds like you are doing well.  :)

       

       

    • schultzy
      Oct. 22, 2010

      Thanks

  • Xenergetica
    Oct. 07, 2010

    Hi,


    Newly diagnosed with MS (Dec 2009).


    Unemployed and my premiums will be "astronomical" on Nov 1st.....WAAAAY out of reach for an unemployed person....


    Just found out from NORD that I have to be on Meds for them to pay my premium, or are they actually paying premium or just co-pays?

    What are the requirements for them to continue paying the premium once...

    RHMLucky777

    Read More

    Hi,


    Newly diagnosed with MS (Dec 2009).


    Unemployed and my premiums will be "astronomical" on Nov 1st.....WAAAAY out of reach for an unemployed person....


    Just found out from NORD that I have to be on Meds for them to pay my premium, or are they actually paying premium or just co-pays?

    What are the requirements for them to continue paying the premium once started?


    Trying to financially survive with this pre-existing condition


    Thanks!

    Xenergetica

    Reply

    • Lisa Emrich
      Health Guide
      Oct. 22, 2010

      Hi there,

       

      I responded to this request for information on another comment.  Have you learned any more about getting assistance from NORD?   If you do, please share what the process is like for you so that maybe it can help someone else.

       

      I do hope that it is working out for you financially.  Having to worry about the money is...

      RHMLucky777

      Read More

      Hi there,

       

      I responded to this request for information on another comment.  Have you learned any more about getting assistance from NORD?   If you do, please share what the process is like for you so that maybe it can help someone else.

       

      I do hope that it is working out for you financially.  Having to worry about the money is one of the most frustrating things about living with MS or any other expensive and debilitating chronic disease.

       

      Good luck!

  • estreetanne
    Oct. 06, 2010

    To answer your question, more than likely I will be trying to get on this pill.  I've been a (blinded) member of the TRANSFORMS study aince March of '09 and will remain so into March of '11.  Then I'll get three months worth of the real thing. I figure I'll make my decision then. Even though I believe I've been on real drug all this time, I don't...

    RHMLucky777

    Read More

    To answer your question, more than likely I will be trying to get on this pill.  I've been a (blinded) member of the TRANSFORMS study aince March of '09 and will remain so into March of '11.  Then I'll get three months worth of the real thing. I figure I'll make my decision then. Even though I believe I've been on real drug all this time, I don't think I'm going to actually be unblinded until about this time next year, so these three months of real drug are going to have to be my decision maker. Lisa, you did a phenomenal job with disseminating this information here. Well done!

    • Lisa Emrich
      Health Guide
      Oct. 22, 2010

      Hi Anne,

       

      It is nice that trial participants will be getting three months of drug.  That does help to fill the gap in time between being blinded and then unblinded.  From what I read in your blog, you are doing quite well.  I hope that continues.

       

      You know, it might be nice if you could share your story with the folks on this site...

      RHMLucky777

      Read More

      Hi Anne,

       

      It is nice that trial participants will be getting three months of drug.  That does help to fill the gap in time between being blinded and then unblinded.  From what I read in your blog, you are doing quite well.  I hope that continues.

       

      You know, it might be nice if you could share your story with the folks on this site who may not read your blog.  Folks who have been in the fingolimod/Gilenya trials are a well-connected group in the blogosphere, but their stories are not found on the forums so much.

       

      I hope that the rest of the trial goes uneventfully for you.  Wouldn't that be great, for nothing exciting to really happen regarding your MS?  Sounds good to me.  :)

       

      Thanks for your comment, Anne.

       

      Lisa

  • Maris B. Mohr
    Oct. 06, 2010

    Hi Lisa,

     

    I know I'm months late to respond to this info, but I will anyway.

     

    I've been on Betaferon for about 9 years. Prior to that, I was on Copaxone for almost 2 years. I've gotten to the point where I presented with some new MS activity in my brain on my last MRI and my clinical sx have been progressing steadily for the last 11 years, i.e....

    RHMLucky777

    Read More

    Hi Lisa,

     

    I know I'm months late to respond to this info, but I will anyway.

     

    I've been on Betaferon for about 9 years. Prior to that, I was on Copaxone for almost 2 years. I've gotten to the point where I presented with some new MS activity in my brain on my last MRI and my clinical sx have been progressing steadily for the last 11 years, i.e. decline in ability to walk, difficulty using my hands and arms, some cognitive decline. In addition, I starting developing weird skin rashes and sensitivies to sun exposure and heat.

     

    I nag my neuro all the time about changing treatment and he always answers, "Let's wait for the first oral one." We received a letter from the Israel MS Society about 3 months ago that Gilenya would get here (to Israel) around Sept 2010. I emailed my neuro to see if it's actual yet. I really hope so.

     

    Good luck to all the MSers who give it a try. I hope to join you soon.

     

    Have a beautiful day,

    Maris

    • Lisa Emrich
      Health Guide
      Oct. 22, 2010

      Hi Maris,

       

      I hope you are doing well.  It's October now, is Gilenya available in Israel yet?  It's supposed to be available in the US now although I haven't been in contact with anybody who has filled a prescription.

       

      Sorry to hear that there is new activity on your MRI scans.  That is something we each never want to hear.  And...

      RHMLucky777

      Read More

      Hi Maris,

       

      I hope you are doing well.  It's October now, is Gilenya available in Israel yet?  It's supposed to be available in the US now although I haven't been in contact with anybody who has filled a prescription.

       

      Sorry to hear that there is new activity on your MRI scans.  That is something we each never want to hear.  And the new symptoms are not good.

       

      However, it will be exciting to see if Gilenya makes a hugh difference for you.  Please tell us about it when you get the medication.

       

      XO

      LIsa