Last week, the FDA approved Biogen’s long-awaited oral MS drug, Tecfidera (formally known as BG 12). Naturally, the news was featured most prominently in the financial sections of newspapers/websites (click here), as an uptick in shareholder value is much more newsworthy than a potentially breakthrough drug that could help hundreds of thousands of patients suffering from a heinous disease. Much was also reported about the drug's yearly price of $54,900, which is actually considered reasonable in the demented world of MS drug pricing. Such are the priorities of our whacked out society. Okay, social commentary over…
Tecfidera’s active ingredient is dimethyl fumarate (DMF – click here), a derivative of fumaric acid, a naturally occurring substance that can be found in mushrooms, lichens, and moss. DMF was first used for medicinal purposes in a highly effective anti-psoriasis drug called Fumaderm, which has been marketed in Germany since 1994. It’s important to note that Tecfidera and Fumaderm are not identical compounds, which must be kept in mind when comparing the actions and side effects of the two drugs. Much might be inferred by reviewing the history of Fumaderm, but trying to make precise, direct comparisons could well in lead to erroneous conclusions. More on that later…
The release of Tecfidera has been much anticipated in the MS community, as clinical trials showed the pill to be significantly more effective in reducing relapses and slowing the progression of multiple sclerosis disability than the current frontline MS treatments (Copaxone, Rebif, Avonex, and Betaseron – all injectables), while its side effect profile appears to be quite mild when compared to many of the other MS disease modifying treatments.
Tecfidera joins Gilenya and Aubagio as the only MS treatments currently in pill form. In clinical trials, Gilenya was more effective in terms of reducing relapse rates, but concerns about potentially serious side effects (dangerously low blood pressure and pulse rates, potential for opportunistic infections) have kept the drug from reaching "blockbuster" status. There are some indications that Gilenya may have neuroprotective properties, and it is currently undergoing trials for use against Primary Progressive Multiple Sclerosis (click here). It is one of the few drugs being tested for the progressive forms of the disease. In trials, Aubagio proved to be just about as effective as the CRAB drugs in reducing relapses, and has exhibited some potential in inhibiting disease progression, but the drug comes with two black box warnings (the strongest issued by the FDA) concerning liver toxicity and the possibility that it can cause major birth defects (click here). Tecfidera’s comparatively mild side effect profile, which is comprised primarily of flushing of the skin and gastric disturbances, its high rate of efficacy, and oral dosing have led to the expectation that it will soon be a leader in the multiple sclerosis drug market.
Tecfidera’s mechanism of action, which is not fully understood (something that is not uncommon, the action of many pharmaceuticals are not fully understood), appears to be threefold. The drug exhibits immunomodulatory, anti-inflammatory, and antioxidant properties, the combination of which theoretically affords the compound its potency. In two large-scale studies, called DEFINE and CONFIRM, Tecfidera reduced relapse rates by approximately 50% over placebo, and reduced the progression of disability by about 30%. By comparison, the CRAB drugs reduce relapse rates by about 35%, and Tysabri cuts relapses about 65%. Whether these drugs impact disease progression has yet to be firmly established.
Much of the excitement surrounding Tecfidera involves the prospect that, in addition to its disease modifying characteristics, the drug may be neuroprotective. Neuroprotection is one of the holy grails of MS research. If the cells of the central nervous system can be protected from the ravages of multiple sclerosis, then the progression of the disease can be inhibited. The notion that Tecfidera may be neuroprotective is based on the fact that one of the drug’s supposed mechanisms of action is the activation of Nrf2 pathways in the human body. Nrf2 (click here) is simply a protein that exists within every human cell, inoperative until it is kicked into action by a Nrf2 activator (think of it like a bottle rocket – until lit, it sits there doing nothing, but once lit (activated) it zooms into action). Once activated, Nrf2 migrates into the nucleus of the cell and bonds to the DNA within, initiating the production of powerful antioxidants. If Nrf2 was a bottle rocket, it’s thought that Tecfidera could initiate the process that lights its fuse.
Antioxidants (the good guys) are the body’s defense against free radicals (the bad guys), cell damaging oxygen molecules that are released during the biological process of turning food into energy, much like noxious exhaust fumes are released by an automobile engine turning gasoline into energy. Once free radicals are released they act like wrecking balls, smashing through cell walls and inflicting injury. The process by which free radicals do damage to the body’s tissues is known as oxidative stress, which is believed to be one of the primary drivers of MS disease progression, as well as a factor in many other diseases (click here). Therefore, by combating oxidative stress through Nrf2 activation, Tecfidera may protect central nervous system tissues from damage by free radicals, which would be a very good thing.
Some Facebook pages and websites, including a previous post on Wheelchair Kamikaze (click here), have mistakenly equated Tecfidera with a nutraceutical product called Protandim (click here). In laboratory tests, Protandim has proven to be a powerful Nrf2 activator, a quality it does share with Tecfidera. However, Tecfidera’s mechanism of action appears to be much more complex and wide-ranging, and not confined only to Nrf2 activation. It also effects cytokines (chemical signals that influence the inflammatory process – click here), and down regulates the immune system. This down regulation of the immune system may in fact be the primary driver of Tecfidera’s effectiveness. According to the official report detailing the results of the DEFINE trial (click here), which appeared in the New England Journal of Medicine, “It is difficult to determine whether the therapeutic effect of BG 12 stems predominantly from immunomodulatory mechanisms or from neuroprotective mechanisms.”
Now back to Fumaderm, Tecfidera’s very effective German anti-psoriasis cousin. Fumaderm's efficacy in treating psoriasis, an autoimmune disease, is well documented, with 50% of the patients taking it achieving at least 70% improvement in their condition. Since Fumaderm’s primary component, like Tecfidera, is dimethyl fumarate, its side effect profile is similar to Tecfidera’s. Through 20 years of use, the most prevalent Fumaderm side effects have been gastric disturbances (stomach ache, vomiting, and diarrhea) and flushing of the skin, which, according to a paper prepared by Britain’s NHS (click here), can lead to discontinuance and/or noncompliance in 30% to 40% of patients. In the Tecfidera drug trials, though, dropout rates were negligible, with no significant difference between those patients taking the actual drug and those on placebo. Gastric disturbances and flushing of the skin were the most commonly reported side effects in the Tecfidera trials, but appeared to be manageable and diminished significantly after one month on the therapy. This discrepancy between the patient experience with Fumaderm versus Tecfidera is likely due to the different chemical makeup of the two compounds (Tecfidera is composed only of DMF, while Fumaderm includes DMF and some other derivatives of fumaric acid), and/or to differences in dosing, as patients on Fumaderm generally take a higher dose of DMF than will be given to Tecfidera users. Still, only real world experience will tell us how troublesome these side effects prove to be.
Another effect seen in both drugs is leukopenia, a reduction in white blood cell counts. This condition is accompanied by lymphopenia, a reduction in specific white blood cells, including B and T cells, which are the targets of many of the current MS drugs (Tysabri, Rituxan, Gilenya, Aubagio). This suppression of immune system cells may play a part in the two drugs' effectiveness, but can be problematic if the cell counts get too low, as this might open the patient up to opportunistic infections, although none were seen during the clinical trials. Tecfidera induced lymphopenia and leukopenia are reversible with cessation of drug therapy.
In its 20 years on the German market, comprising over 170,000 patient hours, Fumaderm has been linked to four cases of PML (click here), the opportunistic brain infection associated with Tysabri. While this may initially seem troublesome, it’s important to keep in mind that these cases occurred over a very long time period, and at least one of these patients was using other powerful immunosuppressive drugs. Generally, opportunistic infections are not seen in patients using Fumaderm.
During the Tecfidera DEFINE trial, white cell and lymphocyte cell counts dropped an average of 10% and 28% respectively, which could very well play a role in the drug’s efficacy. Importantly, though, over the two-year run of the trial, no instances of opportunistic infections were reported. It was noted, however, that 4% of trial patients experienced a more serious drop in cell counts (this info can be found on page 1106, paragraph 3 in the NEJM article – click here). In Germany, Fumaderm patients are required to have blood tests once a month for the first six months they are on the therapy, and then every other month thereafter, to keep an eye on cell counts The FDA guidelines for Tecfidera only call for yearly blood tests, and though I’m no doctor, this recommendation seems a bit questionable. Even though no opportunistic infections were noted in the two Tecfidera trials, why not err on the side of caution? We’re only talking about simple blood tests, which could head off potential problems before they get started.
Some other rare but potentially serious side effects noted in the Tecfidera study were liver and kidney events, although most were mild and reversible. There were no reported incidences of kidney failure. Still, I would think, all the more reason for regular blood tests, especially since so many MS patients are on other drugs that can be liver or kidney toxic.
So, what do I make of all this, as an educated patient? Tecfidera seems to be a very promising new drug for MS sufferers, one which might even help those with progressive disease due to its antioxidant, neuroprotective potential. I will very likely begin Tecfidera therapy sometime in the near future, even though my diagnosis is still uncertain and none of the other MS drugs have helped me. I’m encouraged by the fact that Tecfidera is related to a drug that is very effective in treating psoriasis, and has also anecdotally been noted to have a positive effect on a host of other diseases, including sarcoidosis and alopecia. I definitely show signs of some sort of systemic autoimmune activity, a condition against which Tecfidera’s mechanisms of action suggest might make it effective.
Tecfidera’s clinical trials convincingly demonstrate it to be effective in treating RRMS. Whether you believe MS is an autoimmune disease or not, it’s indisputable that the immune system plays some significant role in the MS disease process, and Tecfidera’s combination of immunomodulation, anti-inflammatory action, and antioxidant activation should provide a potent mix to help tame the disease. We’ll have to see just how troublesome the gastric and skin flushing side effects turn out to be, although, as stated above, in the trials they appeared to drop off dramatically after the first month of therapy.
Personally, if and when I do go on Tecfidera, I am going to insist on blood tests every 4-6 weeks, based on the study data concerning leukopenia and lymphopenia, as well as renal and hepatic toxicity. I’m on so many drugs that I rattle when I move, and I’ve learned to take nothing for granted. I’d suggest patients sharing similar concerns print out the New England Journal of Medicine DEFINE trial article linked to above and show the pertinent sections to their neurologist. The 4% rate of serious lymphopenia has not been publicized, as far as I can tell, and that alone should be reason for regular monitoring of blood counts. Better safe than sorry, especially when using a drug new to the market. Of course, that’s just my humble “I'm not a doctor” opinion…
(Update: for more information on Tecfidera and PML, please see my latest post on the topic, by clicking here)
According to their website, Tecfidera has a co-pay program of only $10 per month or even free for patients without insurance.ReplyDelete
So the price tag shouldn't stop patients from requesting it.
Yes they have a $10 per month copay program for those can not afford to pay for the cost. They will coordinate with insurance if you have one otherwise they will cover it all.Delete
Problem is with patients who are middle class (eg. earning $55-80K/yr), If your insurance doesn't cover the cost, you won't pay just $10/month---they will make you pay a lot more before you see any help.
Well, that's good news for those in need. Still, the price of the drug is outrageous, around $55,000 a year. The raw chemical used to make the drug can be bought from wholesale distributors for about 100 bucks for a year supply. From what I understand, a first-year chemistry student could do the work to transform the raw material into the compound found in Tecfidera. The pricing of MS drugs is simply outrageous…Delete
On the site it actually states $10 per month, regardless of income......so please check before you write off tecfidera!!Delete
I personally plan on waiting at least 3 months before starting the process. Rebif has worked perfect for me, besides injection site reactions so I'm in no rush. Good luck everyone.
I am seeing that for those covered by Medicare, Medicaid, the VA/DoD, etc.. are not eligible. Currently, the drug is not covered ASAIK. Just adding my input.. Thanks.Delete
Medicare, Medicaid, etc., recipients don't qualify for the $10 copay program, but they may qualify for full patient assistance. It's worth calling MS ActiveSource and asking about it.Delete
I am starting as soon as they ship it to me. I am on Medicaid.Delete
Thanks for a great post!
Well, I have been on Tecfidera for 2 weeks now. My insurance told me my co-pay was gonna be $200 for a 60-day supply - which was the same as Avonex, which I was paying. However, when I contacted Biogen and inquired about the $10 co-pay program, they signed me up immediately, and that is what I am paying! Don't give up!Delete
Thank you everyone for the helpful information. Been waiting to go on this. Does anyone know if Kaiser covers it yet?Delete
Melinda, I think Kaiser must cover it. I have MS and Kaiser and my neurologist is recommending I try it. I'm out here in Hawaii int the middle of the Pacific so if we have, I'd think everywhere else would too...Delete
My Insurance company (BCBS) has denied me Tecfidera stating that I must try two other cheaper drugs first. After trying for a month I called MS Active Source through Biogen. They shipped my the drug at no cost the next day. There is help out there if you look for it. I started four days ago. About two hours after I take my morning pill my face gets warm and my upper body itches. It goes away in about 2 or 2.5 hours. Sometimes I get nautious but eating something help. So far not as bad as I expected.Delete
I started Tecfidera July 9. A couple of hours after my very first pill I turned red from head to toe. I didn't have an itching situation but I did look like I had poison oak from head to toe. The flush went away after a couple of hours. Now (12 days later), I am not getting the flash at all. I haven't had any gastrointestinal problems at all.Delete
Trying not to slam big pharma anymore, they are already punching bag regarding the price of drugs, whether deserved or not. But none the less, DMF is relatively simple molecule, the cost for 100g from Sigma is ~$56.00. 240 mg x 2/day x 365 days = 175g. Clearly, the cost of 55K/yr is covering extensive R&D and clinical trials. And so it goes......ReplyDelete
Whoops, didn't see your reply before I replied to the above post. There's plenty to slam Big Pharma on, well beyond the price of their products. My biggest beef is that since they now pretty much dictate the direction of most medical research in this country, there are barely any researchers searching for cures to disease, rather putting their efforts into finding potentially blockbuster compounds used for disease management.Delete
For those who would discount the above as paranoid conspiracy theory, it's actually a product of free market capitalism. All of the major drug companies are public companies mandated to be beholden to their shareholders, not to the patients who take their drugs. Therefore, their quest is profit, not patient benefit. If the two dovetail, fine, but healthy people don't take drugs, and therefore don't generate profit. There is no financial impetus for finding cures, but there were fortunes to be made finding treatments that patients must stay on for life. Capitalism is a wonderful engine for driving an economy, but when applied to the practice of medicine the results can be horrific.
Hi Marc another great article.ReplyDelete
I have been reading a few books of late about Lyme disease and the treatments. I have found that the herbalists such as Stephen Buhner and the Functional DR's such as Dr David Jernigan provide some very important insights to our disease 'MS'.
I am also reading a book 'Canary In the Coal Mine' by Elaine Marie Graham (US$3.99 on line) which is very insightful from several angles and that interlinks the Leaky Gut issues and Autoimmunity.
Like you I am on all sorts of drugs and supplements as I'm on the Wheldon CPn infection Protocol. Anyway, I have an endo-toxin build up and secondary porphyria recycling issue because of not being able to de-tox efficiently. This has created symptoms and exaserbated symptoms and has made me aware of a Lifetime of a progressive increase in ill health that I have created through Life Style and also Stress Style. Much of the MS has been building and waiting for a Stress event and or an injury to blossom into the PPMS form. I now have a very good detox herbal mix with some other trace elements that has made a huge difference, as well as the simple and very effective lemon juice and warm water each morning a half hour before food to increase alkalinity of my system, this change from the other detox systems I had been using is 'Magic'.
So I wanted to throw in some food for thought regarding all the drugs etc that you have tried over the years and offer that there may be issues with the Leaky Gut Syndrome from an ABx etc. The drugs that you are trying may not be able to work in your system purely because of the issues that are Historically happening from endothelial layer dysfunction to fibrin coating, bio-films and so on, that needs addressing before moving from treatment to treatment.
All the best,
I think that you have hit the nail on the head. All of you folks have very educated posts. I believe that there is much to be found in the alternative world in regards to helping MS. I have learned from experience that the gut leaks. Staying away from foods and meds that pass through that gut barrier, can sure help MS. Never take Advil or related drugs. A very strict diet of nothing white, no lectins, NO sugar, limited omega 6's, and supplements seem to help some people as well as the traditional drugs. I am sure that all of you follow or have read Dr. Terry Wahl's work and Dr. Ashton Embry's work. Has anyone here been on LDN?
Enjoy your brilliant post.
Nigel, thank you for your comments. I would love to know the ingredients of herbal detox mix you are taking, and would appreciate it if you emailed me at WheelchairKamikaze@Gmail.com. I completely agree that the pharmaceutical cocktail that I take now, as well as everything I've ingested in the past, certainly may be adversely affected by faulty biological processes/mechanisms within my body. My MS clinic has an on staff naturopathic Dr., with who I regularly consult. We are now doing some experiments with Traditional Chinese Medicines, so this should be interesting…Delete
I'll have to give the lemon and water thing to try as well. I'm sure I could do with a good detox…
Nanette-I wasn't aware that Advil was a no-no. Thanks for the info. As with all things MS, I believe that diet can dramatically alter the disease path of some patients, while hardly having any effect at all on others. Such is the heterogeneous nature of the disease.Delete
I tried LDN soon after my diagnosis, but found it did nothing for me. But I'm a very bad patient on which to base any opinions, as my disease is highly atypical and has stumped some of the best minds in the business…
I tried LDN for a year and I found it did nothing and I also had a major vision exacerbation which is why I stopped it.Delete
I am on LDN for a year. It did not help me with anything. It is written that LDN might stop progression of MS. I believe it and I am staying on it. I also follow Dr. Terry Wahl's protocol.Delete
On the sad to me front, I was reading the MS Research Update put out by Multiple Sclerosis Association of America, and it seems BG12 did not significantly slow symptom progression in it's trials. They note the placebo group had an unusually low amount of symptom progression which may have caused the result. Still, it's not great news for what was supposed to be the best oral pill yet.ReplyDelete
There were actually two phase 3 trials done, and in one trial BG 12 did display a statistically significant effect on progression. As you note, this effect was not apparent in the other trial, but the placebo group progressed slower than was expected. Given the supposed mechanism of the drug, it's reasonable to think it may have some effect on progression. Because of the very imperfect nature of the competition, I do believe that Tecfidera is the best oral med currently available to treat MS.Delete
good article on how pharma sets the price of drugsReplyDelete
Thanks for the link, interesting stuff…Delete
hi whelchair kamikaxeDelete
my wife has progressive ms. it started out as relapsing/remitting. that phase lasted 10 yrs approx. she then slowly transitioned into a wheelchair and since 1992 has slowly lost almost all her mobility. we have been to many doctors and tried many things including the ccsvi operation. i was told about this drug(tecfidera) and i have read quite a lot about and am now trying to see if it could help Sharryl my wife. what do you think
So sorry to hear about your wife. As I'm sure you know, the progressive forms of the disease are extremely hard to treat, but Tecfidera does show some promise in that regard. I wouldn't expect miracles, but I think it's worth a try. At least, there doesn't seem to be much of a downside, although we won't know for sure until the drug has been on the market for some time…Delete
Does your Chinese alternative treatment include a root of Chinese hydrangea? There was a study completed few months ago how it suppresses a production of "bad" proteins that cause inflammation.
No, I haven't been using Chinese hydrangea. I'll have to ask my naturopathic about it… Thanks for the suggestion.Delete
First time visting; Found your blog well-written and informative. I'm newly diagnosed (GW MS-like symptoms and findings)and rather nervous about using a drug that is so new to the market. Also have T1 (auto-immune) diabetes for nearly 20 yrs. and very briefly tried Copaxone (more shots anyone[grin]?), but was not for me. As you aptly stated, seems like Tecfidera is worth a try... Still, I remain apprehensive. I will likely take the plunge and hope it's not another Vioxx, etc.ReplyDelete
Well, it's not exactly a brand-new compound, as a very similar drug was used to treat psoriasis in Germany for many years, with few serious side effects. Still, your caution is quite understandable, and probably even warranted. Unfortunately, those of us with more advanced disease don't have the luxury of time…Delete
Since you are newly diagnosed, I would recommend getting on one of the therapies sometime soon, even though none of them are close to perfect. There's an increasing amount of data that shows that treating early and aggressively can have an effect on the disease…
My first time visiting your blog too and I just trashed my first attempt at a post by navigating away, so now I'm more carefully composing my thoughts in Word first.ReplyDelete
I’m in the study of BG-12/Tecfidera, and was only made aware of its approval at a discussion I had about MS and exercise with a meeting last week. Duh! You’d think I’d pay more attention, but maybe since I’m slated to continue the extension study for around a year and a half more, I was not clamoring for an approval date.
The drug is fine. I’ve had no relapses since taking the real drug. I was most definitely on the placebo initially because as soon as I started to full dose of the real drug two years ago, I experienced VERY noticeable side effects. Bad GI issues – I thought I had food poisoning, and lost about 10 pounds in a month. The flushing was apparent too. But happily, my tummy was better after a month or two. The flushing remains but is intermittent and weirdly un-relatable to any other factor than taking the drug – 10 minutes later, itchy scalp, hands , red face and within an hour, gone. But it does not always occur. The flushing is weird, but only mildly annoying.
I’ve had no relapses and no apparent increase in disability. The last noted MRI activity was in 2008, but I was on the placebo at that time. I will take occasional flushing if it means I do not progress (in a bad way). Sometimes I search for signs of restoration, but nothing really. I was also in a study of daclizumab, and I felt GREAT. But that’s a monoclonal antibody, and I only was in a 6 month phase 2 study of that. The further studies went overseas. I would highly recommend dacizumab once it resurfaces.
I linked to your post in an article I just wrote on examiner.com. I also wrote about the study back in September.
So did you start taking Tecfidera? Feedback?
Thanks for your commentary, I'm sure many readers will find your experiences quite valuable. Glad to hear that Tecfidera has been good to you, despite the initial gastrointestinal distress. Not progressing is definitely a good thing…Delete
I have read many positive things daclizumab, but it probably won't be on the market for at least another year or so. Time's a wasting…
Oh, forgot to say that I have not yet started taking Tecfidera. Due to discuss this with my neuro this week…Delete
My first time visiting your blog too and I just trashed my first attempt at a post by navigating away, so now I’ve wisely composed my thoughts in Word first.ReplyDelete
I’m in the study of BG-12/Tecfidera, and was only made aware of its approval at a discussion I had about MS and exercise last week. Duh! You’d think I’d pay more attention, but maybe since I’m slated to continue the study for around a year and a half more, I was not clamoring for an approval date.
The drug is fine. I’ve had no relapses since taking the real drug. I was most definitely on the placebo initially because as soon as I started to full dose of the real drug two years ago, I experienced VERY noticeable side effects. Bad GI issues – I thought I had food poisoning, and lost about 10 pounds in a month. The flushing was apparent too. But happily, my tummy was better after a month or two. The flushing remains but is intermittent and weirdly unrelated to any other factor than taking the drug – 10 minutes later, itchy scalp, hands, red face and within a half hour, gone. The flushing is weird, but only mildly annoying.
I’ve had no relapses and no apparent increase in disability. The last noted MRI activity was in 2008, but I was on the placebo at that time. I will take occasional flushing if it means I do not progress (in a bad way). Sometimes I search for signs of restoration, but nothing really. I was also in a study when I lived in NYC (another reason I like your blog) of daclizumab, and I felt GREAT. But that’s a monoclonal antibody, and I only was in a 6 month phase 2 study of that. The further studies went overseas. I would highly recommend dacizumab.
I linked to your post in an article I just wrote on examiner.com. I also wrote one about the Tedfidera study back in September. So did you start taking Tecfidera? Feedback?
Found your article via Google. Searching BG12 before I go see my neuro this week. He has been waiting for this drug to be approved for awhile now. Currently I am not on any MS therapies as I have had very bad reactions to some and the side effects of others are too risky.ReplyDelete
Article was very informative and easily presented then others I have found. I also seen some things on here that I thought were said about the drug before the FDA passed it but I have not seen via Tecfidera site. Thank you for sharing. I will be discussing some of these points with my neuro.
Hello all. I found your extremely interesting blog and great stories today on a search for bg 12 vs. Aubagio. I have worked in clinical research as a nurse for 10 years now and it has become increasingly distressing. I have seen time after time wonderful products that are abandoned in Phase III because they didn't help 'enough people.' I have also worked on very effective products (ie Rituximab for RA) that are priced so far out of the market I knew elderly patients mortgaging their homes to meet the co pays. I was completely and utterly shocked by the cost of BG12 and Aubagio. Particulary because of the metabolite nature of Aubagio and common 'shroom nature of BG12. The article mentioned above at http://www.forbes.com/sites/johnlamattina/2013/04/02/myths-in-the-pricing-of-new-drugs/?partner=yahootix was so interesting and confirms what I have known for years. Big pharma always claims/ claimed they are recouping R & D costs which is bunk. It takes $5-6 billion per compound to make it through the pipeline. They can make that back in 3 years for a non blockbuster drug. If a compound fails they have rarely invested that much and they DO have their blockbusters to make up the difference. My rambling point is this. I know the big pharma lobby has 1.5 lobbyists in DC for every congressmen. They are hard to beat but not unstoppable. Find organizations that bolster your cause and contribute or volunteer your time to emailing, calling, faxing, writing, or whatever it takes. It is well established the next few generations which will govern will be more progressive and utilitarian that this baby boomer disaster. (Props to India for screwing the whole system. But good luck legally exporting it.)Keep the faith (I returned to MS research after a 5 year hiatus and couldn't believe all the pipeline drugs!) and ALL of LUCK IN THE WORLD TO YOU ALL. Oh and I just got back from an NP conference. EVERYTHING is anti inflammatory now. I started juicing once a day and NO WHITE STUFF.ReplyDelete
You mentioned that it takes 5-6 billion to make it through the pipeline, which they can make back in 3 years for a non blockbuster drug? From what I have read, Tecfidera is thought to make $300 million in it's first year. Seems it would take longer to make back $6 billion?Delete
Excellent article. Thank you for your work on this.ReplyDelete
This is a very nice article. You have given me affirmation that taking my daily Protandim is still the best option in prevention.... since I've personally already had positive health changes and know its not causing other issues. Thank you!ReplyDelete
Exellent article. Thank you.ReplyDelete
I have had RRMS for 8 years now and had a lot of issues with medication.
Copa gave me an anafylactic reaction, had to call an ambulance. Rebif made me lose 25kg of weight in short time due to no appetite. Avonex did not help.
I am now on old fashioned azathioprin which makes my hair fall out.
I really hope this drug would soon be available here in Finland. :-)
When will it be available?ReplyDelete
When will it be available?ReplyDelete
Should be available now, although I understand the application process takes about four weeks…Delete
My neuro is still waiting for some paperwork on BG12. Because of this, BG12 has not been available to me yet. Is there a more precise date?ReplyDelete
I am in the same boat. I think the delay is getting insurance approval. Therefore, every patient will have a different experience, since each patient has different insurance. Hang in there, it shouldn't take too long…Delete
I start tomorrow can't wait... also I didn't read all the comments but I am middle class but live in a state that has a Medicaid protection secondary insurance that i qualify for but i can't had it for this drug for the first month or i can't get the starter titration kit... also i know my rebif was 1600 a month to my ins and copaxone was 1800 don't care what they cost I pay thousands a year for my medical treatments and i am happy to as long as i get to see my kids grow up and get old and i can still move around some!ReplyDelete
The BG-12 material that I have read said that four psoriasis patients who took a similar drug developed rare but sometimes deadly conditions. The article "Ingredients in New MS Drug Linked to serious Brain Disease" from, http://www.everydayhealth.com/multiple-sclerosis/0425/ingredient-in-new-,s-drug-linked-to-serious-brain-disease." Stated it caused brain damage, blindness, loss of speaking, and other side effects. One of the studies in the article at the Mellen Center for MS at the Cleveland Clinic at Ohio was hauled when 3% of the patients in the Tecfidera trials were taken off the meds after their white blood cell count dropped too low, Dr. R. Fox, Neurologist.ReplyDelete
I was going to start the drug, but after reading so many bad stories about it and the compounds making up the drug that have caused side effects that can not be reversed or possibly stopped. I have actually thought about going off of the Avonex. I have been on it for over ten years, but it is believed to be causing the major migraines that have been plagued with since I started Avonex. The new neurologist that took over for the retired neurologist that I had said that he believed Avonex caused my 5 to 6 migraines a week, to go off Avonex and on DG-12 to stop the migraines. So now I just want a better quality of life without the migraines. So now I think I will stop the Avonex and see what happens with no medication.
Guess I really am confused on what to do.
Found this on the ms world.org post thought maybe it would help put more info out there: anonymous,teachReplyDelete
Some context for the PML headline:
Dr.Gavin Giovannoni, “… I was the principal investigator on the Define phase 3 BG-12 trial at Barts Health, and sit on the Define BG12 steering committee, and I am co-author on several papers and conference abstracts in relation to BG12…”
This question was asked of Dr. Gavin Giovannoni… Based on these fumaderm cases will you warn people going onto BG-12 about PML?
Dr. Giovannoni replied… "Yes, why wouldn't I? A quick search via Google will alert most people to this issue. Transparency is the name of the game."
"I would however frame my answer is a specific way: "PML as a complication of BG-12 therapy is a potential risk that is currently undefined. The risk is likely to be very low and limited to patients with lymphopaenia. We will monitor your blood counts for lymphopaenia and if your counts drop too low we would obviously stop the drug."
The link to these quotes: http://multiple-sclerosis-research.b...fumarates.html
Keep in mind that Dr. Giovannoni was principal investigator and he said, “The (PML) risk is likely to be very low and limited to patients with lymphopaenia”.
Since we don’t have a long track record for dimethyl fumarate in Tecfidera (BG-12) finding figures on Lymphopaenia is impossible. However, we can look at the lymphopaenia figures for the dimethyl fumarate in Fumaderm.
Quote from the safety data on Fumaderm, “Leucopenia occurs in a quarter of patients [8,29]. A reduction in lymphocyte count occurs in around 70% of patients [6,8,25,29] and can exceed 50% in about 10% of patients . http://www.evidence.nhs.uk/search?q=fumaderm+safety
It is important to note that a 50% reduction in lymphocyte count occurred in 10% of the patients taking Fumaderm. Only time will tell if similar numbers are seen with Tecfidera. If lymphocytes fall to a certain level, whether it is Fumaderm or Tecfidera, treatment would be halted. Obviously, blood counts will be monitored closely, along with liver and kidney functions.
Typically, Fumaderm is used in psoriasis for short periods. Dr Giovannoni said, “Most people with psoriasis are treated with short courses. Therefore we cannot assume that the Fumaderm long-term safety will extrapolate to BG12. We need to wait and see!” http://multiple-sclerosis-research.b...n-we-make.html
Judging by the last few posts, some people didn't read Kamikaze's article. Here's the relevant info from the very blog post to which you're responding:ReplyDelete
"In its 20 years on the German market, comprising over 170,000 patient hours, Fumaderm has been linked to four cases of PML (click here), the opportunistic brain infection associated with Tysabri. While this may initially seem troublesome, it’s important to keep in mind that these cases occurred over a very long time period, and at least one of these patients was using other powerful immunosuppressive drugs. Generally, opportunistic infections are not seen in patients using Fumaderm."
Kamikaze posted that on March 31st, 6 days before the New England Journal of Medicine's coverage / letters on April 25th. Long story short, this is not new information and it's nothing that Biogen tried to cover up in its documentation. Some people (more paranoid than myself) have suggested that competitors (Teva, possibly) pushed these letters with the "new" information included to coincide with Biogen's 1st quarter financial reports and strike fear into the hearts or investors / potential patients. Who knows? I mean, it isn't like Teva's engaged in some sketchy behaviour before, right?
I'll just leave this here: http://www.zacks.com/research/get-news.php?id=115d9909
Oh, and this: http://www.fiercebiotech.com/story/teva-tries-slow-arrival-biogens-competing-ms-blockbuster/2013-01-10
Hi, I'm new here, but I just started taking Tecfidera on Wednesday, May 8th. I didn't really have any reaction on Wednesday, but Thursday I got the common flushing and itching reaction, very red and itchy, and it lasted about 2 hours...so next time I won't freak out since it only lasted 2 hours. Both Thursday and Friday (today), I am very swollen, can barely get my rings on, and feel just full of fluid. I think that will work itself out. I took my pill this morning and haven't had the same skin reaction as yesterday, thank God! But overall it definitely beats Copaxone and Avonex from a patient point of view (mine - of course, I know everyone is different.) Copaxone was my first choice and didn't work out at all for me, I had HORRIBLE site reactions. And with Avonex, who wants to have the flu once per week. I was very cranky and a generally angry person on Avonex. So hopefully, Tecfidera will be the one for me. Has anyone else started? How are you doing on it?ReplyDelete
Talked to my neuro this week about trying Tecfidera (I'm currently on Rebif, and have also been on Avonex and Copaxone in the past. I have gone from using a cane in 2005, to becoming completely bedridden as of 2012. I call myself a tri-plegic since both legs are gone as well as my right hand.). Since I've progressed so fast, I wanted to try the new med since none of the injectables have worked.ReplyDelete
Anyway, my neuro (who also has M.S. himself and is on Rebif) told me that a side effect of Tecfidera is explosive diarrhea. I have not read that on any of the blogs. Has anyone heard of this happening? I'm very interested in finding out. Thanks for any info.
Hi there just wanted to let you know I have started Tecfidera and they did tell me that diarrhea was common especially in the first two weeks however this has not been my case no explosive or diarrhea. Best of luck to you. ElizabethDelete
just a reminder we all seem to ignore - 40% of health care costs and research lab budgets is for liability. Why nothing is done about that? do you know where we could put this money? why our darling politicians do nothing about that? or Mr Obamacare?ReplyDelete
Do you know the first thing that happened when Avonex became "legal MS drug"? my daughter got letters from lawyers telling her she could sue the lab. Soon they stopped writing after they got her answer. Lets do something about this liability. Yes there are cases, but do not throw the baby with the bathwater away...
a very angry mother
hmmm, was hoping someone would have reported back....my pills are due to arrive tomorrow and i dont know if i should wait another month to hear from others feedback. Its still a bit early, Nj just started writing scripts last week and even my own doctor didnt know the proper protocol without calling the company. We must be our own advocate , practice dual dilligence, and keep informed-thanks for such an informative blog that i accidentally stumbled upon....ReplyDelete
Start the med. It beats the daily or every other day injections. I am on the second week, which is full dosage. Flushing is very tolerable! I use a cool wash cloth on my face and wear my Polar Kool Max vest when I feel very hot. I am working full time and it is no problem at work. The data from the trials is excellent. In my opinion, it is worth a try. good luck!Delete
This article really accurately sums up the current research. I am currently taking Tecfidera, starting my second week. So far, my side effect symptoms were extreme flushing for the first few days , then decreasing. Some minor itching as well. With the increase in dosage yesterday, I did get diarhea. Not explosive though. I am keeping with it so far. I am blogging my experiences with it...ktmslog.wordpress.com for those who are interested.ReplyDelete
Tried to find your blog but it does not come up. I increase my tecfidera to full dosage tomorrow. So far, so good. The flushing is tolerable but I have used a cool washcloth on my face to cool down the heat! Good luck with the treatment...I prefer taking two pills a day over the daily injections even with the flushing! K.
I was on this drug for almost 2 weeks. The first 1.5 weeks were fine. Then i was struck with the gastrointestinal side effects, only mine were outrageous. I was having diarrhea over 100 times/day for nearly 5 days. The stomach cramps were the worst pain I have ever experienced (kidney stones would have been a welcome respite). Nausea and some vomiting, too. After 2 trips to the ER, I was admitted to the hospital for 4 days with severe dehydration (due to the unrelenting diarrhea).ReplyDelete
I don't mean to be a scaremonger, but I wanted to share my experience so others can make an informed decision before going on this one. I'm disappointed I reacted so poorly. It was so nice to just take a pill twice a day -- daily Copaxone injections were my previous hell. I'm back to square one with drugs, but I suspect a lot of other folks will do well on this drug. It still makes me shake my head to think the only reason I lost a week of my life to a hospital stay is that I took a medicine designed to "help" me. Onto the next one...
I went through a pile of drugs (Rebif, Copaxone, massive IV steroids, etc.) with horrid side effects each time. My logical brain told me they were missing the real problem, so I trusted a neurologist who had a monumental success with clients and autism (a reverse situation of MS but the two are oddly linked. Many women with MS have children with autism.) My son and I began a rigid regimen to eliminate any foods that initiated the immune response through blood tests (IGe and IGg) which helped us both. I am not saying it was a cure, but when I eliminated the offending foods, my relapses became fewer and father between. I have not had a relapse in well over 4 years and that is also about how long it has been since I took a bite of something with wheat in it. My doctor wants me to try Tecfidera, but why mess with something that is working already? If I have another relapse, I will try the oral meds, but for now, I am happy to flip the bird at Monsanto.
I hope you find a solution.
I've been taking Tecfidera for 5 weeks now and have experienced only minimal side effects: no diarrhea or other gastric issues whatsoever, and the flushing is also not an issue - it does happen for about 5-10 minutes and then it disappears, it's rather a weird or even funny feeling than being a real nuisance. Plus, after the first two weeks the frequency and severity considerably decreased.ReplyDelete
I have Kaiser and my copay is 30$ per month.
I just contacted BIOGEN IDEC, maker of Tecfidera, and was told that ANYONE can be enrolled in the copay program (every year). The copay is only $10 a month as the insurance company charges the difference to BIOGEN IDEC. I have been approved to go on the drug and await it to be delivered. Wish me luck as I will report back how I am doing.Delete
I started Tecfidera about 3 weeks ago. The first 12days went very well. Minor flushing but that was all. Then on day 13, I couldn't sleep at all. Terrible heart burn, indigestion, nausea, and bloating. This continued for the next 2 days and got so bad that I had to stop taking the medicine. My doctor suggested that I go back on the 120mg dose for 2 weeks to give my body time to adjust. Had to stop after 2 days. I couln't deal with the side effects. The only good part is that I didn't have explosive or any diarrhea. I did throw up a banana on day 2 and that wasn't fun. After 14 years on shots, I am going back on Copaxone, but not Avonex. I was taking Avonex and Copaxone together of the last 13 years. I won't miss the once a week Avonex flu. I don't mind taking the shots, but I thought taking pills would be a whole lot better. Sorry it didn't work for me. Good luck to everyone giving it a try!!!ReplyDelete
Very Glad to have found this article, I've been pouring over journals about Tecfidera for the past month. I've been on Avonex for 8 months and side effects only slightly declined. I was losing my whole weekends to feeling like I had the worst hang over in my life and body aches, as if my muscles were bruised. I am 2nd yr. public school teacher so weekends are 'for the most part' all I have to get things done that are unrelated to school work. Had to ask myself, was my quality of life better before starting treatment?, the answer was yes, it was. I will be hoping my insurance doesn't give me and Doc's to much of a hard time making the switch.ReplyDelete
I'm on my 3rd week, full dose. Only 2 days did I get the flushing and itching. Thought I had been attacked by a swarm of mosquitos. Explosive diarrhea 2 times. On the happier end of this. I have some quasi-normal feeling in and on my left arm. The hand is more mobile, looser and not as spastic.ReplyDelete
Everyday I go forward it gets a tiny bit better. The symptoms lessen. I guess I am one of he lucky ones?
I worked on this study and I can tell you the man-hours alone were into the billions. It was put through in-human testing for years, all over the world and there had been many, many adjustments for the protocols that came out. Before you slam "big pharma" - look at the governments and what the regulations are they must adhere to, also remember the US our congress is the one influencing the FDA at every turn and research. And $55K a year for a brand new drug - that is pretty damn good considering others out there. Be glad it is MS and not cancer. Many of those new drugs cost into the millions. Personally, I am quite happy that this drug and others are now available to those who suffer from MS. There are other diseases out there which very little research is being done - say Stage 4 Breast Cancer.ReplyDelete
55k is NOT "pretty damn good". Maybe it's GREAT for BIG PHARMA's profits, but costs like that WILL bankrupt the U.S.ReplyDelete
Hi! Just started Tecfidera 120mg last week on my 13th pill so far so good there is nothing remarkable to report for now only interesting thing was first night on the medication I talked in my sleep the whole night since a teen this has not happened anyway so far so good. I did have blood work prior to starting the medication and I must say this will be my last attempt of therapy with the Pharma Company. I have been on Avonez, Copaxone, Rebif then back to Copax; I chickened out on the very last stage of starting therapy for Gilenya (good idea) I believe this was a wise decision on my part. MS now for over 16 years I am 45 now...wow (still feel like my 20’s on a good day!) Elizabeth♥ReplyDelete
Hi again, for those interested I am still on Tecfidera with no apparent ill effects on the 120 mg dose, my Doctor and I before starting treatment discussed if I should stay on the low dose longer since I have had so many reactions from medications in the past and he agreed this would be good. I am and very surprised no gastro issues, flushing , if at all a little itching on scalp for those starting I would recommend eating food before taking the pill and drinking plenty of water so far so good will keep updating. Nutrition is so important I stay away from fats and sugar as much as possible; meditation is really a must♥ ElizabethReplyDelete
Just started Tecfidera and now know what "flush" means. It subsided; I am undeterred, but cautious.ReplyDelete
I started Tecfidera on July 12th. First 2 weeks mild indigestion and flushing was taking Pepto Bismul tablet and a baby aspirin with each dose. Start of week 3, nausea and vomiting. Week 4 is going quite well. I periodically take Pepto Bismul or aspirin. BCBS of IL would not cover medication. Biogen is paying for it. We appealed BCBS's decision and they approved it so start paying my co-pay next month. I was diagnosed with MS 9 years ago and started Avonex a week later. Avonex worked great for me up until April 2013. So far the transition to Tecfidera has gone relatively smooth. I am going for my blood test next week and saying my prayers that I can stay on Tecfidera.ReplyDelete
Hello again, just started my full dose of 240 mg cap of tec did 28 of the 120 mg some flushing and stomach is making strange sounds..lets see how it goes just sharing for those who are thinking of starting this type of therapy. I did Avonex, Copax, Rebif then Copax . Ps still having strange dreamsReplyDelete
:< also Wheelchair Kamikaze saw one of your You Tube videos..loved it!
I started Tecfidera May 6. Two hours after the 1st dose, I experienced flushing, very similar to a Niacin flush. For me, that is no big deal. In any case, by the 2nd day, the flush was greatly reduced, and the 3rd day -non-existant. When I went to the full dose after a week, I had no reaction whatsoever. Since then, I (VERY) occasionally have a slight flush. I've had no gastro-intestinal upset at all.ReplyDelete
hmm I posted a few days back my most rrcent update on Tecfidera but I see it was not apporoved showed pending as I promised myelf I would try to keep updating through my journey 9i hope you dont mind Kamikaze throught this venue) any how I had two stopped Tecfidera unrill further noticedue to a bad reaction flushing lasting over 9 hours (sunburn lobster style) liquid stool...severe cramping once I was on the 240mg twice daily cut o once a day 240 still sick. I am waiting to restart initial dose of 120 mg mind you I was on the initial starting dose for 28 days vs 14 days only due to my reactions to medication. Tecfidera will be my last stop if it doesnt work out (rebif, Avonex Copaxone) I have tryed others eventually having to stop also lost weight now 111 lbs. Any suggestions, anyone?ReplyDelete
I'm having lots of gastro issues with Tecfidera, too, and am back down to one pill (240 mg) a day since I couldn't tolerate two.
here's what's helped a bit: eating a full meal with protein, far, carbs half hour before taking the pill; taking the pill with a zantac (never in my life have I had indigestion, so this is new).
Oh, and I go for a walk or swim laps immediately after taking the tecfidera. If I sit or am inactive, the side effects are worse.
I'm not sure I"ll be able to stay on the meds, either.
Thanks Kate, starting 120 twice daily hopefully that works. Good Luck!Delete
Hello! Do you use Twitter? I'd like to follow you if that would beReplyDelete
okay. I'm absolutely enjoying your blog and look
forward to new updates.
Feel free to surf to my weblog - Lee Trotman
Sorry, but I don't do Twitter. I'm a bit of a technological Luddite. Don't even really do Facebook much, although people keep telling me I need to set up a Facebook Wheelchair Kamikaze page. Maybe one of these days, when I decide to put both feet into the 21st century…Delete
Hello Wheelchair Kamikaze - I am now 65 years old and on Medicare. The Biogen Active Source people tell me I am not eligible for the co-pay program. My husband is a decade older than I am and still working as he has expensive health issues. In order to be considered for a "grant" by the Active Source people I would have to submit our household income an possibly our joint tax returns for review. What a crock! Why do they think that they have the right to ask for your household financial information which I don't have access to and can be variable anyway. My Neurologist is really wanting me to get on this medication as I have also had bad reactions to Avonex and Copaxone. Talk about stress (which they are finally are admitting is bad for MS)! This is just so overwhelming I don't know where to turn anymore. I was told that if we file separate tax returns they can evaluation on mine alone although we are living in same household. My husband has already said at one point he wanted a divorce and I have been advised to talk to a divorce attorney which also was outrageously expensive. No wonder people with MS have an increased risk of suicide you can just see your life progressing downhill. I am wondering if there are any Medicare Advantage plans that cover the cost of Tecfidera other than Kaiser as we are in the selection period for next year. Thanks for listening and find you posts to be very helpful. I too am suspicious of Facebook as they seem to keep changing their privacy choices. While I am on that subject - Why do I get stuff in the mail from companies who seem to be advertising MS drugs. Isn't that confidential information? How are they getting my name and address and targeting me for advertising. Don't we have laws protecting our confidentiality or am I dreaming?Delete
I have been on Tecfidera for two months and enrolled in the $10 co-pay assistance program. It was easy and it does not go according to your income or your insurance. It literally only took 15 minutes for the rep to enroll me over the phone and I will cover me for the next few months then you have to renew it.ReplyDelete
All of Biogen's promotional material for Tecfidera trumpets a $10 copay which has "NO INCOME REQUIREMENTS" and does not disqualify anyone based on insurance coverage, but this is not true. I called to enroll and was rejected after they asked about my income and my insurance coverage. This is a clear "bait and switch" tactic used to convince doctors to recommend Tecfidera and patients to use it. Everyone is supposed to feel good that Biogen is supposedly a benevolent big pharma company, as opposed to all the other sleazeball companies. Well, Biogen is no better. My doctor's office was furious when I told them I was rejected because Biogen reps told them anyone can get the $10 copay, so that's what my doctor's office told me. Biogen did not even discover this drug -- all they did was repurpose an existing medication which is an incredibly simple chemical compound that costs pennies on the dollar, and which has been used in Germany for years for a different disease. Why should Biogen be balking at a $10 copay when they are making billions of dollars based on a drug they didn't even invent? Call Biogen public affairs and make them be honest.ReplyDelete
I disagree with this post, I signed up and the only thing they asked was what pharmacy I was using and if I was on any government insurance which I am not. Was approved within minutes.Delete
Going OFF this damn drug. I have no tolerance for sides that make my life miserable. Drugs that I need to other drugs in order to take. Too bad I was pretty pumped for the twice a day "vitamin"ReplyDelete
To those of you who have stopped how long should it take before my GI issues normalize?
I’ve been on Tecfidera six months now. Except for the initial two weeks of mild stomach discomfort and flushing, there have been no problems. I’ve had two MRI’s since starting tecfidera. One brain MRI showed three active lesions, but this was only a couple weeks after starting so I discount that MRI. A second CSPINE MRI showed no new lesions. My next MRI isn’t until next year and I’m anxious to see if the tecfidera has stopped or slowed the new lesions.ReplyDelete
I know I’ve had one exacerbation since starting. It happened on a weekend and one box of prednisolone knocked it down well enough that I cancelled the solumedrol infusion for the next week. That is probably the shortest, least severe exacerbation I’ve had in several years.
I’ve known I had MS since 2002. Tecfidera is the first DMD I’ve taken. If I knew then what I know now, I would have started a DMD earlier. My balance is terrible and I’ve got permanent double vision but my biggest problem, trigeminial neuralgia, has been relieved with carbamazepine.
I’ve kept up with the posts on this site, and especially these tecfidera posts. I have always found the site informative, if not exactly cheery. Thank you Marc for doing this. I can’t even imagine the work that goes into it.
Thank you for this blog. I'm thinking of switching to Tecfidera after being on Avonex for 12 years, will let you know how it goes.ReplyDelete
Made it through my first month of Tecfidera, I’ve had mild stomach pain and light flushing but nothing that concerns me. Taking after I eat seems to help. I’ve had MS since 1999 and consider myself one of the lucky ones with mild symptoms of tingling in my right arm and both legs and slight vision issues.ReplyDelete
I have been on Copaxone since that time. I just could not handle those shots anymore so that is why I switched. One side of me is happy to no longer be taking shots while the other side wonders if I am doing enough. However, thank god (or maybe I should say thank Al Gore:-) ) for the internet and sites like this because it does make me feel better.
So far I am happy with the treatment but I am still concerned until my 3 month check with my neurologist and to see how I feel over a year after being on this DMD. I’ve had no exacerbations but its only month, so time will tell.
Financial I got hit up with $1400 copay but within a half hour I got signed up for the $10 copay and they were sending a month supply to me. Good luck to you all and I hope your journey is positive.
My wife has been on Tecfidera for 5 months and has not experienced any side effects that we are aware of. At the same time, she also has not experienced any symptoms she has experienced before with the relapsing/remitting MS. With regards to paying for Tecfidera, she is on Medicare, and last year our co-pays were $75 per month (that was under a Medicare Advantage plan. This year she had to switch to a Medicare Supplement plan and a separate Medicare Rx plan. THE MONTHLY CO-PAY JUMPED TO $2,029 PER MONTH. We are retired and on a fixed income and Social Security, and cannot afford that. I spoke with a Biogen representative, who connected me with U.S. Biosciences. My wife will now get Tecfidera at NO COST for the remainder of 2014. We do not know what 2015 will bring. I have also since read and heard that "The Affordable Care Act (a.k.a Obamacare) will hurt seniors and patients with MS and other debilitating diseases the hardest. By the way, my wife was originally on Avonex, then transitioned to Copaxone, before going on Tecfidera, There were numerous side-effects from the other drugs, and she still had exacerbations from the MS while on them. We are hopeful for Tecfidera. The only question we had and answered by going on Tecfidera is "Which drug seemed to have less side-effects that would affect my wife?" Best wishes and better health to all.ReplyDelete
So glad to hear that your wife is doing well on Tecfidera. That's definitely good news.Delete
As far as Medicare and the affordable care act, in fact the ACA will improve most Medicare benefits, and will reduce the amount of money patients need to spend on drugs while in the "donut hole".
There is much propaganda being bandied about regarding Obama care. It's very important to do your own research, and not believe everything you read/here.
Here's how the Medicare.gov site summarizes the effect of the affordable care act on Medicare:
I recently found out that I am capped via my primary insurance at $7000/yr. for specialty medicines.
Out of panic/despair I found this site. I've only been taking Copaxone for a short time (3 mo last calender yr & 3 mo this calender year). I had no prior knowledge that I would be unable to continue using Cooaxone due to the prohibitive costs at $5000/mo. It seems I don't qualify for assistance due to our income (middle class).
I've supported Obama & Obamacare. I'm beside myself.......I feel defeated & blindsided. How can this be?!? I can't get the meds I require & I don't know what to do. I feel to exhausted to even think about it anymore.
I don't know about anyone else but in my case I feel the system has failed & I'm out of luck.
Wow, I don't think I've ever heard of an insurance company limiting specialty medicines for patients with chronic illnesses like MS. I'm sure there must be an appeals process that you can go through with your insurance company, and your neuro's office should have people who specialize in insurance matters. If none of that works, most states have insurance boards that will intervene on behalf of patients who have been wronged by their insurance company. Many insurance companies have lists of approved medicines that they will pay for, and do sometimes exclude individual medicines that they deem as being replicated by other drugs. I'm pretty sure that wouldn't apply to Copaxone, since the action of Copaxone is unlike any other MS drug. You should definitely fight hard on this one, insurance companies make things difficult expressly because they hope that patients will eventually just wear down and give up fighting them. Don't you dare! If worse comes to worse, find out what approved MS meds are on your insurance companies pharmaceuticals list, and discuss those meds with your doctor. Best of luck to you, and like I said, give them hell…Delete
Just got off Copaxpone after 20 years. Starting telefidera in 2 weeks. Has anyone had to go back to shots? :(ReplyDelete
I have had no problems with Copaxpone but don't want to inject anymore. Worried tecfidera won't be a match for me. Anyone have same situation? Hope its good news hahaReplyDelete
Did any of you ever checked the price of DMF? The raw material cost about $ 160.- per kg.ReplyDelete
I'm about to start this BG12 and they can ship it out to me for $5913.66. No way. Where is this copay of $10. Waiting now to get the companies approval for assistance in the cost?ReplyDelete
Our daughter (31 yrs old) started Tecfidera at half dose for one week-- then did two days at full dose before we took her off of it--- she went into a FULL MANIC/PSYCHOSIS!!! Zero bi-polar history. She was an extremely positive fun person. It has been almost a month and we can't get her back! NIGHTMARE DRUG!!!!ReplyDelete
You should take a look at Protandim if you have not already. Biogen Idec's own "research study" i.e. paid for by them concluded on page S367 (Multiple Sclerosis Journal 2011 S2770-S505) "Interestingly, protandim, a dietary supplement consisting of herbal ingredients, was the most potent inducer and therefore may be the most suited as a therapeutic strategy" They called it BG-12 for this study and changed the name later to it's current name Techfidera If you want to give a it a shot go to https://www.mylifevantage.com/nehs/ or I can send you a bunch of other studies -- 20 peer reviewed studies or you can go to pubmed.gov and search for nrf2, oxidative stress, protandim Keep taking control of your own health!!ReplyDelete
Hi Marc, I'm about to start Tecfidera next week. I was wondering if you are still on it and did you end up doing blood tests every 4-6 weeks? My neurologist said that I should have a blood test 4 months after I first start taking it.ReplyDelete
Hi, I was never put on Tecfidera because I have progressive MS and my doctor didn't think it would be worthwhile.Delete
As for frequency of blood tests, it sounds like your Dr. is using the testing protocol that has been developed since Tecfidera hit the market and doctors have gained experience using it.
Although the following is a bit dense, I would suggest you read the document that is embedded in the following website, which are the protocols that the MS clinic at Barts medical school in London uses for their Tecfidera patients. Of most interest to you would be the section on the next to last page under the heading "Protocols", which describes their testing regimen in great detail. You might even want to print out the document and discuss it with your doctor.
Barts Tecfidera document
Hi Marc, I am just beginning to go to full dose. It's taken 2 goes as I felt really ill the first month. This time I feel fine. I was on LDN but feel much better without it. I think there may be a bad interaction, but I don't know for sure.ReplyDelete
I was going to ask the LDN trust about this, but I doubt their advice. They've just announced work with Lyme literat drs. This almost broke my heart. They whole chronic Lyme thing is just a crock. I also read Science based medicine and the Barts blog. I trust their opinions. Acute Lyme is real and serious. Chronic Lyme is as reliable and real as csvvi. Desperate people look for hope and the US is full of faux groups of medics just waiting to take their money.