BG-12 Summary

[Myoak]

Kate, if one had to guess it would be that there are a great number of MSers interested in BG-12. Its effectiveness and safety profile both appear to excel the crab drugs. And since it is not an immunosuppressant many may prefer it to Gilyena, especially since it has a solid safety profile compared with that drug, also.

October will be about 10 months from when Biogen submitted BG-12 for FDA approval, so we may see approval during Oct or soon after, 10 months being a roughly average time before an FDA approval.

Toss-up whether it will be taken twice or three times a day. Twice would be more convenient for patients, but just a guess.

IF BG-12 works as trials indicate, the popularity of CRAB drugs may quickly fade. Considering no needles, no flu-like symptoms, safety, and effectiveness Biogen may have a huge winner. But cost will be a factor.

I believe they intend to price BG-12 similar to Tysabri and Gilyena, both of which are just under $4000 a month, I believe. I could be wrong, JMHO.

For MSers who might be thinking of doing an end around attempting to source dimethyl fumarate from the German company who makes fumaderm for psoriasis, I hate to tell you but Biogen bought that German company in 2006. Evidently, Biogen has been preparing to reap maximum benefit from BG-12 for several years. They may be right because a safe and effective oral med is likely to be very, very appealing.

A2, Ann Arbor? “Mad scientists” all over the place, Kate. Love that photo!

[Westgrl]

I read somewhere, I wish I could remember where now, that this isn't exactly the same as the drug for psoriasis. It said this was an "improved" version. Not sure what that means, I assume they adjusted it a little in some way.

When I searched about price, nothing specific, but it seemed speculations in news articles were that the price would be comparable to other MS treatments.

I would certainly hope it wouldn't cost more. There is less packaging certainly. Biogen won't have to supply needles, syringes, the pens (for those that opt for them), etc. And if it is more expensive, insurance companies could refuse to cover it because other cheaper medications are available.

I do wonder if they will provide financial assistance like they do with Avonex. I have a very high copay that they lowered for me.

[Thinkimjob]

Why don't neuros just prescribe it off-label? We could all have psoriasis, couldn't we, wink, wink, nudge, nudge?

[BigA]

I read somewhere, I wish I could remember where now, that this isn't exactly the same as the drug for psoriasis. It said this was an "improved" version. Not sure what that means, I assume they adjusted it a little in some way.

When I searched about price, nothing specific, but it seemed speculations in news articles were that the price would be comparable to other MS treatments.

I would certainly hope it wouldn't cost more. There is less packaging certainly. Biogen won't have to supply needles, syringes, the pens (for those that opt for them), etc. And if it is more expensive, insurance companies could refuse to cover it because other cheaper medications are available.

I do wonder if they will provide financial assistance like they do with Avonex. I have a very high copay that they lowered for me.

Why wouldn't it cost more? The cost of the drug has nothing to do with the cost of the needles, etc. at 3-4k per month, $10 worth of supples won't change anything.

The cost of the drug is proving it works. That's very expensive and will have to be paid down over many years.

[KateA2]

Yep, Ann Arbor...love it here. I wouldn't live anywhere without a university/strong research community. I'm not in a medical or scientific field (lots of math/chem in college - alas! instead I draw all day) but would be in another life

Anyway, back to BG12~

[lucidity]

I loved seeing a summary... that's just what I was looking for.

My neuro has been raving about this drug during our two past appointments. It's the only drug he's raved about. I'm on Copaxone and said I'd be fine if I had to take it forever. I said that only three years ago and the shots are already getting really old.

I'll keep an open mind to this drug. I didn't want Gilenya and my neuro never suggessted that one.

But, now I have severe depressions in my hips (though I rotate the sites religiously). And, it's just a pain in the butt to take time every night to stick myself. I'll do it, but it's annoying. A pill (a safe pill) would be awesome.

[Anna R.]

Hi All
I'm new here, just found out about discussion about fumaric acid on msworld.org after searching for new information about it in google
I'm Ana from Poland, diagnosed with MS in October 2008 (with single episode, but with findings in MR, especially in spinal cord).
Just few words about FA - before taking Betaferon I went to visit well-known neurologists and one of them (from Germany) advised me in 2009 to buy fumaric acid online super-smart.eu/article.pl?id=0260&lang=en&fromid=GG132&gclid=CPC5l5HsvLICFUVc3god9DkAAA - it looked the same then apart from the label which was yellow in 2009. I can not copy URLs yet, so above there's no www added

I took it for 6 months (had no side effects so not sure if the dose was correct. I was taking 500 mg daily. On the other hand I didn't receive any information from that neurologist how much I should take it and She didn't want to advise me via e-mail after the visit). In Poland at that early stage BG-12 was almost not known - some people took part in the medical trials, that's all & what is "funny" most neurologists here told me it will not pass all trials/tests so I shouldn't even think about it. I knew they were wrong as NeuroLady from Germany is well educated in all MS trails, working for the some kind of MScommission in EU.

Now I'm not doing injections from Betaferon as I'm pregnant but at the same time I'm desperately searching for the info about fumaric, wondering when will it come out on the Polish market. When do You think it will be approved in US/begging of 2013?

I thought it would be a good idea to buy it via internet next year but now I see that they are telling us that the content is not the same (in psoriasis fumaric acid and the one which is "new", called so on BG-12, wondering if it's true). Other problem is the dosage - those pills with 500 mg are not divisible and I know we should take 240 mg 3 times a day, in separate doses.
that's all for today
Best,
Ana

Please forgive me my English but I'm not usin it everyday and that's why it is so poor

[PBrus4]

Thanks for taking the time to post this!

[cawras001]

Medicare

Anyone have any idea if and how long it would take for Medicare Part D to cover BG-12? My wife would be moving from Tysabri to BG-12. Since Tysabri is covered by Part B there is no cost to us but BG-12 being a pill would be covered by Part D.

[Myoak]

Hi Cawras001,

First, BG-12 must be approved by the FDA. One of my earlier posts suggested the FDA might approve it in Oct but Biogen didn’t apply until Feb 28. So, if the FDA uses a typical 10 month approval period for BG-12, a better guess would be December.

Some insurance plans will probably incorporate BG-12 rather quickly, in a matter of a few weeks, others may take longer. I have no idea how long Medicare would take to cover it after FDA approval but a guess of 2 or 3 months doesn’t seem unreasonable, if they are going to cover it.

I am not familiar with Medicare’s process for covering a new med. If someone has insight please share with us, won’t you? I would make certain that Medicare is covering BG-12 before altering current treatment. And, of course the FDA must approve it first. A few months wait is likely in the best scenario, IMO.

I believe the application was for twice daily. Possibly, Biogen’s thinking was more people would adhere to twice a day than 3 times a day. A name change seems likely since BG-12 is similar in name to vitamin B-12.

I see this is your first post, welcome! May I add a personal perspective? If your wife is doing well on Tysabri you may want to make changes slowly. Moving from a state of being relatively well in the anticipation of better wellness on a new med should be done carefully and thoughtfully.

Remember, if your wife is JCV negative, her chance of PML is 1 in 11,000. Your drive to the infusion center presents more risk, if she is JCV-. Remember too, BG-12 was not as effective as Tysabri according to the drug trials.
There are no perfect solutions in any of the MS treatments but we are fortunate to have several good choices and BG-12 will be a very good addition to them.

The best to you and your wife, may you both receive strength beyond your own and timely help for all your decisions. I believe you will. Peace to you, my friend.

[cawras001]

Myoak,

Thank you for your thoughtful response to my question. My wife's neuro has recommended that she go to every other month on the Tysabri and then switch to BG-12 when available. She was part of the early testing for the JCV and tested positive. Given this it seems like BG-12 might be a less risky road given the information that's out there today. Obviously Medicare coverage will be a factor.

[jimmyd787]

bg-12 approval date

i just got an email (literally 3 minutes ago) from my neuro who said they just heard it'll be early 2013 b4 bg-12 is approved. they do alot of research and stuff so i trust their knowledge on this. it's the MS clinnic in dallas, texas associated with medical school.

jim d.

I thought BG 12 would be available this summer. How long can this take????!!!!

[jimmyd787]

bg-12 approval date pushed back

i just got an email from neuro. bg-12 won't be approved until early 2013....

[1dayitwillNd]

Myoak,

Thank you for your thoughtful response to my question. My wife's neuro has recommended that she go to every other month on the Tysabri and then switch to BG-12 when available. She was part of the early testing for the JCV and tested positive. Given this it seems like BG-12 might be a less risky road given the information that's out there today. Obviously Medicare coverage will be a factor.

This is what I'm looking to do. Jump on to BG-12 once it's available. I'm pretty sure I'm having some side effects from Tysabri (high blood pressure) and just don't want the possible risk of pml (even though I'm jc virus negative). It seems like the most rational choice considering the minor side effects with BG-12. Especially when it's as effective as interferons but you don't have to inject anything. The only question is what will it's effect be like on the liver? Hopefully not too bad.

[rickalex2]

I'm currently on Tysabri and have been for almost 5 years. Loved it! However, I am now JCV positive and having been on it this long has put me at a very high risk for PML. Need to change. My plan is to go on Gilenya in January after the Tysabri is out of my system. HOWEVER, this sounds WAY better! But.. I don't think I can afford to wait much longer than January to start a new treatment... hopefully this will come out sooner then they think and I can just go right to trying this first...before I go to Gilenya. I need something thats not an immunesuppresnt.. (sure I didn't spell that right..) Anyway... my immune system is non existent while on Tysabri. Had a yeast infection for almost 3 months.. have a sinus infection now for almost a month.. Just can't fight the simplest of infections... I defnitely need something like this!!