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Humira now FDA approved for UC

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Ulcerative Colitis
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Posted 5/17/2011 2:32 PM (GMT 0)
At a medical policy group meeting at work yesterday (I work for a large health insurance company) it was announced that Humira is now FDA approved for UC. This means that your health insurance company cannot deny you coverage based on its "investigational" use in UC. However, they can still (and probably will) require a Prior Authorization before covering it. They will review your health history and decide, along with the recommendation of your doctor, whether or not it is medically necessary. Our policy follows the same criteria for Remicade through evidence based medicine. This is great news that there is now another "official" treatment option for UC sufferers that you may get some help paying for by your health insurance (for those with health insurance).
Posted 5/17/2011 3:27 PM (GMT 0)
I saw something about this in the news the other day. It is great news!
Posted 5/17/2011 6:30 PM (GMT 0)
Hurray!
Does anyone know, if you switch but it doesn't work, can you switch back to Remicade??
Posted 5/17/2011 6:47 PM (GMT 0)
I've heard a lot of the biologics don't work as well the 2nd time you try them. If you're stable on Remicade, I doubt that your GI would recommend making the switch. I could be wrong.
Posted 5/17/2011 7:27 PM (GMT 0)
Woohoo!
Posted 5/17/2011 7:54 PM (GMT 0)
what if you are in flare with remicade after six months of using it? I am going to discuss Humira tomorrow with my GI. I started having issues last week and am going down hill fast. just a week after my last infusion at that. Steroids don't help me at all either.
Posted 5/17/2011 9:18 PM (GMT 0)
Chef: I definitely think it is worth trying other biologics if you're not seeing effects from Remicade. I think if you were doing well on Remicade, it would be risky to try something else because if you had to go back to Remicade, it may not work for you. It doesn't sound like you would want to go back on Remicade because it's not working for you so in your case, you should speak with your GI about making the switch. I hope Humira works out to be a loongterm solution for you.
Posted 5/18/2011 12:11 AM (GMT 0)
What's the difference between Humira and Remicade?
Posted 5/18/2011 2:16 AM (GMT 0)
Humira and Remicade are both synthetic proteins that block the same target (an inflammatory protein called TNF alpha), but Humira is a completely human protein whereas Remicade is a hybrid mouse-human protein (it was originally made in mice). The fact that Humira is completely human is a good thing because theoretically, that makes it less likely that your body will recognize the drug as foreign and try to get rid of it before it can treat the disease.

I'm also excited about this development--I'm nearing the decision of whether to try a biologic and I like the idea of having options.
Posted 5/18/2011 2:37 PM (GMT 0)
Wow- this is great news! Searching for something to bring in to my doc- coming up empty!- could someone point me to an article/press release/whatever on this?

Thanks!
Posted 5/18/2011 3:28 PM (GMT 0)
Awesome news! Thankfully my insurance company hasn't had any issues with me taking Humira.
Posted 5/19/2011 12:44 AM (GMT 0)
Any link to the Humira study that got the FDA approval? Like to see it's effectiveness vs placebo over a 1 or 2 year period etc..
Posted 5/19/2011 2:49 AM (GMT 0)
Found this:
http://pharminfo.co.cc/2011/05/abbott-shows-positve-phase-iii-data-of-humira/

Here's the gist of the link:
In the trial adults with ulcerative colitis who had failed to respond to standard therapy were randomised to receive either Humira or a dummy drug. Of those taking Humira, 16.5% achieved clinical remission after eight weeks’ therapy versus 9.3% of the control group, while the figures were 17.3% and 8.5%, respectively, after 52 weeks.

Don't think that this is the announcement of approval, though.
Posted 5/19/2011 2:53 AM (GMT 0)
I saw the results and they weren't too strong which saddens me but it is nice to have another option. Hopefully it helps a lot of people.
Posted 5/23/2011 4:39 PM (GMT 0)
My GI says she does not believe this is correct, that Humira was approved.
She understood the study had just reached some necessary milestones.

She also said that it would not be wise to switch since I am doing well on Remicade, because if Humira didn't work (and she has always said it was her observation that patients do better with Remicade) I would not be able to go back to Remicade because of the antibodies.
Posted 5/23/2011 7:39 PM (GMT 0)
Awesome news!  Great to have another option!! hope I don't need it but good to know it's there.
Posted 5/23/2011 10:28 PM (GMT 0)

runawaybride3 said...
What's the difference between Humira and Remicade?

Humira is also administered differently than remicade. I know I don't respond to the injected style as well vs IV infusion, even if its exact same drug.
Posted 5/23/2011 11:33 PM (GMT 0)
Peety, the news I read said they had positive results in a UC study which would bring them closer to an approval but it didn't quite say Humira was approved for UC. I figured the OP had heard other news.

Humira seems more convenient than Remicade but I don't know if I could give myself a shot, it seems scary. I've also read that Humira is a bit of a painful shot which makes it even more difficult. Is the convenience worth the pain? It may be.
Posted 5/24/2011 4:22 PM (GMT 0)
I would have welcomed the convenience of Humira, and figured it would be quick and not too awful to give myself shots. I had to give my mother shots for a while when she was in an accident so I know I can do it.
Oh well, though, I would probably not risk it.
Posted 5/25/2011 1:20 AM (GMT 0)
This is great news!!! I have exhausted Humira myself, but I am glad to know it has gotten approval finally, and glad I know I was a part of that. (I was on it through a double blind study followed by an open study)

The shots are really no big deal. They sting, and the injection site is tender for a little while, but if that is enough to steer people away from it, I would wonder if going the biologic route is really worthwhile. That sounds harsh, and I am sure for some it is worse than it is for others in terms of getting a shot and how much the drug actually helps, but I would have gone through daily injections of that stuff for the remission it gave me. The pain of my UC and subsequent hospitalization was FAR worse than any shot could ever be-but Humira also gave me a fantastic remission while it lasted. So again, I know it depends on the person, but if your UC is bad enough that you are considering a biologic, the shots honestly should not feel like too big of a deal, in my opinion. And I am pretty sure they have the pen type shots too-which I have always been told are super easy. Mine being given through a study, we just had prefilled syringes. I gave them to myself after my hubby was out of town a few times on injection night.

I hope many UC patients are able to benefit from this medication!!!
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