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The Gland News about Thyrogen
As many of you may know, the FDA restricted the availability of Thyrogen in May per this decree. This is a big deal for thyroid cancer patients—so many of us rely on Thyrogen for scans and blood work so we don’t have to go off our meds. What does this FDA consent decree mean for us? Can our doctors still order Thyrogen for us? What if we don’t meet the guidelines outlined in the FDA consent decree? Will we have to go off our meds?
I spoke with a representative from the Genzyme Medical Information group on Monday to get answers to these questions. (Genzyme is the manufacturer of Thyrogen.) She was most helpful and I’m happy to report I have answers. All of the answers below are based on the information given to me by the Genzyme employee.
Why did the FDA issue the consent decree in the first place?
The FDA issued this decree because they believed more manufacturing control over Thyrogen was needed. With the consent decree, the FDA is essentially telling Genzyme that the manufacturing processes of Thyrogen are sub-standard and they are therefore restricting its availability until Genzyme corrects these manufacturing issues. Of course, the Genzyme employee did not go into detail with me about how far below standard their manufacturing processes are/were.
When will the consent decree be lifted?
Genzyme is moving the manufacturing of Thyrogen to an offsite location with a contract manufacturer. This should take place by November 30, 2010. At this time, the decree will be lifted.
So is there a shortage of Thyrogen?
No. The Genzyme rep assured me there is absolutely no shortage of Thyrogen.
Based on the guidelines outlined in the consent decree, Thyrogen is not “medically necessary” for me. Does that mean I can’t get Thyrogen?
According to the Genzyme rep, the answer to this question is NO, which is great news for all of us who need Thyrogen but were under the impression that we could not receive it.
OK, so how do I get Thyrogen?
Your physician is the one who will deem you medically necessary for Thyrogen. It’s a clinical decision to be made BY YOUR DOCTOR, not by the FDA. According to Genzyme, there is no extra paperwork required. Your physician will just need to submit the order for Thyrogen as usual.
Do you feel that you need Thyrogen but can’t get it? According to Genzyme, there is no reason why you shouldn’t be able to receive it if your doctor agrees that you need it. Feel free to print this article out to show your doctor. Spread this information to other thyroid cancer patients—you can link to this post OR you have permission to embed this information along with proper citation in your own blog/website.
If you have more questions regarding Thyrogen, you can call the medical information group at Genzyme at the following number: (888) 497-6436, option 2.
Tags: Based on the guidelines outlined in the consent decree, is there a shortage of thyrogen, The gland news about Thyrogen, Thyrogen is not “medically necessary” for me. Does that mean I can’t get Thyrogen? How do I get thyrogen, when will the consent decree be lifted, Why the FDA issue the consent decree in the first place, Written by Joanna Isbill
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16 Responses to “The Gland News about Thyrogen”
Leave a Reply to Joanna Isbill
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Joanna,
Thanks so much for the update on Thyrogen. I am glad it is still available. I had it for my thyroid scans; without it I would have been hypothyroid for a few weeks.
HD
So glad you were able to get Thyrogen, HD! Having to go hypo is HORRIBLE!!!
I’ve been a radiographer for 37 yrs (this is our preferred title but most of you know us as x-ray techs) I scheduled many thyroid uptake scans in my day and remember telling the pts that they’d have to be off their meds for 3 weeks- i couldn’t understand the horrified looks on their faces-i understand now! I’m sorry…
Bee, it’s hard to really understand until you deal with it, ya know?! I know you get it now, because you have to deal with it. Thanks for your wonderful support!
Thyrogen is really a great medication. Anyone who had been off their meds and hypo knows what a horror it is. Speaking about being mega tired, cold, grumpy, etc., etc.
Unfortunately is also very expensive, the two thyrogen shots cost me $1900 (I know because the pharma company wanted a promise that I’ll pay them, since at that time my deductible [which is very high] was not met yet).
HD
Thyrogen is a fabulous medication! But you’re right–it is expensive, and I know some patients have trouble getting their insurance provider to approve it.
HDinOregon,
Thank You for the information on “dearthyriod”.
I had my thyroid removed(papilary cancer)over a year ago, along with 17 lyph nodes(15 of which were positive)there’s still a one inch mass in my neck attached to a vascular bundle that the endo and surgeon are concerned with.
I just received my approval for Thyrogen insurance coverage from CVS. $1,831.00 for two shots.
I remember the nurse at my Dr.Endo’s office telling me to “start saving your money”. It’s hard to believe, that even with insurance, we get charged so much!
Is there a more up-to-date blog on this subject anyone?
Mike from Edinboro
Hi Mike! I haven’t written an update to this post, but I will say that there is a MASSIVE shortage of Thyrogen right now. I’m so glad you were able to get some, but I hate hearing your insurance is only covering a small percentage of the cost! I recommend you follow-up with ThyrogenONE, the reimbursement services program for Thyrogen. You can call them at 1-888-497-6436 and check out more about the program here: http://www.thyrogen.com/patient/insurance/thy_pt_thyrogen_one.asp
Joanna,
Thank you for your reply.
A few days ago I was told that I would be placed on a waiting list. The Doc told me not to worry; thyroid cancer is slow growing. Hmmmm…. I think I’m worried.
I’ll check out the web-site you mentioned.
Best Regards,
Mike
Thanks Joanna for this post : ) I’ll keep you updated on my progress next week. xx
Alexa, DEFINITELY keep me updated!! I’ll be so anxious to hear! I’m cheering for ya.
🙂
Whew, thank you for the info!!
You’re welcome, Sarah!!!
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Finding out about what is really going on is so important. The more valid information we share, the better for all. This is very timely. In early August I posted “Thyrogen Shots and Insurance Coverage – Not?” to my blog at http://thyroidcancersurvivor.wordpress.com/2010/08/01/thyrogen-shots/ and I am about to post the update to my Thyrogen journey today.
Agreed, Jenn–it’s SO important to share information such as this!