Generic Gammagard immune globulin? Or, any other?
AnonymousDecember 20, 2010 at 1:25 pm
I wanted to separate the discussion about generic IVIG from limekat’s denial-appeal process.
Get to the bottom line- I called Gammagard at 1-877-655-4273. Quoting them, “…Gammagard does not, nor has it ever, made a generic version. Neither does any other Company, that I know of…”
A search of the FDA website clearly shows Gammagard, or any other Brand as just that- “Branded.”
The FDA, at least as far as I could find, labels any Brand name manufacturer’s generic version as “immune globulin.”
Anybody find otherwise, please share.
December 20, 2010 at 7:09 pm
The only thing I can think of is they are being denied for s/d, the powder formula of gammaguard which is “supposed” to be reserved for specific uses????
AnonymousDecember 20, 2010 at 10:37 pm
I was thinking about this…
I do not think IVIG will EVER be generic. The process of cleaning the plasma & the government regulations associated with it would be too much of a hassle to become generic. The production costs are too high. If a company tried to make a generic version they wouldn’t make any money at all off of their product & we all know that isn’t going to happen.
AnonymousDecember 21, 2010 at 2:57 pm
Yes, and moreover, it is the time of year for annual rubber stamp form letters to go out reminding suppliers and patients that there are at least three tiers being used to help control prescription drug costs.
I usually get this kind of letter around annual medical plan renewal time.
What are the tiers? Here is an example of a four tier plan.
Tier One: This has the lowest and most affordable co-pay and usually covers generic drugs
Tier Two: This covers the average co-pay and covers those brand name drugs which are preferred
Tier Three: This has higher co-pay percentage, covering brand name drugs that are non-preferred
Tier Four: This has the highest amount on co-pay, usually covering highly expensive drugs or those so-called specialty drugs.
Note that some plans have a feature called ‘step therapy.’ This is intended to force us to at least try the least expensive options for certain drugs first and then, to step up as needed.
However, I reviewed some Insurance Company Drug Plans on line and in no case did IVIG, either Branded or generic, appear on a “Drug Plan” list. IVIG, in some cases, are on the Immunological Factors pages on line and they are each different. As mentioned, some Plans require special approval beyond authorization for certain IVIG Brands.
Furthermore, I am covered by the plain vanilla Medicare and I do not have Prescription Drug coverage. Medicare pays for the IVIG as long as I do not get it at home.
Ergo- IVIG is not a Drug under Medicare. Be aware, your current authorization for IVIG may expire with the plan year end.
December 21, 2010 at 7:16 pm
Not sure why if there is no such thing as generic ivig—but the label on mine always reads Gamunex only –no generic equivalent. I will ask the nurse at the infusion center next time why it says this and if it doesnt state this, might something different be used?? I somehow always seem end up in the chair directly cross from the ivig pharmacist–maybe i can see what info he has on it. Lori
AnonymousDecember 21, 2010 at 7:39 pm
The ONLY IVIG to be approved for CIDP is Gammunex.
Carimune is much cheaper, as is Gammagard SD.
Here is the FDA Summary [brand name not mentioned] of the trial:
To my knowledge? There are NO generics of IVIG. Look under ‘specialty pharmacy’ medications or drugs in your insurance plan to see what the ‘ins’ and ‘out’s’ are… Most neuro or rheumy physician’s offices have someone dedicated to knowing the complicated coding systems that are required to sort these issues out to the Ins. Co’s satisfaction.
When any ADMINISTRATING source substitues The PRESCRIBED brand for another [such as a hospital] THEY MUST notify the physician and the patient promptly… to avoid possible reactions. IF NOT? Think lawsuits…
And… someone correct me here? Since Gammunex IS an FDA approved med or ‘blood product’? It should be covered even under Medicare [tho your co-pays are going to be HUGE].
Yuehan? I’d start calling your prescribing doc’s office, the insurance company and any and all others…including senators and representatives to GET answers. While you mite not like the answers? Getting all resources behind you, and facts in line can help you get better and cheaper treatments!
Good luck and bless you in this exhausting struggle!
I’ll keep my fingers crossed that things work out better than well!
This part of having CIDP and getting older IS the PITS!
AnonymousDecember 22, 2010 at 12:03 am
Even though it makes for a highfalutin advertising copy phrase, “FDA Approved” is not nearly as critical as “Authorized” by the patient’s insurance carrier.
The debate here is, “Will we pay more because the Insurance company, or their Proxy, determined that IVIG is a Branded, not a generic, product?”
And, if anyone has paid more as Branded, or if anyone is using a generic, and therefore, paying less, please share that information here.
December 22, 2010 at 1:44 pm
so what is the deciding factor to whether one gets gamunex or gammagard? Is there a huge difference between the two? Lori
December 22, 2010 at 2:35 pm
I personally feel that the company who paid the FDA for the trial gets the stamp of approval.. Spending the money to meet specific criteria allows them to have the official stamp of approval if you will. The difference is in the cleansing agents as well as preserv. etc. For instance, I think gamaguard and gamunex both use glycine and neither uses any sugars as stabalizers. I think octagam which is no longer aproved for use in us used maltose which as a sugar and can cause renal failure for those with diabetes. Maybe there is a difference, but I think if the plasma is the plasma and the same agents and stabalizers are used, it doesn’t seem like there could be a huge difference in efficacy. Who knows
AnonymousDecember 22, 2010 at 8:34 pm
In my experience there is not a huge difference in the two. Neither in effect nor in cost. However, that’s a small sample.
I have learned to ask my doctor for what I want. The doctor prescribes the Brand I request, currently Gammunex-C. I have asked for and received Gammagard liquid-10% in the past.
However, in my experience, there are occasions when the prescribing doctor does not specify a brand…..
In fact, there is a voluntary recall of Octagam dated 24.09.2010:
“…Effective immediately, Octapharma USA Inc. is initiating a voluntary market withdrawal of ALL lots of octagam® [Immune Globulin Intravenous (human)] 5% Liquid Preparation] currently in the US market…”
On the other hand, Octapharma AG has an open study on their 10% IVIG:
Apparently, that study is not yet open for participant recruitment. Stay Tuned:
AnonymousDecember 22, 2010 at 9:18 pm
For many immune issues [off label]. Most of the bigger insurance companies have policies for administering IVIG providing one meets certain criteria…And they have done so for the last 20 years. It has only been recently that IG products have been ‘approved’ for CIDP thru clinical trials! Why not before? Because they simply didn’t have to!
Do keep in mind that insurance companies DO keep their eye on that ‘bottom line’ and we are not on it! While with acceptable practices it is acceptable? That Medicare/Medicaid bugaboo raised it’s head with/for/against us as we get/got older. While Gammunex is FDA approved? It IS a specialty med and your co-pays will likely take your breath away. Sub Cutaneous IG products are that One is now approve FDA-wise and another brand is closing trials. Likely rich as well.
Problem is, this all was going on as the health care ‘debates’ were going on, so where, when and how they fit in is – up in the air? That is where you contacting your US reps and senators to give them [especially if YOU MEET THEM] A first-hand look at a PERSON, not a statistic. Good thing about this? They’re gonna be on ‘break’ for the holidays -Call and make an appt to see your rep. and sen. in person and show them what it means to get this treatment! They don’t have a clue…unless they can see THE FACE of one with this sort of problem.
IVIG is a BLOOD PRODUCT, thus subject to many, many more regulations and conditions than other treatments! Ask your congress and senators to connect you to FDA staff who mite help you work things out w/the insurance companies [they have surprising ‘indirect clout’ once you learn what you need to know!] The regulations are, historically WITH cause. So, that’s cool with me. Don’t know about others?
Dawn? The FDA IS paid a fee to assess these blood products, yes. But what it costs is more to us taxpayers, I’m willing to pay THAT, how about you all?
Lori? It is up to the PRESCRIBING PHYSICIAN as to which IG to use. Ever been in the waiting room? W/all the pharma reps. coming and going? What about those ‘conferences’ the neuros go on? What perks do they pick up where? And write off golf as a ‘business expense’? Only in America. Nuff said.
AnonymousDecember 23, 2010 at 8:58 am
My insurance treats this as a medical procedure. I get Gammunex every month and it is billed and paid for on the medical side, because it is an infusion. Nothing you could go to the pharmacy and do yourself. I was on Gamma guard but lost my job due to CIDP and went to COBRA. On the internet I found groups that will pay for my monthly COBRA Premimum, so I had to switch to Gammunex.
They bill my insurance for over $25k per month for the 4 days of infusion
AnonymousDecember 23, 2010 at 10:54 pm
They bill my insurance for over $25k per month for the 4 days of infusion[/QUOTE]
Wow, you get quite the deal. My insurance gets billed for just over $25K per infusion!
Of course, for both of us, — that in no way means that’s what is actually reimbursed for either of us, that is the amount [U]billed[/U].
Do you happen to know what your provider gets reimbursed for your infusions? It should be on the Explanation of Benefits you receive.
AnonymousDecember 23, 2010 at 11:52 pm
I work for a large PCP practice and it seems like some of you are under the impression that doctors and nurses have all the power of requesting and getting your insurance to do things that are not normally in your plan .
Someone asked if your providers get reimbursed for your transfusions …. I am not sure if you mean a “kickback ” but the answer is no .
What is comes down to is that you HAVE to manage your OWN healthcare as well as what your insurance is willing to pay. We can call and get it precert on it but we have no “special means ” to get them to pay for it . Sometimes it comes down to the way it is coded but again you need to ask ……
You need to have a doctor that you really feel has YOUR best interest at heart . If you have questions ….then by all means ask .
Someone also said ” I ask for what I want ” …..That is great . Not every doctor responds well to that , but again you have to find one that you feel comfortable with enough to do that .
While we would love to be miracle workers and get insurances to pay for everything ….its just not possible . Trust me ….even though I work in the medical field …I am in the same boat . I have had CIDP for 10 years now ….. It’s the same story with ins for me as well .
I wish you all the best and hope you find the answers you are looking for 🙂
December 24, 2010 at 9:54 am
Our ins pays $22K for 70 grams of ivig that is infussed for 5 hours one day every two weeks. (35 grams each time) That is 12 hours of nursing care (access, set up, removal of needle, infussion time) total. BCBS has an agreed amount with Coram our provider as they work together as a preferred provider. 22 is what Coram bills and 22 is what bcbs pays, it is their contractual agreement.
December 24, 2010 at 11:13 am
gamunex 130gm— 2 days of 65 gms ea. day. 4 hours, done at the the hosp infusion ctr.—-15k.–. Hosp settles for this as it is anthems cap for this procedure.
-I dont know about you all–but for me new year–new deductable to meet : ( I never really paid much attention to health ins up until i got cidp–other than an annual physical i never used it. Now that Im forced to use it, I realize how much insurance co’s have to pay and deal with. What a lot of us dont realize for every one of us depending on them to keep our quality of life as good as we can with procedures we NEED…are the people on mainecare who are running to the ER at every little cough, sneeze, ache or pain because they can—because it does not cost them one cent.
I dont know about everywhere but–mainecare is very abused in my state which then forces the insurance companys to pay more to pick up for the low cost of mainecare reimbursement to the hosp’s–then eventually trickles down to us–the people who are buying insurance. Its a sad system and even more so that nobody can come up with a solution to the problem. Lori
AnonymousDecember 28, 2010 at 3:27 pm
wow, I see a huge span of what insurance pays out. Dawns company is paying 22k for 70 grams with the nurse.
my company pays 15k and change for 170 grams of Gammunex per month.
thats with the nurse. two bimonthy infusions of 85gr in about 5 hours each
infusion. I know my HC company manages and suppies the drug and nurse
but the employer is self insured meaning they are directly paying my expenses.
I just got my letter for 2011 approval and instead of Gammunex liquid, it said powder. that must be the SD. I don’t like that. Powder makes me really sick.
so I have a call in for clarification b/c I received to notification from the DR. of a brand switch. That powder gives me about a 5 day headache and then several days of nausea to follow. –tim–
AnonymousJanuary 6, 2011 at 1:57 am
I was receiving Octogam 5% from November-April 2009 for CIDP. The infusion center changed to Privigen 10% & I have getting this up until now. My doctor said Privigen is less expensive compared to other IVIG’s. I am getting weaker (I am getting 25 gms IVIG every 2 weeks) and my doctor says it may be the brand of IVIG that I am getting. Is there a difference between Privigen, Gammunex, Gammaguard? He said Gammunex is targeted for CIDP. But the infusion center I go to only offers Privigen. I don’t think the infusion center will change to Gammunex even though the doctor orders it for me. I am confused as to how infusion centers pick the brand of IVIG to use for patients.
AnonymousJanuary 6, 2011 at 2:52 am
[COLOR=black]There are differences among all the brands of IVIg in how they are processed. These differences can lead to differences in side effect profiles and perhaps efficacy, although there is no scientific data to support the efficacy difference. Anecdotally, some people seem to do better with one brand than another. It might be worth trying, but dose might be more important. [/COLOR]
[COLOR=black][COLOR=black]Part of your decline could be that you are not getting enough IVIg. You are getting 50 g a month. Under typical guidelines, that suggests you weigh 110 pounds. If you weigh more, then you might ask your neurologist to increase the IVIg so that you get 1 g IVIg per kilogram of body weight every month. You might even need to go up to 2 g/kg every couple of weeks for a while, to see if you improve.[/COLOR]
[COLOR=black]If your doctor specifies a brand on the prescription and writes “dispense as written” (or something similar), then the infusion center can either refuse to fill the order or must use the brand of IVIg prescribed. Your state’s law might still allow a substitution, but it would be unusual.[/COLOR]
[COLOR=black]As far as Gammunex being targeted for CIDP, I think that is a misunderstanding. Talecris, the manufacturer of Gammunex, obtained FDA certification that treating CIDP with Gammunex is a “labeled” usage. No other manufacturer currently has this approval. That means it should be harder for an insurance company to deny usage of Gammunex in treating CIDP. It is not that the others don’t work as well as Gammunex; it is just that only Gammunex is labeled for use in CIDP.[/COLOR]
[COLOR=black]How an infusion center picks the brand of IVIg is up for debate. I know that my health care organization uses the cheapest brand it can get. I also know, because my neurologist and I discussed it, that if I had improvement with IVIg, but intolerable side effects, we would switch to another brand.[/COLOR]
[COLOR=black]Godspeed in finding a completely effective treatment,[/COLOR]
AnonymousJanuary 8, 2011 at 1:54 am
Thank you MarkEns for your input. My neurologist tested the strength in my quads & arms and indeed I was weaker (could walk okay but walking upstairs and walking up a hill was difficult). I was on 25 gms IVIG every 2 weeks for 2 months. Therefore my MD changed the frequency back to every 10 days 25 gms IVIG. That’ll be 75 gms/month. He was trying to wean me to every 2 weeks because I was clinically “strong”. But I guess my body didn’t like it. What is the half-life of IVIG? How long is it suppose to stay in your body to help prevent weakness?
I still get a lot of moderately painful electric shocks in my different parts of my body; which I am not taking any meds for. What does this mean? I was dx with CIDP 1 year ago and still wonder how I got this chronic disease. I refuse to take steroids due to side effects. Does IVIG ever lose its effectiveness? Does any know?
I would appreciate anyone’s input.
AnonymousJanuary 8, 2011 at 1:41 pm
I wanna pop out with a number of 21 days for ivig half life.
I found this on the National Institiutes of Health (NIH) web site.
“…The serum half-lives of IgG were highly variable, ranging from 22 to 96 days… Patients with the highest serum IgG concentrations tended to have the longest half-lives, suggesting that intrinsic IgG production might falsely prolong the calculated half-life of IgG.”
So, it would seem that the more ivig your body normally produces the higher your individual half life will be. As to the effectiveness of ivig, ‘they’ told me at Mayo clinic, Mn ‘..you can expect maximum effect (in terms of emg/ncv response) after 30 days from the last treatment.
As for steroids, I hope you’ll reconsider. In the beginning I felt that way too! And, to date, I have not yet taken steroids. But, if ivig fails to work for you, then steroids and chemo, even stemcell transplant become an option.
The bottom line for me is, according to a Neuromuscular Specialist at UCSD La Jolla, Ca “…”IVIG alone does nothing to promote remission.”
Anyway, the answer, as you’ve discovered is in your and your doctors’ hands. Your office visit muscle strength is either higher, lower or unchanged. Tailor the treatment to the higher, unchanged end of the spectrum.
And, I agree with markens. 25 g of ivig is not much, it seems. Unless you really do weigh only 130 lbs. Let’s calculate- 130 lb = 58.9670 kg. Therefore .4g/kg*60kg = 24g. that’s close enough. By comparison, I receive .4g/kg (for me = about 35g) 3 days in a row every three weeks. For 3 months I received .4g/kg twice a week! And my treatments began with the ‘standard’ initial loading dose of 2g/kg, usually given over 5 days. For you that would be 2g/kg*60g = 120g/5 = 24g per day for 5 days.
Shooting pains and their treatment and response are highly variable.
AnonymousJanuary 15, 2011 at 2:01 pm
The electrical pains are a consequence of CIDP. The exact mechanism for the pain is not well understood. I think many of us would suggest that they are a symptom of the demyelination process, though. I feel them if I am getting worse and I feel them as I am getting better.
How and whether to treat them depends on their severity. The two main drugs which treat neuropathic pain are gabapentin (brand = Neurontin) and pregabalin (brand = Lyrica). Both of these have side effects. For me, the gabapentin made me quite tired for a couple of months and made me feel slow mentally. Many people report memory problems with it. Because my job requires that I be sharp mentally, I cut back and finally eliminated gabapentin. While I still get the electrical pains (and the something-crawling-on-my-skin sensation), it is minor enough that the trade for mental sharpness is worth it. If the pains occasionally make it difficult to fall asleep, I find a 25 mg Benadryl works.
As to the cause, nobody knows the mechanism. It could be a response to a previous infection gone awry (this mechanism is thought to be the cause in many GBS cases). It seems likely that many CIDP patients have some sort of genetic/environmental interaction. To illustrate using a different illness, MS is known to have a geographic influence. If you (generic, not the reader specifically) spent your pre-puberty years near the equator, you have a very low (around 1 in 50,000) chance of developing MS. The closer towards the poles you lived, the higher your chances. In the northern US and much of Europe, the chance rises to around 1 in 1000. If you lived in Scotland, your chance goes up to 1 in 500. This result is largely independent of ethnicity, and therefore suggests an environmental trigger.
IVIg can lose its effectiveness in some people, but it does not do so for everybody. I don’t have statistics for how often it loses effectiveness, but based on reading posts here, it does not seem to happen very often. Loss of effectiveness may be more a consequence of disease progression.
Even if IVIg is effective, it may not be optimal. You may find, from a quality-of-life standpoint, that IVIg plus low dose of prednisone or an immunosuppressant gives better results than just IVIg alone.
There are no clear cut clinical guidelines on how to dose IVIg. Many doctors like to keep with a 0.4 to 1 g/kg dose and stretch out the time between infusions. Others like to keep the frequency the same and reduced the amount of the infusion. If your neurologist wanted to keep the frequency at 2 weeks, he could increase the amount to 36 g (IVIg is typically done in 6 g increments).
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