AMPLIGEN - How do we get it?

Discussion in 'Fibromyalgia Main Forum' started by SpecialK82, Apr 13, 2009.

  1. SpecialK82

    SpecialK82 New Member

    Ampligen, the first drug for CFS, may be FDA approved in May.

    I'm wondering how do you think we would access it if approved?

    Would we be able to ask any of our doctors to prescribe it? Because it is administered by IV, we would need a place to go. Do you think they would just send us to the nearest hospital - or would we get home care IV? I'm just wondering since most docs won't be able to administer in their office.

    I'm hoping that we won't have a situation where there are only a handful of places around the country (US) where we can actually receive it - which is how it exits today for open-label study.

    Anybody have an opinion? I am really hoping and praying this gets approved (if you haven't noticed)

  2. street129

    street129 New Member

    hopefully, this clinic that im going to on wednesday 4/15, heard this news and will be using it on his patients.
    [This Message was Edited on 04/13/2009]
  3. outofstep

    outofstep Member

    I've already looked into this and here's what I know-yes, you'd need a prescription, and if you don't have a dr. who can infuse it you can do it via a hospital where they have infusion rooms. If it's prescription then anyone who gets a prescription should be allowed to get it-just like any other drug. It's only limited right now because it hasn't been approved.
    I'm really hoping and praying that it gets approved too.
  4. SpecialK82

    SpecialK82 New Member

    lonely hearts - yes, it will definitely be alot of money....I believe it is about $20,000 per year currently if you go to an open-label study

    I'm guessing too that many insurance companys won't cover it - although since it doesn't have any generic substitute, I wonder if they have to cover something.....

    If it's approved by the FDA, I would assume that it can't be considered "experimental" anymore - but I'm not sure of the rules. You bring up a great point about having to prove you have CFS to the insurance company if they are going to cover anything.

    outofstep - thanks for the insight - you are so proactive already looking into it :)
    I'm happy to hear that we should be able to get it at just about any hospital, that makes alot of sense. I wasn't sure if they have infusion rooms per se at the hospital. I've seen rooms for chemo at oncology offices....

    street129 - just wanted to clarify that it is not expected to be approved until at least May, so your clinic won't be using it yet (unless it's an open label site)


  5. outofstep

    outofstep Member

    I'm just REALLY hoping that it gets approved-am probably jumping the gun at this point :)

    At the hospital by me they do all of the infusion in the same room, including chemo-other hospitals may be set up differently but you should be able to find somewhere to get it infused in your area.

    One of my big concerns has been that it won't get approved b/c it's expensive and insurance co.s won't want to cover it-although the latest studies show that people reduce the number of drugs they're taking after Ampligen treatment so maybe it would end up being the same cost for them. It would seem like once it's approved specifically for CFS treatment then the insurance co.s would have to cover it if you have a CFS diagnosis because it would be the only treatment approved for the disease. We can only hope.
  6. SpecialK82

    SpecialK82 New Member

    I'm getting a little worried if it doesn't get approved that I will get depressed. I know I shouldn't get my hopes up for a drug that may not even help but I just feel so desperate right now - I keep thinking about Mary Schweitzer's story (even though I have heard other negative ones).

    As far as insurance paying for it, this has been my experience with an expensive med:

    I take Prevacid for severe acid reflux and have taken it for years. I have tried to take other less expensive, less effective substitutes over the years, but it will not control it.

    Well (it used to be) everytime I would change insurance companies, they would send me a letter refusing to pay for it - saying that it was not on the "approved" list or some such thing and they would tell me about the less expensive drugs that I could substitute that were "approved".

    Each time, my doctor would have to provide proof to the company and explain why the other meds weren't effective, etc, etc. After that, the Prevacid would then be covered. (It's not an issue anymore, as it seems to have hit the "approved list" in the last year or two and it's not a battle anymore).

    Since we know that Ampligen is about a million more times expensive than a drug like Prevacid, the insurance companies will really kick and scream. But, in this case, there is no other less expensive substitute that they can offer, as you pointed out.

    So it would seem that they could question our diagnosis of CFS, and make us jump through hopes to prove it, as lonely hearts stated, or could they require maybe that we have to prove that no other CDC recommended therapies have worked - like CBT or graded exercise (lol) - could they do something like that?

    It would seem, even if insurance covers it, that they will probably want to put a time limit on covering it. Although, any study that I have read, shows that the benefits are lost when the patient stops the drug.

    I'm just kind of thinking out loud here, excuse the rambling - like you, I'm trying to prepare myself for any roadblock the insurance companies would throw up.

  7. ladybugmandy

    ladybugmandy Member

    kristina....maybe i am not remembering correctly, but aren't you seeing dr. lerner? may i ask how that's going?

    i think the usual antivirals would help just as much as ampligen. even mary schweitzer is going to go on valcyte soon.

    i have heard that people who have been sick for a very long time have to take ampligen for years to improve, just like with vaclyte and valtrex.
  8. TeaBisqit

    TeaBisqit Member

    I've waited eighteen years for this drug to be approved. I don't even care if it works at this point as long as it gets approved because it will legitimize us.

    I would want alot more info before I would take Ampligen. It's not even the original formula that I wanted. They've since changed it. And I've heard so many conflicting things.

    It does sound like something we would have to take forever. I have heard that as soon as you go off it, you relapse. The insurance companies are just going to have to deal with it the same way they deal with diabetes and thyroid disease. People need those meds forever, too.
  9. TigerLilea

    TigerLilea Active Member

    Hi Kristina - The little I know about Ampligen is that it is very expensive. I was told by a pharmacist here in Canada that it would be in the neighbourhood of $10,000 per year.
  10. outofstep

    outofstep Member

    grrrrrr I wrote you a response and the website ate it-here's what I basically said-

    I'll definitely be depressed if it's not approved-plus infuriated. There's no reason (other than politics) that a drug that has been proven affective and has low toxicity should not be available for a disease that has no other approved treatment. But from what I understand there are 3 things that can happen-it can be approved, not approved, or "approvable"-which means that the co. has jump through more hoops. I'm suspicious that the FDA is trying to drag this out as long as possible without approving it but not denying it outright.

    You should call your insurance and ask them what their policy is on newly approved drugs so that you'll know what you're dealing with. That's what I did w/ the infusion issue b/c I had to figure out how to get it covered. I think that some of this will depend on the individual insurance co.s, but I really doubt that any insurance co. in the US could make you "prove" that you are sick once you have a diagnosis or force you to try a non-medical treatment first.

    I've read both re: treatment-that some people have been "cured" and were able to go off of Ampligen, but that others had to stay on it long-term. To me the worst-case scenario (other than it not working) would be that it could be used as a stop-gap until something more practical was developed (the co. that makes it was also working on a pill form at one point). If this drug is approved then other co.s will be more inclined to come up with their own versions.

    I'm trying not to get my hopes up too much, but it's hard when you know that a drug may be the thing that gives you your life back.
  11. SpecialK82

    SpecialK82 New Member

    ladybug (Sue) - I was seeing Dr. Lerner until I was not longer able to tolerate the Valtrex because of stomach problems - I have not seen him since November. I have been trying to decide my next move. I really would like to try something that directly helps the immune system (like Ampligen or Dr. Cheney's peptides). Because my condition is deteriorating quickly I feel like I am getting more desperate.

    I am thinking about maybe only taking 1 or 2 Valtrex a day (as opposed to 4) but am worried that I may develop a resistance. I have an appt. with an infectious disease doctor locally in May, and I am hoping that they will be willing to treat the EBV with Valtrex. I am very weak to travel to see Dr. Lerner now. However, I did set up an appt with Lerner about a week after this appt in case they are unwilling to help me. I think Dr. Lerner may suggest IV Valtrex which means living in MI long-term, I don't know how to afford that.

    I heard that Mary Schweitzer was looking into Valcyte - is she able to take that at the same time as Ampligen?

    TeaBisqit - If I remember correctly, they changed the formula at some point to make it less toxic and it decreased the side effects

    TIgerLilea - thanks for the price, that's actually better than I had heard - I assume that is just for the drug and not for the infusion itself

    outofstep - sorry to hear your whole post disappeared :( I feel your pain. I have started to copy my post into a Word document before I submit it (or if I have to go back and read replys) and then I can just paste back if it goes away.

    Interesting that the FDA can say "approvable" - that would probably mean years more of delay. If the FDA flat out doesn't approve - what would Hemispherx have to do - run more studies or change the formula? I'm concerned also (as I beleive that I've read somewhere) that Hemispherx may give up on Ampligen for CFS at some point and concentrate it's focus on HIV or hepatitis only.

    Like you said, I know Ampligen is not a cure, but I am hoping for a stop-gap to at least make life bearable until the next piece of the puzzle is solved. If they could go on to develop the pill form that would go a long way to reducing the costs! But I agree with you 1000% - get something approved and other drug companies will start jumping in to compete!

  12. ladybugmandy

    ladybugmandy Member

    kristina....have you tried famvir instead of valtrex? that it what dr. lerner prescribes for people with stomach issues on valtrex. i doubt he will do IV valtrex. i think he only does IV for antibiotics, but i could be wrong.

    i think mary schweitzer was looking into valcyte instead of ampligen. i have never heard of anyone taking both at once.....that would be interesting lol

  13. SpecialK82

    SpecialK82 New Member

    Dr. L did switch me to Famvir but I got debilitating headaches and had to stop after 3 painful days. He told me the last time I was there, that we always had an option to do IV Valtrex to avoid the stomach, if I chose that option that I would have to be in MI.

    I didn't ask at the time, because I didn't see how I could do it - but how long do you think that would be? A year? Two years? Unless the Valtrex is stronger by IV and it takes less time then the pills??

    After stopping Valtrex it took a few weeks for my stomach to return to almost normal - it's about 80% better. I don't know if I am also getting digestive problems associated with the CFS and that's why I haven't gone back to pre-Valtrex. It was so bad I thought I had an ulcer and had to have a scope which came back normal.

    Anyway, he told me after my stomach returned to normal to start taking 1 a day for a week and then 2 a day for a week and so on until I'm back to 4. The pain and the worry that I was causing permanent damage to my stomach was such hell that I haven't started back.

    Do you think if I take just 1 or 2 a day long-term (if that's all I can tolerate), would it do any good? or could it cause resistance? I wonder if he would answer my question in an email before I make the trip to see him?

    I would be very surprised if Mary Schweitzer was going to get off Ampligen completely - I hadn't heard that.


  14. outofstep

    outofstep Member

    Yeah I was playing it fast and loose with the posting and got burned :)

    I would be really surprised if Ampligen got a "not approved" at this point-but what would happen in that case is that the drug co. would then have the option of either amending or withdrawing the application or requesting a hearing. I think that it's more likely that they would get an "approvable" which would just be more of the same-my concern is that the co. probably cannot go on like this indefinitely because as far as I know they only have one other product to sell. The drug co. believes that Ampligen can be used for other diseases so it's possible that if it didn't get approved for CFS it could get approved for something else and could then at least be used off-label, but that would take awhile. Let's just hope that they straight up approve it for CFS.

    re: Mary Schweitzer-from what I understand her dr. died, and so the practice had to reapply for permission to give her Ampligen and was denied, so she had to switch. I wonder if she's having any success with her new meds?

    Were you thinking of trying Imunovir? I had terrible allergic/toxic issues with Valcyte and co. so am going to try going the immune modulator route.
  15. ladybugmandy

    ladybugmandy Member

    i wonder how easy it will be to get ampligen even when its approved. in canada it has been approved for emergency release since 1996 but i have not come across even one CFS patient getting it. i do not think they can find a doctor here willing to prescribe it. hopefully things will be different in the US.

    kristina....i have heard of people taking less valtrex under other doctors but i am not sure if it helped or not. maybe it just takes much longer that way. it would be a good idea to ask dr. lerner for sure. i have no idea how long the IV valtrex would take! wouldn't your insurance cover part of the expense?

    the headaches you got on famvir...could that just be a herx-like reaction?


  16. tennisnut

    tennisnut New Member

    Dear SpecialK82 (Are you named after a breakfast cereal?) and others.
    Please can anyone tell me how Ampligen is expected to work. Will it help fatigue, pain, blood cells, immune system? I know the name from all the publicity. But can anyone tell me what a ME patient can expect from this drug?
  17. SpecialK82

    SpecialK82 New Member

    tennisnut - my husband started calling me SpecialK when we were dating (my name is Kristina) - he thinks I'm Special.....but does he mean that in a positive or negative way....hmm.....he won't say :)

    Ampligen is supposed to help your immune system, and then you should be able to more effectively fight any infections you may have (viral/bacteria/fungi) If you have infections, and they are in check, that would theoretically help alot of the CFS/ME symptoms that you feel. It seems that I've heard most often that it may help cognitive function (brainfog).

    "if it didn't get approved for CFS it could get approved for something else and could then at least be used off-label"
    that's a great point – at least that would give us some hope still

    (warning - here I go again with insurance) it would seem if the drug was used off label that would give the insurance a reason to deny coverage ------ however------alot of us use antivirals off label and my insurance company covered it even though the Valtrex was about $800/mo - so I dunno

    If I recall correctly, Mary S did have to stop Ampligen when the practice had to reapply but I thought she was able to get back on it somewhere else

    I have not thought about taking Imunovir - I am blanking on it right now but I thought there was something negative about it - maybe it's not been shown to be very effective?? I can't recall. Are you thinking about it at all?

    Sue (ladybug) - I do think my insurance would cover the IV Valtrex, I’m more concerned about the expense of living in MI and having to support two households - if that’s what we needed to do, we could probably do it for a short time only.

    I wish Dr. L would let me get the infusion in Ohio but he said no. I guess it may be an issue of not be able to practice medicine in another state. Sigh

    I took the Famvir headaches as an adverse drug reaction rather than a herx because I had never felt this type of headache before. When I had herx-like effects with the Valtrex, it was all my usual symptoms only magnified.

  18. ladybugmandy

    ladybugmandy Member

    kristina..if you do need to stay in MI, there is an apartment complex run by Beaumont Hospital. it is about $50 a night if i remember correctly. you have to haggle a little. they also have security personelle who will drive you back and forth from the hospital, Dr. Lerner's office, and the supermarket. they have a full kitchen and everything. you may want to take an aero bed cuz the beds are awful.

    can you find a local doctor to prescribe the IV valtrex?
  19. outofstep

    outofstep Member

    My insurance covers off-label stuff too so I guess that it would depend on the plan-some of them seem really restrictive.

    I hope that Mary S. was able to get back on Ampligen!

    I'm planning on trying Imunovir next-you can get it from Canada w/a prescription-figure I may as well try whatever is out there while waiting on the FDA. There are some other drugs being used in Europe that may be helpful too but are difficult to get here at this point-hopefully that will change soon.
  20. TigerLilea

    TigerLilea Active Member

    Imunovir is "prescription only" in Canada. Also, it is not approved for CFS.