Ampligen price more than doubles, available soon in Europe


Ampligen price more than doubling in the US?

As many patients who are receiving Ampligen in the US already know, the price of Ampligen is set to dramatically increase.

Two patients I spoke with today said the price would more than double from $75 a vial to $200 per bottle. At their current dosages, that would raise the annual cost of Ampligen from $15,600 per year to $41,600 per year, not including the doctors’ fees for the infusion.

Many patients will either have to lower their dosages or forgo treatment altogether.

Ampligen is a treatment for Chronic Fatigue Syndrome that has not yet been approved by the FDA. It is currently available to some patients at a limited number of sites around the US under a cost recovery program previously known as “compassionate care.”  It is delivered at a doctor’s office via a twice weekly intravenous infusion.

This is the first price increase since 1997. Under the cost recovery program, Hemispherx cannot make a profit on Ampligen, only recover its costs. According to Nancy McGrory, a representative from Hemispherx, the price increase was determined by an independent audit to determine the actual cost of manufacturing the drug.

 

Ampligen soon available in the European Union

Hemispherx also announced today that a Netherlands-based company called myTomorrows will be supplying Ampligen to some Chronic Fatigue Syndrome patients with “unmet medical need” through the Early Access Program (EAP).

Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx said “We are very pleased to be collaborating with myTomorrows to provide rintatolimod under these unique Early Access Programs. Not only will this collaboration create the possibility for physicians to use rintatolimod under certain circumstances, myTomorrows will collaborate with these physicians to capture data on patients treated and such data may add to our other efforts to gain full regulatory approval in Europe, Latin America, Australia, New Zealand as well as the U.S. and elsewhere.”

 


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8 comments on “Ampligen price more than doubles, available soon in Europe
  1. Marcia says:

    I have heard patients online praise ampligen and how it has helped them.
    Why has it not been approved for ME patients in the United States or Europe, why only for certain people?

    Was this drug created specifically for ME ? If patients can,t have access to it why does the price keep skyrocketing?

    Is there real success treating ME with Ampligen?

  2. P K Kuhl says:

    Price will ALWAYS be a factor unless or until the FDA approves for use in the general population then the price can be regulated I dont know how people with cfs or me that are obtaining it now are paying that exorbitant price for it especially if its for the most debilitating patients Where are they getting the $$ to pay for it disability doesn’t pay that well I assure you.Ampligen has been in trials since I was first diagnosed so over 20 yrs I cant imagine what the hold up is Does it work or doesnt it?

  3. I have been on Ampligen since 1999 (with four years off – once voluntarily because I mistakenly thought I was cured, and once when FDA took it away because the head of my practice died). I am lucky in that I respond well to it, and unlucky in that I relapse quickly off of it.

    Before Ampligen (and when in relapse), I am mainly bedridden in pain, listening to movies. I can make it to the bathroom and back. I have ataxia, dyslexia, expressive dysphasia, disorientation, blackouts, poor memory, partial paralysis, and massive confusion. On Ampligen I can walk, drive, read – I’ve even written a bit for publication again (I was a history professor before collapsing in 1994).

    Off Ampligen I have major immune defects – almost no natural killer cell function and the 37kDa Rnase-L defect, abnormal SPECT scans, CPET scores so bad that I could be given permanent disability on that basis alone (as a cardiac patient). Blood tests at different times have shown EBV activation that comes and goes: HHV-6, Variant A (the type found in AIDS patients – I was in early research); HHV-7; CMV (cytomegalovirus); and 3 strains of Coxsackie B. A 2009 spinal tap showed that HHV-6 and CMV were active in my spinal fluid. On Ampligen, the immune biomarkers go away and the viruses (at least as far as we can tell) go dormant.

    Within 6-12 months of going off Ampligen, the viruses, with all the damage they can do, will return. My natural killer cells will tank, leaving me vulnerable to leukemia. But worst of all, I will return to the darkened room, a vegetable in pain.

    I received private disability from my university, and after taxes, it paid for Ampligen (we just looked at it as “suppose you never got disability.”) So that’s how I paid for it. I was lucky to be able to live on my husband’s income as a professor of finance at the University of Delaware. My kids got college tuition for free (one bonus of being a college perfesser). Now they are on their own.

    Bob died of cancer two years ago. I had not known it, but years ago he had taken out enough life insurance so I would be able to pay for Ampligen if something happened to him. So I can afford it at $16,000/year. But I cannot afford it at $40,000/year.

    Unfortunately, my body does not tolerate Vistide, which is the appropriate choice for the combination of HHV-6 and CMV. I am not sure there is any treatment that will do any good. I went through this back in 2008 when the head of my practice died in Philadelphia, and I could not find any way to get Ampligen within 100 miles of my home in Delaware. We tried all sorts of things; nothing worked. I just got sicker.

    It is living hell to have been like a normal person and know you are going to be a vegetable in a few months. This time, without Bob, if I go back to being a vegetable, I will have to move in with one of my grown children, something that would be a hardship for either one of them. At least I got to have a life for a while, so I know I am luckier than most.

    If this drug were approved, how could they still insist that CBT and GET were appropriate treatments? The drug isn’t going to help everyone – I don’t even know what percentage have the biomarkers I have, because our governments pretend they don’t exist. But having an IMMUNE drug approved for ME and CFS would change the way this disease is perceived.

    I have testified to CFSAC, at an NIH conference, at FDA – for Ampligen. I have fought for Ampligen for a long time. There aren’t very many of us left on it. Why would the company do this to us? Why is FDA letting this happen to us? When will anybody anywhere care about any of us with this disease?

  4. marcie myers says:

    Home › FDA Status › Ampligen

    Below is the history of Ampligen since 2007. Read what they discovered in Dec. 2014 and Feb. 2015: That it is effective against EBOLA. So of course they have the perfect opportunity to raise the price double and recoup some of years worth of studies and cost though most of the ME/CFS studies have been captured by the CFS physician and patient and not Hemispherx. Most any IV treatment is terrifically expensive beyond explanation except that Pharm says they must recover some of their years of research costs and the numbers of drugs that never make it to market. Ampligen is a very very serious drug that is given IV twice a week for over a year in the case of ME/CFS. To my knowledge, you get much much sicker for months before any improvement is shown and during that time you still have to get the twice weekly treatments and have someone who can take care of you and your needs during this time. I wouldn’t have that… a fulltime caregiver… never mind the $ cost…to get me through the first half of that year. And even the patients in the Netherlands relapsed after of period of time of not having the Ampligen IV. So it’s not a miracle cure to be looking toward either; it’s simply the ONLY drug that’s been considered specifically for treatment of ME. Good news is that it kills Ebola. Ha!
    Ampligen Approval Status

    FDA approved: No
    Brand name: Ampligen
    Generic name: rintatolimod
    Company: Hemispherx Biopharma, Inc.
    Treatment for: Chronic Fatigue Syndrome

    Ampligen (rintatolimod) is an experimental nucleic acid therapeutic in development for the treatment of a variety of chronic diseases and viral disorders.
    FDA Approval Status for Ampligen
    Date Article
    Feb 9, 2015 Hemispherx Biopharma Posts USAMRIID Ebola Study Concluding Ampligen Produced 100% Survival Rate in Rodents with 100% Mortality in Placebo
    Dec 9, 2014 Hemispherx Announces Data Showing Inhibition of Ebola by Ampligen Enlarged by Howard University Research
    Feb 5, 2013 Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome
    Dec 27, 2012 FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome
    Oct 23, 2012 Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012
    Sep 24, 2012 Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome
    Aug 14, 2012 FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome
    Aug 1, 2012 Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome
    Mar 7, 2008 Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen
    Jan 9, 2008 Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA
    Oct 11, 2007 Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome

  5. leelaplays says:

    I posted this on the biosphere posting of the notice that Hemispherx will keep the price the same for 6 months. Am looking for more sites that published the notice to add the comment there too.

    “‘Patient Assistance Program For Chronic Fatigue Syndrome Open Label Study’ implies an on-going assistance for patients in the study. Instead, after 6 months (instead of the instant increase without notifying patients in person), Hemispherx will raise the price 276%, from $15,600 to $41,600 per year, making it unaffordable for patients. As the FDA hasn;t approved ampligen, patients pay the full cost. No insurance, medicare or medicaid covers it. A true patient assistance program would cover the cost in full or in part on a needs basis for the whole course of the study.”

  6. Marcie most of what you posted is accurate, except that patients get worse for a year after treatment. patients respond differently, some have increased flu like symptoms, while others have no real side effects…As for cost, there has been no definitive decision yet. I assume there will be an increase, but no amount has been ok’d by the FDA at this time. Hemispherx can Not make a profit from Ampligen, they can only recover the cost to make it…

  7. Jan says:

    I see nobody has posted on this in a long time. I was diagnosed with fibro/CFS is the mid 90’s. I was SURE I was dying. I saw Dr Levine in NYC and was put on b-12 injections and kutapression injections. No longer available sadly but I see it was compared to ampligen. I have been having issues again for YEARS but blamed everything under the sun, because I felt I no longer has this issue. HAHAHA!!!! Went back to see her last week, had an IV infusion of mag, C and B. For a few days my chronic neck/shoulder pain and headache went away. I dint feel awesome but it did do something. Started my bi-weekly b-12 today. Waiting to hear from her on all of the labs I had done. I think its a horrible shame that if something works for someone, that they cant get and/or afford it.

    1. Alice Elwert says:

      Last week I was again looking for help on line for my CFS and found info about Ampligen/Rintatolimod. I was so excited, in my usual tired way, to see there was something out there to cure or put in remission this horrible disease. I have been suffering since the 80’s and I’m now 76 and feeling weaker still. I spent a very large amount on Valtrex prescribed by a doctor who insisted I not use the generic. I later found out he was writing a book re use of Valtrex, at my expense. My current doctor has been trying to help with various vitamins and shots and I’ve gone for vitamin infusions that wear off quickly and were expensive. Nothing helps, I feel like I’m only half alive. I lost my last job from it, my marriage died, I seldom go out and am unable to travel. I spent a week in the hospital with a severe asthma attack which I feel was part of this whole mess. Now I see there is still no hope for me because of the price and pace of the government.

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