The 12th Invest in ME Conference, Part 1
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Nexavir users: pls read -- need National Drug Code for FDA

Discussion in 'Antivirals, Antibiotics and Immune Modulators' started by Rrrr, Apr 13, 2015.

  1. Rrrr

    Rrrr Senior Member

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    nexavir question for nexavir users:

    do you happen to know the National Drug Code (NDC) number for Nexavir? my pharmacy said it is 10530-0815-03.

    i was getting it from my pharmacy for many years and my insurance covered it. then i went off it to see if it was really helping. well i guess it was, because i have gone downhill since getting off of it. now, upon trying to get back on it, my insurance company is saying that the National Drug Code is not accurate, because "The NDC number of this drug indicates it is not a FDA approved drug product and therefore does not meet the defintion of a Part D drug."

    can you or anyone you know on Nexavir in the USA do me a favor and ask their pharmacy what the National Drug Code is for Nexavir?

    thanks!
     
  2. halcyon

    halcyon Senior Member

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    It looks like it's no longer in the FDA database. If you go to the FDA site you can search the current database, it doesn't show up. They have the old NDC archive on the same page where it does appear, but it looks like that was archived back in 2012.

    These are the codes that are in the old archived database, the first seems to match the code your pharmacy gave you:

    281472 010530 0815 25.5 MG R NEXAVIR INJECTION
    283247 015801 0815 25.5 MG R NEXAVIR INJECTION
     
  3. Sushi

    Sushi Senior Member Albuquerque

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    @Rrrr I think we use the same pharmacy and have similar insurance. I was also told it was no longer covered. I find that it does help quite a lot and just ordered some out-of-pocket. :nervous:

    If we can discover a way to get it covered that would be great.

    Sushi
     
  4. halcyon

    halcyon Senior Member

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    As best I can tell it was never actually "FDA approved", it was just grandfathered in and then delisted from their database at some point in the last few years.
     
  5. Rrrr

    Rrrr Senior Member

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    I just got off the phone with the guy at the USA Nexavir company mentioned in Dr. Lapp's 2014 newsletter. This is what was on the newsletter:

    (can i include urls? if not, tell me and i'll take it down)

    http://drlapp.com/news/me-letter-june-2014/
    Nexavir™ (formerly known as Kutapressin)
    . Nexavir is an antiviral immunomodulating peptide solution derived from porcine liver. It is a by-product of B12 production. It has been approved for use in the US as a treatment for resistant skin problems and viral infections since about 1947. A 1992 study by Dr. Steinbach, a Texas gastroenterologist, reported significant improvement in 111 of 130 CFS patients. 103 of those subjects improved within 6 months of beginning therapy. Subsequent studies have shown that Nexavir is a potent inhibitor of both EB virus and HHV6. It is also thought to mediate lymphokines (especially interferon) but this role in immunomodulation remains speculative.
    The protocol for use of Nexavir is 2ml injected intramuscularly daily for 25 days, then 2ml IM every other day for 25 days, then 2ml IM three times a week for several months. Because Nexavir is a pork bi-product and contains a preservative plus tyrosine, it is not recommended for those with sensitivities to these ingredients. Nexavir is only available by prescription. If your local pharmacist is unable to obtain it, contact Nexco Pharma, PO Box 820023, Houston, TX 77282-0023, Ph: 713-896-4949, website www.nexcopharma.com; or John Walczyk RPh,PharmD, Johnson Compounding & Wellness Center, 577 Main St, Waltham MA 02542, Tel 781 893 3870. The cost is about $150 per 20 ml vial (=10 injections), and we recommend using 3cc syringes with 23g one-inch needles. Insurance may cover the cost of Nexavir.

    ***
    Anyway, the guy who answered the phone was great! he said the fda is messing around with the National Drug Code for Nexavir, making it hard to get nexavir covered. But that a federal judge in California just ruled that an insurance company (which happens to be my same one) HAS to cover it, regardless of the FDA code. So I'm going back to my insurance with that judicial ruling. If you want to see that judicial ruling, please contact the Nexco guy I talked to.
     
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  6. Rrrr

    Rrrr Senior Member

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    that is exactly what the Nexco Pharma guy said. that nexavir was "grandfathered in."
     
  7. Rrrr

    Rrrr Senior Member

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    how much are you doing nowadays? i was on 1.5 cc per night for the longest time. did not seem to help. but i'm worse off it. or so i think. i could be worse for many other reasons too. yikes.
     
  8. Sushi

    Sushi Senior Member Albuquerque

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    I have been rationing it cause it is so expensive. I'd like to take 1.5 mls every day but am doing it every other day. Could you PM me that judicial ruling? :thumbsup:

    Sushi
     
  9. adj

    adj

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    Attached is the case you're referring to. Best of luck.
     

    Attached Files:

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  10. Rrrr

    Rrrr Senior Member

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    Update: My doctor and I got a letter from my insurance saying that they rejected Nexavir because there was no National Drug Code number or because the National Drug Code number was not accurate. It was really just a way for the insurance to avoid paying for this medication. Anyway, they rejected it and then they rejected our appeal (i.e. denied the appeal).

    So after the appeal was denied, we sent them the court ruling -- the one that was posted in the post just above this one. We asked them to reconsider their denial of the medication, since this FEDERAL judge ruled in favor of the patient (who had been denied the medication for the exact same reason as me).

    Well, I just got a letter back the other day saying they are "re-opening" the case and will consider the "new evidence" (the court ruling). They said they'd let me know within 120 days.

    120 days?! Yes, they have 120 more days to save money by not giving the patient access to this medication.

    But at least they are reconsidering the denial.

    Will keep you posted.
     
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  11. Hip

    Hip Senior Member

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    Does anyone who has tried Nexavir for a short course of a several months, and then stopping taking it for a long period, notice any improvements while on Nexavir, that then slowly disappeared when they stopped?

    I ask this because I did a 4 month course of Nexavir injections (the 4ME brand to be precise) a while ago, taking 2 ml every other day, and in the year in which I took Nexavir, I had significant improvements in my ME/CFS. Though because I started a few other drugs and supplements in that year, I am not sure if the improvement was due to Nexavir, or to the other drugs, or both.

    I wonder if it is worth me doing another course of Nexavir. Like before, I will have to pay for this myself, as the UK NHS is not going to fund this. A four month course of 4ME will cost around £400.

    I know @Sushi tends to take Nexavir all the time, so then it's harder to gauge whether it is working for you or not. It's often only when you start or stop that you notice the benefits of a medication.

    Anyone have a sense of how much benefit Nexavir is providing them?
     
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  12. Rrrr

    Rrrr Senior Member

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    @Hip, i went downhill when i stopped taking nexavir, too. but i am (like you) not CERTAIN it was going off nexavir that made me worse. i had been on it for about 4 yrs. then i went downhill (had a crash) while still on it, at the end of october, and then i stopped the nexavir a month or so after that. i slowly titrated down. now i take a tiny tiny amount (0.20 ml) 5 nights per week -- not enough to have an impact, but i'm still titrating down. anyway, i never really got better after the crash, and i'm not sure if that is due to stopping hte nexavir or for other reasons entirely. which is why i am trying to re-start the nexavir, to see if it hurt to go off of it. so i understand your position.

    i will say that it never seemed to help me much to be on the nexavir. i still got sicker and had crashes, etc. but now i am really sick. so who knows. could be that i'm just getting older!?
     
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  13. Sushi

    Sushi Senior Member Albuquerque

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    I do take it every other day and am going to appeal to my insurance company to try to get them to pay for it so I can take it every day as, I get a big lift the day after the injection. I believe it has metabolic action as well as antiviral. Since I have been on it, all my reactivated viral titers have returned to normal.

    Sushi
     
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  14. Hip

    Hip Senior Member

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    After my very first injection of Nexavir, I had a fantastic lift. I felt this powerful optimistic and spiritual zest. It was a wonderful feeling. I read many patients say Nexavir makes them feel good, and assumed this must be what they are talking about.

    Unfortunately the injection I took the following day did not provide the same effect. In fact I felt nothing from it, and nor from any subsequent injection. So whatever it was that made me feel so spiritually wonderful, somehow my body rapidly habituated to it, so that it stopped working.

    Nexavir has been shown to potentiate the effects of bradykinin, which dilates blood vessels and increases capillary permeability.
     
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  15. Sushi

    Sushi Senior Member Albuquerque

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    I didn't start getting the "next day lift" until after I had been taking it for some time. No idea why, but if I have a day when I know I have over-done it, I make sure to inject Nexavir that night.

    Sushi
     
  16. Hip

    Hip Senior Member

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    The other issue when trying to gauge the benefits of Nexavir is that this drug is usually taken with vitamin B12 injections at the same time. Since many ME/CFS patients benefit from B12 injections anyway, much of the benefit might come from B12.

    When I took Nexavir for 4 months, I was taking 1000 mcg B12 hydroxocobalamin injections.

    I was considering recently whether just to try a course of B12 injections only for several months, to see if just that alone would be beneficial. You can buy hydroxocobalamin injections quite cheaply at goldpharma.com (£35 for 50 injections).
     
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  17. adj

    adj

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    Here's a development.

    The defendants appealed the case I posted, and the Medicare Appeals Council (MAC) overturned it (i.e., ruled against Part D coverage for Nexavir). But you are not obligated to inform your Part D carrier or any appeal entity of this (let 'em do their own homework), and the plaintiff is asking the MAC for a reconsideration, alleging errors of fact and law.

    (It appears the MAC overlooked evidence in the case file that Nexavir is identical to Kutapressin, as the plaintiff argued and the judge agreed. Kutapressin is eligible to be grandfathered into Part D because it was marketed before the 1962 FDA Drug Amendments. Nexavir, being identical, would be eligible too. Let's see what the MAC says.)

    Meanwhile, Nexco has decided to discontinue the injectable form of Nexavir (a business decision, not medical), and supplies are dwindling. Nexco is offering a transdermal gel instead (http://www.eclipseacts.com/nexavir-gel.htm). Whether Nexavir in gel form would be eligible for grandfathering into Part D is a whole other can of worms, as is the fact that currently it appears to be a compounded drug (made up specially for each prescription). It would be a fight.

    Another follow-on option is an injectable form of Hepapressin compounded by College Pharmacy in Colorado (800-888-9358). Same idea except using bovine liver and their formula is not thermostable, which means it must be refrigerated and has only a 90-day shelf life. (On the upside, no preservatives, if that's an issue.) My pricing info is about 2 years old--jeez, time flies when you're lying in bed---but I was quoted $33.08 for each 10 mL vial (the only size they do), and the concentration is a little less, about 22 mg of liver derivative per mL (Nexavir is 25.5 mg/mL). Available by prescription only, but they will ship to the patient. And then there's the compounding problem vis-a-vis coverage under Part D.

    Don't shoot, I'm just the messenger, but maybe there's something useful here.
     
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  18. Sushi

    Sushi Senior Member Albuquerque

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    Update as I just followed up on these links:
    They no longer have it available.
    Well, not at the moment--they told me to call back in a week to check on the status.

    However, another pharmacy said that Nexco will be? ? supplying Nexavir in capsule form. I think you would have to contact them directly if interested.
     
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  19. Vineyard1

    Vineyard1

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    Hi Folks....First time participant and I don't know if I am doing it right...but I have a couple of questions...
    Dr. Black just recommended Nexavir injections, however, when I tried to find Nexavir Johnson Compounding Pharmacy in MA (my state) said that Nexcopharma would not have any available for a minimum of three months as they were manufacturing it.....I asked if that was just through his pharmacy but he said it was not available anywhere in the U.S....they said the gel was not available either but might be ready a little sooner than 3 months and that I could get capsules directly from Nexcopharma ...when I asked about the efficacy of pills versus injection the pharmacist said the best method was the injectable...he said when it was ready it would cost $ 600/ monthl and my insurance (federal employee BC/BS may or may not pay for it )... I asked Dr. Black about trialing Immunovir and she said , "no patient has ever reported any improvement with Immunovir from their Center." Does anybody have any additional information about Nexavir or Immunovir. Thank You!
     
  20. Sushi

    Sushi Senior Member Albuquerque

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    @Vineyard1 That is the latest information I have on Nexavir too. I'd just keep calling Nexco for updates.
     

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