Invest in ME Conference 12: First Class in Every Way
OverTheHills wraps up our series of articles on this year's 12th Invest in ME International Conference (IIMEC12) in London with some reflections on her experience as a patient attending the conference for the first time.
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Will positive results from Norwegian/UK Rituximab trials be enough for insurance to pay in the U.S.?

Discussion in 'Rituximab: News and Research' started by leokitten, May 2, 2015.

  1. leokitten

    leokitten Senior Member

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    When the Norwegian and UK Rituximab trials start publishing results in 2-3 years time and if these results are as positive as their previous studies will this be enough to force insurance companies here in the U.S. to pay for the intervention?

    Also i don't know if anyone has thought of this but a year's worth of Rituximab is cheaper than a year's worth of Valcyte. And most people have had no trouble getting insurance companies to pay for Valcyte (including myself, in fact the insurance company didn't consider it at all special a required no approval at all).

    If you look at GoodRx.com a month's worth of Valcyte @ 3 x 450mg / day ~ $4000 / month ~ $48,000 / year! That's more than a year's worth of Rituximab @ 6 infusions / year so I don't get why insurance won't cover it off-label if your physician prescribes it today?
     
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  2. Denise

    Denise Senior Member

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    Some (less than well though out) thoughts.

    I believe that the Valcyte patent expired this year, so that will likely have an impact on price as generics have been approved.
    Treatment coverage is more likely if for instance there are high-viral titers that indicate that an anti-viral would be effective. So an insurance company would look at lab results showing high titers and agree (one hopes) that an anti-viral is indicated.
    (Also remember that for the most part insurance companies pay much less than "list price", just as they pay much less than 'list price" for healthcare professional's fees.)

    For Rituximab, the European patent expired in 2013. In the US it does not expire until 2018. IF the Norwegian studies corroborate the previous results (or come close) it is possible the manufacturer (Roche) might push for a patent extension and for approval for a different indication (other than the ones it is currently used for). But that's a big if. Roche would have to have a pretty good idea of how many additional people in this country would benefit from Rituximab and how much the company would benefit from having them use the drug.
     
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  3. leokitten

    leokitten Senior Member

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    Good points @Denise. Though the prices I mentioned above for Valcyte are the generic prices which currently are much the same as the brand name price. This is likely due to the fact that there is currently only one generic manufacturer and they are given 6 months exclusivity by the FDA. It will likely come down some when more generics come to play.
     
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  4. minkeygirl

    minkeygirl But I Look So Good.

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    @leokitten valcyte is available for about $6 a pill if you know where to look.
     
  5. WillowJ

    WillowJ คภภเє ɠรค๓թєl

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    I guess to "force" them it would need FDA approval for the given condition.

    Your doctor can always make a special appeal based on your specifics.

    Even if approved, the insurance company might try to substitute an "equivalent" medication. But your doc can argue with them, if the doc really feels it's necessary.

    Atena, for instance has about 2 dozen specified conditons that Rituxan may be used for, and a longer list of conditions it cannot be used for (including Lupus, "Arthritis assocaited with inflammmatory bowel disease", and "Acute myeloid leukemia"... I have no idea of the use of rituxan in these, just pointing out that it's important conditions and even things where a reasonable person might normally consider extra leeway in drugs, like leukemia), and considers all similar "immune modulators" to be the same, and for use as an immune modulator such as in RA, will force the use of whichever one they can get a deal from the drug company with:

    http://www.aetna.com/cpb/medical/data/300_399/0314.html

    So I guess we could also need studies comparing to Humira, Remicade, Orencia, etc., to see which is better. Dr. Edwards had mentioned something specific that he thought might be better (and less costly), but I can't recall which. It might have actually been Remicade.

    I'd still rather have my doc deciding than some bureaucrat.

    Not that Atena is necessarily representative, but from what I hear, it shouldn't get too much worse than that.

    Ok, just need labeling on one kind, if it's a costly one. Would need a comparison study if the costly one were actually better for some reason and two or more were approved. Which is 'more costly' might differ a bit by insurance company for some brands.
     
    Last edited: May 3, 2015
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  6. Snow Leopard

    Snow Leopard Hibernating

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    None of those drugs would be indicated for ME/CFS due to lack of evidence of involvement of what they target (Humira, Remicade and some of the other cytokine targeting MABs), though Abatacept could be interesting.

    The only comparable drugs are other CD20 targeting MABs, but biosimilar products have to undergo their own set of safety and efficacy trials before being approved. It is quite possible for these biosimilars to be much more dangerous or have much poorer efficacy.

    FDA approval is the first step, but that doesn't guarantee insurance companies agreeing to pay for the drug. In my opinion, it is going to be a shitstorm if these Rituximab trials are successful. Without biomarkers, there is uncertainty as to whom the drugs will benefit, and this will be used by some insurance companies (and govt schemes too, like the PBS) to drag their heels as much as possible.

    Of course if someone finds a specific autoantibody and demonstrates how it causes the symptoms and immune system loop with further experiments, then the would be no question about approval.
     
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  7. leokitten

    leokitten Senior Member

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    If FDA approval of Rituximab specifically for ME/CFS is required then we are all screwed, because that means any hope of treatment with Rituximab is at least 10 years off.

    I hope you all know that the UK/Norwegian trials will not mean much at all for the FDA here in the U.S.. Roche will have to sponsor large Rituximab trials here in the U.S. going through phase I, II, III and it will take eons, at least 10 years I would say and this is not a good option.

    For insurance to pay you don't need FDA approval specifically for that indication, in fact doctors prescribe so many drugs off-label that insurance pays for without question. For example Valcyte is only indicated and proven to work for CMV infection, yet insurance gladly pays for people with evidence of only EBV or HHV-6 infection.

    And there are many other classes of drugs that only small research studies have shown are effective but there haven't really been any clinical trials and insurance pays for off-label use because they work for similar conditions.

    If there is as some of you say definitive proof of autoimmunity in ME/CFS then I believe insurance will pay because Rituximab is already FDA approved for a variety of other autoimmune conditions.

    This will shorten the time and many of us need new treatments that give us remission so we can work and have a normal life without constantly managing our symptoms like a roller coaster and crashing.
     
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  8. leokitten

    leokitten Senior Member

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    I would never dare buy and put into my body non-FDA approved generic drugs from India. There have been countless news reports of the FDA banning factories there because of falsified results and safety worries. Many Indian generic drug companies cut corners. Just one of many results from Google search:

    http://mobile.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html
     
    Last edited: May 3, 2015
  9. Valentijn

    Valentijn Senior Member

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    The FDA is an American federal agency. I'm pretty sure that they don't have any jurisdiction over Indian factories.
     
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  10. leokitten

    leokitten Senior Member

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    The thing is here you are comparing apples and oranges. These other autoimmune conditions are also autoinflammatory for which there are known inflammatory targets which these therapies target and are preferred by the insurance companies as first line. Only if they don't work are you then possibly allowed to try B cell depletion.

    ME/CFS has not shown so far to be autoinflammatory at all, no one has been able to reliably find any markers of inflammation like you see with these other conditions. In fact some of these targeted therapies, such as TNF-alpha inhibitors, make ME/CFS patients worse.

    This is why I believe anti-CD20 therapy if autoimmunity is found will be first line.
     
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  11. leokitten

    leokitten Senior Member

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    They can ban drugs which they have done from many major Indian generics plants. And for everyone's information they have banned drugs from plants of the same generics manufacturer that produces this Indian Valcyte.

    I wouldn't put those pills into my body, that's my opinion. I would only trust a generics manufacturer and plant that the FDA periodically inspects and approves.
     
  12. Snow Leopard

    Snow Leopard Hibernating

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    That sequence of trials is about ethically moving from smaller to larger trials while establishing a safety profile. Those trials have been done anyway.

    All that is needed for approval is good evidence of efficacy, demonstrated in phase 3 trials, which assuming the ongoing UK/Norwegian trials have similar strong results, then a case could be made just using a meta-analysis of the 3 studies. Otherwise, just one additional study would make or break the case for the drug.


    Rituxan for RA was approved in 2006ish (FDA) on the strength of the following phase 3 trials.
    (http://www.roche.com/media/store/releases/med-cor-2006-03-01.htm) (admittedly not as a first line treatment)

    http://www.ncbi.nlm.nih.gov/pubmed/16947627
    http://www.nejm.org/doi/full/10.1056/NEJMoa032534#t=articleDiscussion

    Subsequent trials also demonstrated efficacy, but were not relied on in the aforementioned decision.
     
  13. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    It looks like cipla is regarded highly by the fda.
    alldaychemist sell cipla valgan/valcyte for $6 a pill. So its cheap and a proved by fda?

    I think there is a lot of scare mungering with buying overseas meds but has more to do with keeping a monopoly of the market than anything else .
     
  14. leokitten

    leokitten Senior Member

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    No, Cipla absolutely does not have FDA approval to sell their Valgan generic Valcyte and their plant which makes this drug has not been routinely inspected by the FDA, they've only been approved by Indian authories.

    No it's not fear mongering whatsoever, in fact the FDA had first given the go ahead for Ranbaxy (another Indian generics company) to be the first generic Valcyte for US market a couple years ago but Ranbaxy royally screwed things up so badly with quality and manufacturing problems.

    So the FDA took back Ranbaxy's license and gave it to Qualitest/Endo International, another overseas company from Ireland. They have their act together and successfully launched their product late last year, their Valcyte plant is in Canada. They are the FDA approved generic Valcyte which I take and trust because their process is routinely checked by FDA and Canadian government authorities. CVS converted me from brand name to generic in December (see attached photo).

    image.jpg

    This is not fear mongering at all, I've been to India and sorry based on the facts that so many of their generics companies are routinely failing western approvals and quality checks I would not trust their authorities to have the same rigor as the European, Canadian and American authorities.

    And it's not an attempt to keep a monopoly, after 6 months Qualitest/Endo will not have exclusivity and then ANY manufacturer can get into the game IF they can make a quality drug that passes inspections etc by the FDA.
     
    Last edited: May 3, 2015
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  15. leokitten

    leokitten Senior Member

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    I hope you are right but honestly I do not think the Norwegian phase III trial is big enough for FDA approval given the current state of knowledge about ME/CFS, that's why you can't compare it to RA. 152 patients (76 each arm) is not going to be big enough for the FDA especially since we don't have a lot of evidence that ME/CFS is an autoimmune disease other than this hopefully "circumstantial" evidence that Rituximab works.
     
  16. Gingergrrl

    Gingergrrl Senior Member

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    Qualitest is one of the worst companies out there with constant product and safety recalls on everything from birth control pills to painkillers to syringes.

    The FDA is completely biased and has given approval to meds that are neurotoxic like Fluoroquinolone antibiotics. FDA approval carries little weight or meaning IMO.

    But this is separate from the Rituxan issue and I am not yet convinced that Rituxan will be helpful for most with ME/CFS.
     
  17. SaraEngland

    SaraEngland

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    I am sure that you won't need to do phase 1, 2 and 3 in the U.S. I am not sure if the FDA got what they need when the study is published. I do however know that Haukeland University Hospital is prepared to have FDA and Norwegian Medicines Agency scrutinize their work.
    If I am not mistaken they are looking into why some responds to RTX and why some don't. I think they are looking into CD27+. Hopefully we'll know more about why some respond and why some don't when the final study is published late 2017.
     
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  18. alex3619

    alex3619 Senior Member

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    Other countries have organizations that play a role similar to the FDA. In Australia this is the Therapeutic Goods Administration. It not only requires proof of efficacy, but typically demands proof of cost effectriveness. However this might work for us so long as there is only one effective therapy.
     
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  19. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Im sure money is very important in getting approval , not just safety.

    generic valcyte has been available in india for awhile now, ignoring US patents. This has probably saved alot of lives in india as the high cost of valcyte would be way out of reach of many patients requiring this medication.

    so that to me is showing money is a higher motivator for many drug companies , above patient care. People are kidding themselves if they think money isnt a very high priority .

    Are fda concerns all about safety or the power of the $$ . Im sure there are many ways to manipulate approvals?
     
  20. Eeyore

    Eeyore Senior Member

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    I'm not at all convinced that name brand drugs are safer. All the companies outsource production to the cheapest possible labor source, often Indian or some 3rd world country where labor is cheap.

    I don't take (and have not taken) valcyte at all, but lots of my drugs from express scripts now come in as being made from qualitest - no idea who they are.

    Personally, i have yet to notice any difference between a generic and a name brand, but many people seem to - i suspect it's more common among MCS patients (which I'm not), as they are sensitive to dyes or other inert ingredients.

    I definitely wouldn't buy drugs through sketchy not-so-legal mail order pharmacies though - I have no idea what's in them. I do use generics, but these are all FDA regulated/approved. I know some people get desperate and go through those weird mail order places that will sell to anyone, but that seems to risky to me. Better to doctor shop than take that route.

    A lot of the time, the generics are actually made by the manufacturer, they sell both so they can get some of each market. I used to get generic neurontin that was made by pfizer - but was cheaper...
     
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