Need Info/Support for U.S. Appeal

Please help me with facts for making an appeal to have the U.S. Medicare system (for older citizens) cover the costs of methylcobalamin for self-injections. I was blessed with a diagnosing physician who put me on 2 x week injections for life, but it was for transcobalamin. With methylcobalamin injections since last year, I have had more occasions of energy (walk for exercise most days!) and fewer periods of lying in the deep trough of fatigue. I also have less trouble with residual brain effects. Before, I was always deeply fatigued and sometimes struggled to communicate effectively. But I pay all costs to a compounding pharmacy.

There are two parts to such an appeal. First, frequency, which is once per month in the U.S., based on 1994 British Society of Haematology Guidelines. I hope to use information from PAS on this issue and welcome any specific recommendations from others . Second, approval as a safe and effective drug, meaning the Federal Drug Administration must cover it. Failure is highly probable for this part, but I can learn what might be a next step. For this part, I need information about transcobalamin vs. methl or hydrox. I understand that hydroxocobalamin is used in the UK because methycobalamin somehow is not available. But why is transcobalamin not used there when it is the only covered usage in the U.S.? Why is methycobalamin not manufactured in the UK?

It may be that I should contact people in the Pernicious Anemia Society, but I want first to hear from other patients. If you post a response, please say if you are in the UK or the US. I will appreciate what you say.

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  • When you say transcobalamin do you mean cyanocobalamin? Cyanocobalamin is the form that is most frequently used in the US.

    You might find this link useful: ecfr.gov/cgi-bin/text-idx?S...

    It is the FDA's regulation on the treatment of pernicious anemia and it states that injections of cyanocobalamin are safe and effective but only available by prescription. It doesn't list any other forms of B12 (because it hasn't been substantially updated since the 1960's). These regulations also point out that oral supplements are not effective in all cases and that neurological damage can be permanent if not promptly and adequately treated.

    I will be very curious to hear how your appeals goes. I don't have Medicare. My health insurance will only cover items made in a very select few compounding pharmacies and none of the pharmacies on their list make methycobalamin, so I'm in a similar boat where I have to pay for it out of pocket.

    You might be able to find more info on this site: fda.gov/default.htm

    Sometimes you can find references to applications filed with the FDA for a company to distribute a particular substance. In this case I think you'd be looking for proof that the FDA approved the production and sale of methylcobalamin. Documents that show the government agrees that the product is safe would probably be helpful in your appeal.

  • Thank you so much Galixie. Of course it's cyanocobalamin. Put it down to nominal aphasia; my brain is always offering something that is near to what I mean but not quite right. Missed that one when I proofed the post. I want to put together enough evidence that Medicare won't reject this by simply referring to their standards that list only cyanocbl. I want documentation that methylcbl is an approved form, which it must be if our doctors prescribe it. You are right that the core issue is availability, via fda approval of pharm production. I have not looked for applications, that could be a very helpful route. I don't expect anything happening fast but will let you know anything I learn.

  • Is this another instance where ndodge can be of help and assistance please?

  • Clivealive, did you mean my bit of nominal aphasia in using transcobalamin rather than cyanocobalamin? If I am challenged about neurological damage from pa, I have another example. Thank you for paying attention and responding.

  • No my suggestion was simply alerting another member of this community who lives in the U.S. and will know more about "Medicare" than I do.

    I don't know whether a B12 deficiency/P.A. is known to cause inability (or impaired ability) to understand or produce speech, as a result of brain damage and I've never heard of transcobalamin being used when cyanocobalamin is the usual treatment in America.

    I'm sorry I cannot be of any help to you

  • Nominal aphasia, inability to retrieve names of words, is common with pa. My brain substituted transcobalamin for cyanocobalamin. It's ok.

  • Thanks for the vote of confidence, clivealive, but in this case, I can't be of much help. 😔

    I'm on Medicare myself but my medicare GP is not the one that prescribes the methyl that I obtain at a compounding pharmacy.

    My Naturopathy physician prescribes the methyl but Naturopaths are not recognized by medicare! At least not yet....

    Hope you are doing great, Clive! 🌞

    And good luck, bqouss, if you are successful 👍and I hope you will be, could you please post again to let us know? Thanks!

  • It may be a while (bureacracy), but I will post the outcome.

  • hi,

    I'm in the UK. Are you a member of the PAS (Pernicious Anaemia Society)?

    There are two local PAS groups in USA. I thought perhaps if you live close enough to one of them there may be someone who can help?

    pernicious-anaemia-society....

  • Thank you! Yes, I am a member of the PAS. I need to find out how to contact folks in those local US groups via email.

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