Is there anyone who has been able to get Evenity approved for a man?

Posted by sal14 @sal14, Sep 17 11:38am

So far, Evenity has yet to be approved for my husband. I know the FDA has not approved it for men, but we want to know if anyone has succeeded in getting approval despite the FDA or for exceptional circumstances.
My husband had a prostatectomy 11 years ago and has been on Prolia for ten years. His endocrinologist has suggested Evenity for a treatment plan to ween him off Prolia and try to build bone. He had 36 radiation treatments, which caused severe and constant back pain and some immobility. The goal is to make his bones strong enough to withstand back surgery.
Thank you in advance for your suggestions and advice.

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I'm a guy and had Forteo approved. I finished 24 months last September. My bone density improved about 13 percent (7% the first year, 6% the second year).

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I had Evenity approved for myself. My doctor had made the argument that I had hypercalciuria and that is contraindicated for Forteo or Tymlos. He also send in the clinical trial study of Evenity for males to help show the effectiveness. As an added bonus, I was able to get Amgen to help pay for my annual deductible as well. They have a very flexible program. I have private insurance so not sure about pushing it through Medicare.

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Hi Sal14
I'm a guy. I got Evenity covered. I have traditional medicare and medicare supplemental, they covered after the fact. I also got it covered thru Amgen Safety Net. All of that seemed unlikely for a long time. It took 5 months. My case was complicated due to the insurance person at the doctor's office going on sick leave just after they started trying to get approval for it.
After many frustrations and few replies from the doctors office I tried switching doctors. They agreed to try to get me Evenity but had their doubts about success. Eventually I realized their insurance person was reluctant to fight for it. By this time I had submitted the forms and whatever to apply for help with Amgen Safety Net.
Finally they hired a new insurance person at my original doctors office. So, I went back to the original docs office. The new insurance person was a go getter. She had multiple phone calls to Medicare and said she got both yes's and no's depending on which rep she talked to.
Then Safety Net came thru and I started Evenity. Then the doctors office submitted to Medicare and Medicare paid.

Here's how I think it works at Medicare. Medicare will give pre-approval (in writing I think) for some drugs for some conditions like say cancer drugs. I think they do not do an official pre-approval for osteoporosis drugs. They may say yes or no on the phone but that seems to not be a guarantee like you could get for drugs for some other conditions. So I had a definite yes from Amgen Safety Net and the doctor started giving me the drug. Then they submitted to medicare after the first treatment and lo and behold Medicare did cover it and of course that meant the supplemental would and did cover it also.
This is my best understanding of what happened for me. It may not all be correct as I couldn't see behind the scenes at the two doctor's offices and I never found a definitive source on Medicare and osteoporosis drugs. If someone knows more about how this works I'd love to hear about it.

On I had a bad T-Score with a worst of -4.1 in the spine. I had no prior fragility fractures. I'm not sure what else the doctor's office would have put on my Medicare requests.
Evenity has worked great for me. At 10 months I had a 30% improvement in my spine and a small improvement in my hips. I couldn't believe the spine density increase!
Hope this helps and good luck to you and your husband.

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My husband has stage 4 advanced aggressive prostate cancer--in remission right now. He had 2myears of ADT and Zytiga + prednisone and 40 Proton Therapy treatments. ALL cause bone loss. tried to get him approved 2 years ago and no luck. He lost bone mass while on Boniva for 18 months. He's lost slightly more on Prolia after 18 months. Evenity is what he needs so I'm going to try again. Hoping Medicare will approve this time after 2 drug failures. DON'T KNOW WHY THIS ISN'T APPROVED FOR CERTAIN MEN.

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@awfultruth

Hi Sal14
I'm a guy. I got Evenity covered. I have traditional medicare and medicare supplemental, they covered after the fact. I also got it covered thru Amgen Safety Net. All of that seemed unlikely for a long time. It took 5 months. My case was complicated due to the insurance person at the doctor's office going on sick leave just after they started trying to get approval for it.
After many frustrations and few replies from the doctors office I tried switching doctors. They agreed to try to get me Evenity but had their doubts about success. Eventually I realized their insurance person was reluctant to fight for it. By this time I had submitted the forms and whatever to apply for help with Amgen Safety Net.
Finally they hired a new insurance person at my original doctors office. So, I went back to the original docs office. The new insurance person was a go getter. She had multiple phone calls to Medicare and said she got both yes's and no's depending on which rep she talked to.
Then Safety Net came thru and I started Evenity. Then the doctors office submitted to Medicare and Medicare paid.

Here's how I think it works at Medicare. Medicare will give pre-approval (in writing I think) for some drugs for some conditions like say cancer drugs. I think they do not do an official pre-approval for osteoporosis drugs. They may say yes or no on the phone but that seems to not be a guarantee like you could get for drugs for some other conditions. So I had a definite yes from Amgen Safety Net and the doctor started giving me the drug. Then they submitted to medicare after the first treatment and lo and behold Medicare did cover it and of course that meant the supplemental would and did cover it also.
This is my best understanding of what happened for me. It may not all be correct as I couldn't see behind the scenes at the two doctor's offices and I never found a definitive source on Medicare and osteoporosis drugs. If someone knows more about how this works I'd love to hear about it.

On I had a bad T-Score with a worst of -4.1 in the spine. I had no prior fragility fractures. I'm not sure what else the doctor's office would have put on my Medicare requests.
Evenity has worked great for me. At 10 months I had a 30% improvement in my spine and a small improvement in my hips. I couldn't believe the spine density increase!
Hope this helps and good luck to you and your husband.

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I'm a guy. Dx severe OP 2016. Been on forteo 2 years had some increases. Then 13 months different bisphosphates, had to stop, GI issues. Did nothing for 1 yr. Lost all gains. Now been on Tymlos will b2 18 months, next dxa 12/24. Dr said no more Tymlos no matter what dxa says. He said next Prolia, which i refused back in 2016. This is the 1st I'm hearing men getting Evenity, even discussed with Dr. He said can't get approved for men. I also have systemic CV issues and atherosclerosis, which could be a problem. As well as severe high risk inoperable back problems for 8 yrs.I didn't know medicare would approve it for men. I even at one point asked about a Boniva IV push, all he said, it's not done anymore.

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@garycorb Sorry about the rough road you've had with osteoporosis and the meds.
You are in a complicated situation. You have to weigh many factors to decide what is best and then you have your insurance and costs to factor in.
I can just say that I'm not the only guy getting Medicare to cover Evenity. And I had no prior fragility fractures. No spinal or hip fractures - just bad DXAs. It was complicated though and I do not think that Medicare will give you a definite pre approval for osteoporosis drugs. For some drugs they will give pre approvals. In my case I got it covered by Amgen Safety Net and then the docs office submitted it to Medicare after giving me the first shots and lo and behold they covered it.
As to your CV concerns that's where you have to weigh the risks of one thing vs another. In my case it was easier because I seem to be doing ok CV wise. I would not rule out Evenity due to CV concerns. Certainly carefully consider the pros and cons but don't rule it out without considering all the angles. Personally I find Prolia much more scary. In fact other than the possible very slightly elevated risk of CV events I do not find Evenity scary at all. Of course I was nervous at first.
Wishing you all the best on your decisions

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I'm tired of all this! I have been to countless non-caring, useless doctors. I'm in Florida, the worst medical care in the USA. Wanted to move, but can't physically do it. Thanks for the reply.

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@awfultruth

@garycorb Sorry about the rough road you've had with osteoporosis and the meds.
You are in a complicated situation. You have to weigh many factors to decide what is best and then you have your insurance and costs to factor in.
I can just say that I'm not the only guy getting Medicare to cover Evenity. And I had no prior fragility fractures. No spinal or hip fractures - just bad DXAs. It was complicated though and I do not think that Medicare will give you a definite pre approval for osteoporosis drugs. For some drugs they will give pre approvals. In my case I got it covered by Amgen Safety Net and then the docs office submitted it to Medicare after giving me the first shots and lo and behold they covered it.
As to your CV concerns that's where you have to weigh the risks of one thing vs another. In my case it was easier because I seem to be doing ok CV wise. I would not rule out Evenity due to CV concerns. Certainly carefully consider the pros and cons but don't rule it out without considering all the angles. Personally I find Prolia much more scary. In fact other than the possible very slightly elevated risk of CV events I do not find Evenity scary at all. Of course I was nervous at first.
Wishing you all the best on your decisions

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what is the CV blood test someone was talking about prior to taking Evenity? I forget who mentioned it?

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@michaellavacot

I had Evenity approved for myself. My doctor had made the argument that I had hypercalciuria and that is contraindicated for Forteo or Tymlos. He also send in the clinical trial study of Evenity for males to help show the effectiveness. As an added bonus, I was able to get Amgen to help pay for my annual deductible as well. They have a very flexible program. I have private insurance so not sure about pushing it through Medicare.

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What was the CV blood test you mentioned prior to taking Evenity, as I have CV issues and out of options after my tymlos. I also tried to connect with you on Linkedin and sent a friend request. Thank you

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@garycorb

I'm tired of all this! I have been to countless non-caring, useless doctors. I'm in Florida, the worst medical care in the USA. Wanted to move, but can't physically do it. Thanks for the reply.

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hey, Gary. I wonder if you doctor doesn't know that the black box has been lifted from Tymlos.
You might ask about low dose Reclast. You might be able to get 3mg instead of 5mg which would be closer to the Boniva which is also 3mg. I would want the lower dose to determine the extent of any side effects.
I hope you refuse Prolia, again. I wouldn't want Evenity especially with athersclerosis. The impact of Evenity on cardiac events won't be completely evidenced for years.
Best wishes

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