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

Posted by sal14 @sal14, Sep 17, 2024

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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Profile picture for jacjac @jacjac

@reyge99
Thank you sir, for this information.
My husband has had no problems with Prolia - it seems to be the one thing that has improved his situation. The problem now is, he has been on for so long, the endo wants him to give it a break and try another drug. Hence, trying for Evenity, which she (the endo) said insurance denied since wasn't approved for men. The ortho surgeon wanted the endo doc to ask for a "peer-to-peer" with insurance but she said no it would not be approved since FDA hasn't approved it for men. Our insurance is Medicare, with the supplement being UHC thru AARP (not an advantage plan or PPO). May I ask how you were able to be approved for Evenity? That is our goal as both doctor and pharmacist said it is the most targeted drug for his situation. After his hip revision, he was in hospital rehab, a wheel chair for months, walker, and now a cane. Any direction you can give is appreciated. We are fighting for his mobility and quality of life. Thank you.

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@jacjac

I am sorry to hear about your husband’s dilemma. I was told by my doctor’s clinic that my approval for Evenity may have been due to the fact that I had experienced an osteoporosis related spinal fracture, and I was high risk for another and needed significant bone rebuilding. It was submitted to my insurance and approved without question as far as I know. Possibly, you can relay this info to your Endocrinologist?
I hope this helps and best of luck to you and your husband.

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Profile picture for jacjac @jacjac

My 75 y/o husband had a hip revision this summer. The surgeon told us he has never seen such thin bones! He's been on various fosomax drugs over the many years but cannot take them. He's been on prolia injections for 12 years, and the endocrinologist told him he needs to get off for awhile so he took another drug called risdresnote (sp?). He suffered thru 9 months of pain taking it and said no more. He's now back on prolia. The doctors want him on Evenity, but he was told it hasn't been approved for men yet. This is quite the conundrum.

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@jacjac
evenity isn't FDA approved for men. There is off-label use, so your husband could get Evenity if he can find a agile physician. There is a study of starting Evenity three months after the Prolia injection, with a return to Prolia. Risedronate isn't considered strong enough to combat Prolia rebound, so a curious choice. And, probably, a save that your husband refused to tolerate side effects. I think I'd move to find an agreeable physician. Even though it is another curious choice since Evenity basically builds the same type of bone.
The most usual choice after Prolia is Reclast infusion. It is the strongest bisphosphonate and avoids some of the oral and digestive side effects. He could use Zometa infusions. It is the same drug as Reclast, but in smaller doses and usually given more frequently. Maybe a second opinion from a different endocrinologist.
I have read that Prolia concurrently with Forteo yields better bone than either alone. If the helpful surgeon would order Forteo you might have an answer. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.888208/full
The trouble with thin bone and revision surgery is the both the weakness in that bone and the failure of hardware to integrate with bone. Forteo is the one medication known to increase that integration and to increase the fixation strength of the screws.

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Profile picture for jacjac @jacjac

My 75 y/o husband had a hip revision this summer. The surgeon told us he has never seen such thin bones! He's been on various fosomax drugs over the many years but cannot take them. He's been on prolia injections for 12 years, and the endocrinologist told him he needs to get off for awhile so he took another drug called risdresnote (sp?). He suffered thru 9 months of pain taking it and said no more. He's now back on prolia. The doctors want him on Evenity, but he was told it hasn't been approved for men yet. This is quite the conundrum.

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@jacjac the physician who orders the medication for your husband will need to perform a prior authorization request. They fill out the extenuating circumstances and submit it electronically. That should solve the concern I’m also male 73 on Alendronate for osteoporosis. Never had any issues.

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Profile picture for jenatsky @jenatsky

@jacjac the physician who orders the medication for your husband will need to perform a prior authorization request. They fill out the extenuating circumstances and submit it electronically. That should solve the concern I’m also male 73 on Alendronate for osteoporosis. Never had any issues.

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@jenatsky
Thank you for the reply.
Husband was on Fosomax but had terrible reactions - severe muscle pain, spasms, fatigue, etc. - and had to go off.
I think we need to find an endo that has more fight in her and is willing to go to the insurance company with his history. We do have an appt with a rhuematologist/osteo doctor in several weeks for a second opinion.

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Profile picture for gently @gently

@jacjac
evenity isn't FDA approved for men. There is off-label use, so your husband could get Evenity if he can find a agile physician. There is a study of starting Evenity three months after the Prolia injection, with a return to Prolia. Risedronate isn't considered strong enough to combat Prolia rebound, so a curious choice. And, probably, a save that your husband refused to tolerate side effects. I think I'd move to find an agreeable physician. Even though it is another curious choice since Evenity basically builds the same type of bone.
The most usual choice after Prolia is Reclast infusion. It is the strongest bisphosphonate and avoids some of the oral and digestive side effects. He could use Zometa infusions. It is the same drug as Reclast, but in smaller doses and usually given more frequently. Maybe a second opinion from a different endocrinologist.
I have read that Prolia concurrently with Forteo yields better bone than either alone. If the helpful surgeon would order Forteo you might have an answer. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.888208/full
The trouble with thin bone and revision surgery is the both the weakness in that bone and the failure of hardware to integrate with bone. Forteo is the one medication known to increase that integration and to increase the fixation strength of the screws.

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@gently
You have a great understanding of his/this problem.
I appreciate your reply. I will be doing further research on this, thanks to the info you have given here. Much appreciate.

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Profile picture for jacjac @jacjac

@ditobin
I wish I knew how he was approved. We too are in USA. My husband was denied by insurance a month ago and told it has not been FDA approved for men.

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@jacjac

Did the Dr. who recommended the Evenity write to the insurer ? Like a prior authorization or something? I’m sure there must be some studies that exist out there that support this drug for males…I’ve worked in healthcare finance my entire working life. If I were you guys, I would get on the phone with Dr. , Insurance, etc & see how to remediate. Just a shot & it couldn’t hurt.

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I would hope that Amgen could provide the support necessary to get approval.

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Profile picture for njhornung @normahorn

I would hope that Amgen could provide the support necessary to get approval.

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@normahorn
Sorry, what is Amgen?

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Profile picture for ditobin @ditobin

@jacjac

Did the Dr. who recommended the Evenity write to the insurer ? Like a prior authorization or something? I’m sure there must be some studies that exist out there that support this drug for males…I’ve worked in healthcare finance my entire working life. If I were you guys, I would get on the phone with Dr. , Insurance, etc & see how to remediate. Just a shot & it couldn’t hurt.

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@ditobin
Hi,
No she has not - said it wasn't approved for men and that insurance would not approve it! Thank you for your advice - I hope to do just that.

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Profile picture for jacjac @jacjac

@normahorn
Sorry, what is Amgen?

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@jacjac
The pharmaceutical company that makes Evenity.

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