Can darolutamide be prescribed to metastatic, castrate-resistant PC

[Eddy-Merckx]

Has anyone been prescribed darolutamide (NUBEQA) once you had metastatic, castrate-resistant PC? My oncologist at Dana-Farber wants to prescribe darolutamide to me but the insurance company has denied it because they are claiming it is not for metastatic PC. I noticed that the FDA approved darolutamide for metastatic, hormone-sensitive cancer (but I am not hormone-sensitive).

[Tall_Allen]

It can be prescribed off-label, but the challenge is getting your insurance company to pay for it. Sometimes the oncologist can build a case for appeal if you have had seizures, or excessive sleepiness on other drugs.

[Eddy-Merckx in reply to Tall_Allen]

Thanks, Tall. My oncologist wants to replace my abiraterone with darolutamide. Do you think darolutamide will be effective in this case? The other option is to go directly to chemo (cabazitaxel and carboplatin) until I can get lutetium in November (Dana-Farber is scheduling two months out for lutetium).

[Tall_Allen in reply to Eddy-Merckx]

Maybe discuss with him the CARD trial - it showed that Jevtana is better than enzalutamide as a next option after docetaxel and abiraterone:

prostatecancer.news/2019/12...

[Eddy-Merckx in reply to Tall_Allen]

Thanks!

[cesces in reply to Tall_Allen]

Dumb question:

"antiandrogen medication which is used in the treatment of non-metastatic castration-resistant prostate cancer in men."

Why are they using an "antiandrogen" for "castration-resistant prostate cancer"

Once the cancer becomes "castration-resistant" isn't it time to move on to something other than an "antiandrogen"?

[EdBacon in reply to cesces]

"Castrate Resistant" means the cancer is resistant at castrate levels of Testosterone. It does not mean the cancer is not still hormone sensitive, the cancer is just able to use less hormones to survive.

So the second-line AR drugs are there to further suppress the hormones, usually by blocking access to the receptors. Eventually, even that doesn't work. Then it's chemo or LU-177.

[Tall_Allen in reply to cesces]

One of the ways castration-resistance sets in is that the androgen receptors (ARs) make many more copies of itself on each cancer cell. Because of this, even the slightest amount of androgen activates it. That's why one doesn't move on from androgen suppression.

Another mode of resistance is the AR evolves to be activated by weak antiandrogens like Casodex. Then, much stronger anti-androgens are needed to block the AR. Eventually, the AR evolves to work around them too.

[Rilu in reply to Tall_Allen]

Hello Tall! Is there any publication that can support the substitution of xtandi for darolutamide in cases of seizures or headaches? our oncologist does not accept any suggestion that is not supported and I want to propose it for my husband 😅🙏. He is metastasic catration resistent

[Tall_Allen in reply to Rilu]

Darolutamide hasn't completed testing for metastatic castration resistant PC, so there are no such data.

[tango65]

Once the cancer has metastases detected by CT scan or bone scan the cancer is considered metastatic forever.

Darolutamide is approved for non metastatic Castration resistant cancer:

accessdata.fda.gov/drugsatf...

The insurance will check if these 2 studies detected metastases at any time and even when you may not have any mets seen in a bone scan or CT scan right now, your cancer will be considered metastatic.

After abiraterone fails is better to continue with chemo or Lu 177 PSMA. Lu 177 PSMA is as effective or better than cabazitaxel according to the TheraP trial.

pubmed.ncbi.nlm.nih.gov/335...

To have Lu 177 PSMA treatment in the USA one needs to have had chemo. One possibility is having the treatment abroad if possible or applying to a clinical trial:

clinicaltrials.gov/ct2/resu...

[wagscure259 in reply to tango65]

While what you say is definitely true regarding being metastatic forever, I was prescribed darolutamide after I met the requirement ( set up by Bayer- the developer of darolutamide in the ARAMIS trial?) no Mets on bone and CT scans. Medicare part D approved it. I was metastatic at diagnosis over 91/2 years ago. Whether or not private insurance does a long look back in this matter I don’t know. I know at MSK it has been prescribed for metastatic patients according to my MO. Tango65 I want you to know how much I appreciate and highly respect how much information you provide on this forum and how I throughly read your responses!

[tango65 in reply to wagscure259]

Thank you, Large cancer center have an office dedicated to get insurance approval. I do not know what happened in your situation.

I was diagnosed metastatic in 2016 with a PSMA PET/C, bone scan and Ct scan were normal.I needed darolutamide in 2020. Insurance denied payment even when a PSMA PET/CT was negative. Cancer center office argued I never had a diagnosis of metastatic cancer by CT or bone scans and the insurnce approved daro,

[TwilightZone]

Just prescribed NUBEQA, on 7/29/22 started taking 600mg twice per day. I'm nearly 72 y/o, on Medicare, and have nonmetastatic castration resistant prostate cancer. Was prescribed it because PSA increased to 1.17 (after 3 1/2 years Eligard injections). From what I've read, the medication is approved for nonmetastatic cases.

[Spyder54 in reply to TwilightZone]

question TwilightZone: I pay approx $220 p/mo for Abiraterone/Zytiga. What is the monthly on Darolutamide/Nubeqa? Thanks, Mike

[Teacherdude72 in reply to Spyder54]

My medicare plan pays all but $560. NY state pick up all but $20. There are funds that help pay for expensive drugs.

[Teacherdude72 in reply to Teacherdude72]

Duh, forgot to say The Assistance Fund, TAF is one of them.

[TwilightZone in reply to Spyder54]

Currently paying nothing. Medicare Part D (plus a grant) covers entire expense for now. Eventually I'll be paying about $700 per month.

[Teacherdude72 in reply to TwilightZone]

I also take Nubeqa. Started June of 21, now 74 and psa undetectable.

[cesces]

it's just been approved for metastatic cancer:

nubeqahcp.com/

[cesces]

Why is nubeqa superior to xtandi, erleada and similar?

Goodrx list of nubeqa alternatives and prices

goodrx.com/classes/androgen...

flutamide

as low as

$48

Drug Class: Androgen Receptor Inhibitors

FLUTAMIDE blocks the effect of the male hormone called testosterone. It is used in combination with another medication to treat prostate cancer.

Read more

More Info

See Prices

Nilandron (nilutamide)

as low as

$1,839

Drug Class: Androgen Receptor Inhibitors

NILUTAMIDE blocks the effect of the male hormone called testosterone. It is used with surgery to treat prostate cancer.

[Joeym1040]

I am metastatic and hormone resistant (diagnosed in Nov 2021) and put on daralutamide in Jan of 2022. I am covered by medicare, but i believe my MO probably pulled some string to make it happen, but not positive. Good luck. Joe

[joeguy]

I am metastatic and castrate resistant and I have been on nubeqa for over a year. I think I was able to get it because I had some pretty bad side effects from Xtandi, and my doctor made a strong argument for Nubeqa with Orgovyx. It may also be because all of my known mets at the time were in pelvic lymph nodes. It wasnt until I had a PSMA scan about 1 1/2 yr ago that lymph nodes were detected in the para aortic area that would count as metastatic. It worked well for over a year, but is now sadly failing..... moving on to LU177

[Tall_Allen]

You will have to ask them.

[BruceSF]

Actually, the cancer cells that randomly mutate to a form that makes more AR copies survive longer and reproduce more than those which don't, and they eventually become the dominant strain.