Prolia even in patients with normal bone density

Kath1228

I just spoke with my oncologist about my DEXA scan results which showed that I have mild oteopenia in my left hip. The spine is in normal range. I am 52, post-menopausal and have been taking Femara for about 18 months. My baseline two years ago when I was pre-menopausal and prior to taking hormonal therapy was normal.

My doctor says that in her office at a major cancer hospital in NYC , they are giving Prolia injections to post-menopausal patients with early stage hormone receptor positive, Node negative disease - even though they are not showing any signs of osteopenia or osteoporosis. The reason is because of the results of a study that was published in December at ASCO which discussed results of a trial that showed a 4% reduction in recurrence/metastasis in the bone over 8 years in women who got the Prolia injection.

That seems significant to me. So I am considering getting the injections. Is anyone out there in a similar situation receiving the Prolia injections? I would like to hear what your experiences/side effects have been while on it. I already have bad bone and joint pain to deal with everyday from the Femara

Thanks so much!

Katzpjays

Kath,

My DexaScan came back as osteopenia, but my MO recommended Prolia because of the same study you cited. The potential side effect sheet is daunting, but I spoke to an RN at the lab who has been practicing for decades and asked her about her experience giving the injection. She is adamant about people reading and understanding the potential side effects, but has never seen a post administration reaction (anaphylaxis). I went with the MO's recommendation and had the injection. They do blood work pre-injection. The injection is sub-cu and I was given the option of having it in the arm or in the stomach. On the nurses recommendation I had her give it to me in the stomach. Very slight stinging as the liquid was going in and that was it. No real nerve ending in the stomach...frankly, given the option I would have all future sub-cu injections in the stomach. I have had zero side effects. Had to return for blood work one week later as follow up. Came back normal. Will repeat in 6 months..

Kath1228

Sue,

Thank you for your reply. Glad to hear that your oncologist was also aware of study and felt that Prolia would be appropriate for you based on that. Also very glad to hear you are having no adverse effects from it.

How often do you have to go for blood monitoring for the Prolia? Is it just one week after every injection or at more frequent intervals between injections?

Be well!

Katzpjays

Kathi - the blood test is just once before injection and once one week after. No other blood work until the next injection

muska

I am in a similar situation and currently waiting to get insurance approval for Prolia. Have been on anastrozole for over two years, the last dexa showed progression of osteopenia in the spine (hips are fine.) Based on the study you mentioned my MO recommends I get Prolia.

Kath1228

Glad to hear that others are doing Prolia based on this study.Thank you for your replies!

Kath1228

kayb,

If you type in "Prolia" in the search field at the top of the page at the main site here it should be the first article that pops up. I believe it is dated December 10, 2015

BarredOwl

Hi kayb:

cp418 just linked to the Prolia study summaries in another thread. She has used a search filter to extract them--very nice work:

BC.org summaries: http://www.breastcancer.org/research-news/bone-health?tag_ids=220

I have these recent publications from the ABCSG-18 study bookmarked:

Gnant (2015): ABCSG-18 study: http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)60995-3.pdf

Gnant Abstract (2016): ABCSG-18 study: http://cancerres.aacrjournals.org/content/76/4_Supplement/S2-02.abstract

BarredOwl

Kath1228

I also want to clarify something in my first post. I mentioned node negative (out of habit) - but that has nothing to do with this study. Just early stage, hormone receptor positive, post menopausal women taking AIs....

Kathy044

Kath1228 I believe I read somewhere that something like 52% of the women in each arm of the study were node positive but that should not influence the findings, but might influence the absolute numbers of recurrences within 4 years if those were the numbers that looked scary.

(see the The Lancet Oncology (1 Aug 2015 ) for more detail s about the ABCSG-18 study, I believe Barred Owl has posted a link)

ChiSandy

I keep lobbying my MO for Prolia--my pre-letrozole DEXA showed osteopenia (verging on osteoporosis in my R hip)--but she insists on a bisphosphonate. Because I have erosions from GERD, I can’t take the orals, so she wants me to get Zometa infusions--which she says prevent bone mets (though she admitted in Feb. data would probably also show Prolia works, perhaps better). But I have poor veins and now only one arm in which they can safely be tapped--whereas Prolia’s a shot, Zometa’s an I.V.

And therein lies the rub. I am on Medicare Part D, with a BCBS supplement to Part B. Because Zometa must be administered I.V. in-facility, it is covered by Part B w/o co-pay. But Part D considers Prolia a regular drug because I can theoretically be administered a sub-cu shot anywhere (perhaps even self-administer). And my Part D plan (Humana Enhanced, which I chose as the highest-rated in the state) refuses to include it in its formulary--not even as a “non-preferred brand name drug.” It’s $5,000 per dose, which would kick me into the donut hole and then into the “Catastrophic” category in one fell swoop. (And though the co-pay for ‘“catastrophic” specialty drugs is 33%, that’s only for specialty drugs in-formulary--my co-pay would still be 100%). Patients under 65 can get it cheaply or even free, with co-pay cards or mfr. coupons & “assistance.” But for Medicare Part D patients, that’s illegal--even for drugs that since they’re not covered, would cost neither Medicare nor the Part D carrier one red cent!

So I have only three alternatives: get the inferior Zometa and risk blowing more veins; pay $10K a year for Prolia shots; or try to get it when traveling in Europe (if that’s even possible). No way its detail reps would provide samples (which is how I sometimes get some of my meds).

The fourth alternative, which my PCP advocates because he is wary of jaw osteonecrosis (my DDS isn’t worried if I time my dental work right) and paradoxical horizontal femur fractures, is to load up on calcium citrate and walk like crazy (he’d prefer I run or jump rope, but that would knock my artificial knee implants loose and subject me to the pain & risks of revision surgery).

Anyone here on Medicare manage to get Prolia affordably? Perhaps I need to wait till Oct. and switch Part D carriers?

muska

I tried figuring out how much I would have to pay for Prolia if my insurance doesn't cover it. I got about $1,000 per injection (for the drug). Maybe I am missing something here.

Kath1228

My understanding is that osteonecrosis of the jaw is really quite rare. As is always our dilemma - are the benefits worth the risks/side effects?

The % reduction in recurrence riskseems worth it to me. But I will be discussing in much more detail with my MO in a few weeks.

Anyone out there having a bad experience with Prolia?

sbelizabeth

ChiSandy, I don't have any words of wisdom for you; I just wanted to express how much the system totally sucks. I'm sorry they're making it so hard for you.

It sure makes me scared to retire.

SpecialK

kayb - yes, on the ONJ at bone cancer/mets doses - not nearly as frequent with the dose we would get.

chisandy - if your injection is administered in your oncologist's office would it be considered a Rx or "medical treatment" like chemo drugs are? My insurance, not my prescription coverage, is what is billed from my MO for bi-annual Prolia, and they bill it at about $2,400. My insurance only pays part of that, the rest is written off.

7of9

I am set up for my first injection procedure in July. Just finished Taxotere today for a recurrence in the axilla. Had ALND and complete hysterctomy in January. Cancer was still ER + and HER neu/neg. My last bone scan was a year ago and I was normal because I have taken 2 - 3 vitamin D and calcium almost every day the last 4 years.

My doctor changed orders from Zometa to something else insurance is less likely to deny an I have heard Medical Mutual is now denying women with normal scans! Jerks! I am going back on Arimidex (was on it 3 days after surgery until 2 days prior to starting chemo) and my Oncologist also mentioned this study. That it can prevent bone loss and there are findings that it can reduce the risk of bone mets (I though he said 6 - 8%?).

Hopeful82014

ChiSandy - re: Zometa infusions and your veins; bear in mind that it is just once every 6 months and usually for a maximum of 3 years for non- metastatic women.

ChiSandy

SpecialK, my Medicare Part D provider considers injections to be “prescriptions," whereas infusions are “treatments" and covered by Part B. The $5K per shot figure came from my MO.

I just finished reading a Vanity Fair article that has me livid--about the history of Valeant Pharmaceuticals, and the burgeoning industry-wide practice of buying up small drug companies and jacking up prices of lifesaving drugs up to 5000%!!!! (I don't believe in violating the commandment “thou shalt not murder," but if anyone here has a carry permit and sees Martin Shkreli on the streat and can get a clear shot.....I will defend you in any state where I am licensed to practice (IL or WA).

Seriously, the article confirmed my suspicion that the business of business is strictly about ROI for shareholders--productivity, quality, service be damned. The business of business is making money, any way, anyhow--everything else is even less than secondary.

SpecialK

chisandy - I was just doing some reading about Medicare and Prolia. The indication was that Prolia could be covered under Part B if the drug is considered "medically necessary" and you receive advance approval, and is ordered and administered by a physician. Apparently, Prolia can be billed as either Part B or Part D. It seems as though it may depend on how the physician bills, and whether or not the drug is purchased as an in-house supply (it is at my MO - they own the drug as they have purchased it and stock it), or is ordered per patient.

KayaRose

ChiSandy, I have Medicare and BCBS Supplemental (F). My drug plan is the cheapest - Humana Walmart. Prolia is covered under Medicare B, not Medicare D. My MO had to obtain prior approval for the Prolia from Medicare but once approved, no problems with coverage. I live in Northbrook, IL. Not sure why your insurance thinks injections should only be covered under part D. The Neulasta shots I received after each chemo treatment were injections and extremely expensive and, thank goodness, were covered under Medicare not my drug plan. Since we are both in Illinois and have similar insurance coverage, not sure why mine would cover Prolia and yours wouldn't. Maybe you should discuss this further with your MO and your insurance companies.

Kath1228

The more I am reading about this drug and its side effects - the more I think I don't want to take it. Apparently it affects your immune system as well - in addition to severe bone and joint pain. I already have enough of that from the Femara.

Now not sure what to do!!!

sbelizabeth

I had a Zometa infusion last fall, and my MO switched me to Prolia this spring. The Zometa made me feverish and achy. I was ready to be miserable again, but the Prolia was side-effect-less. Seriously, I couldn't tell I'd received anything. I'm glad for the (theoretical) extra weapon against recurrence in my bones.

Kath1228

sbelizabeth,

Thank you for your reply - good to hear you are having no issues. It seems like may patients on these boards are really not running into may issues with Prolia. Gives me hope....

I will be discussing starting on Prolia with my MO on June 30th.....

lbrewer

So much depends on the codes the medical office uses to bill....virtually everything. CPT codes change and office staff dont realize the difference it can make. I have had the insurance company tell me to go back to the dr and have them refill using different cpt codes.

ChiSandy

KayaRose, are you being treated at NorthShore Glenbrook Hospital/Kellogg? I’m at NorthShore Evanston Hospital (and its branch of Kellogg). My MO is Dr. Law--I will contact her before my scheduled Zometa infusion Aug. 4 and make my case why I should get Prolia instead of Zometa. My PCP is definitely against Zometa (actually is no fan of bone drugs, but agrees Prolia has fewer side effects as long as I am careful about infection).

KayaRose

ChiSandy, No, I'm not at North Shore. It's very close to my home but I decided to go to a MO and BS that I've known for quite some time. I worked many years for Resurrection Health Care rand chose docs there. Resurrection merged with Provena and is now known as Presence Health Care. Both of my doctors are also at Advocate Lutheran General but I see them at Resurrection Medical Center. Knowing so many people there, I feel very comfortable. That being said, I wouldn't hesitate to go to North Shore if I felt unsure of the treatment I'm receiving. They have a great reputation.

My MO is Dr. Lisa Baddi. She's with a group called Illinois Cancer Specialists. She suggested I consider going on Prolia. She said she would need prior approval from Medicare to cover the cost but said she very rarely had denials for cancer patients. Medicare did approve my Prolia treatments without any hassle. My dexa did show osteopenia which has gotten worse since my chemo/radiation/anastrozole treatments and that may be why Medicare approved the Prolia.

I just saw her this past Wednesday and had my Prolia. We also discussed the recent findings about staying on anastrozole for 10 years and she highly recommends it in my situation.

Hope you get your Prolia approved.