Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Hi Ladies,

This is what I am finding. If you have had Herceptin, then you do not qualify for Pertuzumab.

Your ins. company can tell you that you do not need pre-authorization for this drug, b/c IT IS an approved drug, but the FDA approved it in such a way that it is for stage 1 breast cancer. (I am stage 4)

You can even get a pre-determination letter. This means nothing, as I have found out. Your company will then send you a letter that says that the pre-determination letter is NOT a garuntee of payment.

1st dose is a loading dose. Cost:$22,000. Next doses are $11,000 every 3 weeks.

Until you get your EOB (Explanation of Benefits) back from your ins. co., WEEKS after that 1st infusion, and likely AFTER the 2nd infusion, and you see if your ins. has paid, you will not know if you are going to be stuck paying this yourself.

My Oncologist told me I had to sign a paper saying I was liable for this entire amount, if my ins. didn't pay this.

My oncologist said the insurance company may come in and after I have already had the infusion, and do what is called, "reto-deny."

Drs. give drugs off label all the time, but since this is so newly approved with the FDA it looks like those of us who need this are just plain stuck.

Really, I have ins., and I am supposed to sign a letter saying I garuntee to pay this huge bill if my ins. co. decides not to pay? There should be a way that we can be sure that the ins. company will pay----or not.

Is there anyone on these boards who works in the ins. industry that could help me? Do you know how I can get the insurance co. to garuntee payment?

I needed this drug yesterday! I have orders in at my onc's office to get this, but here I sit in limbo b/c I can not afford to gamble this huge amount of money ($33,000), while I wait to see if my ins. company will pay this.

Thank you!

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Dearest Seven,
I am hoping experienced and resourceful members here might be able to suggest charities that would pay for this for you. I'm sure anybody who has biked, run, walked, or otherwise fundraised for breast cancer would have gladly been doing that donating for a cause like this!!

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

I think Karen (kDR) is getting pertuzumab via a trial. I don't know your treatment history but if you are having progression on current treatment, maybe you can get on a trial? Sheila will be getting pertuzumab, maybe she will share more info as how to get insurance approve for it. Unfortunately it is approved with such limitations and people who need it most have the minimum access to it. Who hasnt had herceptin if you are her2 positive??? By metastatic I don't know if that includes those with positive lymph nodes or local recurrence to skin such as in my case. I hope something will work out for you.

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Hi 7 and counting, I really hope this works out for you and as Norkdo says, maybe a charity or fundraiser will come to your aid if need be.

I was chatting to my onc here in Australia about the FDA approving pertuzumab for those diagnosed Stage IV who had not previously been treated with Herceptin etc. He said that increasingly the FDA and the TGA (the Australian regulatory authority) were approving the drugs based on what the criteria in the trial setting was. So unless there was a pertuzumab trial for previously treated Her-2 that was complete and results tabled to the FDA, then it may not be approved in that setting. I'm not sure if that's correct for the US (and others may chime in on that), but I'm pretty sure here in Australia the trials were for first line stage 4 treatment (not that it's approved here yet anyway).

I said it seemed women were getting it off-label, and he spoke about the financial liability the doctor may face when prescribing off-label and an audit is undertaken - he said he couldn't take that risk. Maybe it's a little different here, as the government (not the insurance companies) pay for the drugs such as Herceptin, Tykerb, and if approved, pertuzumab.

It really all sucks....... but don't give up hope.

Marie

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

I am wondering if it is your dr or your ins co saying this. I have a hard time believing that an ins co would tell you that " even though you got preauthorization and we said it would be covered, we may not cover it" That is one of the reasons that ins companies have the preauthorization process, so people will know if expensive drugs or procedures are covered.

Myi ins co denied tykerb because I was taking it off label. I went through the appeal process and got them to cover it. If they deny you, you have the right to appeal.
I would call your ins co directly and go up the chain of command until you get a yes or no answer of whether this drug will be covered for you. If you get a yes, have them send you something in writing stating they said it would be covered.



Laurie

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Pertuzumab is approved for "first line" treatment of Stage IV HER-2 positive breast cancer, meaning previously-untreated and/or newly diagnosed. Anyone outside that group might have trouble getting insurance to pay. Most cancer drugs, including Herceptin, are first tested on and approved for metastatic cancer. Pertuzumab is no exception.

http://www.cancer.gov/ncicancerbulletin/061212/page8

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Seven,

I feel your distress. I remember receiving a 20 thousand dollar bill and was told that I would be entirely responsible for it. I cried and cried. I felt my cancer was financially digging us in and we would never get out of debt.

My husband went into the office and raised hell, the administration of the hospital got involved and with much apologies I was told that the bill would be entirely covered.

How scary for you to be faced with this.

I don't care how the current system works, I just think it is madness that there is a treatment that could work for you, and you just can't have it. It doesn't work, it makes patients suffer and die prematurely. And now you have the threat of a financial disaster on top of fighting for your life.

Really? Seriously?

Where do you live Seven? Maybe you can contact the insurance commissioner in your state?

I think the new guidelines for Perjeta are as clear as mud. What - only for those who are Stage IV right from official diagnosis? Not for a recurrence?

What is the FDA thinking?

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

I get my herceptin, tykerb and hopefully perjeta straight from my specialty mail order pharmacy. as long as I pay my copay they ship the drugs to my Oncology office . Therefore bypassing the mark up from Dr office to insurance company. with my herceptin it saves my primary insurance company around 750.00 dollars per week. I pay 50.00 for a 3 month supply. They only bill for the dr fee, the pharm and nurse fees. I also started doing this to reduce my lifetime max before the new law took effect. which hopefully will not be changed by our crazy government. So I not sure I was prescribed Tykerb off label and 2years later have not had "insurance" issues.

Don't give up the fight!!

Prayers and best wishes to you

Darita

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Daria,

What is the name of your specialty pharmacy? Did the onc office call in the prescription order? Your example shows just how big a markup there is in the onc offices.

I am also dealing with the Perjeta confusion. When I saw Dr Slamon two weeks ago, he said there should be no problem-- it is approved. But now his staff told me Genentech will decide who gets the drug. It is all very stressful.

thanks

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Wow, ladies, thank you for your helpful replies. I am needing all the ins. info I can get, and the comment about ordering through the specialty pharmacy sounds very intriguing. Surely my onc can write me an RX, and they would let us know before filling this if it is covered. Excellent idea.

As far as calling the ins. comission. Sadly, I did and that was a joke.

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Dear Seven I really hope that you find a way to get pertuzumab.. Another issue not raised is how can this drug (and new drug generally) cost so much I do not beleive this is justifiable.. I know I know we do not have time to change the system nor the power. I hope that you get a satisfactory outcome and get to try it. Hold on tight.

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Dear Seven,
I am getting Perjeta because I was randomized to it in a trial at my treatment facility. I am no expert on insurance issues or other qualifying criteria; I will, however, ask my onco about it for you when I see her next Friday. Do you have any specific questions you would like to me ask? What is your location?
Just wondering, did you call the number specifically for Perjeta?
Yours
Karen

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Dear Kdr,

Can you please post the ID number of the clinical trial you are on at Sloan? I would like to see if it might be available in California.

Thanks

NancyL

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Nancy,
http://www.mskcc.org/cancer-care/trial/09-093
My trial is referred to as 09-093 (which is in my signature).
Hope this helps.
Karen

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

There is another trial that you might find of interest, run by University of Pennsylvania and Dr. Chau Dang:
http://clinicaltrials.gov/ct2/show/NCT01276041
Karen

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Hmmm.... "If you have had Herceptin, then you do not qualify for Pertuzumab." But I have a stage IV friend who has had lots of Herceptin who is getting it... I don't know about insurance paying, etc, but she is getting it. But, she also knows about mail order pharmacies, and so does her doc. Good advice about the mail order pharmacy... that is the route I took to get Tykerb, as a stage IV girl.

It sounds like there are two different stories going on... 1) is "If you have had Herceptin, then you do not qualify for Pertuzumab" and the other is 2) you can get it but insurance won't pay for it... So, I am more than curious about this conundrum.

You have to stay on State Insurance commissions (they are either told to deny help out of the box (but less than ins companies), or they don't know yet what to do about Pertuzamab), but at least they are there. Medicare has nothing, but hold times of ions of days, from my experience.


Good luck!!

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

Additionally, Perjeta is only given WITH Herceptin.
Karen

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

It will make sense to include the stage V whose disease have progressed on herceptin. I wonder if there is anything we can do? Maybe sign a petition? I am not familiar with the procedure. Anyone has an idea?

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

I would suggest contacting state and federal representatives, lets put our congressman to work on it.

Also, perhaps the news media. This would make an incredible story for 60 Minutes who might be able to light a fire under someones a**

Re: Pertuzumab not avaliable to stage 4 contrary to what you have heard
 

I wanted to add that I finally got Approval for tx from ins . I will get my first infusion of perjetA on Wednesday. So the ins back and forth does help. I was rejected twice and my onc had to send documentation and examples of two studies. I am stage IV and have taken other txs since Feb. I got a conditional three month approval for three treatments of perjetA, Herceptin and Taxotere.