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.

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

I'm glad you finally got approval from your insurance!

As far as I can tell, the approval covers anyone who hasn't previously been treated for Stage IV HER-2 + cancer, meaning, as I said, it's a first line treatment for metastasis. It can be a recurrence or you can be metastatic at diagnosis.

It's good to know that there are people who are not in that rather small box who are also getting it.

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

Yan yan - progressing while taking Herceptin is not the same as progressing on a chemo or failing Herceptin. It has many ways to work, and will often work with other combinations. Don't go off of it because you think it's no longer working. Talk at length with your onc about it.

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

Hi Hutchibk,

I am currently on tykerb and xeloda. Do you know anyone who is on tykerb/xeloda/herceptin at the same time? I thought the regimen is tykerb and xeloda, then tykerb and herceptin. I don't know if tykerb/herceptin together is approved for stage 4 her2+++ only although i have seen people with local recurrence stage 3c on it. Thanks!

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

There have been a few on the boards here who have been on Ty/Xel/Herc together! Whatever works, we say. You should ask that question as a thread. I personally have been on Ty/Xel and Ty/Herc and now TDM1... have been on Ty/Xel and Ty/Herc as well as Herc with various chemos. We have been very shy about blaming Herceptin or other chemos, so we switch up the combos when we need to. I don't think we will (but I could be wrong) go off Herceptin all-together, but we did in 2007/08. Then we went back to it...

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

I have also been denied this drug. I am going to talk to the insurance company again. I really need this drug my HER2 level was 195.5 the last time it was checked.

Amelia

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

I had heard rumors about this conditional approval of pert months ago. Didnt want to believe that This FDA again would say f - you to Stage IV Survivors >>> but its been about two yrs of stonewalling T DM-1. I suggest people push the care2 petition for T DM-1, the petitionsite.com , " Please Ask Congress to Push FDA Approval Of Her2neu cancer treatment T DM-1 ...", started by Joann Rootsey in Fla. ( on FB). She could amend it to include pert. and Cong reps on the HELP Committee.
Any No. Carolinians out there ? Call your Sen., Kay Hagan, shes on the HELP Committee, and has abill the TREAT ACT , aimed overhauling FDA drug approval process. I dont know if details include our mantra of Flexible treatment, In formed Choice for Late Stage IV Survivors , but our input needs to be included.
I hear that Gen would be flexible w/ pert for comp use, but hospitals are being tight w/ off protocol tx. Need to press them, publicize thier actions . I hear that about our giant Partners Healthcare here in Boston. Their IRB supposedly is trying to not give off protocol use for pert. Why ? not sure, afraid of FDA ?
Late Stage IV her2 + who have progr. on taxane, tyk., should try comp use for tdm-1 too. If your ins or doc/hospital obstructs , publicize it !

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

The insurance company often finds it easier to say no and think you will go away. They are not an invinceable dragon, but simply an elephant. Be the mouse that roared. Even elephants will avoid trouble if it is the best way for them. Appeal to the next level in the organization. I actually have a third level that handles all claims for Nina due to me being something other than a lemming. I went to a VP of Marketing and Sales of an insurance company for another case and the agreement was they would have my friend on a commercial and they would pay for treatment. The insurance company showed they were caring and my friend received the medical care she needed.

Never give up. I hate to lose.
Paul

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

I talked my health care nurse from my insurance company today. I am going to get my doctor to send my health records to her along with a letter and try to get the medicine off label.

I will have to take taxotere with the medicine. It was a really hard chemo for me in 2008.

I wish someone would do something about this drug and TDM-1 hanging in limbo.

Amelia

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

Amelia,

My onc said since this is already being given off label you don't have to give chemo with this, b/c you are not giving it the way it was approved.

I believe the way you said is the only way to actually get this approved: a letter to the ins. company asking for approval to get this off label. Us stage 4 women are in a bad fix b/c of the way this drug has been approved.

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

I hope my oncologist will agree to me not doing Taxotere. I plan on going back to work on the 13th of August. I am going to have my ovaries out on the 26th of July. I am currently taking Abraxane.

Did you get approved for the medicine, 7andcounting? I agree with you about us being in a bad fix.

Amelia

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

No, my onc is still working on this. The way this has been approved is making this very difficult to get. I think people are told it is covered but until they get their EOB's back there is no way to know, unless you have a letter stating that coverage is garunteed before you start.

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

Is there such a thing as getting a drug like Pertuzumab off label with Medicare? Has anyone ever been successful?

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

Unfortunately, most of us who need this drug as a last ditch effort, need to get it off label. Anyone who has already been treated for metastatic disease would not qualify under the FDA guidelines right now. By it being given off label, the onc. Does not have to give it with chemo, but can give it with Herceptin. I do know that where I receive treatment, 3 different breast oncologists have applied for this for 13 patients total, and so far I am the only one getting it. The insurance company itself can be a go or a no, depending on type of insurance (so unfair). I do know that mine was applied and ordered for MEDICAL NECCESSITY. Still do not have payment...they approved it, but that is no guarantee they will,pay for it and sent me a letter as such. The insurance people at my hospital said it is usually not able to,process off label drugs through medicare, and there are penalties that apply if they do...somifmone is on Medicare, it might need to be requested through secondary insurance if available. Hoping everyone who needs this drug is able to get it, and that it works. So far, I have only had one dose and I see no change....hoping dose #2 will show a big change when given with Herceptin...that is next week

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

I could have misunderstood, but I believe that Pertuzamab can be prescribed as a doctor wishes... after ONE time with a docetaxol. The FDA requires it be used with a docetaxol, but only once.

Then a doc can use it however he/she sees fit... and potentially off label.

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

Thanks SO much Brenda.

- Kim

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

I failed on Xeloda/Tykerb weeks ago and am in the appeals process to go on perjeta/Herceptin/taxotere. I failed on Herceptin in Jan. My doc thinks they will ultimately approve it. I am on for getting my first infusion Tuesday. The onc office is covering the cost of the first tx while we keep on with the appeal. They have a special fund for things like that and they consider me a great investment. shame the insurance co doesn't think that way. They said I would have to fail on 2 more conventional tx or be in imminenet danger of death before they would possibly approve. Thanks so much to them!!

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

Got my insurance statement today, and they're billed 27000.00 for the first treatment. I have PPO, so they paid their set cost of 14000.00 and since I have met my deductible, I pay nothing. My second dose was half the amount so should end up being Round 14000.00, of which the insurance will pay about half. it was given with Herceptin, so that's another 17900.00 added to the bill...if I continue to,progress, chemo (Carboplatin) will be added in 3 weeks. Since I had already failed Taxotere right before Perjeta, it was not in my combo.

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

Yanyan-I was on Tykerb-Xeloda-Herceptin. It was a tolerable regimen and it was the easiest thus far. Unfortunately, I had some progression on it. We had hoped to drop the Xeloda and continue on Tykerb and Herceptin as "maintenance," but that didn't happen.

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

Hello All,

Well, after being told by my oncologist that getting Perjeta was impossible, I got my first infusion yesterday. Sad that I had to wait WEEKS while this all got ironed out. In the end the only way we found to get assurance that this was going to be paid was to have my oncologist go directly to the medical director (@ my ins. co.) and get his approval. We got that, and 2 days later I had my infusion. What an insurance nightmare!

Thanking God for this miracle drug.

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

So pleased you got it - I hope it now does everything that you need it to.