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.