Deny coverage for Pertuzuman (Perjeta)

[Nguyen]

Hello,

We receive a letter from the insurance company yesterday denying coverage for Pertuzumab with the following reason:

"There is no indication your patient has had no prior chemotherapy for metastatic disease - AND - no prior anti-her2 therapy [i.e Herceptin (trastuzumab)]."

I am not sure how to intepret this double negative. Does this mean Pertuzumab is approved only for metastatic patient WITHOUT prior chemo and herceptin?

OR, the reverse which is Pertuzumab is approved only for metastatic patient WITH prior chemo and herceptin.

Many thanks for your input as we start to fight the insurance battle again,

Nguyen

[Nguyen]

Well, from FDA publication, Perjeta is approved only for people without prior chemo or herceptin.

[jml]

Hi-
Pertuzumab is approved as a 1st line MBC therapy, meaning that you can NOT have had any prior Herceptin. Which in my estimation means that there are about 10 people in the universe that are actual candidates to receive the drug. Finally, a promising drug is approved for MBC but the population that has access to it is so limited.
In my 10.5 yr history with MBC I have only ever known 3, maybe 4 other people dx'd Stage IV from primary dx. This is so frustrating & frightening because 10+ yrs into this battle I'm on the hunt for new systemic therapy, and I'm 14th line!
I can't wait for February 26,2013 for TDM1 to come to market. Wish I could wait, but this disease waits for no one.
So, I'm preparing myself for a battle, with my doctors to fight for Pertuzumab. I think a few here on the board have been successful getting the drug, so I look to them for some direction & optimism.
I'm sure someone will chime in soon.

Keep the Faith ~

Jessica

[chrisy]

Perjeta is approved for First line metastatic disease which means no prior herceptin/chemo FOR METASTATIC DISEASE. If you had adjuvant herceptin or chemo for early stage treatment and the later developed stage IV disease, that is ok. You just can't have had those treatments for metastatic disease. I agree it is very narrow.

That said, the insurance decision can be appealed, start with your wife's oncologist. You may have to fight for it, but it can be done.

Good luck, I hope I haven't jst confused everyone even more!

[jacqueline1102]

Hi there,

I have been on Perjeta and Herceptin since August 1, 2012. I was on the TCH trio for my chemo, then just on the Herceptin until August. My oncologist ensured that I received this. My liver spot went from .9 to .6 mm with just the Perjeta and Herceptin. Your oncologist needs to do his due diligence to ensure you get this. He told me that he wrote the need stating I was "a first line" regimen. For those who have been on multiple chemos through the years, I am not sure what would happen. But for those newly diagnosed as in the last year or so I would think the oncologist would make this happen for you. Good luck.

Jackie

[jacqueline1102]

I was also diagnosed Stage IV from the start so that may help with the criteria. Even though I received TCH, then the Herceptin alone until the Perjeta/Herceptin duo. For those who have been diagnosed at an earlier stage, and then the disease metastizes, then the FDA may be more picky about this particular criteria.

Take good care,

Jackie

[yanyan]

I hope the same thing does not happen to TDM1. Like Perjeta, this "bomb" carries so many hopes from families, friends and patients!

[SoCalGal]

Genentech has a patient assistance program. There is a PDF form for the doc to fill out and one for the patient. Income needs to be under 100K. I just started my first perjeta last week. I'm not sure if anthem has officially denied me yet, but if they do I've applied for the patient assistance program.
They should call it patient persistence program - keep the pressure on with your docs!!

[phil]

Chrisy has it right , very narrow criteria from This FDA . I think some folks are getting it ' off protocol ", thier doc getting thier chief ( IRB ) to sign off. Just like some tnbc'ers are getting avastin still. Then you have to make sure ins . will cover.
With T DM-1 the problem will be the opposite , This FDA could approve for late stage iv only. so first re-occurences may not get it. makes a lot of sense , huh ? , This FDA wants you to wait until you devekop more tumors , before giving the smart bomb ? ? so far This FDA has taken over 4 months of the 6 month priority review time , still no t dm-1 . they had great stats on it way back in 2010, preliminary EMILIA data back in May, and final EMILIA data since August . Their mis-handling of this great drug has reached more and more absurd, tragic dimensions. They seem to be crafting a defense ; will issue a long-winded , jargonistic " Black Box Warning " , limited approval. We Stage IV folks are well-aware of the risks : platelets , neuropathy, liver irritation, the two deaths related more to prior liver issues in Phase I, II . We also are well aware of the " Ultimate Side -Effect " of mbc . We know this drug is much more tolerable than older chemos, and more effective. We don't need Big Brother FDA teling us what we " need ", from patronizing bureaucrats !
If your ins. co . denies pert, appeal, appeal to your state ins board. I would appeal to the media too . While your at it , talk about This FDA too !