Insurance is denying KADCYLA request

NTS

Background:

2017: dx with stage IIB ER+ HER2+ BC, 1 sentinel node involved, ki-67 10%. 6 rounds of TCHP, lumpectomy, another lumpectomy to get clear margins, radiation, and 12 more rounds of Herceptin. followed with tamoxifen.

2020: dx with stage IA recurrence/residual disease (can't confirm which). Same as before in the same breast, ER+ Her2+ but this time ki-67 50%, so behaving more aggressively. I recurred while on tamoxifen. I am not metastatic; bone, body, brain scans are all clear.

I met with 3 separate oncologists to get opinions on treatment.

Onc #1 initially mentioned KADCYLA. After further review with another oncologist she gave me two options:
(1) AC then Taxol/Herceptin or (2) just Taxol/Herceptin

Onc #2 recommendced only KADCYLA. Was very enthusiastic about it. Did not want me to get AC or Taxol due to side effects for heart, and instead would put me on Lupron shot plus AI. (I wasn't comfortable with this treatment plan because I didn't feel like it didn't do enough for the ER+ part of my cancer).

Onc #3 recommended 4 rounds of AC every 2 weeks, followed by 14 rounds of KADCYLA. Also recommended Lupron shot plus AI. I decided to go with this path since it was a combination of the first two Onc suggestions. I like the data on KADCYLA, and this Onc is supposed to be the best of the best.

My problem - Insurance is REFUSING to give me KADCYLA. They say I don't meet FDA or NCCN guidelines. They only approved the first recommendation of AC then Taxol/Hercepin. I have already started AC, but my Onc is encouraging me to keep trying to get insurance to approve KADCYLA. I *DO NOT* want taxol. I don't want to repeat Herceptin when I feel that it didn't work the first time. My onc submitted all the paperwork and support from the Katherine trial, did an expedited appeal and peer to peer. My insurance won't budge. Now it's on *ME* to submit something to insurance??? I'm okay with the 4 rounds of AC but I am adamant that I want to start KADCYLA afterwards. I don't want Taxol. Time is of the essence now. Can anyone provide me with guidance of how to handle? I am just about ready to submit something pleading my case, but I want to make sure I don't miss something.

And just for further info; "On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment." <-- this would be me, yes?? even though the neoadjuvant chemo was in 2017, I recurred in 2020. There is no timeline on the approval. Please help. Thanks.

Newlife4me

that's how I got Kadcyla approved. Original stage 1 in 2010 treated with lump and TCH and rads. Recurred in 2019with exact same type (both ER- so anti hormone does not work). My onc used the failure of H from 2010 as basis and Katherine trial plus another trial I think.I am getting 17 kadcyla no Other chemo. I cannot have A anyway due to existing heart low EF.

FYI did not need an appeal Also another onc at HUP in philly says that’s what they are doing as well so becoming quite standard of care at NIH cancer centers anyway

NTS

Thanks for the reply. I'm assuming I get one shot at the appeal, so I'm doing my best to include the proper backup showing both FDA approval and NCCN guinelines do, in fact, qualify me for KADCYLA.

My insurance is through a major carrier, but I have been told by a dr that they are very difficult with approvals.