ippi and Nivolumab

[Blair77]

The immunotherapy combo was to start today but the insurance company denied approval. Any tips or advice of how to get a access to this combo? Trials are out due to a secondary cancer my hubs has.

[cesces]

Denied on what basis?

In the US you have multiple levels of appeal.

[ctarleton]

What's the insurance? Have you reviewed their appeals process?

You probably have already seen this. A glance at the Full Prescribing Information for "ipi" (Yervoy) shows that the FDA approved Indications for usage are:

1.1 Unresectable or Metastatic Melanoma

1.2 Adjuvant Treatment of Melanoma

1.3 Advanced Renal Cell Carcinoma

1.4 Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient

(dMMR) Metastatic Colorectal Cancer

Similarly, for Nivolumab (Opdivo):

1.1 Unresectable or Metastatic Melanoma

1.2 Adjuvant Treatment of Melanoma

1.3 Metastatic Non-Small Cell Lung Cancer

1.4 Small Cell Lung Cancer

1.5 Advanced Renal Cell Carcinoma

1.6 Classical Hodgkin Lymphoma

1.7 Squamous Cell Carcinoma of the Head and Neck

1.8 Urothelial Carcinoma

1.9 Microsatellite Instability-High or Mismatch Repair Deficient

Metastatic Colorectal Cancer

1.10 Hepatocellular Carcinoma

The combination of the two drugs is mentioned in paragraph 1.9 for Opdivo, but only in the context of Metastatic Colorectal Cancer, associated with MSI-High or Mismatch Repair Deficiency.

I would speculate that your Insurance Drug Formulary and any of their Prior Approval documentation would be based upon these documents, currently excluding the usage of the combination of these drugs for advanced prostate cancer treatment, outside of clinical trials.

If you are not getting any path forward with nearby UCSF and their clinical trials route, you might try Padmanee Sharma at MD Anderson. She has been involved with clinical trials for these agents for prostate cancer, and also has consultantships with many manufacturers. She may have "tips" for using them "off label"? Or be able to point you in another direction or put in a good word somewhere?

This website might lead somewhere, too?

bmsaccesssupport.bmscustome...

Good Luck!

Charles

[Harleyboo]

I would fight the insurance company. My brother did the therapy and his PSA was 26 and went to 1.2. He,also had to take zytiga afterwards. The therapy is not for everyone as doc said.

[Alexcohen]

I am MSH-high and after my insurance denied coverage, my doctors submitted compassionate release request to Bristol Meyer and after I provided financial documentation, the drug company approved free release of the drug -- I have now had 3 of 4 dual drug treatments. Usually these requests are approved.

[Blair77]

You guys are great💖💖💖thanks for the information!!

[ctarleton]

Another route to possibly consider might be the existing FDA "Expanded Access" program. Lots of info to explore here:

fda.gov/news-events/expande...