Story about new Medicare approved diagnostic test in this morning's Boston Globe

Keytruda has been approved for more than a year for certain genetic markers for prostate cancer and some other cancers for several years, notably melanoma, some head and neck cancers and non-small cell lung cancer. The main advertising we see on TV targets the latter. You will remember that former president Carter was successfully treated with Keytruda when his melanoma spread to his brain. Keytruda was first used under FDA approval in 2014. Most recently it has been reported that about 15,000 people per year use the drug and has an annual cost of about $150,000 plus administration and medical fees.

Earlier this year we had a discussion of the role for Keytruda and prostate cancer and it was reported that only about 1.5% of PCa patients had the genetic marker that would allow Keytruda to be used. We had a few members that were using Keytruda, one with some success, but to my knowledge none have posted here in many months so we don't know their results. Keytruda is not without problems as in many patients it so supercharges the immune system that it attacks the body with potentially disastrous effects One of the men using it here had to stop because of the adverse effects. I spoke with a medical oncologist that said it will either save you or kill you.

While it is a breakthrough drug and will help many people, it's current use for PCa is extremely limited. There are currently more than 270 clinical trials underway testing Keytruda in many different cancers. As we learn more about how these drugs work I am positive that more such genetic based drugs will be developed that can help many more people.

Thanks for the clarification regarding the test. I just re-read the article and the FDA approval and marketing approval summary. Interesting that the FDA approval summary does not include PCa as a use nor, in the several cancers it includes, does it list Keytruda as a drug to link. So not sure how Mr. White was tested or linked to Keytruda. Certainly must have been in a trial or entirely off label. The FDA approval was in late 2017 and Mr. White was tested and treated in 2016. It may be that the FDA is waiting for more information to expand the listed cancers and treatments that Foundation One CDx is approved for.

The basic cost for the test is $5,800. I haven’t seen any news indicating any insurance impatiens approving the test or when Medicare or insurance companies would cover the test. It certainly won’t be routinely used, but will require significant previous tests and treatments to qualify for use and reimbursement.

The information says that solid tumor cells must be tested. I wonder whether biopsy slides can be used. If it can only be used on surgical pathology tissue, then non-surgical PCa guys might not have this available.

For years an oncologist in Germany, Dr. Bonkhoff, has used expanded testing on PCa samples to determine the strain, ploidy status, and other cell features and then link to the best treatment regimen. That has never caught in in the USA.

I just read a lengthy list of covered tests by Aetna and it included the Foundation One CDx for several cancers including breast, colorectal, non small cell lung and melanoma, but not prostate cancer. So they appear to be following exactly the direction set by Medicare. It will be interesting to see whether any of our forum members that are advanced stage can get the test and be reimbursed.

So you negotiated the cost to $300. Very savvy. Please let us know the outcome. From what I have read I agree with you that it is unlikely it tells you anything you don’t already know, but here is to the investigation.