Keytruda!

Great news! Please let us know how he responds, and how they are measuring response. I think he's the first HWer to get it.

Excellent news. Looking forward to great results. There was one small trial of about 10 men that I read of and most experienced significant improvement. Best wishes for success.

Thank you all for the good wishes, which I have passed along. The nurse told us not to worry about insurance, but we'll see. We're on private insurance, will let you all know. (He is stopping Xtandi which is roughly the same monthly cost, probably a bit less. Nurse said Keytruda gets billed as a medical (?treatment?) not a drug.)

Beth: I've been away from the forum for a long while and saw your posts just recently. I literally have my fingers crossed (well, I uncrossed them to type) for Gary's test results. Hope seems so painful to me sometimes but so welcome too.
The tumor biopsy had DIFFERENT gene variants than the gene testing Dave had a couple years ago (from blood) - I'd read about this but it's sort of breathtaking to see it actually happening. For example he was BRCA1 negative before but the tumor is positive. Which opens up other treatment options the doc said for the future (PARP inhibitors).
If I was an advanced cancer guy with treatments running out I would for sure right now be asking for gene testing of the tumor. It did take weeks (3?4?) for the results to come back.
We are worried about the potential autoimmune side effects which are truly scary. Dave says if there's a bad side effect, he'll get it. Partly this is from his xgeva/osteonecrosis experience.

So sorry to hear Gary has that too. Warning: unpleasant osteonecrosis details follow. Dave's has resolved completely externally (though always worried about it coming back, the scans are better but not perfect). We had the devil of a time getting someone to treat him (Fox Chase was almost no help though they've been great otherwise.) He did finally go to an oral surgeon who biopsied then debrided bone in his chin twice. (He had a fistula right behind the point of his chin which never quite opened to outside, and a small piece of bone showing inside his mouth.) Then he was on IV antibiotics for six weeks (self administered at home through a port with real cool spherical drug pods!), then oral for a while, and that really did seem to take care of it. The oral surgeon wanted to do more surgery but Dave wouldn't.

I wish the gene thing was a more common variant so more people could benefit, but it feels like this may be coming along for us in the nick of time. The lymph node in Dave's neck is growing and really bothering him - not to mention the scans showing new nodes elsewhere. The first Keytruda infusion is next week, then every three weeks. We'll let you know how it goes.

-- Carolyn

Oh my goodness. It is complicated, I don't pretend to understand it, and I'm sitting here drinking beer at a baseball game. But I'll do my best. First of all, we are talking about the DNA in the tumor - which presumably started out the same as the DNA of the person who is growing it. But it may (or may not, I guess) change over time by getting new mutations.

The thing that got Dave qualified is MSI-H which stands for microsatellite instability is High. A microsatellite is a short repeat - like the CA in CACACACACA..... Evidently there are a lot of those. If your DNA mismatch repair mechanisms (dMMR) are messed up these short repeats can get messed up too. That's measured in mutations per Mb (?)The result of that is that you have all sorts of weird proteins floating around on the surface of your tumor cells. Those proteins are recognizable by your immune system as weird strangers, IF a drug also messes up your immune system's idea of what is you and what isn't.

The DNA mismatch repair mechanism is controlled by a bunch of genes (like MSM1,...). If those genes get certain mutations in them, it can result in mutations in other areas of DNA, including the microsatellites. That's because the dMMR acts like error detection and correction.

More than enough. Somebody else can try to untangle this. Thanks in advance.

Home team down by 7 ☹️

Lehigh Valley (PA) Iron Pigs 🐷!

Yes we were both there. Dave was actually pretty healthy until recently for someone who is so sick (if you know what I mean). He's still working three days a week - he's a speech therapist and works with adults with brain injury. It's very rewarding.

It keeps him going, though I don't know how much longer he's going to stay on that schedule. In the last couple months he's felt permanently bad from the cancer as opposed to from the ADT (which is bad enough). (He's had plenty of issues with bone pain and urinary issues along the way, but radiation & ADT & enzalutimide has taken care of them.)

Hi Carolyn, I'm relatively new here. Thanks for the excellent info. You are really up on your stuff! I know a woman with metastatic lung cancer who recently took Keytruda, after getting a biopsy match that met criteria. Met her in a Cancer Support Group.

BTW, my wife grew up in Coopersburg, PA. Lehigh Valley and all. Small world, huh?

Charles

Quick update: our (previously cooperative) BCBS insurance company has denied Keytruda for Dave - something like "experimental and/or not commonly accepted by the medical community".

Evidently FDA approval is not good enough for them. We'll appeal of course, and also investigate whether he can get it as part of TAPUR or other clinical trial. So we're not discouraged.

See also this:
/aishealth.com/archive/nspn0617-04

-- Carolyn

Best wishes for success with the treatment and your coverage appeal.

This is the challenge we earlier discussed regarding coverage. Generally, the insurance companies and other third party payors wait to see how Medicare will treat a drug or procedure following FDA approval and then most will follow Medicare's lead. To my knowledge Medicare has not yet published a determination for the use of Keytruda in accordance with the recent FDA expansion of use.

The report you post is interesting and this new unprecedented approach by the FDA could significantly affect reimbursements, thus the third party payors have to carefully consider the financial effects. I have seen that approximately 15,000 people per year have been using Keytruda under the original label limitations. I have not seen any estimates as to how many might now be considered under the FDA expansion.

As to the initial denial, it isn't surprising. You are probably their first such claim and I doubt that any of the companies, or Medicare, have actually completed the actuarial studies they must do to determine their reimbursement policies. Just keep at it and build your case for reimbursement. I suggest you start at the top with the BCBS Medical Director and your state insurance commissioner. Also identify your specific political representatives and see where they usually vote on health care issues as you may need their assistance. That is probably where you will end up after a long time if you work from the bottom up. Also find a great investigative health reporter in your area and try to do a personal interest story in the newspaper and TV regarding this new approach and the challenges it brings financially. This may be of assistance in your quest for reimbursement.