Worrying About the Wrong Thing

Yesterday was Randy's Quarterly doctor's appointment. As we near the end of the EMBARK Trial, I have been worried about how we will manage to get Xtandi after the trial concludes. He's not old enough for Medicare, and the co-pay with our employer-provided insurance is $2,000 per month. I've checked into several different programs, but cannot get an answer to anything as long as he's actively in a trial. I've worried myself sick about how to manage the cost. Each time we go, we ask for any information about the end-date. As of now, we still don't know.

When we asked yesterday, the oncologists pointed out that Xtandi isn't FDA approved for Randy's situation (thus the clinical trial). In order for her to prescribe, she'd have to prescribe off label and the insurance company would then deny the claim. She said that sometimes the drug company would continue to provide the drug after the trial...sometimes they don't. There's no way to know. She said she'd certainly 'go to bat' for Randy, but is not sure what will happen when the trial ends. The clinical trial coordinator also seems to be without a clue as to what happens after.

I've read everything I could find about clinical trials, what to expect, questions to ask, and it never occurred to me that ending the trial would be the issue. It's apparently uncommon for someone to continue on a trial for such a long period of time. There is now only one other person at Emory still in this trial and he is no longer on meds, since his PSA is remaining undetectable. Has anybody here participated in a trial until its end-date? Were you able to continue with your treatment after the trial concluded?

I assume Randy in in the Xtandi-only arm of the trial (pills but no injections). What has his PSA been doing since the drug restart?

Djin

As a side note, being on Medicare does not make the high cost of drugs go away and has different rules from private insurance. However, as Tudpock noted, he needs to go straight to the drug companies if the other avenues fail which should be fully investigated first. My wife gets her $2800/mo co-pay drug for free from Pfizer and recently got her third year approved. We are not poor so there is no telling how they make these decisions but the university pharmacy had us apply to them regardless of income and it worked. Don’t give up and stay after it.

To answer a lot of questions:

-Randy is on the blinded arm and either is on Xtandi or a Placebo along with Lupron. We're not 100% sure. A couple of things make us think he's on the Xtandi arm. He's Gleason 9 with no progression and no castrate resistance and if he takes the meds before eating he gets sick.
-Because he's still castrate sensitive and non-metastatic, Xtandi is not FDA approved for his situation. Because of that, the doctors could only prescribe off-label and the insurance companies wouldn't cover it at all.
-We don't know his PSA, since it's blinded. Twice during the trial, the PSA numbers were released to us due to lab errors, and both times, it was undetectable.
-We've reached out to payment assistance programs and the drug companies separately. No one wants to discuss anything with us while he's actively on a trial. The doctor says that sometimes the drug companies continue to provide drugs to people who participated in clinical trials. There's simply no way to know at this point.
-Whatever he's on right now is working and we don't want to mess with "working". His doctor (who also doesn't know) leans toward the "he's on Xtandi" side of things, but again, she doesn't really know.
I just wondered if anyone else had gotten to the end of a trial and what that looked like.
Donna.