Is Optune now part of the Standard of Care? No.
I again talked at length with the FDA today on whether Optune will now have to be added to the Protocol and basically mess up the DCVax-L trial.
Note: the Device department never called me back. So I spoke again at length to one of the ladies in the Biologics Department with the FDA and she clarified things with significantly more detail.
Below are my notes from that discussion…
Option does not become standard of care overnight upon a license being granted.
And the only means by which “Optune” would be added to the protocol would be if the Sponsor requested it of the FDA.
The only reason the sponsor would do that is if many or all patients in the trial say they are going to leave and go instead to this new trial, or use this new drug or device. Or, if the patients are insisting that the sponsor add the new drug or device to the current trial they are enrolled in and threaten to leave the trial to get it. Those would be reasons why the sponsor may consider adding Optune to the trial.
The study “needs to keep the variables constant.”
When adding a treatment that is not in the protocol, you change the variables - and lose keeping them “constant”. You have to modify the protocol to add it. And they simply do not have to do that now… why would they? They are going for median 4 months PFS (or better :) ) - and Optune only offered 2 months.
The FDA has agreed to the sponsor’s protocol… the FDA is not going to require a sponsor to amend their protocol to add a new treatment or arm. The sponsor would decide to do this and then run it by the FDA.
And if the patients in your study decide to leave your study to use Optune… well they would have to give up their vaccine treatments in favor of Optune and thus, be out of the trial. The patient would most likely not be allowed back into the same trial if they wanted to come back. Additionally… other studies may be reluctant to let the patient into another one because the patient can’t be relied on to stay. The sponsor doesn’t want to spend great amounts of money on a patient only to have them abandon the trial.
So to add Optune now to the protocol, it would have to be added as another arm… and my guess is that ain’t happening.
On top of that…
The FDA reviews the data and grants the license. Period. They do not set “standard of care” with their license approval. They will most likely offer well-defined limitations to the product, but a license approval will never set the “standard of care”.
After the license has been given, the CDC may want to review the product. So they look at the product and what it is licensed for and decide if they want to “put it on their schedule” to review. If they decide yes… they may then expand on the limitations and/or expectations - adding in a sense, more “cache” to the product.
Then Medicare will most likely get in on the action and decide whether they will cover the cost of the product and if so… how much. Adding even more “cache” if they do cover it.
Insurance companies will also be reviewing the drug/biologic/device as well. Each insurance company will have their parameters as to whether they will pay and/or what they will pay (e.g. any and all US licensed drugs, only what medicare pays, etc.).
At some point in time, depending upon all the above variables, a drug, biologic or device may become standard of care. Meaning… all of the above are willing to cover “this” in the treatment of “that”. So if you are testing a new something… you may want show it beats what has become to be known as Standard of Care.
That's it on that one. Then we talked about AA and how that might work - never of course, specifically talking about a particular biologic. I have notes on that.. but I will have to get to those later as I have to run. :)
