fda.gov/news-events/press-a...
Note: It is only approved for limited purposes:
1) To detect suspected metastases in unfavorable risk patients who are potentially curable with RT or RP . In this regard, it can be used as bone scans/CT are used in such patients to rule out futility of such treatment.
2) To detect sites of suspected recurrence in patients who have already had RT or RP and may be good candidates for salvage therapy.
Since the Ga-68-PSMA PET scan for these purposes has already been available (for about $3000) for these purposes at UCLA and UCSF, this is not a big change. Sometimes Medicare allows reimbursement on diagnostics that have been FDA approved, but sometimes it doesn't. CMS will have to review. Other insurance companies may or may not reimburse for it - always get pre-authorization.
So far, approval is limited to those two institutions only (similar to the way Mayo was only approved for C-11 Choline PET scans), but other institutions may continue to offer it in clinical trials.
No word yet on DCFPyL and other novel PSMA-based ligands.
Thx TA. Good news. I wonder how that will impact my ability to to pay for a ucla PSMA scan. If you recall I use the PSMA Testing to decide when to end my “vacation”, because I still have 60% of a larger prostate that gives me PSA reading of about 3.5. So far the 3 tests I’ve done over there have all been negative with no discernible changes. Dr. Czernin over there had told me that I could only do the three until they had FDA approval. I’ll email him and Dr. Kishan over there today and ask if this means I can continue to pay for the tests. Any thoughts?
Schwah .
Let me know what they say. They may be concerned by the amount of radiation such frequent use exposes you to - I don't know.
Interestingly Dr Czernin says the radiation exposure on their PSMA tests is minimal especially compared to other imaging. The only reason for the limit of 3 per customer was regulatory for some reason. I just emailed him now and I’ll let you (and others interested) know what he says.
Schwah
Schwah, The PSMA PET scan has less radiation to the body than standard CT scans? I might go to get a PSMA PET scan at the VA and I was wondering about the radiation level.
That’s what I was told. But I can not independently confirm that.
Schwah
Whether PET/CT or CT alone, the CT is full body. The PET part of the scan adds some extra dose. The radiation exposure is not a big deal. In the US, there are a few very expensive PET/MRI machines that cut down on X-ray exposure.
Your radiology report tells you what your exposure was.
does that mean that you agree with this Dr: "Dr Czernin says the radiation exposure on their PSMA tests is minimal especially compared to other imaging."
The radiation from a full body PET+CT is 25 mSV, and about 15 mSV from a narrow slice full-body CT. I agree the dose is small. But it's simple math that A+B>A
OK thanks Allen
Wow. Quick response. What a nice guy! Apparently the approval is pretty broad in his mind but now getting insurance companies to buy off is a new project. He specifically said:
Yes, Mr. Schwartz,
We were granted FDA approval today.
Thus, there is no limit for PSMA scans.
Reimbursement by insurance is a different issue.
We can only now start working on this as nobody even took our calls prior to FDA approval.
The approval is very broad, and you clearly would qualify for a scan.
Would be more than happy to talk on the phone at any time.
Sincerely,
Johannes Czernin
With NaF PET, FDA approved it, but CMS only paid for it if it was part of a clinical trial or a registry. Most insurance would not cover it, but it was always an individual decision. With C-11 Choline, it was left to individual MAC centers to determine whether Medicare would cover it in each region. Medicare is currently covering Axumin for recurrence only, but some insurance won't cover it. It's very complicated.
Well it seems like the PSMA scans will now be covered at least under certain circumstances but who knows how long that might take.
Where did you hear that it will now be covered?
Not ‘now’ , but hopefully soon. With FDA approval won’t insurance companies start covering? That’s the way I interpreted Dr. Czernin’s reply:
“Reimbursement by insurance is a different issue. We can only now start working on this as nobody even took our calls prior to FDA approval.”
Do you not agree?
Schwah
There is always hope. But I am more cautious about insurance coverage based on previous examples. All he is saying was that they wouldn't even discuss the issue. He doesn't know if they will or won't now. At this point, there are no hints of CMS coverage, let alone private insurance coverage.
I too have found Czernin to be very responsive.
Is the UCLA PSMA PET scanner the same one that the VA uses? this address: 11301 Wilshire Blvd.
Los Angeles, CA. 90073
That I can not tell you.
Schwah
TA-thank you for all of your willingness to share your knowledge with us! To follow on the nature of your comment, what do you consider to be “too frequent” with respect to C11 Choline scans?
For C11 Choline, even one is too frequent now that we have so much better scans. Mayo will have to recoup their investment some other way. As far as radiation exposure goes, X-ray exposure comes from the CT and radioactive elements also emit gamma rays. The radiology report gives the total exposure. It is a small dose, but it is full body. It's not something you'd want to do multiple times a year every year, but fine if you need it.