FDA approves Ga-68-PSMA PET scans only at UCSF and UCLA

[Tall_Allen]

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.

[Schwah]

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 .

[Tall_Allen in reply to 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.

[Schwah in reply to Tall_Allen]

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

[GeorgeGlass in reply to 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.

[Schwah in reply to GeorgeGlass]

That’s what I was told. But I can not independently confirm that.

Schwah

[Tall_Allen in reply to GeorgeGlass]

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.

[Tall_Allen in reply to Tall_Allen]

Your radiology report tells you what your exposure was.

[GeorgeGlass in reply to Tall_Allen]

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."

[Tall_Allen in reply to GeorgeGlass]

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

[GeorgeGlass in reply to Tall_Allen]

OK thanks Allen

[Schwah in reply to Tall_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

[Tall_Allen in reply to Schwah]

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.

[Schwah in reply to Tall_Allen]

Well it seems like the PSMA scans will now be covered at least under certain circumstances but who knows how long that might take.

[Tall_Allen in reply to Schwah]

Where did you hear that it will now be covered?

[Schwah in reply to Tall_Allen]

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

[Tall_Allen in reply to 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.

[6357axbz in reply to Schwah]

I too have found Czernin to be very responsive.

[GeorgeGlass in reply to Schwah]

Is the UCLA PSMA PET scanner the same one that the VA uses? this address: 11301 Wilshire Blvd.

Los Angeles, CA. 90073

[Schwah in reply to GeorgeGlass]

That I can not tell you.

Schwah

[Azores1 in reply to Tall_Allen]

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?

[Tall_Allen in reply to Azores1]

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.

[StayingOptimistic]

Thank you very much TA for explaining it because I was wondering about it.

[garyi]

A good start. Hopefully approval of DCFPyL scans and other PSMA ones will occur soon.

[6357axbz in reply to garyi]

The PyL scan has shown better resolution than the Ga68. The University of Wisconsin in Madison would be one place it would be administered. More convenient by far than UCLA for those of us in the Midwest.

[Tall_Allen in reply to 6357axbz]

How much are they charging and under what circumstances?

[6357axbz in reply to Tall_Allen]

I spoke with Dr. Cho there in early June hoping to avoid travel to UCLA. They were not and have not offered for pay scans outside of the PyL trial he was leading there. At the time their trial had been discontinued due to Covid. One of the articles people have provided links to here in the last hour or so said something to the effect that the PyL FDA approval was not far behind.

[Tall_Allen in reply to 6357axbz]

Yes, I am hopeful that FDA will approve PyL too. The PyL trial took place in many institutions so I hope that they will approve its use in many institutions. Meanwhile, it is silly to get carried away with our own hype.

[Jessie5 in reply to 6357axbz]

My husband is stage 4 and a patient of Dr. Lang at UWM. I wonder why this trial hasn’t been offered to him? He did however participate in the PSMA trial 12/2019-but obviously we nor the dr gets to know the results. That scan was performed 1 week before his removal.

[mperloe]

The issue with approval is the ability to generate and bind the Ga68 to the PSMA. There is another company that may be soon approved that will offer a kit so that testing can be more widely available. I assume that PSMA studies will continue.

[Ralph1966]

I am wondering why scientists can't find a way to attach a chemotherapeutic agent and attach it to this PSMA so it will target and kill all cancer cells even the tiny ones.

[Tall_Allen in reply to Ralph1966]

They certainly do. That's what Lu-177-PSMA and Ac-225-PSMA do with targeted radiation. Coupled with immunotherapies, that's what BiTE and antibody-drug-conjugates do. They even couple it with docetaxel and other kinds of chemo. All of them are in clinical trials.

[billyboy3]

This is another sad example of how restricted the treatments involving advanced prostate cancer are being treated by the FDA. It is LONG overdue that some are able to prevent most of us from obtaining treatments, unless we are within the confines of what, only TWO medical facilities. It is draconian treatment and MUST change.

We need to somehow push for more expanded treatments at many more facilities!!!!

Our lives are at stake so WE should be the ones to have a say in treatments that might just save our lives, or at the least, give us more time.

[Tall_Allen in reply to billyboy3]

This is a diagnostic aid, not a treatment. What good does it do you if Homer's Cancer Imaging of Buttfuck, Kentucky says they can do a Ga-68-PSMA PET scan on you and they do not have the right equipment, chemicals, or radiologists who know how to read the results.

IMO, the gov't or some major NGO should qualify equipment and radiologists. Neither you nor I know enough about the technology to do quality control by ourselves. I think many men were misdiagnosed when every hospital in the US rushed to advertise that they were able to do mpMRIs. Do we want to make the same mistake?

[Fightinghard in reply to Tall_Allen]

Ever visited Kentucky? Very pretty state with lots of friendly and well educated people.

Maybe stop by and have a drink with Homer while there.

[Tall_Allen in reply to Fightinghard]

I've been to Louisville, never been to Buttfuck, though.

[V10fanatic in reply to billyboy3]

And here I thought it was just because California needs more tourist dollars now that COVID restrictions have shut down virtually everything else 😆

[dhccpa]

How does this differ from an Axumin PET scan or a PET Bone scan? I've had both of those. Thanks.

[Concerned-wife in reply to dhccpa]

This has a section that discusses your question. And other good info. ascopubs.org/doi/full/10.12...

[dhccpa in reply to Concerned-wife]

Thanks I'll take a look.

[Tall_Allen in reply to dhccpa]

This explains them:prostatecancer.news/2016/12...

[dhccpa in reply to Tall_Allen]

Thanks, TA. Very informative on several levels.

[JPnSD]

Does this remove the PSA of 2 that was used as a screening tool for getting UCLA PSMA scans previously? I am now undetectable (<.01) since starting ADT in Oct., but recent tenderness under the right armpit and right groin have me concerned (Drs. have said they are not concerned it is related and say I had a neg Auximin in July) ....and my salvage radiation is now pushed back until after the new year or getting a COVID vaccination. Thanks...and happy holidays.

[Tall_Allen in reply to JPnSD]

UCLA uses and has always used a PSA of 0.2 ng/ml to define recurrence after prostatectomy. It never used 2.0. Enlarged LNs in the armpit and groin probably have nothing to do with your PCa, especially since you are on ADT.

[6357axbz in reply to Tall_Allen]

I believe it’s the lower end of PSA where the UCLA scan has good resolution.

[Tall_Allen in reply to 6357axbz]

The higher the better in terms of detection, but we want a PET scan that detects at a lower PSA of course.

[JPnSD in reply to Tall_Allen]

Sorry...typo. .2 was the intent. So are they requiring a PSA of .2 to get a scan there now? (Meaning I would not qualify at present?) Thanks for the reassurance on the lymph nodes. Meeting with Primary next week.

[6357axbz in reply to JPnSD]

For my UCLA scan in June I was required to allow my PSA rise from undetectable to at least 0.5

[Tall_Allen in reply to 6357axbz]

That may have been a requirement for some clinical trial you were on. It is not a UCLA requirement:healthunlocked.com/prostate...

[billyboy3]

Tal, exactly the point I was trying to get at. There is nowhere near sufficient resources being put into place to effectively deal with the huge number of cases of prostate cancer, and your noting a lack of experts in this new area, is again proof of men being treated as SECOND class citizens!!!!

I could on in comparing the large dollars spent on aids back in its crisis days, while prostate has always received the lowest fund input. Breast cancer (and no slight on them) also receives a much greater amount of funding than does prostate cancer.

I repeat, take it like a man, die like a man, is total BS and until we rise up and say that we are NOT going to take it anymore, we will continue to see only marginal lip service paid to our cause. 40,000 men die each year, enough said boys!! TIME FOR WAR TO GET OUR SHARE OF THE PIE.

As a start, once the virus is under control, perhaps we could get the research facilities to expend the same energies toward finding a cure or making prostate cancer a chronic disease.

Am I wrong to think this???????

[Tall_Allen in reply to billyboy3]

Prostate cancer is second only to breast cancer in the number of research dollars spent on it. People with, say, lung cancer, argue that PCa is overfunded relative to their cancer because of the lethality of lung cancer. But that is competition for the size of a slice of a pie. The other way is to get a bigger pie.

Biden has a particular interest in cancer research, so I expect we'll see his proposals for funding increase, but whether Congress passes his proposals will probably have more to do with the Senate elections in Georgia next month. There are NGOs like PCF that are an important source of private funding. So what you, as a private citizen can do, is contribute to political campaigns and charitable donations.

[Tall_Allen]

There are several privately funded tests to improve on PSA for early detection. The hot new one is the Sentinel RNA test.

[billy1950]

T_A Would you if medicare covers the cost for GA-68-PSMA outside of those centers UCSF and UCLA…I had it done at MSKCC in NY.

Thanks

[Tall_Allen in reply to billy1950]

I don't understand. Would I what?

[billy1950]

Sorry, would you know if medicare covers the cost for the PSMA test ?

[Tall_Allen]

Yes they do.

[TEBozo]

Now available at UT Southwestern Medical Center Dallas. Medicare + Blue Cross Supplement paid.