FDA approves PSMA Imaging

Excellent news! I wonder if it will be covered for the post-diagnosis initial workup. It has been used for some men who are initially diagnosed with a high PSA when mets are suspected. Of course that would bump up the cost of the workup (I don't think it can replace the usual MRI or CT imaging).

It will be interesting to see who gets insurance coverage for this scan in addition to men who encounter BCR after primary treatment.

I know that some institutions have been waiting for this approval -- you need to have a Ga-68 nucleotide generator near the point of imaging. The half-life of the nucleotide is only 68 minutes, so you have to hustle

Djin

Thanks for posting...should be interesting to see if insurance covers...

I probably didn’t have anything to do with getting this approved...but I participated in some of the early PSMA imaging studies at NIH a few years ago.

The usual routine following FDA approval is for Medicare to do a cost benefit evaluation. If they approve it for reimbursement then they will set the reimbursement level. After which the VA typically follows suit. Then the commercial insurance companies and union plans start the negotiation process to set reimbursement limits for their network providers. This process often takes months.

If my memory serves, this was approved in Europe a few years ago. We are always slower . Maybe a good thing but who knows, in this case I dont think so

steve0 said...
I feel so fortunate because as a veteran the VA paid for mine to be done at a outside hospital.. Thank you Donald Trump

God bless.

This is great news! I've had two C-11 Acetate scans in Phoenix (before and after taxotere- 2017 / 2018), and a recent PSMA Gallion scan at UCLA. While each cost me $3,000, there's nothing like these scans for presenting PC mets.

Although my scan at UCLA showed only a few "minor" bone mets when my PSA had climbed to 4.7, I'll need to do another one next year, given the current PSA of 17.7. Hope insurance will cover--but if it doesn't, I'll be back at UCLA to take another look at things.

Is anyone waiting in line for this test? Very anxious to sign up as soon as we can and assuming Aetna approves.

I was just reading the Second Quarter Medicare CMS coding assignments. The document shows that they received HCPCS coding requests from UCLA and UCSF and assigned specific codes to each because the pharmaceuticals are similar, but not identical. The codes are effective July 1. This is an initial step in the process toward Medicare reimbursement approval.

The FDA approval is specific to the pharmaceuticals from UCLA and UCSF. According to a recent report neither institution has applied to get approval for distribution to other institutions/providers. Until that happens, it looks like they will be the only source for the scans.

However, another report indicated that neither institution sought exclusivity. So it may be that other manufacturers can use the information to produce the pharmaceutical and distribute it. There are specific approval processes that must be followed by the manufacturer. It indicated that other manufacturers are rumored to be in process, but won’t go formal until they know what they can charge for the pharmaceutical. Thus, waiting on Medicare and then the other third party payors to set reimbursement amounts.

Actually the FDA just approved a second drug for use in conjunction with PSMA scans that should have much broader availability....for example this is available in New Orleans, which is much more convenient for me.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-second-psma-targeted-pet-imaging-drug-men-prostate-cancer

These two PSMA imaging agents (Ga 68 PSMA-11 and piflufolastat F 18) should be compared in a trial.