PYLARIFY PSMA - Where and when

The FDA just recently approved the PSMA (piflfolastat F 18) scan. In the press release they say it will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the US by year end.

Does anyone know if this is available anywhere currently? And any timeframe for when it will be available?

Thanks.

I would call local imaging centers and ask.

JNF,

Thanks for the info...

I was thinking that the PSMA that was just FDA approved (The Lantheus PyL F 18) had nothing to do with UCLA’s Gallium-68 PSMA. The PyL is on a national scale...but after reading a bit more ... I think that they are also looking at making the Gallium-68 commercially available which needs FDA approval...So, we will probably see two tracers available at some point.

I have contacted a few institutions and I don’t have any word yet. I realize it is early in the approval process....and I really didn’t think this out, but you’re probably correct in that each facility might need individual FDA approvals...

Years ago I participated in a PSMA trial at NIH, but I don’t think it was either one of these tracers.

Thanks again.

I am seeing a specialist at Tulane (New Orleans) that has the Pylarify available for PSMA scans. Just hoping I wont need it or my insurance covers it before I get to a PSA of 2.0. Currently at 0.7. I saw a map somewhere that showed the locations it would be offered, but I cant find it now. Will post if I locate it.

As promised, here is the locations Pylarify is/will be available ->
https://www.pylarify.com/ordering-and-reimbursement

DaysBetween and Jerry. I just looked at their map and everything just says planned and doesn’t disclose the institution they will be working with in each area. Looks like the reimbursement information is pretty boilerplate with nothing specific. You can check the CMS Medicare website and get the billing code, assuming it has been issued. Also call your insurance company and ask them the reimbursement status. It is early in the rollout and doesn’t really look like they are operable yet.

DaysBetween, reading the summary of the trials it indicated detecting PCa with PSA as low as .8. So you are borderline from that standpoint. I am sure that PSA will be one of the qualifying factors for the use.

Are you seeing Dr. Oliver Sartor?

Just so everyone understands....these are not locations where you can get the PSMA scan done....I think these are Lantheus locations that will provide the tracer/agent to imaging centers...As of yet, I don’t know what imaging centers are doing this scan now...it’s still early and things are getting set up...

Jerry L. said...
Just so everyone understands....these are not locations where you can get the PSMA scan done....I think these are Lantheus locations that will provide the tracer/agent to imaging centers...As of yet, I don’t know what imaging centers are doing this scan now...it’s still early and things are getting set up...

Just like some of the other radioactive tracers, Pylarify has a short half-life (110 min), and must be produced in an expensive cyclotron. This means that scanning sites either need to have their own on-site cyclotron or have the tracer produced and brought to them per scan as needed. It would appear the company is going the distribution-only route. Short half-lives are important, because we want the body to completely eliminate the agent in a relative short time. For those interested, there is company information on Plyarify itself where I read that "In the first 8 hours post-injection, approximately 50% of administered radioactivity is excreted in the urine."

Djin

one in FT Lauderdale is 1st--more avail. almost immed. on Atlantic coast
NOT the same one in CA--that is only in trial and self-pay : PYLARIFY® (piflufolastat F 18) Injection, the First and Only COMMERCIALLY Available PSMA PET Imaging Agent for Prostate Cancer
this was FDA approved 5/27/21

Purple,

I noticed as well that Fort Lauderdale, Florida was doing starting to schedule…I signed up but haven’t heard back yet.

I have tried John’s Hopkins and a few other larger institutions and so far not yet…

Thanks for the info….

On their Plarify website, Lantheus has altered the availability map to show it is now available at 12 sites, including Atlanta. However, I can find no link to the specific clinics or any contact information. So no way I know of to contact the local clinics to find out about scheduling and reimbursement.

Plus, as of this morning, I can find no Medicare reimbursement approval, as yet. Until Medicare issues reimbursement guidance, there probably won’t be any actual treatments or pricing information. That is probably why they aren’t returning calls. If Medicare approves reimbursement then the other third party payors will make and communicate their determinations and the scanning can begin. If Medicare doesn’t grant reimbursement, or issues a very narrow use, then the clinics will set a cost that will apply to a self-pay condition and some will start scanning.

For those of you interested in the scan, I trust you have discussed this with your doctor as they have to write the prescription for the scan. What are your doctors telling you?

Thanks Jerry. While your doc wrote the script, exactly to which center is he sending you? Why hasn’t it been scheduled? Do you even have a clinic that says they are ready? What does your insurance company say regarding a pre-treatment approval? Have you filed for it? Again, I don’t think anything is going to happen until there is Medicare reimbursement guidance. CMS has assigned reimbursement codes, but hasn’t yet issued reimbursement guidance. That often takes from three months to a year after FDA approval and issuing the codes.

I agree that Lantheus stonewalling is not helpful for you, but it is to be expected. They have put everything in place so that the second Medicare and third party reimbursement is clarified everything is live with no delays. Currently they are building a database of interested patients that they will focus on at the appropriate time. This backlog also shows potential clinics why they should get on board and make the investment to produce the injectable component and ramp up the training to do the scan. If they didn’t do it this way there would be a multi-month delay between approval and utilization. To Lantheus and the clinics that revenue delay would be very costly.

When I search for Plyarify in Atlanta, all I get is the information that Lantheus is recruiting sales people. One clinic I had seen that was touting it has changed the website and removed the information. Probably got tired of telling people “not yet”.

One issue in front of the reimbursement guidance process is the negative side effect some people have regarding salivary and tearing function. The injectable has a way of concentrating in these areas and can cause damage degrading their function resulting in dry mouth and/or dry eye. I don’t remember these were observed in the two trials but has been reported in other PSMA studies. There is good commentary about this on the PCF website. CMS and third party payors will be very careful with this as they don’t want to potentially have to pay money treating side effects of the scan and injectable. As I recollect in the trials, as low as 12% of the participants were shown to have Mets. One trial showed higher positives than the other and much of it depended on the PSA levels. Obviously the higher the PSA the higher the probability of finding Mets. This goes with most every scan. Even with the some of the relatively low positive results, it was argued that the cost/benefit was significant enough for FDA approval. As a payor if you are paying for 100 scans to find 12 positives you may introduce stricter guidelines for the scan to reduce the ratio of negative results. This saves resources and exposes fewer people to potentially adverse side effects. This balancing act is an example why reimbursement guidance is tricky and time consuming. Examples may include requiring a higher PSA to qualify for reimbursement. While it did find some Mets at .8 PSA, detection was lower as a percentage than at higher PSA levels. Thus it may be reasonable to assume that reimbursement guidance will include several factors for qualification.