Lutetium Psma localized prostate cance

[RickyScott]

Anyone know the status of trials for lutetium Psma in localized prostate cancer either alone or neoadjuvant to surgery. Could really transform the specialty if it pans out. How about lutetium vs as?

Lutetium-PSMA Appears Safe in Locally Advanced High-Risk Prostate Cancer

Treatment with neoadjuvant lutetium prostate-specific membrane antigen followed by radical prostatectomy exhibited a favorable safety profile in patients with locally advanced high-risk prostate cancer.

www.onclive.com

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[DoctwoB]

Think we’re a long away from that sadly, everything so far is single armed looking at small numbers. I can’t even find a true RCT protocol published yet, and from there it’ll be five years to get BCR results and 10 for survival. And even then we’ll still have the debate of surgery plus/minus PSMA vs xrt plus adt plus/minus brachy.

Would be great if it worked. Not holding my breath.

 

[xrt123]

Right now Novartis has 2 trials that I’m aware of. Randomized phase 3 trials.

A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naīve Men with Progressive Metastatic Castrate Resistant Prostate cancer

Another in the newly diagnosed metastatic disease hormone therapy +\-psma lu

 

[DoctwoB]

Right now Novartis has 2 trials that I’m aware of. Randomized phase 3 trials.

A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naīve Men with Progressive Metastatic Castrate Resistant Prostate cancer

Another in the newly diagnosed metastatic disease hormone therapy +\-psma lu

Wow that first trial is giving itself a low bar.

Saying you’re better then enza in a guy that failed abi (or vice versa) is essentially running a placebo controlled trial. Sure a few guys will respond to a second novel hormonal agent but standard of care would be to give the guy docetaxel or maybe a PARP inhibitor.

 

[RickyScott]

Wow that first trial is giving itself a low bar.

Saying you’re better then enza in a guy that failed abi (or vice versa) is essentially running a placebo controlled trial. Sure a few guys will respond to a second novel hormonal agent but standard of care would be to give the guy docetaxel or maybe a PARP inhibitor.

Vinay prassad made this point abt parp trial, but it was “succesful” and written up in the nejm by a paid medical writer, so they are just following the script.

 

[SneakyBooger]

 

[dieABRdie]

 

[Fpg1245]

Between the problems getting LU and the questionable research and the sheer number of other options for these men, my enthusiasm for it has dropped off considerably

 

[xrt123]

Another Novartis trial is closed due to it met its primary endpoint for Pluvicto. The Med Oncs are enthused. Side effects have been nothing. A new facility in Indianapolis will improve supply issues. Patient selection will improve with further data. All we need is a compound for breast....

 

[theradiator]

In theory, Pluvicto administration and related E&M codes should be reimbursed at $100/wRVU like other cancer infusions administered by Medical Oncology. When that will happen is beyond the horizon but I guess there is always hope.

 

[grenz]

Another Novartis trial is closed due to it met its primary endpoint for Pluvicto. The Med Oncs are enthused. Side effects have been nothing. A new facility in Indianapolis will improve supply issues. Patient selection will improve with further data. All we need is a compound for breast....

There is an investigational estrogen targeting tracer that I saw on Twitter recently. I’ve got to imagine someone wants to tag that with Lu177

 

[Fpg1245]

There is an investigational estrogen targeting tracer that I saw on Twitter recently. I’ve got to imagine someone wants to tag that with Lu177

Why that isotope as opposed to I125?

 

[medgator]

In theory, Pluvicto administration and related E&M codes should be reimbursed at $100/wRVU like other cancer infusions administered by Medical Oncology. When that will happen is beyond the horizon but I guess there is always hope.

Nuc med is pretty much dead as a standalone specialty outside of really big centers and we have an oversupply of rad oncs.

So yeah that isn't happening any time soon

 

[BobbyHeenan]

In theory, Pluvicto administration and related E&M codes should be reimbursed at $100/wRVU like other cancer infusions administered by Medical Oncology. When that will happen is beyond the horizon but I guess there is always hope.

The professional fees on these radiopharm infusions like xofigo or pluvicto are abysmal. The payment on a 3D plan for 8 Gy X 1 (just the plan, not the 77431) is superior to the administration of these drugs on the professional side.

There is legit work involved too with checking labs, managing side effects, etc that isn't reimbursed at all.

Maybe it's better for those out there that are employed, but for those of us with PSA's and billing pro fees only it's a nightmare. I do it because it's best for patients, but it is not ideal IMO.

 

[Fpg1245]

The professional fees on these radiopharm infusions like xofigo or pluvicto are abysmal. The payment on a 3D plan for 8 Gy X 1 (just the plan, not the 77431) is superior to the administration of these drugs on the professional side.

There is legit work involved too with checking labs, managing side effects, etc that isn't reimbursed at all.

Maybe it's better for those out there that are employed, but for those of us with PSA's and billing pro fees only it's a nightmare. I do it because it's best for patients, but it is not ideal IMO.

How do med oncs get paid for infusions if they are PC only?

 

[BobbyHeenan]

How do med oncs get paid for infusions if they are PC only?

In my experience that type of set up is not common for med oncs like it is a surgeon or rad onc.

For med onc they are either employed (and are basically getting a cut of infusion costs through some mechanism like high $/RVU or "medical director stipend" that exceeds typical pro fees) or are like some rad onc groups and own a brick and mortar building and their own pharmacy.

I have no clue what a med onc pro fee is on a chemo infusion but I'd bet it's more than the fees for these radionucleotide injections (as implied above by @theradiator

 

[dieABRdie]

How do med oncs get paid for infusions if they are PC only?

Either very high $/RVU amounts if employed... (which they can justify based on current demand); and end up getting paid way more than their pro fees would compensate.

Or I've seen very business savvy private groups that have some kind of "chemo management fee" written into the contract with the hospital system. This serves the same function as $/RVU in funneling the extra revenue the hospital gets (facility / technical / infusion / 340b margin, etc.) into the physician's compensation. That's not common these days as doctors just believe the hospital admin when they say they aren't legally allowed to do that b/c Stark, kickback, etc. If structured correctly, it is completely legal.

But then again, you've got to have leverage in the situation.

 

[RickyScott]

How do med oncs get paid for infusions if they are PC only?

They arent. They recieve 100$+ per rvu. The greatest trick the devil ever pulled was convincing docs that salaries are set by professional fees not supply and demand.

 

[medgator]

The professional fees on these radiopharm infusions like xofigo or pluvicto are abysmal. The payment on a 3D plan for 8 Gy X 1 (just the plan, not the 77431) is superior to the administration of these drugs on the professional side.

There is legit work involved too with checking labs, managing side effects, etc that isn't reimbursed at all.

Maybe it's better for those out there that are employed, but for those of us with PSA's and billing pro fees only it's a nightmare. I do it because it's best for patients, but it is not ideal IMO.

And if you have to bill the drug on the technical side, you better make damn sure your revenue cycle/cash management is pristine.

It's med onc financial inner workings, not rad onc

 

[BobbyHeenan]

And if you have to bill the drug on the technical side, you better make damn sure your revenue cycle/cash management is pristine.

It's med onc financial inner workings, not rad onc

Yes, I have heard it's better now but I know of a multi specialty group that had to eat some Y-90 charges due to patient no shows and it was a mess. Maybe eventually reimbursed but that's a big hole in the balance sheet for a while.

 

[RickyScott]

Yes, I have heard it's better now but I know of a multi specialty group that had to eat some Y-90 charges due to patient no shows and it was a mess. Maybe eventually reimbursed but that's a big hole in the balance sheet for a while.

That’s why it laughable that some push the notion that radiation oncology will be saved by a loss leader.

 

[RadOncDoc21]

That’s why it laughable that some push the notion that radiation oncology will be saved by a loss leader.

It’s better then omitting radiation in my opinion. I know there are still indications for radiation but we’ve made it a hard sell for whatever reason.

The field of nuclear medicine (imaging, therapies) is growing while our field (external radiation) is shrinking.

 

[sirspamalot]

The former big Z mouthpiece of ASTRO (who I first encountered when he was a RESIDENT on a visiting rotation) a few years later at an ASTRO meeting touted the idea of "Interventional Oncology" as a possible specialty. Rolling forward another 10-12 years and.. we're getting there.


ps. If you hang around a Harvard type place long enough, and have even the slightest bit of personality.. you can go far.

 

[grenz]

Came across this interesting article about the radiopharm landscape and drugs in development.

https://www.precisionmedicineonline.com/cancer/pluvictos-arrival-prostate-cancer-brings-competition-debate-over-imaging-agents

If the alpha emitters pan out, it would make these much more feasible to be administered in rad onc clinics. The fact that drugs for breast cancer, RCC, and others are in development tells me that setting up programs now are a hedge for the future. All it takes is a new personalized dosimetry code for them to be more financially viable even if you don’t bill global.

 

[BobbyHeenan]

Came across this interesting article about the radiopharm landscape and drugs in development.

https://www.precisionmedicineonline.com/cancer/pluvictos-arrival-prostate-cancer-brings-competition-debate-over-imaging-agents

If the alpha emitters pan out, it would make these much more feasible to be administered in rad onc clinics. The fact that drugs for breast cancer, RCC, and others are in development tells me that setting up programs now are a hedge for the future. All it takes is a new personalized dosimetry code for them to be more financially viable even if you don’t bill global.

We desperately need new codes on the professional side for this. Reimbursement is abysmal and unless hospital is willing to give you a cut of the drug /technical fees (in my experience unlikely) it's literally like a $90 code (79101) to administer these drugs on the pro side...and no reimbursement for any management during their treatment due to bundling.

 

[grenz]

We desperately need new codes on the professional side for this. Reimbursement is abysmal and unless hospital is willing to give you a cut of the drug /technical fees (in my experience unlikely) it's literally like a $90 code (79101) to administer these drugs on the pro side...and no reimbursement for any management during their treatment due to bundling.

We do xofigo and if the alpha emitters are administered anything like xofigo, it’s $90 for about 10 minutes of physician time. No need to block a consult slot for it, so it’s not like it’s costing you an ebrt pstient. $540/hr rate is nothing to sneeze at. That’s in addition to the E/M before every infusion

 

[RickyScott]

We desperately need new codes on the professional side for this. Reimbursement is abysmal and unless hospital is willing to give you a cut of the drug /technical fees (in my experience unlikely) it's literally like a $90 code (79101) to administer these drugs on the pro side...and no reimbursement for any management during their treatment due to bundling.

And worse, radiology/nuc meds is very protective. It is an absolute joke that ASTRO has a session on how to start a program as there is almost no major center that lets radonc anywhere near radiopharmaceuticals. Nevertheless, this doesnt stop those who dont administer radiopharm from claiming that it is the future of our specialty.

 

[BobbyHeenan]

We do xofigo and if the alpha emitters are administered anything like xofigo, it’s $90 for about 10 minutes of physician time. No need to block a consult slot for it, so it’s not like it’s costing you an ebrt pstient. $540/hr rate is nothing to sneeze at. That’s in addition to the E/M before every infusion

Xofigo is easier, definitely.....but pluvicto or lutathera not so much.

You better check your ability to bill an E/M before every infusion. I was under the impression that cannot be done. Would definitely be good news if you can do that.

 

[thecarbonionangle]

Supposedly ASTRO leadership believes that radiopharm and benign disease is our future. What are we doing to increase pay for these? Would love to hear more on that. I saw the Amdur PRO editorial call to arms but the finances have to make sense.

 

[RickyScott]

Supposedly ASTRO leadership believes that radiopharm and benign disease is our future. What are we doing to increase pay for these? Would love to hear more on that. I saw the Amdur PRO editorial call to arms but the finances have to make sense.

I think SK is open to benign disease, but my guess is that most of astro leadership could care less. radiopharm is not controlled by radonc and these "leaders" certainly can not wrestle it away from rads. I am still searching for a single academic department that provides pluvicto at the main campus?

 

[grenz]

I am still searching for a single academic department that provides pluvicto at the main campus?

Why does what academic centers are doing matter to non-academic? Rad oncs should make the case to admin that because of our scope of practice and role in cancer care, we can make these programs more successful than nuc med.

Also, I’m pretty sure we’re getting paid for the e/m. The amdur editorial indicated they are too.

 

[BobbyHeenan]

Why does what academic centers are doing matter to non-academic? Rad oncs should make the case to admin that because of our scope of practice and role in cancer care, we can make these programs more successful than nuc med.

Also, I’m pretty sure we’re getting paid for the e/m. The amdur editorial indicated they are too.

That's good news. I need to start billing that then. Is it billed as same DOS as the infusion or are you bringing them in for a clinic visit prior to the infusion?

 

[madchemist89]

We gave tons of radiopharm at my residency program including lutathera and pluvicto, on trial at the time. Out in the community giving these would be difficult and take a lot of physician and physics time. You need dedicated space in your clinic too. The reimbursement is a joke and radiopharm is a risk if patient no shows. I just don't see it helping us without reimbursement changes.

 

[OTN]

We are doing it in the community. Rolling it out very slowly and carefully, as it is indeed a much bigger fish to fry than Xofigo.

 

[NotMattSpraker]

I think SK is open to benign disease, but my guess is that most of astro leadership could care less. radiopharm is not controlled by radonc and these "leaders" certainly can not wrestle it away from rads. I am still searching for a single academic department that provides pluvicto at the main campus?

He claims he is making it the theme of the 2025 meeting haha. We will see. I don't know the track record ASTRO presidents of keeping campaign promises. I can't wait to read all about the different races and the rates they get radiation for arthritis.

You don't need ASTROs permission to do anything. Benign is rewarding, I would encourage you to start doing it if it makes sense in your practice/center.

 

[drowsy12]

Supposedly ASTRO leadership believes that radiopharm and benign disease is our future. What are we doing to increase pay for these? Would love to hear more on that. I saw the Amdur PRO editorial call to arms but the finances have to make sense.

I think there's no question that these are part of our future. to give up radiopharm would be short sighted.

in the long term, it doesn't necessarily have to be a pro fees rise. If these therapies play out and become SOC in multiple disease sites, there will be a need for someone to do it, and hospitals will need rad onc docs to do these things, as long as we establish our role now.

med onc pro fees suck. many specialities pro fees suck. they get paid because they provide a service and thus hospitals need them. we are used to pro fees being our bread and butter, but there are other ways in which this can provide value to the specialty as a whole in the future.

I have zero issue with ASTRO having practical sessions on how to build a practice or for the field of rad onc to care about doing stuff like OAR dose deposition studies (which IR can't and won't care to do).

I expect ACRO to have sessions on these in the future too. this is real world practical stuff that we should care about, IMO.

 

[RickyScott]

He claims he is making it the theme of the 2025 meeting haha. We will see. I don't know the track record ASTRO presidents of keeping campaign promises. I can't wait to read all about the different races and the rates they get radiation for arthritis.

You don't need ASTROs permission to do anything. Benign is rewarding, I would encourage you to start doing it if it makes sense in your practice/center.

unprecedented if the astro president does something beneficial for the field.

 

[RickyScott]

med onc pro fees suck. many specialities pro fees suck. they get paid because they provide a service and thus hospitals need them. we are used to pro fees being our bread and butter, but there are other ways in which this can provide value to the specialty as a whole in the future.

radopharm technical and prof fees dont really matter in an employment/supply and demand driven system. My salary is still going to be based on supply and demand even if there was 100K prof fee every time radiopharm was delivered.

 

[BobbyHeenan]

radopharm technical and prof fees dont really matter in an employment/supply and demand driven system. My salary is still going to be based on supply and demand even if there was 100K prof fee every time radiopharm was delivered.

yes.

In my set up though I bill pro fees only. Been very busy so never asked for a cut of technical...but if we have to start up a big radiopharm program then our group is going to have to ask for $ from the hospital. It is my understanding (may be wrong here though) that the reimbursement on the technical/hospital side really isn't amazing either.

 

[NotMattSpraker]

yes.

In my set up though I bill pro fees only. Been very busy so never asked for a cut of technical...but if we have to start up a big radiopharm program then our group is going to have to ask for $ from the hospital. It is my understanding (may be wrong here though) that the reimbursement on the technical/hospital side really isn't amazing either.

Depends if you have a 340B program.

There could be a halo effect too. This is true for proton therapy and things with good branding like Cyberknife. My guess is that at least some patients referred for radiopharm may need palliative radiation and/or SBRT instead or in addition, or at a future time.

 

[drowsy12]

Depends if you have a 340B program.

There could be a halo effect too. This is true for proton therapy and things with good branding like Cyberknife. My guess is that at least some patients referred for radiopharm may need palliative radiation and/or SBRT instead or in addition, or at a future time.

yes, agree.

there's no reason med onc should be the only ones prescribing radiopharma.

we always talk here about how we should take on systemic therapies.

this is as close as it gets right now.

 

[RickyScott]

ly

Depends if you have a 340B program.

There could be a halo effect too. This is true for proton therapy and things with good branding like Cyberknife. My guess is that at least some patients referred for radiopharm may need palliative radiation and/or SBRT instead or in addition, or at a future time.

I am not sure it is covered by 340B. we have 340B and my admins hate pluvicto. We have a very active program, and at time the only site in a large metro with access during the shortage, and have seen zero halo effect. (by the time they need pluvicto, they have longstanding relationship with medon) Pts from outside return to their medoncs.

 

[BobbyHeenan]

ly

I am not sure it is covered by 340B. we have 340B and my admins hate pluvicto. We have a very active program, and at time the only site in a large metro with access during the shortage, and have seen zero halo effect. (by the time they need pluvicto, they have longstanding relationship with medon) Pts from outside return to their medoncs.

We have 340B too and there has been little interest from admin in ramping up radiopharm...though some of that is due to logistics/shielding/infusion staffing/bathroom construction needs.

I would be curious to know if these drugs fall under 340B pricing. I haven't checked on that.

 

[temujim]

Depends if you have a 340B program.

There could be a halo effect too. This is true for proton therapy and things with good branding like Cyberknife. My guess is that at least some patients referred for radiopharm may need palliative radiation and/or SBRT instead or in addition, or at a future time.

Many rad onc departments have ceded radiopharm to nuc med/IR and allowed med onc to drive bc of the reimbursement issue. If leadership was far sighted rad onc would control this space -- imagine having our own pharma! Huge for the field. If you control your follow ups, presence at tumor boards, etc nuc med would be easy to cut out. IR less so -- but eventually dosimetry may be important and in general rad onc controls physics -- so a struggle IR would have difficulty winning. But even better to get in on the ground floor and create the program rather than have a political struggle over it.

 

[grenz]

That's good news. I need to start billing that then. Is it billed as same DOS as the infusion or are you bringing them in for a clinic visit prior to the infusion?

i assume it’s getting paid but haven’t checked with the billers. It’s just a 15 minute on same DOS

Many rad onc departments have ceded radiopharm to nuc med/IR and allowed med onc to drive bc of the reimbursement issue. If leadership was far sighted rad onc would control this space -- imagine having our own pharma! Huge for the field. If you control your follow ups, presence at tumor boards, etc nuc med would be easy to cut out. IR less so -- but eventually dosimetry may be important and in general rad onc controls physics -- so a struggle IR would have difficulty winning. But even better to get in on the ground floor and create the program rather than have a political struggle over it.

My understanding is leaders in the field think there will eventually be personalized dosimetry and associated codes

 

[dieABRdie]

We have 340B too and there has been little interest from admin in ramping up radiopharm...though some of that is due to logistics/shielding/infusion staffing/bathroom construction needs.

This seems to be the issue for us. The admins that are directly responsible for those things; are also responsible for so many other nuclear medicine imaging studies that compete for resources. Pluvicto just gets in the way.

Its the C-suite that sees the monetary benefit... not them.

 

[BobbyHeenan]

i assume it’s getting paid but haven’t checked with the billers. It’s just a 15 minute on same DOS

My understanding is leaders in the field think there will eventually be personalized dosimetry and associated codes

I would be interested to know if you're getting paid for it. Looks like in my quick google search others were asking this question....

Wiki - Hematology/Radiation Oncology

Question for Radiation Oncology coders... We bill a series of 6 injections with and e/m & 25 modifer for each injection (cpt 79101/99213/25). I would like to know if this is how others are billing for radiopharmaceutical therapy? Aslo, are your payers paying or are they bundling your e/m code...

www.aapc.com

If need be, on the day the patient gets their CBC for cycle 2 i'm sure you could see, though again I don't know if anything e/m is paid for since presumably you're also billing a 77263 at some point prior to injection #1.

AT least how I was trained/taught, I was taught to bill:
77263 (complex treatment planning)
77470 (special treatment procedure), though this one is questionable maybe
79191 at each injection.

I was told you definitely can't bill a 77427 and I was told (again, not verified) that you can't bill E/M charges during the treatment course.

===

Use This 3-Step Process for Accurate Xofigo Coding : You Be the Coder

Question: What is the correct way to code for radium Ra 223 (Xofigo) therapy for a patient with advanced resistant prostate cancer? Texas Participant Answer: How you code this will depend on what your oncologist actually does in the therapy and whether your practice supplies the [...]

www.aapc.com

Here is another snippet from a coding website:

Question: What is the correct way to code for radium Ra 223 (Xofigo) therapy for a patient with advanced resistant prostate cancer?

Texas Participant

Answer: How you code this will depend on what your oncologist actually does in the therapy and whether your practice supplies the Xofigo used. Follow these steps to arrive at the most appropriate way to document what your practice has — or not has not — done for the patient in this prostate cancer treatment service.

Step 1: Code for planned follow-up or not. The basic regimen for Xofigo involves administration of six injections of the radiopharmaceutical, usually at four-week intervals. If your provider determines that your patient will need follow-up care for the treatment, you will use 77750 (Infusion or instillation of radioelement solution (includes 3-month follow-up care)). But if your provider decides the patient will not need follow-up, then you will use 79101 (Radiopharmaceutical therapy, by intravenous administration). This code is inclusive of any unplanned follow-up the patient may need during the 90-day global period for the therapy.

 

[sirspamalot]

Rural CEO asked me about radiopharm, should we do it?

"You want the short answer, or the long answer"

"Lets start with the short answer..."

NO

 

[xrt123]

Depends if you have a 340B program.

There could be a halo effect too. This is true for proton therapy and things with good branding like Cyberknife. My guess is that at least some patients referred for radiopharm may need palliative radiation and/or SBRT instead or in addition, or at a future time.

My partner and I have done 40+ patients with Pluvicto and 2 needed palliative single fraction bone met and 1 got SBRT for a single bone met with plan for pluvicto later. The hospital makes all the money on this. We do it for political reasons and patient benefit. Not a big halo so far.

 

[grenz]

Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

www.novartis.com

Sorry not pluvicto but thought it was related enough. Will have to see OS result and how many patients in control arm got lutathera upon progression