Integration of Lutetium-177 and the Value of Shared Decisions with Practice Stakeholders - Jeffrey Zemencik

October 13, 2023

Phillip Koo interviews Jeffrey Zemencik about the challenges and considerations of integrating the PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) treatment into large urology practices. Mr. Zemencik emphasizes the importance of a multi-disciplinary approach, involving stakeholders from various departments like operations and revenue cycle. He underscores the billing and reimbursement guide provided by the manufacturer. Mr. Zemencik also talks about the role of electronic medical records in streamlining the ordering and documentation process. On the operational side, he mentions the need for specific licenses and equipment, estimating an initial capital requirement that will vary depending on your existing equipment. Mr. Zemencik advises practices to plan for the future, as the demand for radiopharmaceuticals is likely to grow, affecting space and resource needs.


Jeffrey Zemencik, Director, Radiation Centers, Chesapeake Urology

Phillip J. Koo, MD, Division Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Arizona

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Phillip Koo: Hi, my name is Phillip Koo, and welcome to UroToday. With the approval of PLUVICTO, we've seen a markedly increased demand for this wonderful drug across multiple markets in the US and across the globe. With that comes challenges with regards to how we increase access to this important treatment for patients, particularly in the United States. We're continuing our special series looking at how we integrate this treatment into large urology group practices in America, and we're very fortunate to have with us Jeff Zemencik, who's the director of radiation therapy at Chesapeake Urology. Welcome, Jeff.

Jeffrey Zemencik: Thank you.

Phillip Koo: So one of your urologists comes to you and says, Jeff, we really need to start this RLT program for our patients. What do you do next to make this happen?

Jeffrey Zemencik: Well, as with anything, it's all about the team, right? So we certainly have to get all the stakeholders involved from if it's a freestanding versus hospital system. In our case, we are freestanding urology owned, so we get the urology stakeholders, CMO authorized users, whether they're radiation oncologists or nuclear medicine physicians, operations, revenue cycle. So it's really important to bring everyone together to discuss, especially when something's new. We were fortunate enough to be doing the clinical trials for Lutetium, so for us, being available on the market now commercially was a lot easier of a transition for us.

Phillip Koo: So if we break that down, I think the one piece is always you want to make sure it's financially sustainable. What are some of the key points that practices need to consider when it comes to the financial piece to an RLT program?

Jeffrey Zemencik: Sure. So it is such a huge benefit to have this for our patients, so of course we want to do everything we could to be able to offer it to them. So of course, Novartis did a great job in having a billing and reimbursement guide for us to go off of, because as with anything, you need codes that are recognized and be able to get paid. So they did a great job at giving us an outline at least so that our revenue cycle department could go and look and see what reimbursement was. We have our in-house legal and financial team. Of course, they looked into their areas of expertise just to make sure that it would be something that would be profitable.

Phillip Koo: Great. So then operations is important. You touched on a lot of the pieces with regards to how you operationalize this. I'm sure the electronic medical record comes into play here. How do you sort of work all that together with the ordering process, the pre-auth, scheduling? How do you make that all successful?

Jeffrey Zemencik: So upfront, we do have a clinical systems group that helped us depending on the specific urology EMR, so that we can make sure, because most EMRs are not set up to do anything radiopharmaceutical wise. So everything from our ordering to basically the directive that the doctor orders the drug through our documentation, even through the day of procedure, is all done in our urology EMR. So we did spend a little time setting all that up to make it easier for the nuke med tech and the physicians administering the doses during the day to be able to document everything in one place so that the other urologists and billing, everybody had access to the electronic medical record.

Phillip Koo: So when this drug, let's say, is ordered or there's a consult put in for a patient potentially eligible for this, does it trigger six appointments ahead of time or is it episode by episode?

Jeffrey Zemencik: No. With this particular drug, you order everything so that they make sure that the patient is locked in, that way they're not starting a therapy and three injections in, all of a sudden there's no available drug. So we do lock in all injections when we get started to make sure.

Phillip Koo: So you get pre-auth and everything for all six. That's great advice. So when it comes to operationalizing it from a physical standpoint, I'm sure there's a lot of considerations. There's getting the appropriate technologist, making adjustments to your RAM license. Can you talk about those pieces with regards to making this successful?

Jeffrey Zemencik: Sure. After all the stakeholders agree we want to move forward with this, licensing certainly does come into play. For us, we already had an existing radioactive materials license for radium 223, so adding PLUVICTO was really not a heavy lift for us, just included notifying the state that we wanted to do this. And again, regulations are different state by state. Some states have a broad use license, it's called, which enables them to use a wide variety of radiopharmaceuticals, versus a limited use license where each time you want to introduce something new, you have to go back to the state and provide them with information and get their approval to move ahead with a different radiopharmaceutical.

Phillip Koo: So now that you make the decision to move forward, obviously a question that a lot of people have are what are the capital expenses required to get this up and running? Can you fill us in on that?

Jeffrey Zemencik: Again, if you have an existing radiopharmaceutical program, it's really not a heavy lift. The additional supplies or equipment that we needed were a beta syringe shield. So the other radiopharmaceutical we were doing was an alpha emitter, so not very penetrating radiation. PLUVICTO was beta emitter, so there was different considerations of additional shielding that we needed. So for us, it was a beta syringe shield, and then we have a syringe shield pump that we purchased so that actually during the injection, the patient, the nuke med tech, and the authorized user are shielded from that more penetrating radiation.

Phillip Koo: So for programs that are giving radium today, I think the lift to get to something like PLUVICTO is probably very small. For those who have not given radium, what do you think the capital requirements look like for those practices?

Jeffrey Zemencik: So initially it was about, I think 15 to $20,000 worth of equipment that we needed to get started.

Phillip Koo: So not a huge amount there. All right. So despite all the best planning efforts, there's always something that's going to go wrong or things that you're going to have to change or you learn from, so help us avoid those mistakes in the future and give us some wisdom there.

Jeffrey Zemencik: I think location was a big consideration for us because we are freestanding, we're urology owned. We had an existing infusion center where we would infuse other drugs to patients. So initially, I would say think towards the future because radiopharmaceuticals are becoming more available to patients. There's more clinical trials that are happening. So plan for the future. Don't just look at, we're just going to do this one thing, so we need one infusion chair and just a cabinet for storage and delivery of radiopharmaceuticals, because as we've grown, of course our space needs have grown. And now in our other markets as well, we're looking at additional space just to house the program.

Phillip Koo: I think that's great advice. There's no doubt this RLT space is going to continue to grow and looking at it strategically and being able to forecast what it might look like in five years, I think it's something that we all should be doing. So thank you very much for sharing your expertise with us.

Jeffrey Zemencik: Sure. Absolutely. Thank you.