Lucio Gordan, MD, president and managing physician, Florida Cancer Specialists & Research Institute (FCS), discusses how FCS has learned to adapt during difficult times, including COVID-19, Hurricane Ian, and current drug shortages.
Adjusting inititatives to meet the demands and challenges of life-changing events is crucial to withstanding adversity, says Lucio Gordan, MD, president and managing physician at Florida Cancer Specialists & Research Institute (FCS), at an Institute for Value-Based Medicine® event by The American Journal of Managed Care® (AJMC®).
AJMC: FCS has embraced value-based care for many years now. How do you see it evolving and what are some current initiatives that the practice is implementing?
Gordan: We have had a very long track record of doing value-based enterprise. We have been on the federal side with the Oncology Care Model and the commercial side as well. Going forward, we will be more aligned with Medicare MIPS [Merit-based Incentive Payment System], and we will continue to enhance our commercial value-based enterprise. We have, again, a long history of success on the commercial side, and we have taken new steps to ensure that will be even more successful.
AJMC: Can you describe how your approaches to working with payers has evolved? Are there examples of how you have adjusted initiatives after seeing data and learning what worked and what didn't work?
Gordan: We are on a mission of increasing the coordination of care at FCS. We have a holistic approach in which the patient and family are seen as one unit, and what I mean by that is we involve other services like behavioral health, nutrition, genetic counseling when appropriate, and early integration with the financial side of the business. So, we make sure that the patients get access to care 24/7, and therefore avoid the expensive sites of service like emergency departments and hospitalizations as much as we can.
The other part that we are working on to continue to improve outcomes and value for the patient in the system is by continuing to foster the data side of the company, matching genomics to patients and treatment to get patients on therapy as fast as we can. We are enhancing patient clinical trial accrual by using the same algorithm in the data side. So, there are many levers that we are pulling and pushing here to get to a scenario that patients are treated under a protocol that is reproducible from clinic to clinic, from area to different areas, and that experience is well controlled and reproducible.
AJMC: How has clinical research expanded at the practice in recent years? Are there lessons from the pandemic about use of telehealth and research that you have carried to the present day?
Gordan: Yeah, so clinical research continues to expand at a fast pace at FCS. We have 37 sites of late-phase studies—phase 2 and phase 3—and we have 3 large phase 1 units in Orlando and 1 in Sarasota.
We continue to increase our footprint. We have leveraged telehealth, which has helped quite a bit since the COVID pandemic. I'm glad that telehealth is still alive and well in terms of availability and access to patients and providers.
I must say that our data governance that we have performed and delivered at FCS has really allowed us to know our patients, from the usual demographics all the way down to the genomic level. And that allows us to get more patients in clinical trials. So, we are very excited for the future, we continue to improve, and 2023 has been quite better than 2022. And so, I'm bullish about the future in research.
As far as research, we have interest in all types. We do a lot of phase 1 trials. At any given time, we have 100-plus phase 1 studies—sometimes less, sometimes more—and another 75 to almost 100 trials in the late phase. So, we are a pretty robust center. We also perform first-in-human clinical trials.
And we have the other side of research that we are very excited about, which we will be speaking about at the meeting today, which is real-world evidence studies. These are equally important, but more of a populational type of analysis. But there's room for research at FCS.
AJMC: What are the most important areas of research at the practice today?
Gordan: I think drug development is always very exciting, right? And we have been part of more than 85% of the drugs approved in the last 10 years as far as development. These drugs were studied at FCS. So we wanted to continue to improve that trend and be part of the innovation and getting patients to the most scientifically sound and modern treatments we can get. As far as phase 2, it's also very important, right? Because as we move from phase 1 to 2, we have to get these patients moving to an approval process. So I cannot say I have a favorite. It's all important. And again, there's a place for phase 3, and an incredible place for real-world evidence studies.
AJMC: It has been almost a year since Florida was hit by Hurricane Ian. What lessons did the practice learn from this experience?
Gordan: Yeah, that's a great question. Hurricane Ian was a very complex event; it was life-changing. We have several teammates who lost everything, lost their homes, and ability to commute back and forth, etc. So, we learned a lot as far as getting together and helping each other out. And this was evident in the very first hours and days after the hurricane hit. We learned to keep the doors open as quickly as we could to the patients who were in need. We were able to make sure that our pharmacies were delivering the drug to our patients as quickly as it was safe to get back to the pharmacy units in Fort Myers, where the hurricane hit the most.
We have some new standard operating procedures as far as more checks on generators and some redundancy here and there. To protect our assets, we moved some assets, meaning chemotherapy or inventory, to areas that are more inland, like Tampa, Orlando, or Gainesville to make sure that we don't get hit too hard. But it was certainly a very traumatic event. But the FCS teammates and community and the patients and other outside institutions rallied around all of us to make sure that we kept the doors open. So, we moved very fast. And if there's another event, which there probably will be, then I think we'll be more prepared.
AJMC: How have the challenges faced during the pandemic and later with the hurricane prepared the practice to address current challenges of chemotherapy drug shortages?
Gordan: Yeah, so chemotherapy drug shortages are a very complex matter. It's a financial challenge that drugs that are generic start getting their value chipped away over time, because of the way that the average sales price works. And then it gets to a point that a manufacturer is not able to produce a drug because it gets at or below the manufacturing price. So that's the main reason that we have drug shortages.
The hurricane and the pandemic events helped us a little bit as we manage inventory and as we get prepared. Remember when we didn't have gloves or other basic things we needed to keep patient safety? That got everybody fast as far as reacting to acute events.
But drug shortages are primarily a separate issue and we're working on different ways of helping the White House and the Energy and Commerce Committee to understand that we need to stabilize the price of generics, so it doesn't go below a floor, so these drugs become available and hopefully we can get more of the manufacturers back to the United States. We can't get quality drugs in abundance here where we are. FCS is very pro generics and pro biosimilars. And we were one of the first adopters of these classes of drugs. We have to have them available. There has to be an equation in which pricing is reasonable for the manufacturers to bring to the table.