Addressing a Growing Need: Creating the ARA Theranostics...

Operational Excellence Addressing a Growing Need: Creating the ARA Theranostics Center August 23, 2024 - Julia Austin, John R. Leahy, MD

ARA has a long history of using radiopharmaceuticals to diagnose and treat disease, having employed radioiodine to diagnose and treat thyroid disease since the 1960s. The identification of radioiodine, a byproduct of nuclear fission, by researchers in the 1940s and 1950s was serendipitous. However, the advent of purpose-built theranostics radiopharmaceuticals would wait until the late 1990s and early 2000s, when microbiology techniques had advanced enough to make such agents feasible.

ARA was the first center in Central Texas to offer I-131 tositumomab and Y-90 ibritumomab tiuxetan for treatment of lymphoma in the 2000s. This was followed by Ra-223 dichloride in the early 2010s. These radiopharmaceuticals had modest efficacy and limited adoption. The first agent with exceptional efficacy and widespread adoption was Lu-177 dotatate, used to treat neuroendocrine tumors.

ARA began offering this treatment in August 2021, followed by Lu-177 vipivotide tetraxetan for prostate cancer in August 2022. At this point, the use of targeted radiopharmaceuticals to diagnose and treat disease was beginning to be known as theranostics.

Building the Theranostics Program at ARA

In its early days, ARA offered theranostics services in an improvised arrangement, incorporating the services into some of its imaging centers. But noting the accelerating cadence in the introduction of new theranostics radiopharmaceuticals, along with the increasing number of patients seeking theranostics treatments, ARA saw an opportunity to serve the community. A purpose-built facility to safely and efficiently administer this rapidly growing group of new radiopharmaceuticals to an increasing number of patients was needed.

For this reason, ARA began development of the ARA Theranostics Center in 2020.

Figure 1: Dr. John Leahy has been instrumental in developing the ARA Theranostics Center.

While developing the Theranostics Center was a group effort, the driving force behind bringing theranostics to ARA was molecular radiologist Dr. John Leahy.

Dr. Leahy has been with ARA since 1999 and was instrumental in bringing in PET, PET/CT, SPECT/CT, and then molecular radiology to the organization. Dr Leahy and all the molecular radiologists at the Theranostics Center are double-boarded in nuclear medicine by the American Board of Nuclear Medicine and diagnostic radiology by the American Board of Radiology.

On the operations side, ARA Chief Operations Officer Debi Brannan was visionary in seeing the possibilities of theranostics and enabling the establishment of the Center. “With the expertise of Dr. Leahy and the ARA molecular radiologists behind the project and the opportunity to serve patients and providers with these life-changing treatments, ARA leadership felt it was the right time and place to develop the Theranostics Center. We couldn’t be happier with the results for our patients,” she says.

Choosing the Location for the Center

Choosing where to situate the center was easily addressed by locating it at the ARA Midtown outpatient imaging center. Here, ARA could draw upon the expertise of the flagship molecular radiology service the organization had already established.

ARA Midtown accounted for the bulk of the organization’s theranostics-related imaging and was providing most of ARA’s limited theranostics treatment services up to that point. Creating a dedicated theranostics center at Midtown would be more of an evolution than a revolution.

As an added benefit, Midtown is centrally located in Austin, mitigating travel time for patients. ARA’s patient population regularly comes from all around the city and regionally — some from as far as South Texas, the Rio Grande Valley, the coastal regions south of Houston, West Texas out to San Angelo, and north to Waco and Temple.

Building Out the Space

The next consideration involved the physical space. Theranostics treatments pose unique challenges, as radiation exposure is inherent in treatments. To start, lead-lined shielding is required around treatment rooms to ensure the safety of staff and surrounding public.

There is also potential for radiation contamination in the facility, so surfaces need to be as non-absorptive as possible. The potential for contamination informs the need for dedicated theranostics bathrooms, as well. Not only is this sound medical practice, but it is also required by law in Texas. Early experience managing these challenges with older theranostics treatments convinced ARA of the need for additional safe and efficient spaces, as the number of treatments started increasing rapidly.

With this in mind, ARA chose purpose-built treatment suites, consisting of infusion rooms and attached bathrooms, rather than repurpose regular clinic rooms and bathrooms. Construction of the suites was carried out prior to the major influx of patients starting in August 2022.

Figure 2: Theranostics suite restroom built for minimum absorption of radioactive substances.

Figure 3: A view of a treatment room and specialized restroom.

Staffing the Center

Staff considerations were equally important. Treatments call for staff experienced in radiation administration and safety, as well as patient care and the ability to respond to treatment-related medical emergencies.

Shannon Wood, clinic manager at ARA Midtown, sought a top-level team. She contacted other institutions doing theranostics treatments to see how they built their staff and determined that a combination of nuclear medicine technologists and paramedics would be the best mix for the center.

“I also had existing staff that became very involved in researching what was needed — they took us to a new level,” Wood says. “I ended up hiring these people from within and was able to produce a full team by the time we administered our first SSRT therapy for neuroendocrine tumor.”

Getting Word Out About the Center

As the physical construction of the Center neared completion, the team turned its attention to getting the word out to a population largely unfamiliar with its services. Because ARA was the only facility offering theranostics treatments in Central Texas, and one of only a few throughout the state, the outreach area expanded beyond ARA’s traditional service area to include distant regional communities.

The ARA marketing team developed a new website, built with improved community outreach and accessibility in mind. Meanwhile, the business development and provider relations teams collaborated on a coordinated plan to identify high-value practitioners and locations, and inform and educate both healthcare providers and patients.

ARA is fortunate to have a team of provider relations associates (PRAs) who are dedicated to maintaining provider satisfaction and education. When it came to the new Theranostics Center, the team realized there would be a dramatically increased commitment of time and energy needed to develop relationships for a brand-new center. In addition, the center would offer largely unknown services. Finally, many providers would be outside ARA’s traditional service area in the Austin metropolitan area, where the team had spent years developing relationships.

For these reasons, ARA assigned one PRA, Patricia Lewandowski, to concentrate her efforts on promoting the Center. Lewandowski became an expert in communicating theranostics information to providers and travels extensively around Central and South Texas, meeting with providers and their teams.

“This is often the first time these providers have heard about theranostics,” Lewandowski says. “They are very receptive and happy for their patients to know that treatments are available in Austin. The website is crucial in explaining offerings to both patients and providers.”

Addressing Regulatory Compliance and Safety Protocols

In planning for the Center, compliance with regulations for handling radioactive materials and operating medical imaging equipment was crucial. “We were fortunate that we already had a Radioactive Materials License (RAML) place that allowed the quantities we needed for our theranostics treatments,” Jon Berg, radiation safety coordinator, says. “We also had extensive experience with Y-90 TheraSpheres used in nuclear medicine and interventional procedures, so we were very familiar with waste and proper disposal. We did need to build an additional waste holding area and increase our waste pickups.”

Beyond compliance, handling radiopharmaceuticals requires strict safety measures to protect staff and patients. Wood ensured that radiologists and staff collaborated on protocols such as checking in the dose (called the “pig”), moving it around the center, and accessing it for patient treatment.

Figure 4: The Theranostics Center was designed to safely and comfortably accommodate patients getting extended infusions.

Taylor Kirk, ARA lead technologist, molecular imaging and theranostics, and her team of technologists were tasked with developing protocols for handling radiopharmaceuticals around patients and staff. “There was not a lot of information out there, so we based our methods on radioiodine protocols,” Kirk says. “Staff cannot use lead shielding because of its immense weight, so we maintain ALARA (as low as reasonably achievable) rules, maintain distance when possible, and pay special attention around restrooms. Safety for patients is the top priority. Patients leave the theranostics center with detailed instructions on how to protect others from the radiation in their bodies as they eliminate it over a period of a few days.”

Navigating Insurance and Reimbursement

While building the physical center and ensuring its safety had its own challenges, one piece of the puzzle proved to be equally, if not more, difficult to navigate. “[Insurance and reimbursement] may have been the hardest part of our job because we were dealing with new treatments that insurance companies were just beginning to add to their coverage options,” Wood says.

The ARA team fought to come up with ways for patients to get coverage for these life-changing treatments, working with Radiology Partners and often directly with insurance groups. The billing and authorization teams analyzed coverage of theranostics procedures and quickly became experts on how to work with insurance groups to increase the likelihood that patients would be covered for these very high-cost procedures.

Current Status of the ARA Theranostics Center

Since its opening in August 2021, ARA has treated over 133 patients and administered over 700 theranostics doses at the Center. It has been a huge success, and due to the rapidly increasing volume of patients, oversight of the Center alone ballooned into a full-time commitment. In addition to other staff hired, a dedicated coordinator, Alex Difonzo, was brought on as part of the team.

In September 2022, the center was designated as a Center of Excellence in Radiopharmaceutical Therapy by the Society of Nuclear Medicine and Molecular Imaging (SNMMI). To gain this certification, the Center had to meet strict regulatory, training, qualification, experience, and performance criteria to ensure rigorous protocols are in place and followed, leading to appropriate patient selection and optimal treatment outcomes from radiopharmaceutical therapy.

The Theranostics Center is currently involved in a clinical trial testing the efficacy of a new theranostics agent for renal carcinoma and other cancers. Patients from all over the country will participate in the trial.

Most importantly, the Theranostics Center and theranostics.ausrad.com are working for patients. A patient who has undergone the PSMA-targeted therapy for prostate cancer wrote:

“This treatment is truly a game changer. I am so fortunate that ARA opened up this treatment in Austin. We had been looking at having to travel to Dallas, which in my then condition was almost too daunting to even consider. The ARA staff in Austin is compassionate and knowledgeable. You and the others allayed any fears we had; you informed us clearly and understandably about the radioactivity precautions and we have had no problem following the instructions. I so hope that every person who is a candidate for this treatment is able to access it.”

What’s Next for the Center

Exciting new theranostics radiopharmaceuticals are currently in development worldwide. As they become available over the next few years, the number of patients who will benefit from the treatments will increase and demand to provide treatment will go up at the Theranostics Center.

ARA is formulating plans to adapt to this growth, including the possibility of local expansion or development of satellite sites in Central Texas. Regardless of what the future brings, ARA will remain committed to making these innovative and impactful treatments available to all who seek them.

ARA Diagnostic Imaging is a leading provider of radiology in Central Texas, with 17 outpatient imaging centers and a presence in 24 area hospitals. Founded in 1954, ARA has a history of bringing innovative technology and procedures to area patients and providers. ARA is physician-led, with over 110 subspecialized radiologists, including musculoskeletal radiologists, neuroradiologists, body imagers, breast imagers, pediatric radiologists, interventional and neurointerventional radiologists, emergency radiologists, and molecular radiologists. The new ARA Theranostics Center is an SNMMI Radiopharmaceutical Therapy Center of Excellence. ARA maintains a high patient satisfaction rate and takes pride in providing our patients with an excellent standard of care. To learn more, visit Theranostics.ausrad.com.

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