Implementing a Radiopharmaceutical Therapy Program:

Radiopharmaceutical therapy (RPT) is a growing modality within oncology care. To improve patient access to this treatment option, it is imperative to build RPT programs in all radiation oncology practice types. Our practice covers a wide geographic reach in both a community hospital system, Intermountain Health, and a private practice, Utah Cancer Specialists. Regardless of the setting, some uniting principles have emerged from building a successful RPT program.

Address Regulatory Requirements Early

Radiopharmaceuticals, under the category of unsealed byproduct materials “for which a written directive is required” (NRC CFR 35.300), requires an Authorized User (AU) for legal delivery. If your practice does not have an available AU to lead your RPT program, then one of your physicians will need to go through the necessary training and documentation to obtain AU status, which can be found in 10 CFR 35.390. When identifying a potential AU, look to those in your practice who are less than seven years from training, as the process to obtain AU status for these physicians is relatively straightforward. Those beyond seven years of training may need additional training and experience to become AUs. It is advised to speak to your regulator about the necessary requirements.^{1, 2}Even if only considering developing a program, it is never too early to assess what is needed to obtain AU status for one or more physicians on your team.

Be Strategic in Your RAM License Application

A radioactive material (RAM) license will be required for your practice. When you do so, make the language as broad as possible. NURREG 1556 vol. 9 rev. 3 suggests that “The chemical/physical form may be ‘Any’ unsealed byproduct material permitted by 10 CFR 35.300.” In one of our locations, it took almost two years to get an amended RAM license, partly due to limiting language in the license. So, if permitted, use broad language. For example, instead of applying for “Lutetium-PSMA 617,” consider applying for “Lutetium-based radiopharmaceuticals.” Additionally, when specifying the amount of on-site radioactivity in your application, consider the half-life of contaminants. This can facilitate in-house storage and help minimize costs associated with using an external broker for waste decay.

Partner with Industry

We have found partnerships with industry helpful in building our program. Many new AUs and their staff have received limited training with RPTs. Industry partners can help prepare administration, revenue cycle teams, treatment delivery staff (nurses, nuclear medicine technicians) and physicians for some of the challenges faced when starting a new program. Establishing research partnerships with industry can also lead to early access to novel drugs and imaging agents. As you build your clinical trial program your practice can be a hub for patients seeking innovative trials and therapies that are often limited by supply and logistics. With the biannual roundtable with industry, ASTRO is actively seeking to build these partnerships and communicate the value that radiation oncologists can provide in the field both in research and standard-of-care therapy.

Embrace Multidisciplinary Care

Delivering RPTs is inherently multidisciplinary. By the time a patient has been referred for RPT, they have been managed for years by their medical oncologist and/or other specialists. You’ll work closely with these referring physicians regarding treatment eligibility, concurrent medication administration, lab evaluation and treatment decision making. Many of these relationships are preexisting; if they aren’t, you’ll need to create ways to facilitate multidisciplinary care. Consider organizing an RPT tumor board where patients can be discussed with the involved stakeholders or making a habit of having regular discussions with referring providers. Implement a routine decision point to evaluate patient progress and collaborate with the referring doctor. For some agents, this can center around interval imaging with post-treatment SPECT/CT or PSMA PET after cycle two or three.

Patient navigation is key to facilitating your multidisciplinary program. Our patient navigators help with scheduling patient visits, communication with referring offices, insurance authorizations and providing assessments on the day of treatment. Although usually a nurse, we have seen programs use other support staff for this role such as medical assistants, advanced practice providers and nuclear medicine technicians.

Be a “Champion”

Every practice needs enthusiastic advocates for the RPT program. At our practice, medical oncologists and nuclear medicine partners share our enthusiasm for the current and future landscape of RPT. However, in some situations, you may be the only one in your region who knows the current applications and the potential of the field. Familiarize yourself with the current data and the ongoing trials. Be willing to speak up at tumor boards and administration meetings and share your successes.

Implementing RPT requires careful planning, interdisciplinary collaboration and adherence to regulatory and safety standards. As RPT evolves, embracing these advanced treatment options will not only improve clinical outcomes but also position the practice at the forefront of precision oncology. With a well-structured approach, radiation oncology teams can successfully implement an RPT program that meets both clinical and operational goals while delivering cutting-edge therapies to patients in need.