In October, Deep Lens’ Director of Provider Network Amy Zuchelkowski, RN, BSN, MS participated in a panel discussion at MAGI’s Clinical Research Conference to discuss cell and gene therapy studies. We’re happy to be able to share her thoughts on the topic here.
For many years, chimeric antigen receptor T cell (CAR T) therapies have generally been restricted to small clinical trials in academic settings. However, with the approval of two CAR T-cell therapies in 2017, axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel), CAR T therapies began to be offered more widely in academic hospitals and oncology practices.
Some would argue that cell therapy (CAR-T, CAR-NK) is not appropriate for community oncology – that its use is too complex. However, with more than 500 active CAR T-cell therapy trials currently being offered across the globe1 coupled with the expectation that the FDA will approve between 10 to 20 gene therapy products per year by 2025, now is the time to consider building your program.
Offering cell-based therapy is uncharted territory for many community oncology practices. The treatments are seen as groundbreaking, and many patients desire access. Participation in clinical trials is one way to allow for this access to the latest, most innovative therapies in addition to close monitoring of care by the entire research team. Eighty-five percent of cancer patients are diagnosed and treated at local community-based clinical practices. Including cell therapy as a close-to-home treatment offers convenience and decreases the logistical burden for cancer patients along with the expenses associated with travel.
Here are some key considerations to consider for building a successful research CAR T program in your community setting:
Infrastructure - Practices with an existing Autologous Stem Cell Transplant program and a well-established Phase I program are already well-positioned to add a cell-based therapy program. You’ll be able to leverage SOPs that are already developed, pre-existing relationships with collection center, and the expertise of the clinical team. A strong partnership with your local hospital is also key. Having the alignment of goals and agreement in allocation of resources is paramount. Begin developing the required SOPs to include the following: Direct admission, administration, toxicity management, post infusion monitoring, billing, scheduling, and discharge.
Education - Educating multidisciplinary care teams is essential. These treatments are complex and should only be administered at treatment centers with experience and infrastructure. Since the successful execution relies on the participation of so many health-care providers across multiple departments including specialists, nurses, pharmacists, operations, as well as IT, finance, scheduling, and legal/compliance, including these individuals in your training sessions is pivotal. Consider providing community educational events either live or virtually for providers, patients, and caregivers. Building a strong culture of research and positioning your practice as the face of CAR T in your community will strengthen your program and contribute to your success. Educate your patients on the need to have a dedicated caregiver who will agree to provide adequate support throughout the process.
Safety - Knowing how to identify and treat both acute and late-phase toxicities is important. Plan for protocol training of staff not only at your practice but at the academic center. Training can be labor intensive since the number of healthcare teams that could potentially interact with the patient is high. Assemble a core team who is committed to following all requirements related to the protocol and patient’s care plan. At minimum, include training on the science behind CAR T, the protocol, REMS, and management of toxicities. Work with your local hospital to implement a policy that allows for a direct admission to avoid the Emergency Room. Patients with high tumor burden or inflammatory markers would be good candidates for this workflow. A weekly cadence of team meetings is an opportunity to discuss contingent patients as well as patients matched and enrolled in the trial.
Billing Considerations - With the already established NCCN toxicity guidelines, some of the protocol requirements have shifted from research to standard of care. In any event, preparing a Medicare Coverage Analysis is crucial. Once completed, share the analysis across the departments you are working with. This is to ensure any billing errors associated with the trial will not result in implications within your practice. NCD310.1 will determine sponsor associated costs with regards to toxicity management. Consider product handling and storage costs, hospital partnership fees, staff fees (time and resources) and cost for hospitalizations especially for first in human protocols.
In summary, the goal of precision medicine is simply to deliver the right cancer treatment to the right patient at the right dose and the right time. Oncology is the one therapeutic area that strongly supports this goal. Over the next 5-10 years as more cellular treatments become FDA approved, the need for established cellular therapy programs in the community setting will be crucial to expand the availability of these novel treatments to patients.
References:1.Upadhaya, S. et al. The clinical pipeline for cancer cell therapies. Nat Rev Drug Discov 20, 503–504 (2021).