For most of the past decade, if a patient with relapsed or refractory lymphoma or multiple myeloma needed CAR-T therapy, the path was predictable: a referral to a major academic medical center, a wait measured in weeks, travel that could span hundreds of miles, and a long inpatient stay, away from home, work, and the people who make recovery possible. For patients in rural and suburban communities (which is most Americans with cancer) the combined barriers of distance, the inpatient stay, and financial toxicity, made this a tough proposition.
The ambulatory delivery model emerging for advanced therapies can fundamentally change the equation for many patients and their community-based physicians. In this model, patients receive their CAR-T infusion in a local ambulatory setting, monitored continuously through the high-risk post-infusion window, with hospitalization only if complications occur that require it.
Why CAR-T has lived in academic centers and why that’s changing
The early concentration of CAR-T therapy in academic settings was inevitable as these treatments emerged from clinical trials with REMS requirements in place. Physicians had to learn to recognize and manage toxicities, academic centers had the facilities for escalation.
However, the landscape is changing. We now understand the toxicity profile of approved CAR-T; we’ve developed and operationalized escalation pathways; and we have a clear clinical picture of what CRS and ICANS look like, when they peak, how they are managed and how they resolve.
Meanwhile, the structural pressures on academic medical centers are growing: limited inpatient beds, continued staffing shortages, and an expanding pipeline of patients. The time is ripe for community clinics to start bringing advanced therapies closer to patients, with the right infrastructure and support.
What community practices already have
There is a tendency in discussions about advanced therapy delivery to focus on what community practices lack. The more instructive question is what they already have and what academic centers cannot replicate at scale.
Community-based physicians often have long-standing relationships with their patients. The post-infusion period is demanding for patients and caregivers. Frequent clinic visits, continuous monitoring, and the anxiety of waiting for toxicity. The entire experience feels easier closer to home. Referral to a distant AMC can provide the therapy, but it is harder to offer the continuity.
Community practices also bring badly needed geographic reach: academic centers cluster in major metropolitan areas, but the patients who need CAR-T do not. Building ambulatory delivery capacity in community settings is, at its core, an equity intervention, extending access to patients for whom the established model would be prohibitive.
The physician incentive is real and it runs in both directions
For community-based physicians, offering advanced therapy delivery is also a strategic move for patient retention.
Community specialists who refer CAR-T patients to academic centers lose those patients from their practice sometimes for months, sometimes longer. The academic center becomes the patient’s primary oncology relationship during a critical period of their care. The downstream consequences for referral retention, care continuity, and practice revenue can be costly.
The ability to keep patients in-practice through the full advanced therapy episode changes the equation. And as CAR-T indications continue to expand into second line and earlier treatment settings, autoimmune and neurological disease, the volume of patients who could benefit, and who currently leave the practice to receive that benefit, will only grow.
Practices that build the capability now will be positioned to capture that volume.
What your practice needs to launch CAR-T delivery
None of this is to suggest that launching an advanced therapy program is simple. The clinical, operational, and administrative requirements are real, but growing outpatient models in leading authorized treatment centers have been paving the path.
Much goes into launching a new advanced therapy program, but the considerations that have emerged specifically for outpatient or ambulatory delivery include:
- Standardized clinical pathways and SOPs policies and procedures for patient selection, CRS and ICANS management, antimicrobial prophylaxis, cell processing, laboratory, pharmacy, outpatient care, transition to inpatient or hospital observation
- FACT accreditation per the community standards
- Caregiver education on CAR-T process, toxicities, and monitoring technology
- 24/7 on-call physician coverage reachable at any hour during the monitoring period
- 24/7 clinical monitoring the ability to catch, assess, manage, and escalate care for toxicities and other adverse events
- Sustainable payment models that recognize the efficiency of community delivery
Leaders from Sarah Cannon Cancer Institute published operational insights from their multi-site outpatient CAR-T programs using Current Health in JCO Oncology Practice.
The case for building a program now
The community oncology practices that move into advanced therapy delivery in the next two to three years will define the standard of care in this space. They will build the operational experience, the clinical pathways, the payer contracts, and the manufacturer relationships that make life-saving therapies sustainable and scalable for providers and accessible to more patients who need them.
The practices that build programs now will accumulate operational experience, established payer contracts, manufacturer relationships, and the clinical confidence that only comes from having treated patients. Those are durable advantages. Practices that wait will find themselves building from scratch in a market where the early movers have already become the default choice for referring physicians and patients alike.
The infrastructure for ambulatory advanced therapy delivery exists, the clinical evidence supports it, and the patients who need it are already in your practice. The only remaining question is which community oncology programs will be the ones to meet them there.