Expanding CAR T-Cell Therapy Access and Building Community Programs: A Q&A With Robert Richards, MS, MBA

AJMC: What education, training, or certification programs are needed before launching a chimeric antigen receptor (CAR) T-cell therapy program?

Robert Richards, MS, MBA: When I came to the [bone marrow transplant] program, it lived in a black box—rich with internal expertise but, aside from policies and procedures, little structured material beyond that. As we geared up for commercial CAR T-cell therapy about 10 years ago, we had 9 nonclinical people running a program of 275 transplants annually. Seeing the full pipeline, I quickly realized we were going to stifle innovation (research) by running out of beds in favor of commercial therapies without an ability to disseminate what we know how to treat already. Additionally, I realized we would be hiring more nonclinical staff to support the growing volume of therapies that the program offered.That pushed us toward 2 priorities: expanding access and standardizing training across the entire organization. We built video education and training programs—not just clinical, but financial and operational as well—alongside detailed process maps laying out every step of the episode of care and the responsible party at each department. That framework became our course program internally, and we’ve since had outside entities approach us about licensing it. Today, we have 75 people at the AMC [academic medical center] doing 500 to 600 cell therapies annually, including research.

AJMC: Which collaboration models with hospitals are most feasible and sustainable?

Robert Richards, MS, MBA: We designed our program around a hub-and-spoke model, with the academic medical center as the hub and our community hospitals as spokes. The reasoning is straightforward: The academic medical center is where next-generation therapies appear first. We take on the newer therapies, then disseminate the ones we know well into the community sites, and repeat that cycle over again [as needed]. This lets us guide community sites about what to expect clinically, financially, and operationally as they grow, and as a by-product, creates capacity at the AMC for the next-generation therapy that we can start treating with in front of offering it to the community. Right now, our academic medical center is a full-service cell therapy and transplant center moving into autoimmune, while our 2 community sites are exclusively oncology. We’re asking them: Do you want to stay oncology only or grow into a full-service program? Both are leaning toward expansion. We’re also seeing outside entities approach us about participating in a similar spoke arrangement, so there are potential business opportunities in this model.

AJMC: Beyond academic collaborations, how can partnerships with payers, health systems, or industry stakeholders enhance CAR T-cell therapy adoption?

Robert Richards, MS, MBA: I’ve been working closely with managed care from day one. When the FDA approved Kymriah [tisagenlecleucel] and Yescarta [axicabtagene ciloleucel] for diffuse large B-cell lymphoma about 10 years ago, our [assistant vice president] of managed care said something I’ve never forgotten: With these high-cost therapies on the horizon, we need to think about alternative payment models. We started with case rate models on the inpatient side: carve out the drug, pass through invoice cost, no markup. But what struck me later was the concept of a global case rate. Managed care initially questioned why we would do it, pointing to our 340B status, but my concern was that as more sites went outpatient, physicians would face pressure to treat in less appropriate settings purely for financial reasons. A global case rate gives doctors the degrees of freedom to treat patients in the right site of care, and we’ve gotten several commercial payers to buy into that. Governmental payers are a different conversation, but you take it one step at a time. Look no further than the [CMS] Sickle Cell Disease Access model and you can see that it has potential application for cell therapy in the future.

AJMC: What upcoming developments are most likely to influence CAR T-cell therapy adoption in the next 5 years?

Robert Richards, MS, MBA: The era of bispecifics has begun, and that’s a significant competitive dynamic for CAR T. Bispecifics fit the way oncologists treat—cycles over a defined number of months, familiar form, and function—so they’ve been adopted across a much wider array of oncologists, from specialists to community generalists. CAR T hasn’t been able to say the same. The science is phenomenal, but if adoption is ever going to improve meaningfully, it has to happen at the community level. When you look at Tecvayli [teclistimab] vs Carvykti [ciltacabtagene autoleucel] in myeloma, for example, and bispecifics are available broadly while CAR T remains limited to a handful of centers, the only way to put them on equal footing is to truly expand access everywhere.

AJMC: What were the unmet needs that led to the expansion of CAR T-cell therapy to the community setting?

Robert Richards, MS, MBA: I want to be clear: We don’t believe CAR T-cell therapy should be everywhere. A 1- or 2-person community practice offering it isn’t realistic. But larger community oncology groups? Absolutely—with appropriate hospital partnerships for toxicity management. The specific drivers for our 2 community sites were rooted in population access. Lancaster General Hospital is 95 miles from our academic medical center and serves a large Mennonite population that strongly prefers not to travel to the city for treatment. Pennsylvania Hospital is only 2-and-a-half miles from the academic medical center, but it runs a bloodless cell therapy program under Dr Pat Ford and Dr Doug Beach, serving a Jehovah’s Witness population we don’t typically serve at the AMC. The goal in both cases is the same as it is at the AMC: to ensure every patient who walks in the door can receive CAR T-cell therapy with the same quality and outcomes as at a center of excellence. We baseline quality, standardize policy and procedure, and align data across all 3 sites.

AJMC: What has worked well so far when incorporating CAR T-cell therapy in the community setting?

Robert Richards, MS, MBA: The video education, training, and process maps have been invaluable. Clinicians understand the value of these therapies; that’s never the issue. The challenges are operational and financial. Having standardized tools lets community sites build out their own workflows and share them with all necessary stakeholders, which also helps enormously when we go to commercial payers to negotiate reimbursement for sites that aren’t FACT accredited or center of excellence designated. Payers reasonably ask: How will you ensure quality and outcomes are comparable to a center of excellence? Being able to show them our training materials and baseline data alongside documented workflows has opened doors for these sites to get started. That said, there are real logistical challenges. For instance, community sites don’t have cryo tanks, so we’ve had to work out just-in-time delivery with manufacturers, and questions arise about product integrity once the shipper is opened. These aren’t insurmountable, but they require working collaboratively with payers and pharma to solve them.

AJMC: How can we grow CAR T-cell adoption in the community practice, and what do providers need to know before this happens?

Robert Richards, MS, MBA: Providers already understand the clinical value; that’s not the barrier. The real challenge is financial structure. Community sites often operate on a straight average sales price–plus model with razor-thin margins. A onetime $500,000 to $600,000 therapy landing on their books with protracted reimbursement is a difficult proposition, especially when bispecifics offer an alternative. The global case rate model we’ve used within our organization is worth exploring for community settings as a way to move away from buy-and-bill for this category of therapy. I understand the pharmacy concern that it could open the door to white bagging and create downstream challenges, but if we’re genuinely going to improve access, pharma, centers, and payers all need to work the problem together. It can’t be an adversarial relationship if we’re going to significantly move the needle on access.

AJMC: Any final thoughts or topics we didn’t cover?

Robert Richards, MS, MBA: We’ve talked mostly about oncology, but autoimmune CAR T-cell therapy deserves attention. The toxicity profile is considerably gentler, which opens the door to community treatment in a meaningful way. However, the nuances are even more complex. Right now, autoimmune CAR T products would be offered through oncology centers—whether community or academic—and those centers will need to think carefully about how they communicate their capabilities to community rheumatologists. Reimbursement dynamics will be equally complex. There’s also a straightforward patient psychology question: Will someone with an autoimmune condition want to receive an infusion at a cancer center? And what happens if they have a toxicity? The broader point is this: Over the past 10 years, we have been building a cell therapy infrastructure that barely existed beyond perhaps 50 academic medical centers nationwide. That work takes time. There are a lot of promising therapies coming, and I’d be very disappointed if the patients who could benefit from them couldn’t access them because the infrastructure wasn’t ready and available.