Dr Simmons on Payer Barriers and Safety in Community-Based CAR T-Cell Therapy

Gary Simmons, DO, MSHA, a medical oncologist and bone marrow transplant physician at Virginia Oncology Associates, has worked to bring chimeric antigen receptor (CAR) T-cell therapy to a standalone community practice. In an interview with Targeted Oncology^TM, Simmons discussed the populations that may benefit most from local access, the shift toward outpatient administration, the operational and payer bottlenecks his team has encountered, and what he would tell skeptics and colleagues considering similar programs.

Targeted Oncology: Are there any populations that are disproportionately helped by having CAR T-cell therapy closer to home?

Gary Simmons, DO, MHSA: That's a difficult question to answer directly, but in our experience, I would say yes, absolutely. We serve a very underserved area, with 2.5 million people and a significant Black and Hispanic population. We know from existing data that these patients are 50% less likely to receive CAR T-cell therapy. Just by doing some math, I think we're serving more than that percentage of patients locally, because we're here to offer the therapy. It's hard to put a number on it, but my gut instinct is yes, because of our location and the population we serve.

How has your approach to outpatient vs inpatient administration evolved as your team has gained experience?

In the early days of CAR T-cell therapy, around 2016 and 2017, a lot was unknown, and we put all the patients in the hospital. We did chemotherapy in the hospital, we did cell infusion in the hospital, and we checked blood work multiple times per day. Over the last decade or so, we've learned as a community that it can definitely be administered safely in the outpatient space with certain parameters. Our program has evolved to always support an outpatient approach because it keeps people out of the hospital. We avoid interruptions to sleep schedules, infection risk, and things like that. We've also been able to use steroids prophylactically and select certain CAR T-cell products for certain patients, which has made the whole journey safer and more tolerable in the outpatient setting.

Have you encountered any operational bottlenecks in bringing CAR T-cell therapy into the outpatient setting?

It's riddled with bottlenecks. I think we're trailblazers in this space, and by that I mean community practices that are standalone and not supported by big health care systems or academic centers. I've been at Virginia Oncology Associates for almost 4 years. Early on, just getting manufacturers to agree to let community sites do this was a bottleneck. Then there was whether we had the staff and infrastructure as a practice to do this. Then there was whether it was sustainable economically. The largest bottleneck is really getting commercial payers on the other side to accept that this can be done in the community, that it should be done in the community, and that it's safe. We've been successful at overcoming these obstacles in the last 4 years, but very slowly and methodically.

What would you say to skeptics who worry that community-based CAR T-cell therapy could compromise safety or outcomes?

I'd have to throw questions back at them and ask what level of quality they want to see. First, I don't expect every community site to be able to do this, or that every site should. Second, if you've ever built a CAR T-cell program, you realize there are so many layers and safety checkpoints required just to get started in your practice. Bringing a program on involves quality agreements between the manufacturers and the program, and there is Foundation for the Accreditation of Cellular Therapy [FACT] accreditation, or community FACT accreditation, which you can now get. At some point, the skeptic is going to have to ask what quality they are looking for. If programs are going through those checkpoints and your data are consistent with what has been done in clinical trials, then I don't know what other people are looking for, except trying to control the market.

What key takeaways from your experience would you share with colleagues in the community?

There are a few things I would say. Number 1, we've shown that it can be done. Enough of us are doing it consistently, time and time again, to show that there is a model out there for this in the community.

Number 2, and I use the swimming pool analogy: Make sure you know how deep the water is before you jump in, and make sure this is a space you want to get into for whatever reasons in your practice. It's a big strain on community practices right now, both from an infrastructure demand and a cost to run the program. And let's be honest, the financial reimbursements are not good. If you're in a cell therapy desert and you really want to provide this therapy for your patients, there's a way to do that. But if you have 3 university hospitals within 2 miles of you, I'm not sure this is the time to jump in. You have to know how deep the water is as a practice before you jump in, but it can definitely be done.

Third, we have to continue to pound the drum and raise awareness with payers that this can be done and should be done. Stop dictating that patients travel hundreds of miles from their homes to get therapy. It's dangling a carrot that they're unable to really achieve, and I think that's an unfair ask of them.