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Accessing Affordability: Overcoming Financial Barriers in CAR T-Cell Therapy

Gwen Nichols, MD, discusses challenges associated with the limited access to CAR T therapy and the need to expand outpatient and community care for patients.

In an interview with Pharmacy Times® at the Community Oncology Alliance (COA) 2024 Payer Exchange, Gwen Nichols, MD, executive vice president and chief medical officer of the Leukemia & Lymphoma Society (LLS), highlights the significant financial burden of cancer care, emphasizing how the high costs often prevent patients from accessing necessary treatments.

Pharmacy Times: What factors regarding treatment affordability were most significant in your session?

Gwen Nichols, MD: My role in the session was to talk about how cellular therapies, in particular, CAR T affordability, impacts patients' access to the treatments. As we're seeing really groundbreaking change and results with CAR T for many patients, we realize how many patients get left behind because either they live a distance from a center that has CAR T, or they make a decision that the out-of-pocket costs are just too great.

Pharmacy Times: What are the most significant barriers preventing patients from accessing high-cost therapies like CAR-T or immunotherapy, and how can payers reduce these hurdles?

Nichols: We talked a bit—and this was quite interesting and not something that I had really thought about—but many of the practitioners, particularly those that are trying to build CAR T into the community setting, are bringing it closer to where the patients live. I think that's a huge plus. But these practitioners are finding that the approval process is very cumbersome and it's extremely variable. So, there was an idea thrown out that payers get together and figure out what are the key elements that you need for approval of CAR T in a given patient for a given disease, and that some consistency there would make a huge difference both to the payers getting the information they need and being able to plan, but also for the docs and the patients who are oftentimes have extraordinary delays in starting the therapy.

Pharmacy Times: What role should pharmaceutical companies play in ensuring the affordability of life-saving cancer treatments, and how do we balance innovation and affordability in drug development?

Nichols: This is a really tricky question, because the pharmaceutical industry and those manufacturers who are making CAR T cell therapy have put an extraordinary amount of dollars and effort into building this manufacturing capability. And the [LLS] is spending a lot of time trying to encourage an easier process such as off the shelf CAR T, different cellular products, ways to do the whole process as an outpatient or in the same setting. And that's a tricky balance, because they've invested a huge amount in the current structure, and we're hoping that that's going to change. So, it is all science and it's a very hard balance to make sure that we can compensate them appropriately for the what they put in, and yet make it accessible for patients. So, I think we're in a transition from CAR T 1.0 to 2.0 to 3.0 and that's going to be tricky for a while.

The other thing that I think the manufacturers have helped with and could do more is helping us think about how to compensate patients for the out-of-pocket costs that they incur. One in particular is the second opinion that you need for CAR T because it is still being offered primarily in large metropolitan areas for anyone who has to travel. I gave the example because I live in New York of someone who lives upstate and has to travel several hundreds of miles to New York City to be evaluated for CAR T; there's the travel, the gas, there's parking in New York City at $60 a day, there's a hotel room at $500 a night. And this all adds up to thousands and thousands of dollars just to find out if you're a candidate. For many patients, that's prohibitive. So much of our discussion was how can we safely open up CAR T to more outpatient and community-based [centers] so that that access issue of having to travel is minimized.

Pharmacy Times: Given the disparities in access to high-cost therapies across different demographic groups, how can payers and providers collaborate to close these gaps?

Nichols: think figuring out ways to allow out-of-pocket costs to be minimized for patients and finding ways, as I said before, to allow for CAR T or parts of the process. And this goes for other expensive therapies, CAR T is just the one we talked about today, because it's the most urgent. How do we get that, at least part of the process, closer to home? We didn't even really dive into what happens to the caregiver. You have to have a partner to be able to go through CAR T cell therapy, someone that you live with, someone who's going to watch to see if you have CRS [cytokine release syndrome] symptoms and be able to connect to your provider. If we let people go home? Well, that's a huge burden on a family. And if that caretaker also has to come to New York City for 2 weeks, they can't work. What about the kids at home? All of that gets decreased the more we can make it outpatient, closer to home, and I think we need as a community to figure out how that is possible, and how do we keep it safe.

Pharmacy Times: Can there be a balance between the needs of patients, providers, and institutions or corporations, and what do you believe is a possible path forward?

Nichols: I think the path forward requires everyone to give a little bit. You know, CAR T can't be done everywhere. It just isn't going to be possible. We need to find ways to make it less expensive to the system overall, we need to find efficiencies in how we make the product. We need to be sure that we're choosing the right patients to get the therapy and that we provide the resources. So, that means societies like LLS, that means other patient groups, that means payers, that means hospitals, that means community oncologists. It requires everyone in the ecosystem and the pharmaceutical industry to say what's feasible for us to do to make this easier and less expensive for everyone.

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pharmacogenetics testing, adverse drug events, personalized medicine, FDA collaboration, USP partnership, health equity, clinical decision support, laboratory challenges, study design, education, precision medicine, stakeholder perspectives, public comment, Texas Medical Center, DNA double helix