Access to CAR T-cell therapy faces regional challenges
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The additional distance that Americans must travel to receive chimeric antigen receptor T-cell therapy compared with other cancer treatments varies greatly by region, according to a study by health care consulting firm Avalere Health.
Extended travel may present financial and logistical challenges for patients, and it also can affect insurance coverage when patients cross state lines to receive CAR-T, according to Jay Jackson, MPH, a principal with Avalere and one of the study’s co-authors.
“The purpose of this research was to quantify whether there are any geographic access barriers,” he told Healio.
A group of consultants with Avalere is systematically examining many aspects of gene and cell therapy delivery to identify gaps care delivery and access — ranging from logistical requirements to reimbursement issues — and enhanced patient support programs that manufacturers could establish.
“Travel is and will be a big challenge,” Jackson said. “It will be an even bigger challenge in some regions.”
The complexity of CAR-T administration requires that patients travel to centers specifically accredited to deliver cellular therapies. Depending on the patient’s location, the additional distance can be substantial.
“It's clear that travel is one of the issues related to patient access and is one of the things that would be addressed by a patient support program,” Jackson said.
The added distance also can create issues with follow-up if the patient lives far away from the treating center.
“It affects both clinicians and patients in this regard, especially patient outcomes,” Jackson said.
Issues surrounding patient follow-up also impact clinics that provide CAR-T and are mandated to follow patients as part of the post-marketing safety surveillance required by the FDA’s Risk Evaluation and Mitigation Strategy program.
Jackson and colleagues reviewed Medicare fee-for-service claims for patients who received therapy for diffuse large B-cell lymphoma between 2017 and 2019. The researchers then identified 64 accredited centers in the U.S. that actively provide CAR T-cell therapy for DLBCL. Next, they determined how far patients traveled from their home ZIP codes to the centers, according to Jackson.
The researchers divided the sample into two cohorts. Cohort A comprised patients who received CAR-T for DLBCL, whereas cohort B included patients who received other types of therapy for the same indication.
The results showed considerable regional variation in median additional distance traveled by patients to reach their CAR-T provider compared with the group that received other treatments, ranging from 0.3 miles in the Middle Atlantic states of New York, New Jersey and Pennsylvania, to 46.7 miles in the East South Central area comprising Kentucky, Tennessee, Mississippi and Alabama.
Following are the median additional distances according to region:
- Middle Atlantic: 0.3 miles
- New England: 2.4 miles
- West North Central: 3.5 miles
- Pacific: 6.3 miles
- East North Central: 9.0 miles
- Mountain: 14.5 miles
- South Atlantic: 17.2 miles
- West South Central: 21.9 miles
- East South Central: 46.7 miles
The results clearly illustrate that patients in the southern portions of the U.S. must travel considerably farther to receive CAR T-cell therapy, Jackson said.
“This research highlights one of the access issues that makes [CAR-T] unique compared with other types of therapies,” he said.
However, he cautioned against calling this a regional disparity at this early stage.
“I think it's really more of a challenge,” Jackson told Healio.
There is not yet enough data to suggest a regional disparity, he said, because his group thus far has only examined distance to treating centers.
Distance may become less of a challenge over time as new CAR-T products with safety profiles that allow for outpatient administration enable cellular therapies to proliferate beyond the limited number of centers that currently provide them.
An accompanying report by Jackson and colleagues concluded that “manufacturers should consider how to redesign and optimize existing and innovative patient support service offerings” to help address challenges associated with traveling to centers that provide CAR-T. Meanwhile, clinicians and health care systems can take steps to help meet this challenge and promote wider access to cellular therapies, Jackson said. These include:
- offering online portals that patients can access to meet a portion of the follow-up care requirements (for example, patient-reported outcomes);
- coordinating imaging and diagnostics off-site, closer to the patient's home and outside the center providing CAR-T; and
- partnering with community systems to coordinate follow-up care closer to the patient’s home.
Some providers already have implemented solutions like these, but more widespread adoption will be required to expand access to CAR-T, Jackson said.
As more of these products come to market and more patients become eligible, clinicians and their patients will need to assess the balance between the effectiveness and toxicity of cellular therapies, he added.
"If the therapy is worth the time, toxicity and expense, then patients may consider it. But if it's not, patients and their providers may opt to remain in the community setting for less complex and expensive therapies, especially if their disease is less aggressive,” Jackson said. “[Although] this balance is always something that needs to be considered, it will be even more true in the case of CAR-T.”
Reference:
Avalere Health. Advancements in cell therapies require new patient support solutions. Available at: https://avalere.com/insights/advancements-in-cell-therapies-require-new-patient-support-solutions. Accessed April 30, 2021.
For more information:
Jay Jackson, MPH, can be reached at jjackson@avalere.com.
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