Once considered highly experimental, chimeric antigen receptor (CAR) T-cell therapy is now an established third-line treatment option for B-cell lymphomas and leukemias. CAR T-cell therapy has saved the lives of people who would otherwise have run out of treatment options. But the question is whether this very expensive treatment that needs to be delivered at specialized centers is generalizable to a broader range of patients—and whether the cost is prohibitive.

A study presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition suggests that not only is CAR T-cell therapy effective in a broader range of patients who would be ineligible for clinical trials, but also, associated health-care costs are reduced by at least one-third at 6 months after the treatment.¹ The study was based on Medicare claims data for older adults with lymphoma who received CAR T-cell therapy between October 1, 2017, and September 30, 2018.

Karl M. Kilgore, PhD

“These data from a Medicare claims database reflect very early experience with [CAR T-cell therapy]. These data showed that in older adults with lymphoma, [CAR T-cell therapy] was associated with fewer hospitalizations, shorter time in the hospital, fewer emergency department visits, and lower total health-care costs,” said lead author Karl M. Kilgore, PhD, of Avalere Health, Washington, DC.

“The study showed that older, sicker lymphoma patients got this treatment under Medicare, and their outcome was good. Although this is not a randomized clinical trial, the data could make the case for older and sicker patients to get [CAR T-cell therapy],” Dr. Kilgore added.

CAR T-Cell Therapy Expense

Two CAR T-cell therapies were approved in 2017 by the U.S. Food and Drug Administration: tisagenlecleucel for pediatric and young adults with B-cell acute lymphoblastic leukemia and axicabtagene ciloleucel for adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma who are ineligible for stem cell transplant. The cost of treatment per patient ranged from about $375,000 to $475,000. This considerable expense gives one pause for thought about “value” and what happens to these patients after CAR T-cell therapy.

“There are limited options for patients with lymphoma who relapse after curative options,” Dr. Kilgore told listeners. “We wanted to look at the real-world use of [CAR T-cell therapy] and the use of health-care resources 6 months before and 6 months after [the treatment],” he said.

Study Details

Data were obtained from the Centers for Medicare & Medicaid Services fee-for-service parts A and B claims for the 1-year period. There were 207 patients with diffuse large B-cell lymphoma (DLBCL) or a related disease for whom there were complete data 6 months before and 6 months after CAR T-cell therapy.

Ninety-one percent had a primary diagnosis of DLBCL; the median age was 71 years. “In clinical trials, the median age is 56 to 58 years old,” Dr. Kilgore noted. Moreover, 74.6% had a Charlson Comorbidity Index score ≥ 2.78, reflecting multiple diseases in addition to their lymphoma.

Dr. Kilgore and coauthors evaluated the demographic and clinical characteristics of Medicare patients treated with CAR T-cell therapy and compared the health-care utilization, costs, and outcomes pre- and post–CAR T-cell therapy.

More than half the patients (51%) had one or more chronic conditions that would have excluded them from participation in clinical trials of CAR T-cell therapy, such as heart failure, renal failure, deep-vein thrombosis, and pulmonary embolism.

Fewer than 5% of patients had undergone a previous autologous stem cell transplant, just over half of the participants (52%) had been treated with intravenous chemotherapy in the 6 months prior to receiving CAR T-cell therapy, and 60% received outpatient lymphodepletion.

At 6 months after CAR T-cell therapy, 73% remained alive and median overall survival had not been reached. “At almost 2 years following [CAR T-cell] therapy, more than 50% are alive,” Dr. Kilgore said. No deaths occurred during the post–CAR T-cell therapy period, but 5% were admitted to hospice care.

Reduced Health-Care Costs

During the 6 months following CAR T-cell therapy, patients spent 17% less time in the hospital and emergency room visits were reduced by one-third, compared with the 6-month period prior to CAR T-cell therapy. The total number of emergency room visits was reduced by 50%.

Overall health-care costs, excluding the cost of CAR T-cell therapy, were 39% lower in the 6 months after it compared with the 6 months before it. Median total health-care costs during the pre-index period were $51,999; post-index, the median was $14,014. Per-patient costs per month were $9,749 pre–CAR T-cell therapy and $7,121 post–CAR T-cell therapy, representing a 27% decrease in expenditures.

The median length of hospital stay for CAR T-cell therapy was 17 days. Median time in the intensive care unit (ICU) was 13 days, but fewer than 50% of patients required an ICU stay.

“The total amount paid for [CAR T-cell therapy] from all sources varied significantly according to whether the patient was on a clinical trial and whether the hospital was reimbursed under standard Medicare [prospective payment services (PPS)] for inpatient facilities or through a PPS-exempt payment system,” he said. “The total cost of stay for the procedure was much higher in the PPS hospitals.”

Dr. Kilgore concluded: “A key take-home point is that older patients with multiple comorbidities can be successfully treated with [CAR T-cell therapy].”

Comment on Study

Laura Michaelis, MD

Press conference moderator Laura Michaelis, MD, Associate Professor at the Medical College of Wisconsin, Milwaukee, found this study “optimistic.”

“Many times, drugs get approved and we use them in patients whose characteristics fall outside those for clinical trial eligibility. This study suggests that patients who get [CAR T-cell therapy] tend to be of higher affluence; 87% were white. However, [CAR T-cell therapy] may not be accessible to others who could benefit. The study tells us who got the treatment under Medicare, but we don’t have any data on the equity of deployment of this treatment,” Dr. Michaelis said.

“Patients in the real world are even sicker than those in clinical trials, and this study shows that older, sicker patients are being treated with [CAR T-cell therapy] and reaping the benefits. Despite their comorbidities, they benefit, and after they have [CAR T-cell therapy], costs are lower for the health-care system. This is a descriptive study, not a prospective randomized trial,” Dr. Michaelis noted. 

DISCLOSURE: The study was funded by Kite Pharmaceuticals. Dr. Kilgore works for Avalere Health. Dr. Michaelis has served in a consulting or advisory role for Celgene, Novartis, and TG Therapeutics and has received research finding from Jazz Pharmaceuticals.

REFERENCE

1. Kilgore KM, Mohammadi I, Schroeder A, et al: Medicare patients receiving chimeric antigen receptor T-cell therapy for non-Hodgkin lymphoma: A first real-world look at patient characteristics, healthcare utilization, and costs. 2019 ASH Annual Meeting & Exposition. Abstract 793. Presented December 9, 2019.