Financial toxicity in a phase I/II trial of LV20.19 CAR-T cell for B-cell malignancies a longitudinal, qualitative study

Abstract

Background:

Financial toxicity, the economic burden associated with cancer treatment, is an evolving concern for patients undergoing innovative therapies like chimeric antigen receptor T-cell (CAR T-cell) therapy. The high costs of CAR T-cell therapy pose significant financial challenges, impacting well-being and treatment adherence.

Objective:

This study explores the financial burdens experienced by patients and caregivers across the CAR T-cell treatment course.

Study Design:

Seventeen patients receiving CAR T-cell therapy were interviewed at four time points: pre-infusion (baseline), Day 90, Day 180, and 1-year post-treatment. Semi-structured interviews explored financial experiences, including direct medical costs, insurance coverage, caregiving demands, and ancillary expenses. Interviews were analyzed using thematic analysis to identify key patterns and track how financial concerns changed over time.

Results:

Six themes emerged: (1) financial strain on caregivers, (2) employment disruptions, (3) healthcare and insurance costs, (4) relocation and travel expenses, (5) long-term financial planning, and (6) financial assistance navigation. Initially, patients were most concerned about treatment access and insurance approval. By Day 90, stress shifted to out-of-pocket costs and job-related disruptions. At later time points, patients emphasized sustained financial planning and recovery-related expenses.

Conclusion:

Patients receiving CAR T-cell therapy face significant and evolving financial burdens. Key stressors include caregiving-related financial strain, insurance complexities, and travel-related expenses. Interventions such as caregiver support, upfront financial counseling, and clearer insurance communication may reduce this burden. Future research should evaluate interventions aimed at alleviating these financial stressors and promoting equitable access to CAR T-cell therapy.

Introduction

Financial toxicity is a term that has been used to describe the distress that cancer patients experience as a result of out-of-pocket medical costs associated with their treatment, as well as opportunity costs and ongoing financial challenges during survivorship.¹ Financial stressors strongly predict lower quality of life, with effects rivaling physical toxicities.^2,3 As cancer therapies continue to evolve, the rising cost of care makes financial toxicity an increasingly important factor in maximizing patient survival and well-being.

Chimeric antigen receptor T-cell (CAR T-cell) therapy is an innovative adoptive cellular therapy that involves the isolation, genetic modification, and reintroduction of a patient’s own T-cells to target and eliminate cancer cells.⁴ The U.S. Food and Drug Administration (FDA) approved the first CAR T-cell therapy in 2017 for relapsed or refractory B-cell acute lymphoblastic leukemia, with subsequent approvals expanding its use in hematologic cancers and, more recently, solid tumors.^5–7 Clinical trial outcomes have been encouraging across institutions.⁸ At our center, a prior completed Phase I/Ib cohort of lentiviral transduced anti-CD20, anti-CD19 (LV20.19) CAR T-cell therapy demonstrated a two-year overall survival rate of 69%.^9,10 Yet even among patients with strong clinical responses, treatment-related burdens persisted. In a separate analysis of this cohort, elevations in kynurenine pathway metabolites were associated with neurotoxicity and depressive symptoms,¹¹ highlighting its broad impact and the need for robust survivorship support.

Despite these advances, CAR T-cell therapy remains financially challenging. Drug acquisition costs range from $373,000 to $475,000,⁵ and newer generations are launching at even higher price points.¹² Inpatient care for post-infusion monitoring adds another $79,466 to $85,267 on average.⁵ A recent analysis found median out-of-pocket costs of $803, with some patients paying up to $38,000. ¹³Yet these figures exclude indirect expenses such as travel, lodging, lost income, and unreimbursed supportive care, leading to significant underestimation of true financial toxicity, especially for patients with limited insurance or support.^14–16

This burden is not new to oncology. Financial toxicity has been linked to poorer quality of life and increased mortality.^14–16 Qualitative research offers essential insight into patient challenges and can guide intervention development. A review of the literature identifies Williams et al.¹⁷ as the only other study, besides our own, to collect qualitative data on cancer patients enrolled in early phase clinical trials. However, their study did not focus on CAR T-cell therapy, leaving a notable gap given CAR T’s substantially higher costs.¹⁸ The urgency of addressing this issue is underscored by the rapid growth of CAR T-cell therapy, with 579 clinical trials currently active in the United States as of January 2025, including 110 new trials initiated within the past year alone.¹⁹

The financial and logistical burdens of CAR T-cell therapy are not equally shared. Socioeconomic disparities persist in clinical trial enrollment, with patients earning <$50,000 per year being 30% less likely to participate.²⁰ Logistical constraints are particularly relevant in CAR T-cell therapy, where FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) protocols require patients to remain within two hours of a certified center for four weeks post-infusion.²¹ Our phase I/II trial imposed even stricter parameters where participants were required to reside within 45 minutes of the center and have a 24-hour caregiver for 28 days post-treatment.²² Such local adaptations are increasingly common across clinical trials and are intended to enhance safety; however, they may amplify financial stress for patients and their families.²⁰

This study explores the evolving financial experiences of patients receiving CAR T-cell therapy in a Phase I/II clinical trial—conducted as a subsequent trial to the earlier Phase I/Ib study—with particular focus on how these burdens change over time and impact quality of life.

Materials and Methods

Patient population

Participants were enrolled in a single-center Phase I/II, first-in-human dual targeted LV20.19 CAR T-cell therapy for the treatment of relapsed, refractory B-cell non-Hodgkin lymphoma (NCT04186520). The trial was conducted at a large academic quaternary referral center in the Midwestern United States with a high-volume cellular therapy program; all patients underwent inpatient infusion and monitoring.

Key eligibility criteria for trial included age ≥18 years; relapsed/refractory B-cell non-Hodgkin lymphoma after ≥2 prior lines of therapy; and no uncontrolled infection or active CNS involvement. The qualitative sub-study included all eligible trial participants approached sequentially, with no additional inclusion or exclusion criteria. Demographic characteristics were obtained from the parent study database.

Seventeen participants completed the qualitative interviews, a sample size consistent with evidence that thematic saturation is commonly reached by the twelfth interview.²³ All participants provided written informed consent. The study was IRB-approved and conducted under FDA IND 17518.

Data collection and handling

Semi-structured interviews

To explore financial experiences related to CAR T-cell therapy, semi-structured interviews were conducted by author E.A. using a four-question guide with optional probes (Table 2). Interviews lasted 5–25 minutes and were conducted primarily by telephone (two were completed in person). All interviews were audio-recorded and transcribed through Health Insurance Portability and Accountability Act (HIPAA) compliant third-party transcription service.

Table 2.

Semi-structured interview questions

Do you have any financial concerns due to the CAR-T treatment? How do you manage this? [Probe] Do you have insurance that covers the medical bills sufficiently (co-pay, out of pocket)? [Probe] What are some examples of financial concerns that you have? If no: [Probe] Think about things other than direct medical bills, such as transportation, child/pet care, house care, changes to your job or how you receive income Did you cut your hours at your job? Do you live close to the hospital? Do you have family or friends to help you out?

Has the financial cost of your cancer treatments up until this point affected your lifestyle? [Probe] What parts of your life are most affected by the cost? [Probe] What are some examples of changes you have made to accommodate the cost of treatment If no: [Probe] Consider similar types of expenses as mentioned above: transportation, child/pet care, house care, vacation

Do you have any other medical needs that add to your medical costs? [Probe] Can you walk me through those other medical costs? If no: [Probe] Does your family have any health concerns that add to your medical bills?

Do you need to give up some things you would like to do or buy as a result of your medical costs? [Probe] What are some of those things you would like to buy or do? If no: [Probe] If you did not have doctors’ appointments, what do you think you would do instead?

Primary questions and follow-up probes used to explore financial toxicity and related experiences during CAR T-cell therapy.

Qualitative analysis

Interviews were transcribed, de-identified, and uploaded to MAXQDA 2024 (VERBI Software, Berlin, Germany).²³ Multidisciplinary members of the research team (E.A., R.C, J.K.) representing psychiatry, sociology, and medicine reviewed ten transcripts to develop an initial codebook. The members double-coded 17% of the transcripts to enhance consistency and ensure intercoder reliability. This proportion was deemed sufficient after coders reached an agreement and no new discrepancies emerged, aligning with best practices for establishing reliability once coding stability is achieved.^23,24 Any edits to the transcript codes or codebook were made based on team consensus. After coding was completed, individual codes were isolated for thematic analysis. A subset of the most prevalent codes was then examined for temporal changes across baseline, Day 90, Day 180, and 1-year post-infusion. To better understand how financial experiences shifted across the treatment course, we conducted a longitudinal analysis of the most prominent themes identified in the initial coding. This analysis focused on themes that were distinctly time dependent.

Results

Patient characteristics

Patient characteristics are summarized in Table 1. Seventeen patients who were enrolled in the Phase I/II LV20.19 CAR T-cell therapy clinical trial participated in this financial toxicity sub-study. Participants had a mean age of 62.1 years (range 40–72), were predominantly male (88%), and mostly identified as White (94%). Compared to the parent study population (mean age 63.3 years; 76% male; 92% White), the sub-study cohort was demographically similar but slightly more male. Diagnoses reflected the advanced disease states characteristic of CAR T-cell therapy candidates: diffuse large B-cell lymphoma (58.8%), mantle cell lymphoma (23.5%), follicular lymphoma (11.8%), and chronic lymphocytic leukemia (5.9%). Patients had 2–6 prior lines of treatment with 64.7% of participants having undergone at least three prior lines of therapy. Geographic data revealed 52.9% of patients resided over 50 miles from the treatment center; within that group, 29.4% resided over 200 miles away. Employment status varied, with 47.1% of patients retired or on long-term disability, and Social Security Disability Insurance (SSDI) being a primary income source for several. Insurance coverage included a mix of private insurance, Medicare, and employer-based supplemental plans.

Table 1.

Patient demographics and summary statistics (N=17)

Characteristic	Summary
Age
Age (years), Mean (SD)	63.5 (±8.4)
Age (years), Median [IQR]	64 [58–69]
Sex
Male	15 (88.2%)
Female	2 (11.8%)
Race
White	16 (94.1%)
Native American	1 (5.9%)
Diagnosis
DLBCL	10 (58.8%)
MCL	4 (23.5%)
FL	2 (11.8%)
CLL	1 (5.9%)
Year Diagnosed
2016 or earlier	8 (47.1%)
2017 or after	9 (52.9%)
Range	2006 – 2021
Treatment Line
Treatment lines, Mean (SD)	2.6 (±1.1)
Treatment lines, Median [IQR]	2 [2–3]
Distance from Center
0 to 45 minutes	9 (52.9%)
>45 minutes	8 (47.1%)
Employment Status
Employed at start of trial	4 (23.5%)
Retired/not working at start of trial	13 (76.5%)

Continuous variables are presented as mean (SD) and median [IQR]; categorical variables are presented as number (%).

^*SD = standard deviation; IQR = interquartile range.

DLBCL = Diffuse Large B-Cell Lymphoma; MCL = Mantle Cell Lymphoma; FL = Follicular Lymphoma; CLL = Chronic Lymphocytic Leukemia.

All 17 participants were interviewed at baseline, with 16 at Day 90, 13 at Day 180, and 8 at 1-year. The reduction in participants at later time points was due to disease progression, which included clinical relapse or death.

Thematic analysis of financial toxicity

Six primary themes emerged from qualitative analysis: (1) financial strain on caregivers, (2) employment disruptions, (3) healthcare costs and insurance concerns, (4) relocation and travel expenses, (5) long-term financial planning, and (6) financial assistance programs (Table 3). These themes represent interconnected domains of financial toxicity that evolve throughout the treatment timeline (Table 3).

Table 3.

Qualitative themes, percent of patients illustrating that theme, and representative quotes

Theme	Definition	Patients who mentioned the theme**	Representative Quotes
Financial Strain on Caregivers	Participants describe concerns about medical costs, insurance coverage, and other expenses related to their care that affected their caregiver’s life. Some caregivers had to stop working or take leave under the Family and Medical Leave Act (FMLA).	41.2% (7/17)	“My daughter had to leave her own family behind to take care of me. It’s not sustainable.” – Female, 63 YO “My wife had to stop working to be here for me, and now we’re both struggling.” – Male, 63 YO “Caregiving is a full-time job for my sister, and she’s not being paid for it.” – Male, 71 YO “Her FMLA leave covered a few weeks, but now we’re running out of options. We’re choosing between her work and my care.” – Male, 65 YO
Employment Disruptions	Participants express stress and frustration due to their inability to work, leading to financial strain, change in insurance coverage, and loss of identity. This loss of income affects their ability to pay bills and maintain their lifestyle.	35.3% (6/17)	“I’ve had to adjust my schedule significantly, and it’s costing me opportunities at work.” – Male, 63 YO “I’ve missed over 20 days of work for this treatment alone. Every day I’m not at work is another day we fall behind financially.” – Male, 40 YO “I had to take a medical retirement because I just couldn’t manage both work and my health.” – Male, 65 YO “I was a [type of law enforcement] and medically retired after my first CAR-T. It was tough because work is such a part of your identity. Not working at 40 is not what I had envisioned for myself.” – Male, 40 YO
Healthcare Costs and Insurance Concerns	Participants discuss the overwhelming costs associated with CAR-T therapy and other medical expenses. There is apprehension about potential bills and uncertainty regarding insurance coverage, creating stress.	70.6% (12/17)	“Months after treatment, I’m still getting surprise bills. It feels impossible to manage.” – Male, 78 YO “No one explains what’s covered and what’s not. It’s like navigating a maze.” – Male, 71 YO “The lack of clarity in coverage is frustrating. It feels like a full-time job just to get answers.” – Male, 40 YO “At one point, insurance flagged $336,000 of my previous treatment, but they eventually accepted responsibility. It was incredibly stressful until it was partially resolved.” – Male, 40 YO
Relocation and Travel Expenses	Participants ranged from local to several hours away. Those farther from the treatment center incurred greater travel costs and were required to relocate for 28 days post-infusion.	52.9% (9/17)	“We’re spending money we saved for emergencies on things like travel and lodging.” – Female, 63 YO “We had to cut back on other essentials just to afford staying near the center for a month.” – Male, 69 YO “Living two hours away meant every appointment was a full-day ordeal. The gas and time off work added up fast.” – Male, 60 YO “Relocating near the center wasn’t just expensive—it was overwhelming to leave everything behind.” – Male, 71 YO
Long-Term Financial Planning	Participants express concerns about the long-term financial implications of their medical condition and treatment. They worry about depleting savings, accumulating debt, and the potential impact on their financial stability and future plans.	29.4% (5/17)	“I thought my health savings account would be enough, but now I’m dipping into personal savings for prescriptions.” – Male, 69 YO “We’re in a bind. We used up all the funds we had set aside for emergencies, and now we’re taking out loans.” – Male, 71 YO “Our savings are gone. I had to borrow money from family just to pay for gas and food during treatment.” – Male, 65 YO “The first couple of years were the hardest financially. My coworkers and family raised money for us, but even with that, the out-of-pocket costs were significant. We didn’t take vacations or spend unnecessarily because we always feared the next expense.” – Male, 40 YO
Financial Assistance Programs	Participants receive various forms of financial assistance and grants to alleviate the burden of medical expenses and other related costs. Participants often encountered stressful barriers during the application process, delaying or inhibiting support.	52.9% (9/17)	“We applied for help, but it took so long to hear back that we had to find other solutions.” – Male, 65 YO “The process is so complicated. It feels like it’s not designed for patients to actually use it.” – Male, 71 YO “I missed out on some grants because I didn’t know they existed until it was too late.” – Male, 55 YO “The social workers at Froedtert were amazing. They helped me apply for grants that made a big difference. Having someone guide you through the process is essential, especially for patients without experience or tech access.” – Male, 40 YO

List of 6 key themes, definition, and percent of patients who mentioned the theme as a relevant experience of their CAR-T therapy, exemplified in the “Representative Quotes” column. The four representative quotes within each theme were provided by different patients.

^*YO - years old

^**Refers to the number and percentage of patients whose interview content, at any timepoint, was coded to this theme. These percentages may differ from those reported in the manuscript, which at times reflect specific timepoints or thematic subdomains (e.g., financial stress, caregiver burden).

1. Financial Strain on Caregivers

CAR T-cell therapy is a novel and systemic treatment; hence, current treatment protocols require that a caregiver be available 24 hours per day for 28 days post-infusion. Many patients’ caregivers took unpaid leave, incurred travel costs, and faced stress from balancing caregiving with other responsibilities. For example, a 65-year-old male noted of his spouse, “Her FMLA [Family and Medical Leave Act] leave covered a few weeks, but now we’re running out of options. We’re choosing between her work and my care.” Caregivers without flexible employment faced amplified challenges, including job insecurity and limited options for respite. Several participants noted that caregiving demands extended beyond the required 28-day period due to delayed recovery or complications. Although not systematically quantified in our sample, this pattern is consistent with U.S. data showing that up to 26% of caregivers report moderate burden even at six months post-CAR T-cell infusion.²⁵

2. Employment Disruptions

Employment instability was a prevalent source of stress. Although 47.1% of participants were retired or receiving disability, of the employed participants, 83.3% reported that they had to reduce their work hours or take extended leave, leading to wage loss and financial strain. For instance, a 40-year-old male explained, “Every day I’m not at work is another day we fall behind financially.” The psychological toll of disrupted employment extended beyond finances. A 65-year-old male, shared, “Work ends up being a part of all of our identities… you identify in some way, shape, or form with the performance that you do.” He emphasized how one’s career is integral to an individual’s character, social circle, and purpose, and can therefore affect several aspects of quality of life.

3. Healthcare Costs and Insurance Concerns

Despite trial sponsorship covering primary treatment costs, 76.4% of participants reported significant out-of-pocket expenses for ancillary services such as imaging, supportive therapies, and follow-up care. Insurance-related stress was commonly reported, particularly around delays, denials, and unclear coverage responsibilities. A 65-year-old male recounted, “I’ve been stuck with a $1,700 bill because the trial and my insurance both said the other should cover it.” A 63-year-old female added, “The stress of insurance disputes is almost as bad as the treatment itself.”

4. Relocation and Travel Expenses

Geographic disparities imposed a substantial financial burden, with over half of participants traveling more than 50 miles for treatment. Per protocol, those living outside a 45-minute radius (approximately 50 miles in our region) were required to stay near the treatment center for the 28-day post-infusion period. Expenses for transportation, lodging, and meals added to the financial strain, despite local non-profit lodging opportunities, pending availability. These requirements created additional expenses for transportation, lodging, and meals, even when nonprofit housing was available. A 71-year-old male stated, “Staying at [non-profit housing] helped, but we still had to pay for meals and commuting.” A 66-year-old female explained how unexpected costs amplified financial strain, “It will cost us just about as much to kennel the dogs as it will to stay at [non-profit housing].” The cumulative costs over time became increasingly challenging to manage for many patients.

5. Long-Term Financial Planning

Anxiety about long-term financial sustainability was pervasive, with 35.2% of participants depleting emergency savings to fund treatment-related expenses. Concerns about potential relapse and future healthcare costs were prominent. A 63-year-old female participant shared, “We’ve used up all our savings. If I relapse, I don’t know how we’ll manage.” A 71-year-old male described tapping into retirement savings to cover essential costs. A 63-year-old male also noted that financial planning tools or guidance would have been helpful earlier in the treatment timeline to avoid drastic measures such as selling assets.

6. Financial Assistance Programs

While grants and assistance programs provided relief for some participants, others encountered delays, stringent eligibility criteria, and limited awareness of available resources. 41.2% of participants mentioned reliance on government aid (unemployment or disability), often experiencing stress and delays from the process. A 55-year-old male mentioned, “There’s a six-month waiting period” regarding disability, leaving him without a paycheck in the meantime. Another participant, a 71-year-old male, said, “By the time my travel reimbursement was approved, I was no longer eligible.” Patients frequently voiced frustration with the complexity and delays inherent in accessing financial assistance programs. Those who successfully secured grants mentioned assistance from social work or personal research efforts.

Longitudinal change in themes

Before infusion, participants focused largely on securing insurance approval and coordinating the logistical arrangements required to begin treatment. By Day 90, discussions shifted toward practical disruptions such as reduced work capacity, unexpected out-of-pocket bills, and confusion around insurance responsibilities. At Day 180, patients emphasized the accumulating impact of ongoing expenses, drained savings, and fears about the financial implications of relapse. At one year, financial reflections were more future-oriented, centering on long-term planning, retirement stability, and managing lingering medical debt. Table 4 outlines how these concerns evolved over time and demonstrates the changing prominence of specific financial experiences during recovery.

Table 4.

Temporal shifts in financial toxicity themes and representative quotes

Time Point	Theme	Example Quotes
Baseline	Focused on insurance coverage and logistical planning.	“We were worried about whether insurance would even cover this treatment at all.” – Male, 71 YO “The upfront costs felt overwhelming before we even started.” – Male, 60 YO
Day 90	Financial strain peaked due to employment disruptions and billing issues.	“The bills just started piling up, and we didn’t know how to pay for them all.” – Male, 65 YO “Missing work really hit us hard during the peak of my treatment.” – Male, 40 YO
Day 180	Shift to long-term planning and cumulative cost management.	“We’ve used up all our savings. Now, we’re thinking about what’s next if I relapse.” – Male, 69 YO “By this point, we were dipping into funds we never thought we’d need to touch.” – Female, 63 YO
1 Year	Anxiety over potential relapses and sustaining financial stability.	“It’s not just about today—it’s about whether we can afford to keep going.” – Female, 63 YO “Looking ahead, it’s hard to feel secure with so much uncertainty.” – Male, 71 YO

Key representative quotes reflecting how patient financial concerns evolved across the CAR T-cell therapy timeline, from pre-treatment to 1-year post-infusion.

^*YO - years old

Discussion

By tracking financial stressors across the treatment timeline, our findings offer unique insights into the evolving burdens faced by patients and their caregivers. Given the expanding role of CAR T-cell therapy in the treatment of relapsed and refractory hematologic malignancies, understanding and addressing financial toxicity is critical to maximizing therapeutic benefits and equity in care.

A key finding from this study is the temporal evolution of financial concerns. Initially, patients were primarily concerned with direct treatment costs, insurance coverage, and out-of-pocket expenses associated with their CAR T-cell therapy. However, as treatment progressed, their concerns shifted toward long-term financial planning. This shift in focus, coupled with the fact that more than one-third of participants explicitly voiced exhausting their personal emergency funds, suggests current financial support models are failing to address cumulative costs. Long-term financial planning, including considerations for potential relapse and the cost of extended care, should be integrated into the treatment paradigm for CAR T-cell therapy.

While access to care shapes patients’ financial experiences, the reverse is also true: the substantial costs associated with CAR T-cell therapy, along with housing, travel, and caregiving demands, can act as barriers to access, particularly for patients with limited financial resources. CAR T-cell therapy is shifting to majority outpatient care, reducing hospitalization costs.²⁶ However, CAR T-cell therapy remains largely restricted to academic or high-volume tertiary centers due to regulatory, safety, and logistical requirements, thereby limiting access for patients treated in community or rural settings.²⁷ Additionally, whether therapy is given inpatient or outpatient, patients must still abide by the FDA REMS requirement of a 2-hour radius for 4 weeks post-infusion.¹² Expanding access through community-based outpatient care is a critical next step. Studies by Perez et al.²⁷ and Myers et al.²⁸ show that this model is feasible and safe when supported by appropriate infrastructure, trained staff, and clear protocols for managing toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Hoffmann et al.²⁵ further highlight that travel to academic centers remains a major barrier to referral, especially for patients with limited caregiver or financial support. Strengthening partnerships with community oncologists and investing in local infrastructure may help reduce these barriers and improve access to this potentially life-saving therapy.

Caregivers played an essential but institutionally under-recognized role, while having similar financial burdens as the patient themselves.^29,30 As noted by participants, caregivers frequently experienced lost wages, increased responsibilities, and substantial out-of-pocket costs related to transportation, housing, and day-to-day caregiving. Yet, beyond the emotional toll, their role in toxicity monitoring (e.g., early detection of CRS or ICANS) places them in a critical clinical support role.³¹ As such, we propose that caregivers should be formally integrated into CAR T-cell protocols with structured support: reimbursement, training, and protected leave. Integration, specific to CAR T-cell therapy is already being explored. Remote monitoring has shown early feasibility in reducing in-person demands,³² and revised caregiver models offer logistical flexibility.³³ Still, both face limitations due to safety concerns, limited scalability, and lack of integration into current protocols. Other, well-established therapies, such as allogeneic hematopoietic stem cell transplant, have developed more comprehensive models that include caregiver stipends, housing assistance, and formalized education, recognizing the critical role caregivers play in patient monitoring and post-treatment recovery.^34,35 Similarly, Medicaid Home and Community-Based Services provides a federal mechanism that states can use to reimburse and train informal caregivers.³⁶ These models could be adapted to the CAR T-cell context, where caregiver responsibilities are substantial but currently unsupported.

Another prominent source of financial distress for participants in our study was insurance complexities and billing issues. Many patients encountered confusion regarding insurance coverage and faced unexpected out-of-pocket costs, particularly for ancillary services that were not always covered by insurers. These billing complexities were compounded by the experimental nature of CAR T-cell therapy, which often has complex agreements between trial sponsors and insurers over cost-sharing responsibilities. Obeng-Gyasi et al.³⁷ and Nipp et al.³⁸ identified similar challenges in cancer clinical trials, where insurance coverage is often unclear, leading to increased patient financial strain and stress. The current findings underscore the need for clearer and more transparent communication between insurers, healthcare providers, and trial sponsors. Even as CAR T-cell therapy has moved beyond the clinical trial stage, this remains an important consideration for future innovative clinical trials. As a 66-year-old female in our study eloquently stated, “Getting financial aid shouldn’t be harder than getting the treatment itself.”

In response to these challenges, one area of opportunity is improving patient access to existing financial resources. Implementation of a standardized financial counseling process for patients prior to trial enrollment is one approach to enhancing communication. This process should include detailed discussions about insurance coverage, out-of-pocket expenses, and the potential need for financial assistance. Although support is available, patients often do not take advantage of it due to lack of awareness.³⁹ In our study, 29.4% of participants reported receiving financial support through a social worker or financial counselor, while others accessed grants from organizations such as National Blood Marrow Donor Program (NMDP)⁴⁰ or Blood Cancer United.⁴¹ One participant successfully negotiated reduced utility bills with their electric company, while several applied for and received disability or unemployment benefits. However, patients consistently described delays in accessing aid and limited knowledge of how to navigate these processes. A dedicated financial coordinator could facilitate timely access to resources and reduce this avoidable burden.

Financial distress has also been linked to worse health outcomes in other oncology populations. Ramsey et al.¹⁴ studied adult patients with newly diagnosed cancer and found that those who filed for bankruptcy, a proxy for severe financial distress, had a significantly higher risk of mortality compared to those who did not. Similarly, Zheng et al.⁴² examined cancer survivors using data from the National Health Interview Survey and reported that individuals who experienced material financial hardship (such as inability to pay medical bills or skipping care due to cost) were more likely to report poor physical and mental health outcomes, including lower quality of life and reduced treatment adherence. These findings, along with the biobehavioral framework inherent to the CAR T-cell process, support the hypothesis that financial toxicity is not only a socioeconomic issue but also a modifiable factor that may influence clinical outcomes in CAR T-cell recipients.⁴³

CAR T-cell recipients experience financial toxicity similar to other cancer patients, including high out-of-pocket costs, job disruption, and insurance stress.⁴² Studies show many cancer patients face financial hardship, with some losing 20% of their income to treatment costs, while 40–85% require extended work leave.^15,44 However, CAR T-cell therapy imposes a heavier burden due to its extreme costs (>$400,000), strict post-treatment requirements (e.g., mandated caregiver presence and proximity to treatment centers), and prolonged indirect expenses.⁴⁵ Even though this study involved patients where the CAR-T itself was covered by the trial, there were many other financial burdens experienced by patients and their caregivers. Caregivers frequently reported anxiety, pain, and treatment-related distress, particularly when patients had poor responses to therapy.⁴⁶ The intensity of caregiving in the post-infusion period, combined with financial and logistical responsibilities, exacerbated strain, underscoring the need for tailored caregiver support.²⁹ These challenges warrant classifying CAR T-cell patients as high-risk for financial toxicity and prioritizing early financial counseling, caregiver support, and policy interventions.

CAR T-cell therapy is a groundbreaking, lifesaving innovation in cancer care. However, as these advanced treatments evolve, ethical questions about equity arise. This study explores direct and indirect financial experiences of patients in costly emerging therapies and the findings raise questions about how to ensure that social factors such as financial toxicity do not hinder treatment success or limit patients’ chances of a cure.⁴³

Study Limitations

While this study provides valuable insights into the financial burdens of patients undergoing CAR T-cell therapy, several limitations should be noted. First, the small sample size (N=17) from a single treatment center with patients on a trial limits generalizability, particularly given the homogeneity in race (94% White), and geographic background (mid-west residents). Broader recruitment across multiple sites and regions is needed to capture the financial experiences of more diverse and underrepresented populations.

Second, the majority of participants in both the parent trial and the qualitative sub-study were male (88%), which may limit the transferability of results to more gender-balanced CAR T populations. Additional work is needed to examine whether financial experiences differ across gender identities.

Third, the reliance on self-reported data introduces potential recall bias. However, interviews were conducted at structured intervals to limit recall periods. Future studies could further reduce bias by incorporating real-time data collection tools such as financial diaries or digital logs.

Lastly, the single-site design may reflect institution-specific practices, resources, or care models that limit the applicability of findings to other settings. Multi-institutional studies would allow for comparisons across different systems and help identify both universal and site-specific drivers of financial toxicity.

Conclusion

This longitudinal, qualitative study explored patient financial experience during CAR T-cell therapy and highlights the urgent need for comprehensive support systems to address both direct and indirect sources of financial toxicity in this population. Extending accessibility to local oncology care sites, offering caregiver financial support, and ensuring transparent insurance practices are critical steps toward improving patient outcomes and making CAR T-cell therapy more accessible. Integrating financial counseling from the onset of treatment, alongside policy reforms to address the long-term financial impact of CAR T-cell therapy, is essential for reducing financial distress.

Future research should explore interventions and potential insurance policy reforms that include indirect costs, such as travel and caregiving requirements. Such interventions might help ensure not only equitable access to CAR T-cell therapy for all patients, regardless of financial resource availability, but potentially improved quality of life and clinical outcomes.

Key Points.

• Patients reported out-of-pocket costs, travel burdens, and lost income; caregiver strain compounded the overall financial impact.

• Financial toxicity evolved over time, shifting from access and insurance concerns to long-term planning and survivorship costs.

Data Sharing Statement

Deidentified qualitative interview transcripts and coding materials are not publicly available due to concerns about patient privacy and the sensitive nature of the data. Reasonable requests for limited data access may be considered by the corresponding author on a case-by-case basis and in accordance with institutional review board (IRB) policies.