Real-World Results Show Medicare Costs Drop After Completion of CAR T-Cell Therapy

Most Medicare patients treated with chimeric antigen receptor (CAR) T-cell therapies in the first year after FDA approval for diffuse large B-cell lymphoma (DLBCL) fared well after the procedure, according to an Avalere Health study presented at the 61^st American Society of Hematology Annual Meeting and Exposition in Orlando, Florida.

More than half the patients treated with this expensive, revolutionary therapy had comorbidities common in seniors, such as heart disease or renal problems, that might have kept them out of clinical trials. But 6 months after treatment, hospital stays dropped 17% from pretreatment levels. And healthcare costs 6 months after CAR T-cell therapy, based on Medicare Part A and B, were 39% lower than they were in the 6 months prior to treatment, said lead study author Karl M. Kilgore, PhD, who shared results from 207 patients in a press briefing Saturday.

The study is the first claims analysis from Medicare patients who received CAR T-cell therapy in the year after October 1, 2017.¹ FDA approved Novartis’ tisagenlecleucel (Kymriah) in August, followed by Gilead’s axicabtagene ciloleucel (Yescarta), in October 2017. Both are approved to treat adult relapsed or refractory large B-cell lymphoma.

Medicare patients in the Avalere study were more than a decade older than the median age of patients in clinical trials, yet many had good outcomes. “Our findings offer evidence that older patients with multiple comorbidities can be treated successfully with CAR-T,” he said in a statement. “While we don’t know the long-term outcomes yet, nearly three-quarters of the patients were still alive 6 months post-treatment.”

Kilgore said this is the first analysis to use real-world evidence—in this case, Medicare claims—to examine how CAR T-cell therapy works in older patients with other health issues.

While the Avalere study found a significant decline in both healthcare utilization and cost, Kilgore was clear that this “is not a cost-effectiveness study,” meaning it was not designed to evaluate the healthcare savings seen after treatment against the cost and benefits of treatment itself. CAR T-cell therapy in this indication costs $373,000 just for the specially engineered therapy manufactured from a patient’s own cells; administration costs, including the cost of treating adverse events, can easily drive the total price tag closer to $1 million.

Medicare and academic centers that offer CAR T-cell therapy have battled over reimbursement rates for more than a year, and while payment is set to rise in 2020, a commentary in the Journal of Clinical Oncology in November estimated that centers lose $300,000 on every Medicare patient they treat.²

Highlights from the Avalere study showed¹:

• The median age of the Medicare patients was 71, compared with 56-58 in clinical trials, and 51% of the Medicare group had 1 or more chronic conditions.
• Results after 177 patients showed the drop in per-patient per-month healthcare utilization costs in Medicare Part A and B fell from $9749 in the period 6 months before CAR T-cell therapy to $7121 in the 6 months post-therapy. Kilgore said in an interview with The American Journal of Managed Care® (AJMC®) that Part D data had not been released in time for ASH and would be analyzed separately.
• Six months after treatment, emergency department (ED) visits dropped by 45%, and the number of patients visiting the ED dropped by one-third.
• The study shed light on the healthcare needs of Medicare patients receiving CAR T-cell therapy: the average hospital stay for the procedure is 17 days; while fewer than half needed time in the intensive care unit, those that did stayed 13 days.

Kilgore noted that reimbursement methods to hospitals performing CAR T-cell treatment vary, with some subject to the acute inpatient prospective payment system (IPPS) rule and others exempt. The Avalere study found that CMS, on average, is reimbursing under IPPS about $422,000, compared $467,000 in the outpatient setting.

Joseph Alvarnas, MD, an oncologist/hematologist who serves as vice president of government affairs and senior medical director for employer strategy for City of Hope in Duarte, California, told AJMC® that while the Avalere analysis is not a cost-effectiveness study or a comparative effectiveness model, “These data add to other data sets that continue to validate the idea that there is a real value proposition for these therapeutics, that provides a path toward developing an economically sustainable model for treating this population of patients.”

The authors acknowledge that the Medicare patient sample remains small, and that it may not be representative of a broader patient population. Kilgore has received research funding from Kite Pharma, which developed the CAR T-cell product that Gilead acquired and launched.

Avalere’s results were part of a set of abstracts that highlighted results involving disparities in care. Other results include:

• A study of 1040 patients with acute myeloid leukemia (AML), presented by Abby Statler, PhD, MPH, of Cleveland Clinic, found that issues with renal function appear to be a barrier to enrollment in clinical trials for African Americans. However, there is no association between clinically insignificant renal lab values and response to treatment or overall survival (OS), so the study recommends adjusting trial eligibility criteria to reduce racial disparities in enrollment.³
• Lena E. Winestone, MD, MSHP, of the University of California at San Francisco, presented data that show children with AML from middle- and high-income areas experience 25% lower mortality risk compared with those from low-income areas (OS, crude hazard ratio [HR] 0.74, 95% CI, 0.62-0.89; adjusted HR 0.79, 95% CI, 0.63-0.99). Clinical trial data were matched with ZIP code data as a proxy for income, and the authors of the study concluded that “ZIP-code based low socio-economic status is an independent risk factor for mortality in pediatric AML.”⁴
• Anita D'Souza, MD, MS, of the Medical College of Wisconsin at Milwaukee, presented a large study of autologous hematopoietic cell transplantation (AHCT) in older adults with multiple myeloma (at least 70 years of age) found that these older patients can safely undergo the transplant procedure with the same benefits that are seen in younger patients. Adjusted results show that compared to patients aged 60-69 years, those 70 years or older had similar non-relapse mortality, with HR 1.3, (95% CI, 1-1.7, P = .06); progression-free survival, HR 1.06 (95% CI 1-1.2, P = .2), and OS, with HR 1.2 (95% CI, 1-1.4, P = .02).⁵

References

1. Kilgore K, 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. Presented at the 61^st American Society of Hematology Annual Meeting and Exposition, Orlando, Florida; December 7-10, 2019; Abstract 793. ash.confex.com/ash/2019/webprogram/Paper124364.html

2. Manz CR, Porter DL, Bekelman JE, et al. Innovation and access at the mercy of payment policy: the future of chimeric antigen receptor therapies [published November 1, 2019]. J Clin Oncol. doi:10.1200/JCO.19.01691.

3. Statler A, Hobbs BP, Radivoyevitch T, et al. Are racial disparities in acute myeloid leukemia clinical trial enrollment associated with comorbidities and/or organ dysfunction? Presented at the 61^st American Society of Hematology Annual Meeting and Exposition, Orlando, Florida; December 7-10, 2019; Abstract 381. ash.confex.com/ash/2019/webprogram/Paper129096.html.

4. Whitestone LE, Getz KD, Bona KO, et al. Area-based socioeconomic disparities in survival of children with newly diagnosed acute myeloid leukemia: a report from the Children’s Oncology Group. Presented at the 61^st American Society of Hematology Annual Meeting and Exposition, Orlando, Florida; December 7-10, 2019; Abstract 703. ash.confex.com/ash/2019/webprogram/Paper130978.html.

5. Munshi PN, Hari P, Vesole DH, et al. Breaking the glass ceiling of age in transplant in multiple myeloma. Presented at the 61^st American Society of Hematology Annual Meeting and Exposition, Orlando, Florida; December 7-10, 2019; Abstract 782. ash.confex.com/ash/2019/webprogram/Paper124804.html