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Relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) is a high-risk non-Hodgkin lymphoma that accounts for about one-third of cases of non-Hodgkin lymphoma in the United States. About 60% of patients with DLBCL respond well to frontline treatment with rituximab in combination with an anthracycline-based regimen; however, patients who experience disease progression following frontline treatment have poor outcomes, demonstrating an unmet need for optimal treatment strategies in this population. Chimeric antigen receptor (CAR) T‐cell therapies have greatly improved clinical outcomes for patients with DLBCL who relapse after two prior therapies and, following the recent Food and Drug Administration (FDA) approval of axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel, may now be considered for second-line treatment.1
Although CAR T-cell therapies have significantly changed the landscape of DLBCL treatment, associated toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and financial toxicities remain concerning. The considerable cost of drug acquisition, procedures, supportive care, and hospitalization restricts patient access and is a financial burden on hospitals.2
The Lymphoma Hub previously published primary analysis results and patient-reported outcomes from the phase III ZUMA-7 trial of second-line axi-cel versus standard-of-care (SoC) in patients with R/R DLBCL (NCT03391466). Below, we summarize an article by Kambhampati, et al. published in Blood on the cost-effectiveness of second-line axi-cel in the ZUMA-7 trial.2
Table 1. Outcomes and cost-effectiveness of SoC and second line axi-cel in primary refractory/early relapse patients with DLBCL*
Parameters |
SoC |
Second-line axi-cel |
||
---|---|---|---|---|
Scenario 1† |
Scenario 2‡ |
Scenario 3§ |
||
2-year OS, % |
53 |
62 |
62 |
62 |
2-year EFS, % |
16 |
41 |
41 |
41 |
5-year OS, % |
26 |
41 |
49 |
32 |
5-year EFS, % |
10 |
35 |
40 |
20 |
Life, years |
3.67 |
6.96 |
7.55 |
4.69 |
Cost- effectiveness, QALY |
2.60 |
5.42 |
5.90 |
3.99 |
Increased cost |
— |
2.82 |
3.29 |
1.39 |
Cost, USD |
508,034 |
771,838 |
751,602 |
832,497 |
Increased cost, USD |
— |
263,804 |
243,568 |
324,463 |
ICER |
— |
93,547 |
73,968 |
233,967 |
axi-cel, axicabtagene ciloleucel; DLBCL, diffuse large B-cell lymphoma; EFS, event-free survival; OS, overall survival; QALY, quality-adjusted life year; ICER, incremental cost-effectiveness ratio; SoC, standard of care; USD, U.S. Dollar. |
Table 2. Sensitivity analyses of the 5-year EFS with second-line axi-cel in primary refractory/early relapse patients with DLBCL*
5-year EFS with second line axi-cel |
20% |
25% |
30% |
35% |
40% |
---|---|---|---|---|---|
Life gained, years |
1.02 |
2.12 |
2.65 |
3.29 |
3.88 |
Cost-effectiveness, QALY |
3.99 |
4.47 |
4.95 |
5.42 |
5.90 |
Increased cost-effectiveness, QALY |
1.39 |
1.87 |
2.35 |
2.82 |
3.29 |
Cost, USD† |
832,497 |
812,288 |
792,068 |
771,838 |
751,602 |
Increased cost, USD |
324,463 |
304,254 |
284,033 |
263,804 |
243,568 |
ICER |
233,967 |
162,778 |
121,024 |
93,547 |
73,968 |
50,000 USD† |
4 |
7 |
15 |
34 |
41 |
100,000 USD† |
19 |
26 |
44 |
57 |
72 |
150,000 USD† |
31 |
47 |
61 |
73 |
84 |
axi-cel, axicabtagene ciloleucel; DBCL, diffuse large B-cell lymphoma; EFS, event-free survival; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life year; USD, U.S. Dollar; WTP, willingness to pay. |
The results of this analysis demonstrated the cost-effectiveness of axi-cel vs SoC in the second-line setting for primary refractory/ early relapse DLBCL at WTP thresholds of $100,000 and $150,000, providing that the response was durable. Despite the positive results, routine use of second-line CAR T-cell therapy for patients with primary refractory/ early relapse DLBCL in the United States will significantly increase healthcare costs; therefore, further cost-reduction strategies are warranted to reduce the healthcare expenditure burden of CAR T-cell therapies.
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