Budget Impact Analysis of CAR T-cell Therapy for Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma in Germany

Abstract

The aim was to assess the incremental costs of chimeric antigen receptor (CAR) T-cell therapy (axicabtagene ciloleucel, tisagenlecleucel) compared with standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) from the German third-party payer perspective. A budget impact model was established over a 6-year period. Estimation of the third-line population: partitioned survival model based on outcome data from peer-reviewed literature, a top-down approach based on population forecasts, and age-standardized incidences. Cost data were derived from the controlling department of a tertiary hospital and a German cost-of-illness study. In the scenario analysis, the budget impact of treating second-line DLBCL patients was calculated. One-way deterministic sensitivity analyses were conducted to test the robustness of the model. For the period 2021-2026, 788-867 (minimum population, min) and 1,068-1,177 (maximum population, max) adult third-line r/r DLBCL patients were estimated. The budget impact ranged from €39,419,562; €53,426,514 (min; max) in year 0 to €122,104,097; €165,763,001 (min; max) in year 5. The scenario analysis resulted in a budget impact of €65,987,823; €89,558,611 (min; max) and €204,485,031; €277,567,601 (min; max) for years 0 and 5, respectively. This budget impact analysis showed a significant but reasonable financial burden associated with CAR T-cell therapy for a limited number of patients requiring individualized care. Further, this study presents challenges and future needs in data acquisition associated with cost analysis in personalized medicine. For comprehensive economic discussions, complementary cost-effectiveness analyses are required to determine the value of innovative therapies for r/r DLBCL.

Cost‐effectiveness analysis of transplant‐ineligible relapsed or refractory diffuse large B‐cell lymphoma treatment options—Experience of the efficiency frontier approach

“…With a variety of emerging interventions for transplant-ineligible R/R DLBCL, health economic evaluations from a healthcare payer's perspective are needed. 4,58 We found that the 2L EF is formed by BR and Tafa-L, illustrating an innovation shift provided by Tafa-L. Therefore, Tafa-L can be seen as the currently most cost-effective intervention in the 2L setting.…”

“…2 In addition, from 2001 to 2011, the number of new NHL cases increased by 16.9% for women and by 35.6% for men. 3,4 Using the anti-CD20 antibody rituximab alongside cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as first-line treatment has improved survival rates of patients with DLBCL. 5 However, 30%-40% of patients experience relapse or become refractory (R/R).…”

“…[18][19][20] Despite these promising clinical outcomes, such innovative treatment options often incur high costs, while healthcare resources are scarce. 4,21,22 Health economic models can support decision-making processes and provide guidance for appropriate reimbursement by comparing the costs and benefits of treatment options for a specific indication area. Regarding 3L treatment options for R/R DLBCL patients, axi-cel was evaluated as a cost-effective treatment option, compared to tisa-cel and allogeneic SCT based on real-world inpatient costs in Germany.…”

“…21 A budget impact analysis of CAR-T therapies for R/R DLBCL showed a significant economic burden of these innovative therapies, concluding that cost-effectiveness analyses (CEAs) are necessary. 4 Thus, the objective of our study was to analyze treatment options for transplant-ineligible R/R DLBCL patients regarding their costeffectiveness from a healthcare payer's perspective in Germany.…”

“…In Germany, 18 470 patients were diagnosed with NHL in 2018 (age‐standardized incidence rate 11.4–16.6/100 000) 2 . In addition, from 2001 to 2011, the number of new NHL cases increased by 16.9% for women and by 35.6% for men 3,4 . Using the anti‐CD20 antibody rituximab alongside cyclophosphamide, doxorubicin, vincristine, and prednisone (R‐CHOP) as first‐line treatment has improved survival rates of patients with DLBCL 5 .…”