COST-EFFECTIVENESS ANALYSIS OF TALICABTAGENE AUTOLEUCEL (TALI-CEL), ANTI-CD19 CAR-T CELL THERAPY, FOR THE TREATMENT OF RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA IN INDIA...
Author(s)
Jyoti Dixit, Sr., PhD, MPH1, Pankaj Malhotra, MBBS, MD2, Gaurav Jyani, PhD, MPH1, Navin Khattry, MBBS, MD3, Shankar Prinja, MD, MSc1.
1Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 2Dept. of Clinical Hematology & Medical Oncology, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 3Dept of Medical Oncology, Tata Memorial Hospital, Mumbai, Mumbai, India.
1Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 2Dept. of Clinical Hematology & Medical Oncology, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 3Dept of Medical Oncology, Tata Memorial Hospital, Mumbai, Mumbai, India.
OBJECTIVES: Relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) is associated with poor survival and high economic burden among adolescents and young adults. Although CAR T-cell therapy has demonstrated promising clinical benefits, its high cost raises concerns regarding value for money in resource-constrained settings. This study evaluated the cost-effectiveness of talicabtagene autoleucel (Tali-Cel), an indigenous CAR T-cell therapy, compared with inotuzumab ozogamicin (InO) followed by allogeneic HSCT in India.
METHODS: A Markov model was developed to estimate lifetime costs and health outcomes from an abridged societal perspective. Clinical effectiveness data for Tali-Cel were obtained from an Indian CAR T-cell trial, while comparator efficacy inputs were derived from a pivotal international randomized study. Costs included both health system expenditures and direct out-of-pocket expenses. Health outcomes were assessed in terms of life-years (LYs) and quality-adjusted life-years (QALYs). Future costs and outcomes were discounted at 3% annually. Cost-effectiveness was evaluated using incremental cost-effectiveness ratios (ICERs) against a willingness-to-pay threshold equivalent to one-time India’s per capita gross domestic product (GDP) for 2024-25 (₹248,764).
RESULTS:
CAR T-cell therapy resulted in higher lifetime costs compared with InO followed by HSCT (₹5,040,382 vs ₹2,942,100), but generated substantially greater health benefits. Patients receiving Tali-Cel lived 8.24 LYs and 6.49 QALYs compared with 3.66 LYs and 2.65 QALYs in the comparator arm. The incremental gain was 4.58 LYs and 3.84 QALYs at an additional cost of ₹2,098,282. The ICER was estimated as ₹582,661 per QALY gained, indicating that Tali-Cel was not cost-effective at the current threshold. A price reduction of approximately 45% would be required for Tali-Cel to become cost-effective.
CONCLUSIONS: Tali-Cel offers substantial survival and quality-of-life benefits for adolescents and young adults with R/R B-ALL in India. However, strategic price reductions and evidence-based reimbursement mechanisms are necessary to improve affordability and support sustainable adoption within the Indian health system.
METHODS: A Markov model was developed to estimate lifetime costs and health outcomes from an abridged societal perspective. Clinical effectiveness data for Tali-Cel were obtained from an Indian CAR T-cell trial, while comparator efficacy inputs were derived from a pivotal international randomized study. Costs included both health system expenditures and direct out-of-pocket expenses. Health outcomes were assessed in terms of life-years (LYs) and quality-adjusted life-years (QALYs). Future costs and outcomes were discounted at 3% annually. Cost-effectiveness was evaluated using incremental cost-effectiveness ratios (ICERs) against a willingness-to-pay threshold equivalent to one-time India’s per capita gross domestic product (GDP) for 2024-25 (₹248,764).
RESULTS:
CAR T-cell therapy resulted in higher lifetime costs compared with InO followed by HSCT (₹5,040,382 vs ₹2,942,100), but generated substantially greater health benefits. Patients receiving Tali-Cel lived 8.24 LYs and 6.49 QALYs compared with 3.66 LYs and 2.65 QALYs in the comparator arm. The incremental gain was 4.58 LYs and 3.84 QALYs at an additional cost of ₹2,098,282. The ICER was estimated as ₹582,661 per QALY gained, indicating that Tali-Cel was not cost-effective at the current threshold. A price reduction of approximately 45% would be required for Tali-Cel to become cost-effective.
CONCLUSIONS: Tali-Cel offers substantial survival and quality-of-life benefits for adolescents and young adults with R/R B-ALL in India. However, strategic price reductions and evidence-based reimbursement mechanisms are necessary to improve affordability and support sustainable adoption within the Indian health system.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
EE93
Topic
Economic Evaluation
Disease
SDC: Oncology, STA: Multiple/Other Specialized Treatments