PMID- 32397772 OWN - NLM STAT- MEDLINE DCOM- 20210629 LR - 20210629 IS - 1941-837X (Electronic) IS - 1369-6998 (Linking) VI - 23 IP - 9 DP - 2020 Sep TI - Estimation of total costs in patients with relapsed or refractory diffuse large B-cell lymphoma receiving tisagenlecleucel from a US hospital's perspective. PG - 1016-1024 LID - 10.1080/13696998.2020.1769109 [doi] AB - Aims: This study estimated the total costs associated with tisagenlecleucel treatment in adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) based on the JULIET trial from a United States hospital's perspective.Methods: An economic model was developed to assess the total costs associated with tisagenlecleucel treatment (from leukapheresis to two months post-infusion) in adults (aged >/=18 years) with r/r DLBCL using a fee-for-service approach. Costs were considered during the pre-treatment, tisagenlecleucel infusion, and follow-up periods, and were estimated based on the health resource utilization and safety data from the JULIET trial. Cost components included leukapheresis, lymphodepleting chemotherapy, tisagenlecleucel infusion/administration, inpatient and intensive care unit (ICU) admission, medical professional visits, lab tests/procedures, and management of adverse events (AEs). The base-case model estimated the total costs using observed hospitalization, ICU, and AE data from JULIET, while scenario analyses varied key assumptions related to AEs and hospitalization.Results: The estimated overall cost associated with tisagenlecleucel treatment from leukapheresis to two months post-infusion was $437,927/patient, of which $64,784 (14.8%) was additional to tisagenlecleucel's list price ($373,000) and the associated administration cost ($143). The top three key drivers of the additional cost were AE management ($30,594; 47.2%), inpatient/ICU not attributed to AEs ($24,285; 37.5%), and lab tests/procedures ($5,443; 8.4%). In the scenario analyses, total costs ranged from $382,702 (no AEs, no hospitalization) to $469,006 (cytokine release syndrome and B-cell aplasia, hospitalization).Limitations: This analysis was limited to two months of follow-up after tisagenlecleucel infusion, which cannot capture long-term safety outcomes associated with the treatment and may underestimate AE costs.Conclusions: The total cost of tisagenlecleucel administration from leukapheresis to two months was estimated at $437,927. In addition to tisagenlecleucel's price, the main drivers were AE management costs and inpatient/ICU costs. Future studies based on real-world, long-term use of tisagenlecleucel are warranted. FAU - Yang, Hongbo AU - Yang H AD - Analysis Group, Inc., Boston, MA, USA. FAU - Hao, Yanni AU - Hao Y AD - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. FAU - Chai, Xinglei AU - Chai X AD - Analysis Group, Inc., Boston, MA, USA. FAU - Qi, Cynthia Z AU - Qi CZ AD - Analysis Group, Inc., Boston, MA, USA. FAU - Wu, Eric Q AU - Wu EQ AD - Analysis Group, Inc., Boston, MA, USA. LA - eng PT - Journal Article DEP - 20200602 PL - England TA - J Med Econ JT - Journal of medical economics JID - 9892255 RN - 0 (Receptors, Antigen, T-Cell) RN - 0 (Receptors, Chimeric Antigen) RN - Q6C9WHR03O (tisagenlecleucel) SB - IM MH - Cost-Benefit Analysis MH - Health Expenditures/statistics & numerical data MH - Health Resources/economics MH - Humans MH - Immunotherapy, Adoptive/adverse effects/*economics/*methods MH - Lymphoma, Large B-Cell, Diffuse/*drug therapy MH - Models, Economic MH - Receptors, Antigen, T-Cell/administration & dosage/*therapeutic use MH - Receptors, Chimeric Antigen MH - United States OTO - NOTNLM OT - Chimeric antigen receptor T-cell therapy OT - I11 OT - I12 OT - costs OT - diffuse large B-cell lymphoma OT - health resource use OT - tisagenlecleucel EDAT- 2020/05/14 06:00 MHDA- 2021/06/30 06:00 CRDT- 2020/05/14 06:00 PHST- 2020/05/14 06:00 [pubmed] PHST- 2021/06/30 06:00 [medline] PHST- 2020/05/14 06:00 [entrez] AID - 10.1080/13696998.2020.1769109 [doi] PST - ppublish SO - J Med Econ. 2020 Sep;23(9):1016-1024. doi: 10.1080/13696998.2020.1769109. Epub 2020 Jun 2.