PMID- 33343819
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220419
IS  - 1942-2962 (Print)
IS  - 1942-2970 (Electronic)
IS  - 1942-2962 (Linking)
VI  - 13
IP  - 5
DP  - 2020 Oct-Nov
TI  - Economic Burden of Neurologic Toxicities Associated with Treatment of Patients 
      with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in the United States.
PG  - 192-199
AB  - BACKGROUND: Chimeric antigen receptor (CAR) T-cell therapy, which is approved for 
      the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), 
      can be associated with potentially severe and costly neurologic adverse events 
      (AEs). OBJECTIVES: To develop an evidence-based list of treatment-related 
      neurologic AEs in patients with relapsed or refractory DLBCL, including AEs 
      related to CAR T-cell therapies, and to estimate the healthcare costs associated 
      with these neurologic AEs in a real-world setting. METHODS: We identified grade 
      >/=3 neurologic AEs that occurred in >/=2% of patients by reviewing drug prescribing 
      information and published clinical trials with therapies used for relapsed or 
      refractory DLBCL. Data from 3 nationally representative claims databases were 
      used to identify adults with relapsed or refractory DLBCL, who were eligible for 
      the study if they received 1 of 4 types of therapy, including CAR T-cell therapy, 
      high-intensity cytotoxic therapy, low-intensity cytotoxic therapy, or targeted 
      therapies. The rates of neurologic AEs and total healthcare costs were calculated 
      for patients with and without neurologic AEs within 30 days of treatment. The 
      costs were inflated to 2019 first-quarter US dollars. RESULTS: A total of 16 
      types of neurologic AEs were identified, including 13 events related to CAR 
      T-cell therapy and 5 related to conventional immunochemotherapy regimens, with 2 
      overlapping event types. Of these AEs, 11 were included in the claims analysis, 
      based on available diagnosis codes. Of the 11,098 adults with relapsed or 
      refractory DLBCL in the study, 118 patients received CAR T-cell therapy, 9483 
      received a high-intensity cytotoxic therapy, 1259 received a low-intensity 
      cytotoxic therapy, and 238 received a targeted therapy. A total of 299 (2.7%) 
      patients had >/=1 neurologic AEs during the 30-day postindex period. Of these 
      patients, 43 received CAR T-cell therapy (36.4% of the 118 CAR T-cell therapy 
      users). The mean total healthcare cost was $71,982 higher for patients with 
      neurologic AEs than for patients without neurologic AEs. The trend of higher 
      costs in patients with neurologic AEs was consistent across the treatment groups 
      and was most pronounced in CAR T-cell therapy users ($143,309; 95% confidence 
      interval, $5838-$280,779). CONCLUSION: Patients with relapsed or refractory DLBCL 
      who had severe or life-threatening neurologic AEs incur substantially higher 
      costs than their counterparts who do not have neurologic AEs, with the largest 
      cost difference in patients who receive CAR T-cell therapy.
CI  - Copyright (c) 2020 by Engage Healthcare Communications, LLC.
FAU - Broder, Michael S
AU  - Broder MS
AD  - President, Partnership for Health Analytic Research, Beverly Hills, CA.
FAU - Ma, Qiufei
AU  - Ma Q
AD  - Director, Global Value & Access & HEOR Lead, Cell & Gene Therapies Unit, Novartis 
      Pharmaceuticals, East Hanover, NJ.
FAU - Yan, Tingjian
AU  - Yan T
AD  - Director, Health Services Research, Partnership for Health Analytic Research, 
      Beverly Hills.
FAU - Zhang, Jie
AU  - Zhang J
AD  - Head, Global Value and Access, Cell and Gene Therapeutics Unit, Novartis 
      Pharmaceuticals, East Hanover.
FAU - Chang, Eunice
AU  - Chang E
AD  - Chief Statistician, Partnership for Health Analytic Research, Beverly Hills.
FAU - Kuzan, David
AU  - Kuzan D
AD  - Global Medical Director, Novartis Pharmaceuticals, East Hanover.
FAU - Eldjerou, Lamis
AU  - Eldjerou L
AD  - Senior Global Medical Director, Novartis Pharmaceuticals, East Hanover.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Am Health Drug Benefits
JT  - American health & drug benefits
JID - 101479877
PMC - PMC7741176
OTO - NOTNLM
OT  - CAR T-cell therapy
OT  - cytotoxic therapy
OT  - healthcare costs
OT  - neurologic adverse events
OT  - relapsed or refractory diffuse large B-cell lymphoma
OT  - targeted therapy
EDAT- 2020/12/22 06:00
MHDA- 2020/12/22 06:01
PMCR- 2020/10/01
CRDT- 2020/12/21 06:06
PHST- 2020/12/21 06:06 [entrez]
PHST- 2020/12/22 06:00 [pubmed]
PHST- 2020/12/22 06:01 [medline]
PHST- 2020/10/01 00:00 [pmc-release]
PST - ppublish
SO  - Am Health Drug Benefits. 2020 Oct-Nov;13(5):192-199.