title: Healthcare and economic burden of adverse events among patients with chronic myelogenous leukemia treated with BCR-ABL1 tyrosine kinase inhibitors.
abstract: OBJECTIVE
  BCR-ABL1 tyrosine kinase inhibitors (TKIs) are established treatments for chronic myelogenous leukemia (CML); however, they are associated with infrequent, but clinically serious adverse events (AEs). The objective of this analysis was to assess healthcare resource utilization and costs associated with AEs, previously identified using the FDA Adverse Event Reporting System (FAERS) in another study, among TKI-treated patients.
  
  
  METHODS
  Adult patients with ≥1 inpatient or ≥2 outpatient ICD-9-CM diagnosis codes for CML and ≥1 claim for a TKI treatment between January 1, 2006 and September 30, 2012 were identified from the Commercial and Medicare MarketScan databases. The first claim for a TKI was designated as the index event. Patients were required to have no TKI treatment during a 12-month baseline period. Healthcare resource utilization and costs associated with select AEs having the strongest association with TKI treatment (femoral arterial stenosis [FAS], peripheral arterial occlusive disease [PAOD], intermittent claudication, coronary artery stenosis [CAS], pericardial effusion, pleural effusion, malignant pleural effusion, conjunctival hemorrhage) were evaluated during a 12-month follow-up period.
  
  
  RESULTS
  The study sample included 2,005 CML patients receiving TKI therapy (mean age = 56 years; 56% male). Among all evaluated AEs, the highest mean inpatient healthcare costs were observed for FAS ($16,800 per patient) and PAOD ($14,263 per patient), which had total mean medical costs (inpatient + outpatient) of $17,015 and $15,154 per patient, respectively. Mean outpatient healthcare costs were highest for CAS ($1,861 per patient), followed by intermittent claudication ($947 per patient), PAOD ($891 per patient), and pleural effusion ($890 per patient). Total mean medical costs for fluid retention-related AEs, including pericardial effusion and pleural effusion, were $2,797 and $1,908 per patient, respectively.
  
  
  CONCLUSIONS
  The healthcare costs of AEs identified in the FAERS as having the strongest association with TKI treatment are substantial. Vascular stenosis-related AEs, including FAS and PAOD, have the highest cost burden.
authors.affiliation: a Novosys Health , Green Brook , NJ , USA.
authors.forename: Jay
authors.initials: J
authors.lastname: Lin
authors.affiliation: b Bristol-Myers Squibb , Princeton , NJ , USA.
authors.forename: Dinara
authors.initials: D
authors.lastname: Makenbaeva
authors.affiliation: a Novosys Health , Green Brook , NJ , USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Lingohr-Smith
authors.affiliation: b Bristol-Myers Squibb , Princeton , NJ , USA.
authors.forename: Robyn
authors.initials: R
authors.lastname: Bilmes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000191:economics* / Q000627:therapeutic use; D000069439:Dasatinib / Q000009:adverse effects / Q000191:economics; D005260:Female; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D000068877:Imatinib Mesylate / Q000009:adverse effects / Q000191:economics; D007345:Insurance Claim Review; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D010996:Pleural Effusion / Q000139:chemically induced / Q000191:economics; D047428:Protein Kinase Inhibitors / Q000009:adverse effects* / Q000191:economics* / Q000627:therapeutic use; D011743:Pyrimidines / Q000009:adverse effects / Q000191:economics; D012189:Retrospective Studies; D014652:Vascular Diseases / Q000139:chemically induced / Q000191:economics; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate; C498826:nilotinib; D000069439:Dasatinib
keywords: Adverse events; Chronic myelogenous leukemia; Cost; Healthcare; Tyrosine kinase inhibitors