title: Cost Effectiveness of Ofatumumab Plus Chlorambucil in First-Line Chronic Lymphocytic Leukaemia in Canada.
abstract: OBJECTIVE
  Our objective was to estimate the cost effectiveness of ofatumumab plus chlorambucil (OChl) versus chlorambucil in patients with chronic lymphocytic leukaemia for whom fludarabine-based therapies are considered inappropriate from the perspective of the publicly funded healthcare system in Canada.
  
  
  METHODS
  A semi-Markov model (3-month cycle length) used survival curves to govern progression-free survival (PFS) and overall survival (OS). Efficacy and safety data and health-state utility values were estimated from the COMPLEMENT-1 trial. Post-progression treatment patterns were based on clinical guidelines, Canadian treatment practices and published literature. Total and incremental expected lifetime costs (in Canadian dollars [$Can], year 2013 values), life-years and quality-adjusted life-years (QALYs) were computed. Uncertainty was assessed via deterministic and probabilistic sensitivity analyses.
  
  
  RESULTS
  The discounted lifetime health and economic outcomes estimated by the model showed that, compared with chlorambucil, first-line treatment with OChl led to an increase in QALYs (0.41) and total costs ($Can27,866) and to an incremental cost-effectiveness ratio (ICER) of $Can68,647 per QALY gained. In deterministic sensitivity analyses, the ICER was most sensitive to the modelling time horizon and to the extrapolation of OS treatment effects beyond the trial duration. In probabilistic sensitivity analysis, the probability of cost effectiveness at a willingness-to-pay threshold of $Can100,000 per QALY gained was 59 %.
  
  
  CONCLUSIONS
  Base-case results indicated that improved overall response and PFS for OChl compared with chlorambucil translated to improved quality-adjusted life expectancy. Sensitivity analysis suggested that OChl is likely to be cost effective subject to uncertainty associated with the presence of any long-term OS benefit and the model time horizon.
authors.affiliation: RTI Health Solutions, 200 Park Offices Drive, Research Triangle Park, Durham, NC, 27709, USA. wherring@rti.org.
authors.forename: William
authors.initials: W
authors.lastname: Herring
authors.affiliation: RTI Health Solutions, Didsbury, Manchester, UK.
authors.forename: Isobel
authors.initials: I
authors.lastname: Pearson
authors.affiliation: RTI Health Solutions, 200 Park Offices Drive, Research Triangle Park, Durham, NC, 27709, USA.
authors.forename: Molly
authors.initials: M
authors.lastname: Purser
authors.affiliation: GlaxoSmithKline, Mississauga, ON, Canada.
authors.forename: Hamid Reza
authors.initials: HR
authors.lastname: Nakhaipour
authors.affiliation: GlaxoSmithKline, Collegeville, PA, USA.
authors.forename: Amin
authors.initials: A
authors.lastname: Haiderali
authors.affiliation: RTI Health Solutions, Didsbury, Manchester, UK.
authors.forename: Sorrel
authors.initials: S
authors.lastname: Wolowacz
authors.affiliation: GlaxoSmithKline, Mississauga, ON, Canada.
authors.forename: Kavisha
authors.initials: K
authors.lastname: Jayasundara
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002170:Canada; D002699:Chlorambucil / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000191:economics*; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000191:economics*; D018803:Models, Economic; D019057:Quality-Adjusted Life Years
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D002699:Chlorambucil; C527517:ofatumumab