title: Cost-effectiveness of novel relapsed-refractory multiple myeloma therapies in Norway: lenalidomide plus dexamethasone vs bortezomib.
abstract: OBJECTIVE
  To estimate the cost-effectiveness (cost per additional life-year [LY] and quality-adjusted life-year [QALY] gained) of lenalidomide plus dexamethasone (LEN/DEX) compared with bortezomib for the treatment of relapsed-refractory multiple myeloma (rrMM) in Norway.
  
  
  METHODS
  A discrete-event simulation model was developed to predict patients? disease course using patient data, best response, and efficacy levels obtained from LEN/DEX MM-009/-010 trials and the bortezomib (APEX) published clinical trial. Predictive equations for time-to-progression (TTP) and post-progression survival (PPS) were developed by identifying the best fitting parametric survival distributions and selecting the most significant predictors. Disease and adverse event management was obtained via survey from Norwegian experts. Costs, derived from official Norwegian pricing data bases, included drug, administration, monitoring, and adverse event management costs.
  
  
  RESULTS
  Complete or partial responders were 65% for LEN/DEX compared to 43% for bortezomib. Derived median TTP was 11.45 months for LEN/DEX compared to 5.15 months for bortezomib. LYs and QALYs were higher for LEN/DEX (4.06 and 2.95, respectively) than for bortezomib (3.11 and 2.19, respectively). The incremental costs per QALY and LY gained from LEN/DEX were NOK 247,978 and NOK 198,714, respectively, compared to bortezomib. Multiple sensitivity analyses indicated the findings were stable. The parameters with the greatest impact were 4-year time horizon (NOK 441,457/QALY) and higher bound confidence intervals for PPS (NOK 118,392).
  
  
  CONCLUSIONS
  The model analyzed two therapies not compared in head-to-head trials, and predicted results using an equation incorporating patient-level characteristics. It is a limited estimation of the costs and outcomes in a Norwegian setting.
  
  
  CONCLUSIONS
  The simulation model showed that treatment with LEN/DEX leads to greater LYs and QALYs when compared to bortezomib in the treatment of rrMM patients. The incremental cost-effectiveness ratio indicated treatment with LEN/DEX to be cost-effective and was the basis of the reimbursement approval of LEN/DEX in Norway.
authors: United BioSource Corporation, London, UK. jorgen.moller@unitedbiosource.com
authors: Jörgen
authors: J
authors: Möller
authors: Lars
authors: L
authors: Nicklasson
authors: Ananthram
authors: A
authors: Murthy
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D001897:Boronic Acids / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D000069286:Bortezomib; D017326:Clinical Trials, Phase III as Topic; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D003907:Dexamethasone / Q000008:administration & dosage / Q000191:economics; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D009101:Multiple Myeloma / Q000188:drug therapy*; D009664:Norway; D011719:Pyrazines / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000191:economics
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; D000077269:Lenalidomide