title: Cost-effectiveness analysis of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.
abstract: OBJECTIVE
  Perform a cost-effectiveness analysis of the treatment of diabetic macular edema (DME) with ranibizumab plus prompt or deferred laser versus triamcinolone plus prompt laser. Data for the analysis were drawn from reports of the Diabetic Retinopathy Clinical Research Network (DRCRnet) Protocol I.
  
  
  METHODS
  Computer simulation based on Protocol I data. Analyses were conducted from the payor perspective.
  
  
  METHODS
  Simulated participants assigned characteristics reflecting those seen in Protocol I.
  
  
  METHODS
  Markov models were constructed to replicate Protocol I's 104-week outcomes using a microsimulation approach to estimation. Baseline characteristics, visual acuity (VA), treatments, and complications were based on Protocol I data. Costs were identified by literature search. One-way sensitivity analysis was performed, and the results were validated against Protocol I data.
  
  
  METHODS
  Direct cost of care for 2 years, change in VA from baseline, and incremental cost-effectiveness ratio (ICER) measured as cost per additional letter gained from baseline (Early Treatment of Diabetic Retinopathy Study).
  
  
  RESULTS
  For sham plus laser (S+L), ranibizumab plus prompt laser (R+pL), ranibizumab plus deferred laser (R+dL), and triamcinolone plus laser (T+L), effectiveness through 104 weeks was predicted to be 3.46, 7.07, 8.63, and 2.40 letters correct, respectively. The ICER values in terms of dollars per VA letter were $393 (S+L vs. T+L), $5943 (R+pL vs. S+L), and $20 (R+dL vs. R+pL). For pseudophakics, the ICER value for comparison triamcinolone with laser versus ranibizumab with deferred laser was $14 690 per letter gained. No clinically relevant changes in model variables altered outcomes. Internal validation demonstrated good similarity to Protocol I treatment patterns.
  
  
  CONCLUSIONS
  In treatment of phakic patients with DME, ranibizumab with deferred laser provided an additional 6 letters correct compared with triamcinolone with laser at an additional cost of $19 216 over 2 years. That would indicate that if the gain in VA seen at 2 years is maintained in subsequent years, then the treatment of phakic patients with DME using ranibizumab may meet accepted standards of cost-effectiveness. For pseudophakic patients, first-line treatment with triamcinolone seems to be the most cost-effective option.
authors.affiliation: Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Vinay
authors.initials: V
authors.lastname: Dewan
authors.forename: Dennis
authors.initials: D
authors.lastname: Lambert
authors.forename: Joshua
authors.initials: J
authors.lastname: Edler
authors.forename: Steven
authors.initials: S
authors.lastname: Kymes
authors.forename: Rajendra S
authors.initials: RS
authors.lastname: Apte
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000191:economics* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000191:economics*; D005260:Female; D005938:Glucocorticoids / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation / Q000191:economics*; D008269:Macular Edema / Q000188:drug therapy / Q000191:economics*; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D009010:Monte Carlo Method; D000069579:Ranibizumab; D014222:Triamcinolone Acetonide / Q000191:economics* / Q000627:therapeutic use; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D014222:Triamcinolone Acetonide; D000069579:Ranibizumab