title: Drug pricing for a novel treatment for wet macular degeneration: using incremental cost-effectiveness ratios to ensure societal value.
abstract: OBJECTIVE
  Health economic models can assist policy-makers in determining the value of novel treatments from the viewpoint of society. In this context, value is defined as the benefit of treatment, given its cost. A new treatment for wet age-related macular degeneration (AMD), juxtascleral administration of anecortave acetate, 15 mg for depot suspension (Retaane), is now in a late-phase clinical trial. In a theoretical analysis, we sought to determine the cost at which this treatment might offer economic value to society, using incremental cost-effectiveness ratios (ICERs).
  
  
  METHODS
  A series of 1-year cost-utility models was created for the investigational treatment and standard treatment (photodynamic therapy [PDT] with verteporfin [Visudyne]). Value to society was defined in terms of theoretical associated ICERs (in US dollars): $100,000 per quality-adjusted life-year (QALY), $50,000/QALY, $20,000/QALY and $0/QALY, the point of economic indifference. Models were created from the societal perspective and included a patient-derived utility assessment involving regression equations to estimate time trade-off preferences, event probabilities derived from a randomized clinical trial comparing the safety and efficacy of anecortave administration and PDT with verteporfin, decision analysis and relevant costing information.
  
  
  RESULTS
  An ICER of $100,000/QALY would be associated with an anecortave cost of $3022/vial, an ICER of $50,000/QALY with an anecortave cost of $2986/vial and an ICER of $20,000/QALY with an anecortave cost of $2964/vial. The point of economic indifference between anecortave administration and standard therapy would occur with an anecortave cost of $2950/vial.
  
  
  CONCLUSIONS
  In theory, an anecortave cost of $2986/vial is associated with an ICER of $50,000/QALY, the threshold used by many health technology assessment and reimbursement agencies.
authors.affiliation: Cost-Effective Ocular Health Policy Unit, Department of Ophthalmology & Community Health and Epidemiology, Queen's University, Hotel Dieu Hospital, Kingston, Ontario, Canada.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Sharma
authors.forename: Jeff
authors.initials: J
authors.lastname: Bakal
authors.forename: Susan M
authors.initials: SM
authors.lastname: Sharma
authors.forename: Dave
authors.initials: D
authors.lastname: Covert
authors.forename: Gaurav K
authors.initials: GK
authors.lastname: Shah
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D003365:Costs and Cost Analysis; D016527:Drug Costs; D017723:Drug Utilization Review / Q000639:trends*; D006801:Humans; D008268:Macular Degeneration / Q000188:drug therapy / Q000191:economics*; D018803:Models, Economic; D010778:Photochemotherapy / Q000191:economics*; D017319:Photosensitizing Agents / Q000191:economics* / Q000627:therapeutic use; D011166:Porphyrins / Q000191:economics* / Q000627:therapeutic use; D012959:Socioeconomic Factors; D000077362:Verteporfin
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin