title: Cost-Effectiveness and Cost-Utility Analysis of Ingenol Mebutate Versus Diclofenac 3% and Imiquimod 5% in the Treatment of Actinic Keratosis in Spain.
abstract: OBJECTIVE
  To perform a cost-effectiveness and cost-utility analysis of ingenol mebutate in the treatment of actinic keratosis in Spain.
  
  
  METHODS
  We used an adapted Markov model to simulate outcomes in a cohort of patients (mean age, 73 years) with actinic keratosis over a 5-year period. The comparators were diclofenac 3% and imiquimod 5%. The analysis was performed from the perspective of the Spanish National Health System based on direct costs (2015 retail price plus value added tax less the mandatory discount). A panel of experts estimated resources, taking unit costs from national databases. An annual discount rate of 3% was applied. Deterministic and probabilistic sensitivity analyses were performed.
  
  
  RESULTS
  The effectiveness of ingenol mebutate-with 0.192 and 0.129 more clearances gained in treatments for face and scalp lesions and trunk and extremity lesions, respectively-was superior to diclofenac's. The total costs of treatment with ingenol mebutate were lower at € 551.50 (face and scalp) and € 622.27 (trunk and extremities) than the respective costs with diclofenac (€ 849.11 and € 844.93). The incremental cost-effectiveness and cost-utility ratios showed that ingenol mebutate was a dominant strategy vs diclofenac. Ingenol mebutate also proved to be more effective than imiquimod, based on 0.535 and 0.503 additional clearances, and total costs of € 551.50 and € 527.89 for the two drugs, respectively. The resulting incremental cost-effectiveness ratio was € 728.64 per clearance gained with ingenol mebutate vs imiquimod.
  
  
  CONCLUSIONS
  Ingenol mebutate was a dominant treatment option vs diclofenac and was efficient vs imiquimod (i.e., more effective at a higher cost, achieving an incremental cost-utility ratio of<€30000/quality-adjusted life-years).
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia, Madrid, España.
authors.forename: I
authors.initials: I
authors.lastname: Elías
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia, Madrid, España.
authors.forename: N
authors.initials: N
authors.lastname: Ortega-Joaquín
authors.affiliation: Departamento de Dermatología, Hospital Universitario Infanta Leonor, Madrid, España.
authors.forename: P
authors.initials: P
authors.lastname: de la Cueva
authors.affiliation: Departamento de Dermatología, Hospital Universitario Son Espases, Mallorca, España.
authors.forename: L J
authors.initials: LJ
authors.lastname: Del Pozo
authors.affiliation: Departamento de Dermatología, Hospital Universitario Virgen de la Macarena, Sevilla, España.
authors.forename: D
authors.initials: D
authors.lastname: Moreno-Ramírez
authors.affiliation: Departamento de Dermatología, Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, España.
authors.forename: A
authors.initials: A
authors.lastname: Boada
authors.affiliation: Departamento de Dermatología, Hospital Costa del Sol, Marbella, Málaga, España.
authors.forename: M
authors.initials: M
authors.lastname: Aguilar
authors.affiliation: Laboratorios LEO Pharma, S. A., Barcelona, España.
authors.forename: A
authors.initials: A
authors.lastname: Mirada
authors.affiliation: Laboratorios LEO Pharma, S. A., Barcelona, España.
authors.forename: E
authors.initials: E
authors.lastname: Mosquera
authors.affiliation: LEO Pharma, Berkshire, Reino Unido.
authors.forename: C
authors.initials: C
authors.lastname: Gibbons
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia, Madrid, España. Electronic address: ioyaguez@porib.com.
authors.forename: I
authors.initials: I
authors.lastname: Oyagüez
mesh_terms: D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000191:economics*; D003362:Cost-Benefit Analysis; D004008:Diclofenac / Q000008:administration & dosage* / Q000191:economics*; D004224:Diterpenes / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D000077271:Imiquimod; D055623:Keratosis, Actinic / Q000188:drug therapy* / Q000191:economics*; D013030:Spain
chemical_list: C486592:3-ingenyl angelate; D000634:Aminoquinolines; D004224:Diterpenes; D004008:Diclofenac; D000077271:Imiquimod
keywords: Actinic keratosis; Análisis coste-efectividad; Cost-effectiveness analysis; Ingenol mebutate; Ingenol mebutato; Queratosis actínica