title: A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts.
abstract: OBJECTIVE
  To evaluate the cost-effectiveness and treatment-cost impact of sinecatechins (Veregen) as first-line therapy against its principal comparator, imiquimod (Aldara), in the treatment of external genital warts (EGWs).
  
  
  METHODS
  A two-stage decision model is proposed to compare sinecatechins with its principal comparator, imiquimod, as a first-line topical therapy in the treatment of EGWs. The model utilizes estimates of sustained clearance from two pivotal sinecatechins trials and from a systematic literature review for imiquimod. Resource inputs are: (1) trial-based estimates of average drug utilization and (2) CPT (Current Procedural Terminology) codes describing anticipated office visits and utilization of second-line ablative procedures. The analysis considers: (1) comparative costs of achieving a successful outcome with sinecatechins versus imiquimod, and (2) comparative cost-consequences of sinecatechins versus imiquimod. As a modeled approach to evaluating comparative product effectiveness, the claims made reflect the structure of the model, which focuses on topical products as first-line therapy in EGW interventions and in its reliance on estimates of sustained clearance from pivotal randomized clinical trials (RCTs). Sustained clearance in this context being defined as the proportion of patients who report initial wart clearance over the RCT period corrected for subsequent recurrence.
  
  
  RESULTS
  As first-line therapy, sinecatechins dominates imiquimod as a lower cost treatment with a higher sustained clearance rate (51.9 vs. 40.6%). First-line average cost of treatment with sinecatechins is $774 compared to imiquimod at $930. Cost per successful outcome with sinecatechins is $1,492, which is lower than $2,289 for imiquimod. Taking account of patients failing first-line therapy moving to a second-line ablative therapy yields an average cost of treatment for patients initiated to sinecatechins of $943 and $1,138 for those initiated to imiquimod. A sensitivity assessment confirmed the position of sinecatechins within the decision-model framework.
  
  
  CONCLUSIONS
  Sinecatechins yields a lower cost of treatment compared to imiquimod in the treatment of EGW. It also offers cost savings to healthcare systems. This conclusion should be qualified by the limitations of the decision framework within which the assessment has been made. The model focuses on topical preparations as first-line therapies, with estimates of sustained clearance taken from pivotal RCTs. Treatment cost estimates are generated independently, but reflect current product and ancillary costs.
authors.affiliation: College of Pharmacy, University of Minnesota, Minneapolis, MN, USA. P8366@MSN.com
authors.forename: Paul C
authors.initials: PC
authors.lastname: Langley
mesh_terms: D000634:Aminoquinolines / Q000191:economics* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D028241:Camellia sinensis / Q000737:chemistry; D002392:Catechin / Q000191:economics* / Q000627:therapeutic use; D003218:Condylomata Acuminata / Q000188:drug therapy / Q000191:economics*; D016001:Confidence Intervals; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D004363:Drug Utilization; D006801:Humans; D000077271:Imiquimod; D018803:Models, Economic; D010936:Plant Extracts / Q000191:economics* / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D010936:Plant Extracts; D002392:Catechin; D000077271:Imiquimod