College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
J Med Econ. 2010 Mar;13(1):1-7. doi: 10.3111/13696990903451461.
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).
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.
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.
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.
评估喜疗妥（Veregen）作为一线疗法治疗生殖器疣（EGW）的成本效益和治疗费用影响，与主要对照药物咪喹莫特（Aldara）相比。
提出了一个两阶段决策模型，用于比较喜疗妥与主要对照药物咪喹莫特作为 EGW 一线局部治疗药物。该模型利用两项喜疗妥试验和系统文献综述中关于咪喹莫特的持续清除率估计值。资源投入包括：（1）基于试验的平均药物使用量估计值，（2）描述预期就诊次数和二线消融程序使用情况的 CPT（当前程序术语）代码。该分析考虑了：（1）喜疗妥与咪喹莫特治疗成功的成本比较，（2）喜疗妥与咪喹莫特的成本后果比较。作为评估比较产品有效性的建模方法，所提出的主张反映了模型的结构，该模型侧重于 EGW 干预中一线治疗的局部产品，以及对主要随机临床试验（RCT）中持续清除率的估计的依赖。在这种情况下，持续清除被定义为报告初始疣清除的患者比例，该比例在 RCT 期间经过后续复发的校正。
作为一线治疗药物，喜疗妥的成本低于咪喹莫特，且具有更高的持续清除率（51.9% 对 40.6%）。喜疗妥的一线治疗平均成本为 774 美元，而咪喹莫特为 930 美元。喜疗妥成功治疗的成本为 1492 美元，低于咪喹莫特的 2289 美元。考虑到一线治疗失败的患者转而接受二线消融治疗，接受喜疗妥治疗的患者的平均治疗成本为 943 美元，接受咪喹莫特治疗的患者的平均治疗成本为 1138 美元。敏感性分析证实了喜疗妥在决策模型框架内的地位。
与咪喹莫特相比，喜疗妥治疗生殖器疣的治疗成本更低。它还为医疗保健系统节省了成本。这一结论应受到评估所依据的决策框架的限制。该模型侧重于一线治疗的局部制剂，持续清除率估计值来自主要 RCT。治疗成本估计值是独立生成的，但反映了当前的产品和辅助成本。
