The management of actinic keratoses in the United States with topical fluorouracil: a pharmacoeconomic evaluation.
Actinic keratosis (AK) may be an early stage of carcinoma in situ and invasive carcinoma. Excision or destruction of AKs is one of the most frequently performed procedures in dermatology. The most common treatments for AKs in the United States are liquid nitrogen cryotherapy and 5-fluorouracil. This paper focuses on the topical 5% fluorouracil cream (Efudex), 1% fluorouracil cream (Fluoroplex), and 0.5% fluorouracil cream (Carac) formulations. Our objective was to evaluate the cost-effectiveness of topical fluorouracil cream formulations for managing facial AKs from the perspective of the third-party payer, with a one-year time period. Initial estimates were based on the treatment of facial AKs only, using topical fluorouracil regimens approved by the US Food and Drug Administration. Analysis was based on the efficacy rates of each regimen as found in the literature and summarized using meta-analysis. The cost of therapy included drug-acquisition costs and medical management costs for 1 or 2 topical fluorouracil treatments per calendar year. Sensitivity analysis was performed by evaluating the cost per cured facial AK and the number of patients cured of AK (cost-effectiveness of treatment) for patients with 1 to 20 facial AKs. For one treatment cycle, the average efficacy rates of a topical fluorouracil treatment based on lesional response (proportion of facial AKs cured in a given patient) or patient cure (number of patients whose facial AKs were completely cured) were 87.8% and 62.5%, respectively. For more than 6 AKs, 0.5% fluorouracil cream may be more cost-effective than the 1% and 5% formulations. The true costs of therapy are underestimated however, as the costs of managing adverse events are not included. Our study suggests that once-daily use of 0.5% fluorouracil cream is a cost-effective way of managing a patient with multiple facial AKs.