Cost–effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain

Abstract

Objective: The aim of this study is to conduct a cost–effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain. Methods: An analytical decision-making model was constructed to compare whether 5-FU/SA was a cost-effective option compared with cryotherapy from the perspective of the Spanish National Health System with a time horizon of 6 months. Costs were expressed in 2014 euros. Results: The cost of patients with hyperkeratotic actinic keratosis treated with 5-FU/SA or cryotherapy was €266 and €285, respectively. 5-FU/SA was associated with higher rates of treatment success and, consequently, more quality-adjusted life years, than cryotherapy. Therefore, 5-FU/SA was the dominant treatment, as it was associated with a lower treatment cost and greater effectiveness than cryotherapy. Conclusions: Economically, 5-FU/SA was a dominant option compared with cryotherapy in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain.

Keywords:

• 5-fluorouracil/salicylic acid
• actinic keratosis
• cost–effectiveness analysis
• cryotherapy
• Spain

Financial & competing interests disclosure

This study was sponsored by Almirall. D Nieves received a fee from Almirall to conduct the research. R Puig-Peiro participated in the study as expert in health economics. C Ferrandiz participated as clinical expert in the carrying out of the study. M Josep Plazas works of Almirall the sponsor of the study. M Brose received a fee from Almirall to conduct the research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The early diagnosis and introduction of the most effective treatment of actinic keratosis are two key factors in eliminating the lesions and reducing the risk of evolving to invasive squamous cell carcinoma.

• Actinic keratosis may have serious clinical implications if not treated and can adversely affect the quality of life and have a significant economic impact on the healthcare system.

• 5-FU/SA was included recently in the Spanish NHS portfolio for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (clinical grade I/II) in immunocompetent adult patients.

• Cryotherapy is the most frequently used destructive treatment for hyperkeratotic actinic keratosis in routine clinical practice in Spain.

• Based on an analytical decision-making model, in terms of cost–effectiveness, 5-FU/SA was the dominant option compared to cryotherapy in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain. 5-FU/SA was associated with a lower treatment cost than cryotherapy (€266 vs €285, respectively) and greater effectiveness (0.9902 QALYs vs 0.9875 QALYs, respectively).

• The sensitivity analyses showed that even with variations in the efficacy data and the cost of all treatments, 5-FU/SA remained a dominant option compared with cryotherapy.