Cost-Effectiveness Analysis of Topical Treatments for Actinic Keratosis in Italian National Health System

Sep 21, 2026

Uploaded by Eden

Actinic keratosis (AK) is a widespread pre-cancerous condition with potential progression to squamous cell carcinoma, making effective topical management important in clinical practice. The study performs a cost-effectiveness analysis of field-directed topical treatments used in the Italian National Health System, estimating costs from AIFA-reported prices and effectiveness data abstracted from the literature. The combined 0.5% 5-fluorouracil plus 10% salicylic acid approach is most convenient, being more effective and less expensive than most options, except when compared with 5% imiquimod.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Introduction

Disease background and risks

Therapeutic approaches

Methods

Treatments assessed

Effectiveness and cost inputs

Results

Cost-effectiveness comparisons

Article Cost-Effectiveness Analysis of Topical Treatments for Actinic Keratosis in Italian National Health System Mariafrancesca Hyeraci *,†, Gianluca Pistore †, Francesco Ricci , Francesco Moro, Giovanni Di Lella, Elena Dellambra , Damiano Abeni and Luca Fania Citation: Hyeraci, M.; Pistore, G.; Ricci, F.; Moro, F.; Lella, G.D.; Dellambra, E.; Abeni, D.; Fania, L. Cost-Effectiveness Analysis of Topical Treatments for Actinic Keratosis in Italian National Health System. J. Clin. Med. 2024, 13, 6312. [https://](https://)[ ](https://)[doi.org/10.3390/jcm13216312](doi.org/10.3390/jcm13216312) Academic Editor: Guy Orchard Received: 19 August 2024 Revised: 11 October 2024 Accepted: 18 October 2024 Published: 22 October 2024 Copyright: © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ([https://](https://)[ ](https://)[creativecommons.org/licenses/by/](creativecommons.org/licenses/by/)[ ](creativecommons.org/licenses/by/)[4.0/](4.0/)) . IDI-IRCCS, Dermatological Research Hospital, Via dei Monti di Creta 104, 00167 Rome, Italy; [gianluca@gianlucapistore.com](gianluca@gianlucapistore.com) (G.P.); [f.ricci@idi.it](f.ricci@idi.it) (F.R.); [f.moro@idi.it](f.moro@idi.it) (F.M.); [g.dilella@idi.it](g.dilella@idi.it) (G.D.L.); [e.dellambra@idi.it](e.dellambra@idi.it) (E.D.); [d.abeni@idi.it](d.abeni@idi.it) (D.A.); [l.fania@idi.it](l.fania@idi.it) (L.F.) * [Correspondence: mariafrancesca.hyeraci@gmail.com](Correspondence: mariafrancesca.hyeraci@gmail.com) † These authors contributed equally to this work. Abstract: Introduction: Actinic keratosis (AK) is a widespread pre-cancerous skin condition that may evolve to squamous cell carcinoma, a non-melanoma skin cancer, which is able to become locally invasive and metastatic. Thus, it is important to treat AK. Methods: We conducted a costeffectiveness analysis for the field-directed therapeutic approaches: local application of drugs containing 5-fluorouracil, both alone at a 4% concentration and associated to 10% salicylic acid at a 0.5% concentration (0.5% 5-FU + 10% SA cut. sol.); diclofenac-hyaluronic acid gel; imiquimod, both at 3.75% and 5%(5% IMQ cream) concentrations; and tirbanibulin ointment. The effectiveness data were abstracted from the literature. The cost-effectiveness analysis was performed by considering the prices reported by Agenzia Italiana del Farmaco (AIFA) for each medicine. Results: We obtained the total cost for each treatment by computing the cost of a single treatment for its duration. Application of 0.5% 5-FU + 10% SA cut. sol. appeared as the most convenient approach, as it was more effective and less expensive than all treatments except for 5% IMQ cream. For this last option, the incremental cost/effectiveness ratio analysis showed that a modest gain in effectiveness has a cost of EUR 7.94, therefore making it less cost effective. Keywords: actinic keratosis; cost-effectiveness; Italian healthcare system; 5-fluorouracil; diclofenac; imiquimod; tirbanibulin 1. Introduction Actinic keratosis (AK) is a very common pre-cancerous lesion arising from the abnormal proliferation of keratinocytes in skin areas chronically damaged by exposure to ultraviolet (UV) rays, affecting about 40% of the adult population [1,2] . In the light spectrum, wavelengths corresponding to UV-B (290–320 nm) are considered as the most damaging for skin health, and the ozone layer is reported as the main natural filter of UV-B light. Unfortunately, the thickness of ozone layer is gradually reducing, and this event represents the main cause of the continuously increasing incidence of AK disease [3] . The main risk factors for AK include exposure to UV rays, age, male sex, Fitzpatrick skin type I–II, immunosuppression, and previous diagnosis of AK or non-melanoma skin cancer (NMSC) . On the contrary, the use of both topic a

FAQs

What is the purpose of the study on AK topical treatments?

To evaluate which topical therapies for actinic keratosis are most cost-effective within the Italian National Health System.

Which treatments were included in the cost-effectiveness analysis?

The analysis covers 0.5% 5-fluorouracil plus 10% salicylic acid (0.5% 5-FU + 10% SA), 5-fluorouracil formulations, diclofenac-hyaluronic acid gel, imiquimod at 3.75% and 5%, and tirbanibulin ointment.

Which approach was found to be most convenient and how did 5% imiquimod compare?

The 0.5% 5-FU + 10% SA cut. sol. combination was more effective and less expensive than all treatments except 5% imiquimod. For 5% imiquimod, the incremental cost/effectiveness ratio indicates only a modest effectiveness gain at an added cost of EUR 7.94, making it less cost-effective.

Sep 21, 2026

Uploaded by Eden