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Valentina Lorenzoni,1 Agatina Chiavetta,2 Vincenzo Curci,3 Giuseppe Della Pepa,4 Carmelo Licciardello,5 Felicia Pantò,6 Alessia Scatena,7 Giuseppe Turchetti1 1Institute of Management, Scuola Superiore Sant’Anna, Pisa, Italy; 2A.O. Cannizzaro, Catania, Italy; 3Centro per La Cura del Piede Diabetico, Ospedale Costantino Cantù di Abbiategrasso, Milan, Italy; 4Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy; 5Unit of Metabolic and Endocrine Diseases, Centro Catanese di Medicina e Chirurgia, Catania, Italy; 6Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine, University of Palermo, Palermo, Italy; 7Diabetology Unit, Cardioneurovascular Department, San Donato Hospital Arezzo Local Health Authorities South East Tuscany, Arezzo, ItalyCorrespondence: Valentina LorenzoniInstitute of Management, Scuola Superiore Sant’Anna, Piazza Martiri della Libertà 33, Pisa, 56127, ItalyTel +39050388826Email v.lorenzoni@sssup.itObjective: To perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile.Design: An early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone.Setting: The Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen.Participants: Hypothetical patients with diabetic foot infection (DFI) grades I/IIB.Interventions: The PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs.Main Outcomes: Days within which the clinical target was achieved and direct health costs for patients’ management.Results: Additional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7– 28 days, ICERs varied from about 1€ to 70€ for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7– 28 days, BI was 8,100,000€ to 700,000€, with saving less than 2,000,000€ with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process.Conclusion: The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system.Keywords: diabetic foot ulcer, diabetic foot infection, photodynamic therapy, costs, economic, impact