Budget Impact Analysis of Sofosbuvir-Based Regimens for The Treatment of Hiv/Hcv Co-Infected Patients In Northern Italy: The Liguria Region Simulation

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OBJECTIVES: Chronic HCV is a leading cause of hospitalization and death in populations coinfected with HIV in Italy. Sofosbuvir (SOF) is a pan-genotypic drug, which can be used alone or combined with other agents (e.g.Simeprevir,Daclatasvir, Ledipasvir) as oral treatment for HCV, with different price levels. We performed a 5 year-horizon budget impact analysis of SOF-based regimens for the management of HIV/HCV-coinfected patients. METHODS: This prospective study involved 4 Italian Infectious Diseases Departments in the Liguria Region. A total of 1.005 coinfected patients (30% cirrhotics) in any stage of their hepatic disease stages was considered (F0-F4, cirrhosis,transplanted, , HCC). Disease stage costs per patient were collected, taking into account the rate of expected disease progression in absence of treatment and the rate of Sustained Virological Response (SVR)with SOF-based regimens. The success rate for SOF-based Regimens was estimated based on literature data and expert opinion. Drugs prices used in the calculation were those paid by the Italian Health Service. Two scenarios were compared: "no treatment" versus b) SOF-based treatment. Data were analyzed from the Regional Health Service standpoint. RESULTS: Over the next 5 years, the total expense in a "no treatment" scenario (base case) should approximate 54 M Euros,, with 89 deaths. Assuming an SVR success rate of 90%, average SOF-based regimens price higher than € 50.000 costs more than € 55 millions, resulting not convenient. At the average price of 15.000 € per patient, the total expense in the SOF-based scenario should approach 20 MEuros , i.e. more than 60% lower than in the "no-treatment" scenario. CONCLUSIONS: The results suggest that at the average price of € 15.000 per patient over the next 5 years, the use of SOF should allow saving half of the economic resources needed to manage the HIV/HCV disease population.

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