OBJECTIVES: The April-2015 Spanish Strategic Plan for Hepatitis C Virus (SSP-HCV) established access to free-interferon direct-acting antivirals (DAAs). As hospital-delivered drugs, the main objective of this study is to analyze real-life budget impact of SSP-HCV in a Spanish Hospital Pharmacy Service (HPS).

METHODS: Retrospective study 3 years before (Pre: 2012/April-2015/March) and 3 after (Post: 2015/April-2018/March; Post-I: 2015/April-2016/March; Post-II: 2016/April-2017/March; Post-III: 2017/April-2018/March) SSP-HCV implementation, following the Ispor Good Practice for Budget Impact Analysis. Features of the health care system: universal-free access to interferon-based therapies or DAAs. Scope: health area with 550.000 inhabitants. Perspective: Public Health System (HPS). Eligible population: HCV-infected patients. Pre-SSP-HCV intervention: peginterferon±ribavirin±boceprevir/telaprevir (IFN-based). Post-SSP-HCV intervention: any free-interferon DDAs combination. Costs: direct drug costs (€). Time horizon: 3 years. Uncertainty and Scenario Analyses: parameter uncertainty in the input values contemplates a reduction of 10% -25% -50% of drug prices and no structural uncertainty was considered. Data sources: real-life use and cost data from registries or databases from HPS.

RESULTS: : 1,3%; : 16,2%; : 7,0%; CONCLUSIONS: The April/2015 SSP-HCV has had a very high budget impact on HPS, but has been declining by 50% per annum since its implementation. Currently, DAAs cost/patient is like interferon-based therapy Pre-SSP-HCV. In a 3-year time horizon, the budgetary impact could be like Pre-SSP-HCV.