Organizational and Economic Issues Related to the Introduction of Boceprevir in the Treatment of Patients with Genotype 1 Chronic Hepatitis C in Italy

Objectives: To present the critical points concerning organizational and economic issues of the introduction of boceprevir in the treatment of patients with genotype 1 chronic hepatitis C in Italy. Methods: A budget impact analysis was conducted adapting the NICE (UK) scheme for this drug, using the Italian epidemiological context and the perspective of the National Health Service. The cost-utility analysis (CUA) was carried out using a Markov model comparing the triple therapy (TT) with peginterferon alfa, ribavirin and boceprevir to the double therapy (DT) with peginterferon alfa and ribavirin. Available Italian published scientific literature provided data source. The main outcome of the CUA was the incremental cost-effectiveness ratio (ICER). The organizational aspects considered were: clinical management of patient with HCV chronic infection, access modalities, outpatient visit, planned and unplanned visits, hospital admission, role of the general practitioner (GP). Results: The budget impact analysis shows that, considering both naïve and previously treated patients, the treatment with boceprevir has an impact on the National Health Service of almost €66 million for the first year. Compared to treatment with DT, the cost-utility analysis shows for the boceprevir-based treatment strategy an ICER of €8.622,00. The management of TT for its intrinsic complexity requires monthly outpatients visits, at least at the beginning of treatment, for monitoring the compliance to treatment, efficacy and side effects. A critical organizational point is potentially the request for boceprevir for each single patient by the medical prescriptor, who needs to fill in detailed form from the Italian Agency of Drug (AIFA). Conclusions:The impact of the introduction of boceprevir on the budget is high, even if the ICER is favourable. Patients’ management is particularly complex and there is the need for an alliance between the patients, their relatives, GPs and specialized centers.