Monitoraggio delle terapie innovative anti-HCV basate sui farmaci
ad azione antivirale diretta (DAA) e valutazione dell’impatto farmacoeconomico nella ASL Roma 6
Gabriele Bagaglini, Alessandra Armati, Roberto Piloni, Marina Bruno
Background Hepatitis C virus (HCV) infection has a great importance in our society with a deep impact in social and economic Country’s contest. Costs associated with the chronic disease generated, known as Hepatitis C, are very high: there is a direct correlation between the progression of liver disease and the increase in treatment costs. Since the beginning of 2015, new directly acting antiviral (DAAs) drugs have been introduced into therapy, which in Phase III clinical studies have shown, compared to standard treatments, a better profile in terms of therapeutic success, tolerability and safety.
Materials and Methods Data relating to the clinical history and treatment plans were extrapolated for patients enrolled in therapy with new DAAs in health local authority “ASL Roma 6”, in the period between January 1, 2015 and May 1, 2017. The economic impact of these high expenses therapies was evaluated. From these data and the costs of HCV-related pathologies the costs saved at one year were hypothesized.
Results and discussion In the period analyzed 124 patients were enrolled. Different viral genotypes were expressed without significant differences in terms of distribution.
Clinical profile observed at the beginning of the study was:
94 patients (76%) with chronic hepatitis C and advanced cirrhosis (F4 state);
26 patients (21%) with high fibrosis without cirrhosis (F3 state);
2 patients (1.5%) with portal fibrosis with few septa (F2 state)
2 patients (1.5%) with no fibrosis (F0 state).
However, at the time of recruiting:
58 patients (47%) had never received any treatment;
38 patients (31%) were not responders to previous treatments (including protease inhibitors Boceprevir and Telaprevir);
16 patients (13%) were relapser: they responded favorably to the first therapy, with the reappearance of the virus afterwards;
3 patients (2%), were partial responders to previous treatments;
9 patients (7%) were unknown for therapeutic history.
The cost of therapy for all patients treated was approximately € 6,390,000.
Based on the literature data on efficacy of the DAA and HCV related pathologies costs, the initial investments could be recovered in a few years.
Conclusion New DAAs are effective but expensive and their use in enlarged population of HCV positive subjects has to consider clinical urgency criteria to guarantee economic sustainability for National Health Systems. This high initial investment finds its rationale on the long-term advantages, both in economic terms and in terms of increasing quality of life, as confirmed by the international literature.
Key words: HCV infection, Hepatitis C costs associated, DAAs treatment criteria, DAAs treatment costs