Cost-effectiveness of Sofosbuvir-based Regimens for HCV
Cost-effectiveness of Sofosbuvir-based Regimens for HCV
Background A new scenario of therapy for chronic hepatitis C (CHC) is being established with the approval of sofosbuvir (SOF).
Objective To estimate the cost-effectiveness of SOF-based regimens approved in the Summary of Product Characteristics (SmPC) versus the standard of care for different genotypes and patient populations (naive or pretreated).
Methods A Markov model simulating CHC progression was used to estimate disease treatment costs and effects over patients' lifetimes, from the Spanish National Public Healthcare System perspective. Different therapeutic options were analysed for genotypes 1, 2 and 3 in naive population and for genotype 2 and 3 pretreated patients, according to data obtained from clinical trials. A one-way sensitivity analysis was performed to evaluate the uncertainty of certain parameters: treatment starting age, transition probabilities, drug costs and discount rate. A probabilistic sensitivity analysis was also carried out.
Results For the naive population, the option SOF+pegylated-interferon-α (pIFN)+ribavirin (RBV) for 12 weeks recorded in SmPC for genotype 1 and 3 versus pIFN+RBV for 24 weeks estimated an incremental cost-effectiveness ratio (ICER) below the €40 000/quality-adjusted life-year (QALY) benchmark. For the pretreated population, SOF triple therapy reached an ICER on the threshold limit for genotype 3. Other options included in SmPC for different genotypes exceeded the accepted efficiency limit in our setting.
Conclusions The options that included SOF+RBV+pIFN in a 12-week course regimen fell below the efficiency threshold considered in our setting. IFN-free regimens administered for 24 weeks reached figures over the benchmark of €40 000/QALY.
Chronic hepatitis C (CHC) is the leading cause of chronic liver disease and liver transplantation in Western Europe and the USA. The prevalence ranged from 0.4% to 3.5% by country in Europe, making CHC an important public health issue.
Pegylated-interferon-α (pIFN) plus ribavirin (RBV) has been the standard of care (SoC) for the last decade, until the approval of the protease inhibitors (PIs) boceprevir and telaprevir in 2011. These new drugs added to pIFN and RBV have led to an increase in sustained viral response (SVR) but also to a profile of unfavourable side effects and high acquisition costs. This new therapeutic scenario has been established for both naive and pretreated patients, but only for HCV genotype 1 infection.
Sofosbuvir (SOF), an oral bioavailable direct-acting antiviral (DAA) recently approved by the US Food and Drug Administration and European Medicines Agency, is a nucleotide analogue inhibitor of the NS5B polymerase protein. Its efficacy in combination with pIFN plus RBV has been analysed in several studies and it has meant the emergent possibility of IFN-free regimens for certain patients' population. Shorter treatment courses, easy-to-administer regimens, an acceptable side effect profile, no resistance-associated mutations evidenced in virological failure and pan-genotypic activity make it a suitable option from the clinical point of view. As generally occurs with therapeutic innovation, its high acquisition cost deserves an efficiency analysis before generalised use is stabilised.
The aim of this study is to estimate the cost-effectiveness of SOF-based regimens for different genotypes and patients' populations according to data obtained from clinical trials (CTs) and summary of product characteristics (SmPC).
Abstract and Introduction
Abstract
Background A new scenario of therapy for chronic hepatitis C (CHC) is being established with the approval of sofosbuvir (SOF).
Objective To estimate the cost-effectiveness of SOF-based regimens approved in the Summary of Product Characteristics (SmPC) versus the standard of care for different genotypes and patient populations (naive or pretreated).
Methods A Markov model simulating CHC progression was used to estimate disease treatment costs and effects over patients' lifetimes, from the Spanish National Public Healthcare System perspective. Different therapeutic options were analysed for genotypes 1, 2 and 3 in naive population and for genotype 2 and 3 pretreated patients, according to data obtained from clinical trials. A one-way sensitivity analysis was performed to evaluate the uncertainty of certain parameters: treatment starting age, transition probabilities, drug costs and discount rate. A probabilistic sensitivity analysis was also carried out.
Results For the naive population, the option SOF+pegylated-interferon-α (pIFN)+ribavirin (RBV) for 12 weeks recorded in SmPC for genotype 1 and 3 versus pIFN+RBV for 24 weeks estimated an incremental cost-effectiveness ratio (ICER) below the €40 000/quality-adjusted life-year (QALY) benchmark. For the pretreated population, SOF triple therapy reached an ICER on the threshold limit for genotype 3. Other options included in SmPC for different genotypes exceeded the accepted efficiency limit in our setting.
Conclusions The options that included SOF+RBV+pIFN in a 12-week course regimen fell below the efficiency threshold considered in our setting. IFN-free regimens administered for 24 weeks reached figures over the benchmark of €40 000/QALY.
Introduction
Chronic hepatitis C (CHC) is the leading cause of chronic liver disease and liver transplantation in Western Europe and the USA. The prevalence ranged from 0.4% to 3.5% by country in Europe, making CHC an important public health issue.
Pegylated-interferon-α (pIFN) plus ribavirin (RBV) has been the standard of care (SoC) for the last decade, until the approval of the protease inhibitors (PIs) boceprevir and telaprevir in 2011. These new drugs added to pIFN and RBV have led to an increase in sustained viral response (SVR) but also to a profile of unfavourable side effects and high acquisition costs. This new therapeutic scenario has been established for both naive and pretreated patients, but only for HCV genotype 1 infection.
Sofosbuvir (SOF), an oral bioavailable direct-acting antiviral (DAA) recently approved by the US Food and Drug Administration and European Medicines Agency, is a nucleotide analogue inhibitor of the NS5B polymerase protein. Its efficacy in combination with pIFN plus RBV has been analysed in several studies and it has meant the emergent possibility of IFN-free regimens for certain patients' population. Shorter treatment courses, easy-to-administer regimens, an acceptable side effect profile, no resistance-associated mutations evidenced in virological failure and pan-genotypic activity make it a suitable option from the clinical point of view. As generally occurs with therapeutic innovation, its high acquisition cost deserves an efficiency analysis before generalised use is stabilised.
The aim of this study is to estimate the cost-effectiveness of SOF-based regimens for different genotypes and patients' populations according to data obtained from clinical trials (CTs) and summary of product characteristics (SmPC).
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