Economic Assessment of an Anti-HCV Screening Program in Italy

Ruggeri, Matteo; Coretti, Silvia; Gasbarrini, Antonio; Cicchetti, Americo

doi:10.1016/j.jval.2013.07.005

Cited by 33 publications

(33 citation statements)

References 15 publications

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“…Focused testing has been shown to be costeffective in most higher risk populations and settings [43,48,55,56,[58][59][60][61][64][65][66]71] and has a high yield of case finding. In addition, the higher the treatment rates, the greater the population impact, and the more cost-effective HCV case finding becomes [72].…”

Section: Recommendation and Rationale On Testing Approachesmentioning

confidence: 99%

Who to test and how to test for chronic hepatitis C infection – 2016 WHO testing guidance for low- and middle-income countries

Easterbrook

2016

Journal of Hepatology

111

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Section: Recommendation and Rationale On Testing Approachesmentioning

confidence: 99%

Who to test and how to test for chronic hepatitis C infection – 2016 WHO testing guidance for low- and middle-income countries

Easterbrook

2016

Journal of Hepatology

111

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“…Annual health care costs were associated with their respective disease status. The cost of the resources related to each HCV health state, used for the implementation of the model, was quantified from the perspective of the Italian National Health Service by the permanent members of the Workshop of Economics and Drugs in Hepatology, as reported . Unit costs were valorized using the Italian National Health Service inpatient and outpatient reimbursement tariffs.…”

Section: Methodsmentioning

confidence: 99%

Modeling cost‐effectiveness and health gains of a “universal” versus “prioritized” hepatitis C virus treatment policy in a real‐life cohort

et al. 2017

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We evaluated the cost‐effectiveness of two alternative direct‐acting antiviral (DAA) treatment policies in a real‐life cohort of hepatitis C virus–infected patients: policy 1, “universal,” treat all patients, regardless of fibrosis stage; policy 2, treat only “prioritized” patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus–infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies’ cost‐effectiveness. The patients’ age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality‐adjusted life‐years (QALY) and incremental cost‐effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country‐specific health states costs and mean treatment cost of €30,000. For the Italian base‐case analysis, the cost‐effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost‐effective in 94%‐97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0‐F3 post–sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost‐saving for the base price (€15,000) discounts of at least 75% applied in patients with F0‐F2 fibrosis. Conclusion: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost‐effective; cost‐effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814–1825)

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“…Attraverso questo nuovo modello si vuole fornire uno strumento di lavoro innovativo al decisore che cerchi di indirizzare le principali problematiche legate all'introduzione di nuovi trattamenti. La peculiarità del nuovo modello, più che la capacità di stimare il rapporto costo-efficacia di un singolo trattamento con prezzo ed un'efficacia definiti, è l'impianto metodologico che riproduce la storia naturale della patologia con un dettaglio maggiore rispetto alla versione precedente [22]. Questo approccio è utile ad individuare il giusto momento in cui trattare coorti di pazienti diverse in condizioni di incertezza e non semplicemente replicare e proiettare i risultati di un singolo studio.…”

Section: Obiettivi Dello Studiounclassified

“…), allorché ci si accinga ad informare i decisori sulla sostenibilità economica di questi nuovi trattamenti, si rende necessario migliorare gli strumenti analitici ad oggi a disposizione per condurre valutazioni economiche in questa importante area terapeutica [20][21]. In particolare, la modellistica tradizionale, utilizzata per stimare il rapporto costo-efficacia di boceprevir e telaprevir, non si concentrava sulle transizioni fra diversi livelli di fibrosi, né distingueva fra diversi livelli di scompenso epatico [22].…”

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A new decision model for economic evaluation of novel therapies for HCV

Ruggeri¹,

Cicchetti

Coretti

et al. 2014

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In 2014, the European Medicines Agency (EMA) has given the license to two new direct-acting antiviral: sofosbuvir and simeprevir. The evidence provided by the studies, reported a high rate of SVR even in patients with decompensated cirrhosis. This and other innovative elements are potentially adept at changing the entire natural course of HCV. However, the dramatic prevalence rates of HCV observed in Italy, and the high prices that are expected to be required by the pharmaceutical industry, raises some critical issues about how to regulate access to such drugs. The objective of this article is to present a new decision model for the evaluation of novel therapies for HCV. This model is intended to provide a tool for the decision-maker that seeks to address the main issues related to the introduction of HCV new treatments. The model that we have structured follows the classic Bayesian approach, using data from reference literature for staging the action of treatments depending on the level of fibrosis (F0, F1, F2, F3, F4). The model is designed to consider patients with all genotypes and allows to make comparisons between innovative and traditional therapies (dual, triple, IFN free, PI combinations, etc.), for both experienced and naïve patients. In addition, the model is used to simulate mixed cohorts of patients, representing a population with HCV with different levels of fibrosis and different genotypes. To show the potential of the model, we created some simple scenarios assuming different levels of SVR and pricing. The results of our model show that, even assuming an SVR rate of 100%, the administration of new treatments for HCV subjects F1 / 2 has an incremental cost-effectiveness ratio not sustainable. In contrast, for the subjects F3 and F4, low incremental SVR rates and an incremental cost of the innovative therapy of € 40,000 would be cost effective. The added value of this model is its versatility and applicability to diverse assessment needs. In addition, the model offers an opportunity for reflection even to the industry, which in the years to come will have to develop strategies for entering the market and offer sustainable prices for decision-makers and at the same time remunerate the investment in research and development consistently with the expectations of the shareholders.

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Economic Assessment of an Anti-HCV Screening Program in Italy

Abstract: The anti-HCV screening program is a valid health-related investment improving patients' quality of life and survival with an acceptable expenditure increase for the National Health Service.

Cited by 33 publications

References 15 publications

Who to test and how to test for chronic hepatitis C infection – 2016 WHO testing guidance for low- and middle-income countries

Who to test and how to test for chronic hepatitis C infection – 2016 WHO testing guidance for low- and middle-income countries

Modeling cost‐effectiveness and health gains of a “universal” versus “prioritized” hepatitis C virus treatment policy in a real‐life cohort

A new decision model for economic evaluation of novel therapies for HCV

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