Economic Evaluation of the Hepatitis C Virus Treatment Extension to Early-Stage Fibrosis Patients: Evidence from the PITER Real-World Cohort

Matteo Ruggeri, Silvia Coretti, Federica Romano, Loreta A Kondili, Stefano Vella, Americo Cicchetti

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: To conduct a cost-effectiveness analysis of two planning strategies of the second-generation direct-acting antiviral interferon-free regimens for the treatment of chronic hepatitis C virus infection.

METHODS: A lifetime multicohort model comprised 8125 real-life patients enrolled in the PITER (Italian platform for the study of viral hepatitis) registry, implemented by the ISS (Istituto Superiore di Sanità). Two treatment planning strategies were compared: 1) policy 1-treat all patients regardless of the stage of fibrosis (F0-F4) with second-generation direct-acting antivirals and 2) policy 2-treat patients at F3/F4 stage and those who are prioritized by the scientific guidelines first, and the remaining patients when they reach the F3 stage. Clinical outcomes and costs were evaluated by using a lifetime horizon Markov model and adopting the third-party payer perspective. Health outcomes were expressed in terms of quality-adjusted life-years (QALYs). A sensitivity analysis was run to explore first- and second-order uncertainty and heterogeneity. An expected value of perfect information analysis was also conducted.

RESULTS: Policy 1 exhibits an incremental cost-effectiveness ratio of €8,775/QALY gained and remains less than €30,000/QALY in 94% of realizations produced by the Monte-Carlo simulation. Such a proportion increases to 97% when adopting a threshold of €40,000/QALY gained.

CONCLUSIONS: Moving from the urgency criterion to evidence-based escalating strategies when prioritizing the access to new anti-hepatitis C virus treatments is a good investment in health, whose affordability should be explored through context-specific budget impact analyses.

Original languageEnglish
Pages (from-to)783-791
Number of pages9
JournalValue in Health
Volume21
Issue number7
DOIs
Publication statusPublished - Jul 2018

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Quality-Adjusted Life Years
Hepacivirus
Cost-Benefit Analysis
Fibrosis
Antiviral Agents
Health Insurance Reimbursement
Health
Budgets
Chronic Hepatitis C
Virus Diseases
Therapeutics
Interferons
Hepatitis
Uncertainty
Registries
Guidelines
Costs and Cost Analysis

Keywords

  • Hepatitis C virus (HCV)
  • fibrosis
  • cohort

Cite this

Economic Evaluation of the Hepatitis C Virus Treatment Extension to Early-Stage Fibrosis Patients : Evidence from the PITER Real-World Cohort. / Ruggeri, Matteo; Coretti, Silvia; Romano, Federica; Kondili, Loreta A; Vella, Stefano; Cicchetti, Americo.

In: Value in Health, Vol. 21, No. 7, 07.2018, p. 783-791.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVES: To conduct a cost-effectiveness analysis of two planning strategies of the second-generation direct-acting antiviral interferon-free regimens for the treatment of chronic hepatitis C virus infection.METHODS: A lifetime multicohort model comprised 8125 real-life patients enrolled in the PITER (Italian platform for the study of viral hepatitis) registry, implemented by the ISS (Istituto Superiore di Sanit{\`a}). Two treatment planning strategies were compared: 1) policy 1-treat all patients regardless of the stage of fibrosis (F0-F4) with second-generation direct-acting antivirals and 2) policy 2-treat patients at F3/F4 stage and those who are prioritized by the scientific guidelines first, and the remaining patients when they reach the F3 stage. Clinical outcomes and costs were evaluated by using a lifetime horizon Markov model and adopting the third-party payer perspective. Health outcomes were expressed in terms of quality-adjusted life-years (QALYs). A sensitivity analysis was run to explore first- and second-order uncertainty and heterogeneity. An expected value of perfect information analysis was also conducted.RESULTS: Policy 1 exhibits an incremental cost-effectiveness ratio of €8,775/QALY gained and remains less than €30,000/QALY in 94{\%} of realizations produced by the Monte-Carlo simulation. Such a proportion increases to 97{\%} when adopting a threshold of €40,000/QALY gained.CONCLUSIONS: Moving from the urgency criterion to evidence-based escalating strategies when prioritizing the access to new anti-hepatitis C virus treatments is a good investment in health, whose affordability should be explored through context-specific budget impact analyses.",
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T1 - Economic Evaluation of the Hepatitis C Virus Treatment Extension to Early-Stage Fibrosis Patients

T2 - Evidence from the PITER Real-World Cohort

AU - Ruggeri, Matteo

AU - Coretti, Silvia

AU - Romano, Federica

AU - Kondili, Loreta A

AU - Vella, Stefano

AU - Cicchetti, Americo

N1 - Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

PY - 2018/7

Y1 - 2018/7

N2 - OBJECTIVES: To conduct a cost-effectiveness analysis of two planning strategies of the second-generation direct-acting antiviral interferon-free regimens for the treatment of chronic hepatitis C virus infection.METHODS: A lifetime multicohort model comprised 8125 real-life patients enrolled in the PITER (Italian platform for the study of viral hepatitis) registry, implemented by the ISS (Istituto Superiore di Sanità). Two treatment planning strategies were compared: 1) policy 1-treat all patients regardless of the stage of fibrosis (F0-F4) with second-generation direct-acting antivirals and 2) policy 2-treat patients at F3/F4 stage and those who are prioritized by the scientific guidelines first, and the remaining patients when they reach the F3 stage. Clinical outcomes and costs were evaluated by using a lifetime horizon Markov model and adopting the third-party payer perspective. Health outcomes were expressed in terms of quality-adjusted life-years (QALYs). A sensitivity analysis was run to explore first- and second-order uncertainty and heterogeneity. An expected value of perfect information analysis was also conducted.RESULTS: Policy 1 exhibits an incremental cost-effectiveness ratio of €8,775/QALY gained and remains less than €30,000/QALY in 94% of realizations produced by the Monte-Carlo simulation. Such a proportion increases to 97% when adopting a threshold of €40,000/QALY gained.CONCLUSIONS: Moving from the urgency criterion to evidence-based escalating strategies when prioritizing the access to new anti-hepatitis C virus treatments is a good investment in health, whose affordability should be explored through context-specific budget impact analyses.

AB - OBJECTIVES: To conduct a cost-effectiveness analysis of two planning strategies of the second-generation direct-acting antiviral interferon-free regimens for the treatment of chronic hepatitis C virus infection.METHODS: A lifetime multicohort model comprised 8125 real-life patients enrolled in the PITER (Italian platform for the study of viral hepatitis) registry, implemented by the ISS (Istituto Superiore di Sanità). Two treatment planning strategies were compared: 1) policy 1-treat all patients regardless of the stage of fibrosis (F0-F4) with second-generation direct-acting antivirals and 2) policy 2-treat patients at F3/F4 stage and those who are prioritized by the scientific guidelines first, and the remaining patients when they reach the F3 stage. Clinical outcomes and costs were evaluated by using a lifetime horizon Markov model and adopting the third-party payer perspective. Health outcomes were expressed in terms of quality-adjusted life-years (QALYs). A sensitivity analysis was run to explore first- and second-order uncertainty and heterogeneity. An expected value of perfect information analysis was also conducted.RESULTS: Policy 1 exhibits an incremental cost-effectiveness ratio of €8,775/QALY gained and remains less than €30,000/QALY in 94% of realizations produced by the Monte-Carlo simulation. Such a proportion increases to 97% when adopting a threshold of €40,000/QALY gained.CONCLUSIONS: Moving from the urgency criterion to evidence-based escalating strategies when prioritizing the access to new anti-hepatitis C virus treatments is a good investment in health, whose affordability should be explored through context-specific budget impact analyses.

KW - Hepatitis C virus (HCV)

KW - fibrosis

KW - cohort

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DO - 10.1016/j.jval.2017.10.021

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C2 - 30005750

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SP - 783

EP - 791

JO - Value in Health

JF - Value in Health

SN - 1098-3015

IS - 7

ER -