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Marcellusi A, Mennini FS, Andreoni M, Kondili LA. Screening strategy to advance HCV elimination in Italy: a cost-consequence analysis. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2024; 25:1261-1273. [PMID: 38280068 DOI: 10.1007/s10198-023-01652-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/06/2023] [Accepted: 11/21/2023] [Indexed: 01/29/2024]
Abstract
BACKGROUND AND AIMS Italy has the greatest burden of hepatitis C virus (HCV) infection in Western Europe. The screening strategy represents a crucial prevention tool to achieve HCV elimination in Italy. We evaluated the cost-consequences of different screening strategies for the diagnosis of HCV active infection in the birth cohort 1948-1968 to achieve the HCV elimination goal. METHODS We designed a probabilistic model to estimate the clinical, and economic outcomes of different screening coverage uptakes, considering the direct costs of HCV management according to each liver fibrosis stage, in the Italian context. A decision probabilistic tree simulates 4 years of HCV testing of the 1948-1968 general population birth cohort, (15,485,565 individuals to be tested) considering different coverage rates. A No-screening scenario was compared with two alternative screening scenarios that represented different coverage rates each year: (1) Incremental approach (coverage rates equal to 5%, 10%, 30%, and 50% at years 1, 2, 3, and 4, respectively) and (2) Fast approach (50% coverage rate at years 1, 2, 3 and 4). Overall 106,200 cases were previously estimated to have an HCV active infection. A liver disease progression Markov model was considered for an additional 6 years (horizon-time 10 years). RESULTS The highest increased number of deaths and clinical events are reported for the No-screening scenario (21,719 cumulative deaths at the end of ten years; 10,148 cases with HCC and/or 7618 cases with Decompensated Cirrhosis). Following the Fast-screening scenario, the reductions in clinical outcomes and deaths were higher compared with No-screening and Incremental-screening. At ten years time horizon, less than 5696 liver deaths (PSA CI95%: - 3873 to 7519), 3,549 HCC (PSA CI95%: - 2413 to 4684) and less than 3005 liver decompensations (PSA CI 95%: - 2104 to 3907) were estimated compared with the Incremental-scenario. The overall costs of the Fast-screening, including the costs of the DAA and liver disease management of the infected patients for 10 years, are estimated to be € 43,107,543 more than no-investment in screening and € 62,289,549 less compared with the overall costs estimated by the Incremental-scenario. CONCLUSION It is necessary to guarantee dedicated funds and efficiency of the system for the cost-efficacious screening of the 1948-1968 birth cohort in Italy. A delay in HCV diagnosis and treatment in the general population, yet not addressed for the HCV free-of-charge screening, will have important clinical and economic consequences in Italy.
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Affiliation(s)
- Andrea Marcellusi
- Faculty of Economics, CEIS, Economic Evaluation and HTA (EEHTA), University of Rome "Tor Vergata", Rome, Italy
| | - Francesco Saverio Mennini
- Faculty of Economics, CEIS, Economic Evaluation and HTA (EEHTA), University of Rome "Tor Vergata", Rome, Italy
- Institute for Leadership and Management in Health, Kingston University London, London, UK
| | - Massimo Andreoni
- Policlinico Tor Vergata, University of Rome "Tor Vergata", Rome, Italy
| | - Loreta A Kondili
- Center for Global Health, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161, Rome, Italy.
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Shetty A, Lee M, Valenzuela J, Saab S. Cost effectiveness of hepatitis C direct acting agents. Expert Rev Pharmacoecon Outcomes Res 2024; 24:589-597. [PMID: 38665122 DOI: 10.1080/14737167.2024.2348053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2023] [Accepted: 04/23/2024] [Indexed: 05/04/2024]
Abstract
INTRODUCTION Introduction of direct acting antivirals (DAA) has transformed treatment of chronic hepatitis C (HCV) and made the elimination of HCV an achievable goal set forward by World Health Organization by 2030. Multiple barriers need to be overcome for successful eradication of HCV. Availability of pan-genotypic HCV regimens has decreased the need for genotype testing but maintained high efficacy associated with DAAs. AREAS COVERED In this review, we will assess the cost-effectiveness of DAA treatment in patients with chronic HCV disease, with emphasis on general, cirrhosis, and vulnerable populations. EXPERT OPINION Multiple barriers exist limiting eradication of HCV, including cost to treatment, access, simplified testing, and implementing policy to foster treatment for all groups of HCV patients. Clinically, DAAs have drastically changed the landscape of HCV, but focused targeting of vulnerable groups is needed. Public policy will continue to play a strong role in eliminating HCV. While we will focus on the cost-effectiveness of DAA, several other factors regarding HCV require on going attention, such as increasing public awareness and decreasing social stigma associated with HCV, offering universal screening followed by linkage to treatment and improving preventive interventions to decrease spread of HCV.
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Affiliation(s)
- Akshay Shetty
- Department of Medicine, University of California at Los Angeles, Los Angeles, CA, USA
- Department of Surgery, University of California at Los Angeles, Los Angeles, CA, USA
| | - Michelle Lee
- Department of Surgery, University of California at Los Angeles, Los Angeles, CA, USA
| | - Julia Valenzuela
- Department of Surgery, University of California at Los Angeles, Los Angeles, CA, USA
| | - Sammy Saab
- Department of Medicine, University of California at Los Angeles, Los Angeles, CA, USA
- Department of Surgery, University of California at Los Angeles, Los Angeles, CA, USA
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3
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Calleja JL, Espin J, Kaushik A, Hernandez-Guerra M, Blissett R, Yehoshua A, Igloi-Nagy A. The Efficiency of Increased HCV Testing and Treatment Strategies in Spain to Achieve Elimination Goals. PHARMACOECONOMICS - OPEN 2024; 8:221-233. [PMID: 38100074 PMCID: PMC10884368 DOI: 10.1007/s41669-023-00458-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 11/22/2023] [Indexed: 02/23/2024]
Abstract
BACKGROUND In 2015, Spain launched a national eradication strategy for hepatitis C virus (HCV), resulting in the highest treatment rate in Europe and substantial reductions in HCV prevalence. However, to achieve the goal of HCV elimination, it is necessary to scale-up the diagnosis, treatment, and management of HCV infection. OBJECTIVE Our aim was to assess the prevalence, incidence, and cost effectiveness of scaling-up compared with status quo scenarios. METHODS A compartmental dynamic transmission model was developed comprising of a cascade of care and a liver progression module. Cost and quality-of-life inputs were sourced from the literature. Key outcomes were the prevalence and incidence of HCV and the incremental cost per quality-adjusted life-year (QALY) and per life-year (LY). Outcomes for a hypothetical elimination strategy were compared with the status quo. RESULTS The base-case analysis found that scaling-up testing and treatment reduced both the prevalence and incidence of HCV over time, resulting in incremental costs per QALY and LY of €13,291 and €12,285 respectively, compared with the status quo. The main drivers of the cost-effectiveness results included cost of diagnosis, cost of treatment, proportion of people who are unaware, percentage of population who inject drugs, and calibration parameters related to HCV infection prevalence. CONCLUSIONS This analysis demonstrated that scaling-up testing and treatment with direct-acting antivirals may be an efficient strategy for reducing the incidence and prevalence of HCV and may help achieve HCV elimination goals in Spain.
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Affiliation(s)
- Jose Luis Calleja
- Hospital Universitario Puerta de Hierro, Universidad Autónoma de Madrid, Madrid, Spain
| | - Jaime Espin
- Escuela Andaluza de Salud Pública, Granada, Spain
| | | | | | | | - Alon Yehoshua
- Formerly of Gilead Sciences, Inc., Foster City, CA, USA
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Brigham D, Narkewicz MR. Profile of Sofosbuvir and Velpatasvir Combination in the Treatment of Chronic Hepatitis C in Children and Adolescents: Current Evidence. Ther Clin Risk Manag 2024; 20:1-7. [PMID: 38230373 PMCID: PMC10789568 DOI: 10.2147/tcrm.s326099] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2023] [Accepted: 12/28/2023] [Indexed: 01/18/2024] Open
Abstract
Chronic hepatitis C (HCV) affects up to 3.25 million children and adolescents. Early treatment of HCV in children and adolescents reduces progression to advanced liver disease and cancer. Treatment for HCV has evolved to highly effective direct acting antiviral therapy in adults and now in children ≥3 years of age. This review focuses on the role of sofosbuvir and velpatasvir (SOF/VEL), a newer treatment of children and adolescents with chronic HCV. SOF/VEL is a pangenotypic DAA with primary clearance via the liver and biliary excretion. It has been studied in children and adolescents and is approved in the US for use in children and adolescents ≥3 years of age. Although the data are currently limited, SOF/VEL has demonstrated sustained viral response rates similar to comparable DAAs in the range of 95-98%. To date, side effects have been minimal.
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Affiliation(s)
- Dania Brigham
- Digestive Health Institute, Pediatric Liver Center, Children’s Hospital Colorado and University of Colorado School of Medicine, Section of Pediatric Gastroenterology, Hepatology and Nutrition, Aurora, CO, USA
| | - Michael R Narkewicz
- Digestive Health Institute, Pediatric Liver Center, Children’s Hospital Colorado and University of Colorado School of Medicine, Section of Pediatric Gastroenterology, Hepatology and Nutrition, Aurora, CO, USA
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García-Crespo C, Vázquez-Sirvent L, Somovilla P, Soria ME, Gallego I, de Ávila AI, Martínez-González B, Durán-Pastor A, Domingo E, Perales C. Efficacy decrease of antiviral agents when administered to ongoing hepatitis C virus infections in cell culture. Front Microbiol 2022; 13:960676. [PMID: 35992670 PMCID: PMC9382109 DOI: 10.3389/fmicb.2022.960676] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/03/2022] [Accepted: 07/11/2022] [Indexed: 11/23/2022] Open
Abstract
We report a quantification of the decrease of effectiveness of antiviral agents directed to hepatitis C virus, when the agents are added during an ongoing infection in cell culture vs. when they are added at the beginning of the infection. Major determinants of the decrease of inhibitory activity are the time post-infection of inhibitor administration and viral replicative fitness. The efficacy decrease has been documented with antiviral assays involving the combination of the direct-acting antiviral agents, daclatasvir and sofosbuvir, and with the combination of the lethal mutagens, favipiravir and ribavirin. The results suggest that strict antiviral effectiveness assays in preclinical trials may involve the use of high fitness viral populations and the delayed administration of the agents, relative to infection onset.
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Affiliation(s)
- Carlos García-Crespo
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) del Instituto de Salud Carlos III, Madrid, Spain
| | - Lucía Vázquez-Sirvent
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Department of Clinical Microbiology, IIS-Fundación Jiménez Díaz, UAM. Av. Reyes Católicos, Madrid, Spain
| | - Pilar Somovilla
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Departamento de Biología Molecular, Universidad Autónoma de Madrid, Madrid, Spain
| | - María Eugenia Soria
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) del Instituto de Salud Carlos III, Madrid, Spain
- Department of Clinical Microbiology, IIS-Fundación Jiménez Díaz, UAM. Av. Reyes Católicos, Madrid, Spain
| | - Isabel Gallego
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) del Instituto de Salud Carlos III, Madrid, Spain
| | - Ana Isabel de Ávila
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) del Instituto de Salud Carlos III, Madrid, Spain
| | - Brenda Martínez-González
- Department of Clinical Microbiology, IIS-Fundación Jiménez Díaz, UAM. Av. Reyes Católicos, Madrid, Spain
- Department of Molecular and Cell Biology, Centro Nacional de Biotecnología (CNB-CSIC), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
| | - Antoni Durán-Pastor
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
| | - Esteban Domingo
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) del Instituto de Salud Carlos III, Madrid, Spain
| | - Celia Perales
- Centro de Biología Molecular “Severo Ochoa” (CSIC-UAM), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) del Instituto de Salud Carlos III, Madrid, Spain
- Department of Clinical Microbiology, IIS-Fundación Jiménez Díaz, UAM. Av. Reyes Católicos, Madrid, Spain
- Department of Molecular and Cell Biology, Centro Nacional de Biotecnología (CNB-CSIC), Consejo Superior de Investigaciones Científicas (CSIC), Madrid, Spain
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Kouroumalis E, Voumvouraki A. Hepatitis C virus: A critical approach to who really needs treatment. World J Hepatol 2022; 14:1-44. [PMID: 35126838 PMCID: PMC8790391 DOI: 10.4254/wjh.v14.i1.1] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/08/2021] [Revised: 04/14/2021] [Accepted: 12/31/2021] [Indexed: 02/06/2023] Open
Abstract
Introduction of effective drugs in the treatment of hepatitis C virus (HCV) infection has prompted the World Health Organization to declare a global eradication target by 2030. Propositions have been made to screen the general population and treat all HCV carriers irrespective of the disease status. A year ago the new severe acute respiratory syndrome coronavirus 2 virus appeared causing a worldwide pandemic of coronavirus disease 2019 disease. Huge financial resources were redirected, and the pandemic became the first priority in every country. In this review, we examined the feasibility of the World Health Organization elimination program and the actual natural course of HCV infection. We also identified and analyzed certain comorbidity factors that may aggravate the progress of HCV and some marginalized subpopulations with characteristics favoring HCV dissemination. Alcohol consumption, HIV coinfection and the presence of components of metabolic syndrome including obesity, hyperuricemia and overt diabetes were comorbidities mostly responsible for increased liver-related morbidity and mortality of HCV. We also examined the significance of special subpopulations like people who inject drugs and males having sex with males. Finally, we proposed a different micro-elimination screening and treatment program that can be implemented in all countries irrespective of income. We suggest that screening and treatment of HCV carriers should be limited only in these particular groups.
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Affiliation(s)
- Elias Kouroumalis
- Department of Gastroenterology, University of Crete Medical School, Heraklion 71500, Crete, Greece
| | - Argyro Voumvouraki
- First Department of Internal Medicine, AHEPA University Hospital, Thessaloniki 54621, Greece
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7
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Nicastro E, Norsa L, Di Giorgio A, Indolfi G, D'Antiga L. Breakthroughs and challenges in the management of pediatric viral hepatitis. World J Gastroenterol 2021; 27:2474-2494. [PMID: 34092970 PMCID: PMC8160618 DOI: 10.3748/wjg.v27.i20.2474] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2021] [Revised: 03/04/2021] [Accepted: 04/07/2021] [Indexed: 02/06/2023] Open
Abstract
Chronic infections by hepatitis B virus (HBV) and hepatitis C virus (HCV) major causes of advanced liver disease and mortality worldwide. Although regarded as benign infections in children, their persistence through adulthood is undoubtedly of concern. Recent advances in HCV treatment have restored the visibility of these conditions and raised expectations for HBV treatment, which is currently far from being curative. Herein we describe direct-acting antivirals available for pediatric HCV (sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir) and their real-world use. A critical review of the HBV pediatric classification is provided. Anti-HBV investigational compounds are reviewed in light of the pathophysiology in the pediatric population, including capsid assembly modulators, antigen secretion inhibitors, silencing RNAs, and immune modifiers. Recommendations for screening and management of immunosuppressed children or those with other risk factors or comorbidities are also summarized.
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Affiliation(s)
- Emanuele Nicastro
- Department of Pediatric Gastroenterology Hepatology and Transplantation, ASST Papa Giovanni XXIII, Bergamo 24127, Italy
| | - Lorenzo Norsa
- Department of Pediatric Gastroenterology Hepatology and Transplantation, ASST Papa Giovanni XXIII, Bergamo 24127, Italy
| | - Angelo Di Giorgio
- Department of Pediatric Gastroenterology Hepatology and Transplantation, ASST Papa Giovanni XXIII, Bergamo 24127, Italy
| | - Giuseppe Indolfi
- Department of Neurofarba, Meyer Children's University Hospital of Florence, Florence 50137, Italy
| | - Lorenzo D'Antiga
- Department of Pediatric Gastroenterology Hepatology and Transplantation, ASST Papa Giovanni XXIII, Bergamo 24127, Italy
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Chen P, Jin M, Cao Y, Li H. Cost-Effectiveness Analysis of Oral Direct-Acting Antivirals for Chinese Patients with Chronic Hepatitis C. APPLIED HEALTH ECONOMICS AND HEALTH POLICY 2021; 19:371-387. [PMID: 33210262 DOI: 10.1007/s40258-020-00623-3] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 10/29/2020] [Indexed: 06/11/2023]
Abstract
BACKGROUND AND OBJECTIVE All oral direct-acting antivirals (DAAs) have shown excellent efficacy and safety in Chinese patients with chronic hepatitis C (CHC). However, the cost of DAAs used to be expensive; therefore, large numbers of patients had no access to DAAs in China. Recently, prices have been greatly reduced. The objective of this study was to evaluate the cost-effectiveness of ledipasvir/sofosbuvir (LDV/SOF), sofosbuvir/velpatasvir (SOF/VEL), elbasvir/grazoprevir (EBR/GZR) and glecaprevir/pibrentasvir (GLE/PIB) in Chinese CHC patients stratified by hepatitis C virus (HCV) genotype (GT), cirrhosis status, and treatment history. METHODS On the basis of a Chinese healthcare perspective, a Markov model was constructed to estimate the lifetime costs and health outcomes of patients treated with different DAA regimens. Chinese-specific clinical, cost, and utility inputs were obtained or calculated from published sources and expert opinions. Costs, life-years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were reported as primary outcomes. Base-case analysis and sensitivity analysis were conducted. RESULTS At a willing-to-pay (WTP) threshold of US$30,081/QALY (calculated by three times the GDP per capita in China), SOF/VEL was cost-effective in patients with HCV GT 1, 3, and 6 infections, and the probabilities that SOF/VEL was cost-effective were 9.7-75.7%, 39.1-63.9%, and 35.6-88.0%, respectively. For GT2 patients, noncirrhotic patients, treatment-naïve patients, and treatment-experienced patients, LDV/SOF was the most cost-effective regimen, and the probabilities of cost-effectiveness for each of these groups was 92.1-99.8%, 89.9-99.0%, 61.6-91.2%, and 99.3-100.0%, respectively below the WTP threshold. The GLE/PIB regimen (12-week duration) was the most cost-effective in cirrhotic patients, whereas the probability of its cost-effectiveness varied with that of EBR/GZR (4.1-93.8% versus 6.2-93.3%) below the WTP threshold. CONCLUSIONS Overall, SOF/VEL and LDV/SOF regimens are more likely to be cost-effective among various subgroups of Chinese patients with CHC.
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Affiliation(s)
- Pingyu Chen
- Department of Health Economics, China Pharmaceutical University, Nanjing, China
- Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing, China
| | - Min Jin
- Department of Health Economics, China Pharmaceutical University, Nanjing, China
| | - Yang Cao
- Department of Health Economics, China Pharmaceutical University, Nanjing, China
| | - Hongchao Li
- Department of Health Economics, China Pharmaceutical University, Nanjing, China.
- Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing, China.
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Clinical and economic benefits of a new paradigm of HCV diagnosis and treatment. GLOBAL & REGIONAL HEALTH TECHNOLOGY ASSESSMENT 2021; 8:58-66. [PMID: 36627870 PMCID: PMC9616196 DOI: 10.33393/grhta.2021.2183] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2020] [Accepted: 02/15/2021] [Indexed: 01/13/2023] Open
Abstract
Introduction The current paradigm (CP) of hepatitis C virus (HCV) diagnosis and treatment in Italy's National Health Service system has numerous steps. The European Association for the Study of the Liver recommends initiation of a pan-genotypic direct-acting antiviral regimen after a simple diagnostic process. The present study estimated the efficiency gains resulting from two simplified pathways from diagnosis to treatment of chronic hepatitis C patients in Italy over the next 5 years from a societal perspective. Methods The CP, a New Paradigm 1 (NP1), and a New Paradigm 2 (NP2) were evaluated in a Markov model. The NP1 model simplifies monitoring and laboratory test requirements in the diagnosis and treatment phases. The NP2 model also eliminates the primary care referral requirement. Results Treatment process time for non-cirrhotic patients was 48, 43, and 25 weeks in the CP, NP1, and NP2, respectively, and in cirrhotic patients was 49, 46, and 37 weeks. Under the CP, 19% of patients/year would be lost to follow-up, which decreases by 11% in NP1 and 100% in NP2. Compared with the CP, implementation of NP1 at 5 years would reduce compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver-related deaths by 12.6%, 12.4%, 8.1%, and 8.8%, respectively; these cases would be reduced by 94.0%, 93.8%, 61.0%, and 58.4% in NP2. Total 5-year costs with the CP, NP1, and NP2 are estimated at 135.6€ million, 110.5€ million, and 80.5€ million, respectively. Conclusions Simplification of HCV diagnosis and monitoring requirements would allow Italy to move closer to international guidelines with significant health benefits and economic gains.
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Han R, François C, Toumi M. Systematic Review of Health State Utility Values Used in European Pharmacoeconomic Evaluations for Chronic Hepatitis C: Impact on Cost-Effectiveness Results. APPLIED HEALTH ECONOMICS AND HEALTH POLICY 2021; 19:29-44. [PMID: 32661846 DOI: 10.1007/s40258-020-00600-w] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/11/2023]
Abstract
BACKGROUND Health state utility values (HSUVs) identified from utility elicitation studies are widely used in pharmacoeconomic evaluations for chronic hepatitis C (CHC) and are particularly instrumental in health technology assessment (HTA) evaluations such as those from the National Institute for Health and Care Excellence (NICE). OBJECTIVE The aim of this study was to identify HSUVs used in cost-utility analyses (CUAs) for CHC in Europe and to evaluate the impact of HSUV selection on cost-effectiveness results in terms of the incremental cost per quality-adjusted life-year (QALY) gained (ICER). METHODS A systematic search of pharmacoeconomic evaluations for CHC was updated in the MEDLINE and EMBASE databases for the periods 2012-2017 and 2017-2020. Data on health states, HSUVs, and utility elicitation studies were extracted. The difference in HSUVs of the same health state in different CUAs, and the difference between HSUVs of one health state and of the interlink health state in the same CUAs, were calculated. A quality assessment was performed to evaluate the selection of HSUVs in CUAs. Sets of HSUVs identified were used in a reconstructed CUA model to assess the impact on the ICER. RESULTS Twenty-six CUAs conducted in European countries and referring to 17 utility elicitation studies were included. The difference in HSUVs of the same health state in different CUAs ranged from 0.021 (liver transplant) to 0.468 (decompensated cirrhosis). The difference between HSUVs of one health state and of the interlink health state of the next disease severity level was calculated between the health states of F0-F1/mild and F2-F3/moderate (n = 11, 0.040-0.110), F2-F3/moderate and F4/compensated cirrhosis (n = 18, 0.027-0.130), compensated cirrhosis and decompensated cirrhosis (n = 22, 0.020-0.100), decompensated cirrhosis and hepatocellular carcinoma (n = 24, 0.000-0.200), hepatocellular carcinoma and liver transplant in the first year (n = 17, - 0.329 to 0.170) and liver transplant in the first and subsequent years (n = 17, - 0.340 to 0.000). The utility elicitation study selected by most CUAs (n = 11) was recommended as the source of HSUVs, at least for the CUAs conducted in the UK, based on the results of quality assessment. Seven sets of HSUVs were generated to fit the reconstructed model and changed the results of the incremental analysis from being cost effective to not being cost effective (ICER ranging from £2460 to £24,954 per QALY gained), and to being dominated in the UK setting. CONCLUSIONS The CUAs for CHC were found to apply to various HSUVs from different utility elicitation studies in the same health state. This variability in HSUVs has the potential to significantly affect ICER and ICER-based reimbursement decisions. A rigorous selection of HSUVs in CUAs to inform healthcare resource allocation is suggested for future studies of CUAs and for guideline development.
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Affiliation(s)
- Ru Han
- University of Aix-Marseille, Marseille, France.
- Creativ-Ceutical, 215, rue de Faubourg St-Honoré, 75008, Paris, France.
| | - Clément François
- University of Aix-Marseille, Marseille, France
- Creativ-Ceutical, 215, rue de Faubourg St-Honoré, 75008, Paris, France
| | - Mondher Toumi
- University of Aix-Marseille, Marseille, France
- Creativ-Ceutical, 215, rue de Faubourg St-Honoré, 75008, Paris, France
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Rodrigues JPV, Cazarim MDS, Chachá SGF, Martinelli ADLC, Pereira LRL. Cost-effectiveness analysis is a mandatory strategy for health systems: evidence from a study involving therapies for hepatitis C. CAD SAUDE PUBLICA 2020; 36:e00036619. [PMID: 32022174 DOI: 10.1590/0102-311x00036619] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2019] [Accepted: 08/02/2019] [Indexed: 11/22/2022] Open
Abstract
Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.
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Affiliation(s)
- João Paulo Vilela Rodrigues
- Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brasil.,Faculdade de Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil
| | - Maurílio de Souza Cazarim
- Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brasil
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Marcellusi A, Viti R, Kondili LA, Rosato S, Vella S, Mennini FS. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data. PHARMACOECONOMICS 2019; 37:255-266. [PMID: 30378086 DOI: 10.1007/s40273-018-0733-3] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
OBJECTIVE We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. METHODS A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. RESULTS The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. CONCLUSIONS This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.
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Affiliation(s)
- Andrea Marcellusi
- CEIS-Economic Evaluation and HTA (EEHTA), Faculty of Economics, University of Rome "Tor Vergata", Via Columbia 2, 00133, Rome, Italy.
- Institute for Leadership and Management in Health, Kingston University London, London, UK.
| | - Raffaella Viti
- CEIS-Economic Evaluation and HTA (EEHTA), Faculty of Economics, University of Rome "Tor Vergata", Via Columbia 2, 00133, Rome, Italy
| | | | | | | | - Francesco Saverio Mennini
- CEIS-Economic Evaluation and HTA (EEHTA), Faculty of Economics, University of Rome "Tor Vergata", Via Columbia 2, 00133, Rome, Italy
- Institute for Leadership and Management in Health, Kingston University London, London, UK
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