Cost-effectiveness analysis with direct-acting antivirals in a cohort of HCV-infected inmates in Italy
Analisi di costo-efficacia dei farmaci ad azione antivirale diretta nel trattamento dell’epatite cronica C nella popolazione carceraria italiana
DOI:
https://doi.org/10.33393/ao.2020.2190Keywords:
Cost, Direct-acting antivirals, HCV, HCV-infected inmates, Italian NHSAbstract
Objective: To evaluate the cost-effectiveness of a strategy based on direct-acting antivirals (DAAs) versus no drug strategy in HCV-infected inmates, from the perspective of the Italian National Health System (iNHS).
Methods: A previous Markov model was adapted to the Italian setting to evaluate the direct medical costs and health outcomes (quality-adjusted life years, QALY) throughout the life of HCV-infected inmates. Epidemiological data, patient characteristics (genotype, METAVIR classification), DAAs sustained virological response (SVR), annual likelihood of transition, treatment costs and utilities were gathered from the literature. The DAAs strategy included the administration of elbasvir/grazoprevir or sofosbuvir/velpatasvir or glecaprevir/pibrentasvir. Direct medical costs and QALYs were discounted at a 3.0% annual rate. Cost-effectiveness was evaluated as incremental cost-effectiveness ratio (€, 2019) per QALY gained. A deterministic sensitivity analysis (DSA) was performed.
Results: Over a lifetime horizon, the DAAs strategy showed higher health costs per patient compared to no drugs strategy in the base-case analysis (€ 42,571 vs. € 26,119). However, it was associated with an increase of QALYs gained (21.14 vs. 15.67), showing an incremental cost-effectiveness ratio of € 3,010 per QALY. The sensitivity analysis confirmed the base-case results.
Conclusions: Extending the DAAs treatment to HCV-infected inmates was estimated to be cost effective from the perspective of the Italian NHS, regardless genotype and METAVIR classification. (HTA & Market Access)
Downloads
References
Chen SL, Morgan TR. The natural history of hepatitis C virus (HCV) infection. Int J Med Sci. 2006;3(2):47-52. https://doi.org/10.7150/ijms.3.47 PMID:16614742
Lavanchy D. The global burden of hepatitis C. Liver Int. 2009;29(suppl 1):74-81. https://doi.org/10.1111/j.1478-3231.2008.01934.x PMID:19207969
Younossi ZM, Singer ME, Mir HM, Henry L, Hunt S. Impact of interferon free regimens on clinical and cost outcomes for chronic hepatitis C genotype 1 patients. J Hepatol. 2014;60(3):530-537. https://doi.org/10.1016/j.jhep.2013.11.009 PMID:24269472
Butt AA, Wang X, Moore CG. Effect of hepatitis C virus and its treatment on survival. Hepatology. 2009;50(2):387-392. https://doi.org/10.1002/hep.23000 PMID:19591128
van der Meer AJ, Veldt BJ, Feld JJ, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308(24):2584-2593. https://doi.org/10.1001/jama.2012.144878 PMID:23268517
Suwanthawornkul T, Anothaisintawee T, Sobhonslidsuk A, Thakkinstian A, Teerawattananon Y. Efficacy of second generation direct-acting antiviral agents for treatment naïve hepatitis C genotype 1: a systematic review and network meta-analysis. PLoS One. 2015;10(12):e0145953. https://doi.org/10.1371/journal.pone.0145953 PMID:26720298
Pérez-Pitarch A, Guglieri-López B, Ferriols-Lisart R, Merino-Sanjuán M. A model-based meta-analysis of sofosbuvir-based treatments in chronic hepatitis C patients. Int J Antimicrob Agents. 2016;47(3):184-194. https://doi.org/10.1016/j.ijantimicag.2015.12.008 PMID:26915476
Zhang J, Nguyen D, Hu KQ. Chronic hepatitis C virus infection: a review of current direct-acting antiviral treatment strategies. N Am J Med Sci (Boston). 2016;9(2):47-54. PMID:27293521
Kondili LA, Andreoni M, Alberti A, et al. Estimated prevalence of undiagnosed Hepatitis C virus infected individuals in Italy: a mathematical model to accurately measure HCV prevalence with a route of transmission granularity. AASLD ABSTRACTS (Poster). Hepatology. 2019.
Gardini I, Bartoli M, Conforti M, Mennini FS, Marcellusi A. Estimation of the number of HCV-positive patients in Italy. PLoS One. 2019;14(10):e0223668. https://doi.org/10.1371/journal.pone.0223668 PMID:31671120
Ranieri R, Starnini G, Carbonara S, et al; SIMSPe Group. Management of HCV infection in the penitentiary setting in the direct-acting antivirals era: practical recommendations from an expert panel. Infection. 2017;45(2):131-138. https://doi.org/10.1007/s15010-016-0973-0PMID:28025726
United Nations. 45/111 Basic principles for the treatment of prisoners, 1990. http://www.un.org/documents/ga/res/45/a45r111
Dublin declaration on HIV/AIDS in prisons in Europe and central Asia, 2004. http://16889-presscdn-048.pagely.netdna-cdn.com/wp-content/uploads/2013/06/rep-2004-dublin-declarationen.pdf
Bretschneider W, Elger BS. Expert perspectives on Western European prison health services: do ageing prisoners receive equivalent care? J Bioeth Inq. 2014;11(3):319-332. https://doi.org/10.1007/s11673-014-9547-y PMID:24965437
Drummond MF, O’Brien BJ, Stoddart GL, et al. Methods for the economic evaluation of health care programmes. Oxford (UK). Oxford University Press. 2005.
Gruppo di lavoro AIES (coordinato da G. Fattore). Proposta di Linee Guida per la valutazione economica degli interventi sanitari in Italia. PharmacoEconomics - Italian Research Articles. 2009;11(2):83-93.
Ministero della Giustizia. https://www.giustizia.it/giustizia/it/mg_1_14_1.page?facetNode_1=0_2&facetNode_2=0_2_10&contentId=SST225648&previsiousPage=mg_1_14. (Accesso Dicembre 2019).
Stöver H, Meroueh F, Marco A, et al. Offering HCV treatment to prisoners is an important opportunity: key principles based on policy and practice assessment in Europe. BMC Public Health. 2019;19(1):30. https://doi.org/10.1186/s12889-018-6357-x PMID:30621658
Babudieri S. Presentazione. Agorà penitenziaria 2019 XIX Congresso Nazionale SIMSPe-ONLUS. 4-5 ottobre 2019 Roma.
Ranieri R, Giuliani R. Presentazione. Infezione da HCV: l'importanza del test and treat. Agorà penitenziaria 2019 XX Congresso Nazionale SIMSPe-ONLUS. Il carcere è territorio. 3-4 ottobre 2019 Milano.
Pontali E, Fiore V, Ialungo AM, et al; Gruppo Infettivologi Penitenziari. Treatment with direct-acting antivirals in a multicenter cohort of HCV-infected inmates in Italy. Int J Drug Policy. 2018;59:50-53. https://doi.org/10.1016/j.drugpo.2018.06.017 PMID:29986272
Foschi A, Casana M, Radice A, Ranieri R, d’Arminio Monforte A. Hepatitis C management in prisons: an insight into daily clinical practice in three major Italian correctional houses. Hepatology. 2016;64(5):1821-1822. https://doi.org/10.1002/hep.28609 PMID:27118063
Turnes J, Domínguez-Hernández R, Casado MÁ. Cost-effectiveness analysis of two treatment strategies for chronic hepatitis C before and after access to direct-acting antivirals in Spain. Gastroenterol Hepatol. 2017 Aug Sep;40(7):433-446. Epub 2017 Jun 21. https://doi.org/10.1016/j.gastre.2017.07.008
Chahal HS, Marseille EA, Tice JA, et al. Cost-effectiveness of early treatment of hepatitis C virus genotype 1 by stage of liver fibrosis in a US treatment-naive population. JAMA Intern Med. 2016;176(1):65-73. https://doi.org/10.1001/jamainternmed.2015.6011 PMID:26595724
Younossi ZM, Park H, Saab S, Ahmed A, Dieterich D, Gordon SC. Cost-effectiveness of all-oral ledipasvir/sofosbuvir regimens in patients with chronic hepatitis C virus genotype 1 infection. Aliment Pharmacol Ther. 2015;41(6):544-563. https://doi.org/10.1111/apt.13081 PMID:25619871
San Miguel R, Gimeno-Ballester V, Blázquez A, Mar J. Cost-effectiveness analysis of sofosbuvir-based regimens for chronic hepatitis C. Gut. 2015;64(8):1277-1288. https://doi.org/10.1136/gutjnl-2014-307772 PMID:25311032
Buti M, San Miguel R, Brosa M, et al. Estimating the impact of hepatitis C virus therapy on future liver-related morbidity, mortality and costs related to chronic hepatitis C. J Hepatol. 2005;42(5):639-645. https://doi.org/10.1016/j.jhep.2004.12.031 PMID:15826711
Maylin S, Martinot-Peignoux M, Moucari R, et al. Eradication of hepatitis C virus in patients successfully treated for chronic hepatitis C. Gastroenterology. 2008;135(3):821-829. https://doi.org/10.1053/j.gastro.2008.05.044 PMID:18593587
Saab S, Hunt DR, Stone MA, McClune A, Tong MJ. Timing of hepatitis C antiviral therapy in patients with advanced liver disease: a decision analysis model. Liver Transpl. 2010;16(6):748-759. https://doi.org/10.1002/lt.22072 PMID:20517909
Ferrante SA, Chhatwal J, Brass CA, et al. Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study. BMC Infect Dis. 2013;13(1):190. https://doi.org/10.1186/1471-2334-13-190 PMID:23621902
Fattovich G, Giustina G, Degos F, et al. Morbidity and mortality in compensated cirrhosis type C: a retrospective follow-up study of 384 patients. Gastroenterology. 1997;112(2):463-472. https://doi.org/10.1053/gast.1997.v112.pm9024300 PMID:9024300
Heffernan A, Cooke GS, Nayagam S, Thursz M, Hallett TB. Scaling up prevention and treatment towards the elimination of hepatitis C: a global mathematical model. Lancet. 2019; 393(10178):1319-1329. https://doi.org/10.1016/S0140-6736(18)32277-3 PMID: 30704789
Elbasvir/grazoprevir. https://www.ema.europa.eu/en/documents/product-information/zepatier-epar-product-information_it.pdf. (Accesso dicembre 2019).
Sofosbuvir/velpatasvir. https://ec.europa.eu/health/documents/community-register/2016/20160706135323/anx_135323_it.pdf. (Accesso dicembre 2019).
Glecaprevir/pibrentasvir. https://www.ema.europa.eu/en/documents/product-information/maviret-epar-product-information_it.pdf. (Accesso dicembre 2019).
Nomenclatore dell’assistenza specialistica ambulatoriale. 28.01.2013 Supplemento ordinario n. 8 alla Gazzetta Ufficiale. Serie generale n.23 https://www.trovanorme.salute.gov.it/norme/renderPdf.spring?seriegu=SG&datagu=28/01/2013&redaz=13A00528&artp=3&art=1&subart=1&subart1=10&vers=1&prog=001
Ruggeri M, Romano F, Basile M, et al. Cost-Effectiveness Analysis of Early Treatment of Chronic HCV with Sofosbuvir/Velpatasvir in Italy. Appl Health Econ Health Policy. 2018;16(5):711-722. https://doi.org/10.1007/s40258-018-0410-x PMID:30039348
Ruggeri M, Rolli FR, Kondili LA, et al. Cost-effectiveness analysis of Daclatasvir/Sofosbuvir for the treatment of the HCV patients failed after the first line with second generation of DAAs in Italy. Expert review of pharmacoeconomics & outcomes research. 2019;19(3):363-374.
Fattore G. Gruppo di lavoro AIES (coordinato da G. Fattore). Proposta di Linee Guida per la valutazione economica degli interventi sanitari in Italia. PharmacoEconomics-Italian Research Articles. 2009;11(2):83-93. https://doi.org/10.1007/BF03320660
Puig-Junoy J, Pascual-Argente N, Puig-Codina L, Planellas L, Solozabal M. Cost-utility analysis of second-generation direct-acting antivirals for hepatitis C: a systematic review. Expert Rev Gastroenterol Hepatol. 2018;12(12):1251-1263. https://doi.org/10.1080/17474124.2018.1540929 PMID:30791790
Souliotis K, Siakavellas S, Golna C, Manesis E, Papatheodoridis G, Hatzakis A. Real-life cost of managing chronic HCV infection in Greece prior to Direct-Acting Antivirals (DAAs): an undeniable truth of spending more for less. Hippokratia. 2018;22(3):127-131. PMID:31641333
He T, Lopez-Olivo MA, Hur C, Chhatwal J. Systematic review: cost-effectiveness of direct-acting antivirals for treatment of hepatitis C genotypes 2-6. Aliment Pharmacol Ther. 2017;46(8):711-721. https://doi.org/10.1111/apt.14271. Review. PMID:28836278
Aggarwal R, Chen Q, Goel A, et al. Cost-effectiveness of hepatitis C treatment using generic direct-acting antivirals available in India. PLoS One. 2017;12(5):e0176503. https://doi.org/10.1371/journal.pone.0176503 PMID:28520728
Li X, Chan NS, Tam AW, Hung IFN, Chan EW. Budget impact and cost-effectiveness analyses of direct-acting antivirals for chronic hepatitis C virus infection in Hong Kong. Eur J Clin Microbiol Infect Dis. 2017;36(10):1801-1809. https://doi.org/10.1007/s10096-017-2995-7PMID:28516201
Ciaccio A, Cortesi PA, Bellelli G, et al. Direct-acting antivirals combination for elderly patients with chronic hepatitis C: A cost-effectiveness analysis. Liver Int. 2017;37(7):982-994. https://doi.org/10.1111/liv.13339 PMID:27943549
Chhatwal J, He T, Lopez-Olivo MA. Systematic Review of Modelling Approaches for the Cost Effectiveness of Hepatitis C Treatment with Direct-Acting Antivirals. Pharmacoeconomics. 2016;34(6):551-567. https://doi.org/10.1007/s40273-015-0373-9 PMID:26748919
Assoumou SA, Tasillo A, Vellozzi C, et al. Cost-effectiveness and budgetary impact of HCV testing, treatment and linkage to care in U.S. prisons. Clin Infect Dis. 2020;70(7):1388-1396. https://doi.org/10.1093/cid/ciz383 PMID:31095676
Marco A, Domínguez-Hernández R, Casado MA. Análisis coste-efectividad del tratamiento de la hepatitis c crónica en población reclusa. Póster Nº EI15. XII Congreso Nacional y XX Jornadas de la Sociedad Española de Sanidad Penitenciaria 2018.
Published
How to Cite
Issue
Section
Categories
License
Copyright (c) 2020 The authors
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Accepted 2020-11-19
Published 2020-12-23