A Microsimulation Study of the Cost-Effectiveness of Hepatitis C Virus Screening Frequencies in Hemodialysis Centers.
Journal
Journal of the American Society of Nephrology : JASN
ISSN: 1533-3450
Titre abrégé: J Am Soc Nephrol
Pays: United States
ID NLM: 9013836
Informations de publication
Date de publication:
01 02 2023
01 02 2023
Historique:
received:
02
03
2022
accepted:
14
10
2022
pmc-release:
01
02
2024
entrez:
3
2
2023
pubmed:
4
2
2023
medline:
8
2
2023
Statut:
ppublish
Résumé
National guidelines recommend twice-yearly hepatitis C virus (HCV) screening for patients receiving in-center hemodialysis. However, studies examining the cost-effectiveness of HCV screening methods or frequencies are lacking. We populated an HCV screening, treatment, and disease microsimulation model with a cohort representative of the US in-center hemodialysis population. Clinical outcomes, costs, and cost-effectiveness of the Kidney Disease Improving Global Outcomes (KDIGO) 2018 guidelines-endorsed HCV screening frequency (every 6 months) were compared with less frequent periodic screening (yearly, every 2 years), screening only at hemodialysis initiation, and no screening. We estimated expected quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) between each screening strategy and the next less expensive alternative strategy, from a health care sector perspective, in 2019 US dollars. For each strategy, we modeled an HCV outbreak occurring in 1% of centers. In sensitivity analyses, we varied mortality, linkage to HCV cure, screening method (ribonucleic acid versus antibody testing), test sensitivity, HCV infection rates, and outbreak frequencies. Screening only at hemodialysis initiation yielded HCV cure rates of 79%, with an ICER of $82,739 per QALY saved compared with no testing. Compared with screening at hemodialysis entry only, screening every 2 years increased cure rates to 88% and decreased liver-related deaths by 52%, with an ICER of $140,193. Screening every 6 months had an ICER of $934,757; in sensitivity analyses using a willingness-to-pay threshold of $150,000 per QALY gained, screening every 6 months was never cost-effective. The KDIGO-recommended HCV screening interval (every 6 months) does not seem to be a cost-effective use of health care resources, suggesting that re-evaluation of less-frequent screening strategies should be considered.
Sections du résumé
BACKGROUND
National guidelines recommend twice-yearly hepatitis C virus (HCV) screening for patients receiving in-center hemodialysis. However, studies examining the cost-effectiveness of HCV screening methods or frequencies are lacking.
METHODS
We populated an HCV screening, treatment, and disease microsimulation model with a cohort representative of the US in-center hemodialysis population. Clinical outcomes, costs, and cost-effectiveness of the Kidney Disease Improving Global Outcomes (KDIGO) 2018 guidelines-endorsed HCV screening frequency (every 6 months) were compared with less frequent periodic screening (yearly, every 2 years), screening only at hemodialysis initiation, and no screening. We estimated expected quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) between each screening strategy and the next less expensive alternative strategy, from a health care sector perspective, in 2019 US dollars. For each strategy, we modeled an HCV outbreak occurring in 1% of centers. In sensitivity analyses, we varied mortality, linkage to HCV cure, screening method (ribonucleic acid versus antibody testing), test sensitivity, HCV infection rates, and outbreak frequencies.
RESULTS
Screening only at hemodialysis initiation yielded HCV cure rates of 79%, with an ICER of $82,739 per QALY saved compared with no testing. Compared with screening at hemodialysis entry only, screening every 2 years increased cure rates to 88% and decreased liver-related deaths by 52%, with an ICER of $140,193. Screening every 6 months had an ICER of $934,757; in sensitivity analyses using a willingness-to-pay threshold of $150,000 per QALY gained, screening every 6 months was never cost-effective.
CONCLUSIONS
The KDIGO-recommended HCV screening interval (every 6 months) does not seem to be a cost-effective use of health care resources, suggesting that re-evaluation of less-frequent screening strategies should be considered.
Identifiants
pubmed: 36735375
doi: 10.1681/ASN.2022030245
pii: 00001751-202302000-00010
pmc: PMC10103100
doi:
Substances chimiques
Antiviral Agents
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
205-219Subventions
Organisme : NIDA NIH HHS
ID : L30 DA049308
Pays : United States
Organisme : NIAID NIH HHS
ID : T32 AI052074
Pays : United States
Organisme : NIDA NIH HHS
ID : K01 DA052821
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001430
Pays : United States
Organisme : NIDA NIH HHS
ID : P30 DA040500
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI042853
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2022 by the American Society of Nephrology.
Références
Sawinski D, Forde KA, Lo Re V, et al. Mortality and kidney transplantation outcomes among hepatitis C virus-seropositive maintenance dialysis patients: a retrospective cohort study. Am J Kidney Dis. 2019;73:815-826. doi: 10.1053/j.ajkd.2018.11.009
doi: 10.1053/j.ajkd.2018.11.009
Goodkin DA, Bieber B, Jadoul M, Martin P, Kanda E, Pisoni RL. Mortality, hospitalization, and quality of life among patients with hepatitis C infection on hemodialysis. Clin J Am Soc Nephrol. 2017;12:287-297. doi: 10.2215/CJN.07940716
doi: 10.2215/CJN.07940716
Owens DK, Davidson KW, Krist AH, et al. Screening for hepatitis C virus infection in adolescents and adults: US Preventive Services Task Force recommendation statement. JAMA. 2020;323:970-975. doi: 10.1001/jama.2020.1123
doi: 10.1001/jama.2020.1123
Schillie S. CDC recommendations for hepatitis C screening among adults—United States, 2020. MMWR Recomm Rep. 2020;69:1-17. doi: 10.15585/mmwr.rr6902a1
doi: 10.15585/mmwr.rr6902a1
Jadoul M, Berenguer MC, Doss W, et al. Executive summary of the 2018 KDIGO hepatitis C in CKD Guideline: welcoming advances in evaluation and management. Kidney Int. 2018;94:663-673. doi: 10.1016/j.kint.2018.06.011
doi: 10.1016/j.kint.2018.06.011
American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. Accessed June 13, 2022. www.hcvguidelines.org .
Alter MJ, Lyerla RL, Tokars JI, et al. Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR Recomm Rep. 2001;50:1-43.
Labs Not for the Treatment of ESRD FAQs—OneView Knowledge Base. https://help.oneviewdps.davita.com/article/122-labs-not-for-the-treatment-of-esrd-faqs . Accessed July 21, 2022
Finelli L, Miller JT, Tokars JI, Alter MJ, Arduino MJ. National surveillance of dialysis-associated diseases in the United States, 2002. Semin Dial. 2005;18:52-61. doi: 10.1111/j.1525-139X.2005.18108.x
doi: 10.1111/j.1525-139X.2005.18108.x
Somsouk M, Langfield DE, Inadomi JM, Yee HF Jr. A cost-identification analysis of screening and surveillance of hepatitis C infection in a prospective cohort of dialysis patients. Dig Dis Sci. 2008;53:1093-1099. doi: 10.1007/s10620-007-9966-2
doi: 10.1007/s10620-007-9966-2
Centers for Disease Control and Prevention. Health Care-Associated Hepatitis B and C Outbreaks (≥2 Cases) Reported to the CDC 2008-2019. Reported to the CDC 2008-2019. 2021. Available at https://www.cdc.gov/hepatitis/outbreaks/healthcarehepoutbreaktable.htm . Accessed December 11, 2021
AASLD-IDSA HCV Guidance Panel. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clin Infect Dis . 2018;67(10):1477-1492. doi: 10.1093/cid/ciy585
Tang W, Chen W, Amini A, et al. Diagnostic accuracy of tests to detect hepatitis C antibody: a meta-analysis and review of the literature. BMC Infect Dis. 2017;17:695. doi: 10.1186/s12879-017-2773-2
doi: 10.1186/s12879-017-2773-2
Linas BP, Morgan JR, Pho MT, et al. Cost effectiveness and cost containment in the era of interferon-free therapies to treat hepatitis C virus genotype 1. Open Forum Infect Dis. 2016;4:ofw266. doi: 10.1093/ofid/ofw266
doi: 10.1093/ofid/ofw266
Linas BP, Barter DM, Morgan JR, et al. The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection. Ann Intern Med. 2015;162:619-629. doi: 10.7326/m14-1313
doi: 10.7326/m14-1313
Center USRDSC. United States Renal Data System. Accessed 2020. https://usrds.org/ . Accessed December 11, 2021
Assoumou SA, Wang J, Nolen S, et al. HCV testing and treatment in a national sample of US federally qualified health centers during the opioid epidemic. J Gen Intern Med. 2020;35:1477-1483. doi: 10.1007/s11606-020-05701-9
doi: 10.1007/s11606-020-05701-9
Assoumou SA, Nolen S, Hagan L, et al. Hepatitis C management at federally qualified health centers during the opioid epidemic: a cost-effectiveness study. Am J Med. 2020;133:e641-e658. doi: 10.1016/j.amjmed.2020.05.029
doi: 10.1016/j.amjmed.2020.05.029
Barocas JA, Savinkina A, Lodi S, et al. Projected long-term impact of the COVID-19 pandemic on hepatitis C outcomes in the United States: a modelling study. Clin Infect Dis. 2022;75:e1112-e1119. doi: 10.1093/cid/ciab779
doi: 10.1093/cid/ciab779
Grubbs V, Vittighoff E, Grimes B, Johansen KL. Mortality and illicit drug dependence among hemodialysis patients in the United States: a retrospective cohort analysis. BMC Nephrol. 2016;17:56. doi: 10.1186/s12882-016-0271-1
doi: 10.1186/s12882-016-0271-1
Sacks-Davis R, Grebely J, Dore GJ, et al. Hepatitis C virus reinfection and spontaneous clearance of reinfection—the InC3 study. J Infect Dis. 2015;212:1407-1419. doi: 10.1093/infdis/jiv220
doi: 10.1093/infdis/jiv220
Shamshirsaz AA, Kamgar M, Bekheirnia MR, et al. The role of hemodialysis machines dedication in reducing hepatitis C transmission in the dialysis setting in Iran: a multicenter prospective interventional study. BMC Nephrol. 2004;5:13. doi: 10.1186/1471-2369-5-13
doi: 10.1186/1471-2369-5-13
Bravo Zuñiga JI, Loza Munárriz C, López-Alcalde J. Isolation as a strategy for controlling the transmission of hepatitis C virus (HCV) infection in haemodialysis units. Cochrane Database Syst Rev. 2016;8:CD006420. doi: 10.1002/14651858.CD006420.pub2
doi: 10.1002/14651858.CD006420.pub2
Bruno S, Zuin M, Crosignani A, et al. Predicting mortality risk in patients with compensated HCV-induced cirrhosis: a long-term prospective study. Am J Gastroenterol. 2009;104:1147-1158.
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;308:2584-2593. doi: 10.1001/jama.2012.144878
doi: 10.1001/jama.2012.144878
Patzer RE, McPherson L, Wang Z, et al. Dialysis facility referral and start of evaluation for kidney transplantation among patients treated with dialysis in the Southeastern United States. Am J Transplant. 2020;20:2113-2125. doi: 10.1111/ajt.15791
doi: 10.1111/ajt.15791
Coyle C, Moorman AC, Bartholomew T, et al. The HCV care continuum: linkage to HCV care and treatment among patients at an urban health network, Philadelphia, PA. Hepatology. 2019;70:476-486. doi: 10.1002/hep.30501
doi: 10.1002/hep.30501
Tsui JI, Miller CM, Scott JD, Corcorran MA, Dombrowski JC, Glick SN. Hepatitis C continuum of care and utilization of healthcare and harm reduction services among persons who inject drugs in Seattle. Drug Alcohol Depend. 2019;195:114-120. doi: 10.1016/j.drugalcdep.2018.11.026
doi: 10.1016/j.drugalcdep.2018.11.026
Scott J, Fagalde M, Baer A, et al. A population-based intervention to improve care cascades of patients with hepatitis C virus infection. Hepatol Commun. 2020;5:387-399. doi: 10.1002/hep4.1627
doi: 10.1002/hep4.1627
Dupont SC, Fluker S-A, Quairoli KM, et al. Improved hepatitis C cure cascade outcomes among urban baby boomers in the direct-acting antiviral era. Public Health Rep. 2019;135:107-113. doi: 10.1177/0033354919888228
doi: 10.1177/0033354919888228
Konerman MA, Thomson M, Gray K, et al. Impact of an electronic health record alert in primary care on increasing hepatitis C screening and curative treatment for baby boomers. Hepatology. 2017;66:1805-1813. doi: 10.1002/hep.29362
doi: 10.1002/hep.29362
Reader SW, Kim HS, El-Serag HB, Thrift AP. Persistent challenges in the hepatitis C virus care continuum for patients in a central Texas public health System. Open Forum Infect Dis. 2020;7:ofaa322. doi: 10.1093/ofid/ofaa322
doi: 10.1093/ofid/ofaa322
Calner P, Sperring H, Ruiz-Mercado G, et al. HCV screening, linkage to care, and treatment patterns at different sites across one academic medical center. PLoS One. 2019;14:e0218388. doi: 10.1371/journal.pone.0218388
doi: 10.1371/journal.pone.0218388
McLernon DJ, Dillon J, Donnan PT. Health-state utilities in liver disease: a systematic review. Med Decis Making. 2008;28:582-592. doi: 10.1177/0272989X08315240
doi: 10.1177/0272989X08315240
Pyne JM, French M, McCollister K, Tripathi S, Rapp R, Booth B. Preference-weighted health-related quality of life measures and substance use disorder severity. Addiction. 2008;103:1320-1329. doi: 10.1111/j.1360-0443.2008.02153.x
doi: 10.1111/j.1360-0443.2008.02153.x
Wyld M, Morton RL, Hayen A, Howard K, Webster AC. A systematic review and meta-analysis of utility-based quality of life in chronic kidney disease treatments. PLoS Med. 2012;9:e1001307. doi: 10.1371/journal.pmed.1001307
doi: 10.1371/journal.pmed.1001307
Neumann PJ, Ganiats TG, Russell LB, Siegel JE, Ganiats TG. Cost-Effectiveness in Health and Medicine, 2nd ed. Oxford University Press; 2016.
Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371:796-797. doi: 10.1056/NEJMp1405158
doi: 10.1056/NEJMp1405158
Schalasta G, Speicher A, Börner A, Enders M. Performance of the new aptima HCV quant Dx assay in comparison to the Cobas TaqMan HCV2 test for use with the high pure system in detection and quantification of hepatitis C virus RNA in plasma or serum. J Clin Microbiol. 2016;54:1101-1107. doi: 10.1128/JCM.03236-15
doi: 10.1128/JCM.03236-15
Department of Health and Human Services. Clinical Laboratory Fee Schedule Files 2020. Accessed December 15, 2020. https://www.cms.gov/medicaremedicare-fee-service-paymentclinicallabfeeschedclinical-laboratory-fee-schedule-files/20clabq2 .
Centers for Disease Control and Prevention. Notes from the field: hepatitis C outbreak in a dialysis clinic—Tennessee, 2014. MMWR Morb Mortal Wkly Rep. 2016;64:1386-1387.
Centers for Disease Control and Prevention. Chronic Kidney Disease Surveillance System—United States. http://www.cdc.gov/ckd . Accessed December 14, 2021
Nguyen DB, Bixler D, Patel PR. Transmission of hepatitis C virus in the dialysis setting and strategies for its prevention. Semin Dial. 2019;32:127-134. doi: 10.1111/sdi.12761
doi: 10.1111/sdi.12761
Center for Behavioral Health Statistics and Quality (CBHSQ), Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services (HHS), and by RTI International. Results From the 2016 National Survey on Drug Use and Health: Detailed Tables. 2017. Available from https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.htm . Accessed July 23, 2018
Assoumou SA, Tasillo A, Leff JA, et al. Cost-effectiveness of one-time hepatitis C screening strategies among adolescents and young adults in primary care settings. Clin Infect Dis. 2018;66:376-384. doi: 10.1093/cid/cix798
doi: 10.1093/cid/cix798
Galai N, Safaeian M, Vlahov D, Bolotin A, Celentano DD. Longitudinal patterns of drug injection behavior in the ALIVE Study Cohort, 1988–2000: description and determinants. Am J Epidemiol. 2003;158:695-704. doi: 10.1093/aje/kwg209
doi: 10.1093/aje/kwg209
Smith DJ, Combellick J, Jordan AE, Hagan H. Hepatitis C virus (HCV) disease progression in people who inject drugs (PWID): a systematic review and meta-analysis. Int J Drug Policy. 2015;26:911-921.
Erman A, Krahn MD, Hansen T, et al. Estimation of fibrosis progression rates for chronic hepatitis C: a systematic review and meta-analysis update. BMJ Open. 2019;9:e027491. doi: 10.1136/bmjopen-2018-027491
doi: 10.1136/bmjopen-2018-027491
Program to Eradicate Hep C From Dialysis Patients Finds Early Success|FMCNA, Accessed December 12, 2021. https://fmcna.com/insights/articles/program-to-eradicate-hep-c-from-dialysis-patients-finds-early-success/ .
Lawitz E, Flisiak R, Abunimeh M, et al. Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection. Liver Int. 2019;40:1032-1041. doi: 10.1111/liv.14320
doi: 10.1111/liv.14320
Reau N, Kwo PY, Rhee S, et al. Glecaprevir/pibrentasvir treatment in liver or kidney transplant patients with hepatitis C virus infection. Hepatology. 2018;68:1298-1307. doi: 10.1002/hep.30046
doi: 10.1002/hep.30046
Lawitz E, Flisiak R, Abunimeh M, et al. Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection. Liver Int. 2020;40:1032-1041. doi: 10.1111/liv.14320
doi: 10.1111/liv.14320
Gane E, Lawitz E, Pugatch D, et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017;377:1448-1455. doi: 10.1056/NEJMoa1704053
doi: 10.1056/NEJMoa1704053
U.S. Department of Veterans Affairs. Pharmaceutical Prices. https://www.va.gov/oal/business/fss/pharmPrices.asp . Accessed January 21, 2020
Davis KL, Mitra D, Medjedovic J, Beam C, Rustgi V. Direct economic burden of chronic hepatitis C virus in a United States managed care population. J Clin Gastroenterol. 2011;45:e17-e24. doi: 10.1097/MCG.0b013e3181e12c09
doi: 10.1097/MCG.0b013e3181e12c09
Coffin PO, Sullivan SD. Cost-effectiveness of distributing naloxone to heroin users for lay overdose reversal. Ann Intern Med. 2013;158:1-9. doi: 10.7326/0003-4819-158-1-201301010-00003
doi: 10.7326/0003-4819-158-1-201301010-00003
Sullivan PW, Ghushchyan V. Preference-based EQ-5D index scores for chronic conditions in the United States. Med Decis Making. 2006;26:410-420. doi: 10.1177/0272989X06290495
doi: 10.1177/0272989X06290495
United States Renal Data System. 2021 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; 2021. Available from https://adr.usrds.org/ . Accessed August 4, 2022
Sakamoto N, Enomoto N, Marumo F, Sato C. Prevalence of hepatitis C virus infection among long-term hemodialysis patients: detection of hepatitis C virus RNA in plasma. J Med Virol. 1993;39:11-15. doi: 10.1002/jmv.1890390104
doi: 10.1002/jmv.1890390104
Pereira BJ, Levey AS. Hepatitis C virus infection in dialysis and renal transplantation. Kidney Int. 1997;51:981-999. doi: 10.1038/ki.1997.139
doi: 10.1038/ki.1997.139
Papadopoulos N, Griveas I, Sveroni E, et al. HCV viraemia in anti-HCV-negative haemodialysis patients: do we need HCV RNA detection test? Int J Artif Organs. 2018;41:168-170. doi: 10.1177/0391398817752326
doi: 10.1177/0391398817752326
Vidales-Braz BM, da Silva NM, Lobato R, et al. Detection of hepatitis C virus in patients with terminal renal disease undergoing dialysis in southern Brazil: prevalence, risk factors, genotypes, and viral load dynamics in hemodialysis patients. Virol J. 2015;12:8. doi: 10.1186/s12985-015-0238-z
doi: 10.1186/s12985-015-0238-z
Konstantinidou EI, Kontekaki EG, Kefas A, et al. The prevalence of HCV RNA positivity in anti-HCV antibodies-negative hemodialysis patients in Thrace Region. Multicentral study. Germs. 2021;11:52-58. doi: 10.18683/germs.2021.1240
doi: 10.18683/germs.2021.1240
Assoumou SA, Tasillo A, Vellozzi C, et al. Cost-effectiveness and budgetary impact of hepatitis C virus testing, treatment, and linkage to care in US prisons. Clin Infect Dis. 2020;70:1388-1396. doi: 10.1093/cid/ciz383
doi: 10.1093/cid/ciz383
Tasillo A, Eftekhari Yazdi G, Nolen S, et al. Short-term effects and long-term cost-effectiveness of universal hepatitis C testing in prenatal care. Obstet Gynecol. 2019;133:289-300. doi: 10.1097/AOG.0000000000003062
doi: 10.1097/AOG.0000000000003062