Commercial insurance delays direct-acting antiviral treatment for hepatitis C kidney transplantation into uninfected recipients.
hepatitis C
insurance authorization
kidney transplant
Journal
Transplant infectious disease : an official journal of the Transplantation Society
ISSN: 1399-3062
Titre abrégé: Transpl Infect Dis
Pays: Denmark
ID NLM: 100883688
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
08
04
2020
revised:
28
07
2020
accepted:
11
08
2020
pubmed:
19
8
2020
medline:
4
8
2021
entrez:
19
8
2020
Statut:
ppublish
Résumé
The advent of direct-acting antivirals (DAAs) has created an avenue for transplantation of hepatitis C virus (HCV)-infected donors into uninfected recipients (D+/R-). The donor transmission of HCV is then countered by DAA administration during the post-operative period. However, initiation of DAA treatment is ultimately dictated by insurance companies. A retrospective chart review of 52 D+/R- kidney recipients who underwent DAA treatment post-transplant was performed. Patients were grouped according to their prescription coverage plans, managed by either commercial or government pharmacy benefit managers (PBMs). Thirty-nine patients had government PBMs and 13 had commercial PBMs. Demographics were similar between the two groups. All patients developed HCV viremia, but cleared the virus after treatment with DAA. Patients with government PBMs were treated earlier compared to those with commercial PBMs (11 days vs 26 days, P = .01). Longer time to DAA initiation resulted in higher peak viral loads (β = 0.39, R D+/R- transplantation offers patients an alternative strategy to increase access. However, treatment can be profoundly delayed by a third-party payer authorization process that may be subjecting patients to unnecessary risks and worsened outcomes.
Substances chimiques
Antiviral Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13449Informations de copyright
© 2020 Wiley Periodicals LLC.
Références
Goldberg DS, Abt PL, Blumberg EA, et al. Trial of transplantation of HCV-infected kidneys into uninfected recipients. N Engl J Med. 2017;376(24):2394-2395.
Durand CM, Bowring MG, Brown DM, et al. Direct-acting antiviral prophylaxis in kidney transplantation from hepatitis C virus-infected donors to noninfected recipients: an open-label nonrandomized trial. Ann Intern Med. 2018;168(8):533-540.
Molnar MZ, Nair S, Cseprekal O, et al. Transplantation of kidneys from hepatitis C-infected donors to hepatitis C-negative recipients: single center experience. Am J Transplant. 2019;19(11):3046-3057.
Graham JA, Torabi J, Ajaimy M, et al. Transplantation of viral positive hepatitis C positive kidneys into uninfected recipients offers an opportunity to increases organ access. Clin Transplant. 2020:e13833.34(4).
Kapila N, Menon KVN, Al-Khalloufi K, et al. HCV NAT positive solid organ allografts transplanted into HCV negative recipients: a real-world experience. Hepatology (Baltimore, MD). 2019;72(1):32-41.
Bowring MG, Shaffer AA, Massie AB, et al. Center-level trends in utilization of HCV-exposed donors for HCV-uninfected kidney and liver transplant recipients in the United States. Am J Transplant. 2019;19(8):2329-2341.
Kwong AJ, Wall A, Melcher M, et al. Liver transplantation for hepatitis C virus (HCV) non-viremic recipients with HCV viremic donors. Am J Transplant. 2019;19(5):1380-1387.
Wadei HM, Pungpapong S, Cortese C, et al. Transplantation of HCV-infected organs into uninfected recipients: advance with caution. Am J Transplant. 2019;19(3):960-961.
Gupta G, Yakubu I, Bhati CS, et al. Ultra-short duration direct acting antiviral prophylaxis to prevent virus transmission from hepatitis C viremic donors to hepatitis C negative kidney transplant recipients. Am J Transplant. 2020;20(3):739-751.
Woolley AE, Singh SK, Goldberg HJ, et al. Heart and lung transplants from HCV-infected donors to uninfected recipients. N Engl J Med. 2019;380(17):1606-1617.
Sise ME, Strohbehn IA, Chute DF, et al. Preemptive treatment with elbasvir and grazoprevir for Hepatitis C viremic donor to uninfected recipient kidney transplantation. Kidney Int Rep. 2020;5:459-467.
Henry B. Drug pricing & challenges to hepatitis C treatment access. J Health Biomed Law. 2018;14:265-283.
Barua S, Greenwald R, Grebely J, Dore GJ, Swan T, Taylor LE. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States. Annals of Internal Medicine. 2015;163(3):215.
Canary LA, Klevens RM, Holmberg SD. Limited access to new hepatitis C virus treatment under state medicaid programs. Ann Intern Med. 2015;163(3):226-228.
Barua S, Greenwald R, Grebely J, Dore GJ, Swan T, Taylor LE. Restrictions for medicaid reimbursement of sofosbuvir for the treatment of hepatitis C virus infection in the United States. Ann Intern Med. 2015;163(3):215-223.
Stepanova M, Kanwal F, El-Serag HB, Younossi ZM. Insurance status and treatment candidacy of hepatitis C patients: analysis of population-based data from the United States. Hepatology (Baltimore, MD). 2011;53(3):737-745.
Lo Re 3rd V, Gowda C, Urick PN, et al. Disparities in absolute denial of modern hepatitis C therapy by type of insurance. Clin Gastroenterol Hepatol. 2016;14(7):1035-1043.
Wong RJ, Jain MK, Therapondos G, et al. Race/ethnicity and insurance status disparities in access to direct acting antivirals for hepatitis C virus treatment. Am J Gastroenterol. 2018;113(9):1329-1338.
Centers for Medicare & Medicaid Services. Assuring medicaid benificiaries access to hepatitis C (HCV) drugs. 2017. https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/rx-releases/state-releases/state-rel-172.pdf
Carter LDB, Aronsohn A. Overcoming injustice: a roadmap to improve access to hepatitis C virus therapy for our medicaid patients. Hepatology (Baltimore, MD). 2017;65(5):1735-1740.
Rice Jr D, Ordoveza M, Palmer A, Wu G, Chirch LM. Factors associated with delay in therapy for chronic hepatitis C. Open Forum Infect Dis. 2016;3(suppl_1):599.
Gowda C, Lott S, Grigorian M, et al. Absolute insurer denial of direct-acting antiviral therapy for hepatitis C: a national specialty pharmacy cohort study. Open Forum Infect Dis. 2018;5(6):1.
Treatment of HCV-uninfected transplant recipients receiving organs from HCV-viremic donors. 2019. https://www.hcvguidelines.org/unique-populations/organs-from-hcv-viremic-donors
Kutzler HL, Collins K, Maneckshana B, et al. Aggressive Epstein-Barr virus-negative B-cell post-transplant lymphoproliferative disorder in a hepatitis C-negative liver transplant recipient who received a hepatitis C-positive graft: Implications for D+/R− hepatitis C virus seroconversion. Transpl Infect Dis. 2019;21(5):e13144.
Levitsky J, Goldberg D, Smith AR, et al. Acute rejection increases risk of graft failure and death in recent liver transplant recipients. Clin Gastroenterol Hepatol. 2017;15(4):584-593.e2.
Eckman MH, Woodle ES, Thakar CV, Alloway RR, Sherman KE. Cost-effectiveness of using kidneys from HCV-viremic donors for transplantation into HCV-uninfected recipients. Am J Kidney Dis. 2020;75:857-867.
Gupta G, Zhang Y, Carroll NV, Sterling RK. Cost-effectiveness of hepatitis C-positive donor kidney transplantation for hepatitis C-negative recipients with concomitant direct-acting antiviral therapy. Am J Transplant. 2018;18(10):2496-2505