Highlights
- •Although all patients were able to access HCV DAA therapy, 35% of patients required an insurance appeal process.
- •Median time from transplant to first dose was 45 days.
- •Prior authorization denials necessitating insurance appeals led to delays in therapy.
- •Patient cost was minimal after utilization of copay assistance programs, which are a limited resource.
- •Access to DAA therapy for solid-organ transplant patients may require added administrative efforts to complete the insurance approval process.
Abstract
Background
Emerging data supports expanding the solid organ donor pool with transplantation from
hepatitis C virus (HCV)-positive donors into HCV-negative recipients. However, concerns
exist regarding the ability to access direct-acting antivirals (DAAs) post-transplant
in a real-world setting.
Methods
This single-center, retrospective study evaluated DAA access rates, time to first
dose, and patient cost in donor-derived HCV solid-organ transplant recipients utilizing
an integrated specialty pharmacy process.
Results
Among 91 patients, all accessed DAAs through prescription insurance (97%) or patient
assistance programs (3%). Of those who received DAAs through insurance, only 65% received
approval on initial insurance submission. Median time from transplant to first dose
was 45d [IQR 34–66]. The on-site specialty pharmacy was used by 69% of patients. Copay
assistance programs reduced the median monthly patient cost from $1914 [range $7-7536]
to $0 [range $0–5].
Conclusion
Our findings indicate that access to DAAs in donor-derived HCV post-transplant is
achievable and affordable; however, significant added administrative efforts may be
required for insurance approval as well as obtaining copay assistance, which is a
limited resource.
Keywords
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References
- Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.N Engl J Med. May 2014; 370: 1889-1898https://doi.org/10.1056/NEJMoa1402454
- Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis.J Hepatol. 08 2017; 67: 263-271https://doi.org/10.1016/j.jhep.2017.03.039
- Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection.N Engl J Med. Dec 2015; 373: 2599-2607https://doi.org/10.1056/NEJMoa1512610
- Short-term outcomes of deceased donor renal transplants of HCV uninfected recipients from HCV seropositive nonviremic donors and viremic donors in the era of direct-acting antivirals.Am J Transplant. 2019; 11 (19): 3058-3070https://doi.org/10.1111/ajt.15496
- Utilization rates and clinical outcomes of hepatitis C positive donor hearts in the contemporary era.J Heart Lung Transplant. 09. 2019; 38: 907-917https://doi.org/10.1016/j.healun.2019.06.023
- Increasing utilization and excellent initial outcomes following liver transplant of hepatitis C virus (HCV)-Viremic donors into HCV-negative recipients: outcomes following liver transplant of HCV-viremic donors.Hepatology. Jun 2019; 69: 2381-2395https://doi.org/10.1002/hep.30540
- Expanding heart transplant in the era of direct-acting antiviral therapy for hepatitis C.JAMA Cardiol. Feb 1. 2020; 5: 167-174https://doi.org/10.1001/jamacardio.2019.4748
- Twelve-month outcomes after transplant of hepatitis C-infected kidneys into uninfected recipients: a single-group trial.Ann Intern Med. Sep 4. 2018; 169: 273-281https://doi.org/10.7326/m18-0749
- Trial of transplantation of HCV-infected kidneys into uninfected recipients.N Engl J Med. Jun 15 2017; 376: 2394-2395https://doi.org/10.1056/NEJMc1705221
- Direct-acting antiviral prophylaxis in kidney transplantation from hepatitis C virus-infected donors to noninfected recipients: an open-label nonrandomized trial.Ann Intern Med. Apr 17. 2018; 168: 533-540https://doi.org/10.7326/m17-2871
- Multicenter study to transplant hepatitis C-infected kidneys (MYTHIC): an open-label study of combined glecaprevir and pibrentasvir to treat recipients of transplanted kidneys from deceased donors with hepatitis C virus infection.J Am Soc Nephrol. Aug 2020; https://doi.org/10.1681/ASN.2020050686
- Transplanting hepatitis C virus-infected hearts into uninfected recipients: a single-arm trial.Am J Transplant. Sep 2019; 19: 2533-2542https://doi.org/10.1111/ajt.15311
- Transplantation of kidneys from hepatitis C-infected donors to hepatitis C-negative recipients: single center experience.Am J Transplant. Nov 2019; 19: 3046-3057https://doi.org/10.1111/ajt.15530
- Hepatitis C virus NAT-positive solid organ allografts transplanted into hepatitis C virus-negative recipients: a real-world experience.Hepatology. Jul 2020; 72: 32-41https://doi.org/10.1002/hep.31011
- 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. Mar 2020; 20: 739-751https://doi.org/10.1111/ajt.15664
- Survey of clinician opinions on kidney transplantation from hepatitis-C virus-positive donors: identifying and overcoming barriers.Kidney. 2020; (10.34067/KID.0004592020)https://doi.org/10.34067/KID.0004592020
- Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.J Biomed Inf. Apr 2009; 42: 377-381https://doi.org/10.1016/j.jbi.2008.08.010
- The REDCap consortium: building an international community of software platform partners.J Biomed Inform. 07. 2019; 95: 103208https://doi.org/10.1016/j.jbi.2019.103208
- Recommendations for testing, managing, and treating hepatitis C.(Available at:)http://wwww.hcvguidelines.org/(Accessed)Date accessed: September 28, 2020
- Donor hepatitis-C seropositivity is an independent risk factor for the development of accelerated coronary vasculopathy and predicts outcome after cardiac transplantation.J Heart Lung Transplant. Mar 2004; 23: 277-283https://doi.org/10.1016/S1053-2498(03)00148-7
- Lessons from the real world: HCV-infected donor kidney transplantation as standard practice.Am J Transplant. 2019; 11 (19): 2969-2970https://doi.org/10.1111/ajt.15582
- Drug authorization for sofosbuvir/ledipasvir (harvoni) for chronic HCV infection in a real-world cohort: a new barrier in the HCV care cascade.PloS One. 2015; 10e0135645https://doi.org/10.1371/journal.pone.0135645
- Contract a Virus to Save a Life: A Comparison of Short Term Outcomes between Adult Hepatitis C Negative Kidney Transplant Recipients Receiving a Hepatitis C NAT Positive versus Hepatitis C Negative Deceased Donor Kidney.([abstract])2020
- Cost-effectiveness of hepatitis C-positive donor kidney transplantation for hepatitis C-negative recipients with concomitant direct-acting antiviral therapy.Am J Transplant. 10. 2018; 18: 2496-2505https://doi.org/10.1111/ajt.15054
- Cost-effectiveness of using kidneys from hepatitis C nucleic acid test-positive donors for transplantation in hepatitis C-negative recipients.Am J Transplant. 10. 2018; 18: 2457-2464https://doi.org/10.1111/ajt.14929
- Trends in discard of kidneys from Hepatitis C viremic donors in the United States.Clin J Am Soc Nephrol. 2. 2021; 16: 251-261https://doi.org/10.2215/CJN
Article info
Publication history
Published online: September 13, 2021
Accepted:
September 6,
2021
Received in revised form:
August 20,
2021
Received:
June 12,
2021
Identification
Copyright
© 2021 Elsevier Inc. All rights reserved.
