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Abstract Details
Access to hepatitis C direct-acting antiviral therapy in hepatitis C-positive donor to hepatitis C-negative recipient solid-organ transplantation in a real-world setting
Am J Surg. 2021 Sep 14;S0002-9610(21)00528-6. doi: 10.1016/j.amjsurg.2021.09.005.Online ahead of print.
Cori Edmonds1, Alicia Carver2, Josh DeClercq3, Leena Choi4, Megan Peter5, Kelly Schlendorf6, Roman Perri7, Rachel C Forbes8, Beatrice P Concepcion9
Author information
1Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: cori.edmonds@vumc.org.
2Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Alicia.b.carver@vumc.org.
3Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Josh.declercq@vumc.org.
4Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Leena.choi@vumc.org.
5Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Megan.peter@vumc.org.
6Section of Heart Failure and Cardiac Transplantation, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Kelly.h.schlendorf@vumc.org.
7Department of Medicine, Division of Hepatology, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Roman.perri@vumc.org.
8Department of Surgery, Division of Kidney and Pancreas Transplantation, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Rachel.forbes@vumc.org.
9Department of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Beatrice.p.concepcion@vumc.org.
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.