Date: Saturday, May 30, 2020
Session Name: Poster Session D: Non-Organ Specific: Viral Hepatitis
Session Time: 3:15pm-4:00pm
Presentation Time: 3:30pm-4:00pm
*Purpose: Emerging data supports transplantation of organs from hepatitis C-positive (HCV) donors to expand the donor pool, but access to direct acting antivirals (DAAs) to treat patients who develop donor-derived hepatitis C (dd-HCV) has not been well described when implemented as standard practice. This study evaluated DAA access rates, timing to first dose and drug cost for these patients.
*Methods: We conducted a retrospective review of all patients prescribed outpatient DAAs at our center post dd-HCV solid-organ transplantation between 10/2016-5/2019. Our on-site specialty pharmacy managed the DAA access process for the patients. Outcomes of interest included DAA approval rate, copay assistance use and patient drug cost. Univariate, proportional odds, logistic regression was used to determine if length of time from DAA request to first dose was associated with insurance type, insurance appeal, pharmacy location or off-label use.
*Results: We included 91 patients (54% private insurance, 59% off-label use, 46% ledipasvir/sofosbuvir, 41% glecaprevir/pibrentasvir, 13% velpatasvir/sofosbuvir). All accessed DAA therapy: 97% insurance, 3% assistance programs. In the 88 insured patients, 65% had DAAs approved on initial prior authorization (PA) and 35% required an appeal. Common PA denial reasons were absence of chronic HCV diagnosis (42%) and request for more than 8 weeks of therapy (36%). Median time from transplant to DAA request was 28 days [IQR 18.5-41.5]. Median time from DAA request to approval was 6 days [IQR 4-12]. Table 1 shows time between events by transplant type. Private insurance, use of an off-site pharmacy and need for insurance appeal were associated with a longer time from DAA request to first dose, but off-label use was not (Table 2). Of the 63 patients who filled DAA therapy at our center’s on-site specialty pharmacy, 49% used copay assistance reducing average monthly out-of-pocket cost from $2,003 [range $7-7,536] to $2 [range $0-5].
*Conclusions: Access to outpatient DAA therapy in dd-HCV post solid-organ transplant patients is achievable and affordable. Use of an on-site specialty pharmacy is associated with a significantly shorter time to first dose.
|Transplant Type||N||Days, Mean (SD)||Days, Mean (SD)|
|Transplant to First Dose||DAA Request to First Dose|
|Heart||47||62 (29)||22 (16)|
|Kidney||27||31 (11)||14 (8)|
|Liver||10||66 (31)||26 (21)|
|Lung||2||47 (21)||22 (1)|
|Heart/Kidney||5||107 (80)||22 (15)|
To cite this abstract in AMA style:Edmonds C, Carver A, DeClercq J, Choi L, Peter M, Forbes R, Concepcion B, Schlendorf K, Perri R. Access to Direct Acting Antiviral Therapy for Recipients of Solid Organs from Hepatitis C Viremic Donors [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/access-to-direct-acting-antiviral-therapy-for-recipients-of-solid-organs-from-hepatitis-c-viremic-donors/. Accessed March 1, 2021.
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