- Email: [email protected]
Comorbidities, Resource Utilization and Health Care Costs of Patients with Chronic Hepatitis C in a Spanish Population
POSTER PRESENTATIONS
SAT-117 COMORBIDITIES, RESOURCE UTILIZATION AND HEALTH CARE COSTS OF PATIENTS WITH CHRONIC HEPATITIS C IN A SPANISH POPULATION A. Sicras1, V. Ferrer2, R. Navarro3, M. Saez-Zafra4. 1CAP Vicenç Papaciet, La Roca del Vallés, Barcelona; 2CAP Vicenç Papaciet, La Roca del Vallés; 3 Medical Information, Hospital Germans Trias i Pujol, Badalona, Barcelona; 4GRECS, Girona University, Girona, Spain E-mail: [email protected] Background and Aims: Assess comorbidities, resource utilization and health care costs of patients with chronic hepatitis C (CHC) in a Spanish population. Methods: Observational, retrospective study of chronic hepatitis C patients ≥18 years, registered in the electronic prescriptions database, with a minimum of 12 months of active follow-up (at least two contacts with the healthcare system) in the 2010–2013 period. For each patient, the last 12 months of follow-up were considered. Outcomes of interest were: Charlson comorbidity index (CCI) as a proxy for the severity of the patient, the individual case mix index by bands resource utilization (BUR) resource use and health costs (direct medical costs including planned and emergency visits, hospitalizations, diagnosis testing, and indirect costs- lost productivity valued according to Eurostat and Eurofund). Analyses were performed overall and by presence/absence of cirrhosis. Statistical analysis was done with regression models and ANCOVA, p < 0.05. S748
Results: 1,055 patients with an average age of 57.9 years, 55.5% men were included. The average time from diagnosis to inclusion in the analysis was 18.1 years, and 7.5% died. Cirrhosis was associated with cardiovascular events-odds ratio (OR) = 3.8, organ failure OR = 2.2, alcoholism OR = 2.1, diabetes OR = 1.2 and age OR = 1.2; p < 0.05. Summary of results are presented in Table. The average CCI was 1.5 (1.3). Comorbidities were significantly higher among cirrhotic patients. The average annual total cost was € 3,198 (71.5% direct medical costs, 28.5% indirect costs). In the adjusted model were € 2,211 without cirrhosis and 7,641 EUR with cirrhosis; p < 0.001 (Table).
Journal of Hepatology 2016 vol. 64 | S631–S832
POSTER PRESENTATIONS Conclusions: CHC is associated with a high comorbidity, not only in patients with liver cirrhosis but also in those without it, a circumstance that results in greater use of resources and costs for the Spanish National Health System. SAT-118 REASONS FOR DENIAL OF DIRECTLY ACTING ANTIVIRALS (DAA’S) FOR CHRONIC HEPATITIS C IN A UNITED STATES TREATMENT COHORT A.P. Mehta1, O. Oltulana1, S. Gonzalez2, M. Gautam2, A. Mohammad2, M. Silvi2, I. Gonzalez2, A.A. Modi2. 1Plaza Medical Center; 2Liver Consultants of Texas, Fort Worth, United States E-mail: [email protected] Background and Aims: The recent advent of direct acting antivirals (DAAs) has led to revolutionary changes in chronic hepatitis C (HCV) treatment (Tx) with SVR achieved in over 90% for almost all genotypes. Despite these advances, the cost of medications & approval process has posed a hurdle in initiating Tx. To assess overall rate of denial, denial in previous Tx exp pts, reasons for denial based on type of insurance, time from prior authorization request to denial & approval, number of appeals, rate & reason of denial in pts post OLT, & rate of denial in pts with cirrhosis. Methods: This is a retrospective study among HCV pts across all genotypes prescribed a DAA from Nov2014 to Nov2015. The study included 313 pts, which included 27 pts who had received a liver/ kidney transplant. Tx denial was defined as failure to obtain prescribed DAA after submitting prior authorization paperwork to the concerned insurance carrier. Incidence of denial was calculated for the entire cohort. Results: Overall rate of at least one denial was 27% (86/313). Of the denials, 64% were males & 74% had gen 1. 37% (32/86) were previous Tx experienced, which included 13% (11/86) who failed prior DAA therapy. Notably, 32% of pts denied had cirrhosis and 55% (15) of transplanted pts with recurrent HCV were denied. Of pts denied, 30% had Medicaid or Medicare, while the other 70% had commercial insurance. Top reasons for denial did not differ based on type of insurance (commercial vs Medicare/Medicaid). The most common reason for denial included missing information in prior authorization, which included (1) fibrosis score 16% (2) HCV virus quantification level within the previous 30–90 days 10% and (3) urine drug screen in pts with history of IV drug abuse 4% Another reason was non-inclusion of the requested Tx on the Insurance preferred drug list 18% (16/86). The avg number of days from prior authorization request to approval was 11 days (1–94) and the avg number of days from appeal to approval was 13 (range 1–107). The max number of appeals required for final Tx approval was 3 with 20% requiring >1 appeal. 1 pt in the entire cohort was denied Tx despite 2 appeals. Conclusions: 27% pts with chronic hepatitis C were initially denied effective DAA therapy in our Tx cohort. Notably, 1 in 3 pts with cirrhosis were also initially denied therapy. The appeal process involved in eventually getting Tx approved lead to delay in initiating therapy, which can be associated with unfavorable clinical consequences in pts with cirrhosis. SAT-119 HIGH EFFICACY OF LEDIPASVIR/SOFOSBUVIR PLUS RIBAVIRIN AMONG PATIENTS WITH DECOMPENSATED CIRRHOSIS WHO UNDERWENT LIVER TRANSPLANT DURING PARTICIPATION IN THE SOLAR-1 AND -2 STUDIES B. Müllhaupt1, P. Kwo2, K. Agarwal3, C. Duvoux4, F. Durand5, M. PeckRadosavljevic6, E.M. Yoshida7, L. Lilly8, B. Willems9, H. Vargas10, P. Kumar11, R.S. Brown12, Y. Horsmans13, S. De-Oertel14, S. Arterburn15, H. Dvory-Sobol15, D.M. Brainard15, J.G. McHutchison15, N. Terrault16, M. Rizzetto17. 1Department for Gastroenterology and Hepatology, UniversitätsSpital Zürich, Zürich, Switzerland; 2Division of
Gastroenterology and Hepatology, Indiana University School of Medicine, Indiana, United States; 3Institute of Liver Studies, King’s College Hospital Foundation Trust, London, United Kingdom; 4Unite d‘Hepatologie et de Transplantation Hepatique, Centre Hospitalier Universitaire Henri-Mondor, Paris; 5Hepatology Department, Beaujon Hospital, Assistance Publique-Hôpitaux de Paris, Paris VII University, Clichy, France; 6Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria; 7Division of Gastroenterology, Vancouver General Hospital and University of British Columbia, Vancouver; 8Multi-Organ Transplant Program, Toronto General Hospital, University Health Network, Toronto; 9Hospital Saint Luc, Montreal, Canada; 10Division of Gastroenterology and Hepatology, Department of Transplant Hepatology, Mayo Clinic, Phoenix; 11Division of Infectious Diseases, Georgetown University, Washington, DC; 12Division of Digestive and Liver Diseases, Columbia University Medical Center/New York Presbyterian, New York, United States; 13Universite Catholique de Louvain, Brussels, Belgium; 14Gilead Sciences, Inc, Foster City; 15Gilead Sciences, Foster City, CA; 16Division of Gastroenterology and Hepatology, University of California, San Francisco, CA, United States; 17Azienda ospedaliero-universitaria, Torino, Italy E-mail: [email protected] Background and Aims: In untreated HCV-infected patients who undergo liver transplantation, recurrence of HCV infection is universal and is associated with poorer graft and patient survival compared with patients undergoing liver transplantation for other causes. The aim of this analysis is to evaluate outcomes in patients who underwent liver transplant after initiating treatment with ledipasvir (LDV)/sofosbuvir (SOF) + ribavirin (RBV) in the SOLAR-1 and SOLAR-2 trials. Methods: We combined data from the SOLAR-1 and SOLAR-2 studies, in which 7 groups of patients with HCV genotype (GT) 1 or 4, from US, Europe, Canada, Australia and New Zealand, were randomized to receive 12 or 24 weeks of LDV/SOF + RBV: patients without a transplant with 1) Child-Pugh-Turcotte (CPT) B or 2) CPT C cirrhosis; or transplanted patients with 3) no cirrhosis (F0 to F3), 4) CPT A, 5) CPT B or, 6) CPT C cirrhosis, or 7) fibrosing cholestatic hepatitis. Results: Seventeen patients underwent liver transplantation during the study. For all but one patient, this was the first liver transplant. In terms of disease characteristics, 11 of the 17 were GT1a, 5 were GT1b, and 1 was GT4. Six were CPT B at screening (5 Group 1, 1 Group 5) and 11 were CPT C (Group 2). Median baseline MELD score was 17 (range 7–23), with the majority (11/17) having scores ≥15. Seven patients underwent transplant prior to completing their full course of treatment. All patients were HCV RNA < LLOQ at the time of liver transplant. All but one patient (94%, 16/17) maintained virologic response 12 weeks after transplant ( pTVR12). All patients who achieved pTVR12 received at least 11 weeks of LDV/SOF + RBV. The one patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. His baseline MELD score was 16 but the value increased to 40 by Day 11 and was 36 at Day 18. CPT score was 10 at baseline and increased to 13 from Day 11–18. The subject had HCV RNA < LLOQ at post-transplant Week 2 but died 15 days post-transplant due to multi-organ failure and septic shock. Conclusions: Few patients with decompensated cirrhosis treated in the SOLAR studies underwent liver transplantation after initiating LDV/SOF + RBV therapy. For the 17 who did undergo transplant, 94% achieved pTVR12. The data suggest that 11 weeks of treatment prior to transplantation can prevent reinfection of the graft. Future studies are needed to assess the optimal timing and length of treatment in the peri-transplant setting.
Journal of Hepatology 2016 vol. 64 | S631–S832
S749
SAT-117 COMORBIDITIES, RESOURCE UTILIZATION AND HEALTH CARE COSTS OF PATIENTS WITH CHRONIC HEPATITIS C IN A SPANISH POPULATION A. Sicras1, V. Ferrer2, R. Navarro3, M. Saez-Zafra4. 1CAP Vicenç Papaciet, La Roca del Vallés, Barcelona; 2CAP Vicenç Papaciet, La Roca del Vallés; 3 Medical Information, Hospital Germans Trias i Pujol, Badalona, Barcelona; 4GRECS, Girona University, Girona, Spain E-mail: [email protected] Background and Aims: Assess comorbidities, resource utilization and health care costs of patients with chronic hepatitis C (CHC) in a Spanish population. Methods: Observational, retrospective study of chronic hepatitis C patients ≥18 years, registered in the electronic prescriptions database, with a minimum of 12 months of active follow-up (at least two contacts with the healthcare system) in the 2010–2013 period. For each patient, the last 12 months of follow-up were considered. Outcomes of interest were: Charlson comorbidity index (CCI) as a proxy for the severity of the patient, the individual case mix index by bands resource utilization (BUR) resource use and health costs (direct medical costs including planned and emergency visits, hospitalizations, diagnosis testing, and indirect costs- lost productivity valued according to Eurostat and Eurofund). Analyses were performed overall and by presence/absence of cirrhosis. Statistical analysis was done with regression models and ANCOVA, p < 0.05. S748
Results: 1,055 patients with an average age of 57.9 years, 55.5% men were included. The average time from diagnosis to inclusion in the analysis was 18.1 years, and 7.5% died. Cirrhosis was associated with cardiovascular events-odds ratio (OR) = 3.8, organ failure OR = 2.2, alcoholism OR = 2.1, diabetes OR = 1.2 and age OR = 1.2; p < 0.05. Summary of results are presented in Table. The average CCI was 1.5 (1.3). Comorbidities were significantly higher among cirrhotic patients. The average annual total cost was € 3,198 (71.5% direct medical costs, 28.5% indirect costs). In the adjusted model were € 2,211 without cirrhosis and 7,641 EUR with cirrhosis; p < 0.001 (Table).
Journal of Hepatology 2016 vol. 64 | S631–S832
POSTER PRESENTATIONS Conclusions: CHC is associated with a high comorbidity, not only in patients with liver cirrhosis but also in those without it, a circumstance that results in greater use of resources and costs for the Spanish National Health System. SAT-118 REASONS FOR DENIAL OF DIRECTLY ACTING ANTIVIRALS (DAA’S) FOR CHRONIC HEPATITIS C IN A UNITED STATES TREATMENT COHORT A.P. Mehta1, O. Oltulana1, S. Gonzalez2, M. Gautam2, A. Mohammad2, M. Silvi2, I. Gonzalez2, A.A. Modi2. 1Plaza Medical Center; 2Liver Consultants of Texas, Fort Worth, United States E-mail: [email protected] Background and Aims: The recent advent of direct acting antivirals (DAAs) has led to revolutionary changes in chronic hepatitis C (HCV) treatment (Tx) with SVR achieved in over 90% for almost all genotypes. Despite these advances, the cost of medications & approval process has posed a hurdle in initiating Tx. To assess overall rate of denial, denial in previous Tx exp pts, reasons for denial based on type of insurance, time from prior authorization request to denial & approval, number of appeals, rate & reason of denial in pts post OLT, & rate of denial in pts with cirrhosis. Methods: This is a retrospective study among HCV pts across all genotypes prescribed a DAA from Nov2014 to Nov2015. The study included 313 pts, which included 27 pts who had received a liver/ kidney transplant. Tx denial was defined as failure to obtain prescribed DAA after submitting prior authorization paperwork to the concerned insurance carrier. Incidence of denial was calculated for the entire cohort. Results: Overall rate of at least one denial was 27% (86/313). Of the denials, 64% were males & 74% had gen 1. 37% (32/86) were previous Tx experienced, which included 13% (11/86) who failed prior DAA therapy. Notably, 32% of pts denied had cirrhosis and 55% (15) of transplanted pts with recurrent HCV were denied. Of pts denied, 30% had Medicaid or Medicare, while the other 70% had commercial insurance. Top reasons for denial did not differ based on type of insurance (commercial vs Medicare/Medicaid). The most common reason for denial included missing information in prior authorization, which included (1) fibrosis score 16% (2) HCV virus quantification level within the previous 30–90 days 10% and (3) urine drug screen in pts with history of IV drug abuse 4% Another reason was non-inclusion of the requested Tx on the Insurance preferred drug list 18% (16/86). The avg number of days from prior authorization request to approval was 11 days (1–94) and the avg number of days from appeal to approval was 13 (range 1–107). The max number of appeals required for final Tx approval was 3 with 20% requiring >1 appeal. 1 pt in the entire cohort was denied Tx despite 2 appeals. Conclusions: 27% pts with chronic hepatitis C were initially denied effective DAA therapy in our Tx cohort. Notably, 1 in 3 pts with cirrhosis were also initially denied therapy. The appeal process involved in eventually getting Tx approved lead to delay in initiating therapy, which can be associated with unfavorable clinical consequences in pts with cirrhosis. SAT-119 HIGH EFFICACY OF LEDIPASVIR/SOFOSBUVIR PLUS RIBAVIRIN AMONG PATIENTS WITH DECOMPENSATED CIRRHOSIS WHO UNDERWENT LIVER TRANSPLANT DURING PARTICIPATION IN THE SOLAR-1 AND -2 STUDIES B. Müllhaupt1, P. Kwo2, K. Agarwal3, C. Duvoux4, F. Durand5, M. PeckRadosavljevic6, E.M. Yoshida7, L. Lilly8, B. Willems9, H. Vargas10, P. Kumar11, R.S. Brown12, Y. Horsmans13, S. De-Oertel14, S. Arterburn15, H. Dvory-Sobol15, D.M. Brainard15, J.G. McHutchison15, N. Terrault16, M. Rizzetto17. 1Department for Gastroenterology and Hepatology, UniversitätsSpital Zürich, Zürich, Switzerland; 2Division of
Gastroenterology and Hepatology, Indiana University School of Medicine, Indiana, United States; 3Institute of Liver Studies, King’s College Hospital Foundation Trust, London, United Kingdom; 4Unite d‘Hepatologie et de Transplantation Hepatique, Centre Hospitalier Universitaire Henri-Mondor, Paris; 5Hepatology Department, Beaujon Hospital, Assistance Publique-Hôpitaux de Paris, Paris VII University, Clichy, France; 6Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria; 7Division of Gastroenterology, Vancouver General Hospital and University of British Columbia, Vancouver; 8Multi-Organ Transplant Program, Toronto General Hospital, University Health Network, Toronto; 9Hospital Saint Luc, Montreal, Canada; 10Division of Gastroenterology and Hepatology, Department of Transplant Hepatology, Mayo Clinic, Phoenix; 11Division of Infectious Diseases, Georgetown University, Washington, DC; 12Division of Digestive and Liver Diseases, Columbia University Medical Center/New York Presbyterian, New York, United States; 13Universite Catholique de Louvain, Brussels, Belgium; 14Gilead Sciences, Inc, Foster City; 15Gilead Sciences, Foster City, CA; 16Division of Gastroenterology and Hepatology, University of California, San Francisco, CA, United States; 17Azienda ospedaliero-universitaria, Torino, Italy E-mail: [email protected] Background and Aims: In untreated HCV-infected patients who undergo liver transplantation, recurrence of HCV infection is universal and is associated with poorer graft and patient survival compared with patients undergoing liver transplantation for other causes. The aim of this analysis is to evaluate outcomes in patients who underwent liver transplant after initiating treatment with ledipasvir (LDV)/sofosbuvir (SOF) + ribavirin (RBV) in the SOLAR-1 and SOLAR-2 trials. Methods: We combined data from the SOLAR-1 and SOLAR-2 studies, in which 7 groups of patients with HCV genotype (GT) 1 or 4, from US, Europe, Canada, Australia and New Zealand, were randomized to receive 12 or 24 weeks of LDV/SOF + RBV: patients without a transplant with 1) Child-Pugh-Turcotte (CPT) B or 2) CPT C cirrhosis; or transplanted patients with 3) no cirrhosis (F0 to F3), 4) CPT A, 5) CPT B or, 6) CPT C cirrhosis, or 7) fibrosing cholestatic hepatitis. Results: Seventeen patients underwent liver transplantation during the study. For all but one patient, this was the first liver transplant. In terms of disease characteristics, 11 of the 17 were GT1a, 5 were GT1b, and 1 was GT4. Six were CPT B at screening (5 Group 1, 1 Group 5) and 11 were CPT C (Group 2). Median baseline MELD score was 17 (range 7–23), with the majority (11/17) having scores ≥15. Seven patients underwent transplant prior to completing their full course of treatment. All patients were HCV RNA < LLOQ at the time of liver transplant. All but one patient (94%, 16/17) maintained virologic response 12 weeks after transplant ( pTVR12). All patients who achieved pTVR12 received at least 11 weeks of LDV/SOF + RBV. The one patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. His baseline MELD score was 16 but the value increased to 40 by Day 11 and was 36 at Day 18. CPT score was 10 at baseline and increased to 13 from Day 11–18. The subject had HCV RNA < LLOQ at post-transplant Week 2 but died 15 days post-transplant due to multi-organ failure and septic shock. Conclusions: Few patients with decompensated cirrhosis treated in the SOLAR studies underwent liver transplantation after initiating LDV/SOF + RBV therapy. For the 17 who did undergo transplant, 94% achieved pTVR12. The data suggest that 11 weeks of treatment prior to transplantation can prevent reinfection of the graft. Future studies are needed to assess the optimal timing and length of treatment in the peri-transplant setting.
Journal of Hepatology 2016 vol. 64 | S631–S832
S749