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Health Utilities in Patients with Chronic Hepatitis C Treated with Sofosbuvir (SOF) Containing Regimens: Results from POSITRON, FISSON, FUSION and NEUTRINO Studies

Zobair M. Younossi1 , 6, Maria Stepanova1 , 6, Eric Lawitz2, David R. Nelson3, Ira M. Jacobson4, Edward J. Gane5, Fatema Nader1, Sharon L. Hunt1 , 6
1Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA; 2Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX; 3Division of Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, FL; 4Division of Gastroenterology and Hepatology, Weill Medical College of Cornell University, New York, NY; 5New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand; 6Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA

BACKGROUND: Health utilities measure patients' preferences for a health state and are important for economic analyses. AIM: Assess health utilities for SOF-containing regimens. METHODS: SF6D scores (a preference-based index) were derived from the Short Form-36 (SF-36) instrument. SF-36 was administered at baseline, end-of-treatment and post-treatment to IFNineligible, -intolerant, or -unwilling CH-C subjects with G2-3 CH-C subjects receiving either SOF+Ribavirin (RBV) vs. placebo (POSITRON), treatment-naīve G2-3 CH-C subjects receiving 12 weeks of SOF+RBV vs. 24 weeks of PEG-IFN+RBV (FISSION), treatment-experienced G2-3 subjects receiving 12 vs. 16 weeks of SOF+RBV (FUSION) and treatment-naīve G1 CH-C subjects receiving PEG-IFN+RBV+SOF for 12 weeks (NEUTRINO). Clinical-laboratory data were collected. RESULTS: The data was analyzed for 994 patients with CH-C [POSITRON (N=260), FISSION (N=214), FUSION (N = 195) and NEUTRINO (N=325)]. Of those, 16% in POSITRON, 21% in FISSION, 34% in FUSION and 17% in NEUTRINO had established cirrhosis. Baseline SF6D scores for CH-C patients were 0. 66±0. 13 (POSITRON), 0. 71±0. 16 (FISSION), 0. 70±0. 14 (FUSION) and 0. 72±0. 152 (NEUTRINO). After 12 weeks of treatment, patients receiving SOF+RBV (POSITRON) had similar health status to placebo (p>0. 05). Furthermore, patients receiving 12 or 16 weeks of SOF+RBV had similar health status (FUSION). In FISSION, patients receiving SOF+RBV had better utilities as compared to patients receiving PEG-IFN+RBV (0. 69±0. 18 vs. 0. 63±0. 15, p=0. 04). Finally, patients receiving SOF+RBV+PEG-IFN (NEUTRINO) had a major decrease in their utilities after 12 weeks of treatment (0. 62±0. 13, p<0. 0001). This decline was similar to that observed in patients receiving PEG-IFN+RBV in FISSION (from 0. 72±0. 16 to 0. 63±0. 15, p<0. 0001). After 12 weeks of follow-up, patients who achieved SVR (FUSION) had improvement in utilities (+0. 026 increase in SF6D score from the baseline, p=0. 016). In multivariate analyses, baseline depression, anxiety, fatigue, insomnia and treatment-related anemia were the most consistent predictors of health utilities. CONCLUSIONS: This large health utility assessment of patients with CH-C shows that Interferonfree regimens are associated with better health status during treatment than PEG-IFN containing regimens. Patients' health utilities are minimally impacted by SOF+RBV treatment. SVR seems to be associated with improvement of health status. Side effects related to PEG-IFN (anxiety, depression, fatigue, insomnia) and RBV (anemia) predict health utility impairment during treatment. These data can be used to further inform the economic analyses of SOF containing regimens.

Disclosures:

Zobair M. Younossi - Advisory Committees or Review Panels: Merck, Vertex, Īibotec/J and J; Consulting: Gilead Sciences Eric Lawitz - Advisory Committees or Review Panels: AbbVie, Achillion Pharmaceuticals, BioCryst, Biotica, Enanta, Idenix Pharmaceuticals, Janssen, Merck & Co, Novartis, Santaris Pharmaceuticals, Theravance, Vertex Pharmaceuticals; Grant/Research Support: AbbVie, Achillion Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Idenix Pharmaceuticals, Intercept Pharmaceuticals, Janssen, Merck & Co, Novartis, Presidio, Roche, Santaris Pharmaceuticals, Vertex Pharmaceuticals; Speaking and Teaching: Gilead, Kadmon, Merck, Vertex

David R. Nelson - Advisory Committees or Review Panels: Merck; Grant/Research Support: Abbot, BMS, Beohringer Ingelheim, Gilead, Genentech, Merck, Bayer, Idenix, Vertex, Jansen

Ira M. Jacobson - Consulting: Vertex, Abbott, Achillion, Boehringer Ingelheim, Bristol Myers Squibb, Enanta, Gilead, Glaxo Smithkline, Idenix, Kadmon, Novartis, Presidio, Roche / Genentech, Merck, Janssen; Grant/Research Support: Abbott, Achillion, Vertex, Boehringer Ingelheim, Bristol Myers Squibb, Gilead, Novartis, Pfizer, Roche / Genentech, Schering / Merck, Tibotec / Janssen; Speaking and Teaching: Vertex, Bristol Myers Squibb, Gilead, Roche / Genentech, Schering / Merck

Edward J. Gane - Advisory Committees or Review Panels: Roche, AbbVie, Novartis, Tibotec, Gilead Sciences, Janssen Cilag, Vertex, Achillion; Speaking and Teaching: Novartis, Gilead Sciences, Roche

The following people have nothing to disclose: Maria Stepanova, Fatema Nader, Sharon L. Hunt

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A Cost-Minimization Analysis of Ribavirin Dose Reduction versus Erythropoietin Based Anemia Management in Treatment Naϊve Gentoype 1 Chronic Hepatitis C Patients Treated Boceprevir Plus Peginterferon Alfa & Ribavirin

Temitope Olufade1, Scott Devine1, Frank Dutko2, Janice Wahl3, Fred Poordad4
1US Outcomes Research, Merck Sharp & Dohme Corp, Whitehouse Station, NJ; 2Global Scientific and Medical Publications, Merck Sharp & Dohme Corp, Whitehouse Station, NJ; 3Clinical Research- Hepatology Merck Sharp & Dohme Corp, Whitehouse Station, NJ; 4Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX

Background: Anemia is a commonly occurring adverse event associated with treatment for hepatitis C viral (HCV) infections with boceprevir plus peginterferon alfa and ribavirin (BOC+PR). A recent randomized controlled trial (RCT) showed management of anemia with ribavirin dose reductions (RDR) or erythropoietin (EPO) resulted in equivalent sustained virologic response rates. We hypothesized that an anemia management strategy starting with RDR would have lower anemia-related treatment costs. We conducted a cost-minimization analysis (CMA) to compare medication costs between first-line RDR to first-line EPO for HCV- treatment associated anemia. Additionally, we compared the overall HCV related medication costs. Methods: The data source for this study was a RCT of anemia management in HCV genotype 1 patients treated with BOC+PR (Protocol No. P06086). Details on the patient population, study design and primary endpoint results have been published elsewhere. Patients who became anemic (hemoglobin approximately <10 g/dL) during HCV treatment were randomized to RDR (200mg/step) or EPO (40, 000units/week) for the primary management of the anemia. If a patient's anemia worsened after randomization (i. e. hemoglobin <8. 5g/dL), EPO was added in the RDR arm, or RDR was added in the EPO arm. The CMA was conducted from the perspective of a healthcare payer. Wholesale acquisition cost was used to estimate the cost of medication regimens. Patient level medication data (medication dose, total weekly dose, dosing changes) was utilized. Anemia management costs included the increased cost of EPO and the reduced cost of ribavirin from RDR. Patients incurred cost until discontinuation or completion of HCV therapy. Results: 249 patients were in the RDR arm and 251 were in the EPO arm. Total HCV treatment-related anemia management costs were higher among patients randomized to EPO relative to those in the RDR arm ($20, 673. 20 vs. $ 10, 626. 90; p<0. 0001). 18% of patients in the RDR arm added EPO, whereas 37% of patients in the EPO arm received RDR (p <0. 0001). The total HCV-treatment medication costs were higher in EPO arm versus the RDR arm ($80, 174. 50 vs. $70, 844. 00; p=0. 0006). The BOC+PR costs were similar in the EPO and the RDR arms ($69, 116. 00 vs. $68, 718. 70; p=0. 8683). Conclusions: RDR is the recommended treatment for BOC+PR associated anemia. These results indicate that RDR prior to EPO results in anemia management medication related savings of approximately $9, 000/patient. As this approach has equivalent efficacy and lower cost, this cost-minimization analysis supports RDR as the first-line treatment approach for the management of BOC+PR induced anemia.

Disclosures:

Temitope Olufade - Employment: Merck Scott Devine - Employment: Merck

Frank Dutko - Employment: Merck Sharp & Dohme Corp.; Stock Shareholder: Merck Sharp & Dohme Corp.

Janice Wahl - Employment: Merck & Co,

Fred Poordad - Advisory Committees or Review Panels: Abbott, Achillion, BMS, Inhibitex, Boeheringer Ingelheim, Pfizer, Genentech, Idenix, Gilead, Merck, Vertex, Salix, Janssen, Novartis; Grant/Research Support: Abbott, Anadys, Achillion, BMS, Boehringer Ingelheim, Genentech, Idenix, Gilead, Merck, Pharmassett, Vertex, Salix, Tibotec/Janssen, Novartis

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Framework for Determining the Cost-effectiveness of New Antiviral Agents for Hepatitis C

Jagpreet Chhatwal, Kapil B. Chopra, Mark S. Roberts, Michael A. Dunn
University of Pittsburgh, Pittsburgh, PA

Purpose: With multiple new antiviral agents likely to be released in the near future for therapy of hepatitis C virus (HCV) infection, we anticipate intensified complexity of the task of comparing the efficacy, safety and cost of new regimens. Balancing risk-benefit profiles with costs of treatment will be challenging in part because of the perspectives of multiple stakeholders. There is a need for the clinical community to have an objective framework to estimate the cost-effectiveness of multiple HCV therapies. The aim of our study was to develop a flexible framework for cost-effectiveness analysis that can incorporate rapidly emerging information from clinical trials and real-life data. We then demonstrated the framework's potential utility by performing a cost-effectiveness analysis based on newly reported data for sofosbuvir-based therapies. Methods: We extended our previously validated Markov model reported for assessment of telaprevir and boceprevir based regimens to simulate treatment with sofosbuvir-based therapies for genotype 2/3 patients using data from 3 phase 3 studies published through May 2013—P〇SITR〇N, FUSION, and FISSION. We projected a price below which sofosbuvir-based therapies will be cost-effective at willingness-to-pay threshold of $50, 000 per quality-adjusted life-years. For comparison arms, we also modeled no treatment and the EPIC study of genotype 2/3 (g2/3) previous relapsers or non-responders. We modeled the natural history of HCV disease by including METAVIR fibrosis scores (F0-F4), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), liver transplant (LT) and liver-related death (LD). Our model's outcomes were externally validated with published cohort studies using accepted criteria for gains in quality of life. Results: Our model suggested that the sofosbuvir-based treatment is cost-effective for G2/3 untreated patients and patients without treatment options when priced at less than $1, 600 and $7, 200 per week, respectively. The new therapies are projected to reduce the cumulative incidence of DC, HCC and LD by 27-80% in comparison with the currentstandard of care. Conclusions: We propose a flexible decisionanalytic framework to evaluate the cost-effectiveness of new regimens by using rapidly emerging data for new HCV antivirals. Our framework is objective and can be quickly adapted to include new data on adverse effects, efficacy, and treatment durations. We believe that an objective cost effectiveness standard based on validated modeling parameters will add clarity to treatment choices that must be made in a context of rapidly increasing complexity.

Disclosures:

Jagpreet Chhatwal - Consulting: Merck & Co., Inc.; Grant/Research Support: NIH/National Center for Advancing Translational Sciences

The following people have nothing to disclose: Kapil B. Chopra, Mark S. Roberts, Michael A. Dunn

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Trends in Liver-Related Healthcare Resource Utilization for HCV-Infected Individuals in the US: 2002-2010

Kit N. Simpson2, Annie N. Simpson2, Stephanie K. Cline1/ Katherine L. Gooch1
1 Global Health Economics and Outcomes Research, AbbVie Pharmaceuticals, North Chicago, IL; 2Department of Health Leadership and Management, Medical University of South Carolina, Charleston, SC

Background: Increases in healthcare utilization related to liver complications among HCV patients have occurred between 1994 and 2001, particularly among individuals aged 40 to 60 years. Average annual percentage growth rates of total HCV liver-related charges during this period approached 30% and 40% for individuals aged 40-49 and 50-59, respectively. The risk of disease progression, combined with relatively low cure rates over the past decade, has potentially resulted in continued growth of the large HCV-related economic burden, as HCV leads to costly liver disease and other morbidity. The objective of this study was to examine trends in HCV liverrelated healthcare utilization between 2002 and 2010 in the US. Methods: Years 2002-2010 of the National Inpatient Sample (NIS) data set of hospital admissions from the Healthcare Cost and Utilization Project (HCUP) were analyzed in order to determine the number of adult (age 20+ years) liver-related hospital admissions occurring to HCV-infected patients (identified by ICD-9 codes). These data included a total of 71. 7 million hospital admissions from 1, 051 US hospitals. The number of liver-related admissions occurring to HCV-infected patients and non-infected patients was recorded for each year, as well as total hospital days and total charges. Trends over time were compared for each age group. Results: Of the 71 million admissions examined over the study period, there were a total of 0.434, 226 admissions for HCV-infected adult patients with liver-related diagnoses. Patients aged 50-59 demonstrated the largest increases between 2002 and 2010 in the number of liver-related admissions (164%), liver-related hospital days (133%), and liver-related hospital charges (341%). Patients aged 60+ had the second largest increases in liver-related hospital days and charges (89% and 300%, respectively), and patients aged 20-29 had the second largest increase in liverrelated admissions (131%). Liver-related admissions, hospital days and charges did not increase between 2002 and 2010 among patients who were not infected by HCV. Conclusions: These results suggest that HCV-infected individuals aged 50-59 continue to account for the largest increases in liver-related hospital admissions and costs. However, in contrast to previous research, in these analyses, individuals aged 60+ had the second highest increase in liver-related costs, which may be reflective of an aging HCV cohort.

Disclosures:

Annie N. Simpson - Grant/Research Support: AbVie

Stephanie K. Cline - Employment: AbbVie Pharmaceuticals; Stock Shareholder: AbbVie Pharmaceuticals

Katherine L. Gooch - Employment: Abbvie

The following people have nothing to disclose: Kit N. Simpson

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A Decision Analytic Markov Model to Evaluate the Health Outcomes of Sofosbuvir for Previously Untreated Patients with Chronic Hepatitis C Virus Genotype 1 Infection

Zobair M. Younossi1, Stuart C. Gordon2, Sammy Saab3, Aijaz Ahmed4, Anita Brogan5, Sandrine Cure6
]Center for Liver Disease, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA; 2Henry Ford Hospital, Detroit, MI; 3UCLA, Los Angeles, CA; 4Stanford University Medical Center, Stanford, CA; 5RTI Health Solutions, Research Triangle Park, NC; 6OptumInsight, Uxbridge, United Kingdom

BACKGROUND & AIM: Sofosbuvir (SOF) is a nucleotide polymerase inhibitor with excellent clinical efficacy in previously untreated patients with chronic hepatitis C virus (HCV) genotype 1 in combination with pegylated interferon alfa and ribavirin (PR) for 12 weeks. A decision-analytic Markov model evaluated the health outcomes of SOF compared with current treatment options. METHODS: The analysis modeled a cohort of treatment-naīve chronic HCV genotype 1 patients with an average age of 52 and 17% with cirrhosis to 100 years of age from a US third-party payer perspective. SOF+PR was compared with telaprevir (TLV)+PR for 24-48 weeks, boceprevir (B〇C)+PR for 28-48 weeks, and PR for 48 weeks. Sustained virologic response (SVR) and adverse event rates were based on phase III clinical trials (SVR = 92% and 80% for SOF+PR, 82% and 66% for TLV+PR, 64% and 55% for BOC+PR, and 58% and 33% for PR in non-cirrhotics and cirrhotics, respectively). Transition probability and utility were based on a literature review and consensus by a panel of 4 hepatologists. RESULTS: The SOF+PR regimen resulted in the best outcomes compared with TLV+PR, BOC+PR, and PR, with the lowest numbers of patients with liver-related complications. In addition, analysis of the number needed to treat (NNT), which is the number of patients who would need to be treated with SOF+PR rather than the comparator to achieve one positive outcome or avoid one negative outcome, also indicated favorable outcomes with SOF+PR. CONCLUSIONS: The SOF-based regimen was projected to yield better health outcomes. Large discrepancies in efficacy, side effect, and adherence rates have been reported for currently available regimens in the real-world vs. clinical trial settings. Additional analyses are necessary to determine the potential impact of the greater expected realworld differences between the SOF-based regimen and other therapies.

Health Outcomes (for cohort of 10, 000)SOF+PRTLV+PRBOC+PRPR
  1. DCC=decompensafed cirrhosis; HCC=hepafocellular carcinoma; QALY=quality-adjusfed life year

New cases of compensated cirrhosis480106721402480
Cases of HCC179350598763
Cases of DCC32864110981376
Number of liver transplants16325468
Number of HCV-related deaths43584814511821
QALYs per patient15. 415. 114. 614. 3
NNT (SOF+PR vs Comparator)SOF+PRTLV+PRBOC+PRPR
NNT to achieve an additional successfully treated patient 1043
NNT to avoid a new case of compensated cirrhosis 1875
NNT to avoid a case of DCC 321310
NNT to avoid a case of HCC 592418
NNT to avoid a liver transplant 647264194
NNT to prevent an HCV-related death 25108

Disclosures:

Zobair M. Younossi - Advisory Committees or Review Panels: Merck, Vertex, Īibotec/J and J; Consulting: Gilead Sciences

Stuart C. Gordon - Advisory Committees or Review Panels: Īibotec; Consulting: Merck, CVS Caremark, Gilead Sciences, BMS; Grant/Research Support: Roche/Genentech, Merck, Vertex Pharmaceuticals, Gilead Sciences, BMS, Abbott, Intercept Pharmaceuticals, Exalenz Sciences, Inc.

Sammy Saab - Advisory Committees or Review Panels: BMS, Gilead, Merck, Vertex, Genentech; Grant/Research Support: Merck, Gilead; Speaking and Teaching: BMS, Gilead, Merck, Vertex, Genentech, Salix, Onyx, Bayer, Kadman; Stock Shareholder: Salix, Johnson and Johnson

Aijaz Ahmed - Advisory Committees or Review Panels: Salix Pharmaceuticals, Schering-Plough, Vertex Pharmaceuticals, Three Rivers Pharmaceuticals; Consulting: Bristol-Myers Squibb, Gilead Sciences Inc., Hoffman-LaRoche; Grant/Research Support: Gilead Sciences Inc., Romark Laboratories

Anita Brogan - Consulting: Gilead Sciences; Employment: RĪI Health Solutions

Sandrine Cure - Consulting: Gilead Sciences

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Evaluation of the Long-Term Health Outcomes Associated with Earlier Versus Later Initiation of Treatment in Previously Untreated Patients with Chronic Hepatitis C Virus Genotype 1 Infection

Zobair M. Younossi1, Sammy Saab2, Stuart C. Gordon3, Aijaz Ahmed4, Anita Brogan5, Ines Guerra6
1 Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA; 2UCLA, Los Angeles, CA; 3Henry Ford Hospital, Detroit, MI; 4Stanford University Medical Center, Stanford, CA; 5RTI Health Solutions, Research Triangle Park, NC; OptumInsight, Uxbridge, United Kingdom

BACKGROUND & AIM: To address the ongoing debate on the downstream costs and sequelae associated with waiting to treat chronically infected hepatitis C virus (HCV) patients, a decision-analytic Markov model assessed the long-term health outcomes associated with treating patients in the non-cirrhotic stage and in the cirrhotic stage. METHODS: The analysis modeled two cohorts of treatment-naīve chronic HCV genotype 1 patients with a mean age of 52 from a US third-party payer perspective for a lifetime horizon: one cohort initiating treatment in the non-cirrhotic stage, and the other starting treatment in the cirrhotic stage. The model included the following regimens: sofosbuvir (SOF) in combination with pegylated interferon plus ribavirin (PR) for 12 weeks, telaprevir (TLV) plus PR for 24-48 weeks, boceprevir (BOC) plus PR for 28-48 weeks, and PR for 48 weeks. Sustained virologic response (SVR) and adverse event rates were based on published data (SVR = 92% vs. 80% for SOF+PR, 82% vs. 66% for TLV+PR, 64% vs. 55% for BOC+PR, and 58% vs. 33% for PR in patients without and with cirrhosis, respectively). Transition probability, utility, and cost estimates (in 2013 US dollars) were based on a literature review, public sources, and consensus by a panel of 4 hepatologists. RESULTS: Cases of liver disease complications were more than triple in the cohort of patients with cirrhosis than in the cohort without cirrhosis. Among the 4 regimens, SOF+PR had the most favorable health outcomes. CONCLUSIONS: This study projects that the watchful waiting approach to the treatment of HCV genotype 1 could lead to substantially more cases of advanced liver disease. Earlier treatment with more effective therapies like sofosbuvir could curb future liver disease and the downstream costs associated with advancing disease.

Health Outcomes for Cohorts of 10, 000SOF+PRTLV+PRBOC+PRPR
  1. DCC=decompensated cirrhosis; HCC=hepatocellular carcinoma

Cases of HCC
-With Cirrhosis51987611561771
-W/out Cirrhosis109241483553
Cases of DCC
-With Cirrhosis950160321143101
-W/out Cirrhosis2004438871016
Number of Liver Transplants
-With Cirrhosis4983109160
-W/out Cirrhosis10214349
Number of HCV-Related Deaths
-With Cirrhosis1284217128744235
-W/out Cirrhosis26157711591327

Disclosures:

Zobair M. Younossi - Advisory Committees or Review Panels: Merck, Vertex, Īibotec/J and J; Consulting: Gilead Sciences

Sammy Saab - Advisory Committees or Review Panels: BMS, Gilead, Merck, Vertex, Genentech; Grant/Research Support: Merck, Gilead; Speaking and Teaching: BMS, Gilead, Merck, Vertex, Genentech, Salix, Onyx, Bayer, Kadman; Stock Shareholder: Salix, Johnson and Johnson

Stuart C. Gordon - Advisory Committees or Review Panels: Īibotec; Consulting: Merck, CVS Caremark, Gilead Sciences, BMS; Grant/Research Support: Roche/Genentech, Merck, Vertex Pharmaceuticals, Gilead Sciences, BMS, Abbott, Intercept Pharmaceuticals, Exalenz Sciences, Inc.

Aijaz Ahmed - Advisory Committees or Review Panels: Salix Pharmaceuticals, Schering-Plough, Vertex Pharmaceuticals, Three Rivers Pharmaceuticals; Consulting: Bristol-Myers Squibb, Gilead Sciences Inc., Hoffman-LaRoche; Grant/Research Support: Gilead Sciences Inc., Romark Laboratories

Anita Brogan - Consulting: Gilead Sciences; Employment: RĪI Health Solutions

Ines Guerra - Consulting: Gilead Sciences

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Comparing the Cost of Screening for Hepatocellular Carcinoma in Persons with Chronic Hepatitis B Virus Infection by Ultrasound Alone Versus a Two-Step Approach Using Alpha-Fetoprotein Followed by Ultrasound

Prabhu Gounder1, Lisa Bulkow1, Michael Bruce1, Thomas W. Hennessy1, Mary Snowball3, Philip R. Spradling2, Brian J. McMahon3
1Arctic Investigations Program Office, Centers for Disease Control and Prevention, Anchorage, AK; 2Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA; 3Liver Disease and Hepatitis Program, Alaska Native Tribal Health Consortium, Anchorage, AK

BACKGROUND: The American Association for the Study of Liver Diseases guidelines recommend hepatocellular carcinoma (HCC) surveillance by using ultrasound (US) for males >40 years and females >50 years with chronic hepatitis B (CHB). Since 1982, the Alaska Native health system has screened persons with CHB by serum alpha-fetoprotein (AFP) every 6 months; persons with AFP >10 ng/mL received US (AFP[RIGHTWARDS ARROW]US).We used data from this cohort to compare the estimated cost of HCC screening per year of life gained using 2 approaches: US alone every 6 months versus AFP[RIGHTWARDS ARROW]US. METHODS: We calculated the number of AFP measurements (i. e., screening opportunities) and person-years of follow-up for persons with CHB who met age criteria from 1983-2012. Persons were censored at the time of death or HCC diagnosis. We considered tumors detectable by screening if an AFP was documented <2 years prior to diagnosis. We calculated median survival among persons with HCC by 3 tumor size categories: <3 cm, 3-6 cm, and >6 cm. We assumed US alone would have identified tumors at <3 cm (unless persons refused US or a normal US result was documented at time of HCC diagnosis). Tumors >6cm, of undocumented size, or >1 tumor at diagnosis were considered untreatable and, therefore, missed by AFP[RIGHTWARDS ARROW]US. In calculating median years of life gained, we assumed persons with tumors >6 cm represented survival in the absence of screening; the additional years of survival in persons with tumors <3 cm and 3-6 cm were attributed to screening. We summed the additional median years of survival resulting from screening and applied a 3% discount rate at median survival for tumors <3 cm to determine the total years of life gained. We calculated costs by using 2012 Medicare reimbursement rates for AFP and US. RESULTS: We followed 839 persons for 10, 405 person-years (median: 11 years/person) and performed 10, 931 AFP measurements (median: 11/person). Among 21 persons with HCC, 16 were detectable by screening; 12 would have been detected only by US alone and 6 by AFP^US or US. Surveillance by US alone would have resulted in 78 years of life gained compared with 33 years of life gained by AFP[RIGHTWARDS ARROW]US. US alone would have cost $1. 2 million ($15, 300/year of life gained), and AFP[RIGHTWARDS ARROW]US would have cost $422, 000 ($12, 700/year of life gained). CONCLUSIONS: Among Alaska Native people with CHB, HCC surveillance by US alone might detect more tumors at a treatable stage but can be approximately 3-times the cost of AFP[RIGHTWARDS ARROW]US. The cost/year of life gained by AFP[RIGHTWARDS ARROW]US was comparable with US alone. AFP[RIGHTWARDS ARROW]US should be considered as an alternative in areas with limited access to US, such as rural Alaska.

Disclosures:

The following people have nothing to disclose: Prabhu Gounder, Lisa Bulkow, Michael Bruce, Thomas W. Hennessy, Mary Snowball, Philip R. Spradling, Brian J. McMahon

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Resource Utilization During Antiviral Therapy for Chronic Hepatitis C In A Large Health Maintenance Organization

Lisa Nyberg1, Kevin Chiang2, Yi-Lin Wu2, Anders H. Nyberg1, Zobair M. Younossi3, T Craig Cheetham2
1 Hepatology Research, Kaiser Permanente, San Diego, CA; 2Pharmacy Analytical Service, Kaiser Permanente, Downey, CA; 3Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Chuch, VA

Antiviral therapy for chronic hepatitis C (HCV) results in substantial, yet unclear, health care (HC) utilization. Objective: To determine resource utilization within a large health care system before and during HCV treatment with pegylated interferon and ribavirin (dual) and with either boceprevir or telaprevir with pegylated interferon and ribavirin (triple). Methods: A retrospective cohort study using data from Kaiser Permanente Southern California. Study participants were >18 years old with a diagnosis code and/or a positive lab result for HCV RNA and >6 months continuous membership plus drug benefit prior to HCV treatment. HC utilization was determined using an electronic algorithm tabulating email and telephone encounters, hospitalizations, emergency department (ED) and office visits, labs, and all new prescriptions. We determined HC utilization during treatment, during the 6-month period prior to treatment and compared HC utilization before and during dual vs triple therapy. Results: From 1/02 through 12/12, 44, 442 HCV patients were identified. After applying inclusion criteria, 6, 93 1 treatment courses were identified in 6, 481 patients. 6, 519 treatment courses were dual and 409 were triple therapy (174 boceprevir/235 telaprevir). 5, 810 dual and 269 triple treatment courses were in treatment-naive patients. Baseline demographics were similar in the two groups. Pre-treatment utilization (−180 to −1 day prior to treatment) expressed as ED visits and prescriptions was similar in dual vs triple (0. 18±0. 58 vs 0. 18±0. 53, respectively). There was a significant increase in pre-treatment outpatient visits for triple therapy vs dual (9. 01 ±5. 56 vs 6. 78±5. 37, p=<0. 001). Triple therapy was associated with significantly greater HC utilization than dual therapy for treatment days 0-89 (Table 1). Conclusions: The treatment of HCV requires substantial HC resource utilization with significantly increased utilization when treating with triple vs dual therapy. Future treatment may require less HC resources due to increased potency, expected shorter treatment duration and better side effect profiles.

Table 1. Average Visits Per Patient±SD

DualTriplep-value
  1. ★Significant increases in telephone and email encounters in triple vs. dual; however, relatively recent increased use of electronic medical records makes data difficult to interpret.

ED0. 1310. 440. 2±0. 550. 006
Outpatient4. 37±3. 746. 24±4. 04<0. 001
Pharmacy11. 18±5. 6214. 6±5. 78<0. 001
Lab108. 91171. 81145. 57±81. 18<0. 001
Phone0. 33±1. 121. 17±1. 91<0. 001*
Email0. 08±0. 560. 83±1. 85<0. 001*

Disclosures:

Lisa Nyberg - Grant/Research Support: Merck, Vertex, Gilead, Abbvie, Bristol Myers Squibb

Zobair M. Younossi - Advisory Committees or Review Panels: Merck, Vertex, Īibotec/J and J; Consulting: Gilead Sciences

T Craig Cheetham - Grant/Research Support: Gilead, BMS

The following people have nothing to disclose: Kevin Chiang, Yi-Lin Wu, Anders H.Nyberg

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Operating Room (OR) Efficiency Improves Economic Performance

Richard Gilroy, Elizabeth A. Charlton, James Kindscher, Winston Dunn, Tracy Giacoma, Sean Kumer, Timothy Schmitt
University of Kansas Medical Center, Kansas City, KS

BACKGROUND: With healthcare reform comes the need to address budget shortfalls by improving efficiency. To date few studies have looked specifically at clinical efficiency and how this impacts resource utilization and charges. Here we analyze OR activities for their impact upon resource utilization and charges generated, a surrogate marker of cost. METHODS: A chart review of 155 consecutive patients who underwent liver transplantation between 2011 & 2012 was undertaken. 6 different primary surgeons were compared. The piggyback surgical technique was used in over 80% of cases with no difference in technique by surgeon. Outcomes evaluated were OR charges (time & supplies), anesthesia charges and time, blood product utilization, ICU and hospital length of stay (LOS) and total admission and readmission charges. ANOVA was used to compare the individual surgeons; comparisons were controlled for donor risk index (DRI), re-transplants, combined transplant and MELD score. RESULTS: The population had an average age of 55, average MELD (INR, BR, Cr) of 20 and 64% were male with no differences between surgeons. 145 of the 155 patients are alive and actuarial survival at 1 year was 92%. The average LOS was 11 days with 36% readmitted within 30 days. Average surgical time was 4. 24 hours with a significant difference between fastest and slowest surgeon (p=0. 0001). After adjustment for DRI, death, re-transplants, and MELD, the variation in surgeon accounts for 50% of the total surgery charges (p=0. 0001). Of note, when the most and least efficient surgeons are compared, we identify a difference in OR charges of $17, 133. 64 and a 3 hour difference in OR time and anesthesiology time (p=0. 0001) (table 1). However, overall total charges, blood utilization and LOS did not reach significance. No difference in mortality or retransplant rate was noted. A primary surgeon derived from a high volume, high performing program by SRTR outcomes appeared most efficient. CONCLUSIONS: A surgeon's individual efficiency significantly impacts charges in the OR, lowers resource utilization, and improves economic performance. In an era of healthcare reform and increasing oversight, irrespective of centers academic priorities, efficient surgical performance will become more important during difficult economic times. Deserving future review is whether the caliber of a surgeon's fellowship program, derived from SRTR outcome data and clinical volumes, predicts future OR performance.

Table 1

Average Surgical Time (Hr.)2: 483: 194: 085: 065: 215: 47
Average OR Charges ($)19, 757. 2521, 716. 6827, 295. 3331, 821. 9335, 004. 1536, 890. 89
Average Anesthesia Charges ($)5, 634. 006, 293. 006, 302. 006, 905. 006, 941. 007, 003. 00
Average Blood Utilization Charges ($)1, 200. 841, 275. 971, 950. 261, 317. 191, 701. 272, 158. 67

Disclosures:

Richard Gilroy - Advisory Committees or Review Panels: FDA GIDAC; Speaking and Teaching: Salix, Vertex, Gilead

The following people have nothing to disclose: Elizabeth A. Charlton, James Kindscher, Winston Dunn, Tracy Giacoma, Sean Kumer, Timothy Schmitt

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Age-Comorbidity Index and Resource Utilization in Liver Transplantation

Nyingi Kemmer, Guy W. Neff, Elizabeth Cece Fallon, Erin Parkinson, Angel Alsina
Tampa General Medical Group, Tampa, FL

Several studies have shown that comorbidity is an independent predictor of surgical mortality and morbidity, and this contributes substantially to resource utilization. The burden of comorbid illness on liver transplant (LT) outcomes in the perioperative period independent of MELD or CTP class is unclear. Therefore the aim of this study is to determine the impact of comorbid illness on resource utilization in LT. Method: Using our LT database, we identified all patients who received LT (Jan 2012 - Dec 2012). The data collected included demographics, comorbidities, laboratory data including MELD score and surrogate marker of resource utilization (i. e. length of hospital stay). Comorbidity burden was measured using the modified Charlson-Age Comorbidity Index (CACI) which includes nine comorbidities (CHF, coronary artery disease, DM, COPD, cerebrovascular disease, peripheral vascular disease, connective tissue disease, renal insufficiency and malignancy with exclusion of HCC) and Age categorized into 4 groups (< 40yrs, 40 一 49 yrs, 50 一 69 yrs and > 70 yrs). Each comorbidity and age was assigned a weighted score. A p-value < 0. 05 was considered to be statistically significant. Results: The study population (n=94) was predominantly white, male (78%) and HCV was the most common diagnosis. The median age of our study cohort was 46 (range 28 一 70 years) with median MELD of 20. In our study cohort, 60(63%) had at least one comorbid condition. The median length of stay (LOS) was 9 days (range 5 - 34 days) and mean CACI score was 2. The CACI score was categorized into 3 groups (0, 1-3 and 4 - 6). In our study population, 8% had a CACI score of 0, CACI score 1 一 3 (59%) and CACI score 4 一 6 (33%). No patient had a CACI greater than 6. There was a significant correlation between CACI and LOS. The higher the CACI score the longer the LOS. Candidates with CACI score of 0, 1-3 and 4-6 had LOS of 7. 3 days, 10. 4 days and 12. 5 days respectively (Figure 2). Thus CACI correlates with LOS, which is a surrogate marker for resource utilization and healthcare costs. Conclusion: Pre-transplant comorbidities in ESLD is an independent predictor of LOS post LT. Thus comorbid burden significantly impacts resource utilization. CacI is a useful tool that can be utilized by public health policy makers and transplant programs in evaluating and assessing current healthcare reimbursement schemes. Our study identifies a simple, reproducible and readily available tool (CACI) that can be incorporated in patient selection criteria for liver transplantation with the goal of decreasing morbidity and optimizing patient outcome.

Disclosures:

Guy W. Neff - Consulting: Genentech, Vertex, Salix; Speaking and Teaching: Genentech, Vertex, Salix, BMS, Merck

Erin Parkinson - Advisory Committees or Review Panels: Gilead; Speaking and Teaching: Merck

Angel Alsina - Advisory Committees or Review Panels: Bayer; Grant/Research Support: Novartis; Speaking and Teaching: Bayer, Novartis

The following people have nothing to disclose: Nyingi Kemmer, Elizabeth Cece Fallon

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Hospital Costs, Length of Stay, and Readmission Rates in a Cohort of Cirrhotic Patients Discharged with Hepatic Encephalopathy

Guy W. Neff1, Andrew C. Barrett2, Camelia M. Graham3, Julie Gayle3, Frank R. Ernst3
1 Tampa General Medical Group, Tampa, FL; 2Salix Pharmaceuticals, Inc, Raleigh, NC; 3Premier Healthcare Alliance, Charlotte, NC

Cirrhosis leads to over 150, 000 hospitalizations annually, totaling almost $4 billion dollars in cost. Hepatic encephalopathy (HE) is a common neuropsychiatric complication of cirrhosis that contributes significantly to these healthcare costs. With increased attention to value-based purchasing models, it is important to understand the impact of cirrhosis-related complications on overall healthcare costs. Purpose: To assess patient demographics, length of hospital stay, hospital readmissions, and healthcare costs in HE patients discharged from the hospital. Methods: Adult inpatients (n=8, 766) discharged from June 2010 through December 2011 with a primary diagnosis of HE (ICD-9 code 572. 2) were selected from the Premier research database. The Premier database contains clinical and financial information from >500 US hospitals, including patient demographics and disease state, and billed services from de-identified patient-level daily service records. Descriptive analyses of patient demographics, comorbid conditions, and pertinent outcomes such as hospital length of stay, total hospital costs, and readmissions (all cause and HE-related) were calculated. Results: The mean (SD) age of discharged patients with HE was (11. 6) years and 58. 4% were male. The most frequent comorbid complications were anemia (52. 6%), ascites (33. 0%), acute kidney injury/hepatorenal syndrome (24. 2%), and thrombocytopenia/coagulation (23. 9%). The most common primary payors were Medicare (48. 8% of discharges) and Medicaid (1 8. 8%). More than 30% of patients were discharged to a facility (e. g., skilled nursing facility, hospice, shortterm hospital, rehabilitation facility) rather than to their home; 7. 3% expired during the hospital stay. The most common specialty of the attending physician was internal medicine (45. 2% of discharges), followed by hospitalist (28. 0%) and family practice (12. 6%). Mean (SD) length of hospital stay was 5. 8 (6. 1) days, with a mean (SD) of 0. 9 (2. 7) days in intensive care. Mean (SD) cost per hospitalization was $10, 629 ($14, 234). Room and board accounted for approximately 52% of overall hospitalization costs (mean $5, 518 [$7, 688]), and pharmacy costs accounted for 11. 5% of overall hospitalization costs ($1, 223 [$2, 857]). Incidence rates for 30-day all-cause and HE-related readmissions were 27. 4% and 17. 6%, respectively. At one year, the incidence rates of such readmissions were 56. 4% and 39. 5%, respectively. Conclusions: HE is a serious complication of cirrhosis that portends poor outcomes and is associated with a high rate of costly hospital readmissions. These findings provide a framework for evaluating optimal treatment strategies in HE.

Disclosures:

Guy W. Neff - Consulting: Genentech, Vertex, Salix; Speaking and Teaching: Genentech, Vertex, Salix, BMS, Merck

Andrew C. Barrett - Employment: Salix; Stock Shareholder: Salix

Frank R. Ernst - Employment: Premier, which contracted withthe study sponsor to conduct the study

The following people have nothing to disclose: Camelia M. Graham, Julie Gayle

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A Review and Summary Analysis of Major Studies of the Cost-effectiveness Birth Cohort Testing for Hepatitis C in United States

David B. Rein
NORC at the University of Chicago, Atlanta, GA

We reviewed and analyzed all cost-effectiveness studies of CDC's 2012 recommendation for a one-time antibody test for hepatitis C virus of all US residents born during 1945 to 1965 published since 2011. From each study, we recorded parameter values of interest, and costs and quality adjusted life years (QALYs) per person. From each study, we evaluated the strategy with the nearest equivalence to the CDC's birth cohort recommendation. We used bootstrapping with replacement to generate 1, 000 replicate observations of the average mean cost and QALY per person observed across all studies, and used these to summarize the distribution of incremental net benefits (INB) and incremental cost effectiveness ratios. Our results identified six studies which contained nine scenarios that were relevant to the question of birth-cohort testing. There was wide agreement across the models regarding the structure and the parameters that governed the natural history of hepatitis C disease. Important parameter value differences included the population size, the proportion tested in the comparator and intervention, the proportion of identified cases that initiated treatment, the type of treatment, the effectiveness and cost of treatment, and the medical cost of detected but untreated patients. Mean costs were $213 per person (95% Cr. I.; $147 - $282) and mean QALYs were 0. 005 (95% Cr. I.;. 004 -. 006), yielding an ICER based on these means of $39, 933. At a willingness to pay of $50, 000 per QALY, 93. 3% of the replicate samples exhibited a positive INB. The annual cost of medical care for diagnosed but untreated patients, and utility losses from early stages of disease were the two most important areas of unresolved uncertainty regarding the decision. All studies found birth cohort testing to be cost-effective at a willingness to pay at or below $65, 000 per QALY.

Figure 1. Per Person Costs and QALYs From 9 Scenarios Identified Across 6 Studies (Letters refer to Study Identifiers, PR indicates Pegylated Interferon Treatment with Ribavirin, DAA indicates treatment with direct acting antivirals in additionto PR).

Disclosures:

The following people have nothing to disclose: David B. Rein

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Health Insurance Literacy in Liver Transplant Candidates

M. Katherine Dokus, Mary Salter, Nancy Metzler, Randeep Kashyap, Mark S. Orloff, Patricia M. Milof
Solid Organ Īransplant, University of Rochester Medical Center, Rochester, NY

Background: Though liver transplant patients have frequent contact with the health care system, little is known about their understanding of health insurance. An adequate level of health insurance literacy is vital for patients to weigh potential health and financial outcomes of various insurance plans. Methods: With IRB approval, 100 subjects were recruited from our pretransplant clinic. Patients had been formally evaluated by the transplant team including a financial assessment. All were asked to fill out a survey developed for this study; questions included general insurance concepts and knowledge of personal insurance coverage. The Short Test of Functional Health Literacy in Adults (STOFHLA) was administered to assess health literacy and numeracy. Results: 55% of the subjects are male with a mean age of 56 (19-72 yrs). The majority of the study population is Caucasian (88%); half of subjects had a 12th grade education or less. The mean MELD score was 16 (6-31); 51. 2% were listed for transplant. The primary insurance of 51. 2% was private, Medicare and Medicaid comprised 23. 8 & 21. 4%, respectively. The mean STOFHLA score in our population is 32. 9 of 36 possible points (15-36), only 5% had marginal or inadequate health literacy (≤ 23). No correlation was found between STOFHLA and the patent's questionnaire accuracy. Patients with Medicaid as primary insurance had the highest score on the survey (69. 1%) vs. 59. 3% private and 59% Medicare; though not significantly so. Conclusions: Liver transplant candidates at our center have an adequate level of health literacy and numeracy. Despite this, there is poor understanding of the extent of their insurance coverage. We plan to develop an intervention to engage our patients in optimizing their health insurance and prescription coverage to facilitate bringing patients to transplantation and maintaining the health of their transplanted organ.

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Disclosures:

The following people have nothing to disclose: M. Katherine Dokus, Mary Salter, Nancy Metzler, Randeep Kashyap, Mark S. Orloff, Patricia M. Milot

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Cost-Effectiveness Of Image-Based Screening Methods For Hepatocellular Carcinoma In Cirrhotic Patients: A Systematic Review

Zhengping Xiong1, Wendong Chen2, Fang Huang3, Morris Sherman4
1Interventional Radiology, Hunan Provincial Tumor Hospital, Central South University, Changsha, China; 2Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada; 3Infectious Diseases, The Third Xiangya Hospital, Central South University, Changsha, China; 4Gastroenterology, Toronto General Hospital, Toronto, ON, Canada

Purpose: To conduct a systematic review on the cost-effectiveness of image-based screening methods for HCC in cirrhotic patients. Methods: Main medical databases were searched to identify any published studies assessing the cost-effectiveness of image-based screening methods for HCC in cirrhotic patients. The qualified studies were reviewed for data extraction on screening methods, characteristics of screening population, model structure, model variables, and results of cost-effectiveness analysis. Single arm meta-analysis was performed on probability and utility variables to demonstrate uncertainty associated with model variables. The reported incremental costeffectiveness ratios (ICER) per gained life year and quality adjusted life year (QALY) associated with screening methods were adjusted to current value and presented in ratio to 2012 gross domestic product (GDP) per capita in the country the costeffectiveness analysis was based on. Univariate linear regression analysis taking ICER per gained QALY as dependent variable was performed to explore the main factors affecting cost-effectiveness of image-based screening methods for HCC. Results: 12 studies were identified to assess the cost-effectiveness of screening cirrhotic patients for HCC using ultrasound (US), alpha-fetoprotein (AFP), contrast-enhanced ultrasound (CEUS), computed tomography (CT), or magnetic resonance imaging (MRI) with screening frequency of 3 to 12 months in 8 countries. Significant uncertainty were identified for the specificity and sensitivity of CEUS for small HCC detection (< 3 cm) and the annual transition probability of HCC from small to large size after transarterial embolization treatment. Base case ICER per gained life year associated with US per 6 months (0. 16 GDP per capita), CEUS per 6 months (0. 17 GDP per capita), US plus AFP per year (0. 54 GDP per capita), CT plus AFP per 6 months (0. 60 GDP per capita), US plus AFP per 6 months (0. 63 GDP per capital) were very cost-effective when compared to no screening. Univariate linear regression analysis indicated that the cost-effectiveness of HCC screening was significantly associated with screening frequency of 6 months (coefficient 1. 919, p=0. 002). HCC recurrence had the strongest association with the cost-effectiveness of HCC screening but it was not statistically significant (coefficient 41. 899, p=0. 357). Conclusion: Applying US every 6 months to cirrhotic patients for HCC screening is the most cost-effective strategy according to current economic evidence. Preventing HCC recurrence could substantially improve the cost-effectiveness of image methods based screening for HCC in cirrhotic patients.

Disclosures:

Morris Sherman - Consulting: Gilead, Merck, Bayer, Arqule, Celsion, Boehringer Ingelheim, Janssen, Abbvie

The following people have nothing to disclose: Zhengping Xiong, Wendong Chen, Fang Huang