Blackburn, S.

Humphrey, L.

Machouf, N.

McCool, R.

Mitchell, L.

Panter, C.

Peterson, S.

Scott, J.

Young, V.

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CE4 Interviews With Patients With Chronic Hepatitis C (CHC) Virus Infection Document Unmet Needs, Content Validity, And Comprehension Of Pros For Clinical Trials 

A6 V A L U E  I N  H E A L T H  1 6  ( 2 0 1 3 )  A 1 - A 2 9 8  
  
 
PODIUM SESSION II:  
INFECTIOUS DISEASE OUTCOMES RESEARCH STUDIES  
 
IN1  
INTERVIEWS WITH PATIENTS WITH CHRONIC HEPATITIS C (CHC) VIRUS 
INFECTION DOCUMENT UNMET NEEDS, CONTENT VALIDITY, AND 
COMPREHENSION OF PROS FOR CLINICAL TRIALS  
Blackburn S1, McCool R1, Panter C1, Young V1, Peterson S2, Mitchell L2, Machouf N3,  
Scott J4, Humphrey L1 
1Adelphi Values, Manchester, UK, 2Janssen Cilag, Canada, Toronto, ON, Canada, 3L’Actuel Clinic, 
Montreal, QC, Canada, 4Janssen Global Services, High Wycombe, UK  
OBJECTIVES: Recent advances in treatment for chronic hepatitis C (CHC) virus 
infection have shortened duration of treatment and increased the likelihood of 
treatment success. To understand what unmet needs remain with available CHC 
treatments, patient interviews explored what it is like to live with CHC infection 
and undergo CHC treatment. A subset of interviews also evaluated the content 
validity and comprehension of patient-reported outcome (PRO) questionnaires 
for use in CHC clinical trials. METHODS: Sixty-five patients with clinician-
confirmed diagnosis of CHC infection provided informed consent and completed 
interviews in Germany (n=15), France (n=15), the USA (n=16), and Canada (n=19). 
Targeted sampling enrolled a demographically and clinically diverse sample. 
Concept elicitation (CE) interviews (n=58) using in-depth, open-ended 
questioning encouraged spontaneous discussion of patients’ experience of CHC 
and its treatment. Patients in the USA and Canada also completed cognitive 
debriefing (CD) interviews using a ‘think aloud’ protocol to evaluate content 
validity and comprehension of the Fatigue Severity Scale (FSS, n=34), Work 
Productivity and Activity Impairment questionnaire for Hepatitis C 
(WPAI:Hepatitis C, n=7) and the SKINDEX-16 (n=12). Verbatim transcripts were 
translated to English and analyzed using thematic analysis. RESULTS: 
Treatment-related symptoms cause a significant burden for patients during 
treatment with tiredness (60.0%), sleep problems (57.5%), fatigue (50.0%), 
depression (45.0%) and itchy skin (40.0%) among the most commonly reported 
symptoms mentioned in CE interviews. In the 40 patients with CHC treatment 
experience, treatment-related symptoms led to discontinuation or lack of 
adherence in 25% and 10%, respectively. CD interviews confirmed that the 
questionnaires were relevant, understandable and easy to complete. Patients 
suggested minor wording changes that may make these questionnaires easier to 
complete. CONCLUSIONS: Treatment-related symptoms cause a significant 
burden for CHC patients and affect their adherence to treatment. The FSS, 
WPAI:Hepatitis C, and SKINDEX-16 are valid tools for PRO assessment in CHC 
clinical trials.  
 
IN2  
CLINICAL CHARACTERISTICS AND TREATMENT DURATION AMONG PATIENTS 
WITH CHRONIC HEPATITIS C VIRUS (HCV) INFECTION INITIATING DIRECT-
ACTING ANTIVIRAL THERAPY IN A LARGE COMMERCIAL INSURANCE 
DATABASE IN THE UNITED STATES  
Bonafede MM1, Suthoff ED2, Eynullayeva E1 
1Truven Health Analytics, Cambridge, MA, USA, 2Vertex Pharmaceuticals, Inc., Cambridge, MA, USA  
OBJECTIVES: To describe patient characteristics and treatment duration among 
patients initiating telaprevir (T) or boceprevir (B) combination treatments with 
pegylated interferon and ribavirin (T/PR; B/PR) using administrative claims data. 
METHODS: A retrospective analysis of data from patients initiating T/PR or B/PR 
(index date) was conducted (MarketScan Research Databases 2011-2012). Study 
criteria included 7 months of continuous enrollment pre-index, 6 months post-
index, diagnosis of chronic HCV and claim for PR within 40 days of index date. 
Pre-index comorbidities were ascertained using ICD-9-CM codes. Indicated T 
duration is 12 weeks (84 days); and minimum indicated B duration is 24 weeks 
(168 days; maximum 44 weeks). Medication Possession Ratios (MPR, adherence 
indicator) and persistence were estimated over the indicated duration of 
treatment for each drug respectively. RESULTS: A total of 3288 patients met the 
study criteria (T/PR, n=2582 [79%]; and B/PR, n=706 [21%]). Age (mean±SD) and 
gender were similar between cohorts (T/PR=53.7±8.4 years, 35% female; 
B/PR=53.7±8.7 years, 39% female). Patients treated with T/PR were more likely to 
have a claim for liver cirrhosis in the pre-index period (T/PR=24%; B/PR=18%, 
p=0.002). Prevalence rates of other comorbidities were similar between cohorts: 
diabetes (T/PR=14%; B/PR=13%), hypertension (T/PR=12%; B/PR=12%), and anxiety 
or depression (T/PR=11%; B/PR=11%). MPR (mean±SD) was 0.91±0.2 for T/PR 
patients in the first 84 days post-index and 0.78±0.3 for B/PR in the first 168 days 
post-index (p<0.001). At 84 days, 82% (95% confidence interval [CI]: 80%-83%) of 
T/PR patients were on therapy compared with 84% (CI: 81%-87%) of B/PR patients; 
54% (CI: 51%-58%) of B/PR patients were still on therapy at 168 days. 
CONCLUSIONS: Chronic HCV-infected patients initiating telaprevir or boceprevir 
combination treatment had similar demographic characteristics and non-liver 
comorbidities. Cirrhosis was more prevalent among patients receiving telaprevir 
combination treatment. Data suggest adherence to indicated duration of 
treatment was higher among telaprevir patients than boceprevir patients.  
 
IN3  
THE BURDEN OF HCV TO INSURERS IN THE UNITED STATES: TRENDS IN 
HEALTH CARE RESOURCE UTILIZATION 2002-2012  
Simpson KN1, Simpson AN1, Kirbach SE2, Gooch K2 
1Medical University of South Carolina, Charleston, SC, USA, 2Abbott Laboratories, Abbott Park, 
IL, USA  
OBJECTIVES: Trends in health care utilization among HCV patients have 
demonstrated marked increases between 1994 and 2001, particularly among 
individuals aged 40 to 60 years. Furthermore, the proportion of treated 
individuals who achieve disease cure remains relatively low. This has potentially 
resulted in a large economic burden, as HCV leads to costly liver disease and 
other morbidity. The objective of this study was to examine trends in HCV-
related health care utilization by insurer 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 utilized in order to determine the number of adult 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 admissions occurring to HCV-infected patients was recorded for each 
year, as well as total charges. Trends over time were compared for three 
insurers: Medicaid, Medicare, and private. RESULTS: Of the 71 million 
admissions examined over the study period, 5,350,991 were admissions for HCV-
infected adults. More HCV-related admissions were covered by Medicaid and 
Medicare than private insurance. In 2002, total HCV-related charges were $693M 
for admissions covered by Medicare, $708M for Medicaid, and $579M for private 
insurance (costs adjusted to 2010 values). Between 2002 and 2010, total HCV-
related charges increased most for Medicare (84%), followed by Medicaid (77%) 
and private insurance (16%). HCV-related admissions covered by Medicare, 
Medicaid and private insurance increased commensurately by 84%, 77% and 16%, 
respectively. CONCLUSIONS: Use of inpatient care for HCV-infected patients has 
increased rapidly. Increases in the number of HCV patients who seek care, as 
well as possible increases in the intensity of care and/or escalation in hospital 
charges has resulted in nearly doubling HCV-related charges from 2002-2010.  
 
IN4  
DIRECT AND INDIRECT COST BURDEN OF CHRONIC HEPATITIS C INFECTION IN 
PRIVATELY-INSURED PATIENTS, STRATIFIED BY LIVER DISEASE SEVERITY  
Tandon N1, Reddy KR2, Lefebvre P3, Parisé H3, Laliberté F3, Pilon D3, Duh MS4,  
Prabhakar A5, Cho M5, Balart LA6, Fastenau J1 
1Janssen Scientific Affairs, LLC, Titusville, NJ, USA, 2Hospital of the University of Pennsylvania, 
Philadelphia, PA, USA, 3Groupe d’analyse, Ltée, Montréal, QC, Canada, 4Analysis Group, Inc., 
Boston, MA, USA, 5Janssen Services, LLC, Titusville, NJ, USA, 6Tulane University Health Sciences 
Center, New Orleans, LA, USA  
OBJECTIVES: To assess the direct health care and indirect work-loss cost burden 
of chronic hepatitis C virus (HCV) infection and stratify the economic burden by 
disease severity. METHODS: Health insurance claims from 60 self-insured US 
companies and disability data for employees in 29 of these companies covering 
the period 01/2001-09/2011 were analyzed. Adult patients with ≥2 diagnosis 
claims of chronic HCV infection and no HIV diagnosis were selected. A 6-month 
baseline period of continuous eligibility preceding HCV diagnosis was imposed. 
HCV patients were stratified into groups of non-cirrhotic, compensated cirrhotic, 
and end-stage liver disease (ESLD). HCV patients were matched 1:1 with non-
HCV controls using an exact factors and propensity score matching algorithm. 
Matched cohorts were compared for direct (pharmacy dispensings and medical 
services) and indirect (disability and medically related absenteeism) costs using 
per-patient per-year (PPPY) cost differences. RESULTS: Both cohorts (N=9,841 for 
each) were well matched with respect to age (mean=52 years), gender 
(female=39%), Quan-Charlson comorbidity index (mean=0.5), share of employees 
with disability coverage (26%), and non-HCV related co-morbidities. HCV patients 
incurred significantly greater direct and indirect costs relative to non-HCV 
patients (PPPY direct costs: $16,721 vs. $6,063, cost difference [95% CI] = $10,503 
[9,683-11,361], P<0.001; PPPY indirect costs: $3,310 vs. $1,723, cost difference [95% 
CI] = $1,523 [1,248-1,794], P<0.001). The direct incremental cost burden associated 
with HCV increased with disease severity (incremental direct cost [95% CI]: non-
cirrhotic HCV = $5,536 [4,844-6,333]; compensated cirrhotic = $6,833 [5,326-8,474]; 
ESLD = $22,466 [20,182-24,729], P<0.001 for all comparisons versus matched non-
HCV controls in each sub-category). Among the subset of employees with 
disability coverage, the incremental indirect cost burden associated with HCV 
also increased with disease severity. CONCLUSIONS: Chronic HCV infection was 
associated with significant direct health care and indirect work-loss cost 
burdens. The magnitude of the cost burden increased with disease severity.  
 
PODIUM SESSION II:  
MEDICATION ADHERENCE STUDIES  
 
MA1  
IMPACT OF A VALUE-BASED COPAYMENT WAIVER BENEFIT ON MEDICATION 
ADHERENCE AND SPENDING  
Gibson TB1, Maclean R2, Carls G1, Moore BJ1, Ehrlich ED1, Baigel C3 
1Truven Health Analytics, Ann Arbor, MI, USA, 2Bristol-Myers Squibb Company, New York, NY, 
USA, 3Bristol-Myers Squibb, New York, NY, USA  
OBJECTIVES: Most copayment waiver (value-based benefit design) programs 
have been applied at the individual level. In this study we evaluate the impact of 
a family-based copayment waiver at a large employer. METHODS: Enrollees with 
diabetes in eligible health and all of their family members (regardless of health 
status) were automatically enrolled in a copayment waiver ($0 copay) benefit 
beginning January 2011 for diabetes, cardiovascular, and lipid lowering 
medications, screenings, and related medical services. The study included 708 
enrollees who were propensity score matched to a comparison group (total 
n=1416) within nine similar companies without these benefits. An enrollee-
calendar quarter panel data set was constructed from 2009-2011. Program impact 
was measured as the change in outcomes (medication adherence and health 
care spending) post-program in the copayment waiver group relative to the 
change in the comparison group (difference-in-differences). Adherence was 
defined as percent of days covered by a medication class greater than or equal to 
80%. A falsification test of adherence to asthma and migraine medications, 
where copayments did not change, was conducted. RESULTS: Prior to program 
implementation, enrollees in the value-based program had a similar level of 


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CE4 Interviews With Patients With Chronic Hepatitis C (CHC) Virus Infection Document Unmet Needs, Content Validity, And Comprehension Of Pros For Clinical Trials

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