BMC Gastroenterology Jan 17 2013
Jeffrey Vietri, Girish Prajapati and
Antoine Khoury
"Conclusions: The humanistic and economic burden of HCV
in Europe is substantial. The pattern of results is similar among
treatment-naïve patients, which suggests that the burden of treatment is not
driving the elevated resource use and lower HRQoL observed in the broader
sample. Effective treatment of HCV may alleviate the work impairment associated
with HCV and lower use of healthcare resources, while providing improved
quality of life to the individual."
Abstract (provisional)
Background
Few studies have examined the impact of Hepatitis C
virus (HCV) infection on patient reported outcomes in Europe. This study was
conducted to assess the burden of HCV infection in terms of work productivity
loss, activity impairment, health-related quality of life, healthcare resource
utilization, and associated costs.
Methods
The 2010
European National Health and Wellness Survey (n = 57,805) provided data.
Patients reporting HCV infection in France, Germany, the UK, Italy, and Spain
were matched to respondents without HCV using propensity scores. Outcome
measures included the Work Productivity and Activity Impairment (WPAI)
questionnaire and the Medical Outcomes Study Short Form-12 (SF-12v2)
questionnaire. Subgroup analyses focused on treatment-naive
patients.
Results
HCV Patients (n = 286) had more work
impairment (30% vs. 18%, p < .001), more impairment in non-work activities
(34% vs. 28%, p < .05), and more annual physician visits per patient (19.8
vs. 13.3, p < .001). Estimated indirect and direct costs were [euro
sign]2,956 (p < .01) and [euro sign]495 (p < .001) higher than in matched
controls, respectively. Health-related quality of life was also lower among HCV
patients. Treatment-naive HCV patients (n = 139) also reported higher work
impairment (29% vs. 15%, p < .01), as well as more frequent physician visits
(19.5 vs. 12.1, p < .01) than matched controls. Each treatment-naive HCV
infected patient incurred [euro sign]934 in direct costs vs. [euro sign]508 (p
< .01 in matched controls. Employed treatment-naive patients reported higher
productivity loss per year compared to matched controls ([euro sign]6,414 vs.
[euro sign]3,642, p < .05).
Conclusion
HCV infection in
Europe is associated with considerable economic and humanistic burden. This is
also true of diagnosed patients who have never been treated for
HCV.
DISCUSSION
The present study included data from a
large survey of European adults with and without HCV infection across five
counties, which measured outcomes through widely used validated scales.
Patients reporting a physician diagnosis of HCV infection had significantly
impaired work productivity, greater impairment in non-work activities, more
healthcare resource utilization, and worse HRQoL than both the general
population without HCV and propensity-matched individuals without HCV
infection. The economic costs of HCV infection are considerable. We estimated
work-productivity impairment due to HCV costs over euro 7,500 per employed
patient per year, an incremental indirect cost of almost
euro 3,000
over matched controls. Direct costs are also elevated by almost euro 500 per
patient when compared to matched controls. The intangible cost of lower HRQoL
observed in this sample was also significant, particularly regarding physical
quality of life and health utility. HCV patients had consistently worse
outcomes than matched controls across almost all outcome measures, though some
measures of healthcare resource use did not reach significance. This seems to
be primarily an issue of statistical power, as those that did not reach
significance-ER visits and hospitalizations-were those measuring rare events
experienced by a minority of respondents. A previous study using the same
measures but using a larger, US sample found significant results, despite
observing numerically smaller differences between HCV patients and controls
[24]. Otherwise, the HRQoL decrements and work impairment observed in the
present analysis are consistent with those measured in the US NHWS, and of a
similar magnitude [18].
In addition to examining HCV infected patients
as a whole, the present study also considered treatment-naïve patients
separately. The treatment-naïve patients are an especially interesting
subgroup, as they are neither burdened by the adverse events of treatment, nor
benefited from a successful therapy, and so may better represent the burden of
untreated HCV infection. Relative to matched controls, these patients reported
greater impairment at work and more frequent physician visits, and estimated
costs were also higher. Unlike treatment-experienced patients, these
individuals' elevated resource use would not be due to treatment or adverse
events associated with such treatment, nor would work impairments or reduced
HRQoL be due to side effects. The pattern of results in this subgroup was
generally consistent with the findings in the broader comparisons, with few
exceptions. Treatment-naïve patients did not show significantly elevated
absenteeism relative to matched controls, but the magnitude of the difference
was actually larger than in the broader comparison, suggesting that this
difference is simply due to a lack of power rather than a different pattern
among treatment-naïve patients.
The use of propensity scoring matching
ensures that none of the effects observed could be attributed to any
demographic or health history variables included in the matching analyses.
However, we cannot rule out the possibility that additional variables (such as
prior drug use) not included in the matching may explain the observed
differences in health outcomes. However, most of the likely factors (co-morbid
health conditions, health behaviors, etc.) were equated by the matching
procedure.
The self-report survey methodology did not allow us to
verify HCV diagnosis. However, the findings coincide with those of previous
studies, suggesting this HCV sample is similar to that of other,
clinically-verified HCV samples. We were also unable to confirm that controls
were free of HCV infection, and given that many HCV patients are unaware of the
infection it is possible that HCV patients were in the control group, causing
us to underestimate the impact of HCV infection. The current study did not
assess reasons for healthcare resource utilization but, given the propensity
score methodology, the assumption was made that the additional resources used
by the HCV group were due to the virus itself, as none of the assessed
demographic or non-HCV health history variables differed between the groups.
Some selection bias may also be present, in that individuals who completed the
survey may have differed in some meaningful way from those who did not respond.
However, for such a bias to affect the conclusions, the effect of HCV would
have to be different among those who chose not to complete the survey than in
those who did respond, which seems unlikely. Finally, the modest number of HCV
infected respondents limits the precision of the estimates of the associated
burden, though this would not contribute to spurious positive
findings.
Conclusions
The humanistic and economic burden
of HCV in Europe is substantial. The pattern of results is similar among
treatment-naïve patients, which suggests that the burden of treatment is not
driving the elevated resource use and lower HRQoL observed in the broader
sample. Effective treatment of HCV may alleviate the work impairment associated
with HCV and lower use of healthcare resources, while providing improved
quality of life to the individual.
Jeffrey Vietri, Girish Prajapati and
Antoine Khoury
"Conclusions: The humanistic and economic burden of HCV
in Europe is substantial. The pattern of results is similar among
treatment-naïve patients, which suggests that the burden of treatment is not
driving the elevated resource use and lower HRQoL observed in the broader
sample. Effective treatment of HCV may alleviate the work impairment associated
with HCV and lower use of healthcare resources, while providing improved
quality of life to the individual."
Abstract (provisional)
Background
Few studies have examined the impact of Hepatitis C
virus (HCV) infection on patient reported outcomes in Europe. This study was
conducted to assess the burden of HCV infection in terms of work productivity
loss, activity impairment, health-related quality of life, healthcare resource
utilization, and associated costs.
Methods
The 2010
European National Health and Wellness Survey (n = 57,805) provided data.
Patients reporting HCV infection in France, Germany, the UK, Italy, and Spain
were matched to respondents without HCV using propensity scores. Outcome
measures included the Work Productivity and Activity Impairment (WPAI)
questionnaire and the Medical Outcomes Study Short Form-12 (SF-12v2)
questionnaire. Subgroup analyses focused on treatment-naive
patients.
Results
HCV Patients (n = 286) had more work
impairment (30% vs. 18%, p < .001), more impairment in non-work activities
(34% vs. 28%, p < .05), and more annual physician visits per patient (19.8
vs. 13.3, p < .001). Estimated indirect and direct costs were [euro
sign]2,956 (p < .01) and [euro sign]495 (p < .001) higher than in matched
controls, respectively. Health-related quality of life was also lower among HCV
patients. Treatment-naive HCV patients (n = 139) also reported higher work
impairment (29% vs. 15%, p < .01), as well as more frequent physician visits
(19.5 vs. 12.1, p < .01) than matched controls. Each treatment-naive HCV
infected patient incurred [euro sign]934 in direct costs vs. [euro sign]508 (p
< .01 in matched controls. Employed treatment-naive patients reported higher
productivity loss per year compared to matched controls ([euro sign]6,414 vs.
[euro sign]3,642, p < .05).
Conclusion
HCV infection in
Europe is associated with considerable economic and humanistic burden. This is
also true of diagnosed patients who have never been treated for
HCV.
DISCUSSION
The present study included data from a
large survey of European adults with and without HCV infection across five
counties, which measured outcomes through widely used validated scales.
Patients reporting a physician diagnosis of HCV infection had significantly
impaired work productivity, greater impairment in non-work activities, more
healthcare resource utilization, and worse HRQoL than both the general
population without HCV and propensity-matched individuals without HCV
infection. The economic costs of HCV infection are considerable. We estimated
work-productivity impairment due to HCV costs over euro 7,500 per employed
patient per year, an incremental indirect cost of almost
euro 3,000
over matched controls. Direct costs are also elevated by almost euro 500 per
patient when compared to matched controls. The intangible cost of lower HRQoL
observed in this sample was also significant, particularly regarding physical
quality of life and health utility. HCV patients had consistently worse
outcomes than matched controls across almost all outcome measures, though some
measures of healthcare resource use did not reach significance. This seems to
be primarily an issue of statistical power, as those that did not reach
significance-ER visits and hospitalizations-were those measuring rare events
experienced by a minority of respondents. A previous study using the same
measures but using a larger, US sample found significant results, despite
observing numerically smaller differences between HCV patients and controls
[24]. Otherwise, the HRQoL decrements and work impairment observed in the
present analysis are consistent with those measured in the US NHWS, and of a
similar magnitude [18].
In addition to examining HCV infected patients
as a whole, the present study also considered treatment-naïve patients
separately. The treatment-naïve patients are an especially interesting
subgroup, as they are neither burdened by the adverse events of treatment, nor
benefited from a successful therapy, and so may better represent the burden of
untreated HCV infection. Relative to matched controls, these patients reported
greater impairment at work and more frequent physician visits, and estimated
costs were also higher. Unlike treatment-experienced patients, these
individuals' elevated resource use would not be due to treatment or adverse
events associated with such treatment, nor would work impairments or reduced
HRQoL be due to side effects. The pattern of results in this subgroup was
generally consistent with the findings in the broader comparisons, with few
exceptions. Treatment-naïve patients did not show significantly elevated
absenteeism relative to matched controls, but the magnitude of the difference
was actually larger than in the broader comparison, suggesting that this
difference is simply due to a lack of power rather than a different pattern
among treatment-naïve patients.
The use of propensity scoring matching
ensures that none of the effects observed could be attributed to any
demographic or health history variables included in the matching analyses.
However, we cannot rule out the possibility that additional variables (such as
prior drug use) not included in the matching may explain the observed
differences in health outcomes. However, most of the likely factors (co-morbid
health conditions, health behaviors, etc.) were equated by the matching
procedure.
The self-report survey methodology did not allow us to
verify HCV diagnosis. However, the findings coincide with those of previous
studies, suggesting this HCV sample is similar to that of other,
clinically-verified HCV samples. We were also unable to confirm that controls
were free of HCV infection, and given that many HCV patients are unaware of the
infection it is possible that HCV patients were in the control group, causing
us to underestimate the impact of HCV infection. The current study did not
assess reasons for healthcare resource utilization but, given the propensity
score methodology, the assumption was made that the additional resources used
by the HCV group were due to the virus itself, as none of the assessed
demographic or non-HCV health history variables differed between the groups.
Some selection bias may also be present, in that individuals who completed the
survey may have differed in some meaningful way from those who did not respond.
However, for such a bias to affect the conclusions, the effect of HCV would
have to be different among those who chose not to complete the survey than in
those who did respond, which seems unlikely. Finally, the modest number of HCV
infected respondents limits the precision of the estimates of the associated
burden, though this would not contribute to spurious positive
findings.
Conclusions
The humanistic and economic burden
of HCV in Europe is substantial. The pattern of results is similar among
treatment-naïve patients, which suggests that the burden of treatment is not
driving the elevated resource use and lower HRQoL observed in the broader
sample. Effective treatment of HCV may alleviate the work impairment associated
with HCV and lower use of healthcare resources, while providing improved
quality of life to the individual.
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