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All-cause and incremental per patient per year cost associated with chronic hepatitis C virus and associated liver complications in the United States: a managed care perspective: HCV costs double comparison non-HCV patient group
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Journal of Managed Care Pharmacy September 2011
Carrie McAdam-Marx, PhD, RPh; Lisa J. McGarry, MPH; Christopher A. Hane, PhD; Joseph Biskupiak, PhD, MBA; Baris Deniz, MSc; and Diana I. Brixner, PhD, RPh
Conclusion
This large, retrospective matched comparison cohort study found that patients diagnosed with HCV infection have PPPY all-cause costs that on average are almost twice as much as those of non-HCV patients. Furthermore, PPPY costs were higher in patients with AdvLD. While a majority (82.4%) of patients in the current study had not progressed to AdvLD, epidemiologic data predict that the number of HCV patients with AdvLD and thus health care costs for the HCV population will increase substantially in the next 2 decades.8 Data from this study may help MCOs project future HCV costs and facilitate planning for HCV patient management efforts.
"The burden of AdvLD should be of interest to managed care payers to understand the effects of current and future HCV costs on their plans. Therefore, the purpose of this study was to estimate the all-cause medical costs to payers associated with HCV, both overall and by stage of liver disease. This study focused on enrollees with employer-sponsored health insurance and compared a
cohort of HCV patients with a matched comparison cohort of patients without HCV....... For the overall HCV cohort of 34,597 patients, the estimated PPPY cost from 2002 to first quarter of 2010 was $19,660 per patient (in 2009 dollars). This amount was almost twice as high as the PPPY cost for the 330,435 matched comparison enrollees ($9,979)....... The PPPY health care cost identified in the current study for patients with HCV but with no indication of liver disease was $14,915. This amount was $5,870 higher than that of matched comparisons and close to twice the U.S. per capita annual health care expenditure of approximately $8,000 in 2009,5 suggesting that all-cause health care costs for HCV patients are higher than those of non-HCV patients even in the absence of AdvLD.......From a public payer perspective, annual HCV medical costs are projected to increase from $12.2 billion in 2010 to $51.4 billion in 2028 (321% increase).41 The proportion of costs attributable to AdvLD for public payers is estimated to increase from 19% to 40% over the same time frame.41 In considering HCV costs, the trend of undiagnosed HCV is also important to monitor because as more HCV-infected patients experience disease progression and are diagnosed, the costs associated with diagnosis and treatment will further amplify the incremental cost differences between those with HCV and those without HCV..... While this study addressed the overall and incremental costs associated with HCV and AdvLD, the study did not address cost or cost-effectiveness of treatment, particularly as it relates to agents recently approved (boceprevir and telaprevir). Thus, additional work is encouraged to assist managed care decision makers in making such trade-offs in cost and outcome;"
"it is estimated that significant clinical and economic consequences of HCV will be observed within the next decade, mainly driven by the individuals who have had the virus for 10 to 20 years (or more) and those who progress to AdvLD.... studies suggest that more cases of HCC, decompensated cirrhosis, and liver transplants due to HCV will be observed in the coming years.....A recent study suggests that the HCV-related mortality rate increased in the United States from 1995 to 2004 by 123%.14 In accordance with this finding, Davis et al. (2003) suggest a similar trend in HCV-related mortality and morbidity in the future and estimate that the peak in prevalence of HCV-related cirrhosis in the United States in 2020 will be approximately 1 million cases"
"Health care costs related to HCV was estimated to be $5.46 billion in 1997......direct medical expenditures for HCV are predicted to grow to $10.7 billion for the 10-year period from 2010-2019.9 Other burden-of-illness studies have reported annual amounts paid by managed care plans for HCV-related medical care between 1995 and 1999 to be between $5,100 and $13,000 per HCV patient.16-18 However, in the most recently published economic analysis of HCV, which was based on a large database of medical and pharmacy claims from 2002-2006, Davis et al. reported that the regression-estimated total PPPY all-cause cost paid by managed care plans was $20,961 for HCV patients compared with $5,451 for patients in a matched non-HCV cohort.19 HCV-related costs accounted for $6,864 PPPY in the HCV cohort.19"
[in this study] "Mean (SD) age of all HCV cases was 49.9 (8.5) years; 61.7% were male. Incremental mean (SD) PPPY costs in 2009 dollars for all HCV patients relative to comparison patients were $ 9,681 ($176) PPPY. Incremental PPPY costs were $5,870 ($157) and $5,330 ($491) for HCV patients without liver disease and with compensated cirrhosis, respectively. Incremental PPPY costs for patients with AdvLD were $27,845 ($ 965) for decompensated cirrhosis, $43,671 ($2,588) for HCC, and $ 93,609 ($4,482) for transplant. Incremental prescription drug costs, including the cost of antiviral drugs, were $2,739 ($37) for HCV patients overall, $2,659 ($41) for HCV without liver involvement, and $3,102 ($157) for HCV with compensated cirrhosis. These between-group differences were statistically significant at P<0.001."
What is already known about this subject
· Annual total direct and indirect costs related to infections with the hepatitis C virus (HCV) in the United States were estimated at $5.46 billion in 1997. Davis et al. (2011) estimated that all-cause health care costs for managed care organization (MCO) enrollees with HCV were $20,961 per patient per year (PPPY), of which $6,864 PPPY was HCV-related, from 2002 through 2006.
· The burden of illness for HCV is predicted to grow over the next 2 decades, partly due to increased prevalence of advanced liver disease (AdvLD) in the current HCV population.
What this study adds
· In a retrospective analysis of administrative claims data for approximately 50 million MCO enrollees, the annual direct all-cause health care costs to commercial insurers for patients diagnosed with HCV were estimated to be almost twice as high as costs for matched non-HCV enrollees with similar health statuses, with incremental all-cause costs of more than $9,000 PPPY.
· All-cause PPPY incremental costs were higher for patients diagnosed with AdvLD than for matched comparison group patients, ranging from more than $27,000 PPPY in patients with decompensated cirrhosis to more than $93,000 in patients requiring a liver transplant.
All between-group differences in PPPY costs were significant (P < 0.001) overall and for each place of service or service type, and when classified by stage of liver disease (Table 3). Mean (SD) total PPPY costs, per bootstrap estimates, for all HCV patients were $19,660 ($210) versus $9,979 ($34) for the matched comparison cohort (mean difference of $9,681, SD = $176).
This study was conducted to evaluate all-cause health care costs associated with HCV and AdvLD from a commercial payer perspective using a matched cohort design to control for numerous factors that could influence cost trends including age, prior health care costs, and comorbidities. For the overall HCV cohort of 34,597 patients, the estimated PPPY cost from 2002 to first quarter of 2010 was $19,660 per patient (in 2009 dollars). This amount was almost twice as high as the PPPY cost for the 330,435 matched comparison enrollees ($9,979). An important feature of this study was the evaluation of health care costs based on the stage of liver disease. Costs were substantially higher for the 17.6% of HCV patients who had progressed to AdvLD than for those without AdvLD. These findings confirm the incremental costs of HCV patients within managed care membership and the proportional increase in these costs as patients with HCV advance in their disease.
The PPPY health care cost identified in the current study for patients with HCV but with no indication of liver disease was $14,915. This amount was $5,870 higher than that of matched comparisons and close to twice the U.S. per capita annual health care expenditure of approximately $8,000 in 2009,5 suggesting that all-cause health care costs for HCV patients are higher than those of non-HCV patients even in the absence of AdvLD. Other studies have found that patients with HCV who have not developed liver disease generally have higher costs after diagnosis than before diagnosis, as well as higher costs than comparisons.31,32 In a Canadian study of patients newly diagnosed with HCV, mean per patient all-cause health care costs increased by 34% from $2,630 in the pre-diagnosis year to $3,514 in the first year after diagnosis.31 Only a small portion of the post-diagnosis costs (10%) in the Canadian study could be explained by liver-related care, which did not distinguish between screening/monitoring and AdvLD. Furthermore, costs for prescription drugs were not included, which suggests that patients with HCV have higher overall health care costs than similar patients, even when the costs of antiviral therapy are not considered.
Abstract
BACKGROUND:
Approximately 3.2-3.9 million U.S. residents are infected with the hepatitis C virus (HCV). Total annual costs (direct and indirect) in the United States for HCV were estimated to be $5.46 billion in 1997, and direct medical costs have been predicted to increase to $10.7 billion for the 10-year period from 2010 through 2019, due in part to the increasing number of HCV patients developing advanced liver disease (AdvLD).
OBJECTIVE:
To quantify in a sample of commercially insured enrollees (a) total per patient per year (PPPY) all-cause costs to the payer, overall and by the stage of liver disease, for patients diagnosed with HCV; and (b) incremental all-cause costs for patients diagnosed with HCV relative to a matched non-HCV cohort.
METHODS:
This retrospective, matched cohort study included patients aged at least 18 years and with at least 6 months of continuous enrollment in a large managed care organization (MCO) claims database from July 1, 2001, through March 31, 2010. Patients with a diagnosis of HCV (ICD-9-CM codes 070.54, 070.70) were identified and stratified into those with and without AdvLD, defined as decompensated cirrhosis (ICD-9-CM codes 070.44, 070.71, 348.3x, 456.0, 456.1, 456.2x, 572.2, 572.3, 572.4, 782.4, 789.59); hepatocellular carcinoma (HCC, ICD-9-CM code 155); or liver transplant (ICD-9-CM codes V42.7, 50.5 or CPT codes 47135, 47136). For patients without AdvLD, the index date was the first HCV diagnosis date observed at least 6 months after the first enrollment date, and at least 6 months of continuous enrollment after the index date were required. HCV patients without AdvLD were stratified into those with and without compensated cirrhosis (ICD-9-CM codes 571.2, 571.5, 571.6). For patients with AdvLD, the index date was the date of the first AdvLD diagnosis observed at least 6 months after the first enrollment date, and at least 1 day of enrollment after the index date was required. Cases were matched in an approximate 1:10 ratio to comparison patients without an HCV diagnosis or AdvLD diagnosis who met all other inclusion criteria based on gender, age, hospital referral region state, pre-index health care costs, alcoholism, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), and a modified Charlson Comorbidity Index. For the HCV and comparison patient cohorts, PPPY all-cause costs to the payer were calculated as total allowed charges summed across all patients divided by total patient-days of follow-up for the cohort, multiplied by 365, inflation-normalized to 2009 dollars. Because the calculation of PPPY cost generated a single value for each cohort, bootstrapping was used to generate descriptive statistics. Incremental PPPY costs for HCV patients relative to non-HCV patients were calculated as between-group differences in PPPY costs. T-tests for independent samples were used to compare costs between case and comparison cohorts.
RESULTS:
A total of 34,597 patients diagnosed with HCV, 78.0% with HCV without AdvLD, 4.4% with compensated cirrhosis, 12.3% with decompensated cirrhosis, 2.8% with HCC, and 2.6% with liver transplant, were matched to 330,435 comparison patients. Mean (SD) age of all HCV cases was 49.9 (8.5) years; 61.7% were male. Incremental mean (SD) PPPY costs in 2009 dollars for all HCV patients relative to comparison patients were $ 9,681 ($176) PPPY. Incremental PPPY costs were $5,870 ($157) and $5,330 ($491) for HCV patients without liver disease and with compensated cirrhosis, respectively. Incremental PPPY costs for patients with AdvLD were $27,845 ($ 965) for decompensated cirrhosis, $43,671 ($2,588) for HCC, and $ 93,609 ($4,482) for transplant. Incremental prescription drug costs, including the cost of antiviral drugs, were $2,739 ($37) for HCV patients overall, $2,659 ($41) for HCV without liver involvement, and $3,102 ($157) for HCV with compensated cirrhosis. These between-group differences were statistically significant at P<0.001.
CONCLUSIONS:
Based on a retrospective analysis of data from a large, MCO claims database, patients diagnosed with HCV had annual all-cause medical costs that were almost twice as high as those of enrollees without a diagnosis of HCV. Health care costs increased dramatically with AdvLD. Data from this study may help MCOs project future HCV costs and facilitate planning for HCV patient management efforts.
It is estimated that 2%-3% of the worldwide population (130-170 million people) is infected with the hepatitis C virus (HCV)1-3 including approximately 3.2-3.9 million in the United States.4,5 In prospective studies of patients who acquired HCV from blood transfusions (duration of time from diagnosis: 8 to 16 years), 7%-16% developed cirrhosis, 0.7%-1.3% developed hepatocellular carcinoma (HCC), and 1.3%-3.7% experienced liver-related death.6 In retrospective studies primarily in diagnosed HCV patients referred for liver disease (duration of time from diagnosis: 9-29 years), 17%-55% developed cirrhosis, 1%-23% progressed to HCC, and 4%-15% experienced liver-related death.6 The differences in findings between retrospective and prospective studies are due in part to the notable difference in duration of follow-up and time since infection. Age at the time of infection is also thought to play a role in liver disease progression. It has been estimated that 20% of patients first infected after 40 years of age progressed to cirrhosis within 20 years after infection, versus 3%-8% of those less than 40 years of age at the time of infection.6
The majority of HCV infections in the United States occurred in the 1980s and early 1990s, before the identification of the virus and appropriate testing processes.5 Because HCV is a mainly asymptomatic and slowly progressing disease, most cases remain undiagnosed until the onset of liver disease. 7 While the incidence of new HCV cases has declined over the last 2 decades,5 it is estimated that significant clinical and economic consequences of HCV will be observed within the next decade, mainly driven by the individuals who have had the virus for 10 to 20 years (or more) and those who progress to AdvLD.8,9
The health burden of HCV is driven, in part, by the development of AdvLD,10 which may also lead to liver transplant.11 Currently HCV is the leading cause for HCC and liver transplants in the United States,10,12 and studies suggest that more cases of HCC, decompensated cirrhosis, and liver transplants due to HCV will be observed in the coming years.13 A recent study suggests that the HCV-related mortality rate increased in the United States from 1995 to 2004 by 123%.14 In accordance with this finding, Davis et al. (2003) suggest a similar trend in HCV-related mortality and morbidity in the future and estimate that the peak in prevalence of HCV-related cirrhosis in the United States in 2020 will be approximately 1 million cases.13
These trends are expected to affect both public and private health insurers in the United States. Health care costs related to HCV are already significant; total annual cost (direct and indirect) in the United States was estimated to be $5.46 billion in 1997.15 Meanwhile, direct medical expenditures for HCV are predicted to grow to $10.7 billion for the 10-year period from 2010-2019.9 Other burden-of-illness studies have reported annual amounts paid by managed care plans for HCV-related medical care between 1995 and 1999 to be between $5,100 and $13,000 per HCV patient.16-18 However, in the most recently published economic analysis of HCV, which was based on a
large database of medical and pharmacy claims from 2002-2006, Davis et al. reported that the regression-estimated total PPPY all-cause cost paid by managed care plans was $20,961 for HCV patients compared with $5,451 for patients in a matched non-HCV cohort.19 HCV-related costs accounted for $6,864 PPPY in the HCV cohort.19
Data on the amounts paid for HCV care by MCOs are limited in that current studies do not provide a comprehensive analysis of HCV by stage of liver disease. The burden of AdvLD should be of interest to managed care payers to understand the effects of current and future HCV costs on their plans. Therefore, the purpose of this study was to estimate the all-cause medical costs to payers associated with HCV, both overall and by stage of liver disease. This study focused on enrollees with employer-sponsored health insurance and compared a
cohort of HCV patients with a matched comparison cohort of patients without HCV.
Results
Baseline Characteristics
After matching and prior to classification by liver disease severity, the sample included 34,597 patients diagnosed with HCV and 330,435 comparison enrollees (Figure 1). The mean age for both cohorts was 49.9 years (SD = 8.5 years for HCV patients and SD = 8.9 years for comparisons); 61.7% were male in the HCV cohort versus 61.1% in the comparison group. The mean (median, interquartile range) number of days of followup after the index date for HCV patients overall was 837 (650, 362-1,163) days and 909 (713, 359-1,286) days for comparison enrollees.
The distribution of study patients by index year is provided in Table 1. Enrollment was generally steady from 2002 to 2009 for patients who had HCV without AdvLD, but the enrollment of HCV patients with AdvLD increased over the study period. Due to the comparison cohort selection criterion for a minimum duration of enrollment, no comparison patients had an index date in 2002, while an enrollment surge in 2003 or 2004 occurred because comparison enrollees were selected based on the first date they qualified as comparators. Thus, there is a significantly large set of comparison enrollees in the initial years of the time frame.
For patients with diagnosed HCV (n = 34,597), a majority (78.0%, n = 26,977) did not have indication of cirrhosis, and 4.4% (n = 1,521) of patients had diagnosis codes indicating compensated cirrhosis but no evidence of AdvLD (Figure 1, Table 2). A total of 6,099 (17.6%) had indication of AdvLD, including 4,249 (12.3%) with decompensated cirrhosis without HCC or liver transplant, 959 (2.8%) with HCC and without liver transplant, and 891 (2.6%) with a liver transplant. Of all liver transplant patients, 509 (57.1%) were enrolled in the database for more than 1 year and contributed data for the analyses of cost beyond the first transplant year.
When patients were evaluated by stage of liver disease, differences in baseline characteristics between cases and comparisons were generally similar to those for the full cohort, although differences emerged with advancing liver disease (Table 2). Mean (SD) age ranged from 49.1 (8.3) years for HCV patients without liver disease to 55.7 (8.7) years for patients with HCC. The proportion of male patients similarly increased with liver disease severity, and the prevalence of comorbidities generally increased with advancing stage of liver disease.
PPPY Costs
All between-group differences in PPPY costs were significant (P < 0.001) overall and for each place of service or service type, and when classified by stage of liver disease (Table 3). Mean (SD) total PPPY costs, per bootstrap estimates, for all HCV patients were $19,660 ($210) versus $9,979 ($34) for the matched comparison cohort (mean difference of $9,681, SD = $176). Costs for all HCV patients were similarly distributed among inpatient, outpatient, professional, and prescription drugs, whereas emergency department services contributed substantially less. Costs in the category defined as other were nominal (mean $1, SD < $1) and thus are not included in Table 3. The distributions of costs by place of service were also relatively similar for HCV patients and matched comparison enrollees.
Total PPPY costs ranged from a mean (SD) $14,915 ($196) for HCV patients without indication of liver disease and $16,911 ($659) for patients with HCV and compensated cirrhosis to $113,282 ($4,908) for patients receiving a liver transplant (Table 3). Costs for these HCV cohorts were significantly higher than those of the matched comparison cohorts with a mean difference of $5,870 ($157) and $5,330 ($491) PPPY for HCV without liver disease and HCV with compensated cirrhosis, respectively, and $93,609 ($4,482) for HCV patients receiving a liver transplant (P < 0.001; Table 4).
Incremental all-cause health care costs for transplant patients were further evaluated by time post-transplant on the hypothesis that on average, transplant costs would be higher during the year of transplant than in subsequent years (Table 4). Mean (SD) PPPY total health care costs the first year following transplant for all transplant patients, regardless of post-index enrollment, were $190,995 ($8,022) for transplant patients, which was $168,643 ($7,487) higher than for matched comparison patients. Not surprisingly, inpatient expenses
(mean $118,394, SD $6,507) represented the largest proportion
of costs the year of transplant (data not shown). Total PPPY health care cost for transplant patients after year 1 for those with at least 1 year of follow-up was less than during the transplant year (mean $54,885, SD $4,409; data not shown), although the incremental difference between these patients and matched comparison enrollees with at least 1 year of follow-up remained high at $38,015 ($3,797).
HCV-related PPPY pharmacy use and costs were evaluated for the HCV cohort during the post-index period (data not shown). Of patients in each of the HCV cohorts, 36.6% with compensated cirrhosis had at least 1 prescription claim for antiviral therapy used to treat HCV, and 30.4% of HCV patients without indication of liver disease had antiviral utilization. Antiviral use was identified in 16.7% of transplant patients, 12.5% of patients with decompensated cirrhosis, and 9.5% of patients with HCC. Mean (SD) PPPY costs for HCV-related antiviral therapy were $2,445 ($30) for HCV without liver
involvement, $3,243 ($153) for HCV with compensated cirrhosis,
and $1,474 ($85) for HCV with decompensated cirrhosis. HCV antiviral PPPY costs for HCC and transplant patients were $1,599 ($213) and $1,653 ($189), respectively.
Discussion
This study was conducted to evaluate all-cause health care costs associated with HCV and AdvLD from a commercial payer perspective using a matched cohort design to control for numerous factors that could influence cost trends including age, prior health care costs, and comorbidities. For the overall HCV cohort of 34,597 patients, the estimated PPPY cost from 2002 to first quarter of 2010 was $19,660 per patient (in 2009 dollars). This amount was almost twice as high as the PPPY cost for the 330,435 matched comparison enrollees ($9,979). An important feature of this study was the evaluation of health care costs based on the stage of liver disease. Costs were substantially higher for the 17.6% of HCV patients who
had progressed to AdvLD than for those without AdvLD. These
findings confirm the incremental costs of HCV patients within managed care membership and the proportional increase in these costs as patients with HCV advance in their disease. While this is the first study, to our knowledge, to present costs by stage of liver disease for an entire HCV cohort, the overall health care cost for HCV patients was similar to that reported in a recent study conducted in a large commercial claims database by Davis et al.19 The study by Davis et al. estimated annual health care costs in all HCV patients to be $20,961. Incremental costs for HCV patients versus comparison
patients in the Davis et al. study ($15,510) were higher than in the current study. A potential explanation for this discrepancy is that the Davis et al. study did not match on specific comorbidities or pre-index date costs, nor were these patient characteristics included in their regression analyses.
The PPPY health care cost identified in the current study for patients with HCV but with no indication of liver disease was $14,915. This amount was $5,870 higher than that of matched comparisons and close to twice the U.S. per capita annual health care expenditure of approximately $8,000 in 2009,5 suggesting that all-cause health care costs for HCV patients are higher than those of non-HCV patients even in the absence of AdvLD. Other studies have found that patients with HCV who have not developed liver disease generally have higher costs after diagnosis than before diagnosis, as well as higher costs than comparisons.31,32 In a Canadian study of patients newly diagnosed with HCV, mean per patient all-cause health care
costs increased by 34% from $2,630 in the pre-diagnosis year to $3,514 in the first year after diagnosis.31 Only a small portion of the post-diagnosis costs (10%) in the Canadian study could be explained by liver-related care, which did not distinguish between screening/monitoring and AdvLD. Furthermore, costs for prescription drugs were not included, which suggests that patients with HCV have higher overall health care costs than similar patients, even when the costs of antiviral therapy are not considered.
From an economic perspective, antiviral therapy for HCV is not inconsequential. For instance, 2011 average wholesale prices for a month of antiviral treatment range from approximately $1,500 to $3,200, depending on drug and dose.33 These antiviral therapies, namely interferon or peg-interferon with ribavirin, have been shown to be reasonably cost-effective when used to prevent progression to AdvLD as a single treatment cycle of 24 or 48 weeks.34 Specifically, costs per quality adjusted life year (QALY) when compared with no treatment are generally estimated to fall below cost effectiveness thresholds (e.g., < 30,000 per QALY or < U.S.$50,000 per QALY), although one study found that antiviral treatment may not be
cost-effective in patients with genotype 1 who have progressed to cirrhosis.34-37
In the present study, HCV-related antiviral therapy costs (e.g., interferon α-2a and α-2b, interferon alphacon a, pegylated interferon α-2a and α-2b, and ribavirin), represented a large component of drug costs for HCV patients without AdvLD or with compensated cirrhosis, with PPPY costs for antiviral therapy of $2,445 and $3,243, respectively. HCV antiviral PPPY costs for HCC and transplant patients were less at $1,599 and $1,653, respectively, which represents a smaller proportion of both overall drug costs and incremental drug costs between HCC and transplant patients and their matched comparison enrollees. Lower costs may be attributed to HCC and transplant patients having received antiviral therapy prior to having progressed to a more advanced stage of liver disease or the risk of patients decompensating with HCV treatment. Antiviral therapy was not captured at the patient level by specific treatment regiments. As such, some patients may have been on antiviral therapy for other reasons. Some of the interferon use, for instance, may have been without ribavirin for the treatment of melanoma or other cancers. Thus, this analysis may overstate HCV antiviral drug costs, particularly in the HCC cohort, but given the population and the relatively limited use of interferons in cancer treatment, it is believed that the misclassification of these costs is minimal.
This study provides important information for managed care, because an increased investment in pharmacotherapy early on in HCV may delay the onset of AdvLD and associated costs.34,38 However, 2 new protease inhibitors, telaprevir and boceprevir, were approved for use in combination with peginterferon/ribavirin in genotype 1 HCV patients in May of 2011.39 As these combination therapies are more expensive than peginterferon/ribavirin alone, the increased investment up front will need to be weighed against the benefits of further delay in disease progression. In addition, it is likely that identification of appropriate genotypes to optimize treatment efficacy will also assist MCOs.
The current study and the Davis et al. study have provided higher estimates of HCV costs than observed in previous studies, which ranged from approximately $5,000 to $13,000 per patient per year.16-18 Medical inflation may explain some of this difference, but cost increases over time likely also reflect the HCV "age wave." Recent studies, recognizing this age-related trend in HCV disease severity and related costs, have projected
short- and long-term HCV costs overall and have isolated costs driven by AdvLD.9,40,41 Overall, direct medical costs for HCV in the United States over a 10-year time frame (2010-2019) have been estimated to be $10.7 billion (1999 dollars; range of $6.5 to $13.5 billion) representing approximately $1 billion in direct costs per year.9 For the current study, and assuming that one-quarter of the estimated 3.5 million HCV-infected persons
in the United States are diagnosed, our PPPY cost estimate of approximately $10,000 projects to an annual U.S. burden of $8-$9 billion per year.
Recent nonpeer-reviewed cost estimates have reported costs specifically for private and public payers while also considering the impact of AdvLD. Short-term HCV cost trends from a private payer perspective are projected to increase 88% between 2010 and 2015 (from $21.9 to $41.2 billion) with the proportion of HCV costs related to AdvLD increasing from one-third to more than one-half of total HCV costs by 2015.40 From a public payer perspective, annual HCV medical costs are projected to increase from $12.2 billion in 2010 to $51.4 billion in 2028 (321% increase).41 The proportion of costs attributable to AdvLD for public payers is estimated to increase from 19% to 40% over the same time frame.41 In considering HCV costs,
the trend of undiagnosed HCV is also important to monitor because as more HCV-infected patients experience disease progression and are diagnosed, the costs associated with diagnosis and treatment will further amplify the incremental cost differences between those with HCV and those without HCV. Thus, for MCOs overall, and particularly for those with managed Medicaid beneficiaries, HCV is an important disease to monitor. Cost data from this study, over all HCV patients and stratified by stage of liver disease, can facilitate the projection of short- and long-term costs associated with HCV.
While this study addressed the overall and incremental costs associated with HCV and AdvLD, the study did not address cost or cost-effectiveness of treatment, particularly as it relates to agents recently approved (boceprevir and telaprevir). Thus, additional work is encouraged to assist managed care decision makers in making such trade-offs in cost and outcome; however, the current study provides a good foundation of information about health care costs associated with HCV and AdvLD to facilitate this research.
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