In this study using data from the Florida Medicaid program, the fourth-largest Medicaid program in the United States, we found that patients with HCV with an incident ALD-related diagnosis (cases) had significantly greater all-cause resource use and costs compared to patients with HCV without an ALD diagnosis (comparison patients). Adjusted total mean all-cause costs PPPM in the year following the first ALD-related diagnosis among cases were estimated at $4,956, while mean total PPPM costs for comparison patients were estimated at $1,735. A substantially larger proportion of all-cause costs were comprised of inpatient hospitalizations among cases (54%) vs. controls (19%). Total ALD-related costs in the year following an incident ALD-related diagnosis among patients with both HCV and ALD averaged $1,356 PPPM, or approximately 27% of all-cause costs in this cohort. These increased costs among patients with HCV and ALD may be linked to the observed higher use of healthcare resources in this cohort as shown in these analyses.
There are limited data on the incremental cost burden of ALD among Medicaid patients with HCV. Past research has focused primarily on the burden of HCV in general, not specific to patients with and without ALD-related diagnoses. Additionally, prior research has focused on patients covered by commercial health plans
[4–7, 20], which may be different than those covered by a state Medicaid program. Despite these differences, previous studies showed that annual health care costs among patients with HCV ranged from $9,576 to $22,424 (adjusted to 2009 USD)
[4–7], which is similar to the all-cause estimate among our comparison group of patients with HCV and no ALD ($20,762). In an analysis of patients with an incident diagnosis of chronic HCV who were enrolled in a managed care organization (MCO), the annual all-cause costs in the first year following diagnosis were estimated at $22,424 for patients with HCV and $5,831 for patients without HCV (incremental $16,593; adjusted to 2009 USD)
. In a similar analysis of private MCO data, Poret et al. estimated total all-cause average payments in the year following the first HCV diagnosis at approximately $17,491 versus $3,020 in a comparison cohort with no HCV (adjusted to 2009 USD)
. Armstrong and colleagues reported total annual all-cause costs among patients with HCV who were treated with interferon alfa plus ribavirin therapy and enrolled in a large MCO to be approximately $9,577 (adjusted to 2009 USD)
. Of the total all-cause costs among treated patients with HCV, approximately $8,929 were HCV-related (adjusted to 2009 USD)
. In another analysis of MCO data, this one among patients with HCV aged less than age 65, Rosenberg et al. found total all-cause 3-year costs of $63,055 (annualized approximately $21,018; adjusted to 2009 USD)
. Finally, in a recent retrospective database analysis of administrative claims data from a large MCO the annualized total mean all-cause healthcare charges (not costs) per patient per year (PPPY) were higher for patients with diagnosis of HCV and ALD (decompensated cirrhosis: $27,000; HCC: $58,529; liver transplant: $113,116) compared to patients with HCV and no advanced liver disease ($14,917) (all in 2009 USD)
. These results are similar to our findings of higher costs among patients with HCV and ALD compared to HCV alone particularly among patients with diagnosis of HCC or receipt of a liver transplant, although data on charges are not directly comparable to the Medicaid expenditure information reported in our paper.
Although the incidence of HCV has declined substantially in the last decade, mortality due to liver-related complications is projected to increase over the next 25 years due to the aging of the prevalent HCV population. As the population ages, more patients will progress to development of decompensated cirrhosis or HCC. Increased ALD-related mortality and rates of progression will lead to a significant economic burden among the HCV-infected population. In one model-based estimate of the effect of treatment on HCV progression and liver-related mortality, increasing treatment rates among patients diagnosed with HCV from approximately 25% to 50% was projected to decrease the percentage of patients developing liver failure by 39%, HCC by 30%, and decrease the number of liver-related deaths by 34% between 2010 and 2019
The mortality rate observed among patients with diagnosis of HCV and ALD in this study was 35.1% over a mean of 277 days of follow-up. This estimate is in line with mortality rates reported in a systematic literature review of patients with cirrhosis
. Patients with stage 3 decompensated cirrhosis (i.e., patients with ascites and varices) were found to have a one-year mortality rate of 20% while those with stage 4 decompensated cirrhosis (i.e., those with GI bleeding with or without ascites) had a mortality rate of 57% at one year. Since over 90% of our patients with ALD had a diagnosis of decompensated cirrhosis, our population appears to be similar to the stage 3 and 4 cirrhosis patients examined in the review.
This study is subject to certain limitations that are common to all studies that rely on retrospective claims data, such as potential coding errors and incomplete data
. Our estimates of ALD-related resource use and costs may be slight overestimates, as we defined a claim with any ALD-related diagnosis (primary or secondary diagnosis) as disease-related, which may have in some cases captured nondisease related costs. Additionally, descriptive data also showed patients with HCV and ALD to have higher prevalence of other non-liver related comorbidities, therefore also potentially causing the incremental cost of ALD to be an overestimate. Although we controlled for both alcoholic cirrhosis and hepatitis B, two important comorbid conditions not included in the Charlson score, we cannot rule our residual confounding that could have led to an overestimate of excess costs. Finally, the difference in pharmacy costs observed (higher pharmacy costs among controls) may have skewed differences in total all cause costs between cases and controls due to a higher prevalence of contraindications to interferon-based treatment among patients with HCV and ALD. However, many of these patients were living with HCV for a number of years prior to the first year of our data (1998), and already presumably completed their course of treatment, thus not overly influencing pharmacy costs. However, we do acknowledge that the prevalence of treatment is likely higher in the control group and therefore influencing the significant difference in pharmacy costs observed in our dataset.
The main decrease in sample size in our study was due to the requirement that patients be Medicaid-only eligible with no HMO or Medicare coverage. Therefore, although this study was conducted using a large state Medicaid program, costs may not be generalizable to other Medicaid programs or to other payers. Additionally, exclusion of patients who are dually eligible for Medicaid and Medicare may bias cost estimates downward as Medicaid patients with Medicare are likely to be sicker than other patients