Medicaid Direct-Acting Antiviral Restrictions Linked to Reduced HCV Treatment Rates

Nathan Furukawa, MD, MPH

Credit: Nathan Furukawa on LinkedIn

Findings from a recent study are calling attention to the negative impact of Medicaid nonexpansion status, fibrosis restrictions, and sobriety restrictions on hepatitis C treatment rates among Medicaid recipients.¹

Results of the cross-sectional study suggest removing restrictive direct-acting antiviral (DAA) prior authorization policies could improve timely access to hepatitis C treatment while also reducing disparities in treatment access and enhancing health equity among people who use drugs or alcohol, people experiencing poverty, and people without access to specialty care.¹

“Previous studies have demonstrated a relative increase in DAA prescriptions following the lifting of DAA restrictions,” Nathan Furukawa, MD, MPH, senior advisor at the US Centers for Disease Control and Prevention, and colleagues wrote.¹ “However, an assessment of the overall association between Medicaid expansion and these restrictions with the rate of people with Medicaid treated for hepatitis C nationwide may inform decisions to remove persistent prior authorization requirement.”

According to the World Health Organization, globally, an estimated 50 million people have chronic HCV infection, with about 1 million new infections occurring per year. DAAs are thought to be able to cure more than 95% of persons with hepatitis C infection, but since their advent in 2014, access to this curative treatment has been a persistent issue hindering their uptake. Insurance-related restrictions seeking to control costs have negatively impacted treatment access, but understanding the connection between such restrictions and HCV treatment rates may help inform policies to increase DAA accessibility.²

To estimate the association of jurisdictional DAA restrictions and Medicaid expansion with the number of Medicaid recipients with filled prescriptions for DAAs, investigators examined publicly available Medicaid documents and claims data from January 1, 2014, to December 31, 2021, and compared the number of unique Medicaid recipients treated with DAAs in each jurisdiction year with Medicaid expansion status and categories of fibrosis, sobriety, and prescriber restrictions. For each Medicaid beneficiary, prescription information was longitudinally linked across the Centers for Medicare & Medicaid Services Transformed Medicaid Statistical Information System Analytic Files and Medicaid Analytic eXtract databases.¹

The analysis was restricted to the date of first DAA fill and did not account for subsequent courses of treatment relating to nonadherence, treatment failure, or HCV reinfection. Medicaid recipients from all 50 states and Washington, DC, were included.¹

Investigators compared the number of people with Medicaid coverage who filled DAA prescriptions, the number of people with Medicaid coverage, Medicaid expansion status, and DAA restrictive policies for each year from 2014-2021. The mean annual number of people with filled DAA prescriptions per 100,000 Medicaid recipients per year in each jurisdiction was then compared by year, Medicaid expansion status, and DAA restrictive policies, and multilevel Poisson regression was used to estimate the association between Medicaid expansion and DAA restrictive policies on jurisdictional Medicaid DAA prescription fills.¹

A total of 381,373 Medicaid recipients filled DAA prescriptions during the study period, of whom the majority were 45-64 years of age (57.3%); male (58.7%); and non-Hispanic White (52.2%). Investigators pointed out DAA prescription fills increased from 20,516 in 2014 to a peak of 64,974 in 2019 and then decreased to 53,708 in 2021.¹

The number of jurisdictions that expanded Medicaid increased from 27 in 2014 to 38 in 2021. Among jurisdictions with known DAA restriction policies in 2014, 94.4% had a fibrosis restriction, 95.0% had a sobriety restriction, and 96.7% had a prescriber restriction in place. Restrictions were gradually lifted over time and by 2021, 3.9% had a fibrosis restriction, 53.0% had a sobriety restriction, and 31.4% had a prescriber restriction.¹

Medicaid nonexpansion jurisdictions had fewer filled DAA prescriptions per 100,000 Medicaid recipients per year than expansion jurisdictions (38.6 vs 86.6; adjusted relative risk [ARR], 0.56; 95% CI, 0.52-0.61). Additionally, investigators noted jurisdictions with F3-F4 (34.0; ARR, 0.39; 95% CI, 0.37-0.66) or F1-F2 fibrosis restrictions (61.9; ARR, 0.62; 95% CI, 0.59-0.66) had lower treatment rates than jurisdictions without fibrosis restrictions (94.8 per 100,000 Medicaid recipients per year).¹

Compared with no sobriety restrictions (113.5 per 100,000 Medicaid recipients per year), 6-12 months of sobriety (38.3; ARR, 0.65; 95% CI, 0.61-0.71) and screening and counseling requirements (84.7; ARR, 0.87; 95% CI, 0.83-0.92) were associated with reduced treatment rates, while 1 to 5 months of sobriety was not statistically significantly different. Compared with no prescriber restrictions (97.8 per 100,000 Medicaid recipients per year), specialist consult restrictions were associated with increased treatment (66.2; ARR, 1.05; 95% CI, 1.00-1.10), while specialist-required restrictions were not statistically significant.¹

Investigators outlined multiple limitations to these findings, including the limited documentation of DAA restriction policies during 2014-2016; the lack of a reliable estimate of hepatitis C prevalence among Medicaid recipients by jurisdiction; the assumption that Medicaid policies in a given year applied to all Medicaid-supported plans; the limited limited number of jurisdictions who completely removed prior authorization requirements to enable definitive conclusions on its independent association relative to specific fibrosis, sobriety, and prescriber restrictions; and the possibility of residual confounding.¹

“While a national hepatitis C elimination initiative including a subscription-based payment model covering Medicaid recipients has been proposed, Medicaid programs currently can remove all restrictive DAA prior authorization policies,” investigators concluded.¹ “In the absence of urgent interventions to improve access to lifesaving DAAs, hepatitis C treatment rates may continue to decline and diminish national progress of hepatitis C elimination efforts.”

References

1. ^{Furukawa NW, Ingber SZ, Symum H, et al. Medicaid Expansion and Restriction Policies for Hepatitis C Treatment. JAMA Netw Open. 2024;7(7):e2422406. doi:10.1001/jamanetworkopen.2024.22406}
2. ^{World Health Organization. Hepatitis C. Newsroom. April 9, 2024. Accessed July 17, 2024. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c}