Hepatitis C Therapy Increased After State Medicaid Eased Treatment Restrictions

Findings from a recent study are providing an overview of changes in direct-acting antiviral (DAA) use following modifications to state Medicaid program hepatitis C virus (HCV) treatment coverage restrictions, highlighting greater DAA uptake after states relaxed their policies related to liver disease severity, sobriety, or prescriber specialty.¹

Results published in JAMA Health Forum allude to the potential to improve access to curative HCV treatment by further loosening or eliminating such restrictions, supported by evidence of a significant increase in the number of patients treated for HCV across 32 state Medicaid programs that eased or eliminated their coverage restrictions compared to those that maintained restrictions.¹

“To our knowledge, this study is the first to comprehensively evaluate the effect of easing DAA Medicaid coverage restrictions across the US,” Sonya Davey, MD, resident physician in internal medicine at Harvard Medical School/Brigham and Women's Hospital, and colleagues wrote.¹

What You Need to Know

States that relaxed their policies related to liver disease severity, sobriety, or prescriber specialty saw greater uptake of DAAs for HCV treatment. The study found a significant increase in the number of patients treated for HCV across 32 state Medicaid programs that eased or eliminated their coverage restrictions compared to those that maintained restrictions.

Findings suggest that further loosening or eliminating restrictions could improve access to curative HCV treatment. This aligns with the World Health Organization's goal of eliminating viral hepatitis as a public health problem by 2030, which includes reducing incidence and mortality.

Easing or eliminating restrictions related to liver disease severity and prescriber specialty were associated with increased use of DAAs, while changes in sobriety restrictions did not significantly affect DAA use.

The World Health Organization (WHO) estimates 50 million people have chronic HCV infection, with about 1 million new infections occurring every year.2 In 2016, the WHO set a goal to eliminate viral hepatitis as a public health problem by 2030, including a 90% reduction in incidence and a 65% reduction in mortality compared with a 2015 baseline. Although DAAs offer an effective cure for HCV, access to treatment and care remains an issue hindering their uptake, attributed partially to their high cost.³

To better understand the extent to which state Medicaid program restrictions limited treatment of HCV among Medicaid beneficiaries, investigators performed a difference-in-differences analysis to measure whether the use of DAAs increased in states that lifted or eased restrictions compared to states with no changes. They examined DAA prescriptions among Medicaid beneficiaries from 39 state Medicaid programs, measuring DAA coverage restrictions based on a series of cross-sectional assessments performed from 2014 through 2022 by the US National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation.¹

Quarterly use of DAAs in each Medicaid program was examined from January 1, 2015, to December 31, 2019. Investigators noted this period was selected to begin after the first combination DAA therapy (ledipasvir/sofosbuvir) was introduced during the last quarter of 2014 and national hepatology and infectious disease associations recommended treatment of all individuals with chronic HCV with DAAs, ending the study before 2020 to avoid confounding by changes in access to treatment that occurred during the COVID-19 pandemic.¹

Coverage restrictions were measured in 3 domains: requirements for minimum disease severity measured with the liver fibrosis score, requirements for periods of sobriety before treatment, and limited prescribing to certain specialists. For each domain, investigators stratified each state’s policies as strict, lenient, or no restriction.¹

Among the 39 Medicaid programs included in the study, 7 (18%) states eliminated all 3 DAA coverage restrictions, 25 (64%) eased restrictions, and 7 (18%) maintained the same restrictions from 2015 to 2019. Compared to the states with no changes, investigators pointed out those that eased or eliminated restrictions were more likely to have strict baseline restrictions for disease severity (75% vs 43%), but there were no other significant differences for baseline prescriber or sobriety restrictions, source of Medicaid reimbursement, state HCV prevalence, Medicaid expansion status, and US region.¹

The mean use of HCV treatment in all states increased from 669 to 3601 treatment courses per 100,000 Medicaid beneficiaries from the first quarter of 2015 to the last quarter of 2019. After states eased or eliminated restrictions, the use of DAAs increased by 966 (95% CI, 395 to 1537) treatment courses per 100,000 Medicaid beneficiaries each quarter compared with states that did not ease or eliminate restrictions.¹

When investigators examined each of the 3 domains separately, they found easing or eliminating restrictions related to liver disease severity (986; 95% CI, 512 to 1460) and prescriber specialty (869; 95% CI, 283 to 1456) were associated with increased use of DAAs, while changes in sobriety restrictions were not associated with a change in DAA use (53; 95% CI, −321 to 427).¹

Investigators highlighted several potential limitations to these findings, including the fact they did not account for changes in other Medicaid coverage restrictions, possible lack of generalizability to those with private insurance or Medicare part D plans, and use of calculations based on the FDA-recommended duration for treatment-naive patients without decompensated cirrhosis that may not account for patients who did not fit this assumption.¹

“In this study, from 2015 to 2019, treatment of HCV with DAAs increased after state Medicaid programs eased coverage restrictions compared with states that did not ease restrictions,” investigators concluded.1 “Further reductions or eliminations of these restrictions may maximize the public health effect of these safe and effective treatments for HCV.”