Does the Use of Hepatitis C Antivirals Surge Following an Easing of Medicaid Coverage Restrictions?

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There are more than two million people in the United States who have a chronic hepatitis C virus (HCV) infection, which was also associated with a 400% increase in new HCV infections from 2004 to 2014, a statistic partially attributed to the opioid epidemic. On top of that, in 2019, HCV-related complications were responsible for more than 14,000 deaths in the United States, equivalent to more than the next 60 infectious diseases combined before the COVID-19 pandemic.¹

Direct-acting antivirals (DAAs) are used for virologic suppression, but often come with a high price tag. For example, sofosbuvir—approved back in 2013—was introduced to the marketplace at a price point above $80,000 for a 12-week treatment course.

In order to combat the high upfront costs, payers have enforced varying restrictions that controlled access to these DAAs, which were adopted by state Medicaid programs. These programs cover an estimated 80% of patients with HCV.

However, from 2015 to 2023, many state Medicaid programs have decided to either reduce or completely remove DAA coverage restrictions. A study published in JAMA Health Forum¹ sought to predict the impact that this decision had on the prescription of DAAs to Medicaid patients.

“Although sofosbuvir was cost-effective even at such a high price, the substantial cost of these drugs combined with a high prevalence of disease was associated with an 18% increase in national per capita prescription drug spending between 2013 and 2015, straining budgets of public and private payers,” the study authors wrote. “To control the high upfront cost of treatment, payers imposed varying degrees of restrictions that limited access to DAAs.”

For the study, investigators reviewed the quarterly use of DAAs in 51 Medicaid programs (50 states plus Washington, DC) from Jan. 1, 2015, to Dec. 31, 2019, coinciding with when the first combination DAA (ledipasvir/sofosbuvir) was introduced during Q4 2014, and when national hepatology and infectious disease associations recommended treatment of all patients with chronic HCV with DAAs (excluding those with limited life expectancy due to non-hepatic causes).

Twelve programs were removed from analysis, due to a combination of suppressed DAA use data, a lack of DAA restrictions, and after two of them switched some of their Medicaid population to a subscription-based payment system for DAAs, leaving 39 programs.

Coverage restrictions were measured according to three areas, and each state’s respective policies were defined as either being strict, lenient, or having no restriction:

1. Requirements for minimum disease severity that were measured with the liver fibrosis score
2. Requirements for periods of sobriety prior to treatment
3. Limited prescribing to specific specialists

After conducting this difference-in-differences analysis, 32 programs either eased or eliminated restrictions during the four-year timeframe. The changes in coverage resulted in an additional 966 (95% confidence interval, 409-1523) DAA treatment courses per 100,000 Medicaid beneficiaries per quarter, compared to those states without changes.

“A notable finding from this study was that changes in easing of state restrictions were associated with higher DAA use when DAAs were reimbursed predominantly via fee-for-service Medicaid but not managed care organizations. The most likely explanation is that DAA coverage policies in managed care organizations sometimes deviate from the statewide policies,” the study authors wrote. “A previous study found that HCV DAA use increased after 4 states carved out coverage of DAAs from Medicaid managed care organizations. Together, these findings suggest that better state and federal enforcement is needed to ensure that managed care organizations offer DAA coverage that is no more restrictive than the state rules.”

This specific study presented its share of limitations, one being the fact that investigators prioritized three main Medicaid coverage restrictions while not considering changes in other restrictions, such as documentation of psychiatric and/or housing stability, prohibitions on replacement of lost or stolen medications, requirements to fill DAAs at specialty pharmacies, prior authorization requirements, required documentation of HCV genotype, and review of past adherence to other prescribed medications.

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

Reference

1. Davey S, Costello K, Russo M, et al. Changes in Use of Hepatitis C Direct-Acting Antivirals After Access Restrictions Were Eased by State Medicaid Programs. JAMA Health Forum. 2024;5(4):e240302. doi:10.1001/jamahealthforum.2024.0302