Changes in Use of Hepatitis C Direct-Acting Antivirals After Access Restrictions Were Eased by State Medicaid Programs

Abstract

ImportanceDirect-acting antivirals (DAAs) are safe and highly effective for curing hepatitis C virus (HCV) infection, but their high cost led certain state Medicaid programs to impose coverage restrictions. Since 2015, many of these restrictions have been lifted voluntarily in response to advocacy or because of litigation.ObjectiveTo estimate how the prescribing of DAAs to Medicaid patients changed after states eased access restrictions.Design, Setting, and ParticipantsThis modified difference-in-differences analysis of 39 state Medicaid programs included Medicaid beneficiaries who were prescribed a DAA from January 1, 2015, to December 31, 2019. DAA coverage restrictions were measured 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.ExposureCalendar quarter when states eased or eliminated 3 types of DAA coverage restrictions: limiting treatment to patients with severe liver disease, restricting use among patients with active substance use, and requiring prescriptions to be written by or in consultation with specialists. States with none of these restrictions at baseline were excluded.Main Outcomes and MeasuresQuarterly number of HCV DAA treatment courses per 100 000 Medicaid beneficiaries.ResultsOf 39 states, 7 (18%) eliminated coverage restrictions, 25 (64%) eased restrictions, and 7 (18%) maintained the same restrictions from 2015 to 2019. During this period, the average quarterly use of DAAs increased from 669 to 3601 treatment courses per 100 000 Medicaid beneficiaries. After states eased or eliminated restrictions, the use of DAAs increased by 966 (95% CI, 409-1523) treatment courses per 100 000 Medicaid beneficiaries each quarter compared with states that did not ease or eliminate restrictions.Conclusions and RelevanceThe results of this study suggest that there was greater use of DAAs after states relaxed coverage restrictions related to liver disease severity, sobriety, or prescriber specialty. Further reductions or elimination of these rules may improve access to a highly effective public health intervention for patients with HCV.

State Spending Targets for Prescription Drugs

“…In some cases, this could lead states to restrict patient access to highly effective and potentially life-saving therapies. For example, many state Medicaid programs restricted access to curative hepatitis C antivirals to prevent catastrophic surges in spending, which slowed the uptake of an important but costly public health intervention . More recently, in April 2024, the North Carolina State Health Plan opted to remove coverage of new highly effective antiobesity medications to prevent premiums from climbing by nearly $50 a month .…”

Medicaid Expansion and Restriction Policies for Hepatitis C Treatment

“…Previous studies have demonstrated a relative increase in DAA prescriptions following the lifting of DAA restrictions. 12 , 13 , 14 , 15 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. Furthermore, the historical experience of implementing DAA prior authorization requirements to prioritize hepatitis C treatment among certain groups may inform future decisions around implementing prior authorization for treatment of other conditions with public health implications.…”

“…Previous studies have demonstrated a relative increase in DAA prescriptions following the lifting of DAA restrictions . 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.…”