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. 2024 Apr 5;5(4):e240302.
doi: 10.1001/jamahealthforum.2024.0302.

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

Sonya Davey  1 , Kevin Costello  2 , Massimiliano Russo  3 , Suzanne Davies  2 , Hussain S Lalani  1   4 , Aaron S Kesselheim  1   4 , Benjamin N Rome  1   4
Affiliations

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

Sonya Davey et al. JAMA Health Forum. .

Abstract

Importance: Direct-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.

Objective: To estimate how the prescribing of DAAs to Medicaid patients changed after states eased access restrictions.

Design, setting, and participants: This 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.

Exposure: Calendar 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 measures: Quarterly number of HCV DAA treatment courses per 100 000 Medicaid beneficiaries.

Results: Of 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 relevance: The 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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Davey completed this work while working at Brigham and Women's Hospital; she currently works for Sanofi. Mr Costello and Ms Davies reported receipt of grants for the Center for Health Law & Policy Innovation of Harvard Law School from Gilead Sciences, Bristol Myers Squibb Foundation, AbbVie, Janssen, MAC AIDS Foundation, and Viiv outside the submitted work. Mr. Costello and Ms. Davies have represented an array of plaintiffs in various lawsuits and prelitigation negotiations with state Medicaid programs related to hepatitis C virus treatment coverage restrictions. Dr Kesselheim reported serving as an expert witness on behalf of a class 15 of individual plaintiffs against Gilead related to approval of its tenofovir-containing drugs, and 16 on behalf of a class of state attorneys general and private payers related to generic drug prices. Dr Rome reported grants from the Elevance Health Public Policy Institute and National Academy for State Health Policy outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Trends Over Time in Use of Direct-Acting Antivirals Among States That Did Not Ease Restrictions vs Those That Did
The brown line shows the mean number of hepatitis C virus (HCV) treatment courses per 100 000 Medicaid enrollees from 2016 to 2019. The blue and orange lines stratify states based on whether they had eased or eliminated coverage restrictions up to that point. States changed from the did not ease restrictions to the did ease restrictions categories in the quarter (Q) when a change was made. The number of states in each group is shown below the x-axis. The average number of HCV treatment courses is an unweighted average of the states.
Figure 2.
Figure 2.. Average Difference in Direct-Acting Antiviral (DAA) Use in States That Eased vs Did Not Ease Coverage Restrictions
Each point shows the average difference in the number of DAA treatment courses per 100 000 Medicaid beneficiaries between states that eased restrictions and those that did not. Values greater than 0 represent higher use of DAAs in states that eased restrictions compared with those that did not. Time 0 is the calendar quarter (Q) during which the restrictions were eased, and the effect estimates in the 5 quarters before vs after this change are averaged across models for states that eased restrictions at different times from 2015 to 2019. Whiskers represent 95% CIs. HCV indicates hepatitis C virus.
Figure 3.
Figure 3.. Average Difference-in-Differences Estimates for Sensitivity Analyses
Each row represents the average difference in the number of direct-acting antiviral (DAA) treatment courses per 100 000 Medicaid enrollees per quarter (Q) in states that eased coverage restrictions compared with those that did not. Positive differences represent higher DAA use in states that eased restrictions. Results are shown for the primary analysis and 12 sensitivity analyses. Whiskers represent 95% CIs. HCV indicates hepatitis C virus.
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