Effect of relaxing hepatitis C treatment restrictions on direct-acting antiviral use in a Medicaid program: an interrupted time series analysis

Herink, Megan C.; Geddes, Jonah; Vo, Kim; Zaman, Atif; Hartung, Daniel

doi:10.18553/jmcp.2021.27.7.856

Cited by 10 publications

(10 citation statements)

References 14 publications

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“…The key to reducing mortality was using antiviral treatment in patients with the most advanced liver disease, as this population is most at risk of death[ 21 ]. It should be mentioned at this point that some countries initially reimbursed the therapy only for patients with advanced fibrosis and cirrhosis[ 22 ].…”

Section: Discussionmentioning

confidence: 99%

Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era

Brzdęk¹,

Zarębska-Michaluk²,

Rzymski³

et al. 2023

World J Gastroenterol

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BACKGROUND Nearly 290000 patients with chronic hepatitis C die annually from the most severe complications of the disease. One of them is liver cirrhosis, which occurs in about 20% of patients chronically infected with the hepatitis C virus (HCV). Direct-acting antivirals (DAAs), which replaced interferon (IFN)-based regimens, significantly improved the prognosis of this group of patients, increasing HCV eradication rates and tolerability of therapy. Our study is the first to assess changes in patient profile, effectiveness, and safety in the HCV-infected cirrhotic population in the IFN-free era. AIM To document changes in patient characteristics and treatment regimens along with their effectiveness and safety profile over the years. METHODS The studied patients were selected from 14801 chronically HCV-infected individuals who started IFN-free therapy between July 2015 and December 2021 in 22 Polish hepatology centers. The retrospective analysis was conducted in real-world clinical practice based on the EpiTer-2 multicenter database. The measure of treatment effectiveness was the percentage of sustained virologic response (SVR) calculated after excluding patients lost to follow-up. Safety data collected during therapy and the 12-wk post-treatment period included information on adverse events, including serious ones, deaths, and treatment course. RESULTS The studied population ( n = 3577) was balanced in terms of gender in 2015-2017, while the following years showed the dominance of men. The decline in the median age from 60 in 2015-2016 to 57 years in 2021 was accompanied by a decrease in the percentage of patients with comorbidities and comedications. Treatment-experienced patients dominated in 2015-2016, while treatment-naive individuals gained an advantage in 2017 and reached 93.2% in 2021. Genotype (GT)-specific options were more prevalent in treatment in 2015-2018 and were supplanted by pangenotypic combinations in subsequent years. The effectiveness of the therapy was comparable regardless of the period analyzed, and patients achieved an overall response rate of 95%, with an SVR range of 72.9%-100% for the different therapeutic regimens. Male gender, GT3 infection, and prior treatment failure were identified as independent negative predictors of therapeutic success. CONCLUSION We have documented changes in the profile of HCV-infected cirrhotic patients over the years of accessibility to changing DAA regimens, confirming the high effectiveness of IFN-free therapy in all analyzed periods.

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Section: Discussionmentioning

confidence: 99%

Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era

Brzdęk¹,

Zarębska-Michaluk²,

Rzymski³

et al. 2023

World J Gastroenterol

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“…Oregon Medicaid expanded coverage criteria for DAAs at the beginning of the study period, which made it possible for patients to afford these medications. 20 Our study had several limitations. Time restrictions associated with a pharmacy residency training program and due to the coronavirus disease (COVID-19) pandemic limited our ability to assess 12-week viral loads, cure rates, and some patient's laboratory values.…”

Section: Discussionmentioning

confidence: 91%

“…Oregon Medicaid expanded coverage criteria for DAAs at the beginning of the study period, which made it possible for patients to afford these medications. 20…”

Section: Discussionmentioning

confidence: 99%

Adherence to Hepatitis C Treatment Among Underserved Patients With Substance Use Disorder in a Pharmacist-led Treatment Model

McKenzie

Noble

Herink

et al. 2023

Journal of Pharmacy Practice

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Background Treatment with medications for opioid use disorder (MOUD) may improve hepatitis C virus (HCV) treatment outcomes by providing additional contact with health care professionals to support patient engagement. Objective: We describe a pharmacist-led HCV treatment model and assessed the effect of MOUD on adherence to direct-acting antivirals (DAAs) in an underserved patient population. Methods: This was a retrospective cohort study of adults (age≥18 years) treated for HCV infection with DAAs at a Federally Qualified Health Center in Portland, Oregon, between March 1, 2019, and March 16, 2020. Patients were followed to 12 weeks to assess adherence to DAAs by MOUD status. Results: Among 59 eligible patients, 16 (27%) were prescribed MOUD. Baseline characteristics were similar between patients who did and did not receive MOUD. Adherence to DAAs was overall high and not significantly different between the groups (median: 98.5% vs median: 100%; P = .06). Five patients missed at least one dose due to an adverse drug effect and two of these patients discontinued HCV therapy due to these effects. Conclusion: Adherence to HCV therapy was nearly 100% among underserved patients in a pharmacist-led HCV treatment model and did not differ by MOUD engagement.

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“…21,30 Other studies have identified increases in HCV treatment rates after changes to Medicaid coverage restrictions in Indiana, 31 4 New England states, 32 and Oregon. 33 To our knowledge, this study is the first to comprehensively evaluate the effect of easing DAA Medicaid coverage restrictions across the US. This approach had several strengths.…”

Section: Discussionmentioning

confidence: 99%

“… 21 , 30 Other studies have identified increases in HCV treatment rates after changes to Medicaid coverage restrictions in Indiana, 31 4 New England states, 32 and Oregon. 33 …”

Section: Discussionmentioning

confidence: 99%

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

Davey,

Costello,

Russo

et al. 2024

JAMA Health Forum

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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.

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Effect of relaxing hepatitis C treatment restrictions on direct-acting antiviral use in a Medicaid program: an interrupted time series analysis

Cited by 10 publications

References 14 publications

Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era

Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era

Adherence to Hepatitis C Treatment Among Underserved Patients With Substance Use Disorder in a Pharmacist-led Treatment Model

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

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