Top Hepatitis C Articles for the Year

Hepatitis C infections continue to be a huge burden on the United States healthcare system. While there is a cure for the disease, there are 3 million Americans infected with the virus and the treatment has a hefty price tag that could cost upwards of $100,000 for a full course of treatment.

Here are the top 5 papers published by The American Journal of Managed Care and its sister publications about hepatitis C, treatment, and costs of care.

Revolutionizing Treatment Outcomes in Hepatitis C: Managed Care Implications and Considerations—The New and Evolving Standards of Care

Although the prevalence of hepatitis C virus (HCV) infection is declining, overall costs associated with HCV infection and the burden of advanced liver disease are projected to increase. The recent approval of all-oral, fixed-dose combination treatments for patients with HCV infection has resulted in unprecedented rates of treatment success, and in debate regarding treatment costs and appropriation. With all-oral therapies becoming the standard of care for HCV infection, high drug costs and improved clinical outcomes—now including the eradication of disease—must be weighed when selecting the most appropriate therapy. Patient “warehousing” has reached an all-time high as payers and providers strive to strike the fine balance between clinical efficacy and cost-effectiveness of currently available treatments, and this “wait and see” period may very well continue until an acceptable balance has been achieved. As such, it is imperative that managed care clinicians maintain an informed understanding of the disease burden and current climate of HCV infection in the United States.

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Developing Evidence That Is Fit for Purpose: A Framework for Payer and Research Dialogue

A decision-making framework that can be used to harmonize the evidence payer’s desire for coverage and formulary decisions with the evidence generated by researchers. The framework was applied to 3 clinical cases: 1) determining coverage for a new hepatitis C virus therapy (sofosbuvir); 2) confirming coverage for oral anticoagulants (rivaroxaban, dabigatran, apixaban); and 3) limiting utilization for a multiple sclerosis therapy (natalizumab) with known safety concerns.

Take-Away Points

Key insights into when new evidence is needed to inform payer decision making and what issues should be addressed include:

• Payers are not necessarily seeking more evidence about treatment efficacy. Rather, they are seeking more evidence for relevant end points.
• Payers are interested in obtaining new evidence that goes beyond efficacy with an emphasis on effectiveness, longer-term safety, and delivery system impact.
• In an era focused on care coordination, quality of care, and risk sharing, evidence to understand and improve outcomes associated with real-world use take on increasing importance.

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On Lessons Learned: Express Scripts’ Steve Miller, MD, Discusses HCV Experience, PCSK9 Inhibitors, and More

On the eve of FDA's deadline for acting on the first of an expensive new class of cholesterol therapies, the chief medical officer of the nation's largest pharmacy benefit manager weighed in on what steps it is taking on behalf of customers in this changing landscape.

The pharmacy benefits manager (PBM) Express Scripts has made news in recent months with its novel strategies for containing drug costs. Steve Miller, MD, senior vice president and chief medical officer, explains why costs have risen so fast, which new drugs could break the bank, and how payers might be able to keep prices reasonable without stifling innovation.

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Evaluation of Dual Versus Triple Therapy for Hepatitis C

In this retrospective chart review, patients with hepatitis C had a sustained virologic response with either dual or triple therapy.

Take-Away Points

A retrospective analysis examined the efficacy and safety outcomes of treatment-naïve, genotype 1 patients with hepatitis C virus (HCV) treated with either dual or triple therapy.

• Sustained virologic response in both treatment groups was found to be comparable to that in published randomized controlled trials.
• More patients in the triple-therapy group had hospitalizations, emergency department visits, and transfusions.
• Anemia, nausea, and shortness of breath were more common in the triple-therapy treatment group.
• Most patients completed the HCV treatment course, and the majority of patients received concomitant medication(s) to assist with the mitigation of adverse effects.

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Direct and Indirect Cost Burden of Chronic Hepatitis C

An estimation of the direct healthcare and indirect work-loss cost burden of chronic hepatitis C virus using health insurance claims covering 13 million individuals.

Take-Away Points

• In this study, patients with chronic hepatitis C virus (HCV) were hospitalized 2.5 times more frequently, visited an emergency department 1.9 times more frequently, and visited outpatient clinics 1.7 times more frequently, relative to a matched cohort of patients without HCV.
• Patients with chronic HCV had significantly higher direct healthcare and indirect work-loss cost burden compared with non—HCV-infected individuals, and the magnitude of the cost burden increased with disease severity.
• This study suggests that providing early therapeutic interventions that may prevent liver disease progression related to HCV can potentially further reduce the economic burden associated with chronic hepatitis infection.

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