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The Cost-effectiveness, Health Benefits, and Financial Costs of New Antiviral Treatments for Hepatitis C Virus and Editorial
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"New treatments are cost-effectiveness......at least six published studiesfound HCV testing and treatment to be cost-effectiveness.....In 2012, the US Centers for Disease Control and Prevention (CDC) recommended that Americans born during 1945-1965 receive a one-time antibody test to identify hepatitis C virus (HCV) infection (birth-cohort testing) ....In 2013, this recommendation was affirmed by theUnited States Preventive Services Task Force (USPSTF) citing the large health benefits of birth cohort testing predicted by modeling studies".....[from Jules: yet we have no major commitment to fund HCV screening]
Clinical Infectious Diseases Advance Access
published March 16, 2015
David B. Rein1, John S. Wittenborn1, Bryce D. Smith2, Danielle K. Liffmann1, John W. Ward2
1NORC at the University of Chicago, Public Health Department. 3520 Piedmont Rd. N.E., Suite 225, Atlanta, GA 30305 2U.S. Centers for Disease Control and Prevention, Division of Viral Hepatitis, 1600 Clifton Road, Atlanta, GA 30333
New hepatitis C virus (HCV) treatments deliver higher cure rates with fewer contraindications increasing demand for treatment and health care costs. The cost-effectiveness of new treatments is unknown.
Methods. We conducted a microsimulation of guideline testing followed by alternative treatment regimens for HCV among the U.S. population aged 20 and older to estimate cases identified, treated, sustained viral response (SVR); deaths; medical costs; quality-adjusted life years (QALYs); and the incremental cost-effectiveness ratio (ICER) of different treatment options expressed as discounted lifetime costs and benefits from the healthcare perspective.
Results. Compared to treatment with pegylated interferon, ribavirin (PR), and a protease inhibitor (PI) for HCV genotype (G) 1 and PR alone for G2/3, treatment with PR and Sofosbuvir (PRS) for G1/4 and treatment with Sofosbuvir and ribavirin (SR) for G2/3 increased QALYs by 555,226, reduced deaths by 80,682, at an incremental cost of $26.2 billion, and an ICER of $47,304 per QALY gained. As compared to PRS/SR, treating with an all oral regimen of Sofosbuvir and Simeprevir (SS) for G1/4 and SR for G2/3, increased QALYs by 1,110,451 and reduced deaths by an additional 164,540 at an incremental cost of $80.1 billion and an ICER of $72,169. In sensitivity analysis, where treatment with SS effectiveness was set to the list price of Viekira Pak™ and then Harvoni™, treatment cost $24,921 and $25,405 per QALY gained as compared to SS/SR [correction: should be PRS/SR].
Conclusions. New treatments are cost-effectiveness per person treated but pent up demand for treatment may create challenges for financing.
With no testing or treatment (scenario 1), we estimated that 1.18 million of those chronically infected (41.1%) would develop DCC or HCC and die in those states prior to model termination at age 100 (Table 2). For comparison to other studies, the model's 45-year mortality rate was 18.7% assuming age of infection of 25 years and a starting fibrosis state of F0. With no testing or treatment, currently infected patients were expected to generate $100.3 billion in discounted incremental hepatitis C medical costs during their lifetimes.
Our estimates indicate that the treatment alternatives for HCV of pegylated interferon combined with ribavirin and Sofosbuvir, and the all-oral combinations of Sofosbuvir and Simeprevir increase QALYs compared to their alternatives at a cost of $47,237 per QALY gained for PRS/SR and $72,169 per QALY gained for SS/SR. During review of this article, two interferon-free combination treatments for genotype 1 HCV patients (Harvoni™ and Viekira Pak™) with lower list prices ($94,500 and $83,319) compared to SS/SR. Assuming an equal effectiveness for these combinations as for SS, the lower prices would result in cost-effectiveness of approximately $25,000 per QALY gained for new treatments compared to PRS/SR, and of approximately $32,000 to $35,000 per QALY gained compared to NT. Potentially lower prices would improve treatment cost-effectiveness further.
However, financing the treatment of all Americans who could benefit from antiviral therapy will be a continuing challenge given the number of individuals who are undiagnosed, untreated, or failed to respond to older treatment regimens. Simply linking diagnosed patients to clinical settings in which they can be evaluated for treatment remains an ongoing challenge which is likely to reduce the potential benefits and costs of new treatments for the foreseeable future.
Our paper reports an overall mortality rate of 41% among prevalent hepatitis C cases given NT [no treatment], a rate higher than reported in earlier model publications.[2, 22]
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