Jagpreet Chhatwal, PhD; Fasiha Kanwal, MD, MSHS; Mark S. Roberts, MD, MPP; Michael A. Dunn, MD
Acknowledgment: The authors thank Elamin Elbasha, PhD, and Scott Cantor, PhD, for constructive comments that improved the quality of the manuscript; Mina Kabiri, MS, and Qiushi Chen for help with data analysis; and Jill Delsigne, PhD, and Diane Hackett for editing the manuscript.
Financial Support: This study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number KL2TR000146. Dr. Kanwal was supported in part by the Veterans Affairs Health Services Research and Development Center for Innovations in Quality, Effectiveness and Safety (#CIN 13-413).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1336.
Reproducible Research Statement:Study protocol: Not applicable. Statistical code and data set: Available from Dr. Chhatwal (e-mail, JChhatwal@mdanderson.org).
Requests for Single Reprints: Jagpreet Chhatwal, PhD, Department of Health Services Research, Unit 1444, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030; e-mail, JChhatwal@mdanderson.org.
Current Author Addresses: Dr. Chhatwal: Department of Health Services Research, Unit 1444, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030.
Dr. Kanwal: Houston Veterans Affairs Health Services Research and Development Center for Innovations in Quality, Effectiveness and Safety, John P. McGovern Campus, 2450 Holcombe Boulevard, Suite 01Y, Houston, TX 77021.
Dr. Roberts: Department of Health Policy and Management, University of Pittsburgh, 130 Desoto Street, Pittsburgh, PA 15261.
Dr. Dunn: Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh, PUH, M2, C Wing, 200 Lothrop Street, Pittsburgh, PA 15213.
Author Contributions: Conception and design: J. Chhatwal, M.S. Roberts, M.A. Dunn.
Analysis and interpretation of the data: J. Chhatwal, F. Kanwal, M.S. Roberts, M.A. Dunn.
Drafting of the article: J. Chhatwal, M.A. Dunn.
Critical revision of the article for important intellectual content: J. Chhatwal, F. Kanwal, M.S. Roberts, M.A. Dunn.
Final approval of the article: J. Chhatwal, F. Kanwal, M.S. Roberts, M.A. Dunn.
Statistical expertise: J. Chhatwal.
Obtaining of funding: J. Chhatwal.
Administrative, technical, or logistic support: J. Chhatwal, M.S. Roberts.
Collection and assembly of data: J. Chhatwal.
Chhatwal J, Kanwal F, Roberts MS, Dunn MA. Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United States. Ann Intern Med. 2015;162:397-406. doi: 10.7326/M14-1336
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Published: Ann Intern Med. 2015;162(6):397-406.
Sofosbuvir and ledipasvir, which have recently been approved for treatment of chronic hepatitis C virus (HCV) infection, are more efficacious and safer than the old standard of care (oSOC) but are substantially more expensive. Whether and in which patients their improved efficacy justifies their increased cost is unclear.
To evaluate the cost-effectiveness and budget impact of sofosbuvir and ledipasvir.
Microsimulation model of the natural history of HCV infection.
Treatment-naive and treatment-experienced HCV population defined on the basis of HCV genotype, age, and fibrosis distribution in the United States.
Simulation of sofosbuvir–ledipasvir compared with the oSOC (interferon-based therapies).
Quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs.
Sofosbuvir-based therapies added 0.56 QALY relative to the oSOC at an ICER of $55 400 per additional QALY. The ICERs ranged from $9700 to $284 300 per QALY depending on the patient's status with respect to treatment history, HCV genotype, and presence of cirrhosis. At a willingness-to-pay threshold of $100 000 per QALY, sofosbuvir-based therapies were cost-effective in 83% of treatment-naive and 81% of treatment-experienced patients. Compared with the oSOC, treating eligible HCV-infected persons in the United States with the new drugs would cost an additional $65 billion in the next 5 years, whereas the resulting cost offsets would be $16 billion.
Results were sensitive to drug price, drug efficacy, and quality of life after successful treatment.
Data on real-world effectiveness of new antivirals are lacking.
Treatment of HCV is cost-effective in most patients, but additional resources and value-based patient prioritization are needed to manage patients with HCV.
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Gastroenterology/Hepatology, Infectious Disease, Healthcare Delivery and Policy, High Value Care, Viral Hepatitis.
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