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Original Research |

Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United StatesCost-Effectiveness of HCV Treatment With Sofosbuvir and Ledipasvir

Jagpreet Chhatwal, PhD; Fasiha Kanwal, MD, MSHS; Mark S. Roberts, MD, MPP; and Michael A. Dunn, MD
[+] Article, Author, and Disclosure Information

From the University of Texas MD Anderson Cancer Center, Baylor College of Medicine, Houston Veterans Affairs Health Services Research and Development Center of Excellence, and Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, and University of Pittsburgh Graduate School of Public Health and University of Pittsburgh, Pittsburgh, Pennsylvania.

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.


Ann Intern Med. 2015;162(6):397-406. doi:10.7326/M14-1336
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Background: 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.

Objective: To evaluate the cost-effectiveness and budget impact of sofosbuvir and ledipasvir.

Design: Microsimulation model of the natural history of HCV infection.

Data Sources: Published literature.

Target Population: Treatment-naive and treatment-experienced HCV population defined on the basis of HCV genotype, age, and fibrosis distribution in the United States.

Time Horizon: Lifetime.

Perspective: Third-party payer.

Intervention: Simulation of sofosbuvir–ledipasvir compared with the oSOC (interferon-based therapies).

Outcome Measures: Quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs.

Results of Base-Case Analysis: 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 of Sensitivity Analysis: Results were sensitive to drug price, drug efficacy, and quality of life after successful treatment.

Limitation: Data on real-world effectiveness of new antivirals are lacking.

Conclusion: Treatment of HCV is cost-effective in most patients, but additional resources and value-based patient prioritization are needed to manage patients with HCV.

Primary Funding Source: National Institutes of Health.

Figures

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Appendix Figure 1.

State-transition diagram of HCV treatment model for a cost-effectiveness analysis of sofosbuvir–ledipasvir.

At a given time, a patient occupies one of the health states represented by the circles or ovals. Arrows between states represent possible transitions based on annual probabilities. As time progresses, patients can transition to another state and acquire cost and health utilities associated with that state. The model stops when all patients transition to the death state. A patient could transition to a death state from any of the other states because of background mortality (these transitions are not shown for clarity). DC = decompensated cirrhosis; HCC = hepatocellular carcinoma; HCV = hepatitis C virus; LRD = liver-related death; LT = liver transplantation; SVR = sustained virologic response.

* The DC and LT states were further divided into first-year and subsequent-year states to account for different mortality rates and costs; however, they are collapsed into 1 state for presentation purposes only.

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Figure 1.

Total spending on sofosbuvir–ledipasvir to treat all HCV-infected patients in the United States in the next 5 y.

HCV = hepatitis C virus.

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Appendix Figure 2.

One-way sensitivity analysis showing the 10 most sensitive parameters.

DC = decompensated cirrhosis; HCC = hepatocellular carcinoma; ICER = incremental cost-effectiveness ratio; LDV = ledipasvir; oSOC = old standard of care; p: F4 to DC = probability of DC associated with METAVIR fibrosis score F4; p: F4 to HCC = probability of HCC associated with fibrosis score F4; p: Post-SVR to DC = probability of DC in patients with fibrosis score F4 who achieved SVR; QALY = quality-adjusted life-year; q: F1 = QOL weight associated with fibrosis score F1; q: F3 = QOL weight associated with fibrosis score F3; q: F4 = QOL weight associated with fibrosis score F4; QOL = quality of life; q: Post-SVR = QOL after achievement of SVR; SOF = sofosbuvir; SVR = sustained virologic response; SVR Delta: oSOC = reduction in SVR with the oSOC; SVR Delta: SOF–LDV = reduction in SVR with SOF–LDV.

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Figure 2.

Probability of cost-effectiveness of sofosbuvir–ledipasvir, by WTP threshold.

Results are from probabilistic sensitivity analysis. TE = treatment-experienced; TN = treatment-naive; WTP = willingness-to-pay.

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Figure 3.

ICERs of sofosbuvir–ledipasvir, by METAVIR fibrosis score (F0 to F4), sex, and age.

ICERs were higher for men because of their higher background mortality. ICER = incremental cost-effectiveness ratio; QALY = quality-adjusted life-year.

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