Mehdi Najafzadeh, PhD; Karin Andersson, MD; William H. Shrank, MD, MSHS; Alexis A. Krumme, MS; Olga S. Matlin, PhD; Troyen Brennan, MD, JD, MPH; Jerry Avorn, MD; Niteesh K. Choudhry, MD, PhD
Acknowledgment: The authors thank Danielle L. Isaman, BS, for her administrative support.
Grant Support: By an unrestricted grant from CVS Health to Brigham and Women's Hospital. Dr. Najafzadeh received a Canadian Institutes of Health Research (CIHR) fellowship during the study.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1152.
Reproducible Research Statement:Study protocol: Not applicable. Statistical code: Available from Dr. Najafzadeh (e-mail, firstname.lastname@example.org). Data set: Input parameters and sources are provided in the text.
Requests for Single Reprints: Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital, Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, email@example.com.
Current Author Addresses: Drs. Najafzadeh, Avorn, and Choudhry and Ms. Krumme: Division of Pharmacoepidemiology and Pharmacoeconomics, 1620 Tremont Street, Suite 3030, Boston, MA 02120.
Dr. Andersson: Massachusetts General Hospital, 55 Fruit Street, Blake Building, Boston, MA 02114-2696.
Drs. Shrank and Brennan: CVS Health, One CVS Drive, Mailstop 4036, Woonsocket, RI 02895.
Dr. Matlin: CVS Health, 2211 Sanders Road, Northbrook, IL 60062.
Author Contributions: Conception and design: M. Najafzadeh, K. Andersson, W.H. Shrank, T. Brennan, N.K. Choudhry.
Analysis and interpretation of the data: M. Najafzadeh, W.H. Shrank, A.A. Krumme, J. Avorn, N.K. Choudhry.
Drafting of the article: M. Najafzadeh, A.A. Krumme, N.K. Choudhry.
Critical revision of the article for important intellectual content: M. Najafzadeh, W.H. Shrank, O.S. Martin, T. Brennan, J. Avorn, N.K. Choudhry.
Final approval of the article: M. Najafzadeh, K. Andersson, W.H. Shrank, O.S. Martin, J. Avorn, N.K. Choudhry.
Statistical expertise: M. Najafzadeh, N.K. Choudhry.
Obtaining of funding: O.S. Martin, T. Brennan, N.K. Choudhry.
Administrative, technical, or logistic support: W.H. Shrank, A.A. Krumme, O.S. Martin, T. Brennan, J. Avorn, N.K. Choudhry.
Collection and assembly of data: M. Najafzadeh, K. Andersson, W.H. Shrank.
New regimens for hepatitis C virus (HCV) have shorter treatment durations and increased rates of sustained virologic response compared with existing therapies but are extremely expensive.
To evaluate the cost-effectiveness of these treatments under different assumptions about their price and efficacy.
Treatment-naive patients infected with chronic HCV genotype 1, 2, or 3.
Usual care (boceprevir–ribavirin–pegylated interferon [PEG]) was compared with sofosbuvir–ribavirin–PEG and 3 PEG-free regimens: sofosbuvir–simeprevir, sofosbuvir–daclatasvir, and sofosbuvir–ledipasvir. For genotypes 2 and 3, usual care (ribavirin–PEG) was compared with sofosbuvir–ribavirin, sofosbuvir–daclatasvir, and sofosbuvir–ledipasvir–ribavirin (genotype 3 only).
Discounted costs (in 2014 U.S. dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.
Assuming sofosbuvir, simeprevir, daclatasvir, and ledipasvir cost $7000, $5500, $5500, and $875 per week, respectively, sofosbuvir–ledipasvir was cost-effective for genotype 1 and cost $12 825 more per QALY than usual care. For genotype 2, sofosbuvir–ribavirin and sofosbuvir–daclatasvir cost $110 000 and $691 000 per QALY, respectively. For genotype 3, sofosbuvir–ledipasvir–ribavirin cost $73 000 per QALY, sofosbuvir–ribavirin was more costly and less effective than usual care, and sofosbuvir–daclatasvir cost more than $396 000 per QALY at assumed prices.
Sofosbuvir–ledipasvir was the optimal strategy in most simulations for genotype 1 and would be cost-saving if sofosbuvir cost less than $5500. For genotype 2, sofosbuvir–ribavirin–PEG would be cost-saving if sofosbuvir cost less than $2250 per week. For genotype 3, sofosbuvir–ledipasvir–ribavirin would be cost-saving if sofosbuvir cost less than $1500 per week.
Data are lacking on real-world effectiveness of new treatments and some prices.
From a societal perspective, novel treatments for HCV are cost-effective compared with usual care for genotype 1 and probably genotype 3 but not for genotype 2.
Najafzadeh M, Andersson K, Shrank WH, et al. Cost-Effectiveness of Novel Regimens for the Treatment of Hepatitis C Virus. Ann Intern Med. 2015;162:407–419. doi: https://doi.org/10.7326/M14-1152
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Published: Ann Intern Med. 2015;162(6):407-419.
Gastroenterology/Hepatology, Healthcare Delivery and Policy, High Value Care, Infectious Disease, Viral Hepatitis.
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