Nick Bansback, PhD; Ciaran S. Phibbs, PhD; Huiying Sun, PhD; James R. O'Dell, MD; Mary Brophy, MD, MPH; Edward C. Keystone, MD; Sarah Leatherman, PhD; Ted R. Mikuls, MD, MSPH; Aslam H. Anis, PhD; for the CSP 551 RACAT Investigators *
Note: Dr. Bansback is a Canadian Institutes of Health Research New Investigator.
Acknowledgment: The authors thank Amgen for donating the placebo etanercept and Tima Mohammadi for her help with the lifetime model analysis.
Disclosures: Dr. Bansback reports grants from Canadian Institutes for Health Research during the conduct of the study. Dr. O'Dell reports nonfinancial support from the U.S. Department of Veterans Affairs during the conduct of the study. Dr. Keystone reports grants and personal fees from Abbott Laboratories, Amgen, AstraZeneca, Bristol-Myers Squibb, Hoffmann-La Roche, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB; personal fees from Biotest, Crescendo Bioscience, Genentech, and Merck; and grants from Sanofi-Aventis, outside the submitted work. Dr. Mikuls reports personal fees from Pfizer and grants from Bristol-Myers Squibb and Roche Genentech outside the submitted work. Dr. Anis reports grants from Canadian Institutes for Health Research during the conduct of the study and grants and personal fees from Pfizer, personal fees from Sanofi, and grants from AbbVie outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0713.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Not available. Statistical code: Available from Dr. Bansback (e-mail, email@example.com). Data set: Individual-level RACAT data are not available; statistical results are presented in the Supplement.
Requests for Single Reprints: Nick Bansback, PhD, 588-1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Bansback, Sun, and Anis: 588-1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Dr. Phibbs: 795 Willow Road (152MPD), Menlo Park, CA 94025.
Dr. O'Dell: 4101 Woolworth Avenue, Omaha, NE 68105.
Drs. Brophy and Leatherman: 150 South Huntington Avenue, Jamaica Plain, MA 02130.
Dr. Keystone: 60 Murray Street, Room 2-006, Box 4, Toronto, Ontario M5T 3L9, Canada.
Dr. Mikuls: 986270 Nebraska Medical Center, Omaha, NE 68198.
Author Contributions: Conception and design: N. Bansback, C.S. Phibbs, J.R. O'Dell, M. Brophy, A.H. Anis.
Analysis and interpretation of the data: N. Bansback, C.S. Phibbs, H. Sun, J.R. O'Dell, M. Brophy; E.C. Keystone.
Drafting of the article: N. Bansback, J.R. O'Dell, M. Brophy, T.R. Mikuls, A.H. Anis.
Critical revision for important intellectual content: N. Bansback, C.S. Phibbs, J.R. O'Dell, M. Brophy, E.C. Keystone, T.R. Mikuls, A.H. Anis.
Final approval of the article: N. Bansback, C.S. Phibbs, H. Sun, J.R. O'Dell, M. Brophy, E.C. Keystone, S. Leatherman, T.R. Mikuls, A.H. Anis.
Provision of study materials or patients: N. Bansback, J.R. O'Dell, M. Brophy, T.R. Mikuls.
Statistical expertise: N. Bansback, H. Sun.
Obtaining of funding: C.S. Phibbs, J.R. O'Dell, M. Brophy, A.H. Anis.
Administrative, technical, or logistic support: J.R. O'Dell, M. Brophy, A.H. Anis.
Collection and assembly of data: C.S. Phibbs, J.R. O'Dell, M. Brophy, S. Leatherman, T.R. Mikuls.
The RACAT (Rheumatoid Arthritis Comparison of Active Therapies) trial found triple therapy to be noninferior to etanercept–methotrexate in patients with active rheumatoid arthritis (RA).
To determine the cost-effectiveness of etanercept–methotrexate versus triple therapy as a first-line strategy.
A within-trial analysis based on the 353 participants in the RACAT trial and a lifetime analysis that extrapolated costs and outcomes by using a decision analytic cohort model.
The RACAT trial and sources from the literature.
Patients with active RA despite at least 12 weeks of methotrexate therapy.
24 weeks and lifetime.
Societal and Medicare.
Etanercept–methotrexate first versus triple therapy first.
Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).
The within-trial analysis found that etanercept–methotrexate as first-line therapy provided marginally more QALYs but accumulated substantially higher drug costs. Differences in other costs between strategies were negligible. The ICERs for first-line etanercept–methotrexate and triple therapy were $2.7 million per QALY and $0.98 million per QALY over 24 and 48 weeks, respectively. The lifetime analysis suggested that first-line etanercept–methotrexate would result in 0.15 additional lifetime QALY, but this gain would cost an incremental $77 290, leading to an ICER of $521 520 per QALY per patient.
Considering a long-term perspective, an initial strategy of etanercept–methotrexate and biologics with similar cost and efficacy is unlikely to be cost-effective compared with using triple therapy first, even under optimistic assumptions.
Data on the long-term benefit of triple therapy are uncertain.
Initiating biologic therapy without trying triple therapy first increases costs while providing minimal incremental benefit.
The Cooperative Studies Program, Department of Veterans Affairs Office of Research and Development, Canadian Institutes for Health Research, and an interagency agreement with the National Institutes of Health–American Recovery and Reinvestment Act.
Bansback N, Phibbs CS, Sun H, O'Dell JR, Brophy M, Keystone EC, et al. Triple Therapy Versus Biologic Therapy for Active Rheumatoid Arthritis: A Cost-Effectiveness Analysis. Ann Intern Med. ;167:8–16. doi: 10.7326/M16-0713
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Published: Ann Intern Med. 2017;167(1):8-16.
Published at www.annals.org on 30 May 2017
Healthcare Delivery and Policy, High Value Care, Rheumatoid Arthritis, Rheumatology.
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