![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
Abstract
Objective:
To evaluate the cost-effectiveness of the multivariate index assay (MIA) for use in triaging women with an adnexal mass relative to modified American College of Obstetricians and Gynecologists (mACOG) referral guidelines and CA-125 testing alone.
Methods:
The MIA triage algorithm was based on qualitative serum testing of five biomarkers: transthyretin, apolipoprotein, A-1, 2-microglobulin, transferrin, and CA-125. An economic analysis was developed to evaluate the clinical and cost implications of adopting MIA in clinical practice versus the mACOG referral guidelines and CA-125 alone, over a lifetime horizon, from the perspective of the public payer. Clinical parameters used to characterize patients’ disease status, quality of life, and treatment decisions were estimated using the results of published studies; costs were approximated using reimbursement rates from CMS fee schedules. Model endpoints included overall survival (OS), costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). The cost-effectiveness threshold was set to $50,000 per QALY. One-way sensitivity analysis was performed to assess uncertainty of individual parameters included in the analysis. All costs were reported in 2014 US dollars.
Results:
Use of MIA was cost-effective, resulting in fewer re-operations and pre-treatment CT scans. Overall MIA resulted in an ICER of $35,094/QALY gained. MIA was also cost-saving and QALY-increasing compared to use of CA-125 alone with an ICER of $12,189/QALY gained. One-way sensitivity analysis showed the ICER was most affected by the following parameters: (1) sensitivity of MIA; (2) sensitivity of mACOG; and (3) percentage of patients, not referred to a gynecologic oncologist, who were correctly diagnosed with advanced epithelial ovarian cancer (EOC).
Conclusion:
Use of MIA is a more cost-effective triage strategy than mACOG or CA-125. It is expected to increase the percentage of women with ovarian cancer that are referred to gynecologic oncologists, which is shown to improve clinical outcomes. Limitations include the use of assumptions when published data was unavailable, and the use of multiple sources for survival data.
Transparency
Declaration of funding
This research is supported by Vermillion Inc.
Declaration of financial/other relationships
J.H. and S.M. have disclosed that they were employees of Cedar Associates LLC during this research, which received funding from Vermillion Inc. to conduct this study. The primary research was solely the responsibility of the authors who are not affiliated with Vermillion Inc. G.K.F. has disclosed that he was supported by Ruth L. Kirschstein National Research Service Award Institutional Training Research Grant No. 2T32 CA06039611. R.E.B. has disclosed that he was supported in part by the Queen of Hearts Foundation and is on the Scientific Advisory Board of Vermillion LLC. Publication of the study results was not contingent on sponsor’s approval or censorship of the manuscript; analysis and its reporting was directed without influence from the sponsors.
The CMRO peer reviewer on this manuscript has received an honorarium from CMRO for the review work, but has no relevant financial or other relationships to disclose.
Acknowledgments
Jenny Tighe and Qianyi Li coordinated the research process and helped edit the manuscript. They are employees of Cedar Associates LLC, which received funding from Vermillion Inc. to participate in this study.
Previous presentation: Cost-effectiveness analysis of a multivariate index assay compared to modified ACOG criteria and CA-125 in the triage of women with adnexal masses. Annual Meeting of the American College of Medical Quality, March 2015, Alexandria, VA, USA.