Vermillion Reports Landmark OVA1 Cost-Effectiveness Analysis Compared to Current Standard at ACMQC

Vermillion, Inc.

, a bio-analytical solutions company focused on gynecologic disease, today announced initial results from a cost-effectiveness analysis study which will be presented today at the Annual Meeting of the American College of Medical Quality in Alexandria, Virginia. The study was co-authored by Dr. Robert E. Bristow and Dr. Gareth K. Forde, clinicians at the UC Irvine and Dr. John Hornberger, a leading health economist at Stanford University School of Medicine. This new study, entitled: "Cost Effectiveness Analysis of a Multivariate Index Assay compared to Modified ACOG Criteria and CA-125 in the Triage of Women with Adnexal Masses", further establishes important advantages that OVA1^® may provide in the detection, triage and cost-effective management of ovarian cancer. Recent publications continue to show a dire national status quo for women with ovarian cancer, in which the majority are detected at late stage with only 10-25% having a five-year survival, despite the existence of treatment pathways that have been shown to improve overall survival by as much as 30%. The study compared clinical outcomes and costs using OVA1 versus the off-label but commonly used CA-125 (CA 125-II), an ovarian cancer biomarker, or current gynecologic best-practice care known as Dearking-modified ACOG guidelines (mod-ACOG). Model endpoints included overall survival, costs, quality-adjusted life years (QALY) and incremental cost effectiveness ratio (ICER). The analysis considered a lifetime horizon from the standpoint of a public payer (using Medicare reimbursement rates) and an accepted cost-effectiveness threshold of $50,000 per QALY. The analysis reported by Dr. Forde and his colleagues differed from previous studies in that it: o Utilized OVA1 test performance characteristics derived directly from two OVA1 clinical trials o Compared cost-effectiveness using only common, validated benchmark protocols and cutoffs o Evaluated a single prospectively enrolled and double-blinded registry study cohort for which each benchmark method was compared on a per-patient basis with OVA1 results o Included an expert treatment decision path analysis, independently published epidemiology and quality of life utility assumptions and a robust hidden Markov model methodology o Considered direct costs from a Medicare reimbursement perspective, and separately, inclusion of indirect costs associated with lost patient and caregiver productivity Several important health economic and quality outcomes conclusions were reported in the new study: o Use of OVA1 resulted in fewer projected re-operations and pre-treatment CT scans versus CA 125-II or mod-ACOG o OVA1 was QALY-increasing and cost-effective relative to CA 125-II or mod-ACOG o ICERs of $12,189/QALY and $35,094/QALY were calculated versus CA 125-II and mod-ACOG, respectively; resulting in a "cost-effective" outcome based on the $50,000 threshold o Relative to the best-practice mod-ACOG benchmark, OVA1 projected an annual increase in patient survival and QALY in excess of 1,000 years, when the surgical cohort was projected to national annual adnexal mass surgeries including about 22,000 new cases of ovarian cancer Valerie Palmieri, President and Chief Executive Officer of Vermillion, stated, "Vermillion's goal is to ensure each patient with an adnexal mass receives optimal treatment in the most efficient way while markedly improving the quality and cost of care, one life at a time. We expect payers and clinicians to welcome this rigorous analysis showing how OVA1 compares to standard of care diagnostics in achieving quality outcomes and cost-effectiveness. The findings clearly demonstrate that the time has come to evaluate retiring off-label use of CA 125-II for ovarian cancer triage, and to consider updating the ACOG guidelines to include the more sensitive and cost-effective use of OVA1 for pre-surgical evaluation of ovarian cancer risk."