Ovarian Cancer News: OVA1 Cost-Effectiveness Analysis Compared to Current Standard of Care for Ovarian Cancer Presented at Medical Conference

Ovarian Cancer News: OVA1 Cost-Effectiveness Analysis Compared to Current Standard of Care for Ovarian Cancer Presented at Medical Conference


Ovarian Cancer News: OVA1 Cost-Effectiveness Analysis Compared to Current Standard of Care for Ovarian Cancer Presented at American College of Medical Quality Conference

Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, today announced initial results from a cost-effectiveness analysis study presented today at the Annual Meeting of the American College of Medical Quality in Alexandria, Virginia.  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,” addresses advantages that OVA1® may provide in the detection, triage and cost-effective management of ovarian cancer.
As reported in the Fourth Quarter 2014 Vermillion Earnings Conference Call on March 25, 2015, Valerie Palmieri, President and Chief Executive Officer of Vermillion, explained that “Vermillion’s new mission has expanded from ovarian cancer to driving care path lead solutions for all benign and malignant pelvic mass conditions. The estimated size of this market is 1 million patients in the U.S. Our primary mission is to improve patient outcomes, increase physician effectiveness and thus reduce the cost of healthcare via proprietary technology and informatics.”
Vermillion’s initial focus starts with ovarian cancer, the cancer with the highest mortality rate of all gynecologic cancers. The goal is to provide diagnostic solutions with Vermillion’s patented technologies to determine the risk of malignancy and thereby ensure patients receive optimal treatment in the shortest amount of time.
Palmieri explained, “Two patients die every hour from ovarian cancer. Currently, the diagnosis for these patients frequently comes too late to change the outcome. We have the ability to change this.”
To improve clinical outcomes for physicians, payers and most of other patients, Vermillion does not believe there is one silver bullet that solves the healthcare paradigms. “It is the compilation of clinical data, other modalities and diagnostics to drive optimal care,” said Palmieri.
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.
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SOURCE: Vermillion [NASDAQ: VRML]

Landmark OVA1 Cost-Effectiveness Analysis Compared to Current Standard of Care for Ovarian Cancer Presented at American College of Medical Quality Conference

AUSTIN, Texas, March 27, 2015 /PRNewswire/ — Vermillion, Inc. (NASDAQ: VRML), 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:
   Utilized OVA1 test performance characteristics derived directly from two OVA1 clinical trials
   Compared cost-effectiveness using only common, validated benchmark protocols and cutoffs
   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
   Included an expert treatment decision path analysis, independently published epidemiology and quality of life utility assumptions and a robust hidden Markov model methodology
   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:
   Use of OVA1 resulted in fewer projected re-operations and pre-treatment CT scans versus CA 125-II or mod-ACOG
   OVA1 was QALY-increasing and cost-effective relative to CA 125-II or mod-ACOG
   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
   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.”
About Vermillion 
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for women. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic disease. The company’s lead diagnostic, OVA1, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.  
Investor Relations Contact: 
Michael Wood 
LifeSci Advisors LLC 
Tel 1-646-597-6983 
mwood@lifesciadvisors.com
SOURCE Vermillion, Inc.
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