AUSTIN, Texas, November 1, 2017 /PRNewswire/ — ASPiRA Labs, a Vermillion company (NASDAQ: VRML) and the exclusive distributor of OVA1 (Multivariate Index Assay) (MIA), today announced that it has substantially expanded positive policy coverage with the addition of 14 key managed care providers. This positive coverage is a transition from negative policy to positive policy for many of these plans.
“ASPiRA Labs has increased positive coverage for OVA1 with 14 providers totaling over 26 million lives,” stated Fred Ferrara, Chief Operating Officer of Vermillion, Inc. “Two policies totaling approximately 3.8 million covered lives are effective as of October 1, 2017, with the remainder being effective January 2018. This positive policy coverage is the first step to in-network contracts and market adoption. We are finishing this year strong with managed care rapidly increasing support of OVA1 to over 123 million lives, as of January 2018. OVA1 provides the only pelvic mass risk assessment product proven to get patients to the highest standard of care for ovarian cancer treatment.”
These recent positive coverage policies specify that OVA1 is medically necessary for the below plans:
- BlueCross BlueShield (BCBS) plans associated with a national plan, Health Care Service Corporation (HCSC) that include Illinois, Montana, New Mexico, Oklahoma and Texas (approximately 14.8 million covered lives)
- Horizon BCBS plans in New Jersey (approximately 3.7 million covered lives)
- Highmark BCBS plans that include Pennsylvania, West Virginia and Delaware (approximately 3.2 million covered lives)
- Wellcare: Government sponsored managed care across the U.S. (approximately 2.9 million covered lives)
- Other Plans:
- Health Alliance Medical Plans, Oscar and Prominence Health Plans (together, approximately 1.0 million covered lives)
- 1199 SEIU Benefits in New York (approximately 351,000 covered lives)
- Health New England (approximately 191,000 covered lives)
OVA1 is the most comprehensive risk assessment test that can stratify women at risk for ovarian cancer in all ages, stages and subtypes. These new policies will bring the total number of covered lives for OVA1 to more than 123 million, as of January 2018.
We expect the 2018 Centers for Medicare and Medicaid Services (CMS) pricing for OVA1 and Overa to be finalized in the fourth quarter of 2017, based on Protecting Access to Medicare Act of 2014 (PAMA) calculated rates. In addition, we expect that OVA1 will be also listed on the 2018 Clinical Lab Fee Schedule (CLFS), effective January 1, 2018, with a PAMA assigned price. We believe these prices will further support our value to the healthcare system.
Each year in the US, there is a 5-10% lifetime risk for women undergoing surgery for a suspected ovarian neoplasm. The majority of the masses are benign and, as a result, triaging the low and high risk masses is vital to improved patient outcomes. Today, more than 60% of the ovarian cancer patients do not receive National Comprehensive Cancer Network (NCCN) guideline treatment, which includes surgical treatment by a gynecologic oncologist, and, as a result, the survival rate is reduced by 30-40%. OVA1 helps ensure that rare ovarian cancer is triaged appropriately to the gynecological oncologist and benign cysts are managed by the general practitioner in the most cost effective and efficient way. Our goal is to have the right patient managed by the right specialist with the right treatment the first time.
Links to our complete list of payer coverage and multiple clinical studies showing OVA1’s strong performance compared to existing technologies, such as CA125 and ROMA, can be found on our website:
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 gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases. The company’s initial in vitro diagnostic test, OVA1® (MIA), was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016, Vermillion received FDA clearance for Overa™, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements regarding the number of covered lives for OVA1 as of January 2018, CMS pricing of OVA1 and Overa, inclusion of OVA1 on the CLFS and the anticipated impact of expected pricing on Vermillion’s value to the healthcare system. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on Vermillion’s expectations as of the date of this press release. A variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements, including changes to interpretations of existing laws and regulations and other factors that are described in Vermillion’s Form 10-K for the year ended December 31, 2016 and Form 10-Q for the quarter ended March 31, 2017 as filed with the Securities and Exchange Commission. Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
Investor Relations Contact:
LifeSci Advisors LLC