The OVA1 multivariate index assay (Vermillion; Austin, Texas) is a cost-effective strategy for triaging women with pelvic masses prior to surgery, according to an abstract presented at the American College of Medical Quality annual meeting (Alexandria, Virginia; March 26-28). Compared with both the Dearking-modified American Congress of Obstetricians and Gynecologists guidelines (mod-ACOG) and off-label CA-125 biomarker testing, OVA1 both achieves cost-savings and improves referral of women with risk of ovarian cancer to gynecologic oncologists. OVA1 is a U.S. Food and Drug Administration-approved blood test for pre-surgical assessment of ovarian tumors for malignancy. The protein-based assay uses qualitative serum testing of five biomarkers (pre-albumin, apolipoprotein A1, beta 2 microglobulin, transferrin, and CA-125II) along with a proprietary algorithm to generate a numerical score to stratify patients by risk of malignancy. The researchers compared the cost-effectiveness of the OVA1 test to evaluate the clinical and cost implications of adopting the assay in clinical practice from the perspective of public payers. Costs were based on reimbursement rates from Centers for Medicare & Medicaid Services Fee Schedules. CA-125, which is frequently used off-label for ovarian cancer diagnosis, is known to be plagued by false negatives and a lack of specificity for detecting early-stage ovarian cancer. […]
The OVA1 multivariate index assay (Vermillion; Austin, Texas) is a cost-effective strategy for triaging women with pelvic masses prior to surgery, according to an abstract presented at the American College of Medical Quality annual meeting (Alexandria, Virginia; March 26-28). Compared with both the Dearking-modified American Congress of Obstetricians and Gynecologists guidelines (mod-ACOG) and off-label CA-125 biomarker testing, OVA1 both achieves cost-savings and improves referral of women with risk of ovarian cancer to gynecologic oncologists.
OVA1 is a U.S. Food and Drug Administration-approved blood test for pre-surgical assessment of ovarian tumors for malignancy. The protein-based assay uses qualitative serum testing of five biomarkers (pre-albumin, apolipoprotein A1, beta 2 microglobulin, transferrin, and CA-125II) along with a proprietary algorithm to generate a numerical score to stratify patients by risk of malignancy.
The researchers compared the cost-effectiveness of the OVA1 test to evaluate the clinical and cost implications of adopting the assay in clinical practice from the perspective of public payers. Costs were based on reimbursement rates from Centers for Medicare & Medicaid Services Fee Schedules. CA-125, which is frequently used off-label for ovarian cancer diagnosis, is known to be plagued by false negatives and a lack of specificity for detecting early-stage ovarian cancer.
The researchers found that OVA1 was cost-effective from the payer perspective, driven in part by fewer re-operations and pre-surgical CT scans. Overall, the assay resulted in an incremental cost-effectiveness ratio (ICER) of $35,094 per quality-adjusted life year (QALY) gained, superior to the commonly accepted cost-effectiveness threshold of $50,000 per QALY. Compared to CA-125 alone, OVA1 was also cost saving with an ICER of $12,189/QALY gained. Sensitivity analysis showed that ICER was affected by the percentage of patients not referred to a gynecologic oncologist when diagnosed with advanced epithelial ovarian cancer. Appropriate referral is known to considerably improve clinical outcomes.
“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,” Valerie Palmieri, Vermillion’s CEO, said in a statement.
The test was initially launched in 2010 and offered through Quest Diagnostics. However, Vermillion recently launched a wholly-owned subsidiary, ASPiRA Labs, and will begin to transition testing of Quest customers there. OVA1 lists for $1,495.
“As we are moving towards an accountable care environment, the trend is that more gynecologic oncologists are becoming employees of health care systems and being paid a salary, regardless of the number of surgeries they perform,” Palmieri, tells DTET. “They are also measured on outcomes, which are based on the need to perform surgery on the right patients. Our test helps the physician determine if the patient is low-risk and can be treated by the local gynecologist, or at high-risk of being malignant and needs referral to a gynecological oncologist. Timing wise, the environment is right for adoption of this test.”
Takeaway: Appropriate triage of ovarian cancer patients using a multivariate index assay is cost-effective and will additionally aid survival through improved specialist referral of women at higher risk for malignancy.
