NEW YORK (GenomeWeb News) – National managed healthcare company WellPoint has revised its medical policy regarding non-invasive fetal aneuploidy screening, suggesting that it will begin covering tests such as Sequenom's MaterniT21 Plus test.
News of the change by WellPoint sent shares of Sequenom up as much as 9 percent today on the Nasdaq with the number of shares traded more than double Sequenom's average daily volume during the past three months.
In addition to Sequenom, privately held firms Verinata Health and Ariosa Diagnostics offer non-invasive prenatal tests using cell-free fetal DNA, and Natera plans to offer its test in the near future.
WellPoint's medical policy change, which takes effect today, said that cell-free fetal DNA-based prenatal screening is considered medically necessary if it meets a set of criteria that includes the mother being tested is carrying a single gestation and is considered at high risk for fetal aneuploidy.
A patient is deemed so if she is at least 35 years of age at the time of delivery; or the fetus has ultrasonographic findings that indicate an increased risk of aneuploidy; or the expectant mother has a history of a prior pregnancy with trisomy; or she has a positive first or second trimester standard biomarker screening test; or either the mother or father is identified as having a balanced Robertsonian translocation with an increased risk of fetal T13 or T21.
WellPoint said that several studies support the use of non-invasive fetal DNA-based aneuploidy tests. It also noted that various organizations, including the American College of Obstetricians and Gynecologists, the International Society for Prenatal Diagnosis, and the National Society of Genetic Counselors, have "concluded that there is sufficient evidence to support the use [of such] tests in select individuals at high risk for fetal aneuploidy."
WellPoint pointed out, however, that though tests such as MaterniT21 Plus offer advantages such as an improvement in the odds of identifying an abnormal fetus and a reduction in the number of invasive diagnostic tests, as well as a decrease in the number of procedure-related losses of normal fetuses, the new tests have drawbacks.
Not all aneuploidy fetuses can be identified by such testing, the Indianapolis-based firm said, as the usefulness of such tests are currently limited to T21, T18, and T13. Also, such screening tools are not recommended for women not considered at high risk for aneuploidy or in cases of multiple gestations.
"There is also the possibility that in a small percentage of cases, a DNA-based non-invasive prenatal screening result will not be obtainable," WellPoint said.
Nonetheless, David Ferreiro, an analyst at Oppenheimer, said that Sequenom "has made its first significant achievement toward its corporate goal of achieving reimbursement with national payers."
To date, only regional health plans have announced favorable coverage decisions for MaterniT21 Plus, including Tufts Health Plan during the summer. Sequenom stopped disclosing coverage decisions by individual plans after Coventry Health Care National Network terminated a coverage decision for MaterniT21 Plus a week after Sequenom said Coventry would cover the test.
In a research note, Ferreiro noted the sheer size of WellPoint could increase MaterniT21 Plus test volume, saying to date Sequenom has coverage for about 46 million lives through a patchwork of regional payor contracts.
By itself, Wellpoint covers 33.5 million members through its affiliated health plans and almost 64 million individuals through all its subsidiaries. Ferreiro added that a positive coverage decision by WellPoint could spur similar moves by other national payors.
In Wednesday afternoon trading Sequenom's stock was up about 4 percent at $4.82.