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Aetna Throws Support Behind Non-invasive Prenatal Tests for Down Syndrome

NEW YORK (GenomeWeb News) – Aetna this week issued a clinical policy bulletin suggesting that it may soon begin covering non-invasive prenatal DNA tests for Down syndrome.

In its bulletin, the health insurer said that it "considers measurement of cell-free nucleic acids in maternal blood … medically necessary for testing for fetal aneuploidy (trisomy 13, 18, 21) in pregnant women with single gestations," who meet any one of a set of criteria.

That set includes women at least 35 years of age at the time of the delivery; fetal ultrasonic findings of an increased risk of fetal aneuploidy; a prior pregnancy with an aneuploidy; positive screening for an aneuploidy, including first trimester, sequential, or integrated screen, or a positive quadruple screen; and parental balanced Robertsonian translocation with an increased risk for T13 or T21.

Aetna added, however, that it believes cell-free DNA methods for fetal genotyping for Rhesus D factor and for other indications are experimental and investigational.

Aetna, which covers around 18.2 million people through its medical insurance plans, stopped short of saying it would begin covering non-invasive prenatal diagnostic tests for Down syndrome, but in a note Oppenheimer analyst David Ferreiro said that the bulletin suggests Aetna "is likely to pick up coverage" for such tests, in particular Sequenom's MaterniT21 Plus, which was launched in October 2011.

Others firms offering non-invasive prenatal tests include Ariosa Diagnostics, Verinata Health, and Natera.

"[T]he bulletin posted by Aetna is positive for Sequenom and competitors," Ferreiro said. "However, we believe Sequenom is best poised to capitalize on the non-invasive prenatal test market, given its first-mover advantage, superior commercial infrastructure, and product differentiation."

Aetna's bulletin follows a similar one from its competitor Wellpoint. In December it revised its medical policy to say that cell-free fetal DNA-based prenatal screening is considered medically necessary if it meets certain criteria.

Along with 36 million lives covered by Wellpoint, the two payors "would substantially increase MaterniT21 [Plus'] current coverage of 56 million lives largely through regional payors," said Ferreiro.

Positive coverage decisions by Aetna and Wellpoint would also significantly move Sequenom forward toward its stated goal of securing coverage by three national payors in 2013.

In an e-mail to GenomeWeb Daily News, a spokesperson for Sequenom said that this week's development "is a positive next step in the process toward becoming an in-network service provider."

Ariosa CEO Ken Song, the second-largest player in the NIPT space after Sequenom, told GWDN in a statement, "We are encouraged to see that major medical plans endorse the use of non-invasive prenatal testing. NIPT truly represents a major medical advance and can also save the healthcare system money when used in high-risk pregnancies as demonstrated by a recent cost-utility analysis."

Verinata added that Aetna's consideration of NIPT as medically necessary in high-risk expectant mothers "will help patients to receive better insurance coverage for tests such as the verifi prenatal test." And a Natera spokesperson said that the firm expects "more such policy updates to follow and are working with several insurers to ensure that women have access to Panorama," the name of the company's NIPT.

Shares of Sequenom on the Nasdaq were down a fraction of 1 percent in afternoon trading to $4.48.