NEW YORK (GenomeWeb News) – UnitedHealthcare has joined the growing list of national insurers to support non-invasive prenatal diagnostics tests.
The company, which covers about 30 million lives, issued a medical policy decision in favor of such tests under certain circumstances as a screening tool for trisomies 21, 18, and 13.
In a note outlining its policy, UnitedHealthcare said that NIPD testing is proven as a screening tool for such aneuploidies if any of the following criteria are met: mothers who are at least 35 years of age at the time of delivery; fetal ultrasound findings indicating an increased risk of aneuploidy; history of a prior pregnancy with trisomy; positive first- or second-trimester screening test result for aneuploidy; or parental balanced Robertsonian translocation with an increased risk for T13 or T21.
For pregnant women who do not meet any of the above criteria, DNA-based NIPD testing is unproven, UnitedHealthcare said. NIPD is also unproven for women with multiple gestations and additional studies are required to assess the use of these tests for such a population.
The insurer "strongly" recommends genetic testing before NIPD is performed.
In its note, UnitedHealthcare noted tests that include Sequenom's MaterniT21, Verinata Health's Verifi test, and Ariosa Diagnostics Harmony test. Natera's Panorama test was not mentioned by name although UnitedHealthcare's note has the caveat that the tests being covered by its policy are "not limited to" Sequenom, Verinata, or Ariosa's products.
In an e-mail to GenomeWeb Daily News, a spokesperson for Natera said that UnitedHealthcare's coverage decision was "well underway long before Natera launched Panorama. We view [UnitedHealthcare's] decision as a positive for the [non-invasive prenatal testing] field and one that furthers our goal of making NIPT accessible for every eligible pregnant woman."
UnitedHealthcare's policy decision is another boost to developers of NIPD tests and follows similar decisions by Aetna and Wellpoint. In all three instances, however, reimbursement by the payors is still not guaranteed, cautioned a Sequenom spokesperson.
"These decisions mean only that they see the value in the testing and will pay for it, but is not an indication of a contractual relationship," she said in an e-mail.
Ken Song, CEO of Ariosa, agreed and added that in light of growing clinical and scientific evidence that indicates the usefulness of NIPD tests, coverage of them is becoming almost a given. The next step is establishing appropriate reimbursement rates for each firm's test.
The prices for the tests vary greatly from about $2,000 for Sequenom's MaterniT21 Plus to $795 for Ariosa's Harmony.
In a research note, Piper Jaffray analyst William Quirk said that contracts with the test makers are about six months to one year away.
"Rarely have we seen reimbursement roll up as quickly as it has for the NIPD space, and while the payers are not differentiating amongst the leaders in terms of overall coverage, we believe Sequenom will be arguing the differentiating features of its test strongly (along with economic data) to secure an appropriate reimbursement level," he said.
Last week, Quirk upgraded Sequenom's stock to Overweight, and said today that he anticipates additional positive coverage decisions coming down the pike for NIPD tests.