Offering insurance coverage of non-invasive prenatal testing (NIPT) for pregnant women under the age of 35 increases NIPT utilization, decreases conventional screening methods, yet costs less than 3 cents per member per month, according to study results from San Diego-based Illumina, the University of Colorado, and Harvard Pilgrim Health Care (HPHC).1

Illumina and HPHC, which covers around 3 million people in the Northeastern United States, entered into a first-of-its-kind agreement in 2018 to open NIPT coverage for all pregnant, single gestation women under 35. Many payers limit NIPT coverage to woman over the age of 35.

“Our findings show that expanding NIPT coverage to women under 35 increased NIPT use and modestly increased prenatal screening costs,” says R. Brett McQueen, PhD, associate professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. “This increased use suggests patients and physicians may prefer a more accurate screening method.”

The results of risk-sharing agreements involving commercial companies are not always made public, and this study aimed to address that lack of transparency. Illumina and HPHC engaged a third-party academic collaborator to develop a study protocol, complete the analyses, and lead the publication development. The work published in PharmacoEconomics, is the first-ever published manuscript on a value-based agreement between a biomedical technology company and a payer.

“As the clinical utility of NIPT is undeniable, we’ve focused on publishing real-world evidence assessing the economic implications,” says Ammar Qadan, vice president and global head of market access at Illumina. “This study, and other efforts, highlight how payers can provide NIPT access to all pregnant women and produce better outcomes at about the same cost.”

In August 2020, the American College of Obstetricians and Gynecologists (ACOG) updated their clinical practice guidelines, recommending NIPT for all pregnant women, regardless of age.

Following the ACOG change, a number of payers, such as UHC and Aetna, updated their coverage policies to match these guidelines. Given the results from this study, it’s likely that even more payers will follow suit and expand NIPT coverage to women under 35.

“These results were the best possible outcome,” says Michael Sherman, MD, MBA, MS, and chief medical officer for the combined organization of Harvard Pilgrim Health Care and Tufts Health Plan. “We are proud to be on the cutting edge of precision medicine and in providing preferred access for our members to diagnostic tests that can improve their lives. That we were able to demonstrate this without adversely impacting affordability provides important real-world evidence that others across the ecosystem are noticing. It is a tremendous win for everyone, especially the patient.”

For more information, visit Illumina


1. Quinlan TAG, Schroeder B, Kwon S, et al. Economic impact of coverage expansion for non-invasive prenatal testing through a performance-based risk-sharing agreement. Pharmacoecon Open. Epub. March 10, 2021. oi: 10.1007/s41669-021-00261-y.