A new study by R. Brett McQueen, PhD, assistant professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, supports expanding coverage of non-invasive prenatal testing (NIPT) to pregnant women less than 35 years of age.
R. Brett McQueen, PhD,
The study, published in PharmacoEconomics-Open evaluated the impact of an innovative risk-sharing agreement between biotechnology company Illumina, Inc. and insurer Harvard Pilgrim Health Care (HPHH) that opened insurance coverage of NIPT, a simple maternal blood draw which screens for fetal chromosomal disorders including trisomy 13 (Patau syndrome), trisomy 18 (Edwards syndrome), and trisomy 21 (Down syndrome).
The PharmacoEconomics-Open article is the first-ever published manuscript on a value-based agreement between a bio/medical technology company and a payer for NIPT coverage. Through this partnership, thousands of women gained access to NIPT and the economic impact was minimal. The study showed expanding NIPT services only increased HPHC’s costs by less than 3 cents per member per month.
“Our findings show that expanding NIPT coverage to women under 35 increased NIPT use and modestly increased prenatal screening costs,” said McQueen. “This increased use suggests patients and physicians may prefer a more accurate screening method.”
“As the clinical utility of NIPT is undeniable, we’ve focused on publishing real-world evidence assessing the economic implications,” said 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 cover to women under 35.
“These results were the best possible outcome,” said 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.”