Study Shows Noninvasive Prenatal Testing Is Clinically Beneficial and Cost-Effective

Noninvasive prenatal testing (NIPT) improves detection of trisomy 21 (T21) with lower total health care expenditures compared to conventional screening methods. A study in the Journal of Maternal-Fetal and Neonatal Medicine highlights the cost-effectiveness of NIPT with cell-free DNA in high-risk women. NIPT test makers, including Ariosa Diagnostics (San Jose, Calif.), which funded the study, are hopeful that such data will enhance ongoing reimbursement discussions with payers. The researchers used a decision-analytic model with a cohort of 4 million pregnant U.S. women and three screening strategies: first trimester combined screening, integrated screening, or NIPT (first-line testing in women 35 years or older or those with a personal or family history that elevates risk or as a second-line test in women with a positive conventional screening test). NIPT was shown to have clinical benefit over conventional screening tests (detected 65 percent to 85 percent more T21 cases, reduced invasive procedures by over 95 percent, and reduced more than 99 percent of unnecessary fetal loss). At a price point of $795 per test, NIPT demonstrated cost savings to the health care system over both other strategies. For more information on how studies of clinical utility and cost-effectiveness impact coverage and reimbursement of next-generation sequencing-based tests, please see Inside the Diagnostics Industry on page 5.