Expanding coverage for noninvasive prenatal testing (NIPT) through a performance-based, risk-sharing agreement (PBRSA) resulted in a significant increase in NIPT use, a significant decrease in conventional prenatal screening methods, and a negligible increase in per member per month (PMPM) cost at Harvard Pilgrim Health Care (HPHC) in New England.
A manuscript published in PharmacoEconomics – Open reported the results of a study assessing the impact of extending NIPT coverage to women under the age of 35 through the PBRSA between HPHC and technology company Illumina Inc.
“At the time we started discussions, in 2017, there was a split in how U.S. payers provided coverage for NIPT testing,” said co-author Brock Schroeder, PhD, senior Director of Global Market Access and Health Economics and Outcomes Research at lllumina. “Some payers already provided coverage for pregnant women of any age, while many payers would only reimburse for NIPT in pregnant women with a higher risk of prenatal aneuploidy, such as women over the age of 35.”
After the project was initiated, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) published an updated practice bulletin that screening should be offered to all patients, regardless of maternal age or baseline risk, and that cell-free DNA testing is the most sensitive and specific screening test for common fetal aneuploidies.
“After the publication of this guideline, several large payers, including UnitedHealthcare and Aetna, made changes to their medical policies to provide coverage for NIPT for pregnant women of any age,” Schroeder told Contemporary OB/GYN®.
A total of 5,041 pregnant patients under the age of 35 who were screened and tested pre-coverage expansion (March 2016 to February 2018) were compared to 4,109 similar patients during post-coverage expansion (March 2018 to September 2019).
Screening orders for conventional methods decreased by 13% after coverage expansion, whereas orders for NIPT increased by 41%.
The increase in PMPM was only roughly 3 cents post-coverage expansion.
Schroeder is not surprised by any of the study results because they align closely with the investigators’ hypotheses that the budget impact for payers would be relatively small and indeed offset by decreases in conventional prenatal test spending. “The increase in NIPT use also reflects patient/physician preference for a more accurate screening method,” he said.
Another key finding of the study is that there was no evidence of inappropriate use of NIPT, such as simultaneous testing with multiple screening methods, thus conforming to ACOG-SMFM’s recommendation that patients should not receive simultaneous prenatal screening tests.
“Most new technologies that enter the healthcare marketplace may initially cost more than previous methods,” Schroeder said. “Importantly, that cost impact should be weighed against the additional clinical value provided by the new technology. In this case, it is well established that NIPT provides higher sensitivity and specificity than conventional tests. Thus, a key downstream impact is that far fewer pregnant women will have false-positive results from screening with NIPT and fewer women will require invasive diagnostic tests like amniocentesis.”
In addition, the cost of the technologies underlying molecular testing like NIPT continues to decrease, according to Schroeder. “Therefore, we would certainly anticipate that the cost to payers will decline over time as well,” he said.
Besides the clinical and health economic reasons for undertaking the project, “we feel strongly that PBRSAs like this one is an innovative way for payers and industry to work together in a collaborative manner to provide access to new technologies, while also building additional evidence that can be shared publicly,” Schroeder said. “This kind of transparency is often absent in industry-payer partnerships. However, we felt it was an essential part of creating a win-win-win-win for patients, healthcare providers, payers and the technology industry.”
Schroeder is an employee and stockholder of Illumina, Inc.
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. Published online March 10, 2021. doi:10.1007/s41669-021-00261-y