Economic Validity
Often, new medical technologies add significant cost to the health system. However, a recently published, evidence based health economic cost-model developed by Bridgehead International to model the clinical and economic impacts of verifi® prenatal test utilization in a managed care population illustrates that the test can greatly reduce the number of costly avoidable procedures and result in an overall cost savings to the health system.
Clinical and Cost Consequences of Incorporating a Novel Non-Invasive Prenatal Test into the Diagnostic Pathway for Fetal Trisomies. Garfield S et al. Journal of Managed Care Medicine. 2012 15(2):34-41. Available at: http://www.namcp.org/journals/jmcm/articles/15-2/Non%20Invasive%20Penatal.pdf
Background: “Since 2007, the American College of Obstetricians and Gynecologists (ACOG) has recommended that all pregnant women be offered prenatal screening for fetal aneuploidy (i.e., trisomies 21, 18, 13). Current screening options include tests with sub-optimal sensitivity and specificity rates, while diagnostic procedures are invasive and create risk of procedure related miscarriage. The verifi® test, a non-invasive test using circulating cell-free DNA (cfDNA), extracted from a maternal blood sample as early as 10 weeks gestation has demonstrated comparable sensitivity and superior specificity to invasive diagnostics in detecting fetal aneuploidy in chromosomes 21, 18, and 13.”
Methods: “A cost-model was developed to evaluate the impact of incorporating this prenatal test into routine high-risk maternal screening practice. The multi-stage transition probability model leveraged published cost estimates from Medicare as well as practice patterns and disease rates from published literature.”
Results: “The model demonstrates that inclusion of the verifi® prenatal test provides clear clinical benefits. These include a 66 percent reduction in invasive diagnostic induced miscarriages and 38 percent more women receiving a T21 diagnosis. Total costs for prenatal screening and diagnosis for fetal aneuploidies are reduced by 1 percent annually.”
Conclusion: “Significant clinical and cost advantages are likely to occur when novel non-invasive prenatal screening tests with high sensitivity and specificity are incorporated into routine high-risk screening practice.”
Key Study Findings:

When the verifi® prenatal test is incorporated as a secondary screen with confirmatory testing for all patients with positive test results:
- “The biggest benefit to women comes from a reduction in miscarriages due to invasive testing. In the modeled population of 100,000 pregnancies, invasive diagnostic induced miscarriages were reduced 66%.”
- “The model shows that with this test, the number of invasive procedures necessary to diagnose a single aneuploidy is reduced by 81%, from 43 to 8.”
- Using the list price of the verifi® test, the model demonstrates a 1% reduction in the total annual cost of prenatal screening and diagnosis for fetal aneuploidy.
To arrange for a customized demonstration of the cost model, contact us at payer.info@verinata.com.

