What is the Value of Using NIPT as a Diagnostic Test for Fetal RhD status?
BACKGROUND AND PURPOSE:
Saramago et al. (BJOG, 2018) evaluated the cost-effectiveness of high-throughput, non-invasive prenatal testing (HT-NIPT) for fetal Rhesus D (RhD) genotype to guide antenatal prophylaxis with anti-D immunoglobulin compared with routine antenatal anti-D immunoglobulin prophylaxis (RAADP)
This study was devised to inform NICE recommendations
Cost-effectiveness decision-analytic modeling
A decision tree model was used to characterize the antenatal care pathway in England and the long-term consequences of sensitization events
The diagnostic accuracy of HT-NIPT was derived from relevant literature sources and databases
HT‐NIPT is assumed to be introduced early enough in the care pathway to guide the use of anti-D immunoglobulin at 28 weeks of gestation
For women with false‐negative HT‐NIPT results who receive only postpartum anti‐D immunoglobulin, the model assumes a rate of sensitization of 0.95%
HT-NIPT is considered highly accurate (treating inconclusive result as positive)
Five alternative strategies measuring the impact HT-NIPT would have on existing postpartum care were considered
Postpartum cord serology for all; fetal-maternal hemorrhage testing as necessary and anti-D immunoglobulin based on fetal-maternal hemorrhage results
HT-NIPT Strategy 1
Any HT-NIPT RhD result: Postpartum cord serology; fetal-maternal hemorrhage testing and anti-D immunoglobulin as appropriate
HT-NIPT Strategy 2
Negative result treated as diagnostic (potential for false negatives)
Positive or inconclusive confirmed with cord blood serology
HT-NIPT Strategy 3
RhD-negative result requires confirmation
Positive (including inconclusive) treated as diagnostic (potential to overtreat false positives)
HT-NIPT Strategy 4
All NIPT results treated as diagnostic, with inconclusive treated as positive
HT-NIPT Strategy 5
NIPT negative requires cord blood confirmation
NIPT positive does not require cord blood confirmation
Inconclusive requires cord blood confirmation
HT-NIPT is highly accurate and appears to be economical, but also less effective than current practice, irrespective of the postpartum strategy evaluated
Authors found the “magnitude of the potential cost‐savings appeared sufficient to outweigh the small increase in sensitisations and the associated small QALY loss”
A postpartum strategy in which inconclusive test results are distinguished from positive results lead to the best performance (Strategy 5)
The cost-effectiveness of HT-NIPT is dependent on the overall test cost being less than or equal to £26.60
HT-NIPT could reduce unnecessary treatment with routine anti-D immunoglobulin and is cost saving compared to current practice
Authors point out an important limitation – data on the diagnostic accuracy of HT-NIPT among non-white ethnicity is lacking and this group of pregnant women may have more inconclusive test results
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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