The impact of insurance on equitable access to non-invasive prenatal screening (NIPT): private insurance may not pay

Benoy, Megan E.; Iruretagoyena, J. Igor; Birkeland, Laura E.; Petty, Elizabeth M.

doi:10.1007/s12687-020-00498-w

Cited by 11 publications

(17 citation statements)

References 17 publications

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“…This supports concerns regarding potential disparities in the uptake of NIPT, which conflicts with the primary goals of a government‐supported national screening program of equitable access and reproductive autonomy. Our study corroborates findings from other high‐income countries such as Australia, 17,18 the United Kingdom 12 and the United States, 19 where socioeconomic disparities in fetal aneuploidy screening uptake were also reported.…”

Section: Discussionsupporting

confidence: 90%

“…On the one hand, it has been argued that a (small) financial barrier may encourage informed decision‐making among pregnant women by promoting deliberation 20 . On the other hand, requiring a payment for NIPT could actively hinder equitable access to the test due to women being unable to pay for fetal aneuploidy screening, thus impeding on their freedom to choose 5,19 . A survey study among European healthcare providers indicated that the costs and a lack of reimbursement policy were considered to be the primary barrier to broader NIPT uptake 21 .…”

Section: Discussionmentioning

confidence: 99%

“…Studies have shown that when fetal aneuploidy screening is reimbursed, utilization increases significantly 19,24 . A Canadian survey study showed that a majority of pregnant women (66.4%) agreed that reimbursement of NIPT would greatly impact their decision to choose the test 25 .…”

Section: Discussionmentioning

confidence: 99%

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Non‐invasive prenatal test uptake in socioeconomically disadvantaged neighborhoods

et al. 2021

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Objective Non‐Invasive Prenatal Testing (NIPT) is increasingly being implemented worldwide. In public health programs, equitable access to healthcare is a fundamental principle which also applies to fetal aneuploidy screening. However, the out‐of‐pocket costs of NIPT may lead to sociodemographic disparities in uptake of screening. This study assessed whether there is a difference in the uptake of NIPT in socioeconomically disadvantaged neighborhoods compared to all other neighborhoods in the Netherlands, where NIPT is implemented in a national screening program (TRIDENT‐2 study). Method NIPT uptake, postal code and age of 156,562 pregnant women who received pre‐test counselling for prenatal screening in 2018 were retrieved from the national prenatal screening database. Postal codes were used as a proxy to categorize neighborhoods as being either socioeconomically disadvantaged or other. The out‐of‐pocket costs for NIPT were €175. Results NIPT uptake in socioeconomically disadvantaged neighborhoods was 20.3% whereas uptake in all other neighborhoods was 47.6% (p < 0.001). The difference in NIPT uptake between socioeconomic disadvantaged neighborhoods and other areas was smaller for the youngest maternal age‐group (≤25 years) compared to other age‐groups. Conclusion The variation in uptake suggest underlying disparities in NIPT uptake, which undermines the goals of a national fetal aneuploidy screening program of providing reproductive autonomy and equitable access. This has ethical and policy implications for ensuring fair and responsible implementation of fetal aneuploidy screening.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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Non‐invasive prenatal test uptake in socioeconomically disadvantaged neighborhoods

et al. 2021

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“…13 14 Moreover, the cost of NIPT varies widely, which creates a potential financial burden for pregnant women in low-income and middle-income countries. 15 These factors may further limit the widespread use of NIPT. 16 In China, the price of NIPT in the private sectors varies from US$202.49 to US$332.46, as the cost is only partially covered by health insurance in most provinces, pregnant women may have to bear the cost for this service.…”

Section: Open Accessmentioning

confidence: 99%

Introducing the non-invasive prenatal testing for detection of Down syndrome in China: a cost-effectiveness analysis

Shang

Wan²,

Chen

et al. 2021

BMJ Open

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ObjectiveThis study aimed to compare the health economic value of a non-invasive prenatal testing (NIPT) strategy against a second-trimester triple screening (STS) strategy for the detection of Down syndrome based on real-world data from China.DesignA decision-analytical model was developed to compare the cost-effectiveness of five strategies from a societal perspective. Cost and probability input data were obtained from the real-world surveys and published sources.SettingChina.ParticipantsWomen with a singleton pregnancy.InterventionsThe five strategies for screening were: (A) maternal age with STS (no NIPT); (B) STS plus NIPT screening; (C) age-STS plus NIPT screening (the currently referral strategy in China); (D) maternal age with NIPT screening and (E) universal NIPT screening.Main outcome measuresIncremental cost-effectiveness ratios (ICERs) per additional Down syndrome case terminated, univariate and probabilistic sensitivity analysis and cost-effectiveness acceptability curves were obtained.ResultsStrategy A detected the least number of Down syndrome cases. Compared with the cheapest Strategy B, Strategy D had the lowest ICER (incremental cost, US$98 944.85 per additional Down syndrome case detected). Strategy D had the highest probability of being cost-effective at the willingness-to-pay level between US$110 000.00 and US$535 000.00 per additional Down syndrome case averted. Strategy E would not be cost-effective unless the unit cost of the NIPT could be decreased to US$60.50.ConclusionIntroducing NIPT screening strategies was beneficial over the use of STS strategy alone. Evaluating maternal age in combination with the NIPT screening strategy performs better than China’s currently referral strategy in terms of cost-effectiveness and safety. Lowering the price of NIPT and optimising payment methods are effective measures to promote universal NIPT strategies in China.

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“…However, the high overall costs and operational complexities of the NGS-NIPT might hinder its implementation to a wide-spread clinical routine practice. Even though, the NGS-NIPT has been recommended in many counties as the first-tier screen method for fetal aneuploidies screen, majority of pregnant women cannot afford to choose this test because it is currently not universally covered by healthcare systems or private insurances [ 30 , 31 ]. To effectively balance the benefits and higher cost regarding the NGS-NIPT, many countries select the contingent strategy (CS) that uses the SBT as a primary screen tool and use the NGS-NIPT as a confirmation test for the high risk pregnancies identified by the SBT.…”

Section: Introductionmentioning

confidence: 99%

A dPCR-NIPT assay for detections of trisomies 21, 18 and 13 in a single-tube reaction-could it replace serum biochemical tests as a primary maternal plasma screening tool?

Dai

Yang

et al. 2022

J Transl Med

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Background The next generation sequencing (NGS) based non-invasive prenatal test (NIPT) has outplayed the traditional serum biochemical tests (SBT) in screen of fetal aneuploidies with a high sensitivity and specificity. However, it has not been widely used as a primary screen tool due to its high cost and the cheaper SBT is still the choice for primary screen even with well-known shortages in sensitivity and specificity. Here, we report a multiplex droplet digital PCR NIPT (dPCR-NIPT) assay that can detect trisomies 21, 18 and 13 (T21, T18 and T13) in a single tube reaction with a better sensitivity and specificity than the SBT and a much cheaper price than the NGS-NIPT. Methods In this study, the dPCR-NIPT assay’s non-clinical characteristics were evaluated to verify the cell free fetal DNA (cffDNA) fraction enrichment efficiencies, the target cell free DNA (cfDNA) concentration enrichment, the analytical sensitivity, and the sample quality control on the minimum concentration of cfDNA required for the assay. We validated the clinical performance for this assay by blindly testing 283 clinical maternal plasma samples, including 36 trisomic positive samples, from high risk pregnancies to access its sensitivity and specificity. The cost effectiveness of using the dPCR-NIPT assay as the primary screen tool was also analyzed and compared to that of the existing contingent strategy (CS) using the SBT as the primary screen tool and the strategy of NGS-NIPT as the first-tier screen tool in a simulating situation. Results For the non-clinical characteristics, the sample processing reagents could enrich the cffDNA fraction by around 2 folds, and the analytical sensitivity showed that the assay was able to detect trisomies at a cffDNA fraction as low as 5% and the extracted cfDNA concentration as low as 0.2 ng/μL. By testing the 283 clinical samples, the dPCR-NIPT assay demonstrated a detection sensitivity of 100% and a specificity of 95.12%. Compared to the existing CS and the NGS-NIPT as the first-tier screen strategy, dPCR-NIPT assay used as a primary screen tool followed by the NGS-NIPT rescreen is the most economical approach to screen pregnant women for fetal aneuploidies without sacrificing the positive detection rate. Conclusion This is the first report on a dPCR-NIPT assay, consisting of all the necessary reagents from sample processing to multiplex dPCR amplification, can detect T21, T18 and T13 in a single tube reaction. The study results reveal that this assay has a sensitivity and specificity superior to the SBT and a cost much lower than the NGS-NIPT. Thus, from both the test performance and the economic benefit points of views, using the dPCR-NIPT assay to replace the SBT as a primary screen tool followed by the NGS-NIPT rescreen would be a better approach than the existing CS for detection of fetal aneuploidies in maternal plasma.

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The impact of insurance on equitable access to non-invasive prenatal screening (NIPT): private insurance may not pay

Cited by 11 publications

References 17 publications

Non‐invasive prenatal test uptake in socioeconomically disadvantaged neighborhoods

Non‐invasive prenatal test uptake in socioeconomically disadvantaged neighborhoods

Introducing the non-invasive prenatal testing for detection of Down syndrome in China: a cost-effectiveness analysis

A dPCR-NIPT assay for detections of trisomies 21, 18 and 13 in a single-tube reaction-could it replace serum biochemical tests as a primary maternal plasma screening tool?

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