Should pregnant women be charged for non-invasive prenatal screening?

The new article concludes that requiring (substantial) copayments for NIPT (non-invasive prenatal testing) in universal access healthcare systems fails to promote reproductive autonomy and is unfair.

NIPT is procedurally safe and simple, and its test performance for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome) is better than that of the conventional combined test based on nuchal translucency ultrasound, blood tests and maternal age. NIPT is not a diagnostic test; as cell-free DNA is derived not from the fetus but from the placenta, an abnormal NIPT result requires confirmation through invasive follow-up diagnostic testing (ie, chorionic villus sampling or amniocentesis). Because of its better test performance for trisomies 21, 18 and 13, however, NIPT requires fewer invasive follow-up tests than does the combined test, and thus leads to fewer iatrogenic miscarriages.

In some countries, including the UK, France, Canada and the Netherlands, NIPT is available in implementation research settings. In the USA, Israel and Australia, Russia NIPT is available primarily through commercial providers.³ In other countries, such as Belgium, Denmark and Singapore, it is either already part of routine antenatal care⁴ or offered through publicly funded screening programmes.

The ongoing introduction of NIPT around the world requires a reconsideration of funding policies for first-trimester prenatal screening. Should pregnant women and their partners be charged for NIPT, and on what grounds? There are practical as well as principled reasons to charge women for NIPT. In resource-constrained settings, societies may not have sufficient funds to offer NIPT free of charge. Universal NIPT is both more effective than the first-trimester combined test in detecting trisomies and more costly. In most ‘cost-effectiveness’ studies, however, the costs of the care and support required for children with chromosomal abnormalities are not taken into account. Furthermore, although the costs of NIPT may currently be among the main reasons for states to charge women, these costs will likely decrease in the future as the technology develops.

The new study, therefore, focuses on principled reasons for charging. We critically discuss two principled rationales for asking pregnant women and their partners to (co)pay for NIPT: to prevent increased uptake of screening and to improve informed decision-making. Charging is believed to help women understand that first-trimester screening is not part of routine antenatal care, but something different. Copayment is believed to help create ‘choice awareness’ and to ensure well-considered participation in screening. Both rationales merit further scrutiny, as it is not self-evident that charging for NIPT is justifiable from a justice perspective or contributes to well-considered choices.

Rationale 1: charging women to prevent increased uptake of screening

One reason for charging pregnant women for NIPT is to prevent an increase in uptake of prenatal screening, and thus to prevent an increase in the number of abortions. Although commentators do not usually explicitly mention this rationale, it follows from the reverse concern that public funding of NIPT may encourage women to take part in prenatal screening. If the state offers prenatal screening free of charge, it gives the impression that it condones screening as a form of routine care among other antenatal care services. An offer of NIPT would lead to a higher uptake of screening and—following this rationale—a higher uptake is perceived to be problematic.

With the start of the Dutch NIPT implementation study in April 2017, for instance, it was feared that pregnant women would ‘rush’ to academic medical centres to obtain NIPT. The notion that all Dutch women would engage in screening was seen as intrinsically undesirable. Pregnant women and mothers of children with Down syndrome were concerned that abortion rates would rise, and that Down syndrome might disappear from society.

This is not likely. In the Netherlands, the majority of women decline first-trimester screening altogether, even today, now NIPT is widely available. Moreover, not all prenatal screening results in abortion. In the period 2000–2013, around 85% of pregnancies with a confirmed diagnosis of Down syndrome resulted in termination, which means that a substantial minority chose to continue the pregnancy. Certain groups in Dutch society hold a relatively high acceptance and positive image of Down syndrome; some Dutch women do not consider Down syndrome ‘severe enough to justify termination of pregnancy’. The number is consistent with termination rates found in other countries, such as the USA, the UK and other European countries, but lower than the rates reported elsewhere, such as 93% in Australia² and 98% in Denmark. Overall, the prevalence of Down syndrome has been relatively stable around the world since the early 1990s. This is not likely to change with the introduction of NIPT, as in countries like the UK and the Netherlands some women continue to opt for first-trimester prenatal screening ‘for information only’ and refrain from abortion. A recent review of studies from the USA, Asia and Europe suggested that termination rates following the introduction of NIPT were unchanged or even decreased.

Charging money can be thought of as a political compromise to those who oppose widespread use of prenatal screening and/or abortion and believe that first-trimester screening may (need to) be available to women who actively and purposively request it, but should not be too readily available. (Co)payment thus serves as a barrier to access, aimed at discouraging women from taking part. However, this is not consistent with the aim of prenatal screening. Women should not be withheld from screening, just as those who oppose screening should not be put under pressure to take part. In Dutch counselling practices, women are presented with an ‘information offer’ about screening first, which they are free to refuse, to safeguard their ‘right not to know’. Such measures should be in place in screening programmes around the world to avoid any pressure on women to participate in screening just because it is ‘the norm’.

Rationale 2: charging women to improve informed decision-making

A second argument brought forward in public discussions for charging money for NIPT is that it will improve decision-making. A financial contribution to NIPT is thought to have the benefit of signalling to pregnant women and their partners that screening is optional: screening is an offer that may have far-reaching implications that should be considered beforehand. Because NIPT requires only a simple blood draw, just like other routine screening tests offered during the pregnancyб observers are concerned that women will thoughtlessly accept NIPT.

It is feared that because of the non-invasive character of NIPT, health professionals may treat the informed choice process differently—less stringently—than they would in the context of invasive testing, requiring less time to consider or not asking for written informed consent. NIPT would be presented by counsellors as a routine procedure and would consequently be perceived as such by pregnant women and their partners, a concern referred to as ‘routinisation’. If women may not appreciate the significance of the test, it would ‘become more difficult to achieve the aim of enabling autonomous reproductive choices’. Also, state funding is believed to send a ‘legitimizing’ message about the importance of NIPT, implying that the government encourages screening, making pregnant women more likely to participate without deliberation.

Putting up a (small) barrier by charging women, on the other hand, so it is argued, may help reinstall well-considered decision-making. If women must pay €175, the fee required in the Netherlands, or the small sum of €8.68, the fee required in Belgium, for NIPT, they will deliberate the benefits, risks and implications of screening. Especially in countries like the Netherlands, where all ‘medically necessary’ healthcare services are offered free of charge, including the 20-week ultrasound scan, the copayment requirement may signal to women that NIPT is a different test, and help them understand that NIPT ‘is an offer that can be declined’. 

“We have argued that the (co)payment requirement for NIPT is not a necessary nor a subsidiary approach to the promotion of informed choice among pregnant women and their partners, and does not serve reproductive autonomy. While informed choice remains of paramount importance in all prenatal screening programmes, there are no indications that charging women for NIPT will prove effective in accomplishing this.”

Journal Reference: https://www.ncbi.nlm.nih.gov/pubmed/31527142