a new fetal rhd genotyping test costs and benefits of mass testing to target antenatal anti-d prophylaxis in england and wales一个新的胎儿rhd基因分型测试成本和收益的质量测试目标产前anti-d预防在英格兰和威尔士.pdfVIP

Szczepura et al. BMC Pregnancy and Childbirth 2011, 11:5 /1471-2393/11/5 RESEARCH ARTICLE Open Access A new fetal RHD genotyping test: Costs and benefits of mass testing to target antenatal anti-D prophylaxis in England and Wales * Ala Szczepura , Leeza Osipenko, Karoline Freeman Abstract Background: Postnatal and antenatal anti-D prophylaxis have dramatically reduced maternal sensitisations and cases of rhesus disease in babies born to women with RhD negative blood group. Recent scientific advances mean that non-invasive prenatal diagnosis (NIPD), based on the presence of cell-free fetal DNA in maternal plasma, could be used to target prophylaxis on “at risk” pregnancies where the fetus is RhD positive. This paper provides the first assessment of cost-effectiveness of NIPD-targeted prophylaxis compared to current policies. Methods: We conducted an economic analysis of NIPD implementation in England and Wales. Two scenarios were considered. Scenario 1 assumed that NIPD will be only used to target antenatal prophylaxis with serology tests continuing to direct post-delivery prophylaxis. In Scenario 2, NIPD would also displace postnatal serology testing if an RhD negative fetus was identified. Costs were estimated from the provider’s perspective for both scenarios together with a threshold royalty fee per test. Incremental costs were compared with clinical implications. Results: The basic cost of an NIPD in-house test is £16.25 per sample (excluding royalty fee). The two-dose antenatal prophylaxis policy recommended by NICE is estimated to cost the NHS £3.37 million each year. The estimated threshold royalty fee is £2.18 and £8.83 for Scenarios 1 and 2 respectively. At a £2.00 royalty fee, mass NIPD testing would produce no saving for Scenario 1 and £507,154 per annum for Scenario 2. Incremental cost