Original Title: First trimester screening for risk of preeclampsia using a multiple marker algorithm

Authors' objectives: This health technology assessment evaluates the safety, effectiveness, and cost-effectiveness of a population-wide screening program for pre-eclampsia risk that uses a multiple-marker algorithm taken between 11+0 and 13+6 weeks’ gestation, compared with standard care. It also evaluates the accuracy of the algorithm used in the screening program, the budget impact of publicly funding the program, and experiences, preferences, and values among pregnant people.

Authors' results and conclusions: RESULTS We included nine studies in the clinical evidence review. The FMF-based screening program likely reduces the risk of pre-eclampsia with delivery at less than 37 weeks’ gestation compared with standard care, when initiated at 11+0 to 13+6 weeks’ gestation; risk ratios ranged from 0.64 (95% confidence interval [CI] 0.46-0.93) to 0.70 (95% CI 0.58-0.84) (GRADE: Moderate). It may reduce the risks of low birth weight (risk ratio 0.89 [95% CI 0.85-0.94]) and low Apgar score (risk ratio 0.73 [95% CI 0.63-0.85]) (GRADE: Low). Evidence on the effectiveness of the FMF-based screening program in reducing the risk of stillbirth and neonatal death was highly uncertain (GRADE: Very low). In addition, the FMF algorithm can improve the detection rate of pre-eclampsia with delivery at less than 37 weeks’ gestation or at less than 34 weeks’ gestation compared with conventional algorithms, although there are concerns about bias and applicability across studies. The population-wide FMF-based screening program is more effective and more costly than standard care. The incremental cost-effectiveness ratio of the population-wide FMF-based screening program compared with standard care is $3,446 per prevented case of pre-eclampsia with delivery at less than 37 weeks. The annual budget impact of publicly funding the population-wide FMF-based screening program in Ontario ranges from an additional $1.23 million in year 1 to $3.56 million in year 5, for a total of $8.50 million over the next 5 years. The population-wide FMF-based screening program was seen as valuable by those who have experienced pregnancy and their family members. Strong emphasis was placed on providing education and equitable access as part of any screening program, and participants valued the potential clinical benefits that the population-wide FMF-based screening program could provide. CONCLUSIONS The FMF-based screening program is likely more effective than standard care in reducing the risk of pre-eclampsia with delivery at less than 37 weeks’ gestation. Also, the FMF algorithm can improve the detection rate of pre-eclampsia with delivery at less than 37 weeks’ gestation or at less than 34 weeks’ gestation when compared with conventional algorithms. The population-wide FMF-based screening program is more effective and more costly than standard care. We estimate that publicly funding the population-wide FMF-based screening program in Ontario would result in additional costs of $8.50 million over the next 5 years. Pregnant people and their family members valued the potential equitable access, information, and clinical benefits that the population-wide FMF-based screening program could provide.

Authors' recommendations: Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends publicly funding a population-wide first-trimester screening program for the risk of pre-eclampsia using the screening algorithm developed by the Fetal Medicine Foundation

Authors' methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each study using the Risk of Bias in Non-randomized Studies—of Interventions tool and the Quality Assessment of Diagnostic Accuracy Studies—Comparative tool, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing the FMF-based screening program to standard care (screening for risk of pre-eclampsia using maternal factors alone) from a public payer perspective. We also analyzed the budget impact of publicly funding a population-wide FMF-based screening program in Ontario. We spoke with people who have experience with pregnancy and preeclampsia and their family members through direct interviews to gather preferences and values surrounding pre-eclampsia and the potential screening program.

Project Status: Completed

URL for project: https://ontariohealth.ca/system/health-innovation-pathway/reviews/hta-details?cf=first-trimester-pre-eclampsia-screening

URL for protocol: https://www.crd.york.ac.uk/PROSPERO/view/CRD42022315346

Year Published: 2022

URL for published report: https://pmc.ncbi.nlm.nih.gov/articles/PMC10530459/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Ontario

Pubmed ID: 37772268

Organisation Name: Ontario Health

Contact Address: 525 University Ave, Toronto, ON M5G 2L3

Contact Name: HealthInnovationPathway@ontariohealth.ca

Contact Email: HealthInnovationPathway@ontariohealth.ca

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