Original Title: Exames diagnósticos para trombofilia em gestantes

Authors' results and conclusions: The Conitec’s members present at the 84th Ordinary Meeting, on December 4th, 2019, unanimously decided to recommend the incorporation of the following diagnostic tests for thrombophilia in pregnancy, in the scope of SUS, according to the Clinical Protocol and Therapeutic Guidelines: a) Prothrombin gene mutation; b) Protein C functional assay; c) Free protein S assay; d) Anti-beta2-glycoprotein - IgG; e) Anti-beta2-glycoprotein - IgM; and f) Lupus anticoagulant. The Deliberation Record No. 494/2019 was signed.

Authors' recommendations: Scientific evidence: Currently, the recommendation to perform thrombophilia testing includes all the tests mentioned above, but only in the following situations: (a) Pregnant women with a personal history of venous thromboembolism (VTE), with or without recurrent risk factor, and without previous thrombophilia testing; and (b) Pregnant women with a first-degree relative with a history of high-risk inherited thrombophilia. Hereditary factors: factor V Leiden; prothrombin gene mutation; deficiencies of protein C, protein S and antithrombin III; APS: aCL IgG and IgM, anti-β2GPI IgG and IgM; lupus anticoagulant. Budget impact analysis: The total budget impact of incorporating diagnostic tests for thrombophilia in pregnancy into the Brazilian Public Health System (SUS), in a scenario with market share, was estimated to range from approximately BRL 5.4 to BRL 12.2 million after five years. Considerations: Considering that tests for accurate diagnosis of thrombophilia in pregnancy are not yet available in SUS – which have been indicated in the Recommendation Report No. 502/2019 - Clinical Protocol and Therapeutic Guidelines for the Prevention of Venous Thromboembolism in Pregnant Women with Thrombophilia (6), approved by the Deliberation Record No. 493/2019 –, the Conitec’s members decided to recommend the incorporation of diagnostic tests for thrombophilia in pregnancy.

Project Status: Completed

URL for project: http://conitec.gov.br/images/Consultas/Relatorios/EN2020/20201119_Report503_DiagnosticTests_ThrombophiliaPregnancy.pdf

Year Published: 2019

URL for published report: http://conitec.gov.br/images/Relatorios/2019/Relatorio_EXAMES_DIAGNOSTICOS_TROMBOFILIA-GESTACIONAL_503_2019_FINAL.pdf

URL for additional information: http://conitec.gov.br/recomendation-reports

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Brazil

Organisation Name: National Committee for Technology Incorporation (CONITEC)

Contact Address: Esplanada dos Ministérios, Bl. G, Ed. Sede, 8º andar, CEP: 70058-900

Contact Name: Clarice Moreira Portugal

Contact Email: clarice.portugal@saude.gov.br

Copyright: 2021 Conitec