O Complexo processo de incorporação de tecnologias em saúde no Brasil

Abstract

he transcatheter aortic valve implantation (TAVI, or TAVR, transcatheter aortic valve replacement), the treatment of choice for patients with severe aortic stricture deemed inoperable (class I, level of evidence B) and an alternative strategy for surgical valve replace-ment surgery in high-risk individuals (class IIa, level of evidence B), has been employed, to date, in over 700 patients in Brazil. This procedure was approved by the Brazilian Federal Council of Medicine in January 2012, after its evaluation as a non-experimental prac-tice. This phase was subsequent to the approval of the device used in the procedure by the Brazilian Health Surveillance Agency (Agencia Nacional de Vigilância Sanitaria – ANVISA).In the Brazilian system of health technology incor-poration, compliance with these first two steps does not guarantee reimbursement by the private health care system or by the Brazilian Unified Health System (Sistema Unico de Saude — SUS). To ensure mandatory reimbursement by health plans, the procedure should integrate the List of Health Procedures and Events de-veloped by the Brazilian National Regulatory Agency for Private Health Insurance and Plans (Agencia Nacio-nal de Saude Suplementar – ANS), which is renewed every two years. To obtain reimbursement by SUS, an approval from the National Committee of Technology Incorporation (Comissao Nacional de Incorporacao de Tecnologias – CONITEC) is required. CONITEC must issue a ruling within 180 days of request of the incorporation.In the case of TAVI, in three opportunities the ANS did not include the technique in the List of Pro-cedures. In the last update, which will be enforced from 2014, a Permanent Technical Group was cre-ated, which may deliberate in favor of the inclusion of new procedures before the regulatory two years. At CONITEC, Brazilian Society of Hemodynamics and Interventional Cardiology (