Abstract
The National Commission for incorporation of Health Technologies (CONITEC), established in 2011, advises the Ministry of Health in decisions related to the incorporation, exclusion or change of medicines, products and procedures in the Unified Health System (SUS).The study investigated the decision-making process, profile of demands and incorporation of new medicines in the SUS from January/2012 to June/2016, based on data available on the CONITEC website. All submissions were evaluated and characterized by technology and applicant type. The incorporations were analyzed according to the Anatomical-Therapeutic-Chemical classification, International Classification of Disease of the clinical indication and active record in the National Health Surveillance Agency. In the period, 485 submissions were received, 92.2% concerning requests for incorporation and 62.1% for medicines, of which 93 (30.1%) received a favorable recommendation for incorporation. Domestic demands were more successful than externally originated ones. Six unregistered drugs were incorporated. Infectious and parasitic diseases and musculoskeletal diseases constituted the main clinical indications. The recommendation of incorporation occurred mainly based on the additional clinical benefits and low budget impact.
Highlights
The 1988 Federal Constitution of Brazil affirms the right to health as being a social right and establishes that the state ought to ensure health care, including public financing that allows universal access and equity in the distribution of medicines and other technologies in health.The impossibility of the Brazilian National Health System (SUS), that is chronically underfunded, to meet health needs and growing demands for new technologies has triggered the phenomenon of health litigation for the provision of medical procedures or therapies that have not been incorporated into the public health system
This study examined the recommendation process and the profile of the incorporations of new medicines into SUS approved by Conitec between 2012 and June 2016
Conitec received 485 submissions in the period of the study, 92.2% of which were related to requests for incorporation of new technologies
Summary
The impossibility of the Brazilian National Health System (SUS), that is chronically underfunded, to meet health needs and growing demands for new technologies has triggered the phenomenon of health litigation for the provision of medical procedures or therapies that have not been incorporated into the public health system Many of these legal cases seek to ensure the right of access for patients to expensive medicines that are not always available on SUS and many times without any proven benefits or in some cases are considered deleterious[1,2]. This situation has led to the approval of Law n° 12401 in April 2011 which aimed to regulate the concept of integrality and make therapeutic assistance more readily available. In 2011 the Decree n° 7646 provided regulation in the composition, competencies, and function of Conitec[5]
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