Incorporação da Vacina contra o Papilomavírus Humano pelo Ministério da Saúde: uma análise do processo decisório.

Abstract

The vaccine against the Human Papillomavirus (HPV) offers protection against four viral subtypes, and from these the subtypes 16 and 18 are associated with about 70% of cases of cervical cancer in the world. The incorporation of this vaccine in Brazil occurred at a time when the evaluation of health technologies was institutionalized within the Ministry of Health. This study examined the process of incorporation of the Quadrivalent vaccine against HPV by the Ministry of Health (MS), that occurred within the National Commission for the Incorporation of Technologies do SUS (CONITEC), in order to (1) characterize the political and institutional context in which this decision was made in the country, identifying the main actors involved in this process and their positions and influences in the decision-making; (2) map the criteria and factors that were considered in the decision to introduce the HPV vaccine by the Brazilian government; (3) discuss the aspects related to the implementation of the incorporated vaccine that were considered in the first moments of its adoption in the SUS. The exploratory study was conducted through a qualitative approach, of a single case study type. The data were collected through analysis of government documents, legislative bills and eight interviews with key actors, identified as process participants through the documents or referred by other interviewees. The analysis of the data sought to identify how the process occurred; the arenas, governmental or not, where the debates were held; the positions and arguments defended by the actors and how the analysis was carried out by CONITEC, seeking the understanding of the decision-making process as a whole. The vaccine was registered by the National Agency of Sanitary Surveillance in 2006 and, since then, added the pressures for its incorporation into the public health system, leading to the formation of several work groups over the years. The initial results of the available evidence do not recommend incorporation, due to the lack of knowledge about its efficacy and reliability and the high budgetary impact for the SUS due to its high prices and problems of technical feasibility for its offer by the National Program of Immunizations (PNI). A cost-effectiveness study showed in 2012 that the vaccine was cost-effective to the system, but before that the Department of Health Surveillance and other departments already evaluated its introduction in the PNI. The transfer of technology through the establishment of a Productive Development Partnership and the reduction of prices were fundamental elements for this decision. The incorporation of the vaccine was a long process, which lasted for years, occurring even when there were still uncertainties about its potential impact on the incidence of cervical cancer. Although the decision had occurred within CONITEC, the discussions have extended to several arenas, including the academia and legislative environment. The incorporation was unanimously approved by the CONITEC Plenary, the decision published in the DOU in November 2013, and its offer in the PNI was initiated in March 2014, which used a mixed strategy, including schools and health services. Since then, the vaccine coverage achieved has been far below the targets recommended for the vaccine to reach its proposed goals, risking its intended future goals of reducing the incidence of cervical cancer.