RESUMO

Abstract Biopharmaceuticals, mainly monoclonal antibodies, and fusion proteins are drugs that have gained notoriety in the treatment of various chronic and inflammatory diseases and have high prices. The study aimed to verify which monoclonal antibodies and fusion proteins were most incorporated into the Unified Health System (SUS), which therapeutic indication most benefited from them and to analyze public spending on these biopharmaceuticals from January 2012 to September 2019. This study performed a qualitative and quantitative analysis of biopharmaceuticals incorporated by SUS. The data were collected on the websites of CONITEC and the Health Price Bank. The results demonstrated that subcutaneous adalimumab was most frequently incorporated, and the most requested therapeutic indication was rheumatoid arthritis. Public spending on biopharmaceuticals exceeded R$ 28 billion (more than US$ 140 billion). However, a downward trend was confirmed (-266.7%) in the period evaluated. Despite the increase in demand and public spending on biologics in general, in Brazil and worldwide, the results of this research show that there was a drop in public spending on the biopharmaceuticals studied in the last seven years.

Assuntos

RESUMO

RESUMO As tecnologias em saúde têm revolucionado a assistência médica e a gestão em saúde. A Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec) é o órgão do Ministério da Saúde que assessora na incorporação, exclusão ou alteração de novas tecnologias no Sistema Único de Saúde (SUS). O presente estudo objetivou descrever o perfil das tecnologias incorporadas no SUS de 1 de janeiro de 2012 a 30 de setembro de 2019. Os dados foram coletados no site da Conitec. Na análise estatística, foi utilizado o teste Qui-quadrado de Pearson e o Teste Exato de Fisher. Os resultados demonstram que foram incorporadas 380 tecnologias, prevalecendo os medicamentos (46,6%). Em relação aos demandantes, os de origem interna superaram os demais (82,4%), principalmente secretarias do Ministério da Saúde (p<0,001). As Doenças Infecciosas e Parasitárias (DIPs) foram as mais beneficiadas (20,3%), com destaque para o HIV (Vírus da Imunodeficiência Humana). A maioria das tecnologias incorporadas passou por consulta pública (p<0,001). Conclui-se que o perfil das tecnologias incorporadas são principalmente medicamentos, por demanda interna, com indicação para DIPs e, sobretudo para o HIV. Os medicamentos continuam sendo o foco das solicitações e as demandas internas passaram a ter mais espaço nesse cenário.

ABSTRACT Health technologies have revolutionized medical care and health management. The National Commission for the Incorporation of Technologies in the SUS (Conitec) is the Ministry of Health's body that advises on the incorporation, exclusion or alteration of new technologies in the Unified Health System (SUS). This study aimed to describe the profile of technologies incorporated in the SUS between January 1, 2012 and September 30, 2019. Data were collected on the Conitec website. Statistical analysis used Pearson's chi-square test and Fisher's exact test. The results show that 380 technologies were incorporated, with medication prevailing (46.6%). In relation to the plaintiffs, those of internal origin surpassed the others (82.4%), mainly secretariats of the Ministry of Health (p<0.001). Infectious and Parasitic Diseases (PIDs) were the most benefited (20.3%), with emphasis on HIV (Human Immunodeficiency Virus). Most of the incorporated technologies underwent public consultation (p<0.001). It is concluded that the profile of the incorporated technologies are mainly medicines, by internal demand, with indication for PIDs and, above all, for HIV. Medicines continue to be the focus of requests and internal demands have gained more space in this scenario.

RESUMO

Houve mudanças no processo de incorporação de tecnologias a partir da implementação da Comissão Nacional de Incorporação de Tecnologias (CONITEC), alterando a dinâmica da entrada de novos produtos no Sistema Único de Saúde (SUS). A incorporação de novas tecnologias é algo importante, mas gera impactos nos gastos públicos. O estudo objetivou avaliar o perfil de todas as tecnologias incorporadas no SUS e analisar os gastos públicos com biofármacos (anticorpos monoclonais e proteínas de fusão) entre janeiro de 2012 a setembro de 2019. Dados como nome e tipo de tecnologia, indicação terapêutica, decisão da CONITEC, demandante e se houve consulta pública foram coletados no site da CONITEC. Os dados dos gastos públicos foram coletados no Banco de Preços em Saúde. Para a análise estatística foi utilizado o teste Qui-quadrado de Pearson, Teste Exato de Fisher e Teste da Razão de Verossimilhança. Foram incorporadas 380 tecnologias, prevalecendo os medicamentos (46,6%). Em relação aos demandantes, os de origem interna superaram os demais (82,4%), principalmente secretarias do Ministério da Saúde (MS) (p<0,001). As doenças infecciosas e parasitárias (DIPs) foram as mais beneficiadas (20,3%), principalmente o HIV. A maioria das tecnologias incorporadas passou por consulta pública (p<0,001). Para os biofármacos, o adalimumabe foi a tecnologia mais incorporada e a artrite reumatoide a indicação terapêutica mais beneficiada. Os gastos com biológicos ultrapassaram R$ 28 bilhões, e os gastos federais foram superiores aos de estados e municípios. Conclui-se que houve um importante avanço na renovação de tecnologias incorporadas no SUS, principalmente medicamentos, através de um processo mais transparente. Além disso, o estudo permitiu demonstrar a relevância dos biológicos estudados não só para a saúde pública no Brasil, mas também para os gastos públicos os quais perfazem uma parcela importante das despesas com medicamentos. Compreender esses gastos torna-se importante para viabilizar a tomada de decisão de gestores, bem como direcionar de forma equilibrada as incorporações de tecnologias no SUS.

There have been changes in the technology incorporation process since the implementation of the National Technology Incorporation Commission (NCIT), changing the dynamics of the entry of new products into the Unified Health System (HUS). The incorporation of new technologies is important, but it impacts public spending. The study aimed to evaluate the profile of all technologies incorporated in SUS and to analyze public spending on biopharmaceuticals (monoclonal antibodies and fusion proteins) between January 2012 and September 2019. Data such as name and type of technology, therapeutic indication, decision of the NCIT, plaintiff and if there was a public consultation were collected on the NCIT website. Public expenditure data were collected from the Health Price Bank. Pearson's chi-square test, Fisher's exact test and likelihood ratio test were used for statistical analysis. 380 technologies were incorporated, with medications prevailing (46.6%). In relation to the plaintiffs, those of internal origin surpassed the others (82.4%), mainly secretariats of the Ministry of Health (MH) (p <0.001). Infectious and parasitic diseases (PIDs) were the most benefited (20.3%), mainly HIV. Most of the technologies incorporated underwent public consultation (p <0.001). For biopharmaceuticals, adalimumab was the most incorporated technology and rheumatoid arthritis was the most benefited therapeutic indication. Spending on biological products exceeded R$ 28 billion, and federal spending was higher than that of states and municipalities. It is concluded that there was an important advance in the renewal of technologies incorporated in SUS, mainly medicines, through a more transparent process. In addition, the study allowed to demonstrate the relevance of the biologicals studied not only for public health in Brazil, but also for public expenditures, which make up an important part of the expenses with medicines. Understanding these expenditures becomes important to enable managers to make decisions, as well as to guide the incorporation of technologies in the SUS in a balanced way.

Assuntos