Métodos de definição de limiar de impacto orçamentário na Avaliação de Tecnologias em Saúde: uma revisão rápida de escopo
Métodos de definição de limiar de impacto orçamentário na Avaliação de Tecnologias em Saúde: uma revisão rápida de escopo
Data
2023
Autores
Souza Filho, Homero Claudio Rocha
Journal Title
Journal ISSN
Volume Title
Publisher
Instituto Nacional de Cardiologia
Resumo
Introdução: No Brasil, a CONITEC definiu um limiar de custo-efetividade a ser considerado nas avaliações para incorporação de tecnologias em saúde no SUS. No documento que o apresenta, a Comissão, entretanto, aborda a necessidade de discussão de um novo tipo de limiar, o de impacto orçamentário. Já adotado em alguns países, como a Inglaterra, esse limiar, quando alcançado, sinalizaria a necessidade de discussões de alternativas, sejam de acordos comerciais, seja de extensão do prazo de incorporação ou restrição de uso da tecnologia devido aos riscos substanciais à sustentabilidade financeira do sistema de saúde.
Objetivos: O objetivo deste estudo é identificar e sintetizar os métodos de definição do limiar de impacto orçamentário disponíveis na literatura e nas principais agências de Avaliação de Tecnologias de Saúde (ATS) do mundo.
Método: Uma revisão rápida de escopo foi empreendida para alcançar o objetivo do estudo de acordo com as orientações do Joanna Briggs Institute e do guia PRISMA-ScR. A pergunta de pesquisa foi definida tendo como participantes a Inglaterra, Canadá, Austrália, Argentina, EUA e Brasil; a definição de limiar de impacto como conceito; e por fim, a ATS como o contexto desta discussão. Após buscas estruturadas na base indexada MEDLINE e nos sítios eletrônicos das agências e institutos de ATS dos países participantes, a revisão considerou revisões sistemáticas, diretrizes metodológicas e revisões narrativas alinhadas aos critérios de inclusão. O software utilizado para gerenciamento das citações e duplicatas foi o Mendeley e a seleção foi conduzida com apoio do software Rayyan.
Resultados: De um total de 406 estudos e registros encontrados nas bases de dados e sites das agências e institutos de ATS, 11 foram incluídos na análise final. Apesar do uso explícito de limiar de impacto orçamentário no processo de avaliação de incorporação tecnologias em saúde na Inglaterra e Austrália, apenas para os EUA o embasamento metodológico foi apresentado de forma reprodutível. O instituto independente de ATS americano Institute for Clinical and Economic Review (ICER) define seus valores de limiar de impacto em um cálculo que considera o crescimento da economia do país, os gastos totais em saúde e em medicamentos, e o número médio anual de medicamentos aprovados pelo FDA nos últimos cinco anos. O limiar anual calculado para o período de 2022/2023 foi de U$ 777 milhões. Segundo a organização, o objetivo não é sugerir um limite nos gastos, mas sinalizar ao sistema
de saúde que acordos especiais devem ser buscados. Em nota técnica elaborada pelo Banco Interamericano de Desenvolvimento (BID), uma proposta é apresentada para adaptar um limiar de impacto orçamentário definido em contextos internacionais de acordo com a fração do gasto per capita em saúde experienciada em países já com o uso desse limiar. Segundo o BID, para o Brasil o valor médio seria cerca de U$ 34 milhões a uma taxa de 2016, ou cerca de R$ 172 milhões em valores atuais.
Conclusões: Comparado ao contexto de limiar de custo-efetividade, observa-se ainda uma escassez de métodos e dados empíricos sobre a definição de limiar de impacto orçamentário. Mesmo quando definido, o racional de sua construção não foi apresentado por nenhuma das entidades pesquisadas, exceto pelo Instituto ICER, o que revela uma fragilidade na transparência metodológica dessa construção. O valor calculado pelo BID para o Brasil deve ser olhado com cautela por adaptar valores de limiares construídos em outros contextos e com incertezas quanto à transparência metodológica.
Palavras-chave: Sustentabilidade; Limiar; Impacto Orçamentário; Avaliação De Tecnologias Em Saúde.
ABSTRACT Introduction: In Brazil, CONITEC has established a cost-effectiveness threshold to be considered in the evaluations for the reimbursement of health technologies into the Brazilian Health System (SUS). However, in the document that presents this, the Commission addresses the need for a new type of threshold, the budget impact threshold. Already adopted in some countries, such as England, this threshold, when reached, would signal the need for discussions on alternatives, whether they involve trade agreements, an extension of the incorporation period, or restrictions on the use of the technology due to substantial risks to the financial sustainability of the healthcare system. Objectives: The aim of this study is to identify and synthesize the methods for defining the budget impact threshold available in the literature and from the leading Health Technology Assessment (HTA) agencies worldwide. Methods: A rapid scoping review was conducted to achieve the study's objective following the guidelines of the Joanna Briggs Institute and the PRISMA-ScR framework. The research question was defined with participants from the England, Canada, Australia, Argentina, the USA, and Brazil; the concept of the budget impact threshold; and Health Technology Assessment (HTA) as the context of this discussion. Following structured searches in the indexed MEDLINE database and the websites of the participating countries' HTA agencies, the review considered systematic reviews, methodological guidelines, and narrative reviews aligned with the inclusion criteria. Citation and duplicate management were performed using Mendeley software, and the selection process was conducted with the assistance of Rayyan software. Results: Out of a total of 406 studies and records identified in the databases and websites of HTA agencies, 11 were included in the final analysis. Despite the explicit use of the budget impact threshold in the process of evaluating the reimbursement of health technologies in England and Australia, only for the United States was the methodological foundation presented in a reproducible manner. The independent American HTA institute, the Institute for Clinical and Economic Review (ICER), defines its budget impact threshold values through a calculation that considers the country's economic growth, total healthcare and medication expenditures, and the average annual number of FDA-approved drugs over the past five years. The annual threshold calculated for the 2022/2023 period was $777 million. According to the organization, the goal is not to suggest a spending limit but to signal to the healthcare system that special agreements should be sought. In a technical note prepared by the Inter-American Development Bank (IDB), a proposal is presented to adapt a budget impact threshold defined in international contexts according to the fraction of per capita healthcare spending experienced in countries already using this threshold. According to the IDB, for Brazil, the average value would be around $34 million at a 2016 rate. Conclusions: Compared to the context of cost-effectiveness thresholds, there is still a scarcity of methods and empirical data for defining budget impact thresholds. Even when defined, the rationale for their construction was not presented by any of the researched entities, except for ICER, which reveals a weakness in the methodological transparency of this construction. The value calculated by the IDB for Brazil should be viewed with caution as it adapts threshold values constructed in other contexts and has uncertainties regarding methodological transparency. Keywords: Sustainability; Threshold; Budgetary Impact; Health Technology Assessment.
ABSTRACT Introduction: In Brazil, CONITEC has established a cost-effectiveness threshold to be considered in the evaluations for the reimbursement of health technologies into the Brazilian Health System (SUS). However, in the document that presents this, the Commission addresses the need for a new type of threshold, the budget impact threshold. Already adopted in some countries, such as England, this threshold, when reached, would signal the need for discussions on alternatives, whether they involve trade agreements, an extension of the incorporation period, or restrictions on the use of the technology due to substantial risks to the financial sustainability of the healthcare system. Objectives: The aim of this study is to identify and synthesize the methods for defining the budget impact threshold available in the literature and from the leading Health Technology Assessment (HTA) agencies worldwide. Methods: A rapid scoping review was conducted to achieve the study's objective following the guidelines of the Joanna Briggs Institute and the PRISMA-ScR framework. The research question was defined with participants from the England, Canada, Australia, Argentina, the USA, and Brazil; the concept of the budget impact threshold; and Health Technology Assessment (HTA) as the context of this discussion. Following structured searches in the indexed MEDLINE database and the websites of the participating countries' HTA agencies, the review considered systematic reviews, methodological guidelines, and narrative reviews aligned with the inclusion criteria. Citation and duplicate management were performed using Mendeley software, and the selection process was conducted with the assistance of Rayyan software. Results: Out of a total of 406 studies and records identified in the databases and websites of HTA agencies, 11 were included in the final analysis. Despite the explicit use of the budget impact threshold in the process of evaluating the reimbursement of health technologies in England and Australia, only for the United States was the methodological foundation presented in a reproducible manner. The independent American HTA institute, the Institute for Clinical and Economic Review (ICER), defines its budget impact threshold values through a calculation that considers the country's economic growth, total healthcare and medication expenditures, and the average annual number of FDA-approved drugs over the past five years. The annual threshold calculated for the 2022/2023 period was $777 million. According to the organization, the goal is not to suggest a spending limit but to signal to the healthcare system that special agreements should be sought. In a technical note prepared by the Inter-American Development Bank (IDB), a proposal is presented to adapt a budget impact threshold defined in international contexts according to the fraction of per capita healthcare spending experienced in countries already using this threshold. According to the IDB, for Brazil, the average value would be around $34 million at a 2016 rate. Conclusions: Compared to the context of cost-effectiveness thresholds, there is still a scarcity of methods and empirical data for defining budget impact thresholds. Even when defined, the rationale for their construction was not presented by any of the researched entities, except for ICER, which reveals a weakness in the methodological transparency of this construction. The value calculated by the IDB for Brazil should be viewed with caution as it adapts threshold values constructed in other contexts and has uncertainties regarding methodological transparency. Keywords: Sustainability; Threshold; Budgetary Impact; Health Technology Assessment.
Description
Palavras-chave
Sustentabilidade, Limiar, Impacto Orçamentário, Avaliação De Tecnologias Em Saúde., Sustainability, Threshold, Budgetary Impact, Health Technology Assessment
Citação
Souza Filho HCR. Métodos de definição de limiar de impacto orçamentário na Avaliação de Tecnologias em Saúde: uma revisão rápida de escopo. Rio de Janeiro. Dissertação [Mestrado Profissional em Avaliação de Tecnologias em Saúde] - Instituto Nacional de Cardiologia; 2023.