Criteria adopted in different models of public healthcare systems for the evaluation of reimbursement recommendations of orphan drugs: a scoping review.
DOI:
https://doi.org/10.22563/2525-7323.2023.v1.s2.p.134Palavras-chave:
HTA; ATS; Rare Diseases; Criteria To HTA.Resumo
Introdução: Access to drugs for rare diseases constitutes a challenge to healthcare systems, especially those with public funding. The difficulty of conducting robust clinical trials limits the quality of evidence and elevates the cost of development, later translated into the drug’s prices. Thus, it is necessary for the Health Technology Assessment (HTA) agencies to have differentiated criteria for the evaluation of reimbursement recommendations when dealing with such drugs. Objetivos: The objective of this research is to identify and summarize the specific criteria used when evaluating reimbursement recommendations for orphan drugs that are adopted by HTA agencies in countries with different models of public healthcare systems. Material e Método: A comprehensive literature search was performed on the databases PubMed, LILACS, Scopus and Embase up to March 2022. We included any publication type (opinion articles, commentaries, editorials, original articles and reviews) that addressed the criteria used by HTA agencies in countries with public healthcare systems when evaluating reimbursement recommendations for orphan drugs. Resultados: This scoping review summarizes the identified criteria for 18 countries and ranks them within three models of healthcare systems (NHS, NHI and SHI). We identified that NHS countries, such as the UK, Sweden, and Italy, lean towards innovation, the collection of real-world data, and the impact on organizational aspects of the system. Meanwhile, SHI countries, such as Germany, France and the Netherlands, often employ budget ceilings and expedited evaluation processes. All models shared concern over unmet need and disease nature. The 16 included studies range from 2015 to 2022 and the majority consists of reviews of HTA reports and original articles. Discussão e Conclusões: This review provides a good basis for the understanding of each model’s classification and general tendencies when creating differentiated criteria to accommodate and compensate for the lack of evidence and investment around rare diseases.
Downloads
Publicado
Como Citar
Edição
Seção
Licença
Copyright (c) 2023 JORNAL DE ASSISTÊNCIA FARMACÊUTICA E FARMACOECONOMIA
Este trabalho está licenciado sob uma licença Creative Commons Attribution 4.0 International License.
Todo o conteúdo dos artigos publicados no JAFF está licenciado sob uma Licença Creative Commons Atribuição 4.0 Internacional, que permite o uso, compartilhamento, adaptação, distribuição e reprodução em qualquer meio ou formato, desde que você dê o devido crédito ao autor(es) original(ais) e a fonte, fornecer um link para a licença Creative Commons e indicar se alterações foram feitas. As imagens ou outros materiais de terceiros neste artigo estão incluídos na licença Creative Commons do artigo, salvo indicação em contrário em uma linha de crédito para o material.