OBJECTIVES: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health. METHODS: Our methods used include extensive literature review, refinement with experts across countries, and public consultation. RESULTS: A comprehensive guideline was developed, which has been adopted by the Brazilian government. CONCLUSION: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.
OBJECTIVES: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health. METHODS: Our methods used include extensive literature review, refinement with experts across countries, and public consultation. RESULTS: A comprehensive guideline was developed, which has been adopted by the Brazilian government. CONCLUSION: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.
Entities:
Keywords:
Biomedical; Health information systems; Health policy; Observational studies; Technology assessment
Authors: Patricia Vella Bonanno; Michael Ermisch; Brian Godman; Antony P Martin; Jesper Van Den Bergh; Liudmila Bezmelnitsyna; Anna Bucsics; Francis Arickx; Alexander Bybau; Tomasz Bochenek; Marc van de Casteele; Eduardo Diogene; Irene Eriksson; Jurij Fürst; Mohamed Gad; Ieva Greičiūtė-Kuprijanov; Martin van der Graaff; Jolanta Gulbinovic; Jan Jones; Roberta Joppi; Marija Kalaba; Ott Laius; Irene Langner; Ileana Mardare; Vanda Markovic-Pekovic; Einar Magnusson; Oyvind Melien; Dmitry O Meshkov; Guenka I Petrova; Gisbert Selke; Catherine Sermet; Steven Simoens; Ad Schuurman; Ricardo Ramos; Jorge Rodrigues; Corinne Zara; Eva Zebedin-Brandl; Alan Haycox Journal: Front Pharmacol Date: 2017-08-23 Impact factor: 5.810
Authors: Isabela Maia Diniz; Augusto Afonso Guerra; Livia Lovato Pires de Lemos; Kathiaja M Souza; Brian Godman; Marion Bennie; Björn Wettermark; Francisco de Assis Acurcio; Juliana Alvares; Eli Iola Gurgel Andrade; Mariangela Leal Cherchiglia; Vânia Eloisa de Araújo Journal: PLoS One Date: 2018-06-21 Impact factor: 3.240
Authors: Ludmila Peres Gargano; Isabella de Figueiredo Zuppo; Mariana Martins Gonzaga do Nascimento; Valéria Maria Augusto; Brian Godman; Juliana de Oliveira Costa; Francisco Assis Acúrcio; Juliana Álvares-Teodoro; Augusto Afonso Guerra Journal: Front Big Data Date: 2022-02-07
Authors: Livia Lovato Pires de Lemos; Augusto Afonso Guerra Júnior; Marisa Santos; Carlos Magliano; Isabela Diniz; Kathiaja Souza; Ramon Gonçalves Pereira; Juliana Alvares; Brian Godman; Marion Bennie; Ivan Ricardo Zimmermann; Vânia Crisitna Canuto Dos Santos; Clarice Alegre Pretramale; Francisco de Assis Acurcio Journal: Pharmacoeconomics Date: 2018-02 Impact factor: 4.981