HEALTH TECHNOLOGY PERFORMANCE ASSESSMENT: REAL-WORLD EVIDENCE FOR PUBLIC HEALTHCARE SUSTAINABILITY

Оценка эффективности медицинских технологий: данные реальной клинической практики для устойчивости государственного здравоохранения
Augusto Afonso Guerra, Lívia Lovato Pires de Lemos, Brian Godman, Marion Bennie, Cláudia Garcia Serpa Osorio-de-Castro, Juliana Álvares Duarte Bonini Campos, Aine Heaney, Carlos Alberto Vassallo, Björn Wettermark, Gaizka Benguria-Arrate, Iñaki Gutiérrez‐Ibarluzea, Vânia Cristina Canuto Santos, Clarice Alegre Petramale, Francisco de Assis Acúrcio
2017-01-01

Brazilian Ministry of Healthdisinvestment decisionshealth technology financinghealth technology performance assessmentreal-world evidence
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.
1
Health technology financing based primarily on controlled Phase III trials may overestimate performance under real-world healthcare conditions.
2
Health technology performance assessment (HTpA) systematically evaluates interventions’ real-world properties, effects, and impacts to inform investment, disinvestment, and clinical guideline decisions.
3
Institutionalizing HTpA and a dedicated program could support continuous use of real-world evidence for sustainable resource allocation in Brazil and other countries.
4
The Brazilian Ministry of Health developed a comprehensive HTpA guideline using literature review, international expert refinement, and public consultation.
5
The guideline was adopted by the Brazilian government and emphasizes disinvestment as a mechanism for optimizing healthcare resources.

financed health interventions and health technologies in real-world healthcare settings

their real-world performance, effects, and impacts assessed to inform investment or disinvestment decisions and clinical guideline updates

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2017-01-01
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Augusto Afonso Guerra
Lívia Lovato Pires de Lemos
Brian Godman
Marion Bennie
Cláudia Garcia Serpa Osorio-de-Castro
Juliana Álvares Duarte Bonini Campos
Aine Heaney
Carlos Alberto Vassallo
Björn Wettermark
Gaizka Benguria-Arrate
Iñaki Gutiérrez‐Ibarluzea
Vânia Cristina Canuto Santos
Clarice Alegre Petramale
Francisco de Assis Acúrcio
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