Implicações para a Inovação das Orientações Portuguesas de Avaliação Fármaco-Terapêutica

Abstract

Introduction: The growth of innovation in health technologies continues to pose new challenges for pharmaceutical companies and authorities. It requires increasingly complex assessment processes and greater expertise. Recently, the Portuguese authorities updated the Health Technology Assessment framework with new guidelines for the evaluation of Added Therapeutic Value. Purpose: The aim is to provide an overview of the recent updates and discuss the implications for future innovative therapeutics. Methodology: This review compared the new guidelines with earlier versions and was followed by a Think Tank discussion with an expert panel. Results: The new guidelines introduced relevant changes regarding the population(s), comparators, outcomes, meta-analysis, indirect comparisons, research and data sources and final assessment decision(s). Discussion: These changes are likely to affect assessments in Portugal directly and indirectly with implications for: defining the population, indication(s), comparators, and outcomes of future studies; analyzing when evidence is limited and dealing with increasingly complex assessments. Some strategies are suggested to support future assessments. Conclusion: Balancing speed and accuracy in health technology assessments will be key for faster access to innovative medicines for patients. These recent updates should result in timely and more robust assessments, and ultimately pave the way for the future of health technologies.

Keywords

• Drug Approval; Health Care Evaluation Mechanisms; Health Services Needs and Demand; Technology Assessment, Biomedical; Value-Based Purchasing