SynthesisInternational journal of technology assessment in health care2025
Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences.
Synthesis in International journal of technology assessment in health care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
aimsHealth technology assessment (HTA) for medical devices (MDs) is essential for adoption decisions, but the sector's particularities studied here defy regulatory frameworks. In Brazil, the National Policy for Health Technology Management (PNGTS) provides guidelines for HTA, but the reimbursement of MDs in the Brazilian National Health System (SUS) still faces challenges. This study aimed to identify and validate relevant domains and attributes for HTA of MDs in the SUS, considering the perspectives of various stakeholders.
objectivesTo analyze and validate the essential domains and attributes for conducting HTA studies focused on the reimbursement of MDs in the SUS.
methodsA baseline systematic review was performed, which was followed by two additional stages: a survey with 115 participants and a Delphi panel with 33 experts. Likert scales were used to assess the importance of the domains and attributes, along with open questions to collect suggestions and comments.
resultsThe domains "clinical benefits," "evidence ecosystem," and "budget impact" were considered fundamental. "Social participation" showed high variability in response, indicating the need for greater engagement and clarity in participation mechanisms. The inclusion of the "public policy" domain emphasizes the importance of aligning government policies with population needs.
conclusionsThis study reinforced the relevance of a multidisciplinary and participatory approach in HTA for MDs, with a focus on clinical outcomes, real-world evidence, and continuous monitoring. Overcoming the identified challenges, such as information gaps and the need for robust methods, is crucial for improving the reimbursement of MDs in the SUS.
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