PP17 Evidence And Economic Models Used By CONITEC In The Evaluation And Incorporation Of Medical Devices In The Unified Health System

Sep 29, 2026

Uploaded by Aurelia

Health technology assessment by Brazil’s CONITEC supports incorporation of medical devices into the Unified Health System (SUS), but the process depends on selecting diverse evidence types and appropriate economic approaches for the national context. Twenty-one CONITEC Recommendation Panel reports from 2012–2021 were analyzed to identify evidence categories, applied economic models, and described limitations. Results show systematic reviews and meta-analyses dominate, patient perspectives are infrequent, and economic detail is often missing. The findings indicate opportunities to strengthen real-world evidence, technology horizon monitoring, and locally grounded economic evaluation.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages1

Reading Time3 min

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PP16 International Approaches To Integrating Sex And Gender In Health Technology Assessment Analía Abt Sacks ([acabt.iacs@aragon.es](acabt.iacs@aragon.es)), Anabel Granja Dominguez, Gustavo Mora, Yolanda Triñanes Pego, Eva Reviriego Rodrigo and Maria Jose Vicente-Edo Introduction: Sex differences and gender inequalities in health are increasingly recognized in health technology assessment (HTA), but their analysis remains inconsistent. Despite advancements in addressing ethical, organizational, and social issues in HTA, neglecting sex/gender (S/G) considerations can distort its outcomes. This initiative aimed to enhance equity by exploring international experiences and identifying frameworks for S/G-sensitive HTA processes. Methods: The first phase involved an exploratory analysis to assess the inclusion of S/G in methodological and report prioritization processes, using both Medical Subject Heading terms and free keywords. The search was then expanded to include international experiences, frameworks, and tools incorporating a S/G approach from organizations such as the World Health Organization, International Network of Agencies for Health Technology Assessment, European Network for Health Technology Assessment, Cochrane Collaboration, and other frameworks (GRADE, VALIDATE) . HTA agencies and ministries of health from Latin America and high-income countries were reviewed. Data were extracted, focusing on the practical application of S/G in HTA. Results: No specific tools were identified, and S/G perspectives were generally absent, with “gender” mainly referring to the male/female distinction. The Cochrane Collaboration has a S/G Methods Group and a S/G in Systematic Reviews Planning Tool. Both the Cochrane Collaboration and GRADE incorporate S/G in equity frameworks (PROGRESS-Plus) . Ecuador and Argentina (Instituto de Efectividad Clínica y Sanitaria) integrate gender in the Sustainable Development Goals. The National Institute for Health and Care Excellence includes S/G in qualitative study appraisals, and Canada’s Drug Agency (CDA) advocates for gender equity in health care. The Institute for Quality and Efficiency in Health Care (IQWiG) in Germany emphasizes the need to account for gender differences in health assessmentsas part of general HTA methods, and the French National Authority for Health (HAS) proposes integrating gender into public health policies and health technology guidance. Conclusions: S/G perspectives are internationally recognized asa key axis of inequity. Several entities incorporate these perspectives into documents and frameworks (the Cochrane Collaboration, CDA’s real-world evidence guidelines, IQWiG’s general methods) . HAS plans methodological frameworks, and both the Institute for Clinical Effectiveness and Health Policy and IQWiG promote non-sexist/ neutral language guidelines. The next exploratory phase would be to see whether and how they are being used in HTA processes. PP17 Evidence And Economic Models Used By CONITEC In The Evaluation And Incorporation Of Medical Devices In The Unified Health System Aldenora Maria Ximenes Rodrigues, Mônica Vinhas de Souza, Katia Elizabete Galdino and Ketinlly Yasmyne Nascimento Martins ([yasmynefisio@gmail.com](yasmynefisio@gmail.com)) Introduction: Health technology assessment (HTA), conducted by the National Committee for Health Technology Incorporation (CONITEC), guides the incorporation of technologies into the Unified Health System (SUS) . This process is challenging because it requires diverse evidence and applying appropriate economic methods to the national context. This study analyzed the types of evidence and economic models used in medical device assessment reports, identifying gaps and opportunities for improvement. Methods: Twenty-one reports published on the CONITEC Recommendations Panel between 2012 and 2021 were analyzed using the filters “Technology Type – Product” and “Ministry of Health Decision – Incorporate.” We reviewed

FAQs

What evidence sources and study types were most frequently used in the CONITEC medical device reports?

Most reports included systematic reviews and meta-analyses, and about half cited observational studies or randomized clinical trials.

How were patient perspectives and technology horizon monitoring handled across the reports?

Public consultations were common, fewer than 20% considered patient perspectives, and technology horizon monitoring appeared in a minority of reports.

What economic modeling approaches and gaps were identified in the reviewed reports?

Cost-effectiveness analysis was the most common economic model, while many reports lacked detailed economic analysis; gaps included reliance on international data and limited local information.

Sep 29, 2026

Uploaded by Aurelia