La RED CRITERIA

Es una iniciativa del BID y tiene como fin apoyar a los países de América Latina y el Caribe para fortalecer sus políticas de priorización del gasto en salud y de diseño y ajuste de sus planes de beneficios en salud y diseño y ajuste de sus planes de beneficios en salud. Se busca que los países cuenten con la evidencia y la institucionalidad requerida con CRITERIA sobre qué servicios y tecnologías de salud financiar con recursos públicos.

En CRITERIA encaminamos nuestros esfuerzos a la identificación de experiencias, tanto nacionales como internacionales, en materia de priorización del gasto en salud y las socializamos a través de múltiples plataformas. Esperamos, en estos medios, facilitar el intercambio de conocimiento entre los técnicos especializados, gobiernos, la comunidad académica y personas interesadas en el tema.

HEALTH TECHNOLOGY ASSESSMENT OF

Objectives: The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies.

Methods: HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1–agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2–semi-structured telephone interviews with key informants of a sub-sample of agencies.

Results: In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non–MD-specific agencies.

Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices.

Conclusions: The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.