HTA studies focused on equipment have particularities. The evaluation of orthoses (ORT) and prostheses (PRT) are even more challenging and tend to present more difficulties when compared to technologies such as medicines. The need for HTA guidelines for the evaluation of non-implantable ORT and PRT has led to collaborative work between an academic research institute (NUTES) — a pioneer in the development of ORT and PRT manufactured by 3D printer— in association with local and regional centers of non-implantable ORT and PRT (beloging to the Brazilian Public health system, the SUS).

OBJECTIVES: The main objectives are: a) to evaluate and disseminate the necessary elements to carry out adequate evaluations of non-implantable ORT and PRT; and, b) produce a guideline on HTA evaluation for non-implantable ORT and PRT.

METHODS: On-site visits to ORT and PRT centers throughout Brazil were carried out to collect data on the production chain, dispensing, adaptation and evaluation of the patient's clinical results. At the same time, we are conducting systematic literature reviews on two topics: a) elements that must be taken into account in the manufacture, dispensing and adaptation of non-implantable ORT and PRT; and, b) HTA guidelines and/or HTA examples focused on ORT and PRT.

RESULTS: Seven out of a total of 12 centers were visited. A scoping review was carried out on body sizing methods for manufacturing non-implantable ORT and PRT. We are now conducting a systematic review of the HTA guidelines and HTA assessment of ORT and PRT— to be completed shortly.

CONCLUSIONS: Only the sum of different actors, such as government agencies, academia, health centers, working together can enable the expansion and knowledge of complex areas such as evaluation in HTA of TRO and PRT. However, even with this effort, the challenges are enormous, the gaps are significant, and the work to be done remains enormous.