Performance evaluation of the incorporation of PET/CT procedures in the SUS

Abstract

Aim/Introduction: High-complexity technologies, such as PET/ CT, should have their incorporation constantly analyzed and enhanced to support their consolidation. The evaluation of the performance of these equipment commits to the understanding of subjects such as the clinical application effectiveness, the usage of these devices in the patient’s real life, and the impact of this technology in the different regions where they are applied. Therefore, this work aimed to evaluate the performance incorporation PET/CT equipments and procedures by the Brazilian National Health System (SUS) according to admissibility, economic, innovation, and technical criteria, accordant to the Methodological Guideline for the Elaboration of Studies for the Evaluation of EMA (medical-assistance equipment). Furthermore, the demand for the application of this technology was also considered. Materials and Methods: The data collection methodology was based on an active search for information, such as the consultation of bibliographies and websites that presented data of interest, such as ANVISA, DATASUS, CNEN, and RHC. Results: Thirteen records of equipment from seven distinct manufacturers were identified within the validity period. Moreover, there are 110 registrations with at least one PET/CT equipment in the National Registration of Health Facilities (CNES) and 160 registrations of facilities authorized by the National Commission of Nuclear Energy (CNEN). Published by the National Health Fund (FNS), the value proposed for such equipment in 2022 is BRL 6,405,000.00. Regarding approved financing proposals, seven are registered and distributed in the records of five facilities. The applied taxes observed are IPI, PIS, and COFINS. Per procedure, according to the SUS table records, the amount paid was BRL 2,107.22, and the total amount paid since the incorporation of the technology is BRL 348,446,738.37. Conclusion: The development of the work led to the perception that, although there was some difficulty in obtaining some data that permeate the PET/CT technology, the incorporation of this technology took place in a satisfactory manner. There was divergence in results such as the number of devices. This fact was due to the way in which information was made available, as many data are self-declared by interested parties. Because it is the incorporation of a high-complexity technology in full use, few studies evaluating its performance were observed. Based on Consolidation Ordinance No. 1/2017 - which adopts the recommendation of one PET/CT unit per 1.5 million inhabitants, it was found that few Brazilian states have available the number of devices to meet the needs of demand.