HTA in nuclear medicine

Abstract

The [ 68Ga]PSMA PET/CT has been an option on clinical research tools to stage and to restage prostate cancer patients, although, with promising results, this radiopharmaceutical cannot be commercialized yet. Hence, up to date, [ 68Ga]PSMA has been used in a clinical research context. Once regulatory body approved it for marketing, health systems are responsible for the reimbursement decision. Health Technology Assessments (HTA) tools should be considered to base and to help decision-makers to spread or not this new technology. Regarding [ 68Ga]PSMA, under HTA framework, the present study searched for secondary studies and hence assessed three systematic reviews with meta-analyses published considering prostate cancer patients in different scenarios, same imaging technology but different comparators and outputs. The secondary studies considered outputs such as accuracy, detectability, positivity and change of management. Using AMSTAR-2, the meta-analysis methods and results were evaluated with 16 questions able to identify critical weaknesses, such as risk of bias, publication bias, true effect, and study heterogeneity. To increase the observational number of patients, to register positive and negative findings, and consolidate regional and multi-center clinical data which were suggestions on study design, structure and statistics made to improve the quality in future primary and secondary studies.