HTA in nuclear medicine: [68Ga]PSMA PET/CT for patients with prostate cancer

The [ 68 Ga]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, [ 68 Ga]PSMA has been used in a clinical research context. Once regulato...

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Bibliographic Details
Published in:Clinical and translational imaging : reviews in nuclear medicine and molecular imaging 2019-02, Vol.7 (1), p.7-20
Main Authors: Pozzo, Lorena, Monteiro, Lucilena Rebelo, Cerci, Juliano Julio, Fanti, Stefano, Negro, Antonella, Trindade, Evelinda
Format: Article
Language:English
Subjects:
Bias
Change detection
Commercialization
Comparators
Diagnostic Radiology
Health technology assessment
Identification methods
Imaging
Interventional Radiology
Literature reviews
Medical and Radiation Physics
Medicine
Medicine & Public Health
Meta-analysis
New technology
Nuclear Medicine
Patients
Prostate cancer
Radiochemical analysis
Radiology
Radiotherapy
Studies
Systematic Review
Technology assessment
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Summary:The [ 68 Ga]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, [ 68 Ga]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 [ 68 Ga]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.
ISSN:2281-5872
2281-7565
DOI:10.1007/s40336-019-00313-8