Modalità per la richiesta di valutazione di dispositivo medico innovativo al Centro Operativo HTA Regionale della Toscana
Pamela Giambastiani, Marisa Anzilotti, Giuseppe Taurino
Introduction According to the resolution of the Regional Government of Tuscany n. 1286/2017, the authorization to the use of a new medical device should be preceded by a technical evaluation by the Regional HTA Operative Center.
Methods In order to standardize the application, a stepwise flow chart was designed. The application should report some elements such as: the expected clinical benefit, alternative devices, the economic burden, the scientific support and the social and ethical impact of the use of the new device.
Results The evaluation by HTA Center is aimed to analyze the safety and the effectiveness of the device. The phases of the evaluation by the HTA Center are: preliminary evaluation, prioritization, evaluation, production of a report and monitoring. This format was applied to the request of a new device for the treatment of female pelvic floor dysfunction. All the steps and the expected timing have been respected to get a decision on the new evaluated device.
Conclusions Operative Center through inspiring criteria such as maximum efficiency, cheapness and transparency safeguards the principle that clinical and technical aspects must be met by effective and safe technologies consistent with allocated resources.
Key words: medical device, innovation, HTA report comparison, prioritization, final appraisal