Emilia Romagna Region announced the launch of two new series of documents, according to the new regional assessment framework for medical devices developed during 2017: rapid assessment reports and preliminary information reports.
The rapid assessment reports are produced around the experience and methods developed for the short reports series (produced from 2009). The production of this kind of reports takes 3-4 months and involve the clinicians that requested the technology and other regional experts in the field. The reports present the technical characteristics of the technology, its cost, its organizational impact, and estimates the eligible population within the Region. Moreover, a critical analysis of available evidence on effectiveness, safety, and technical performance is carried out. The reports are internally and externally peer-reviewed before publication.
The preliminary information reports are brief documents, typically produced in a very short time, resuming information on the technical characteristics of the technology, indications for use, diffusion, and results of preliminary searches of available evidence. The aim of this kind of reports is to allow establishing if an HTA report needs to be produced or if decisions on the use of the technology can be taken, based on the preliminary information report alone.
The production of both documents is requested by the Regional Committee for Medical Devices, after that permission for use has been requested from clinicians.
See the news in Italian here.
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