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. 2021 Jan 13;11(1):e041259. doi: 10.1136/bmjopen-2020-041259

Figure 1.

Figure 1

Criteria used to evaluate innovativeness adopted by the Italian Medicines Agency (adapted from Recchia, 2017).10 *For rare disease there is the following exception: the fully innovative is attributed in the presence of at least important unmet therapeutic need and added therapeutic value in presence of at least low quality of clinical evidence. **The innovativeness appraisal has to be decided on a case-by-case basis. GRADE, Grading of Recommendations Assessment, Development and Evaluation.