On criteria to evaluate the therapeutic innovation of drugs

As authors of two papers proposing the“old”algorithm to assess thetherapeutic innovation of the medicines approved by the EM(E)Abetween 1995 and 2003,1,2we have read with great interest and curi-osity the paper by Filomena Fortinguerra et al. entitled“Using GRADEmethodology to assess innovation of new medicinal products inItaly.”3These authors rightly write that the Italian Medicines Agency(AIFA) was the first regulatory body to introduce a method foracknowledging and ranking the therapeutic innovation when itadopted our algorithm in 2007.4As former chairman (NM) andmember (DM), on behalf of AIFA, of the 2007-AIFA/Industry workinggroup commissioned to support such adoption, we had to arrange afew significant changes on the initial published algorithm. The mostimportant fruit of such bilateral effort was creating the category of“potential therapeutic innovation.”