Table 1.

The new Italian Medicines Agency criteria for assessing a drug's degree of innovation

Dimensions	Level
Therapeutic need	Maximum	Important	Moderate	Poor	Absent
	No alternative therapeutic options available	Alternative therapeutic options available, with no impact on clinically relevant outcomes	Alternative therapeutic options available with limited impact on clinically relevant outcomes, and/or uncertain or not satisfactory safety profile	Alternative therapeutic options available with high impact on clinically relevant outcomes and a satisfactory safety profile	Alternative therapeutic options available, which are able to slow down the progression of the disease and have satisfactory safety profile
Added therapeutic value	Maximum	Important	Moderate	Poor	Absent
	Greater efficacy than alternative therapeutic options (if available) in clinically relevant outcomes, ideally curing the disease or altering its natural history	Greater efficacy based on clinically relevant outcomes, or alternatively one of the following options:	A slightly better efficacy profile or improved efficacy in some patient sub‐populations or based on surrogate endpoints and has limited impact on the quality of life. For situations when the lack of a study comparator is acceptable, evidence showing relative efficacy compared to the available therapeutic options should be taken into account	Greater efficacy only for nonclinically relevant outcomes or based on a poor magnitude of effect. The drug offers minor benefits (e.g. favourable routes of administration) compared to the available therapeutic options	No added therapeutic benefit compared to the alternative available therapeutic options
		(i) the drug can reduce the risk of seriously debilitating or life‐threatening complications;
		(ii) the drug has better risk/benefit ratio compared to the alternative therapeutic options;
		(iii) the drug can avoid the use of high‐risk clinical procedures;
		(iv) the drug can significantly change the natural history of the disease in a subpopulation of patients;
		(v) the drug can provide a clinically relevant added value, e.g. in terms of quality of life and disease‐free interval compared to the available therapeutic options
Quality of clinical evidence *	High		Moderate	Low	Very low
	We are very confident that the true effect lies close to that of the estimate of the effect		We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different	Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect	We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
Innovativeness status	Fully innovative		Conditionally innovative	Non‐innovative
Commercial implication	Funded via innovative drug fund		Immediate inclusion into regional drug formularies	No benefits
	No payback mechanism
	Immediate inclusion into regional drug formularies
	Benefit duration up to 36 months

^* An orphan drug can still be considered innovative, even if the quality of clinical evidence is low or very low, when the other 2 criteria are evaluated as maximum or important.