Table 2.

Role played by the three domains on innovativeness status (2017–2020)

	All medicines		Innovative‡		Not innovative		P value*
Unmet therapeutic need
n	77		51		26
Maximum (scale=1)	10	(13.0%)	7	(70.0%)	3	(30.0%)
Important (scale=2)	30	(39.0%)	22	(73.3%)	8	(26.7%)
Moderate (scale=3)	32	(41.6%)	22	(68.7%)	10	(31.2%)
Poor (scale=4)	5	(6.5%)	0	(0.0%)	5	(100.0%)
Range	1–4		1–3		1–4
Mean (SD)	2.4	(0.8)	2.3	(0.7)	2.7	(0.9)	0.09
Median (IQR)	2	(2–3)	2	(2–3)	3	(2–3)
Added therapeutic value
n	76†		51		25†
Maximum (scale=1)	0	(0.0%)	0	(0.0%)	0	(0.0%)
Important (scale=2)	25	(32.9%)	24	(96.0%)	1	(4.0%)
Moderate (scale=3)	31	(40.8%)	27	(87.1%)	4	(12.9%)
Poor (scale=4)	19	(25.0%)	0	(0.0%)	19	(100.0%)
Very poor (scale=5)	1	(1.3%)	0	(0.0%)	1	(100.0%)
Range	2–5		2–3		2–5
Mean (SD)	2.9	(0.8)	2.5	(0.5)	3.8	(0.6)	<0.01
Median (IQR)	3	(2–4)	3	(2–3)	4	(4–4)
Quality of clinical evidence (GRADE evaluation)
n	77		51		26
High (scale=1)	11	(14.3%)	10	(90.9%)	1	(9.1%)
Moderate (scale=2)	42	(54.5%)	28	(66.7%)	14	(33.3%)
Low (scale=3)	18	(23.4%)	11	(61.1%)	7	(38.9%)
Very low (scale=4)	6	(7.8%)	2	(33.3%)	4	(66.7%)
Range	1–4		1–4		1–4
Mean (SD)	2.2	(0.8)	2.1	(0.8)	2.5	(0.8)	0.03
Median (IQR)	2	(2–3)	2	(2–3)	2	(2–3)

*Comparisons between innovative and non-innovative outcomes were performed using a Student’s t-test, after checking for normal distribution (based on the Shapiro-Wilk statistic), or a Wilcoxon rank-sum test otherwise.

†For one rating (10—Nivolumab), the added therapeutic value was reported as ‘not assessable’.

‡Innovative status includes fully and conditionally innovative.

GRADE, Grading of Recommendations Assessment, Development and Evaluation.