Table 2.
Frequency distribution of evaluations for each of the three domains according to the final decision on drug innovativeness
| All drug reports [n = 141] |
Fully innovative [n = 45] |
Conditionally innovative [n = 42] |
Not innovative [n = 54] |
p-Value | |
|---|---|---|---|---|---|
| Unmet need | |||||
| N | 141 | 45 | 42 | 54 | 0.03 |
| Maximum (scale = 1) | 14 (9.9) | 5 (11.1) | 5 (11.9) | 4 (7.4) | |
| Important (scale = 2) | 52 (36.9) | 23 (51.1) | 13 (30.9) | 16 (29.6) | |
| Moderate (scale = 3) | 70 (49.6) | 17 (37.8) | 24 (57.1) | 29 (53.7) | |
| Small (scale = 4) | 5 (3.6) | 0 | 0 | 5 (9.3) | |
| Null (scale = 5) | 0 | 0 | 0 | 0 | |
| Mean (SD) | 2.47 (0.72) | 2.27 (0.65) | 2.45 (0.71) | 2.65 (0.76) | 0.03 |
| Median (IQR) | 3 (1) | 2 (1) | 3 (1) | 3 (1) | |
| Added therapeutic valuea | |||||
| N | 135 | 45 | 42 | 48 | |
| Maximum (scale = 1) | 1 (0.7) | 1 (2.2) | 0 | 0 | <0.001 |
| Important (scale = 2) | 40 (29.6) | 39 (86.7) | 0 | 1 (2.1) | |
| Moderate (scale = 3) | 56 (41.5) | 5 (11.1) | 42 (100.0) | 9 (18.7) | |
| Small (scale = 4) | 32 (23.7) | 0 | 0 | 32 (66.7) | |
| Null (scale = 5) | 6 (4.4) | 0 | 0 | 6 (12.5) | |
| Mean (SD) | 3.01 (0.86) | 2.09 (0.36) | 3 (0) | 3.90 (0.63) | <0.001 |
| Median (IQR) | 3 (2) | 2 (0) | 3 (0) | 4 (0) | |
| GRADE evaluation | |||||
| N | 141 | 45 | 42 | 54 | |
| High (scale = 1) | 20 (14.2) | 11 (24.4) | 4 (9.5) | 5 (9.3) | 0.03 |
| Moderate (scale = 2) | 72 (51.1) | 23 (51.1) | 22 (52.4) | 27 (50.0) | |
| Low (scale = 3) | 37 (26.2) | 9 (20.0) | 15 (35.7) | 13 (24.1) | |
| Very low (scale = 4) | 12 (8.5) | 2 (4.4) | 1 (2.4) | 9 (16.7) | |
| Mean (SD) | 2.29 (0.82) | 2.04 (0.80) | 2.31 (0.68) | 2.48 (0.88) | 0.04 |
| Median (IQR) | 2 (1) | 2 (0) | 2 (1) | 2 (1) | |
GRADE Grading of Recommendations, Assessment, Development, and Evaluation, IQR interquartile range, SD standard deviation
aIn a few cases, the added therapeutic value was deemed ‘not evaluable’