Table 2 Characteristics of drugs and NHI price revision
Characteristic | Without price revision | With price revision | Total | P-value | ||||
|---|---|---|---|---|---|---|---|---|
Total | 58 | 71.6% | 23 | 28.4% | 81 | 100.0% | - | |
Indication | Solid tumor | 32 | 55.2% | 18 | 78.3% | 50 | 61.7% | 0.003 |
Hematologic tumor | 26 | 44.8% | 5 | 21.7% | 31 | 38.3% | ||
Additional indication | Yes | 17 | 29.3% | 15 | 65.2% | 32 | 39.5% | 0.003 |
No | 41 | 70.7% | 8 | 34.8% | 49 | 60.5% | ||
Initial indication | Rare cancer | 35 | 60.3% | 8 | 34.8% | 43 | 53.1% | 0.046 |
Normal cancer | 24 | 41.4% | 15 | 65.2% | 39 | 48.1% | ||
Initial indication | Major Cancer | 18 | 31.0% | 10 | 43.5% | 28 | 34.6% | 0.297 |
Normal cancer | 40 | 69.0% | 13 | 56.5% | 53 | 65.4% | ||
Drug | Drug | 57 | 98.3% | 23 | 100.0% | 80 | 98.8% | 0.526 |
Regenerative medicine | 1 | 1.7% | 0 | 0.0% | 1 | 1.2% | ||
Sakigake designation (Breakthrough therapy designation) | Yes | 1 | 1.7% | 0 | 0.0% | 1 | 1.2% | 0.526 |
No | 57 | 98.3% | 23 | 100.0% | 80 | 98.8% | ||
Conditional approval | Yes | 1 | 1.7% | 0 | 0.0% | 1 | 1.2% | 0.526 |
No | 57 | 98.3% | 23 | 100.0% | 80 | 98.8% | ||
Priority/Expedited review | Yes | 7 | 12.1% | 5 | 21.7% | 12 | 14.8% | 0.269 |
No | 51 | 87.9% | 18 | 78.3% | 69 | 85.2% | ||
Post-marketing all-case surveillance | Yes | 40 | 69.0% | 11 | 47.8% | 51 | 63.0% | 0.076 |
No | 18 | 31.0% | 12 | 52.2% | 30 | 37.0% | ||
Guideline for proper clinical use of the drug | Yes | 2 | 3.4% | 3 | 13.0% | 5 | 6.2% | 0.106 |
No | 56 | 96.6% | 20 | 87.0% | 76 | 93.8% | ||
Dosage form | Oral | 26 | 44.8% | 12 | 52.2% | 38 | 46.9% | 0.550 |
Injection | 32 | 55.2% | 11 | 47.8% | 43 | 53.1% | ||
Novelty of the drug | First in class | 13 | 22.4% | 6 | 26.1% | 19 | 23.5% | 0.725 |
Other | 45 | 77.6% | 17 | 73.9% | 62 | 76.5% | ||
Compound type | Molecularly targeted drug | 33 | 56.9% | 10 | 43.5% | 43 | 53.1% | 0.025 |
Hormonal drug | 2 | 3.4% | 4 | 17.4% | 6 | 7.4% | ||
Antibody | 14 | 24.1% | 1 | 4.3% | 15 | 18.5% | ||
Cytotoxic drug | 6 | 10.3% | 5 | 21.7% | 11 | 13.6% | ||
Immunotherapy drug | 2 | 3.4% | 3 | 13.0% | 5 | 6.2% | ||
Other | 1 | 1.7% | 0 | 0.0% | 1 | 1.2% | ||
NHI pricing method | Similar efficacy comparison method (I) | 39 | 67.2% | 12 | 52.2% | 51 | 65.4% | 0.057 |
Similar efficacy comparison method (II) | 3 | 5.2% | 0 | 0.0% | 3 | 3.8% | ||
Cost accounting method | 16 | 27.6% | 9 | 39.1% | 25 | 32.1% | ||
Inter-specification adjustment | 0 | 0.0% | 2 | 8.7% | 2 | 2.6% | ||
Corrective premium rate | Yes | 41 | 70.7% | 16 | 69.6% | 57 | 73.1% | 0.920 |
No | 17 | 29.3% | 7 | 30.4% | 24 | 30.8% | ||
Sales ranking of the company | Top 10 in Japan | 22 | 37.9% | 6 | 26.1% | 28 | 34.6% | 0.312 |
Other | 36 | 62.1% | 17 | 73.9% | 53 | 65.4% | ||
Type of pharmaceutical company | Japanese domestic company | 24 | 41.4% | 8 | 34.8% | 32 | 39.5% | 0.584 |
Foreign company | 34 | 58.6% | 15 | 65.2% | 49 | 60.5% | ||
Peak sales amounts (Oku-yen) | 86.4 ± 115.2 | 102.3 ± 120.3 | 90.9 ± 116.9 | 0.585 | ||||
From application to approval (days) | 305.0 ± 88.9 | 402.6 ± 169.6 | 332.7 ± 125.6 | <0.001 | ||||
From approval to NHI price listing (days) | 70.6 ± 39.6 | 80.1 ± 53.4 | 73.3 ± 44.1 | 0.387 | ||||
From NHI price listing to date of analysis (days) | 1415.3 ± 937.2 | 2510.8 ± 994.3 | 1726.4 ± 1074.1 | <0.001 | ||||