Table 1 Characteristics of compounds and regulatory programs of 81 oncology drugs

Compound type

Molecularly targeted drug

43

53.1%

Antibody

15

18.5%

Cytotoxic drug

11

13.6%

Hormonal drug

6

7.4%

Immunotherapy drug

5

6.2%

Other

1

1.2%

Indication

Hematologic tumor

31

38.3%

Solid tumor

50

61.7%

Dosage form

Oral

43

53.1%

Injection

38

46.9%

Number of approvals for additional indication

None

50

61.7%

1

13

16.0%

2

12

14.8%

3

1

1.2%

4

2

2.5%

5

2

2.5%

NHI initial drug package price

<1,000 yen

2

2.5%

<10,000 yen

34

42.0%

<100,000 yen

25

30.9%

<1,000,000 yen

19

23.5%

>1,000,000 yen

1

1.2%

Calculation system for NHI price standard

Cost accounting method

25

30.9%

Similar efficacy comparison method (I)

51

63.0%

Similar efficacy comparison method (II)

3

3.7%

Inter-specification adjustment

2

2.5%

Corrective premium rate

With premium rate

57

70.4%

None

24

29.6%

NHI price revision

Yes

23

28.4%

(as of April 1, 2020)

No

58

71.6%

Number of NHI price revisions

None

58

71.6%

1

18

22.2%

2

3

3.7%

3

1

1.2%

4

0

0.0%

5

1

1.2%

Type of pharmaceutical company

Japanese domestic company

32

39.5%

Foreign company

49

60.5%

Review period (days)

Average ± SD

Maximum

Minimum