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PB 32 of 2020 Other as made
This instrument temporarily modifies the circumstances mentioned in Part 1 of Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), and Schedule 3 of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) for circumstances codes for pharmaceutical benefits.
Administered by: Health
Registered 30 Apr 2020
Tabling HistoryDate
Tabled HR12-May-2020
Tabled Senate12-May-2020
Date of repeal 02 Sep 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

PB 32 of 2020

 

National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020

I, Thea Daniel, as delegate of the Minister for Health, make the following instrument.

Dated   29 April 2020

Thea Daniel
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments                                                                                                                          2

Part 1—Amendments of main listing instrument                                                                      2

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)      2

Part 2—Amendments of special arrangement                                                                             7

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)            7

 


1  Name

             (1)  This instrument is the National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020.

             (2)  This instrument may also be cited as PB 32 of 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 May 2020.

1 May 2020

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the following:

                     (a)  subsection 85(7) of the National Health Act 1953;

                     (b)  subsection 100(2) of the National Health Act 1953.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

Part 1Amendments of main listing instrument

 

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

1  After subsection 10(3)

Insert:

          (3A)  Subsection (3) has effect subject to section 10A (which temporarily modifies the circumstances mentioned in Part 1 of Schedule 4 for circumstances codes for pharmaceutical benefits that are pharmaceutical items described in Schedule 6).

2  After section 10

Insert:

10A  Modified prescription circumstances during COVID‑19 pandemic

             (1)  This section affects the circumstances in which a prescription may be written by an authorised prescriber for the supply of a pharmaceutical benefit that is a listed brand of a pharmaceutical item described in Schedule 6 to a person (the patient) if the authorised prescriber is satisfied the patient has, in accordance with Part VII of the Act, already been supplied with the benefit on the basis of a prescription written in circumstances determined by subsection 10(3) unaffected by this section.

             (2)  For the purposes of subsection 10(3), Part 1 of Schedule 4 has effect as if each circumstances code for the pharmaceutical benefit:

                     (a)  did not mention any circumstance that, having regard to the patient’s situation and the state of affairs associated with precautions against the spread of the coronavirus known as COVID‑19, it is not reasonably practicable to establish in relation to the patient; and

                     (b)  mentioned the circumstance that the authorised prescriber keeps a written record of the reason it is not practicable to establish the circumstance described in paragraph (a).

             (3)  This section, subsection 10(3A) and Schedule 6 are repealed at the start of 1 October 2020.

3  At the end of the instrument

Add:

Schedule 6Pharmaceutical items with modified prescription circumstances during COVID‑19 pandemic

Note:       See section 10A.

  

  

 

Pharmaceutical items with modified prescription circumstances during COVID‑19 pandemic

Item

Column 1
Listed drug

Column 2
Form

Column 3
Manner of administration

1

Abatacept

Injection 125 mg in 1 mL single dose autoinjector,

Injection

2

Abatacept

Injection 125 mg in 1 mL single dose pre‑filled syringe

Injection

3

Abatacept

Powder for I.V. infusion 250 mg

Injection

4

Adalimumab

Injection 20 mg in 0.4 mL pre‑filled syringe

Injection

5

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled syringe

Injection

6

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled syringe, 6

Injection

7

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled pen

Injection

8

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled pen, 4

Injection

9

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled pen, 6

Injection

10

Ambrisentan

Tablet 5 mg

Oral

11

Ambrisentan

Tablet 10 mg

Oral

12

Baricitinib

Tablet 2 mg

Oral

13

Baricitinib

Tablet 4 mg

Oral

14

Benralizumab

Injection 30 mg in 1 mL single dose pre‑filled syringe

Injection

15

Benralizumab

Injection 30 mg in 1 mL single dose pre‑filled pen

Injection

16

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

17

Bosentan

Tablet 125 mg (as monohydrate)

Oral

18

Certolizumab pegol

Injection 200 mg in 1 mL single use pre‑filled syringe

Injection

19

Certolizumab pegol

Solution for injection 200 mg in 1 mL pre‑filled pen

Injection

20

Dornase alfa

Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL

Inhalation

21

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium)

Injection

22

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

23

Epoprostenol

Powder for I.V. infusion 1.5 mg (as sodium)

Injection

24

Epoprostenol

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

25

Etanercept

Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL

Injection

26

Etanercept

Injection 50 mg in 1 mL single use auto‑injector, 4

Injection

27

Etanercept

Injections 50 mg in 1 mL single use pre‑filled syringes, 4

Injection

28

Golimumab

Injection 50 mg in 0.5 mL single use pre‑filled pen

Injection

29

Golimumab

Injection 50 mg in 0.5 mL single use pre‑filled syringe

Injection

30

Golimumab

Injection 100 mg in 1 mL single use pre‑filled pen

Injection

31

Guselkumab

Injection 100 mg in 1 mL single use pre‑filled syringe

Injection

32

Iloprost

Solution for inhalation 20 micrograms (as trometamol) in 2 mL

Inhalation

33

Infliximab

Powder for I.V. infusion 100 mg

Injection

34

Ivacaftor

Sachet containing granules 50 mg

Oral

35

Ivacaftor

Sachet containing granules 75 mg

Oral

36

Ivacaftor

Tablet 150 mg

Oral

37

Ixekizumab

Injection 80 mg in 1 mL single dose pre‑filled pen

Injection

38

Lenalidomide

Capsule 5 mg

Oral

39

Lenalidomide

Capsule 10 mg

Oral

40

Lenalidomide

Capsule 15 mg

Oral

41

Lenalidomide

Capsule 25 mg

Oral

42

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg

Oral

43

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg

Oral

44

Lumacaftor with ivacaftor

Tablet containing lumacaftor 100 mg with ivacaftor 125 mg

Oral

45

Lumacaftor with ivacaftor

Tablet containing lumacaftor 200 mg with ivacaftor 125 mg

Oral

46

Macitentan

Tablet 10 mg

Oral

47

Mannitol

Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers

Inhalation by mouth

48

Mepolizumab

Powder for injection 100 mg

Injection

49

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

50

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

51

Nintedanib

Capsule 100 mg

Oral

52

Nintedanib

Capsule 150 mg

Oral

53

Omalizumab

Injection 75 mg in 0.5 mL single dose pre‑filled syringe

Injection

54

Omalizumab

Injection 150 mg in 1 mL single dose pre‑filled syringe

Injection

55

Pirfenidone

Capsule 267 mg

Oral

56

Pirfenidone

Tablet 267 mg

Oral

57

Pirfenidone

Tablet 801mg

Oral

58

Pomalidomide

Capsule 3 mg

Oral

59

Pomalidomide

Capsule 4 mg

Oral

60

Riociguat

Tablet 500 micrograms

Oral

61

Riociguat

Tablet 1 mg

Oral

62

Riociguat

Tablet 1.5 mg

Oral

63

Riociguat

Tablet 2 mg

Oral

64

Riociguat

Tablet 2.5 mg

Oral

65

Risankizumab

Injection 75 mg in 0.83 mL pre‑filled syringe

Injection

66

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

67

Secukinumab

Injection 150 mg in 1 mL pre‑filled pen

Injection

68

Sildenafil

Tablet 20 mg (as citrate)

Oral

69

Somatropin

Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)

Injection

70

Somatropin

Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)

Injection

71

Somatropin

Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)

Injection

72

Somatropin

Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)

Injection

73

Somatropin

Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)

Injection

74

Somatropin

Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)

Injection

75

Somatropin

Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)

Injection

76

Somatropin

Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)

Injection

77

Somatropin

Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)

Injection

78

Somatropin

Injection 4 mg (12 i.u.) vial with diluent (with preservative)

Injection

79

Somatropin

Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

80

Somatropin

Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

81

Somatropin

Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative)

Injection

82

Somatropin

Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative)

Injection

83

Somatropin

Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

84

Somatropin

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre‑filled pen

Injection

85

Somatropin

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)

Injection

86

Somatropin

Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)

Injection

87

Somatropin

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

Injection

88

Somatropin

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre‑filled pen

Injection

89

Somatropin

Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

Injection

90

Somatropin

Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)

Injection

91

Somatropin

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)

Injection

92

Somatropin

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre‑filled pen

Injection

93

Somatropin

Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)

Injection

94

Tadalafil

Tablet 20 mg

Oral

95

Tezacaftor with ivacaftor and ivacaftor

Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg

Oral

96

Tildrakizumab

Injection 100 mg in 1 mL single dose pre‑filled syringe

Injection

97

Tocilizumab

Concentrate for injection 80 mg in 4 mL

Injection

98

Tocilizumab

Concentrate for injection 200 mg in 10 mL

Injection

99

Tocilizumab

Concentrate for injection 400 mg in 20 mL

Injection

100

Tocilizumab

Injection 162 mg in 0.9 mL single use pre‑filled pen

Injection

101

Tocilizumab

Injection 162 mg in 0.9 mL single use pre‑filled syringe

Injection

102

Tofacitinib

Tablet 5 mg

Oral

103

Ustekinumab

Injection 45 mg in 0.5 mL

Injection

104

Ustekinumab

Solution for I.V. infusion 130 mg in 26 mL

Injection

105

Vedolizumab

Powder for injection 300 mg

Injection

 

Part 2Amendments of special arrangement

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

4  At the end of section 9

Add:

             (3)  This section has effect subject to section 9AA (which temporarily modifies the circumstances mentioned in Schedule 3 for circumstances codes for HSD pharmaceutical benefits that are pharmaceutical items described in Schedule 5).

5  After section 9

Insert:

9AA  Modified prescription circumstances during COVID‑19 pandemic

             (1)  This section affects the circumstances in which a prescription may be written by an authorised prescriber for the supply of an HSD pharmaceutical benefit that is a listed brand of a pharmaceutical item described in Schedule 5 to a person (the patient) if the authorised prescriber is satisfied the patient has, in accordance with this Special Arrangement, already been supplied with the benefit on the basis of a prescription written in circumstances determined by subsection 9(1) unaffected by this section.

             (2)  For the purposes of subsection 9(1), Schedule 3 has effect as if each circumstances code for the HSD pharmaceutical benefit:

                     (a)  did not mention any circumstance that, having regard to the patient’s situation and the state of affairs associated with precautions against the spread of the coronavirus known as COVID‑19, it is not reasonably practicable to establish in relation to the patient; and

                     (b)  mentioned the circumstance that the authorised prescriber keeps a written record of the reason it is not practicable to establish the circumstance described in paragraph (a).

             (3)  This section, subsection 9(3) and Schedule 5 are repealed at the start of 1 October 2020.

6  At the end of the instrument

Add:

Schedule 5HSD pharmaceutical benefits with modified prescription circumstances during COVID‑19 pandemic

Note:       See section 9AA.

  

  

 

Pharmaceutical items with modified prescription circumstances during COVID‑19 pandemic

Item

Column 1
Listed drug

Column 2
Form

Column 3
Manner of administration

1

Abatacept

Powder for I.V. infusion 250 mg

Injection

2

Adalimumab

Injection 20 mg in 0.4 mL pre‑filled syringe

Injection

3

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled syringe

Injection

4

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled pen

Injection

5

Ambrisentan

Tablet 5 mg

Oral

6

Ambrisentan

Tablet 10 mg

Oral

7

Benralizumab

Injection 30 mg in 1 mL single dose pre‑filled syringe

Injection

8

Benralizumab

Injection 30 mg in 1 mL single dose pre‑filled pen

Injection

9

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

10

Bosentan

Tablet 125 mg (as monohydrate)

Oral

11

Dornase alfa

Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL

Inhalation

12

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium)

Injection

13

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

14

Epoprostenol

Powder for I.V. infusion 1.5 mg (as sodium)

Injection

15

Epoprostenol

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

16

Etanercept

Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL

Injection

17

Etanercept

Injection 50 mg in 1 mL single use auto‑injector, 4

Injection

18

Etanercept

Injections 50 mg in 1 mL single use pre‑filled syringes, 4

Injection

19

Iloprost

Solution for inhalation 20 micrograms (as trometamol) in 2 mL

Inhalation

20

Infliximab

Powder for I.V. infusion 100 mg

Injection

21

Ivacaftor

Sachet containing granules 50 mg

Oral

22

Ivacaftor

Sachet containing granules 75 mg

Oral

23

Ivacaftor

Tablet 150 mg

Oral

24

Lenalidomide

Capsule 5 mg

Oral

25

Lenalidomide

Capsule 10 mg

Oral

26

Lenalidomide

Capsule 15 mg

Oral

27

Lenalidomide

Capsule 25 mg

Oral

28

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg

Oral

29

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg

Oral

30

Lumacaftor with ivacaftor

Tablet containing lumacaftor 100 mg with ivacaftor 125 mg

Oral

31

Lumacaftor with ivacaftor

Tablet containing lumacaftor 200 mg with ivacaftor 125 mg

Oral

32

Macitentan

Tablet 10 mg

Oral

33

Mannitol

Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers

Inhalation by mouth

34

Mepolizumab

Powder for injection 100 mg

Injection

35

Omalizumab

Injection 75 mg in 0.5 mL single dose pre‑filled syringe

Injection

36

Omalizumab

Injection 150 mg in 1 mL single dose pre‑filled syringe

Injection

37

Pomalidomide

Capsule 3 mg

Oral

38

Pomalidomide

Capsule 4 mg

Oral

39

Riociguat

Tablet 500 micrograms

Oral

40

Riociguat

Tablet 1 mg

Oral

41

Riociguat

Tablet 1.5 mg

Oral

42

Riociguat

Tablet 2 mg

Oral

43

Riociguat

Tablet 2.5 mg

Oral

44

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

45

Sildenafil

Tablet 20 mg (as citrate)

Oral

46

Tadalafil

Tablet 20 mg

Oral

47

Tezacaftor with ivacaftor and ivacaftor

Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg

Oral

48

Tocilizumab

Concentrate for injection 80 mg in 4 mL

Injection

49

Tocilizumab

Concentrate for injection 200 mg in 10 mL

Injection

50

Tocilizumab

Concentrate for injection 400 mg in 20 mL

Injection

51

Ustekinumab

Solution for I.V. infusion 130 mg in 26 mL

Injection

52

Vedolizumab

Powder for injection 300 mg

Injection