National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020 (PB 32 of 2020) (Cth)

Case
No judgment structure available for this case.

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Note:          This table relates only to the provisions of this instrument as originally made.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 1—Amendments

Part 1—Amendments 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 6—Pharmaceutical 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 2—Amendments 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 5—HSD 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
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0