Federal Register of Legislation - Australian Government

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PB 100 of 2020 Other as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to change the date of repeal of some of the provisions and ensure the temporary measures remain in effect during the current health pandemic.
Administered by: Health
Registered 29 Sep 2020
Tabling HistoryDate
Tabled HR06-Oct-2020
Tabled Senate06-Oct-2020
Date of repeal 03 Feb 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003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 100 of 2020

 

National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020 (No. 2)

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

Dated   29 September 2020

Thea Connolly
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                                                         6

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)            6

 


1  Name

             (1)  This instrument is the National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020 (No. 2).

             (2)  This instrument may also be cited as PB 100 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

The day after this instrument is registered.

 

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  Subsection 10A(3)

            Omit “1 October 2020”, substitute “1 April 2021”.

2  Schedule 6

Omit table and substitute:

 

Pharmaceutical items with modified prescription circumstances during COVID-19 pandemic

Listed drug

Form

Manner of administration

Abatacept

Injection 125 mg in 1 mL single dose autoinjector

Injection

Abatacept

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

Injection

Abatacept

Powder for I.V. infusion 250 mg

Injection

Adalimumab

Injection 20 mg in 0.4 mL pre‑filled syringe

Injection

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled syringe

Injection

Adalimumab

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

Injection

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled pen

Injection

Adalimumab

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

Injection

Adalimumab

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

Injection

Ambrisentan

Tablet 5 mg

Oral

Ambrisentan

Tablet 10 mg

Oral

Baricitinib

Tablet 2 mg

Oral

Baricitinib

Tablet 4 mg

Oral

Benralizumab

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

Injection

Benralizumab

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

Injection

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Certolizumab pegol

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

Injection

Certolizumab pegol

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

Injection

Dornase alfa

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

Inhalation

Epoprostenol

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

Injection

Epoprostenol

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

Injection

Epoprostenol

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

Injection

Epoprostenol

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

Injection

Etanercept

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

Injection

Etanercept

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

Injection

Etanercept

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

Injection

Golimumab

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

Injection

Golimumab

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

Injection

Golimumab

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

Injection

Guselkumab

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

Injection

Iloprost

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

Inhalation

Infliximab

Powder for I.V. infusion 100 mg

Injection

Ivacaftor

Sachet containing granules 50 mg

Oral

Ivacaftor

Sachet containing granules 75 mg

Oral

Ivacaftor

Tablet 150 mg

Oral

Ixekizumab

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

Injection

Lenalidomide

Capsule 5 mg

Oral

Lenalidomide

Capsule 10 mg

Oral

Lenalidomide

Capsule 15 mg

Oral

Lenalidomide

Capsule 25 mg

Oral

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg

Oral

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg

Oral

Lumacaftor with ivacaftor

Tablet containing lumacaftor 100 mg with ivacaftor 125 mg

Oral

Lumacaftor with ivacaftor

Tablet containing lumacaftor 200 mg with ivacaftor 125 mg

Oral

Macitentan

Tablet 10 mg

Oral

Mannitol

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

Inhalation by mouth

Mepolizumab

Powder for injection 100 mg

Injection

Mepolizumab

Injection 100 mg in 1 mL single dose pre-filled pen

Injection

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Nintedanib

Capsule 100 mg

Oral

Nintedanib

Capsule 150 mg

Oral

Omalizumab

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

Injection

Omalizumab

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

Injection

Pirfenidone

Capsule 267 mg

Oral

Pirfenidone

Tablet 267 mg

Oral

Pirfenidone

Tablet 801mg

Oral

Pomalidomide

Capsule 3 mg

Oral

Pomalidomide

Capsule 4 mg

Oral

Riociguat

Tablet 500 micrograms

Oral

Riociguat

Tablet 1 mg

Oral

Riociguat

Tablet 1.5 mg

Oral

Riociguat

Tablet 2 mg

Oral

Riociguat

Tablet 2.5 mg

Oral

Risankizumab

Injection 75 mg in 0.83 mL pre‑filled syringe

Injection

Rituximab

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

Injection

Secukinumab

Injection 150 mg in 1 mL pre‑filled pen

Injection

Sildenafil

Tablet 20 mg (as citrate)

Oral

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Somatropin

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

Injection

Tadalafil

Tablet 20 mg

Oral

Tezacaftor with ivacaftor and ivacaftor

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

Oral

Tildrakizumab

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

Injection

Tocilizumab

Concentrate for injection 80 mg in 4 mL

Injection

Tocilizumab

Concentrate for injection 200 mg in 10 mL

Injection

Tocilizumab

Concentrate for injection 400 mg in 20 mL

Injection

Tocilizumab

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

Injection

Tocilizumab

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

Injection

Tofacitinib

Tablet 5 mg

Oral

Upadacitinib

Tablet 15 mg

Oral

Ustekinumab

Injection 45 mg in 0.5 mL

Injection

Ustekinumab

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

Injection

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)

3  Subsection 9AA(3)

Omit “1 October 2020”, substitute “1 April 2021”.