National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020 (No. 2) (PB 100 of 2020) (Cth)
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Note: This table relates only to the provisions of this instrument as originally made.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 1—Amendments
Part 1—Amendments 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 2—Amendments 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”.
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