National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020 (PB 109 of 2020) (Cth)

Case

PB 109 of 2020

National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020

I, Paul Hansen, as delegate of the Minister for Health, make the following instrument.

Dated 29 October 2020

Paul Hansen
Acting 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  1

Part 1—Listing of pharmaceutical benefits  1

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)    1

Part 2—Highly specialised drugs  11

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)         11

1  Name

(1)  This instrument is the National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020.

(2)  This instrument may also be cited as PB 109 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.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table 1 November 2020. 1 November 2020
2.  Schedule 1, Part 1 Immediately after the commencement of the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10) (PB 102 of 2020). 1 November 2020
3.  Schedule 1, Part 2 Immediately after the commencement of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9) (PB 106 of 2020). 1 November 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 section 88 and 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—Listing of pharmaceutical benefits

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

1  Section 9 (heading)

Repeal the heading, substitute:

  1. Authorised prescribers—Part 1 of Schedule 1

2  Subsection 9(1A)

After “benefit”, insert “mentioned in Part 1 of Schedule 1”.

3  Subsections 9(1), (2), (3), (4) and (5)

Before “Schedule 1” (wherever occurring), insert “Part 1 of”.

4  Schedule 1 (heading)

Repeal the heading (including the note), substitute:

Schedule 1—Ready‑prepared pharmaceutical benefits

Note:       See sections 5 to 10, 16 to 18, 20, 21 and 23 to 26.

Part 1—Ready‑prepared pharmaceutical benefits for prescription and supply

5  Schedule 1, at the end

Add:

Part 2—Ready‑prepared pharmaceutical benefits for supply only

Note:       Section 9 (authorised prescribers) does not apply to pharmaceutical benefits listed in this Part.

Listed Drug Form Manner of Administration Schedule Equivalent Brand Responsible Person Authorised Prescriber Circumstances Purposes Maximum Quantity Number of Repeats Pack Quantity Determined Quantity Section 100/ Prescriber Bag only
Aciclovir Eye ointment 30 mg per g, 4.5 g Application to the eye Zovirax GK MP NP C5965 1 0 1
Aciclovir Eye ointment 30 mg per g, 4.5 g Application to the eye Zovirax GK AO C5964 1 0 1
Amisulpride Tablet 100 mg Oral a Pharmacor Amisulpride CR MP NP C4246 30 5 30
Amisulpride Tablet 200 mg Oral a Pharmacor Amisulpride CR MP NP C4246 60 5 60
Amisulpride Tablet 400 mg Oral a Pharmacor Amisulpride CR MP NP C4246 60 5 60
Amlodipine Tablet 5 mg (as besilate) Oral a Pharmacor Amlodipine CR MP NP 30 5 30
Amlodipine Tablet 10 mg (as besilate) Oral a Pharmacor Amlodipine CR MP NP 30 5 30
Amoxicillin with clavulanic acid Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral a Clavam 875 mg/125 mg CR MP NP C5832 C5893 C10413 P5832 P5893 10 0 10
Amoxicillin with clavulanic acid Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral a Clavam 875 mg/125 mg CR MP NP C5833 C5894 10 0 10
Amoxicillin with clavulanic acid Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral a Clavam 875 mg/125 mg CR MP NP C5832 C5893 C10413 P10413 20 0 10
Cefazolin Powder for injection 1 g (as sodium) Oral a Cefazolin Sandoz SZ MP NP C5861 C5882 C5883 C5891 10 0 10
Codeine Tablet containing codeine phosphate hemihydrate 30 mg Oral Aspen Pharma Pty Ltd AS MP NP C10479 20 0 20
Cyproterone Tablet containing cyproterone acetate 50 mg Oral a Cyprostat SY MP C5532 20 5 20
Darunavir Tablet 150 mg (as ethanolate) Oral Prezista JC MP C5094 240 5 240 D(100)
Diclofenac Tablet (enteric coated) containing diclofenac sodium 50 mg Oral a Pharmacor Diclofenac 50 CR PDP C6256 C6282 50 0 50
Diclofenac Tablet (enteric coated) containing diclofenac sodium 50 mg Oral a Pharmacor Diclofenac 50 CR MP NP C6149 C6214 C6283 50 3 50
Donepezil Tablet containing donepezil hydrochloride 10 mg Oral a Pharmacor Donepezil 10 CR MP NP C10099 C10100 C10107 C10108 C10110 P10107 P10110 28 1 28
Donepezil Tablet containing donepezil hydrochloride 10 mg Oral a Pharmacor Donepezil 10 CR MP NP C10099 C10100 C10107 C10108 C10110 P10099 P10100 P10108 28 5 28
Donepezil Tablet containing donepezil hydrochloride 10 mg Oral a Pharmacor Donepezil 10 CR MP NP C10108 28 5 28
Escitalopram Tablet 10 mg (as oxalate) Oral a Pharmacor Escitalopram 10 CR MP NP C4755 28 5 28
Escitalopram Tablet 20 mg (as oxalate) Oral a Pharmacor Escitalopram 20 CR MP NP C4755 28 5 28
Esomeprazole Tablet (enteric coated) 20 mg (as magnesium trihydrate) Oral a Pharmacor Esomeprazole CR MP NP C8774 C8775 C8776 C8780 C8827 P8774 P8775 30 1 30
Esomeprazole Tablet (enteric coated) 20 mg (as magnesium trihydrate) Oral a Pharmacor Esomeprazole CR MP NP C8774 C8775 C8776 C8780 C8827 P8776 P8780 P8827 30 5 30
Esomeprazole Tablet (enteric coated) 40 mg (as magnesium trihydrate) Oral a Pharmacor Esomeprazole CR MP NP C8777 C8778 C8902 C8902 30 1 30
Esomeprazole Tablet (enteric coated) 40 mg (as magnesium trihydrate) Oral a Pharmacor Esomeprazole CR MP NP C8777 C8778 C8902 P8777 P8778 30 5 30
Famciclovir Tablet 250 mg Oral a Famciclovir SCP 250 CR MP NP C5951 C5971 P5951 21 0 21
MP NP C5951 C5971 P5971 56 5 56
Flucloxacillin Capsule 250 mg (as sodium) Oral a Medsurge DZ PDP C5298 24 0 28
MP NP MW C5414 24 0 28
Flucloxacillin Capsule 500 mg (as sodium) Oral a Medsurge DZ PDP C5298 24 0 100
MP C5414 C6169 P5414 24 0 100
NP MW C5414 24 0 100
MP C5414 C6169 P6169 48 1 100
Fluconazole Solution for I.V. infusion 200 mg in 100 mL a Fluconazole Sandoz SZ MP NP C6956 C6965 C6969 C6974 C6978 C7897 7 0 1
Folinic acid Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL Injection a Calcium Folinate Ebewe SZ MP 10 1 1
Ketoconazole Shampoo 10 mg per g, 100 mL Application Nizoral 1% JT MP NP C6434 1 1 1
Lenograstim Powder for injection 13,400,000 I.U. (105 micrograms) Injection Granocyte 13 PF MP C6502 C6507 C6516 C6522 C6523 C6532 C6535 C6634 C6644 C6653 C6654 C6657 C6673 C6682 C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327 20 11 1 D(100)
Lenograstim Powder for injection 33,600,000 I.U. (263 micrograms) Injection Granocyte 34 PF MP C6502 C6507 C6516 C6522 C6523 C6532 C6535 C6634 C6644 C6653 C6654 C6657 C6673 C6682 C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327 20 11 1 D(100)
Levodopa with carbidopa Tablet 250 mg‑25 mg (USP) Oral Carbidopa and Levodopa Tablets, USP DZ MP NP 100 5 100
Nifedipine Tablet 20 mg (controlled release) Oral Adalat Oros 20mg BN MP NP 30 5 30
Olanzapine Tablet 7.5 mg (as benzoate) Oral Olanzapine generichealth 7.5 GQ MP NP C5856 C5869 28 5 28
Omeprazole Tablet 20 mg Oral a Pharmacor Omeprazole CR MP NP C8774 C8775 C8776 C8780 C8866 P8774 P8775 30 1 30
Omeprazole Tablet 20 mg Oral a Pharmacor Omeprazole CR MP NP C8774 C8775 C8776 C8780 C8866 P8776 P8780 P8866 30 5 30
Oxaliplatin Solution concentrate for I.V. infusion 50 mg in 10 mL Injection Oxaliplatin SUN RA MP See Note 3 See Note 3 1 D(100)
Phenelzine Tablet 15 mg (as sulfate) (USP) Oral Nardil LM MP C6236 100 1 60
Phenoxybenzamine Capsule containing 10 mg phenoxybenzamine hydrochloride Oral Dibenzyline BZ MP NP C6145 C6178 100 5 100
Ranitidine Tablet, effervescent, 150 mg (as hydrochloride) Oral Zantac AS MP NP 60 5 30
Risperidone Tablet 0.5 mg Oral a Rispericor 0.5 CR MP NP C5903 C6898 C6899 C10020 C10021 P6898 P6899 P10020 P10021 60 2 60
MP NP C5903 C6898 C6899 C10020 C10021 P5903 60 5 60
Risperidone Tablet 1 mg Oral a Rispericor 1 CR MP NP C4246 C5907 C6898 C6899 C10020 C10021 P6898 P6899 P10020 P10021 60 2 60
MP NP C4246 C5907 C6898 C6899 C10020 C10021 P4246 P5907 60 5 60
Risperidone Tablet 2 mg Oral a Rispericor 2 CR MP NP C4246 C5907 C6897 C6938 P6897 P6938 60 2 60
MP NP C4246 C5907 C6897 C6938 P4246 P5907 60 5 60
Sofosbuvir Tablet 400 mg Oral Sovaldi GI

MP NP

 C5969 C5972 P5969 28 2 28

MP NP

 C5969 C5972 P5972 28 5 28
Tenofovir with emtricitabine and efavirenz Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg Oral Atripla GI MP NP C4470 C4522 60 5 30 D(100)
Tramadol Capsule containing tramadol hydrochloride 50 mg Oral a Tramadol SCP CR MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20

Part 2—Highly specialised drugs

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

6  At the end of section 8

Add:

(6)  Subsection (1) does not apply to an HSD pharmaceutical benefit mentioned in Part 2 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (ready‑prepared pharmaceutical benefits for supply only).

Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0