National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 5)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 5)

PB 46 of 2021

Purpose

The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.

PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, number of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).

Authority

This Instrument exercises various powers in Part VII of the Act, as set out below:

Pharmaceutical benefits listed on the PBS

Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies. A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)). Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug. A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB). Subsection 85(6) provides that the Minister may determine a brand of a pharmaceutical item.

The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)). Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.

Prescribing pharmaceutical benefits

Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit. Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).

Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.

Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion. Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated. The maximum quantities and repeats may be determined for all purposes or for particular purposes.

Supplying pharmaceutical benefits

Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.

Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.

Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.

Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions.

Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.

Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).

Paragraph 88(1EB) provides that the Minister can list pharmaceutical benefits without determining any authorised prescribers for the benefit allowing the benefit to be supplied only.

Variation and revocation

Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.

Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation. Advice from the PBAC is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).

Changes to PB 71 of 2012 made by this Instrument

Schedule 1 to this Instrument provides for the addition of the listed drugs beclometasone with formoterol and glycopyrronium, and galcanezumab and forms of the listed drugs desmopressin, high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate, tenofovir with emtricitabine, and tolvaptan to the Schedule of Pharmaceutical Benefits. It also provides for the deletion of forms of the listed drugs epirubicin and somatropin from the PBS. In addition, it also provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs abatacept, adalimumab, baricitinib, bevacizumab, bisacodyl, botulinum toxin type A purified neurotoxin complex, buprenorphine, certolizumab pegol, clonazepam, diclofenac, etanercept, fentanyl, golimumab, haloperidol, hydromorphone, methadone, morphine, obinutuzumab, oxycodone, oxycodone with naloxone, progesterone, sacubitril with valsartan, sertraline, tocilizumab, tofacitinib and upadacitinib.

Schedule 1 to this Instrument also provides for the following changes:

the addition of 21 brands and deletion of 3 brand of existing pharmaceutical items;
the addition of 126 maximum quantity and number of number of repeats for existing brands of pharmaceutical items;
the deletion of 1 maximum quantity and number of number of repeats for existing brands of pharmaceutical items;
the alteration of number of repeats for 22 existing brands of pharmaceutical items;
the alteration of responsible person codes for 4 existing brands of pharmaceutical items; and
the addition of 37 brands of existing pharmaceutical items to supply only.

These changes are summarised, by subject matter, in the Attachment.

Consultation

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits. The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. When recommending the listing of a medicine on the PBS, PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings. This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, guarantee of supply and agreement to final listing details.

It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.

General

A provision-by-provision description of this Instrument is contained in the Attachment.

This Instrument commences on 1 June 2021.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.

ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 5)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 5) and may also be cited as PB 46 of 2021.

Section 2 Commencement

This section provides that this Instrument commences on 1 June 2021.

Section 3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition of listed drugs, the addition and deletion of forms of listed drugs, the addition and deletion of brands, the addition and deletion of maximum quantities and number of repeats, the alteration of number of repeats, the alteration of responsible person codes for brands of pharmaceutical benefits, the addition of 37 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme. These changes are summarised below.

SUMMARY OF CHANGES TO THE PHARMACEUTICAL BENEFITS SCHEME
MADE BY THIS INSTRUMENT

Listed Drugs Added

Listed Drug

Beclometasone with formoterol and glycopyrronium

Galcanezumab

Forms Added

Listed Drug	Form
Desmopressin	Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL, USP (Apotex)
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate	Oral liquid 250 mL, 30 (KetoVie 3:1)
	Oral liquid 250 mL, 30 (KetoVie 4:1)
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg
Tolvaptan	Tablet 15 mg
	Tablet 30 mg

Forms Deleted

Listed Drug	Form
Epirubicin	Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
Somatropin	Injection 4 mg (12 i.u.) vial with diluent (with preservative)

Brands Added

Listed Drug	Form and Brand
Amiodarone	Tablet containing amiodarone hydrochloride 200 mg (Amdarone)
Amitriptyline	Tablet containing amitriptyline hydrochloride 10 mg (APX-Amitriptyline)
	Tablet containing amitriptyline hydrochloride 25 mg (APX-Amitriptyline)
	Tablet containing amitriptyline hydrochloride 50 mg (APX-Amitriptyline)
Bevacizumab	Solution for I.V. infusion 100 mg in 4 mL (Mvasi)
	Solution for I.V. infusion 400 mg in 16 mL (Mvasi)
Bortezomib	Powder for injection 1 mg (Bortezomib Juno)
	Powder for injection 3.5 mg (Bortezomib Juno)
Ciprofloxacin	Tablet 250 mg (as hydrochloride) (APX-Ciprofloxacin)
	Tablet 500 mg (as hydrochloride) (APX-Ciprofloxacin)
	Tablet 750 mg (as hydrochloride) (APX-Ciprofloxacin)
Citalopram	Tablet 20 mg (as hydrobromide) (APX-Citalopram)
Minocycline	Tablet 50 mg (as hydrochloride) (Akamin 50)
Pravastatin	Tablet containing pravastatin sodium 10 mg (APX-Pravastatin)
	Tablet containing pravastatin sodium 20 mg (APX-Pravastatin)
	Tablet containing pravastatin sodium 40 mg (APX-Pravastatin)
	Tablet containing pravastatin sodium 80 mg (APX-Pravastatin)
Pregabalin	Capsule 25 mg (Prebalin)
	Capsule 75 mg (Prebalin)
	Capsule 150 mg (Prebalin)
	Capsule 300 mg (Prebalin)

Brands Deleted

Listed Drug	Form and Brand
Fludarabine	Powder for I.V. injection containing fludarabine phosphate 50 mg (Fludarabine AMNEAL)
Bevacizumab	Solution for I.V. infusion 100 mg in 4 mL (Avastin)
	Solution for I.V. infusion 400 mg in 16 mL (Avastin)

Addition of Maximum Quantity and Number of Repeats

Listed Drug	Form	Brand Name	Maximum Quantity	Number of Repeats
Clonazepam	Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent)	Rivotril	5	1
Fentanyl	Transdermal patch 1.28 mg	Denpax	10	0
	Transdermal patch 2.063 mg	Dutran 12	10	0
	Transdermal patch 2.063 mg	Fenpatch 12	10	0
	Transdermal patch 2.1 mg	APO-Fentanyl	10	0
		Durogesic 12	10	0
		Fentanyl Sandoz	10	0
	Transdermal patch 2.55 mg	Denpax	10	0
	Transdermal patch 4.125 mg	Dutran 25	10	0
	Transdermal patch 4.125 mg	Fenpatch 25	10	0
	Transdermal patch 4.2 mg	APO-Fentanyl	10	0
		Durogesic 25	10	0
		Fentanyl Sandoz	10	0
	Transdermal patch 5.10 mg	Denpax	10	0
	Transdermal patch 7.65 mg	Denpax	10	0
	Transdermal patch 8.25 mg	Dutran 50	10	0
	Transdermal patch 8.25 mg	Fenpatch 50	10	0
	Transdermal patch 8.4 mg	APO-Fentanyl	10	0
		Durogesic 50	10	0
		Fentanyl Sandoz	10	0
	Transdermal patch 10.20 mg	Denpax	10	0
	Transdermal patch 12.375 mg	Dutran 75	10	0
		Fenpatch 75	10	0
	Transdermal patch 12.6 mg	APO-Fentanyl	10	0
		Durogesic 75	10	0
		Fentanyl Sandoz	10	0
	Transdermal patch 16.5 mg	Dutran 100	10	0
	Transdermal patch 16.5 mg	Fenpatch 100	10	0
	Transdermal patch 16.8 mg	APO-Fentanyl	10	0
		Durogesic 100	10	0
		Fentanyl Sandoz	10	0
Haloperidol	Injection 5 mg in 1 mL	Serenace	10	2
Hydromorphone	Injection containing hydromorphone hydrochloride 2 mg in 1 mL	Dilaudid	10	1
		HYDROMORPHONE JUNO	10	1
		MEDSURGE HYDROMORPHONE 2 mg/1 mL	10	1
	Injection containing hydromorphone hydrochloride 10 mg in 1 mL	Dilaudid-HP	10	1
		HYDROMORPHONE JUNO-HP	10	1
		MEDSURGE HYDROMORPHONE HP 10 mg/1 mL	10	1
	Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 200 mL	Dilaudid	2	1
	Tablet containing hydromorphone hydrochloride 2 mg	Dilaudid	40	1
	Tablet containing hydromorphone hydrochloride 4 mg	Dilaudid	40	1
	Tablet containing hydromorphone hydrochloride 8 mg	Dilaudid	40	1
	Tablet (modified release) containing hydromorphone hydrochloride 4 mg	Jurnista	28	0
	Tablet (modified release) containing hydromorphone hydrochloride 8 mg	Jurnista	28	0
	Tablet (modified release) containing hydromorphone hydrochloride 16 mg	Jurnista	28	0
	Tablet (modified release) containing hydromorphone hydrochloride 32 mg	Jurnista	28	0
	Tablet (modified release) containing hydromorphone hydrochloride 64 mg	Jurnista	28	0
Methadone	Injection containing methadone hydrochloride 10 mg in 1 mL	Physeptone	120	0
	Tablet containing methadone hydrochloride 10 mg	Physeptone	120	0
Metoclopramide	Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)	APO-Metoclopramide	100	5
		EMEXLON	100	5
		Maxolon	100	5
		Metoclopramide AN	100	5
		Pramin	100	5
Morphine	Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets)	Kapanol	56	0
	Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets)	Kapanol	56	0
	Capsule containing morphine sulfate pentahydrate 30 mg (controlled release)	MS Mono	28	0
	Capsule containing morphine sulfate pentahydrate 50 mg (containing sustained release pellets)	Kapanol	56	0
	Capsule containing morphine sulfate pentahydrate 60 mg (controlled release)	MS Mono	28	0
	Capsule containing morphine sulfate pentahydrate 90 mg (controlled release)	MS Mono	28	0
	Capsule containing morphine sulfate pentahydrate 100 mg (containing sustained release pellets)	Kapanol	56	0
	Capsule containing morphine sulfate pentahydrate 120 mg (controlled release)	MS Mono	28	0
	Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL	Morphine Juno	10	1
	Injection containing morphine hydrochloride trihydrate 20 mg in 1 mL	Morphine Juno	10	1
	Injection containing morphine hydrochloride trihydrate 50 mg in 5 mL	Morphine Juno	10	1
	Injection containing morphine hydrochloride trihydrate 100 mg in 5 mL	Morphine Juno	10	1
	Injection containing morphine sulfate pentahydrate 10 mg in 1 mL	DBL Morphine Sulfate Pentahydrate	10	1
		MORPHINE SULFATE 10 mg/1 mL MEDSURGE	10	1
	Injection containing morphine sulfate pentahydrate 15 mg in 1 mL	DBL Morphine Sulfate Pentahydrate	10	1
		MORPHINE SULFATE 15 mg/1 mL MEDSURGE	10	1
	Injection containing morphine sulfate pentahydrate 30 mg in 1 mL	DBL Morphine Sulfate Pentahydrate	10	1
		MORPHINE SULFATE 30 mg/1 mL MEDSURGE	10	1
	Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 200 mL	Ordine 5	2	1
	Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 200 mL	Ordine 10	2	1
	Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 20 mg per sachet	MS Contin Suspension 20 mg	56	0
	Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 30 mg per sachet	MS Contin Suspension 30 mg	56	0
	Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 60 mg per sachet	MS Contin Suspension 60 mg	56	0
	Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 100 mg per sachet	MS Contin Suspension 100 mg	56	0
	Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 200 mg per sachet	MS Contin Suspension 200 mg	56	0
	Tablet containing morphine sulfate pentahydrate 5 mg (controlled release)	MS Contin	56	0
	Tablet containing morphine sulfate pentahydrate 10 mg (controlled release)	Momex SR 10	56	0
		Morphine MR AN	56	0
		MORPHINE MR APOTEX	56	0
		Morphine MR Mylan	56	0
		MS Contin	56	0

	Tablet containing morphine sulfate pentahydrate 15 mg (controlled release)	MS Contin	56	0
	Tablet containing morphine sulfate pentahydrate 30 mg (controlled release)	Momex SR 30	56	0
		Morphine MR AN	56	0
		MORPHINE MR APOTEX	56	0
		Morphine MR Mylan	56	0
		MS Contin	56	0
	Tablet containing morphine sulfate pentahydrate 60 mg (controlled release)	Momex SR 60	56	0
		Morphine MR AN	56	0
		MORPHINE MR APOTEX	56	0
		Morphine MR Mylan	56	0
		MS Contin	56	0
	Tablet containing morphine sulfate pentahydrate 100 mg (controlled release)	Momex SR 100	56	0
		Morphine MR AN	56	0
		MORPHINE MR APOTEX	56	0
		Morphine MR Mylan	56	0
		MS Contin	56	0
	Tablet containing morphine sulfate pentahydrate 200 mg (controlled release)	MS Contin	56	0
Oxycodone	Tablet containing oxycodone hydrochloride 10 mg (controlled release)	Novacodone	56	0
		Oxycodone Sandoz	56	0
		OxyContin	56	0
	Tablet containing oxycodone hydrochloride 15 mg (controlled release)	OxyContin	56	0
	Tablet containing oxycodone hydrochloride 20 mg (controlled release)	Novacodone	56	0
		Oxycodone Sandoz	56	0
		OxyContin	56	0
	Tablet containing oxycodone hydrochloride 30 mg (controlled release)	OxyContin	56	0
	Tablet containing oxycodone hydrochloride 40 mg (controlled release)	Novacodone	56	0
		Oxycodone Sandoz	56	0
		OxyContin	56	0
	Tablet containing oxycodone hydrochloride 80 mg (controlled release)	Novacodone	56	0
		Oxycodone Sandoz	56	0
		OxyContin	56	0
Oxycodone with naloxone	Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg	Targin 2.5/1.25 mg	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg	Targin 5/2.5mg	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg	Targin 10/5mg	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg	Targin 15/7.5mg	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg	Targin 20/10mg	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg	Targin 30/15 mg	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg	Targin 40/20mg	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg	Targin 60/30	56	0
	Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg	Targin 80/40	56	0
Progesterone	Pessary 200 mg	Oripro	30	5

Deletion of Maximum Quantity and Number of Repeats

Listed Drug	Form	Brand Name	Maximum Quantity	Number of Repeats
Morphine	Tablet containing morphine sulfate pentahydrate 200 mg (controlled release)	MS Contin	28	2

Alteration of Number of Repeats

Listed Drug	Form	Brand Name	Number of Repeats
Buprenorphine	Transdermal patch 5 mg	Bupredermal	From: 2	To: 0
		Buprenorphine Sandoz	From: 2	To: 0
		Norspan	From: 2	To: 0
	Transdermal patch 10 mg	Bupredermal	From: 2	To: 0
		Buprenorphine Sandoz	From: 2	To: 0
		Norspan	From: 2	To: 0
	Transdermal patch 15 mg	Bupredermal	From: 2	To: 0
		Buprenorphine Sandoz	From: 2	To: 0
		Norspan	From: 2	To: 0
	Transdermal patch 20 mg	Bupredermal	From: 2	To: 0
		Buprenorphine Sandoz	From: 2	To: 0
		Norspan	From: 2	To: 0
	Transdermal patch 25 mg	Bupredermal	From: 2	To: 0
		Buprenorphine Sandoz	From: 2	To: 0
		Norspan	From: 2	To: 0
	Transdermal patch 30 mg	Bupredermal	From: 2	To: 0
		Buprenorphine Sandoz	From: 2	To: 0
		Norspan	From: 2	To: 0
	Transdermal patch 40 mg	Bupredermal	From: 2	To: 0
		Buprenorphine Sandoz	From: 2	To: 0
		Norspan	From: 2	To: 0
Metoclopramide	Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL	Maxolon	From: 0 CN6084	To: 2 CN6084

Alteration of Responsible Person Code

Listed Drug	Form	Brand Name	Responsible Person
Rosuvastatin	Tablet 5 mg (as calcium)	Crestor	From: AP	To: FK
	Tablet 10 mg (as calcium)	Crestor	From: AP	To: FK
	Tablet 20 mg (as calcium)	Crestor	From: AP	To: FK
	Tablet 40 mg (as calcium)	Crestor	From: AP	To: FK

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug	Listed Drug
Abatacept	Haloperidol
Adalimumab	Hydromorphone
Baricitinib	Methadone
Bevacizumab	Morphine
Bisacodyl	Obinutuzumab
Botulinum toxin type A purified neurotoxin complex	Oxycodone
Buprenorphine	Oxycodone with naloxone
Certolizumab pegol	Progesterone
Clonazepam	Sacubitril with valsartan
Diclofenac	Sertraline
Etanercept	Tocilizumab
Fentanyl	Tofacitinib
Golimumab	Upadacitinib

Supply Only Status

Note: From 1 November 2020 Supply Only benefits are available on the Schedule for dispensing but not for prescribing, usually for a period of up to 12 months from when it is deleted.

Listed Drug	Form and Brand
Bisacodyl	Suppositories 10 mg, 10 (Dulcolax; Petrus Bisacodyl Suppositories )
	Suppositories 10 mg, 12 (Petrus Bisacodyl Suppositories)
	Enemas 10 mg in 5 mL, 25 (Bisalax)
	Tablet 5 mg (Lax-Tab)
Dalteparin	Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe (Fragmin)
	Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe (Fragmin)
	Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe (Fragmin)
	Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe (Fragmin)
	Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe (Fragmin)
	Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe (Fragmin)
	Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe (Fragmin)
Diclofenac	Suppository containing diclofenac sodium 100 mg (Voltaren 100)
	Tablet (enteric coated) containing diclofenac sodium 25 mg (APO-Diclofenac; Clonac 25; Diclofenac Amneal; Diclofenac AN; Diclofenac Sandoz; Fenac 25; Voltaren 25)
	Tablet (enteric coated) containing diclofenac sodium 50 mg (APO-Diclofenac; Clonac 50; Diclofenac Amneal; Diclofenac AN; Diclofenac Sandoz; Fenac; Voltaren 50)
Folinic acid	Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL (Leucovorin Calcium (Hospira Pty Limited))
Indometacin	Suppository 100 mg (Indocid)
Macrogol 3350	Sachets containing powder for oral solution 13.125 g with electrolytes, 30 (lax-sachets)
Naloxone	Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule (Junalox)
Naproxen	Tablet 500 mg (Naprosyn)
Temozolomide	Capsule 100 mg (Temozolomide Amneal)
	Capsule 180 mg (Temolide)
Testosterone	Transdermal patches 12.2 mg, 60 (Androderm)
Tirofiban	Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL (Tirofiban AC)
Tramadol	Injection containing tramadol hydrochloride 100 mg in 2 mL (Tramadol ACT)

Documents Incorporated by Reference

Listed Drug

Document incorporated

Document access

Adalimumab

Crohn Disease Activity Index (CDAI). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)b of the Legislation Act 2003.

The Crohn’s Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn’s disease.

Crohn Disease Activity Index (CDAI) is available for download for free from the PubMed website:

https://pubmed.ncbi.nlm.nih.gov/12786607/

A CDAI score calculation form is included in the Services Australia application form

Adalimumab

Paediatric Crohn’s Disease Activity Index (PCDAI). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The PCDAI is a tool used widely to classify the severity of Crohn’s disease in pediatric patients.

The Paediatric Crohn’s Disease Activity Index (PCDAI) is available for download for free from the Services Australia website:

https://www.servicesaustralia.gov.au/

Abatacept

Adalimumab

Baricitinib

Certolizumab pegol

Etanercept

Golimumab

Sacubitril with valsartan

Tocilizumab

Tofacitinib

Upadacitinib

Therapeutic Goods Administration (TGA)-approved Product Information. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine.

TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 5)

(PB 46 of 2021)

This Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Instrument

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 5) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, schedule equivalence, maximum quantities, number of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).

Human rights implications

This Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based. The pharmaceutical industry now has a nominee on the PBAC membership.

Conclusion

This Instrument is compatible with human rights because it advances the protection of human rights.

Nikolai Tsyganov

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Administered by Department of Health, Disability and Ageing

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