EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2020 (No. 11)
PB 111 of 2020
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 protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A to the Schedule of Pharmaceutical Benefits. It also provides for the addition of forms of the listed drugs norethisterone with ethinylestradiol, paracetamol, and rivaroxaban to the PBS, and for the deletion of certain forms of the listed drugs aciclovir, fluconazole, olanzapine, and posaconazole 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, dolutegravir with lamivudine, ixekizumab, obinutuzumab, rifampicin, venetoclax and clostridium botulinum type A toxin – haemagglutinin.
Schedule 1 to this Instrument also provides for the following changes:
- the addition of 29 brands of existing pharmaceutical items;
- the alteration of a responsible person code for 26 existing brands of pharmaceutical items;
- the addition of 2 responsible persons to the list of responsible persons;
- the deletion of 1 responsible person from the list of responsible persons;
- the alteration of a maximum quantity and number of repeats applicable to 2 pharmaceutical items;
- the addition of a maximum quantity for 2 pharmaceutical items;
- the addition of a number of repeats for 2 existing brands of pharmaceutical items; and
- the addition of 21 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 December 2020.
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 2020 (No. 11)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 11) and may also be cited as PB 111 of 2020.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2020.
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 drugs, the addition and deletion of forms of drugs, the addition of brands, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the addition and deletion of responsible person codes from the list of responsible persons, the alteration of maximum quantities and number of repeats, the addition of maximum quantities and number of repeats, the addition of 21 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 |
Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A |
Forms Added
Listed Drug | Form |
Norethisterone with ethinylestradiol | Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP |
Paracetamol | Suppository 500 mg |
Rivaroxaban | Tablet 2.5 mg |
Forms Deleted
Listed Drug | Form |
Aciclovir | Eye ointment 30 mg per g, 4.5 g |
Fluconazole | Solution for I.V. infusion 200 mg in 100 mL |
Olanzapine | Tablet 7.5 mg (as benzoate) |
Posaconazole | Oral suspension 40 mg per mL, 105 mL |
Brands Added
Listed Drug | Form and Brand |
Ambrisentan | Tablet 5 mg (Ambrisentan Mylan; Cipla Ambrisentan) |
Tablet 10 mg (Ambrisentan Mylan; Cipla Ambrisentan) | |
Arsenic | Injection concentrate containing arsenic trioxide 10 mg in 10 mL (Arsenic Trioxide Juno) |
Cefalexin | Capsule 500 mg (as monohydrate) (NOUMED CEFALEXIN) |
Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulfate)-100 mg (APX-Clopidogrel/Aspirin 75/100) |
Furosemide | Tablet 20 mg (Frusemix-M) |
| Tablet 40 mg (Frusemix) |
Lansoprazole | Capsule 30 mg (NOUMED LANSOPRAZOLE) |
Lurasidone | Tablet containing lurasidone hydrochloride 40 mg (Pharmacor Lurasidone) |
| Tablet containing lurasidone hydrochloride 80 mg (Pharmacor Lurasidone) |
Meloxicam | Tablet 7.5 mg (APX-Meloxicam) |
| Tablet 15 mg (APX-Meloxicam) |
Mercaptopurine | Tablet containing mercaptopurine monohydrate 50 mg (MERCAPTOPURINE-LINK) |
Metformin | Tablet (extended release) containing metformin hydrochloride 500 mg (Pharmacor Metformin XR) |
| Tablet containing metformin hydrochloride 500 mg (APX-Metformin) |
| Tablet containing metformin hydrochloride 850 mg (APX-Metformin) |
| Tablet (extended release) containing metformin hydrochloride 1 g (Pharmacor Metformin XR) |
| Tablet containing metformin hydrochloride 1 g (APX-Metformin) |
Posaconazole | Tablet (modified release) 100 mg (Posaconazole Juno) |
Quetiapine | Tablet (modified release) 50 mg (as fumarate) (APX-Quetiapine XR) |
| Tablet (modified release) 150 mg (as fumarate) (APX-Quetiapine XR) |
| Tablet (modified release) 200 mg (as fumarate) (APX-Quetiapine XR) |
| Tablet (modified release) 300 mg (as fumarate) (APX-Quetiapine XR) |
| Tablet (modified release) 400 mg (as fumarate) (APX-Quetiapine XR) |
Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) (Rabeprazole Mylan) |
Tadalafil | Tablet 20 mg (TADALIS 20) |
Trimethoprim | Tablet 300 mg (Trimethoprim Mylan) |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
Asenapine | Sublingual wafer 5 mg (as maleate) | Saphris | From: LU |
| Sublingual wafer 10 mg (as maleate) | Saphris | From: LU |
Betamethasone | Cream 200 micrograms (as valerate) per g, 100 g | Antroquoril | From: FR |
|
| Celestone-M | From: MK |
| Cream 500 micrograms (as dipropionate) | Diprosone | From: MK |
|
| Eleuphrat | From: FR |
| Ointment 500 micrograms (as dipropionate) per g, 15 g | Diprosone | From: MK |
|
| Eleuphrat | From: FR |
| Injection containing betamethasone acetate | Celestone Chronodose | From: MK |
Chorionic gonadotrophin | Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 | Pregnyl | From: MK |
| Powder for injection 5,000 units with solvent | Pregnyl | From: MK |
Corifollitropin alfa | Solution for injection 100 micrograms in | Elonva | From: MK |
| Solution for injection 150 micrograms in | Elonva | From: MK |
Etonogestrel | Subcutaneous implant 68 mg | Implanon NXT | From: MK |
Follitropin beta | Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge | Puregon 300 IU/0.36 mL | From: MK |
| Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge | Puregon 600 IU/0.72 mL | From: MK |
| Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge | Puregon 900 IU/1.08 mL | From: MK |
Ganirelix | Injection 250 micrograms (as acetate) in | Orgalutran | From: MK |
Infliximab | Powder for I.V. infusion 100 mg | Renflexis | From: MK |
Levodopa with carbidopa | Tablet (prolonged release) 200 mg-50 mg | Sinemet CR Prolonged-Release Tablets | From: MK |
Olmesartan with amlodipine and hydrochlorothiazide | Tablet containing olmesartan medoxomil | Sevikar HCT 20/5/12.5 | From: MK |
| Tablet containing olmesartan medoxomil | Sevikar HCT 40/5/12.5 | From: MK |
| Tablet containing olmesartan medoxomil | Sevikar HCT 40/5/25 | From: MK |
| Tablet containing olmesartan medoxomil | Sevikar HCT 40/10/12.5 | From: MK |
| Tablet containing olmesartan medoxomil | Sevikar HCT 40/10/25 | From: MK |
Trastuzumab | Powder for I.V. infusion 150 mg | Ontruzant | From: MK |
Addition of Responsible Person Code
Responsible Person and Code |
Organon Pharma Pty Ltd (OQ; OV) |
Deletion of Responsible Person Code
Responsible Person and Code |
Merck Sharp & Dohme (Australia) Pty Ltd (FR) |
Alteration of Maximum Quantity and Pack Quantity
Listed Drug | Form | Maximum Quantity | Pack Quantity |
Mesalazine | Sachet containing prolonged release granules, 1 g per sachet | From: 120 To:100 | From: 120 To:100 |
| Suppository 1 g | From: 30 To: 28 | From: 30 To: 28 |
Addition of Maximum Quantity
Listed Drug | Form | Brand Name | Maximum Quantity |
Rifampicin | Capsule 150 mg | Rimycin 150 | 120 |
| Capsule 300 mg | Rimycin 300 | 120 |
Addition of Number of Repeats
Listed Drug | Form | Brand Name | Number of Repeats |
Ixekizumab | Injection 80 mg in 1 mL single dose pre-filled pen | Taltz | 1 |
Venetoclax | Tablet 100 mg | Venclexta | 4 |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Clostridium botulinum type A toxin - haemagglutinin |
Dolutegravir with lamivudine |
Ixekizumab |
Obinutuzumab |
Rifampicin |
Venetoclax |
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 the deletion in Schedule 1 Part 1 of the Instrument occurred.
Listed Drug | Form and Brand |
Ampicillin | Powder for injection 1 g (as sodium) (Austrapen) |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial (Bleomycin for Injection, USP) |
Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulfate)-100 mg (Clopidogrel/Aspirin Sandoz 75/100) |
Escitalopram | Tablet 10 mg (as oxalate) (Esitalo) |
| Tablet 20 mg (as oxalate) (Esitalo) |
Labetalol | Tablet containing labetalol hydrochloride 200 mg (Presolol 200) |
Mesalazine | Sachet containing prolonged release granules, 1 g per sachet (Pentasa) |
| Suppository 1 g (Pentasa) |
Metformin | Tablet (extended release) containing metformin hydrochloride 500 mg (Diaformin XR) |
Methyldopa | Tablet 250 mg (as sesquihydrate) (Hydopa) |
Minocycline | Tablet 50 mg (as hydrochloride) (Akamin 50) |
Naproxen | Tablet 250 mg (Inza 250) |
| Tablet 500 mg (Inza 500) |
Nitrazepam | Tablet 5 mg (Alodorm) |
Oxazepam | Tablet 15 mg (Alepam 15) |
| Tablet 30 mg (Alepam 30) |
Pioglitazone | Tablet 15 mg (as hydrochloride) (Pioglitazone Sandoz) |
Ranitidine | Tablet 150 mg (as hydrochloride) (Ranitidine Sandoz) |
| Tablet 300 mg (as hydrochloride) (Ranitidine Sandoz) |
Venlafaxine | Capsule (modified release) 75 mg (as hydrochloride) (Venlafaxine Sandoz XR) |
| Capsule (modified release) 150 mg (as hydrochloride) (Venlafaxine Sandoz XR) |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Ixekizumab | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI is a widely used tool that enables measurement and evaluation of the level of disease activity in Ankylosing Spondylitis. | The BASDAI is available for download for free from the Services Australia website www.servicesaustralia.gov.au |
Obinutuzumab Venetoclax | Cumulative Illness Rating Scale (CIRS). 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 CIRS is one of the existing tools to measure multimorbidity. This index measures the chronic medical illness burden while taking into consideration the severity of chronic diseases. | The CIRS can be accessed from this website: https://www.aftermd.com/downloads/CIRS _CLL_Guide_2017.pdf |
Ixekizumab Venetoclax | 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 2020 (No. 11)
(PB 111 of 2020)
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 2020 (No. 11) 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).
The amendments in Schedule 1 involve the addition of drugs, the addition and deletion of forms of drugs, the addition of brands, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the addition and deletion of responsible person codes from the list of responsible persons, the alteration of maximum quantities and number of repeats, the addition of maximum quantities and number of repeats, the addition of 21 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme.
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.
Thea Connolly
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health