EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 2)
PB 13 of 2012
Purpose
The purpose of this legislative instrument, made under sections 84AF, 85, 85A, 88, and 101 of the National Health Act 1953 (the Act) is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
PB 108 of 2010 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 (responsible persons, prescribing circumstances, maximum quantities and numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements).
Authority
PB 108 of 2010 exercises numerous provisions 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). The Minister may also determine a brand of a pharmaceutical item (subsection 85(6)). The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).
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 PBAC has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.
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).
Variation and revocation of subsection 85(2) declaration
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 Pharmaceutical Benefits Advisory Committee (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 108 of 2010 made by this instrument
This instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). These changes are summarised, by subject matter, in Attachment 2.
Consultation
The involvement of interested parties through the membership of PBAC constitutes a formal and ongoing process of consultation. 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 as pharmaceutical benefits. 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. 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, and agreement to final listing details.
Medical and pharmacy professional groups, key stakeholder groups representing oncologists and pharmacists, State and Territory health departments, as well as the Department of Human Services and the Medical Software Industry Association, were also consulted throughout the process of developing all legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy.
General
A provision by provision description of this Instrument is contained in Attachment 1.
The Instrument commences on 1 April 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT 1
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2012 (No. 2)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 2) and may also be cited as PB 13 of 2012.
Section 2 Commencement
This section provides that the Instrument commences on 1 April 2012.
Section 3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments
The amendments in Schedule 1 involve additions, deletions and changes to drugs, forms, brands, responsible person codes, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), and section 100 only status These changes are summarised in Attachment 2.
ATTACHMENT 2
SUMMARY OF CHANGES
Listed Drug Added
Rilpivirine |
Tadalafil |
Forms Added
Abatacept | Injection 125 mg in 1 mL single dose pre-filled syringe |
Amino acids—synthetic formula | Oral powder 400 g (Neocate Advance Vanilla) |
Clostridium Botulinum Type A Toxin—haemagglutinin Complex | Lyophilised powder for I.M. injection 300 units
|
Nevirapine | Tablet 400 mg (extended release) |
Nilotinib | Capsule 150 mg (as hydrochloride monohydrate) |
Olanzapine | Tablet 5 mg (orally disintegrating) Tablet 10 mg (orally disintegrating) Tablet 15 mg (orally disintegrating) Tablet 20 mg (orally disintegrating) [for brands of the tablets listed above see “Brands Added”] Tablet 2.5 mg (as benzoate) Tablet 5 mg (as benzoate) Tablet 7.5 mg (as benzoate) Tablet 10 mg (as benzoate) |
Forms Deleted
Amino acids—synthetic, formula | Oral powder 400 g (Neocate) |
Epoprostenol | Powder for I.V. infusion 500 micrograms (as sodium) with diluent Powder for I.V. infusion 1.5 mg (as sodium) with diluent |
Glucose Indicator—Blood | Test strips, 50 (Freestyle Papillon) |
Oestradiol | Transdermal patches 8 mg, 8 |
Brands Added
Amlodipine | Tablet 5 mg (as besylate) Tablet 10 mg (as besylate) | Amlodipine Pfizer Amlodipine Pfizer |
Anastrozole | Tablet 1 mg | Anastrol; Anastrozole-DRLA; Anastrozole-GA; Terry White Chemists Anastrozole |
Atorvastatin | Tablet 10 mg (as calcium) | Atorvastatin Pfizer; |
| Tablet 20 mg (as calcium) | Atorvastatin Pfizer; |
| Tablet 40 mg (as calcium) | Atorvastatin Pfizer; |
| Tablet 80 mg (as calcium) | Atorvastatin Pfizer; |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | APO-Bisoprolol; |
| Tablet containing bisoprolol fumarate 5 mg | APO-Bisoprolol; |
| Tablet containing bisoprolol fumarate 10 mg | APO-Bisoprolol; |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. | Bleo 15K |
Clopidogrel | Tablet 75 mg (as besilate) | Clopidogrel GH; |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial | Accord Doxorubicin |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial | Accord Doxorubicin |
Epirubicin | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL | Epiccord |
| Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL | Epiccord |
| Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL | Epiccord; |
| Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL | Epiccord; |
Fluoxetine | Tablet, dispersible, 20 mg (as hydrochloride) | Zactin Tablet |
Frusemide | Tablet 20 mg Tablet 40 mg | Frusemide-PS Frusax; |
Gabapentin | Tablet 600 mg Tablet 800 mg | Nupentin Tabs Nupentin Tabs |
Isotretinoin | Capsule 10 mg Capsule 20 mg | APO-Isotretinoin APO-Isotretinoin |
Letrozole | Tablet 2.5 mg | APO-Letrozole; |
Methotrexate | Injection 50 mg in 2 mL vial | Methaccord |
| Solution concentrate for I.V. infusion 1000 mg in 10 mL vial | Methaccord |
Mycophenolic Acid | Capsule containing mycophenolate mofetil | APO-Mycophenolate; |
| Tablet containing mycophenolate mofetil 500 mg | APO-Mycophenolate; |
Olanzapine | Tablet 2.5 mg
| APO-Olanzapine; |
| Tablet 5 mg
| APO-Olanzapine; |
| Tablet 7.5 mg
| APO-Olanzapine; |
| Tablet 10 mg
| APO-Olanzapine; |
| Tablet 5 mg (orally disintegrating) | APO-Olanzapine ODT; |
| Tablet 10 mg (orally disintegrating) | APO-Olanzapine ODT; |
| Tablet 15 mg (orally disintegrating) | APO-Olanzapine ODT; |
| Tablet 20 mg (orally disintegrating) | APO-Olanzapine ODT; |
| Wafer 5 mg | Lanzek Zydis; |
| Wafer 10 mg | Lanzek Zydis; |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) Tablet 8 mg (as hydrochloride dihydrate) | Ondansetron Tabs Pfizer Ondansetron Tabs Pfizer |
Perindopril with Indapamide | Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg | Indopril Combi 4/1.25 |
Prazosin | Tablet 1 mg (as hydrochloride) | APO-Prazosin; |
| Tablet 2 mg (as hydrochloride) | APO-Prazosin; |
| Tablet 5 mg (as hydrochloride) | APO-Prazosin; |
Quetiapine | Tablet 25 mg (as fumarate) | APO-Quetiapine; |
| Tablet 100 mg (as fumarate) | APO-Quetiapine; |
| Tablet 200 mg (as fumarate) | APO-Quetiapine; |
| Tablet 300 mg (as fumarate) | APO-Quetiapine; |
Quinapril | Tablet 5 mg (as hydrochloride) Tablet 10 mg (as hydrochloride) Tablet 20 mg (as hydrochloride) | Acquin Aspen 5; |
Ramipril | Capsule 10 mg | APO-Ramipril; |
Sertraline | Tablet 50 mg (as hydrochloride) Tablet 100 mg (as hydrochloride) | Sertraline Pfizer Sertraline Pfizer |
Valaciclovir | Tablet 500 mg (as hydrochloride) | Valaciclovir Actavis 500 |
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) | Elaxine SR 37.5; |
| Capsule (modified release) 75 mg (as hydrochloride) | APO-Venlafaxine XR; |
| Capsule (modified release) 150 mg (as hydrochloride) | APO-Venlafaxine XR; |
Brands Deleted
Fluconazole | Capsule 50 mg (DBL Fluconazole) Capsule 100 mg (DBL Fluconazole) Capsule 200 mg (DBL Fluconazole) |
Fluoxetine | Capsule 20 mg (as hydrochloride) (Fluohexal) |
Gentamicin | Injection 80 mg (as sulfate) in 2 mL (Hospira Pty Limited) |
Simvastatin | Tablet 80 mg (Simvahexal) |
Alteration of Form Description and Brand
Listed Drug | Form | Brand |
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | From: Oral powder 400 g To: Oral powder 400 g
| From: Neocate LCP + MCT To: Neocate Gold |
Alteration of Maximum Quantity and Number of Repeats
Listed Drug | Form | Max Qty | Rpts |
Nilotinib | Capsule 200 mg (as hydrochloride monohydrate) | From: 112 To: 120 | From: 2 |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Clopidogrel | Tablet 75 mg (as besilate) | Clopidogrel Actavis | From: To: |
Glatiramer | Injection containing glatiramer acetate | Copaxone | From: To: |
Alteration of Number of Repeats
Listed Drug | Form | Alteration |
Azathioprine | Tablet 25 mg
Tablet 50 mg
| From: 2 To: 5 From: 2 To: 5
|
Alteration of Circumstances
Listed Drug | Alteration |
Apixaban | Circumstances amended in relation to the number of days of therapy required in the prevention of venous thromboembolism in patients undergoing total knee or hip replacement |
Certolizumab pegol | Circumstances amended to remove grandfather provisions (Initial 3, grandfather patients) |
Dalteparin | Circumstances amended to extend availability for haemodialysis [injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe [maximum quantity 20; number of repeats 3] and injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe [maximum quantity 20; number of repeats 3]] |
Dasatinib | Circumstances amended to extend availability for first-line treatment of patients in the chronic phase of chronic myeloid leukaemia |
Golimumab | Circumstances amended to remove grandfather provisions (Initial 3, grandfather patients) |
Imatinib | Circumstances amended in relation to the treatment of patients in the chronic phase of chronic myeloid leukaemia |
Nilotinib | Circumstances amended in relation to the treatment of patients in the chronic phase of chronic myeloid leukaemia |
Pantoprazole | Circumstances amended in respect of the tablet (enteric coated) 20 mg (as sodium sesquihydrate) to extend availability for the treatment of scleroderma oesophagus and Zollinger-Ellison syndrome |
Tocilizumab | Circumstances amended to remove grandfather provisions (Initial 3, grandfather patients) |
Addition of Responsible Person Code
EL [Eli Lilly Australia Pty Ltd] |