EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 13)
PB 74 of 2013
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 (responsible persons, prescribing circumstances, maximum quantities, numbers 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). 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)). 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 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).
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.
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.
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 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 71 of 2012 made by this instrument
Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status. These changes are summarised, by subject matter, in the Attachment.
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, guarantee of supply and agreement to final listing details.
General
A provision by provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 December 2013.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 13)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 13) and may also be cited as PB 74 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2013.
Section 3 Amendment of the 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 additions, deletions and changes to forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drugs Added
Alogliptin |
Atorvastatin and ezetimibe |
Canagliflozin |
Dabrafenib |
Dapagliflozin |
Dimethyl fumarate |
Fluticasone with eformoterol |
Ivabradine |
Olmesartan with amlodipine and hydrochlorothiazide |
Rifaximin |
Teriflunomide |
Forms Added
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | Oral powder 400 g (Alfamino) |
Budesonide with Eformoterol | Pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2 |
Darunavir | Tablet 800 mg (as ethanolate) |
Everolimus | Tablet 2.5 mg |
Milk powder—lactose free formula | Oral powder 900 g (Karicare Aptamil Gold De‑Lact) |
Terbutaline | Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses |
Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | Oral powder 400 g, 6 (Renastart) |
Form Deleted
Ketoconazole | Tablet 200 mg |
Brands Added
Candesartan | Tablet containing candesartan cilexetil 4 mg (Auro-Candesartan 4) |
Carbimazole | Tablet 5 mg (Carbimazol ARISTO) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Deotine 30) |
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL (Latanoprost Actavis) |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 |
Metoprolol | Tablet containing metoprolol tartrate 50 mg (Metatar) |
Perindopril | Tablet containing perindopril arginine 2.5 mg (PREXUM 2.5) |
Perindopril with Indapamide | Tablet containing perindopril arginine 5 mg with indapamide hemihydrate |
Roxithromycin | Tablet 150 mg (Roxithromycin GH) |
Ziprasidone | Capsule 20 mg (as hydrochloride) (APO-Ziprasidone) |
Brands Deleted
Anastrozole | Tablet 1 mg (STADA Anastrozole) |
Atorvastatin | Tablet 10 mg (as calcium) (STADA Atorvastatin) |
Candesartan | Tablet containing candesartan cilexetil 4 mg (STADA Candesartan) |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg (STADA Candesartan HCT 16/12.5) |
Clopidogrel | Tablet 75 mg (as besilate) (STADA Clopidogrel) |
Donepezil | Tablet containing donepezil hydrochloride 5 mg (STADA Donepezil) |
Irbesartan | Tablet 75 mg (STADA Irbesartan) |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg (STADA Irbesartan HCT 150/12.5) |
Letrozole | Tablet 2.5 mg (STADA Letrozole) |
Metoprolol | Tablet containing metoprolol tartrate 50 mg (APO-Metoprolol) |
Olanzapine | Tablet 2.5 mg (as benzoate) (STADA Olanzapine) |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (STADA Pantoprazole) |
Quetiapine | Tablet 25 mg (as fumarate) (STADA Quetiapine) |
Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) |
Venlafaxine | Capsule (modified release) 75 mg (as hydrochloride) (STADA Venlafaxine SR) |
Alteration of Form Description
Listed Drug | Form |
Ifosfamide | From: Powder for I.V. injection 1 g in single dose vial From: Powder for I.V. injection 2 g in single dose vial |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Ceftriaxone | Powder for injection 1 g (as sodium) | From: DBL Ceftriaxone To: Hospira Ceftriaxone |
Clarithromycin | Tablet 250 mg | From: Clarihexal To: Clarithromycin Sandoz |
Miconazole | Tincture 20 mg per mL, 30 mL | From: Daktarin |
Alteration of Maximum Quantity and Number of Repeats
The listed drug, Ivermectin has been amended to increase the maximum quantity and number of repeats for the strongyloidiasis indication.
Listed Drug | Form | Maximum Quantity | Number of Repeats |
Ivermectin | Tablet 3 mg | From: 4 | From: 0 To: 2 |
Alteration of Number of Repeats
Listed Drug | Form | Number of Repeats |
Nicotine | Transdermal patch 17.5 mg
| From: 0 From: 0 |
Deletion of Responsible Person Code
STADA Pharmaceuticals Australia Pty Limited [TD] |
Alteration of Circumstances
Listed Drug | Alteration |
Denosumab | Circumstances amended to remove the criteria which restricts treatment for osteoporosis to female patients only |
Ifosfamide | Restrictions have been removed for the use of ifosfamide |
Imatinib | Circumstances amended relating to adjuvant treatment following complete resection of primary gastrointestinal stromal tumour (GIST) |
Insulin Isophane | A restriction now applies to the injection (bovine) 100 units per mL, 10 mL for the treatment of diabetes mellitus |
Insulin Neutral | A restriction now applies to the injection (bovine) 100 units per mL, 10 mL for the treatment of diabetes mellitus |
Linagliptin | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Nicotine | Authority Requirements amended to Compliance with Written or Telephone Authority Required procedures - Streamlined Authority |
Saxagliptin | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Sitagliptin | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Sitagliptin with metformin | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Sunitinib | Circumstances amended to extend availability for the treatment of metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) |
Vildagliptin | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Vildagliptin with metformin | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
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 2013
(No. 13)
(PB 74 of 2013)
This Legislative 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 Legislative Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 13) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 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, maximum quantities, numbers of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).
Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health