EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 14)
PB 88 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 January 2014.
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. 14)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 14) and may also be cited as PB 88 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 January 2014.
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, number of repeats, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), pack quantities, determined quantities, and section 100 only status. These changes are summarised below.
SUMMARY OF CHANGES
Forms Added
Benztropine | Injection containing benztropine mesylate 2 mg in 2 mL vial |
Cyclophosphamide | Tablet 50 mg (as monohydrate) |
Forms Deleted
Aprepitant | Pack containing 1 capsule 125 mg and 2 capsules 80 mg |
Bromocriptine | Capsule 5 mg (as mesylate) |
Ganciclovir | Intravitreal implant 4.5 mg |
Leflunomide | Pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg |
Miconazole | Cream containing miconazole nitrate 20 mg per g, 15 g |
Milk powder—lactose free formula | Oral powder 900 g (Karicare Aptamil De‑Lact) |
Pamidronic Acid | Injection set containing 4 vials powder for I.V. infusion containing disodium pamidronate 15 mg and 4 ampoules solvent 5 mL |
Triglycerides—medium chain, formula | Oral powder 420 g (Caprilon) |
Alteration of Form Description
Budesonide with Eformoterol | From: Pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2 From: Pressurised inhalation containing budesonide 100 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2 From: Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses, 2 |
Brands Added
Cephalexin | Capsule 250 mg (anhydrous) (Cephalex 250) |
Enalapril | Tablet containing enalapril maleate 5 mg (APO-Enalapril) |
Fosinopril | Tablet containing fosinopril sodium 10 mg (APO-Fosinopril) |
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Actavis 20/12.5) |
Leflunomide | Tablet 10 mg (Leflunomide GH) |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 (APO-MACROGOL plus ELECTROLYTES) |
Olanzapine | Tablet 5 mg (Olanzapine GH) |
Sertraline | Tablet 50 mg (as hydrochloride) (APO-Sertraline) |
Brands Deleted
Alendronic Acid | Tablet 70 mg (as alendronate sodium) (Adronat) |
Cephalexin | Capsule 250 mg (anhydrous) (Pharmacor Cephalexin 250) |
Glucose | I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL (B. Braun Australia Pty Ltd) |
Imiquimod | Cream 50 mg per g, 250 mg single use sachets, 12 (Aldiq) |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL (Duphalac) |
Pindolol | Tablet 15 mg (Barbloc 15) |
Sodium Chloride | I.V. infusion 38.5 mmol per 250 mL, 250 mL (B. Braun Australia Pty Ltd) |
Sodium Lactate Compound | I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person |
Calcitriol | Capsule 0.25 microgram | Calciprox | From: Actavis Pty Ltd (GN) To: Eris Pharmaceuticals (Australia) Pty Ltd (ER) |
Frusemide | Tablet 40 mg | Frusax | From: Actavis Pty Ltd (GN) To: Eris Pharmaceuticals (Australia) Pty Ltd (ER) |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Panthron | From: Actavis Pty Ltd (GN) To: Eris Pharmaceuticals (Australia) Pty Ltd (ER) |
Alteration of Maximum Quantity and Pack Quantity
Listed Drug | Form | Max Qty |
Budesonide with Eformoterol | Pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses Pressurised inhalation containing budesonide 100 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | From: 1 To: 2
|
Alteration of Number of Repeats
Listed Drug | Form | No. of Rpts |
Quetiapine | Tablet 25 mg (as fumarate) | From: 5 To: 0 |
Addition of Responsible Person Code
Eris Pharmaceuticals (Australia) Pty Ltd [ER] |
Alteration of Circumstances
Listed Drug | Alteration |
Amino acids—synthetic, formula | Circumstances amended to extend availability for the treatment of eosinophilic oesophagitis and severe intestinal malabsorption including short bowel syndrome |
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Circumstances amended to extend availability for the treatment of severe intestinal malabsorption including short bowel syndrome |
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | Circumstances amended to extend availability for the treatment of severe intestinal malabsorption including short bowel syndrome |
Amlodipine with valsartan | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Amlodipine with valsartan and hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Apixaban | Circumstances amended to provide for streamlining of authority requirements |
Budesonide with eformoterol | Circumstances amended to restrict availability to patients 12 years of age or older |
Candesartan with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Clozapine | Circumstances amended to include further prescriber instructions in relation to quantities requested |
Dabigatran etexilate | Circumstances amended to provide for streamlining of authority requirements |
Dimethyl fumarate | Circumstances amended to move date criteria from initial to continuing treatment |
Enalapril with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Eprosartan with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Erlotinib | Extend the current Authority required listing to include treatment, as monotherapy of locally advanced (stage IIIB) or metastatic (stage IV) non-squamous or not otherwise specified (NOS) non-small cell lung cancer in patients where there is evidence that the patient has an activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material |
Exenatide | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Fluticasone with eformoterol | Circumstances amended to restrict availability to patients 12 years of age or older |
Fluticasone with Salmeterol | Circumstances amended to increase availability |
Fosinopril with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Gefitinib | Extend the current Authority required listing to include initial and continuing treatment of locally advanced or metastatic (stage IIIB or IV) non-small cell lung cancer in patients where there is evidence that the patient has an activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material |
Irbesartan with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Lercanidipine with enalapril | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Olmesartan with amlodipine | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Olmesartan with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Perindopril with amlodipine | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Perindopril with Indapamide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Pioglitazone | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Protein hydrolysate formula with medium chain triglycerides | Circumstances amended to extend availability for the treatment of proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein |
Quetiapine | Circumstances amended to specify treatment must be for dose titration purposes |
Quinapril with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Ramipril with Felodipine | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Rivaroxaban | Circumstances amended to provide for streamlining of authority requirements |
Rosiglitazone | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Rosiglitazone with Metformin | Circumstances amended to add SGLT2 inhibitors to the classes of anti-diabetic drugs mentioned |
Telmisartan with amlodipine | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Telmisartan with Hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Teriparatide | Amended circumstances only relevant to initial treatment for severe established osteoporosis |
Trandolapril with Verapamil | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
Valsartan with hydrochlorothiazide | Circumstances amended to refer to the classes of drug in the combination rather than to the specific agents within each class |
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. 14)
(PB 88 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. 14) 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