EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits)
Amendment Instrument 2012 (No. 1)
PB 1 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.
Statement of Compatibility
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.
General
A provision by provision description of this Instrument is contained in Attachment 1.
The Instrument commences on 1 March 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. 1)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 1) and may also be cited as PB 1 of 2012.
Section 2 Commencement
This section provides that the Instrument commences on 1 March 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
Linagliptin |
Forms Added
Choriogonadotropin alfa (s.100) | Solution for injection 250 micrograms in 0.5 mL pre-filled pen |
Darunavir (s.100) | Tablet 600 mg (as ethanolate) |
Filgrastim (s.100) | Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim) Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim) |
Gemcitabine | Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL |
Somatropin (s.100) | Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative) |
Forms Deleted
Milk powder—lactose free formula | Oral powder 900 g (Karicare De-Lact) |
Protein hydrolysate formula with medium chain triglycerides | Oral powder 450 g (Pepti-Junior Gold) |
Alteration of Form Description and MaximumQuantity
Listed Drug | Form | Max Qty |
Essential Amino Acids Formula | From: Oral powder 200 g, 2 (Essential Amino Acid Mix) To: Oral powder 200 g (Essential Amino Acid Mix) | From: 3
To: 6
|
Brands Added
Amlodipine | Tablet 5 mg (as besylate) (Auro-Amlodipine 5) Tablet 10 mg (as besylate) (Auro-Amlodipine 10) |
Atenolol | Tablet 50 mg (Atenolol-PS) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Bisoprolol Pfizer) Tablet containing bisoprolol fumarate 5 mg (Bisoprolol Pfizer) Tablet containing bisoprolol fumarate 10 mg (Bisoprolol Pfizer) |
Calcitriol | Capsule 0.25 microgram (Calciprox; Calcitriol-PS) |
Cephalexin | Capsule 250 mg (anhydrous) (Cephalexin-PS) Capsule 500 (anhydrous) (Cephalexin-PS) |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) (Ciprofloxacin-PS) Tablet 750 mg (as hydrochloride) (Ciprofloxacin-PS) |
Citalopram | Tablet 20 mg (as hydrobromide) (Auro-Citalopram 20) Tablet 40 mg (as hydrobromide) (Auro-Citalopram 40) |
Epirubicin (s.100) | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL (Epirubicin Actavis 10) Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL (Epirubicin Actavis 20) Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL (Epirubicin Actavis 50) Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL (Epirubicin Actavis 100) Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL (Epirubicin Actavis 200) |
Escitalopram | Tablet 10 mg (as oxalate) (Escitalopram GA) Tablet 20 mg (as oxalate) (Escitalopram GA) |
Exemestane | Tablet 25 mg (Exemestane Sandoz) |
Fluoxetine | Capsule 20 mg (as hydrochloride) (Fluoxetine-PS) |
Lamotrigine | Tablet 25 mg (Lamotrigine-PS) Tablet 50 mg (Lamotrigine-PS) Tablet 100 mg (Lamotrigine-PS) Tablet 200 mg (Lamotrigine-PS) |
Lisinopril | Tablet 5 mg (Lisinopril-PS) Tablet 10 mg (Lisinopril-PS) Tablet 20 mg (Lisinopril-PS) |
Omeprazole | Tablet 20 mg (Omeprazole-PS) |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoprazole-PS) Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Panthron; Pantoprazole-PS) |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg (Prochlorperazine-PS) |
Ramipril | Capsule 10 mg (Ramipril-PS) |
Ranitidine | Tablet 150 mg (as hydrochloride) (Ranitidine-PS) |
Risperidone | Tablet 0.5 mg (Risperidone Pfizer) Tablet 1 mg (Risperidone Pfizer) Tablet 2 mg (Risperidone Pfizer) Tablet 3 mg (Risperidone Pfizer) Tablet 4 mg (Risperidone Pfizer) |
Sertraline | Tablet 50 mg (as hydrochloride) (Auro-Sertraline 50) Tablet 100 mg (as hydrochloride) (Auro-Sertraline 100) |
Simvastatin | Tablet 10 mg (Auro-Simvastatin 10) Tablet 20 mg (Auro-Simvastatin 20) Tablet 40 mg (Auro-Simvastatin 40) Tablet 80 mg (Auro-Simvastatin 80) |
Brands Deleted
Calcitriol | Capsule 0.25 microgram (Calcitriol-DP) |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) (Douglas Cefaclor-CD) |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) (Ascent Pharmaceuticals Limited) Tablet 750 mg (as hydrochloride) (Ascent Pharmaceuticals Limited) |
Enalapril | Tablet containing enalapril maleate 5 mg (Enalapril-DP 5mg) Tablet containing enalapril maleate 10 mg (Enalapril-DP 10mg) Tablet containing enalapril maleate 20 mg (Enalapril-DP 20mg) |
Famotidine | Tablet 20 mg (Pepcidine M) |
Lamotrigine | Tablet 25 mg (Lamotrigine-DP) Tablet 50 mg (Lamotrigine-DP) Tablet 100 mg (Lamotrigine-DP) Tablet 200 mg (Lamotrigine-DP) |
Lisinopril | Tablet 5 mg (Liprace) Tablet 10 mg (Liprace) Tablet 20 mg (Liprace) |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 10 mg (Medroxyhexal) |
Metformin | Tablet containing metformin hydrochloride 500 mg (Ascent Pharmaceuticals Limited) Tablet containing metformin hydrochloride 850 mg (Ascent Pharmaceuticals Limited) |
Paroxetine | Tablet 20 mg (as hydrochloride) (Paroxetine-DP) |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pravastatin 10) Tablet containing pravastatin sodium 20 mg (Pravastatin 20) Tablet containing pravastatin sodium 40 mg (Pravastatin 40) |
Ramipril | Capsule 1.25 mg (Ramipril-DP) Capsule 2.5 mg (Ramipril-DP) Capsule 5 mg (Ramipril-DP) Capsule 10 mg (Ramipril-DP) |
Roxithromycin | Tablet 150 mg (Roxide) Tablet 300 mg (Roxide) |
Sertraline | Tablet 50 mg (as hydrochloride) (Concorz) Tablet 100 mg (as hydrochloride) (Concorz) |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Foscarnet (s.100) | I.V. infusion containing foscarnet sodium 24 mg per mL, 250 mL | Foscavir | From: AstraZeneca Pty Ltd (AP) To: Clinect Pty Ltd (IX) |
Oestradiol | Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28 | Sandrena | From: Merck Sharp & Dohme (Australia) Pty Ltd (MK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Alteration of Authorised Prescriber
Listed Drug | Form | Alteration |
Amlodipine with valsartan and hydrochlorothiazide | Tablet 5 mg (as besylate)-160 mg-12.5 mg Tablet 5 mg (as besylate)-160 mg-25 mg Tablet 10 mg (as besylate)-160 mg-12.5 mg Tablet 10 mg (as besylate)-160 mg-25 mg Tablet 10 mg (as besylate)-320 mg-25 mg | Allowance to prescribe extended to authorised Nurse Practitioners |
Denosumab | Injection 60 mg in 1 mL pre-filled syringe | Allowance to prescribe extended to authorised Nurse Practitioners |
Alteration of Circumstances
Listed Drug | Alteration |
Abacavir with Lamivudine and Zidovudine (s.100) | Circumstances amended in relation to initial and continuing treatment of HIV infection |
Adefovir (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Denosumab | Streamlined authority now applies in respect of the injection 60 mg in 1 mL pre-filled syringe |
Entacavir (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Exenatide | Streamlined authority now applies to treatment of a patient with type 2 diabetes |
Gemcitabine (s.100) | Circumstances no longer apply to the listed drug gemcitabine |
Interferon Alfa-2a (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Interferon Alfa-2b (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Lamivudine (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Peginterferon Alfa-2a (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Telbivudine (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Tenofovir (s.100) | Circumstances changed in relation to eligibility of a patient with hepatitis B |
Tenofovir with emtricitabine and efavirenz (s.100) | Circumstances amended in relation to initial and continuing treatment of HIV infection |
Addition of Responsible Person Code
DO [Aurobindo Pharma (Australia) Pty Limited] |
IX [Clinect Pty Ltd] |