EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits)
Amendment Instrument 2011 (No. 14)
PB 96 of 2011
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 January 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 2011 (No. 14)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 14) and may also be cited as PB 96 of 2011.
Section 2 Commencement
This section provides that the Instrument commences on 1 January 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
Apixaban |
Listed Drugs Deleted
Drotrecogin Alfa (activated) |
Peginterferon Alfa-2b (s.100) |
Forms Added
Epoprostenol (s.100) | Powder for I.V. infusion, 500 micrograms (as sodium) infusion Powder for I.V. infusion, 1.5 mg (as sodium) infusion |
Etravirine (s.100) | Tablet 200 mg |
Gemcitabine (s.100) | Solution for injection 200 mg (as hydrochloride) in 5.3 mL Solution for injection 1 g (as hydrochloride) in 26.3 mL Solution for injection 2 g (as hydrochloride) in 52.6 mL |
Glucose Indicator—Blood | Test strips, 50 (Accu-Chek Aviva) |
Nicotine | Transdermal patch 17.5 mg Transdermal patch 35 mg |
Form Deleted
Testosterone | Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate, 100 mg testosterone decanoate) in 1 mL |
Alteration of Form Description
Tacrolimus | From: Capsule 500 micrograms To: Capsule 0.5 mg |
Brands Added
Aciclovir | Tablet 200 mg (Aciclovir GH) |
Amisulpride | Tablet 100 mg (APO-Amisulpride) Tablet 200 mg (APO-Amisulpride) Tablet 400 mg (APO-Amisulpride) |
Carboplatin (s.100) | Solution for I.V. injection 450 mg in 45 mL (Carboplatin Kabi) |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) (Cefaclor GH) |
Exemestane | Tablet 25 mg (APO-Exemestane) |
Fentanyl | Transdermal patch 2.1 mg (Fentanyl Sandoz) Transdermal patch 4.2 mg (Fentanyl Sandoz) Transdermal patch 8.4 mg (Fentanyl Sandoz) Transdermal patch 12.6 mg (Fentanyl Sandoz) Transdermal patch 16.8 mg (Fentanyl Sandoz) |
Fluoxetine | Capsule 20 mg (as hydrochloride) (Fluoxetine Sandoz) |
Glimepiride | Tablet 1 mg (Pharmacor Glimepiride 1) Tablet 2 mg (Pharmacor Glimepiride 2) Tablet 3 mg (Pharmacor Glimepiride 3) Tablet 4 mg (Pharmacor Glimepiride 4) |
Irinotecan (s.100) | I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL (Tecan) |
Meloxicam | Capsule 7.5 mg (APO-Meloxicam; Chem mart Meloxicam; Terry White Chemists Meloxicam) Capsule 15 mg (APO-Meloxicam; Chem mart Meloxicam; Terry White Chemists Meloxicam) |
Omeprazole | Capsule 20 mg (APO-Omeprazole; Omeprazole Sandoz) |
Paclitaxel (s.100) | Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxel Pfizer) Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Paclitaxel Pfizer) Solution concentrate for I.V. infusion 300 mg in 50 mL (Paclitaxel Pfizer) |
Perindopril with Indapamide | Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg (Perindopril/Indapamide GH 4/1.25) |
Pioglitazone | Tablet 15 mg (as hydrochloride) (Pioglitazone-GA) Tablet 30 mg (as hydrochloride) (Pioglitazone-GA) Tablet 45 mg (as hydrochloride) (Pioglitazone-GA) |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pharmacor Pravastat 10) Tablet containing pravastatin sodium 20 mg (Pharmacor Pravastat 20) Tablet containing pravastatin sodium 40 mg (Pharmacor Pravastat 40) |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg (Pharmacor Prozine 5) |
Simvastatin | Tablet 10 mg (Simvacor 10) Tablet 20 mg (Simvacor 20) Tablet 40 mg (Simvacor 40) Tablet 80 mg (Simvacor 80; Simvasatin Sandoz) |
Brands Deleted
Simvastatin | Tablet 5 mg (Simvasyn) Tablet 10 mg (Simvasyn) Tablet 20 mg (Simvasyn) Tablet 40 mg (Simvasyn) Tablet 80 mg (Simvasyn) |
Alteration of Form Description and Brand
Listed Drug | Form | Brand |
Glucose Indicator—Blood | From: Test strips, 50 (WaveSense Jazz) To: Test strips, 50 (AgaMatrix Jazz) | From: WaveSense Jazz To: AgaMatrix Jazz |
Glucose Indicator—Blood | From: Test strips, 100 (Optium glucose) To: Test strips, 100 (FreeStyle Optium) | From: Optium glucose To: FreeStyle Optium |
Alteration of Brand
Terbinafine | Tablet 250 mg (as hydrochloride) | From: Lamisil To: Lamisil (Novartis Pharmaceuticals Australia Pty Limited)
|
Alteration of Responsible Person Code (no change to Responsible Person)
Listed Drug | Form | Brand | Responsible Person Code |
Fluoxetine | Capsule 20 mg (as hydrochloride) | Fluohexal | From: SZ To: HX |
Paracetamol | Tablet 500 mg | Chem mart Paracetamol | From: YM To: XS |
Paracetamol | Tablet 500 mg | Terry White Chemists Paracetamol | From: YM To: YS |
Paroxetine | Tablet 20 mg (as mesilate) | Pharmacor Paroxo 20 | From: CR To: MI |
Simvastatin | Tablet 80 mg | Simvahexal | From: SZ To: HX |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Macrogol 3350 | Powder for oral solution 510 g | your pharmacy Clear Laxative | From: Apotex Pty Ltd (TW) To: Orion Laboratories Pty Ltd (OY) |
Methylnaltrexone | Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL | Relistor | From: Pfizer Australia Pty Ltd (PF) To: Link Medical Products Pty Ltd (LM) |
Phenoxybenzamine | Capsules containing phenoxybenzamine hydrochloride 10 mg, 100 | Dibenzyline | From: Goldshield Healthcare (Australia) Pty Limited (GH) To: Boucher & Muir Pty Ltd (BZ) |
Pravastatin | Tablet containing pravastatin sodium 10 mg Tablet containing pravastatin sodium 20 mg Tablet containing pravastatin sodium 40 mg | Pravastatin 10 Pravastatin 20 Pravastatin 40 | From: Pharmacor Pty Limited (CR) To: Meditech Int. Pty Ltd (MI)
|
Valaciclovir | Tablet 500 mg (as hydrochloride) | Valacor 500 | From: Pharmacor Pty Limited (RA) To: Ranbaxy Australia Pty Limited (QR) |
Alteration of Number of Repeats
Nicotine | Transdermal patch 52.5 mg [Repeats reduced for short-term treatment due to the listing of additional forms for this indication. | From: 2 To: 0 |
Alteration of Circumstances
Listed Drug | Alteration |
Docetaxel | Circumstances amended in relation to the treatment of metastatic breast cancer and also the treatment of HER2 positive breast cancer in combination with trastuzumab |
Paclitaxel | Circumstances amended in relation to the treatment of metastatic breast cancer and also the treatment of HER2 positive breast cancer in combination with trastuzumab |
Paclitaxel, nanoparticle albumin-bound | Circumstances amended in relation to the treatment of metastatic breast cancer and also to extend availability for the treatment of HER2 positive breast cancer in combination with trastuzumab |
Addition of Responsible Person Code
BZ [Boucher & Muir Pty Ltd] |
OY [Orion Laboratories Pty Ltd] |
QR [Ranbaxy Australia Pty Limited] |
XS [Symbion Pty Ltd] |
YS [Symbion Pty Ltd] |
Name change for Responsible Person
YM [From: Symbion Pharmacy Services Pty Ltd To: Symbion Pty Ltd] |