EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits)
Amendment Instrument 2011 (No. 9)
PB 57 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) and paragraph 85(8)(a), respectively, provide that the Minister may declare that a particular listed drug or a particular pharmaceutical benefit may only be supplied under special arrangements under section 100. Similarly, 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 changes all references to ‘Medicare Australia CEO’ in PB 108 of 2010 to ‘Chief Executive Medicare’
This instrument also provides for additions, deletions and changes to forms, brands responsible persons, circumstances for prescribing and to the maximum quantities and number of repeats that may be prescribed for various pharmaceutical benefits. 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.
General
A provision by provision description of this Instrument is contained in Attachment 1.
The Instrument commences on 1 September 2011.
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.9)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 9) and may also be cited as PB 57 of 2011.
Section 2 Commencement
This section provides that the Instrument commences on 1 September 2011.
Section 3 Amendment of PB 108 of 2010
This section provides that Schedules 1 and 2 amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments relating to Medicare references
Schedule 1 amends PB 108 of 2010 to change all references to ‘Medicare Australia CEO’ to the new title ‘Chief Executive Medicare’. These changes are made as a consequence of the commencement of the Human Services Legislation Amendment Act 2011.
Schedule 2 Amendments relating to PBS changes
Schedule 2 amends PB 108 of 2010 to reflect the changes to the PBS for 1 September 2011.
The amendments in Schedule 2 involve additions, deletions and changes to forms, brands, responsible persons, circumstances for prescribing and to the maximum quantities and number of repeats that may be prescribed. These changes are summarised in Attachment 2.
.
ATTACHMENT 2
SUMMARY OF CHANGES
Listed Drug Added
Ferrous fumarate |
Fingolimod |
Zuclopenthixol Decanoate |
Listed Drug Deleted
Amiloride |
Clotrimazole |
Neomycin |
Sulindac |
Forms Added
Buprenorphine with naloxone (s.100) | Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride) Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride) |
Calcipotriol with betamethasone | Gel containing calcipotriol 50 micrograms with betamethasone |
Clopidogrel | Tablet 75 mg |
Dalteparin | Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe |
Fentanyl | Transdermal patch 1.28 mg Transdermal patch 2.063 mg Transdermal patch 4.125 mg Transdermal patch 8.25 mg Transdermal patch 12.375 mg Transdermal patch 16.5 mg |
Flupenthixol Decanoate | Oily I.M. injection 20 mg in 1 mL |
Fluconazole | Powder for oral suspension 50 mg in 5 mL, 35 mL |
Glucose Indicator—Blood | Test strips, 50 (TRUEbalance) Test strips, 50 (TRUEresult) |
Forms Deleted
Cimetidine | Tablet 200 mg |
Isosorbide Dinitrate | Tablet 10 mg |
Trimethoprim with Sulfamethoxazole | Tablet 80 mg-400 mg |
Minocycline | Capsule 100 mg (as hydrochloride) |
Brands Added
Escitalopram | Tablet 10 mg (as oxalate) (Escitalopram-DRLA) Tablet 20 mg (as oxalate) (Escitalopram-DRLA) |
Perindopril | Tablet containing perindopril erbumine 2 mg (Idaprex 2) Tablet containing perindopril erbumine 4 mg (Idaprex 4) Tablet containing perindopril erbumine 8 mg (Idaprex 8) |
Exemestane | Tablet 25 mg (Exemestane Pfizer) |
Ondansetron | I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL (Ondansetron Alphapharm) I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL (Ondansetron Alphapharm) |
Perindopril with Indapamide | Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg (Idaprex Combi 4/1.25) |
Brands Deleted
Bromocriptine | Capsule 5 mg (as mesylate) (Parlodel) Capsule 10 mg (as mesylate) (Parlodel) |
Doxycycline | Tablet 100 mg (as hydrochloride) (Vibramycin) |
Gabapentin | Capsule 100 mg (Gantin) |
Alteration of Authorised Prescriber
Listed Drug | Form | Alteration |
Ciprofloxacin | Eye drops 3 mg (as hydrochloride) per mL, 5 mL | Allowance to prescribe extended to authorised optometrists |
Dexamethasone | Eye drops 1 mg per mL, 5 mL [Max Qty 1; No. of Rpts 0] | Allowance to prescribe extended to authorised optometrists |
Gentamicin | Eye drops 3 mg (as sulfate) per mL, 5 mL | Allowance to prescribe extended to authorised optometrists for the specified circumstances |
Folinic acid | Tablet containing calcium folinate equivalent to Injection containing calcium folinate equivalent to
Injection containing calcium folinate equivalent to Injection containing calcium folinate equivalent to | Prescribing by an authorised Nurse Practitioner is revoked |
Ofloxacin | Eye drops 3 mg per mL, 5 mL | Allowance to prescribe extended to authorised optometrists |
Prednisolone with Phenylephrine | Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL [Max Qty 1; No. of Rpts 0] | Allowance to prescribe extended to authorised optometrists for the specified circumstances |
Tobramycin | Eye drops 3 mg per mL, 5 mL Eye ointment 3 mg per g, 3.5 g | Allowance to prescribe extended to authorised optometrists for the specified circumstances |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Calcipotriol | Cream 50 micrograms (as monohydrate) per g, 30 g Scalp solution 50 micrograms (as monohydrate) per mL, | Diavonex | From: CSL Biotherapies Pty Ltd (CS) To: LEO Pharma Pty Ltd (LO)
|
Calcipotriol with betamethasone | Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, | Diavobet | From: CSL Biotherapies Pty Ltd (CS) To: LEO Pharma Pty Ltd (LO)
|
Quinapril | Tablet 5 mg (as hydrochloride) Tablet 10 mg (as hydrochloride) Tablet 20 mg (as hydrochloride)
| Filpril | From: Alphapharm Pty Ltd (AL) To: Pfizer Australia Pty Ltd (FZ)
|
Alteration of Maximum Quantity
Mesalazine | Suppository 1 g From: 28 To: 30 |
Alteration of Number of Repeats
Pramipexole | Tablet (extended release) containing pramipexole hydrochloride From: 0 To: 5 |
Alteration of Maximum Quantity and Number of repeats
Dalteparin | Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe Max Qty from: 10 To: 20 Number of Repeats from: 1 To: 0 Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe Max Qty from: 10 To: 20 Number of Repeats from: 1 To: 0 |
Addition of Responsible Person
LO [LEO Pharma Pty Ltd] |
Deletion of Responsible Person
AW [Aspen Pharma Pty Ltd] |
Alteration of Circumstances
Listed Drug | Alteration |
Cetuximab | Extension of PBS availability for initial treatment of a patient with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy, and continuing treatment of a patient with K-RAS wild type metastatic colorectal cancer with a previous authority prescription for cetuximab and who does not have progressive disease |
Deferasirox (s.100) | Circumstances amended to remove age criteria for the use of this drug |
Filgrastim (s.100) | Circumstances amended to extend availability to patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease |
Imatinib | Extension of PBS availability for resectable primary gastrointestinal stromal tumour |
Pegfilgrastim (s.100) | Circumstances amended to extend availability to patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease |
Risperidone | Circumstances amended to include maintenance treatment of treatment refractory bipolar 1 disorder |
Addition of Purpose
Enoxaparin | Extend availability for the specified maximum quantity and number of repeats for use in haemodialysis to the following forms of this drug: Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe [Max Qty 20; Rpts 3] Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe [Max Qty 20; Rpts 3] |