EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits)
Amendment Instrument 2011 (No. 12)
PB 83 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.
A number of listed drugs (85(2A)) or pharmaceutical benefits (85(8)(a)) will have section 100 only status on 1 December 2011. This aligns with the commencement of the section 100 special arrangement for the Efficient Funding of Chemotherapy, and the addition of the drug Corifollitropin Alfa to the s.100 special arrangement regarding IVF/GIFT, both on
1 December 2011.The drugs or pharmaceutical benefits with section 100 only status are identified 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 December 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. 12)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 12) and may also be cited as PB 83 of 2011.
Section 2 Commencement
This section provides that the Instrument commences on 1 December 2011.
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.
Item [1] Subsections 5(2), 5(3) and 5(4), and notes to 5(2) and 5(4)
Item [2] Subsection 20(1), and note to subsection 20(1)
Minor and mechanical changes have been made to sections 5 and 20, and a note in each section removed, in light of the creation of a number of section 100 only drugs on 1 December 2011.
In accordance with item 32, Schedule 6 of the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2010 (the 2010 Amending Act), a drug or medicinal preparation specified in Schedule 6 of PB 14 of 2010, or PB41 of 2010, as in force immediately prior to 1 December 2010, is to be treated (and may be dealt with) as if a declaration had been made in relation to the drug or medicinal preparation under subsection 85(2) and 85(2A).
On 1 December 2010, when both Schedule 6 of the 2010 Amending Act and PB 108 of 2010 commenced, sections 5 and 20 separately referenced drugs or medicinal preparations appearing in PB 80 of 2010 due to item 32. Consistent with item 32, all of the drugs and medicinal preparations declared under 85(2) (or 85(2A) if applicable) (whether or not via item 32) have appeared as such in Schedule 1 to PB108 of 2010 since 1 December 2010.
Since item 23 required the drugs and medicinal preparations to be treated (and dealt with) as if a declaration had been made under subsection 85(2) and 85(2A), it is now possible to simplify sections 5 and 20 by removing reference to the transitional provision.
ATTACHMENT 2
SUMMARY OF CHANGES
Listed Drug Added
Asenapine |
Corifollitropin Alfa |
Indacaterol |
Losartan |
Magnesium |
Oxycodone with naloxone |
Listed Drug Deleted
Thiotepa |
85(2A) section 100 only drug
Arsenic |
Bevacizumab |
Bleomycin |
Carboplatin |
Cetuximab |
Cisplatin |
Cladribine |
Corifollitropin Alfa |
Cytarabine |
Docetaxel |
Doxorubicin |
Doxorubicin – Pegylated Liposomal |
Epirubicin |
Fluorouracil |
Fotemustine |
Gemcitabine |
Ifosfamide |
Irinotecan |
Mitozantrone |
Oxaliplatin |
Paclitaxel |
Paclitaxel, nanoparticle albumin-bound |
Pemetrexed |
Raltitrexed |
Rituximab |
Topotecan |
Vinblastine |
Vincristine |
85(8)(a) section 100 only pharmaceutical benefit
Cyclophosphamide | Powder for injection 500 mg (anhydrous) |
| Powder for injection 1 g (anhydrous) |
| Powder for injection 2 g (anhydrous) |
Etoposide | Solution for I.V. infusion 100 mg in 5 mL vial |
| Powder for I.V. infusion 100 mg (as phosphate) |
| Powder for I.V. infusion 1 g (as phosphate) |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg |
| Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL |
Idarubicin | Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL |
| Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL |
Methotrexate | Solution concentrate for I.V. infusion 500 mg in 20 mL vial |
| Solution concentrate for I.V. infusion 1000 mg in 10 mL vial |
| Solution concentrate for I.V. infusion 5000 mg in 50 mL vial |
Vinorelbine | Solution for I.V. infusion 10 mg (as tartrate) in 1 mL |
| Solution for I.V. infusion 50 mg (as tartrate) in 5 mL |
Forms Added
Dalteparin | Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe |
Darunavir (s.100) | Tablet 400 mg (as ethanolate) |
Denosumab | Injection 120 mg in 1.7 mL |
Paliperidone | I.M. injection (modified release) 25 mg (as palmitate) in pre-filled syringe I.M. injection (modified release) 50 mg (as palmitate) in pre-filled syringe I.M. injection (modified release) 75 mg (as palmitate) in pre-filled syringe I.M. injection (modified release) 100 mg (as palmitate) in pre-filled syringe I.M. injection (modified release) 150 mg (as palmitate) in pre-filled syringe |
Pramipexole | Tablet (extended release) containing pramipexole hydrochloride 2.25 mg Tablet (extended release) containing pramipexole hydrochloride 3.75 mg |
Forms Deleted
Lacosamide | Oral solution 15 mg per mL, 200 mL |
Norethisterone with Mestranol | Tablets 1 mg-50 micrograms, 21 |
Alteration of Form Description
Bleomycin | From: Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) To: Powder for injection containing bleomycin sulfate 15,000 I.U. |
Botulinum Toxin Type A Purified Neurotoxin Complex | From: Lyophilised powder for I.M. injection 100 units To: Lyophilised powder for injection 100 units |
Cyclophosphamide | From: Powder for injection 500 mg (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) To: Powder for injection 500 mg (anhydrous) From: Powder for injection 1 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) To: Powder for injection 1 g (anhydrous) From: Powder for injection 2 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) To: Powder for injection 2 g (anhydrous) |
Brands Added
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Bisoprolol GH) Tablet containing bisoprolol fumarate 5 mg (Bisoprolol GH) Tablet containing bisoprolol fumarate 10 mg (Bisoprolol GH) |
Dexamethasone | Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL (Dexmethsone) Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL (Dexmethsone) |
Famciclovir | Tablet 500 mg (APO-Famciclovir; Chem mart Famciclovir; Terry White Chemists Famciclovir) |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 10 mg (Medroxyprogesterone Sandoz) |
Morphine | Tablet containing morphine sulfate 10 mg (controlled release) Tablet containing morphine sulfate 30 mg (controlled release) Tablet containing morphine sulfate 60 mg (controlled release) Tablet containing morphine sulfate 100 mg (controlled release) |
Perindopril | Tablet containing perindopril erbumine 2 mg (Perindopril generichealth) Tablet containing perindopril erbumine 4 mg (Perindopril generichealth) Tablet containing perindopril erbumine 8 mg (Perindopril generichealth) |
Roxithromycin | Tablet 300 mg (Roxithromycin Sandoz) |
Sertraline | Tablet 50 mg (as hydrochloride) (Sertraline Sandoz) Tablet 100 mg (as hydrochloride) (Sertraline Sandoz) |
Somatropin (s.100) | Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) (Norditropin FlexPro) Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) (Norditropin FlexPro) Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) (Norditropin FlexPro) |
Temozolomide | Capsule 5 mg (Astromide; Temizole 5) Capsule 20 mg (Astromide; Temizole 20) Capsule 100 mg (Astromide; Temizole 100) Capsule 140 mg (Astromide; Temizole 140) Capsule 250 mg (Astromide; Temizole 250) |
Topiramate | Tablet 25 mg (Topiramate generichealth) Tablet 50 mg (Topiramate generichealth) Tablet 100 mg (Topiramate generichealth) Tablet 200 mg (Topiramate generichealth) |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Valaciclovir generichealth) |
Brands Deleted
Captopril | Tablet 25 mg (Ascent Pharma Pty Ltd) Tablet 50 mg (Ascent Pharma Pty Ltd) |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg (Dolaforte) |
Diltiazem | Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg (Dilzem CD) Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg (Dilzem CD) |
Metformin | Tablet containing metformin hydrochloride 500 mg (Glucohexal) Tablet containing metformin hydrochloride 850 mg (Glucohexal) Tablet containing metformin hydrochloride 1 g (Glucohexal) |
Norethisterone with Ethinyloestradiol | Pack containing 12 tablets 500 micrograms-35 micrograms, 9 tablets |
Alteration of Responsible Person Code (no change to Responsible Person)
Listed Drug | Form | Brand | Responsible Person Code |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 10 mg | Medroxyhexal | From: SZ To: HX |
Roxithromycin | Tablet 300 mg | Roxide | From: SZ To: HX |
Sertraline | Tablet 50 mg (as hydrochloride) Tablet 100 mg (as hydrochloride) | Concorz Concorz
| From: SZ To: HX |
Alteration of Circumstances
Listed Drug | Alteration |
Alendronic Acid | Circumstance amended to alter the stated Bone Mineral Density (BMD) |
Alendronic acid with colecalciferol | Circumstance amended to alter the stated Bone Mineral Density (BMD) |
Alendronic acid with colecalciferol and calcium | Circumstance amended to alter the stated Bone Mineral Density (BMD) |
Arsenic | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Bevacizumab | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Budesonide with Eformoterol | Circumstances amended to extend availability for the symptomatic treatment of chronic obstructive pulmonary disease |
Capecitabine | Circumstance amended for use in adjuvant treatment of Stage III |
Cetuximab | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Dalteparin | Extended availability for the management of symptomatic venous thromboembolism in a patient with a solid tumour(s) [injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe (max qty 30/rpts 5); injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe (max qty 30/rpts 5); and injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe (max qty 30/rpts 5)] |
Docetaxel | Authority requirements amended from authority required to streamlined authority required for all circumstances. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Doxorubicin – Pegylated Liposomal | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Fludarabine | Authority requirements amended from authority required to streamlined authority required for all circumstances. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Gemictabine | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Interferon Alfa -2a | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Interferon Alfa -2b | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Nafarelin (s.100) | Availability extended for use in the s100 IVF/GIFT Program. |
Oxaliplatin | Circumstance is amended for use in adjuvant treatment of Stage III Authority requirements amended from authority required to streamlined authority required for all circumstances. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Paclitaxel | Authority requirements amended from authority required to streamlined authority required for all circumstances. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Paclitaxel, nanoparticle albumin-bound | Authority requirements amended from authority required to streamlined authority required for all circumstances. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Pemetrexed | Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Ribavirin and Peginterferon Alfa-2b | Circumstances amended for patients naïve to interferon based therapies [pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent; pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection |
Rituximab | Availabilty extended to include treatment of a patient with chronic lymphocytic leukaemia in combination with fludarabine and cyclophosphamide Authority requirements amended from authority required to streamlined authority required for the circumstances where the patient is receiving treatment at/from a Public Hospital. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Vinorelbine | Authority requirements amended from authority required to streamlined authority required for all circumstances. This change is due to the commencement of the s.100 National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 on 1 December 2011. |
Zoledronic Acid | Circumstances amended relating to osteoporosis and authority requirements amended from authority required to streamlined authority required for these circumstances. |
Deletion of Responsible Person Code
CO [Chemists’ Own Pty Ltd] |