EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2017 (No. 4)
PB 34 of 2017
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 (equivalent brands, 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 4(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). Subsection 85(6) provides that the the Minister may determine a brand of a pharmaceutical item.
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.
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.
Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.
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.
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
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), equivalent brands, 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 to Australians 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.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.
General
A provision by provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 June 2017.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2017 (No. 4)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 4) and may also be cited as PB 34 of 2017.
Section 2 Commencement
This section provides that this Instrument commences on 1 June 2017.
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, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drugs Added
Fluticasone furoate with vilanterol |
Sacubitril with valsartan |
Listed Drugs Deleted
Colestipol |
Fluphenazine Decanoate |
Fluticasone with vilanterol |
Ribavirin and Peginterferon Alfa‑2b |
Rosiglitazone |
Form Added
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 |
Brands Added
Baclofen | Intrathecal injection 10 mg in 5 mL (Sintetica Baclofen Intrathetecal) [note: brand has pack size of 10] |
Capecitabine | Tablet 150 mg (Xelocitabine) |
Carboplatin | Solution for I.V. injection 450 mg in 45 mL (Carboplatin Accord) |
Docetaxel | Solution concentrate for I.V. infusion 80 mg in 4 mL (Docetaxel Accord) |
Epirubicin | Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL (Epirube) |
Famciclovir | Tablet 250 mg (Famciclovir FBM) |
Fluticasone | Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC‑free formulation) (Fluticasone Cipla Inhaler) |
Fluticasone with Salmeterol | Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC‑free formulation) (Fluticasone + Salmeterol 125/25; SalplusF Inhaler 125/25) |
Oxaliplatin | Solution concentrate for I.V. infusion 100 mg in 20 mL (Oxaliplatin Accord) |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxin) |
Quetiapine | Tablet (modified release) 50 mg (as fumarate) (Tevatiapine XR) |
Temozolomide | Capsule 180 mg (Temozolomide Amneal) |
Zonisamide | Capsule 25 mg (APO-Zonisamide) |
Brands Deleted
Aciclovir | Tablet 800 mg (Acyclo-V 800) |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol (Alendrobell plus D3) |
Alprazolam | Tablet 1 mg (GenRx Alprazolam) |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg (Candesartan HCTZ RBX 32/25) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Duloxetine Sandoz) |
Famotidine | Tablet 20 mg (Pamacid 20) |
Nevirapine | Tablet 400 mg (extended release) (Nevirapine XR APOTEX) |
Selegiline | Tablet containing selegiline hydrochloride 5 mg (Selgene) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
|
Levetiracetam | Tablet 1 g | From: Kevtam | To: Kevtam 1000 |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person |
Bisacodyl | Suppositories 10 mg, 10 | Dulcolax | From: Boehringer Ingelheim Pty Ltd (BY) To: Sanofi‑aventis Healthcare Pty Ltd (VZ) |
Hyoscine | Injection containing hyoscine butylbromide 20 mg in 1 mL | Buscopan | From: Boehringer Ingelheim Pty Ltd (BY) To: Sanofi‑aventis Healthcare Pty Ltd (VZ) |
Rizatriptan | Wafer 10 mg (as benzoate) | Maxalt | From: Merck Sharp & Dohme (Australia) Pty Ltd (MK) To: Alphapharm Pty Ltd (AL) |
The Responsible Person for the following brands has changed from Alcon Laboratories (Australia) Pty Ltd (codes AQ or IQ) to Novartis Pharmaceuticals Australia Pty Limited (codes NM or NV)
Listed Drug | Form | Brand Name |
Apraclonidine | Eye drops 5 mg (as hydrochloride) per mL, 10 mL | Iopidine 0.5% |
Betaxolol | Eye drops, suspension, 2.5 mg (as hydrochloride) per mL, 5 mL | Betoptic S |
Brinzolamide | Eye drops 10 mg per mL, 5 mL | Azopt |
Brinzolamide with brimonidine | Eye drops 10 mg brinzolamide with 2 mg brimonidine tartrate per mL, 5 mL | Simbrinza 1%/0.2% |
Brinzolamide with timolol | Eye drops 10 mg brinzolamide with timolol 5 mg (as maleate) per mL, 5 mL | Azarga |
Carbomer 974 | Ocular lubricating gel 3 mg per g, single dose units 0.5 g, 30 | Poly Gel |
Ciprofloxacin | Ear drops 3 mg (as hydrochloride) per mL, 5 mL | Ciloxan |
Dexamethasone | Eye drops 1 mg per mL, 5 mL | Maxidex |
Fluorometholone | Eye drops 1 mg per mL, 5 mL | Flucon |
Hypromellose | Eye drops 3 mg per mL, 15 mL | Genteal |
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg‑2 mg per g, 10 g | Genteal gel |
Hypromellose with dextran | Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28 | Bion Tears |
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Poly Visc |
Pilocarpine | Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL | Isopto Carpine |
Polyethylene Glycol 400 with Propylene Glycol | Eye drops 4 mg‑3 mg per mL, 15 mL | Systane |
Tobramycin | Eye drops 3 mg per mL, 5 mL | Tobrex |
Travoprost | Eye drops 40 micrograms per mL, 2.5 mL | Travatan |
Travoprost with timolol | Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Duotrav |
Alteration of Authorised Prescriber
The Authorised Prescriber for the following listed drugs used in the treatment of chronic hepatitis C infection is amended to enable prescribing of these drugs by nurse practitioners for this purpose
Daclatasvir |
Grazoprevir with elbasvir |
Ledipasvir with sofosbuvir |
Paritaprevir with ritonavir with ombitasvir and dasabuvir |
Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin |
Peginterferon Alfa‑2a |
Ribavirin |
Sofosbuvir |
Alteration of Maximum Quantity
Listed Drug | Form | Maximum Quantity |
Dimethyl fumarate | Capsule (modified release) 120 mg | From: 14 To: 28 |
Alteration of Number of Repeats
Listed Drug | Form | Maximum Quantity |
Vismodegib | Capsule 150 mg | From: 2 To: 3 |
Addition of Responsible Person Code
Cipla Australia Pty Ltd (YC) | Sun Pharma ANZ Pty Ltd (RA) |
Sanofi-aventis Healthcare Pty Ltd (VZ) | Sun Pharma ANZ Pty Ltd (RN) |
Deletion of Responsible Person Code
Ranbaxy Australia Pty Ltd (RA) | Ranbaxy Australia Pty Ltd (RN) |
Alteration of Circumstances
Adalimumab | Infliximab |
Baclofen | Netupitant with Palonosetron |
Brentuximab vedotin | Risperidone |
Dasatinib | Salbutamol |
Dimethyl fumarate | Teriflunomide |
Everolimus | Testosterone |
Imatinib | Vemurafenib |
Schedule 4, Part 3—General statement for drugs for the treatment of hepatitis C has been amended
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 2017 (No. 4)
(PB 34 of 2017)
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.
Overview of the Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 4) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) 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, schedule equivalence, 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, schedule equivalence, 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.
The listed drugs colestipol; fluphenazine decanoate; fluticasone with vilanterol; ribavirin and peginterferon alfa‑2b and rosiglitazone have been deleted at the request of the relevant responsible persons.
Human rights implications
This Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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.
The PBAC has recommended the delisting of five drugs from the PBS. The PBAC advice is included with the explanatory statement to this Instrument.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Penny Shakespeare
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health