EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2015 (No. 9)
PB 90 of 2015
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 (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 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)). 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.
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).
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.
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.
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), 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 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.
Since the announcement of the PBS Medication Charts for Public and Private Hospitals measure in 2014, the Department of Health has undertaken an extensive consultation process involving all key health stakeholders. These consultations indicate widespread and strong support for the trial of the PBS Hospital Medication Chart and amendments required to the Regulations and associated legislative instruments to support the measure. Consulted stakeholders include States and Territories, Australian Private Hospital Association, Society of Hospital Pharmacists of Australia, Pharmaceutical Society of Australia, Pharmacy Guild of Australia, Australian Medical Association, Cancer Voices Australia, Consumers Health Forum of Australia, National Prescribing Service, the ACSQHC, and the National E-Health Transition Authority. Similarly, the Department of Human Services has received strong support from a range of stakeholders for the implementation of paperless (electronic) claiming of PBS/RPBS medicines. This includes support for transitional arrangements to ensure stakeholder readiness for the implementation of paperless PBS/RPBS claiming.
General
A provision by provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 October 2015.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2015 (No. 9)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 9) and may also be cited as PB 90 of 2015.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 2015.
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 Drug Added
Dapagliflozin with metformin |
Tofacitinib |
Forms Added
Tiotropium | Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 doses) |
Forms Deleted
Fluvastatin | Capsule 20 mg (as sodium) |
Brands Added
Aciclovir | Eye ointment 30 mg per g, 4.5 g (AciVision) |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol (Alendronate Plus D3 Sandoz) |
Clindamycin | Capsule 150 mg (as hydrochloride) (Clindamycin BNM) |
Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulfate)-100 mg (Clopidogrel/Aspirin Sandoz 75/100) |
Doxycycline | Tablet 100 mg (as hydrochloride) (Doxycycline AN) |
Oxycodone | Tablet containing oxycodone hydrochloride 5 mg (Mayne Pharma |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) |
Riluzole | Tablet 50 mg (Riluzole Winthrop) |
Brands Deleted
Azathioprine | Tablet 25 mg (Azran) |
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) (Prexaton) |
Ceftriaxone | Powder for injection 1 g (as sodium) (Ceftriaxone ICP) |
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) (Esomeprazole GH) |
Alteration of Description of Form and Brand Name
Listed Drug | Form | Brand Name |
Milk powder—lactose free formula | From: Oral powder 900 g (Karicare Aptamil Gold De-Lact) To: Oral powder 900 g (Aptamil Gold+ De-Lact) | From: Karicare Aptamil Gold De-Lact To: Aptamil Gold+ De-Lact |
Protein hydrolysate formula with medium chain triglycerides | From: Oral powder 450 g (Karicare Aptamil Pepti-Junior Gold) To: Oral powder 450 g (Aptamil Gold+ Pepti-Junior) | From: Karicare Aptamil Pepti-Junior Gold To: Aptamil Gold+ Pepti-Junior |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Morphine | Tablet containing morphine sulfate 100 mg (controlled release) | From: APOTEX-MORPHINE MR |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person |
Amoxycillin | Capsule 250 mg (as trihydrate) | Amoxycillin-GA
| From: Actavis Pty Ltd (GN) To: Fawns and McAllan Proprietary Limited (FM) |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg 1moxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | GA-Amclav 500/125 | From: Actavis Pty Ltd (GN) To: Fawns and McAllan Proprietary Limited (FM) |
Fentanyl | Lozenge 200 micrograms (as citrate) | Actiq | From: Orphan Australia Pty Ltd (OA) To: Teva Pharma Australia Pty Limited (TB) |
Filgrastim | Injection 300 micrograms in | TevaGrastim | From: Aspen Pharmacare Australia Pty Limited (AS) To: Teva Pharma Australia Pty Limited (TB) |
Modafinil | Tablet 100 mg | Modavigil | From: bioCSL (Australia) Pty Ltd (CS) To: Teva Pharma Australia Pty Limited (TB) |
Paroxetine | Tablet 20 mg (as hydrochloride) | Paroxetine-GA | From: Actavis Pty Ltd (GN) To: Fawns and McAllan Proprietary Limited (FM) |
Ranitidine | Tablet 150 mg (as hydrochloride) | Ranoxyl | From: Actavis Pty Ltd (GN) To: Fawns and McAllan Proprietary Limited (FM) |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (GN) to Amneal Pharmaceuticals Pty Ltd (EA)
Listed Drug | Form | Brand Name |
Amiodarone | Tablet containing amiodarone hydrochloride 200 mg | Amiodarone Actavis |
Ampicillin | Powder for injection 500 mg (as sodium) | Ibimicyn |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. | Bleo 15K |
Carboplatin | Solution for I.V. injection 50 mg in 5 mL | Carbaccord |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Cefaclor-GA |
Clopidogrel | Tablet 75 mg (as besilate) | Clopidogrel-GA |
Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulfate)-100 mg | Clopidogrel/ Aspirin Actavis 75/100 |
Cromoglycic acid | Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic) | Intal Spincaps |
Desvenlafaxine | Tablet (modified release) 50 mg | Desvenlafaxine Actavis |
Docetaxel | Solution concentrate for I.V. infusion 80 mg in 4 mL | Oncotaxel 80 |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial | Accord Doxorubicin |
Electrolyte Replacement, Oral | Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 | restore O.R.S. |
Fentanyl | Transdermal patch 2.063 mg | Dutran 12 |
Flucloxacillin | Powder for injection 500 mg (as sodium) | Flubiclox |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg | Fluvoxamine GA |
Frusemide | Tablet 20 mg | Frusid |
Gabapentin | Capsule 300 mg | Gantin |
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) | Gemaccord |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Irinoccord |
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL | Latanoprost Actavis |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Lercadip |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | LaxaCon |
Meloxicam | Capsule 7.5 mg | Melox 7.5 |
Methotrexate | Injection 50 mg in 2 mL vial | Methaccord |
Nevirapine | Tablet 200 mg | Nevipin |
Omeprazole | Capsule 20 mg | Omepro-GA |
Oxaliplatin | Solution concentrate for I.V. infusion 100 mg in 20 mL | Oxaliccord |
Paracetamol | Tablet 500 mg | Febridol |
Quinapril | Tablet 5 mg (as hydrochloride) | Aquinafil |
Ramipril | Capsule 2.5 mg | Ramipril-GA |
Tamoxifen | Tablet 20 mg (as citrate) | Tamoxen 20 mg |
Temozolomide | Capsule 180 mg | Astromide |
Tramadol | Injection containing tramadol hydrochloride 100 mg in 2 mL | Tramadol ACT |
Vancomycin | Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Vycin IV |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (GN) to Amneal Pharmaceuticals Pty Ltd (ED)
Listed Drug | Form | Brand Name |
Alendronic acid | Tablet 70 mg (as alendronate sodium) | Alendronate-GA |
Amlodipine | Tablet 5 mg (as besylate) | Norvapine |
Atenolol | Tablet 50 mg | Atenolol-GA |
Atorvastatin | Tablet 10 mg (as calcium) | Atorvachol |
Azathioprine | Tablet 50 mg | Azamun |
Bicalutamide | Tablet 50 mg | Bicalutamide-GA |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | Biso 2.5 |
Candesartan | Tablet containing candesartan cilexetil 4 mg | Candesartan-GA |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg | Candesartan HCTZ-GA 16/12.5 |
Capecitabine | Tablet 150 mg | Capecitabine Actavis |
Carvedilol | Tablet 3.125 mg | GN-Carvedilol |
Celecoxib | Capsule 100 mg | Celecoxib Actavis |
Cephalexin | Capsule 250 mg (anhydrous) | Cilex |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | Ciprofloxacin-GA |
Citalopram | Tablet 10 mg (as hydrobromide) | Citalopram-GA |
Clarithromycin | Tablet 250 mg | Clarac |
Cyproterone | Tablet containing cyproterone acetate 50 mg | Procur |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium | Diclofenac-GA |
Donepezil | Tablet containing donepezil hydrochloride 5 mg | Donepezil-GA |
Doxycycline | Tablet 50 mg (as hydrochloride) | Doxy-50 |
Duloxetine | Capsule 30 mg (as hydrochloride) | Drulox |
Escitalopram | Tablet 10 mg (as oxalate) | Escitalopram GA |
Exemestane | Tablet 25 mg | Exemestane-GA |
Famciclovir | Tablet 125 mg | Famciclovir-GA |
Famotidine | Tablet 20 mg | Pepzan |
Fluoxetine | Capsule 20 mg (as hydrochloride) | Fluoxetine-GA |
Gabapentin | Tablet 800 mg | Gantin |
Glimepiride | Tablet 1 mg | Glimepiride GA 1 |
Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200 mg | Hydroxychloroquine Actavis |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg | Indapamide-GA |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL | Tecan |
Isosorbide mononitrate | Tablet 60 mg (sustained release) | Imtrate 60 mg |
Lamotrigine | Tablet 25 mg | Lamotrigine-GA |
Leflunomide | Tablet 10 mg | Leflunomide-GA |
Levetiracetam | Tablet 250 mg | Kepcet |
Lisinopril | Tablet 5 mg | Lisinopril-GA |
Meloxicam | Tablet 7.5 mg | Meloxicam-GA |
Metformin | Tablet containing metformin hydrochloride 500 mg | Metformin-GA |
Metoclopramide | Tablet containing metoclopramide hydrochloride 10 mg | Metoclopramide Actavis |
Metoprolol | Tablet containing metoprolol tartrate 50 mg | Metoprolol Actavis |
Mirtazapine | Tablet 30 mg | Mirtazapine-GA |
Moclobemide | Tablet 150 mg | Clobemix |
Montelukast | Tablet, chewable, 4 mg (as sodium) | Montair 4 |
Olanzapine | Tablet 2.5 mg | Olanzapine-GA |
Omeprazole | Tablet 20 mg | Omeprazole-GA |
Ondansetron | Tablet (orally disintegrating) 4 mg | Onsetron ODT 4 |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Plaxel |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Pantoprazole Actavis |
Perindopril with indapamide | Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg | Perindopril Combi Actavis 4/1.25 |
Pioglitazone | Tablet 15 mg (as hydrochloride) | Pioglitazone-GA |
Pravastatin | Tablet containing pravastatin sodium 10 mg | Pravastatin-GA 10 |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Prochlorperazine-GA |
Ramipril | Capsule 10 mg | Ramipril-GA |
Rosuvastatin | Tablet 5 mg (as calcium) | Rosuvastatin Actavis 5 |
Roxithromycin | Tablet 150 mg | Roxithromycin-GA |
Simvastatin | Tablet 10 mg | Simvastatin-GA 10 |
Sumatriptan | Tablet 50 mg (as succinate) | Sumatriptan-GA |
Telmisartan | Tablet 40 mg | Telmigen |
Telmisartan with Hydrochlorothiazide | Tablet 40 mg-12.5 mg | Telmigen HCT 40/12.5 |
Temozolomide | Capsule 5 mg | Astromide |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 100 mg | GA Tramadol SR 100mg |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (GN) to Amneal Pharmaceuticals Pty Ltd (EF)
Listed Drug | Form | Brand Name |
Citalopram | Tablet 20 mg (as hydrobromide) | Citalopram-GA |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Dilzem 60 mg |
Irbesartan | Tablet 75 mg | Irbesartan-GA |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg | Irbesartan HCTZ-GA 150/12.5 |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) | Pantoprazole-GA |
Risperidone | Tablet 0.5 mg | Risperidone-GA |
Sertraline | Tablet 50 mg (as hydrochloride) | Xydep 50 |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (UA) to Amneal Pharmaceuticals Pty Ltd (EA)
Listed Drug | Form | Brand Name |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol | Alendronate D3 70 mg/70 microgram |
Alendronic acid with colecalciferol and calcium | Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) | Alendronate Plus D3 Calcium Actavis |
Azithromycin | Tablet 500 mg (as dihydrate) | Azithromycin-GA |
Citalopram | Tablet 10 mg (as hydrobromide) | Citalopram Actavis |
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg | Fosinopril/HCT Actavis 20/12.5 |
Frusemide | Tablet 40 mg | Frusid |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL | Irinotecan Actavis 500 |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Paclitaxel Actavis |
Perindopril | Tablet containing perindopril erbumine 2 mg | Perindopril Actavis 2 |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Salbutamol Actavis |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (UA) to Amneal Pharmaceuticals Pty Ltd (ED)
Listed Drug | Form | Brand Name |
Calcitriol | Capsule 0.25 microgram | Calcitriol-GA |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Diltiazem Actavis |
Enalapril | Tablet containing enalapril maleate 5 mg | Enalapril Actavis |
Irbesartan | Tablet 75 mg | Irbesartan Actavis 75 |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg | Irbesartan HCT Actavis 150/12.5 |
Letrozole | Tablet 2.5 mg | Lezole |
Paroxetine | Tablet 20 mg (as hydrochloride) | Paroxetine Actavis |
Perindopril | Tablet containing perindopril erbumine 4 mg | Perindopril Actavis 4 |
Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) | Rabeprazole Actavis 20 |
Risperidone | Tablet 0.5 mg | Risperidone Actavis 0.5 |
Sertraline | Tablet 50 mg (as hydrochloride) | Sertraline Actavis |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Tramadol Actavis |
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) | Venlafaxine Actavis XR |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (UA) to Amneal Pharmaceuticals Pty Ltd (EF)
Listed Drug | Form | Brand Name |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Pantoprazole-GA |
Quetiapine | Tablet 25 mg (as fumarate) | Quetiaccord |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (VN) to Amneal Pharmaceuticals Pty Ltd (EA)
Listed Drug | Form | Brand Name |
Epirubicin | Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL | Epirubicin ACT |
The Responsible Person for the following brands has changed from Actavis Pty Ltd (VN) to Amneal Pharmaceuticals Pty Ltd (ED)
Listed Drug | Form | Brand Name |
Citalopram | Tablet 20 mg (as hydrobromide) | Citalopram Actavis |
Quetiapine | Tablet 25 mg (as fumarate) | Quetiapine Actavis 25 |
Terbinafine | Tablet 250 mg (as hydrochloride) | Terbinafine Actavis |
Valaciclovir | Tablet 500 mg (as hydrochloride) | Valaciclovir Actavis |
Addition of Responsible Person Code
Medsurge Healthcare Pty Ltd (DZ) |
Amneal Pharmaceuticals Pty Ltd (ED) |
Amneal Pharmaceuticals Pty Ltd (EF) |
Extemporaneously-prepared pharmaceutical benefits
A systems error necessitated the removal of restrictions from listed drugs (Schedule 2,
Part 1) that may be used as ingredients in extemporaneously-prepared pharmaceutical benefits. Amendments to PB 71 of 2012 to accurately reflect the data were made by PB 68 of 2015 (effective 1 August 2015). The error has now been rectified and the restrictions are reinstated by items 226-243 of PB 90 of 2015.
Alteration of Circumstances
Listed Drug | Alteration |
Abatacept | Circumstances amended relating to rheumatoid arthritis following the listing of tofacitinib |
Adalimumab | Circumstances amended relating to rheumatoid arthritis following the listing of tofacitinib |
Aflibercept | Circumstances amended relating to macular oedema |
Anakinra | Circumstances amended relating to cryopyrin associated periodic syndromes (CAPS) |
Anastrozole | Circumstances amended relating to the treatment of breast cancer |
Bupropion | Authority requirements are now streamlined |
Calcipotriol with betamethasone | Authority requirements are now streamlined in respect of the gel |
Certolizumab pegol | Circumstances amended relating to rheumatoid arthritis following the listing of tofacitinib |
Clobetasol | Authority requirements are now streamlined |
Cyproterone | Prescribing restricted to the treatment of moderate to severe androgenisation |
Etanercept | Circumstances amended relating to rheumatoid arthritis following the listing of tofacitinib |
Exemestane | Circumstances amended relating to the treatment of breast cancer |
Exenatide | Circumstances amended relating to the treatment of diabetes mellitus type 2 |
Golimumab | Circumstances amended relating to rheumatoid arthritis following the listing of tofacitinib |
Goserelin | Circumstances amended relating to the treatment of breast cancer |
Lanthanum | Circumstances amended relating to the treatment of hyperphosphataemia |
Letrozole | Circumstances amended relating to the treatment of breast cancer |
Levodopa with Carbidopa | Authority requirements are now streamlined in respect of the gel |
Magnesium | Authority requirements are now streamlined |
Panitumumab | Circumstances amended relating to the treatment of metastatic colorectal cancer |
Pimecrolimus | Authority requirements for the treatment of atopic dermatitis are now streamlined |
Sevelamer | Circumstances amended relating to the treatment of hyperphosphataemia |
Sucroferric oxyhydroxide | Circumstances amended relating to the treatment of hyperphosphataemia |
Zolmitriptan | Authority requirements are now restricted |
Alteration of Circumstances Code
The circumstance codes for the following drugs in Schedule 1 and the corresponding circumstance codes in Schedule 4 to the principal instrument have changed. Any other changes to these listings are detailed under the relevant headings in this summary.
Clindamycin |
Clopidogrel |
Clopidogrel with aspirin |
Gentamicin |
Pantoprazole |
Testosterone |
Tobramycin |
Topiramate |
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 2015 (No. 9)
(PB 90 of 2015)
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 2015 (No. 9) 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, 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, 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.
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.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Kylie Jonasson
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health