EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2018 (No. 7)
PB 50 of 2018
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, number 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). Subsection 85(6) provides that 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
This Instrument (PB 50 of 2018) amends PBS 71 of 2012 to make changes to the listing details for pharmaceutical benefits. These changes are detailed in the attached Summary of Changes.
The Instrument makes changes required to implement the International Harmonisation of Ingredient Names (IHIN). Under the IHIN, the names used for active ingredients and pharmaceutical formulations in Australia are being updated to conform with nomenclature used internationally. The changes in the Instrument are consistent with changes already made to the Australian Register of Therapeutic Goods. These changes are detailed in the attached Summary of Changes.
Brand equivalence indicators for pharmaceutical benefits are determined by the Minister under subsection 85(6A) of the Act. Subsection 85(6C) of the Act provides a transitional arrangement such that the 1 November 2015 Schedule of Pharmaceutical Benefits is the reference source for brand equivalence for brands for which there was a listing as a pharmaceutical benefit on that date. A brand specified in 1 November 2015 edition of the Schedule as being equivalent to one or more another brands is taken to have been determined under subsection 85(6A). The Instrument transfers brand equivalence information contained in that edition of the Schedule into PB 71 of 2012. The information transferred is unchanged, unless amended in the interim by another determination under subsection 85(6A).
The Instrument replaces in their entirety Schedule 1, Schedule 4 (Part 1) and Schedule 5 of PB 71 of 2012. The replacement of the Schedules is to better align the presentation of the listings in PB 71 of 2012 with the listings information in the PBS data. The details of the listings in the replaced Schedules are unchanged other than to the extent described in the Summary of Changes and as required to accommodate the incorporation of the brand equivalence indicators.
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. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. 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 July 2018.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2018 (No. 7)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 7) and may also be cited as PB 50 of 2018.
Section 2 Commencement
This section provides that this Instrument commences on 1 July 2018.
Section 3 Amendment of 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
These changes include additions and deletions or changes to the description of listed drugs, forms, brands, brand equivalence indicators, responsible persons, authorised prescribers, manner of administration, maximum quantities, maximum number of repeats, pack quantities and the circumstances in which a pharmaceutical benefit may be prescribed.
SUMMARY OF CHANGES
Listed Drugs Added
Ribociclib |
Forms Added
Adrenaline (epinephrine) | I.M. injection 150 micrograms in 0.15 mL single dose auto-injector (Emerade) |
Adrenaline (epinephrine) | I.M. injection 300 micrograms in 0.3 mL single dose auto-injector (Emerade) |
Zoledronic acid | Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial |
Forms Deleted
Clopidogrel | Tablet 75 mg |
Brands Added
Acamprosate | Tablet (enteric coated) containing acamprosate calcium 333 mg (Acamprosate Mylan) |
Buprenorphine | Transdermal patch 5 mg (Buprenorphine Sandoz) |
Ezetimibe | Tablet 10 mg (Pharmacor Ezetimibe 10) |
Metformin | Tablet containing metformin hydrochloride 1 g (Sandoz Metformin) |
Moxonidine | Tablet 200 micrograms (Moxonidine GX) |
Ondansetron | Tablet (orally disintegrating) 4 mg (Ondansetron Mylan ODT) |
Tenofovir | Tablet containing tenofovir disoproxil fumarate 300 mg (Tenofovir APOTEX) |
Brands Deleted
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Pantofast 40) |
Alteration of Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person |
Calcitonin salmon | Injection 100 I.U. in 1 mL | Miacalcic 100 | From: (NV) To: (EU) |
Deletion of Maximum Quantity
Listed Drug | Form | Maximum Quantity | Number of Repeats |
Balsalazide | Capsule containing balsalazide sodium 750 mg | 180 | 5 |
Alteration of Circumstances
Alemtuzumab |
Balsalazide |
Ceritinib |
Dimethyl fumarate |
Fingolimod |
Glatiramer |
Interferon Beta-1a |
Interferon Beta-1b |
Natalizumab |
Ocrelizumab |
Peginterferon Beta-1a |
Teriflunomide |
Trastuzumab |
International Harmonisation of Ingredient Names – listed drug changes
From | To |
Aclidinium with eformoterol | Aclidinium with formoterol |
Adrenaline | Adrenaline (epinephrine) |
Amoxycillin | Amoxicillin |
Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexanoic acid | Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid |
Amoxycillin with Clavulanic Acid | Amoxicillin with clavulanic acid |
Amphotericin | Amphotericin B |
Bacillus Calmette and Guerin, Tice strain | Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain |
Beclomethasone | Beclometasone |
Benzhexol | Trihexyphenidyl |
Benztropine | Benzatropine |
Budesonide with eformoterol | Budesonide with formoterol |
Cephalexin | Cefalexin |
Cephazolin | Cefazolin |
Chlorthalidone | Chlortalidone |
Cholestyramine | Colestyramine |
Cyclosporin | Ciclosporin |
Clomiphene | Clomifene |
Dexamphetamine | Dexamfetamine |
Eformoterol | Formoterol |
Esomeprazole and Clarithromycin and Amoxycillin | Esomeprazole and clarithromycin and amoxicillin |
Ethacrynic Acid | Etacrynic acid |
Flupenthixol Decanoate | Flupentixol decanoate |
Fluticasone with eformoterol | Fluticasone with formoterol |
Frusemide | Furosemide |
Hexamine | Methenamine |
Hydroxyurea | Hydroxycarbamide |
Indomethacin | Indometacin |
Levonorgestrel with Ethinyloestradiol | Levonorgestrel with ethinylestradiol |
Lignocaine | Lidocaine |
Norethisterone with Ethinyloestradiol | Norethisterone with ethinylestradiol |
Oestradiol | Estradiol |
Oestradiol and Oestradiol with Dydrogesterone | Estradiol and estradiol with dydrogesterone |
Oestradiol and Oestradiol with Norethisterone | Estradiol and estradiol with norethisterone |
Oestradiol with dydrogesterone | Estradiol with dydrogesterone |
Oestradiol with Norethisterone | Estradiol with norethisterone |
Oestriol | Estriol |
Pericyazine | Periciazine |
Phenobarbitone | Phenobarbital |
Procaine Penicillin | Procaine benzylpenicillin |
Salcatonin | Calcitonin salmon |
Sorbitol with sodium citrate and sodium lauryl sulfoacetate | Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate |
Tetracosactrin | Tetracosactide |
Thioguanine | Tioguanine |
Thyroxine | Levothyroxine |
International Harmonisation of Ingredient Names – form changes
Listed drug | From | To |
Aclidinium with formoterol | Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses | Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses |
Amlodipine | Tablet 5 mg (as besylate) | Tablet 5 mg (as besilate) |
Tablet 10 mg (as besylate) | Tablet 10 mg (as besilate) | |
Amlodipine with atorvastatin | Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) |
Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) | |
Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) | |
Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) | |
Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) | |
Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) | |
Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) | |
Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) | |
Amlodipine with valsartan | Tablet 5 mg (as besylate)-80 mg | Tablet 5 mg (as besilate)-80 mg |
Tablet 5 mg (as besylate)-160 mg | Tablet 5 mg (as besilate)-160 mg | |
Tablet 5 mg (as besylate)-320 mg | Tablet 5 mg (as besilate)-320 mg | |
Tablet 10 mg (as besylate)-160 mg | Tablet 10 mg (as besilate)-160 mg | |
Tablet 10 mg (as besylate)-320 mg | Tablet 10 mg (as besilate)-320 mg | |
Amlodipine with valsartan and hydrochlorothiazide | Tablet 5 mg (as besylate)-160 mg-12.5 mg | Tablet 5 mg (as besilate)-160 mg-12.5 mg |
Tablet 5 mg (as besylate)-160 mg-25 mg | Tablet 5 mg (as besilate)-160 mg-25 mg | |
Tablet 10 mg (as besylate)-160 mg-12.5 mg | Tablet 10 mg (as besilate)-160 mg-12.5 mg | |
Tablet 10 mg (as besylate)-160 mg-25 mg | Tablet 10 mg (as besilate)-160 mg-25 mg | |
Tablet 10 mg (as besylate)-320 mg-25 mg | Tablet 10 mg (as besilate)-320 mg-25 mg | |
Amoxicillin with clavulanic acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) |
Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | |
Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | |
Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL |
Beclometasone | Pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) |
Pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | |
Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation in breath actuated device containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) | |
Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) | |
Benzatropine | Tablet containing benztropine mesylate 2 mg | Tablet containing benzatropine mesilate 2 mg |
Injection containing benztropine mesylate 2 mg in 2 mL | Injection containing benzatropine mesilate 2 mg in 2 mL | |
Injection containing benztropine mesylate 2 mg in 2 mL vial | Injection containing benzatropine mesilate 2 mg in 2 mL vial | |
Bromocriptine | Tablet 2.5 mg (as mesylate) | Tablet 2.5 mg (as mesilate) |
Budesonide with formoterol | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses |
Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses | |
Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2 | Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2 | |
Pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses | Pressurised inhalation containing budesonide 50 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses | |
Pressurised inhalation containing budesonide 100 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses | Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses | |
Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses | |
Calcitonin salmon | Injection 100 I.U. in 1 mL ampoule | Injection 100 I.U. in 1 mL |
Cefalexin | Capsule 250 mg (anhydrous) | Capsule 250 mg (as monohydrate) |
| Capsule 500 mg (anhydrous) | Capsule 500 mg (as monohydrate) |
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL |
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL |
Clomifene | Tablet containing clomiphene citrate 50 mg | Tablet containing clomifene citrate 50 mg |
Colestyramine | Sachets containing 4.7 g oral powder (equivalent to 4 g cholestyramine), 50 | Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50 |
Desferrioxamine | Powder for injection containing desferrioxamine mesylate 500 mg | Powder for injection containing desferrioxamine mesilate 500 mg |
Powder for injection containing desferrioxamine mesylate 2 g | Powder for injection containing desferrioxamine mesilate 2 g | |
Dexamfetamine | Tablet containing dexamphetamine sulfate 5 mg | Tablet containing dexamfetamine sulfate 5 mg |
Eprosartan | Tablet 400 mg (as mesylate) | Tablet 400 mg (as mesilate) |
Tablet 600 mg (as mesylate) | Tablet 600 mg (as mesilate) | |
Eprosartan with hydrochlorothiazide | Tablet 600 mg eprosartan (as mesylate) with 12.5 mg hydrochlorothiazide | Tablet 600 mg eprosartan (as mesilate) with 12.5 mg hydrochlorothiazide |
Esomeprazole and clarithromycin and amoxicillin | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) |
Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) | |
Estradiol | Tablet containing oestradiol valerate 1 mg | Tablet containing estradiol valerate 1 mg |
Tablet containing oestradiol valerate 2 mg | Tablet containing estradiol valerate 2 mg | |
Estradiol and estradiol with dydrogesterone | Pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg | Pack containing 14 tablets estradiol 1 mg and 14 tablets estradiol 1 mg with dydrogesterone 10 mg |
Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg | Pack containing 14 tablets estradiol 2 mg and 14 tablets estradiol 2 mg with dydrogesterone 10 mg | |
Estradiol and estradiol with norethisterone | Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate | Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate |
Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate | Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate | |
Estradiol with norethisterone | Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 | Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 |
Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 | Transdermal patches containing 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 | |
Flupentixol decanoate | Oily I.M. injection 100 mg in 1 mL ampoule | Oily I.M. injection 100 mg in 1 mL |
Fluticasone with formoterol | Pressurised inhalation containing fluticasone propionate 50 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses | Pressurised inhalation containing fluticasone propionate 50 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses |
Pressurised inhalation containing fluticasone propionate 125 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses | Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses | |
Pressurised inhalation containing fluticasone propionate 250 micrograms with eformoterol fumarate dihydrate 10 micrograms per dose, 120 doses | Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses | |
Formoterol | Capsule containing powder for oral inhalation containing eformoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer) | Capsule containing powder for oral inhalation containing formoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer) |
Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 6 micrograms per dose, 60 doses | Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 6 micrograms per dose, 60 doses | |
Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses | Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 12 micrograms per dose, 60 doses | |
Lapatinib | Tablet 250 mg (as ditosylate monohydrate) | Tablet 250 mg (as ditosilate monohydrate) |
Levothyroxine | Tablet containing 50 micrograms anhydrous thyroxine sodium | Tablet containing 50 micrograms anhydrous levothyroxine sodium |
Tablet containing 75 micrograms anhydrous thyroxine sodium | Tablet containing 75 micrograms anhydrous levothyroxine sodium | |
Tablet containing 100 micrograms anhydrous thyroxine sodium | Tablet containing 100 micrograms anhydrous levothyroxine sodium | |
Tablet containing 200 micrograms anhydrous thyroxine sodium | Tablet containing 200 micrograms anhydrous levothyroxine sodium | |
Lidocaine | Injection containing lignocaine hydrochloride 50 mg in 5 mL | Injection containing lidocaine hydrochloride monohydrate 50 mg in 5 mL |
Infusion containing lignocaine hydrochloride 500 mg in 5 mL | Infusion containing lidocaine hydrochloride 500 mg in 5 mL | |
Methenamine | Tablet containing hexamine hippurate 1 g | Tablet containing methenamine hippurate 1 g |
Olmesartan with amlodipine | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate) | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) |
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) | Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) | |
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate) | Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) | |
Pamidronic acid | Concentrated injection containing disodium pamidronate 15 mg in 5 mL | Concentrated injection containing pamidronate disodium 15 mg in 5 mL |
Concentrated injection containing disodium pamidronate 30 mg in 10 mL | Concentrated injection containing pamidronate disodium 30 mg in 10 mL | |
Concentrated injection containing disodium pamidronate 60 mg in 10 mL | Concentrated injection containing pamidronate disodium 60 mg in 10 mL | |
Concentrated injection containing disodium pamidronate 90 mg in 10 mL | Concentrated injection containing pamidronate disodium 90 mg in 10 mL | |
Paraffin | Eye ointment, compound, containing liquid paraffin, light liquid paraffin, wool fat, white soft paraffin and retinyl palmitate, 5 g | Eye ointment, compound, containing liquid paraffin, light liquid paraffin, wool fat, white soft paraffin and retinol palmitate, 5 g |
Perindopril with amlodipine | Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) | Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besilate) |
Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) | Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besilate) | |
Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) | Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besilate) | |
Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) | Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besilate) | |
Prochlorperazine | Injection containing prochlorperazine mesylate 12.5 mg in 1 mL | Injection containing prochlorperazine mesilate 12.5 mg in 1 mL |
Saquinavir | Tablet 500 mg (as mesylate) | Tablet 500 mg (as mesilate) |
Sorafenib | Tablet 200 mg (as tosylate) | Tablet 200 mg (as tosilate) |
Telmisartan with amlodipine | Tablet 40 mg 5 mg (as besylate) | Tablet 40 mg 5 mg (as besilate) |
Tablet 40 mg 10 mg (as besylate) | Tablet 40 mg 10 mg (as besilate) | |
Tablet 80 mg 5 mg (as besylate) | Tablet 80 mg 5 mg (as besilate) | |
Tablet 80 mg 10 mg (as besylate) | Tablet 80 mg 10 mg (as besilate) | |
Trihexyphenidyl | Tablet containing benzhexol hydrochloride 2 mg | Tablet containing trihexyphenidyl hydrochloride 2 mg |
Tablet containing benzhexol hydrochloride 5 mg | Tablet containing trihexyphenidyl hydrochloride 5 mg |
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 2018 (No. 7)
(PB 50 of 2018)
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 2018 (No. 7) 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, number 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 Instrument makes changes required to implement the International Harmonisation of Ingredient Names (IHIN). Under the IHIN, the names used for active ingredients and pharmaceutical formulations in Australia are being updated to conform with nomenclature used internationally. The changes in the Instrument are consistent with changes already made to the Australian Register of Therapeutic Goods. These changes are detailed in the attached Summary of Changes.
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 pharmaceutical industry now has a nominee on the PBAC membership.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Lisa La Rance
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health