EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 11)
PB 118 of 2021
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
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.
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.
Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including medical practitioners (subsection 88(1)), participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).
Paragraph 88(1EB) provides that the Minister can list pharmaceutical benefits without determining any authorised prescribers for the benefit allowing the benefit to be supplied only.
This legislative instrument is made pursuant to section 88 and subsection 100(2) of the National Health Act 1953 (the Act).
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 Pharmaceutical Benefits Advisory Committee (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 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 the addition of the listed drugs lanadelumab, and ripretinib, and the addition of a form of the listed drugs high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate, and ribavirin to the Schedule of Pharmaceutical Benefits. It also provides for the deletion of a form of the listed drugs benralizumab, desmopressin, imipramine, and testosterone. Additionally, it provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs etanercept, golimumab, and tocilizumab.
Schedule 1 to this Instrument also provides for the following changes:
- the addition of 23 brands of existing pharmaceutical items;
- the deletion of 298 brands of existing pharmaceutical items;
- the addition of 2 Maximum Quantity and Number of Repeats for an existing pharmaceutical item;
- the deletion of 1 Maximum Quantity and Number of Repeats for an existing pharmaceutical item;
- the addition of 1 responsible persons to the list of responsible persons;
- the deletion of 2 responsible persons from the list of responsible persons;
- the alteration of responsible person codes for 11 existing brands of pharmaceutical items;
- the addition of 3 brands of existing pharmaceutical items to supply only;
- the deletion of 2 brands of existing pharmaceutical items from supply only; and
- the deletion of the listed drug dalteparin from supply only, considered by the PBAC in
March 2021 and deleted in June 2021.
These changes are summarised, by subject matter, in the Attachment.
Consultation
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The 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. The 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the 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 December 2021.
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 2021 (No. 11)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 11) and may also be cited as PB 118 of 2021.
Section 2 Commencement
Subsection 2(1) provides for commencement dates of each of the provisions specified in Column 1 of the table, in accordance with Column 2 of the table. In accordance with Column 2 of the table, Schedule 1 to the Instrument commences on 1 December 2021.
Section 3 Authority
This section specifies that sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 provide the authority for the making of this Instrument.
Section 4 Schedules
Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.
Schedule 1 Amendments
The amendments in Schedule 1 involve the addition of listed drugs, the addition and deletion of forms of listed drugs, the addition and deletion of brands, the addition and deletion of a maximum quantity and number of repeats, the alteration of responsible person codes for brands of pharmaceutical benefits, the addition and deletion of responsible persons from the list of responsible persons, the addition of three brands of pharmaceutical items to supply only status, the deletion of one drug and one brand from supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme. These changes are summarised below.
SUMMARY OF CHANGES TO THE PHARMACEUTICAL BENEFITS SCHEME
MADE BY SCHEDULE 1 OF THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Lanadelumab |
Ripretinib |
Forms Added
Listed Drug | Form |
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral liquid 250 mL, 30 (KetoVie Peptide 4:1) |
Ribavirin | Tablet 200 mg |
Forms Deleted
Listed Drug | Form |
Benralizumab | Injection 30 mg in 1 mL single dose pre-filled syringe |
Desmopressin | Intranasal solution containing desmopressin acetate 100 micrograms per mL, |
Imipramine | Tablet containing imipramine hydrochloride 25 mg USP |
Testosterone | Capsule containing testosterone undecanoate 40 mg |
Brands Added
Listed Drug | Form and Brand |
Ciclosporin | Capsule 25 mg (APO-Ciclosporin) |
Capsule 50 mg (APO-Ciclosporin) | |
Capsule 100 mg (APO-Ciclosporin) | |
Dasatinib | Tablet 20 mg (DASATINIB-TEVA; TE-DASATINIB) |
Tablet 50 mg (DASATINIB-TEVA; TE-DASATINIB) | |
Tablet 70 mg (DASATINIB-TEVA; TE-DASATINIB) | |
Tablet 100 mg (DASATINIB-TEVA; TE-DASATINIB) | |
Deferasirox | Tablet 90 mg (DEFERASIROX-TEVA) |
Tablet 180 mg (DEFERASIROX-TEVA) | |
Tablet 360 mg (DEFERASIROX-TEVA) | |
Follitropin alfa | Injection 300 I.U. in 0.5 mL multi-dose cartridge (Ovaleap) |
Injection 450 I.U. in 0.75 mL multi-dose cartridge (Ovaleap) | |
Injection 900 I.U. in 1.5 mL multi-dose cartridge (Ovaleap) | |
Fulvestrant | Injection 250 mg in 5 mL pre-filled syringe (FULVESTRANT ACCORD) |
Hydromorphone | Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL (Hikma) |
Methylphenidate | Tablet containing methylphenidate hydrochloride 18 mg (extended release) |
Tablet containing methylphenidate hydrochloride 27 mg (extended release) | |
Tablet containing methylphenidate hydrochloride 36 mg (extended release) | |
Tablet containing methylphenidate hydrochloride 54 mg (extended release) | |
Tablet containing methylphenidate hydrochloride 18 mg (extended release) |
Brands Deleted
Listed Drug | Form and Brand |
Aciclovir | Tablet 200 mg (Aciclovir AN; Lovir) |
Acitretin | Capsule 10 mg (Novatin) |
Capsule 25 mg (Novatin) | |
Alendronic acid | Tablet 70 mg (as alendronate sodium (Densate 70) |
Amisulpride | Tablet 100 mg (Amisulpride AN) |
Tablet 200 mg (Amisulpride AN) | |
Tablet 400 mg (Amisulpride AN) | |
Amlodipine | Tablet 5 mg (as besilate) (Amlodipine AN; Auro-Amlodipine 5) |
Tablet 10 mg (as besilate) (Amlodipine AN; Auro-Amlodipine 10) | |
Amoxicillin | Capsule 250 mg (as trihydrate) (Amoxycillin AN) |
Capsule 500 mg (as trihydrate) (Amoxycillin AN) | |
Amoxicillin with clavulanic acid | Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (AMOXICLAV AMNEAL 500/125) |
Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (AMOXICLAV AMNEAL 875/125) | |
Aripiprazole | Tablet 10 mg (Aripiprazole AN) |
Tablet 15 mg (Aripiprazole AN) | |
Tablet 20 mg (Aripiprazole AN) | |
Tablet 30 mg (Aripiprazole AN) | |
Atenolol | Tablet 50 mg (Atenolol-GA; Tenolten 50) |
Atomoxetine | Capsule 10 mg (as hydrochloride) (Atomoxetine Amneal) |
Capsule 18 mg (as hydrochloride) (Atomoxetine Amneal) | |
Capsule 25 mg (as hydrochloride) (Atomoxetine Amneal) | |
Capsule 40 mg (as hydrochloride) (Atomoxetine Amneal) | |
Capsule 60 mg (as hydrochloride) (Atomoxetine Amneal) | |
Capsule 80 mg (as hydrochloride) (Atomoxetine Amneal) | |
Capsule 100 mg (as hydrochloride) (Atomoxetine Amneal) | |
Atorvastatin | Tablet 10 mg (as calcium) (Atorvastatin Amneal) |
Tablet 20 mg (as calcium) (Atorvastatin Amneal) | |
Tablet 40 mg (as calcium) (Atorvastatin Amneal) | |
Tablet 80 mg (as calcium) (Atorvastatin Amneal) | |
Azathioprine | Tablet 50 mg (Azathioprine AN) |
Bimatoprost | Eye drops 300 micrograms per mL, 3 mL (APO-Bimatoprost) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Beprol 2.5; Bisoprolol AN) |
Tablet containing bisoprolol fumarate 5 mg (Beprol 5; Bisoprolol AN) | |
Tablet containing bisoprolol fumarate 10 mg (Beprol 10; Bisoprolol AN) | |
Cabergoline | Tablet 500 micrograms (APO-Cabergoline) |
Candesartan | Tablet containing candesartan cilexetil 4 mg (Candesartan AN) |
Tablet containing candesartan cilexetil 8 mg (Candesartan AN) | |
Tablet containing candesartan cilexetil 16 mg (Candesartan AN) | |
Tablet containing candesartan cilexetil 32 mg (Candesartan AN) | |
Candesartan with hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg |
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg | |
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg | |
Carvedilol | Tablet 3.125 mg (Carvedilol AN) |
Tablet 6.25 mg (Carvedilol AN) | |
Tablet 12.5 mg (Carvedilol AN) | |
Tablet 25 mg (Carvedilol AN) | |
Cefalexin | Capsule 250 mg (as monohydrate) (Cephalexin AN) |
Capsule 500 mg (as monohydrate) (Cephalexin AN) | |
Celecoxib | Capsule 100 mg (Celecoxib AN) |
Capsule 200 mg (Celecoxib AN) | |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) (Ciprofloxacin AN; Loxip 500) |
Tablet 750 mg (as hydrochloride) (Ciprofloxacin AN; Loxip 750) | |
Citalopram | Tablet 10 mg (as hydrobromide) (Citalopram Actavis) |
Tablet 20 mg (as hydrobromide) (Citalopram Actavis) | |
Tablet 40 mg (as hydrobromide) (Citalopram Actavis) | |
Clarithromycin | Tablet 250 mg (Clarac) |
Clopidogrel | Tablet 75 mg (as besilate) (Clopidogrel-GA) |
Tablet 75 mg (as hydrogen sulfate) (Clopidogrel AN) | |
Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulfate)‑100 mg (Clopidogrel/Aspirin Actavis 75/100) |
Cyproterone | Tablet containing cyproterone acetate 50 mg (Cyproterone AN) |
Tablet containing cyproterone acetate 100 mg (Cyproterone AN) | |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg (Diclofenac Amneal) |
Tablet (enteric coated) containing diclofenac sodium 50 mg (Diclofenac Amneal) | |
Donepezil | Tablet containing donepezil hydrochloride 5 mg (Donepezil AN) |
Tablet containing donepezil hydrochloride 10 mg (Donepezil AN) | |
Dorzolamide | Eye drops 20 mg (as hydrochloride) per mL, 5 mL (APO-Dorzolamide) |
Dorzolamide with timolol | Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL (APO-Dorzolamide/Timolol 20/5) |
Doxycycline | Capsule 100 mg (as hyclate) (containing enteric coated pellets) (Doryx) |
Tablet 50 mg (as hyclate) (Doxycycline AN) | |
Tablet 100 mg (as hyclate) (Doxycycline AN) | |
Duloxetine | Capsule 30 mg (as hydrochloride) (Duloxetine AN) |
Capsule 60 mg (as hydrochloride) (Duloxetine AN) | |
Enalapril | Tablet containing enalapril maleate 5 mg (Enalapril Actavis) |
Tablet containing enalapril maleate 10 mg (Enalapril Actavis) | |
Tablet containing enalapril maleate 20 mg (Enalapril Actavis) | |
Entecavir | Tablet 0.5 mg (as monohydrate) (Entecavir Amneal) |
Tablet 1 mg (as monohydrate) (Entecavir Amneal) | |
Eplerenone | Tablet 25 mg (Eplerenone AN) |
Tablet 50 mg (Eplerenone AN) | |
Escitalopram | Tablet 10 mg (as oxalate) (Escitalopram AN) |
Tablet 20 mg (as oxalate) (Escitalopram AN) | |
Esomeprazole | Capsule (enteric) 20 mg (as magnesium) (Esomeprazole ACTAVIS) |
Capsule (enteric) 40 mg (as magnesium) (Esomeprazole ACTAVIS) | |
Famciclovir | Tablet 125 mg (Auro-Famciclovir 125; Famciclovir AN) |
Tablet 250 mg (Auro-Famciclovir 250; Famciclovir AN) | |
Tablet 500 mg (Auro-Famciclovir 500; Famciclovir AN) | |
Famotidine | Tablet 20 mg (Famotidine AN; GenRx Famotidine) |
Tablet 40 mg (Famotidine AN; GenRx Famotidine) | |
Fentanyl | Transdermal patch 2.063 mg (Dutran 12) |
Transdermal patch 4.125 mg (Dutran 25) | |
Transdermal patch 8.25 mg (Dutran 50) | |
Transdermal patch 12.375 mg (Dutran 75) | |
Transdermal patch 16.5 mg (Dutran 100) | |
Fluoxetine | Capsule 20 mg (as hydrochloride) (Fluoxetine AN; Fluoxetine-GA) |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg (Fluvoxamine AN; Fluvoxamine GA) |
Tablet containing fluvoxamine maleate 100 mg (Fluvoxamine AN; Fluvoxamine GA) | |
Fosinopril with hydrochlorothiazide | Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg |
Gabapentin | Capsule 300 mg (Gabapentin AN) |
Capsule 400 mg (Gabapentin AN) | |
Tablet 800 mg (Gabapentin AN) | |
Galantamine | Capsule (prolonged release) 8 mg (as hydrobromide) (Galantamine AN SR) |
Capsule (prolonged release) 16 mg (as hydrobromide) (Galantamine AN SR) | |
Capsule (prolonged release) 24 mg (as hydrobromide) (Galantamine AN SR) | |
Glimepiride | Tablet 1 mg (Glimepiride AN) |
Tablet 2 mg (Glimepiride AN) | |
Tablet 3 mg (Glimepiride AN) | |
Tablet 4 mg (Glimepiride AN) | |
Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200 mg (Hydroxychloroquine AN) |
Indapamide | Tablet containing indapamide hemihydrate 1.5 mg (sustained release) |
Tablet containing indapamide hemihydrate 2.5 mg (Indapamide AN) | |
Irbesartan | Tablet 75 mg (Irbesartan Actavis 75) |
Tablet 150 mg (Irbesartan Actavis 150; Irbesartan AMNEAL; Irbesartan AN) | |
Tablet 300 mg (Irbesartan Actavis 300; Irbesartan AMNEAL) | |
Irbesartan with hydrochlorothiazide | Tablet 150 mg-12.5 mg (Irbesartan HCT Actavis 150/12.5; Irbesartan HCTZ AMNEAL) |
Tablet 300 mg-12.5 mg (Irbesartan HCT Actavis 300/12.5; Irbesartan HCTZ AMNEAL) | |
Tablet 300 mg-25 mg (Irbesartan HCT Actavis 300/25; Irbesartan HCTZ AMNEAL) | |
Isotretinoin | Capsule 10 mg (Isotretinoin AN) |
Capsule 20 mg (Isotretinoin AN) | |
Lamotrigine | Tablet 25 mg (Lamotrigine AN) |
Tablet 50 mg (Lamotrigine AN) | |
Tablet 100 mg (Lamotrigine AN) | |
Tablet 200 mg (Lamotrigine AN) | |
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL (Latanoprost Actavis) |
Leflunomide | Tablet 10 mg (Leflunomide AN) |
Tablet 20 mg (Leflunomide AN) | |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg (Lercadip) |
Tablet containing lercanidipine hydrochloride 20 mg (Lercadip) | |
Levetiracetam | Tablet 250 mg (Kerron 250; Levetiracetam AN) |
Tablet 500 mg (Kerron 500; Levetiracetam AN) | |
Tablet 1 g (Kerron 1000; Levetiracetam AN) | |
Lisinopril | Tablet 5 mg (Auro-Lisinopril 5; Lisinopril AN) |
Tablet 10 mg (Auro-Lisinopril 10; Lisinopril AN) | |
Tablet 20 mg (Auro-Lisinopril 20; Lisinopril AN) | |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 (LaxaCon) |
Meloxicam | Tablet 7.5 mg (Meloxiauro 7.5; Meloxicam AN; Meloxicam-GA) |
Tablet 15 mg (Meloxiauro 15; Meloxicam AN; Meloxicam-GA) | |
Methotrexate | Solution concentrate for I.V. infusion 1000 mg in 10 mL vial (Methaccord) |
Metoclopramide | Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate) |
Metoprolol | Tablet containing metoprolol tartrate 50 mg (Metoprolol AN) |
Tablet containing metoprolol tartrate 100 mg (Metoprolol AN) | |
Mirtazapine | Tablet 15 mg (Mirtazapine AN) |
Tablet 15 mg (orally disintegrating) (Milivin OD 15) | |
Tablet 30 mg (Mirtazapine AN) | |
Tablet 30 mg (orally disintegrating) (Milivin OD 30) | |
Tablet 45 mg (Mirtazapine AN) | |
Tablet 45 mg (orally disintegrating) (Milivin OD 45) | |
Modafinil | Tablet 100 mg (Modafinil AN) |
Montelukast | Tablet, chewable, 4 mg (as sodium) (Auro-Montelukast Tabs 4; Montelukast AN) |
Tablet, chewable, 5 mg (as sodium) (Auro-Montelukast Tabs 5; Montelukast AN) | |
Morphine | Tablet containing morphine sulfate pentahydrate 10 mg (controlled release) |
Tablet containing morphine sulfate pentahydrate 30 mg (controlled release) | |
Tablet containing morphine sulfate pentahydrate 60 mg (controlled release) |
| Tablet containing morphine sulfate pentahydrate 100 mg (controlled release) |
Mycophenolic acid | Tablet containing mycophenolate mofetil 500 mg (Mycophenolate AN) |
Nevirapine | Tablet 400 mg (extended release) (Nevirapine XR APOTEX) |
Olanzapine | Tablet 2.5 mg (Olanzapine AN) |
Tablet 5 mg (Olanzapine AN) | |
Tablet 5 mg (orally disintegrating) (Olanzapine AN ODT) | |
Tablet 7.5 mg (Olanzapine AN) | |
Tablet 10 mg (Olanzapine AN) | |
Tablet 10 mg (orally disintegrating) (Olanzapine AN ODT) | |
Tablet 15 mg (orally disintegrating) (Olanzapine AN ODT) | |
Tablet 20 mg (orally disintegrating) (Olanzapine AN ODT) | |
Olmesartan | Tablet containing olmesartan medoxomil 20 mg (Olmesartan AN) |
Tablet containing olmesartan medoxomil 40 mg (Olmesartan AN) | |
Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide |
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide | |
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg | |
Omeprazole | Tablet 20 mg (Omeprazole AN) |
Ondansetron | Tablet (orally disintegrating) 4 mg (Zilfojim ODT 4) |
Tablet (orally disintegrating) 8 mg (Zilfojim ODT 8) | |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoprazole AN) |
Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Pantoprazole Actavis) | |
Paroxetine | Tablet 20 mg (as hydrochloride) (Roxet 20) |
Perindopril | Tablet containing perindopril erbumine 2 mg (Perindopril Actavis 2; Perindopril AN) |
Tablet containing perindopril erbumine 4 mg (Perindopril Actavis 4; Perindopril AN) | |
Tablet containing perindopril erbumine 8 mg (Perindopril Actavis 8; Perindopril AN) |
Perindopril with indapamide | Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate |
Pioglitazone | Tablet 15 mg (as hydrochloride) (Pioglitazone AN) |
Tablet 30 mg (as hydrochloride) (Pioglitazone AN) | |
Tablet 45 mg (as hydrochloride) (Pioglitazone AN) | |
Pramipexole | Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms (Pramipexole AN) |
Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms (Pramipexole AN) | |
Tablet containing pramipexole dihydrochloride monohydrate 1 mg (Pramipexole AN) | |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pravastatin AN) |
Tablet containing pravastatin sodium 20 mg (Pravastatin AN) | |
Tablet containing pravastatin sodium 40 mg (Pravastatin AN) | |
Tablet containing pravastatin sodium 80 mg (Pravastatin AN) | |
Pregabalin | Capsule 25 mg (Pregabalin AMNEAL) |
Capsule 75 mg (Pregabalin AMNEAL) | |
Capsule 150 mg (Pregabalin AMNEAL) | |
Capsule 300 mg (Pregabalin AMNEAL) | |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg (Prochlorperazine AN) |
Quetiapine | Tablet 25 mg (as fumarate) (Quetiapine AN) |
Tablet 100 mg (as fumarate) (Quetiapine Actavis 100) | |
Tablet 200 mg (as fumarate) (Quetiapine Actavis 200; Quetiapine AN) | |
Tablet 300 mg (as fumarate) (Quetiapine Actavis 300) | |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) (Rabeprazole AN) |
Tablet containing rabeprazole sodium 20 mg (enteric coated) (Rabeprazole AN) | |
Raloxifene | Tablet containing raloxifene hydrochloride 60 mg (Raloxifene AMNEAL; Raloxifene AN) |
Ramipril | Capsule 10 mg (Ramipril AN) |
Tablet 2.5 mg (Ramipril AN) | |
Tablet 5 mg (Ramipril AN) | |
Tablet 10 mg (Ramipril AN) | |
Ranitidine | Tablet 150 mg (as hydrochloride) (Ranitidine AN) |
Risedronic acid | Tablet containing risedronate sodium 35 mg (Risedronate AN) |
Risperidone | Tablet 0.5 mg (Risperidone AMNEAL) |
Tablet 1 mg (Risperidone AMNEAL) | |
Tablet 2 mg (Risperidone AMNEAL) | |
Tablet 3 mg (Risperidone AMNEAL) | |
Tablet 4 mg (Risperidone AMNEAL) | |
Rosuvastatin | Tablet 5 mg (as calcium) (Rostor 5; Rosuvastatin AMNEAL) |
Tablet 10 mg (as calcium) (Rostor 10; Rosuvastatin AMNEAL) | |
Tablet 20 mg (as calcium) (Rostor 20; Rosuvastatin AMNEAL) | |
Tablet 40 mg (as calcium) (Rostor 40; Rosuvastatin AMNEAL) | |
Roxithromycin | Tablet 150 mg (Roxithromycin AN; Roxithromycin-GA) |
Tablet 300 mg (Roxithromycin AN; Roxithromycin-GA) | |
Salbutamol | Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) (Ventolin CFC-free) |
Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | |
Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | |
Sertraline | Tablet 50 mg (as hydrochloride) (Auro-Sertraline 50) |
Tablet 100 mg (as hydrochloride) (Auro-Sertraline 100) | |
Simvastatin | Tablet 10 mg (Simvastatin AN) |
Tablet 20 mg (Simvastatin AN) | |
Tablet 40 mg (Simvastatin AN) | |
Tablet 80 mg (Simvastatin AN) | |
Sumatriptan | Tablet 50 mg (as succinate) (Sumatriptan AN) |
Telmisartan | Tablet 40 mg (Telmisartan AN) |
Tablet 80 mg (Telmisartan AN) | |
Telmisartan with hydrochlorothiazide | Tablet 40 mg-12.5 mg (Telmisartan HCTZ AN 40/12.5) |
Tablet 80 mg-12.5 mg (Telmisartan HCTZ AN 80/12.5) | |
Tablet 80 mg-25 mg (Telmisartan HCTZ AN 80/25) | |
Terbinafine | Tablet 250 mg (as hydrochloride) (Terbinafine AN) |
Topiramate | Tablet 25 mg (Topiramate AN) |
Tablet 50 mg (Topiramate AN) | |
Tablet 100 mg (Topiramate AN) | |
Tablet 200 mg (Topiramate AN) | |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (Tramadol AMNEAL; Tramadol AN) |
Tablet (sustained release) containing tramadol hydrochloride 100 mg (Tramadol AN SR) | |
Tablet (sustained release) containing tramadol hydrochloride 150 mg (Tramadol AN SR) | |
Tablet (sustained release) containing tramadol hydrochloride 200 mg (Tramadol AN SR) | |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Valaciclovir AN) |
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) (Venlafaxine AN SR) |
Capsule (modified release) 75 mg (as hydrochloride) (Venlafaxine AN SR) | |
Capsule (modified release) 150 mg (as hydrochloride) (Venlafaxine AN SR) |
Addition of Maximum Quantity and Number of Repeats
Listed Drug | Form | Brand Name | Maximum Quantity | Number of Repeats |
Venetoclax | Tablet 50 mg | Venclexta | 28 | 2 |
Tablet 100 mg | Venclexta | 120 | 2 |
Deletion of Maximum Quantity and Number of Repeats
Listed Drug | Form | Brand Name | Maximum Quantity | Number of Repeats |
Famciclovir | Tablet 250 mg | Famciclovir-GA | 56 | 5 |
Addition of Responsible Person Code
Pharmaco (Australia) Limited (FQ) |
Deletion of Responsible Person Code
Fair-Med Healthcare (Australia) Pty Ltd (DO) |
AstraZeneca Pty Ltd (ZA) |
Alteration of Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person | |
Atenolol | Tablet 50 mg | Tenormin | From: AP | To: IX |
Cladribine | Solution for I.V. infusion 10 mg in 10 mL single use vial | Leustatin | From: JC | To: IX |
Clomipramine | Tablet containing clomipramine hydrochloride 25 mg | Anafranil 25 | From: SZ | To: PB |
Lisinopril | Tablet 5 mg | Zestril | From: AP | To: IX |
Tablet 10 mg | Zestril | From: AP | To: IX | |
Tablet 20 mg | Zestril | From: AP | To: IX | |
Omeprazole | Tablet 10 mg (as magnesium) | Losec Tablets | From: AP | To: PB |
Tablet 20 mg (as magnesium) | Losec Tablets | From: AP | To: PB | |
Tablet 20 mg (as magnesium) | Omepral | From: ZA | To: FQ | |
Propranolol | Tablet containing propranolol hydrochloride 10 mg | Inderal | From: AP | To: IX |
| Tablet containing propranolol hydrochloride 40 mg | Inderal | From: AP | To: IX |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Etanercept |
Golimumab |
Tocilizumab |
Supply Only - Addition
Note: Supply Only benefits are available on the Schedule for dispensing only, for a period of up to 12 months.
Listed Drug | Form and Brand |
Benralizumab | Injection 30 mg in 1 mL single dose pre‑filled syringe (Fasenra) |
Desmopressin | Intranasal solution containing desmopressin acetate 100 micrograms per mL, |
Testosterone | Capsule containing testosterone undecanoate 40 mg (Andriol Testocaps) |
Supply Only - Deletion
Listed Drug | Form and Brand |
Dalteparin | Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe (Fragmin) Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe (Fragmin) Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe (Fragmin) Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe (Fragmin) Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe (Fragmin) Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe (Fragmin) Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe (Fragmin) |
Mesalazine | Sachet containing prolonged release granules, 1 g per sachet (Pentasa) |
| Suppository 1 g (Pentasa) |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Venetoclax | Approved Product Information. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine. | TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0 |
Etanercept | Psoriasis Area Severity Index (PASI). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The PASI is a widely used tool that enables measurement of the severity and extent of baseline and response of therapy in psoriasis. | The PASI calculation form is available for download for free from the Services Australia website: https://www.servicesaustralia.gov.au/ and forms part of the SA authority application process. |
Ripretinib
| World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The WHO/ECOG performance status is a standard medical diagnostic tool used to measure how cancer impacts a patient’s daily living abilities, by evaluating a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). | The WHO/ECOG Performance Status is available for download for free from the ECOG-ACRIN Cancer Research Group website: https://ecog-acrin.org/resources/ecog-performance-status |
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 2021 (No. 11)
(PB 118 of 2021)
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 2021 (No. 11) 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).
Human rights implications
The right to social security is contained in Article 9 of the International Covenant on Economic Social and Cultural Rights (ICESCR). It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.
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.
Whether there is any detriment to patients by the delisting of these drugs, and if so, how this is compatible with the right to social security
The UN Committee on Economic Social and Cultural Rights reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
When a sponsor submits a request to delist a drug from the PBS, subsection 101(4AAB) of the National Health Act 1953 requires that the Minister or their delegate obtain advice from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent and expert advisory body, before varying or revoking declarations under subsection 85(2) so as to delist the drug. In these instances, one of the matters which the PBAC provides advice on is whether the delisting of a drug will result in an unmet clinical need for patients. PBAC also considers whether the delisting of a form of a drug will result in an unmet clinical need for patients.
Written advice from PBAC is tabled with the monthly amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. An unmet clinical need would arise when a currently treated patient population would be left without treatment options once a delisting occurs. Alternative treatment options could include using a different: form, strength or drug. The PBAC considered the delisting of drugs and the form of drugs in the abovementioned instruments, would not result in an unmet clinical need. The delisting of these items will not affect access to the drugs, as affected patients will be able to access alternative medicines through the PBS and the delisting is unlikely to have an effect on the amount patients pay for those drugs, as co-payment amounts are capped, ensuring their rights to social security are maintained.
Sponsors are private entities that make their own decisions regarding their products and cannot be compelled by the Government to continue to list a product on the PBS. If there are many brands of a listed drug and form, then the delisting of one brand will not adversely affect members of the public as they will be able to obtain any of the other equivalent brands. However, if the final brand of a form of a drug is delisted, this delisting will be considered by PBAC. This includes additional processes to ensure that where a delisting will result in there being only one brand of that form remaining listed on the PBS, that patients will not be negatively affected by having to pay brand premiums. Consequently, the brand delistings in this instrument do not result in an unmet clinical need. Note that delisting of maximum quantities, number of repeats, and pack sizes are equivalent to brand delistings.
Patients accessing PBS subsidised medicines are usually required to pay a co-payment towards their cost. From 1 January 2021, these fees are up to $41.30 for general patients and up to $6.60 for concession card holders. These co-payments are payable for accessing all PBS subsidised medicines. The delisting of the drugs specified below is therefore unlikely to result in a negative financial impact for patients. This is due to the same maximum co-payments applying to all PBS listed medicines.
In the event of a medicine shortage, a provision under section 19A of the Therapeutic Goods Act 1989 allows for temporary approvals to be granted for the import or supply of a brand of medicine that is not registered on the Australian Register of Therapeutic Goods, which could act as a substitute for the medicine that is unavailable or in short supply. Where possible, the Australian Government works with medicine sponsors to organise PBS subsidised access to section 19A medicines, and when the shortage is resolved, the section 19A approval lapses as the medicine is no longer required and is therefore delisted without the need for consideration by the PBAC.
Considerations for drugs being delisted in this instrument
Dalteparin | The sponsor requested the delisting of all strengths of dalteparin injections from the PBS. The PBAC noted there was low utilisation of these items and that there were suitable alternatives available. The PBAC advised that the delisting of dalteparin would not result in an unmet clinical need. |
Considerations for forms being delisted in this instrument
Benralizumab | Injection 30 mg in 1 mL single dose pre-filled syringe | The sponsor requested the delisting of Fasenra from the PBS as the majority of patients are using the alternative form of this drug, Fasenra Pen. The PBAC noted Fasenra Pen was a suitable alternative to Fasenra and considered that the delisting of Fasenra would not result in an unmet clinical need. |
Desmopressin | Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle | The sponsor requested the delisting of desmopressin acetate nasal drops from the PBS. The PBAC noted there were suitable alternative forms of desmopressin available on the PBS. The PBAC therefore advised that the delisting of desmopressin acetate nasal drops would not result in an unmet clinical need. |
Imipramine | Tablet containing imipramine hydrochloride 25 mg USP | Section 19A delisting. Imipramine Tablet containing imipramine hydrochloride 25 mg continues to be available. |
Testosterone | Capsule containing testosterone undecanoate 40 mg | The sponsor requested the delisting of testosterone undecanoate from the PBS due to low utilisation and the discontinuation of supply. The PBAC noted there were alternative forms of testosterone available on the PBS. The PBAC therefore advised that the delisting of testosterone undecanoate capsules would not result in an unmet clinical need. |
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Nikolai Tsyganov
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health