EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2020 (No. 2)
PB 14 of 2020
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 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 durvalumab and glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine and for the addition of forms of the listed drugs isotretinoin, levonorgestrel and tacrolimus to the PBS. It also provides for the deletion of the listed drugs tenofovir with emtricitabine and rilpivirine and tenofovir with emtricitabine, elvitegravir and cobicistat. Additionally, it alters the circumstances in which a prescription may be written for the supply of the listed drugs atezolizumab, budesonide with formoterol, cladribine, dabrafenib, dexamethasone, dimethyl fumarate, dolutegravir with abacavir and lamivudine, donepezil, fingolimod, fluticasone furoate with umeclidinium and vilanterol, fluticasone furoate with vilanterol, fluticasone propionate with salmeterol, galantamine, ipilimumab, levodopa with carbidopa, memantine, nivolumab, pembrolizumab, prednisolone with phenylephrine, rivastigmine, somatropin, teriflunomide, trametinib and vemurafenib (including authority requirements).
Schedule 1 to this Instrument also provides for the following changes:
- the addition of thirteen brands and deletion of twenty-two existing brands of existing pharmaceutical items;
- the deletion of one responsible person; and
- the alteration of nineteen responsible person codes.
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 March 2020.
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 2020 (No. 2)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 2) and may also be cited as PB 14 of 2020.
Section 2 Commencement
This section provides that this Instrument commences on 1 March 2020.
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
The amendments in Schedule 1 involve additions and deletions of drugs, additions of forms, additions and deletions of brands, alterations of responsible person codes for a number of brands of pharmaceutical benefits, deletion of a responsible person from the list of responsible persons, and alteration to 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 THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Durvalumab |
Glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine |
Listed Drugs Deleted
Listed Drug |
Tenofovir with emtricitabine and rilpivirine |
Tenofovir with emtricitabine, elvitegravir and cobicistat |
Forms Added
Listed Drug | Form |
Isotretinoin | Capsule 30 mg |
Levonorgestrel | Intrauterine drug delivery system 19.5 mg |
Tacrolimus | Capsule 3 mg (once daily prolonged release) |
Brands Added
Listed Drug | Form and Brand |
Moxonidine | Tablet 200 micrograms (Moxotens) |
| Tablet 400 micrograms (Moxotens) |
Pegfilgrastim | Injection 6 mg in 0.6 mL single use pre-filled syringe (Ziextenzo) |
Quetiapine | Tablet (modified release) 50 mg (as fumarate) (Quetia XR) |
| Tablet (modified release) 150 mg (as fumarate) (Quetia XR) |
| Tablet (modified release) 200 mg (as fumarate) (Quetia XR) |
| Tablet (modified release) 300 mg (as fumarate) (Quetia XR) |
| Tablet (modified release) 400 mg (as fumarate) (Quetia XR) |
Ramipril | Capsule 10 mg (Prilace) |
| Tablet 1.25 mg (Prilace) |
| Tablet 2.5 mg (Prilace) |
| Tablet 5 mg (Prilace) |
Teriflunomide | Tablet 14 mg (Teriflunomide Dr.Reddy's) |
Brands Deleted
Listed Drug | Form and Brand |
Amoxicillin | Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL (Amoxycillin Sandoz) |
Cefazolin | Powder for injection 1 g (as sodium) (Cefazolin Sandoz) |
Ceftriaxone | Powder for injection 1 g (as sodium) (Ceftriaxone Sandoz) |
Clarithromycin | Tablet 250 mg (Clarihexal) |
Flucloxacillin | Powder for injection 1 g (as sodium monohydrate) (Hospira Pty Limited) |
Fluorouracil | Injection 2500 mg in 50 mL (Fluorouracil Ebewe) |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg (Voxam) |
| Tablet containing fluvoxamine maleate 100 mg (Voxam) |
Folinic acid | Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL (Calcium Folinate Ebewe) |
| Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL (Calcium Folinate Ebewe) |
Idarubicin | Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL (Idarubicin Ebewe) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Hospira Pty Limited) |
| I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL (Hospira Pty Limited) |
Octreotide | Injection 50 micrograms (as acetate) in 1 mL (Hospira Pty Limited) |
| Injection 100 micrograms (as acetate) in 1 mL (Hospira Pty Limited) |
| Injection 500 micrograms (as acetate) in 1 mL (Hospira Pty Limited) |
Oxaliplatin | Solution concentrate for I.V. infusion 100 mg in 20 mL (Oxaliplatin SZ) |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxel Ebewe) |
| Solution concentrate for I.V. infusion 150 mg in 25 mL (Paclitaxel Ebewe) |
Pemetrexed | Powder for I.V. infusion 100 mg (as disodium) (DBL Pemetrexed) |
| Powder for I.V. infusion 500 mg (as disodium) (DBL Pemetrexed) |
| Powder for I.V. infusion 1 g (as disodium) (DBL Pemetrexed) |
Alteration of Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person |
Amoxicillin | Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL | Cilamox | From: QA To: AL |
Bimatoprost | Eye drops 300 micrograms per mL, | Bimtop | From: AS To: AF |
Capecitabine | Tablet 500 mg | Xelabine | From: AS To: AL |
Cladribine | Injection 10 mg in 5 mL | Litak | From: AS To: AF |
Dorzolamide | Eye drops 20 mg (as hydrochloride) per mL, 5 mL | Trusamide | From: AS To: AF |
Dorzolamide with timolol | Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL | Cosdor | From: AS To: AF |
Hypromellose | Eye drops 5 mg per mL, 15 mL | Methopt | From: AS To: AF |
Ipratropium | Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30 | Aeron 250 | From: AS To: AL |
| Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30 | Aeron 500 | From: AS To: AL |
Latanoprost | Eye drops 50 micrograms per mL, | Xalaprost | From: AS To: AF |
Latanoprost with timolol | Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Xalamol 50/5 | From: AS To: AF |
Nicorandil | Tablets 10 mg, 60 | Ikotab | From: AS To: AF |
| Tablets 20 mg, 60 | Ikotab | From: AS To: AF |
Sucralfate | Tablet equivalent to 1 g anhydrous sucralfate | Carafate | From: AS To: AF |
Temozolomide | Capsule 5 mg | Temizole 5 | From: AS To: AL |
| Capsule 20 mg | Temizole 20 | From: AS To: AL |
| Capsule 100 mg | Temizole 100 | From: AS To: AL |
| Capsule 140 mg | Temizole 140 | From: AS To: AL |
| Capsule 250 mg | Temizole 250 | From: AS To: AL |
Deletion of Responsible Person Code
Responsible Person and Code |
Aspen Pharma Pty Ltd (QA) |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Atezolizumab |
Budesonide with formoterol |
Cladribine |
Dabrafenib |
Dexamethasone |
Dimethyl fumarate |
Dolutegravir with abacavir and lamivudine |
Donepezil |
Fingolimod |
Fluticasone furoate with umeclidinium and vilanterol |
Fluticasone furoate with vilanterol |
Fluticasone propionate with salmeterol |
Galantamine |
Ipilimumab |
Levodopa with carbidopa |
Memantine |
Nivolumab |
Pembrolizumab |
Prednisolone with phenylephrine |
Rivastigmine |
Somatropin |
Teriflunomide |
Trametinib |
Vemurafenib |
Document/s incorporated by reference
Listed Drug/s | Document incorporated | Document access |
Donepezil Galantamine Memantine Rivastigmine | The Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE). 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 MMSE is used as a screening test for evaluating cognitive impairment in older adults. The SMMSE provides scoring instructions and clear and unambiguous guidelines for administration of the MMSE tool, in order to increase reliability and reduce variability. | The MMSE/SMME is available for download for free from the Independent Hospital Pricing Authority website: https://www.ihpa.gov.au/what-we-do/standardised-mini-mental-state-examination-smmse |
Donepezil Galantamine Rivastigmine
| Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog). 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 ADAS-Cog is used for comprehensive cognitive assessment and is widely used as an outcome measure in drug and therapy treatments aimed at delaying cognitive decline in dementia. | The ADAS-Cog is available for download for free from the DementiaKT website: http://dementiakt.com.au/doms/downloads/
|
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 2020 (No. 2)
(PB 14 of 2020)
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 2020 (No. 2) 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 and deletions of drugs, additions of forms, additions and deletions of brands, alterations of responsible person codes for a number of brands of pharmaceutical benefits, deletion of a responsible person from the list of responsible persons, and alteration to circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme.
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.
Thea Daniel
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health