EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2020 (No. 10)
PB 102 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 methoxsalen and siponimod to the PBS and the deletion of the listed drugs aurothiomalate, lenograstim, pneumococcal vaccine – polyvalent, and sofosbuvir from the PBS at the request of the pharmaceutical companies. It also provides for the addition of forms of the listed drugs glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine, and topotecan to the PBS, and for the deletion of forms of the listed drugs darunavir, flucloxacillin, glyceryl trinitrate, ketoconazole, nifedipine, oxaliplatin, periciazine, phenoxybenzamine, and quinagolide from the PBS. In addition, it provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs armodafinil, atezolizumab, bevacizumab, codeine, dexamethasone, lenvatinib, modafinil, olaparib, sorafenib, and topotecan.
Schedule 1 to this Instrument also provides for the following changes:
- the addition of 9 brands and deletion of 19 brands of existing pharmaceutical items;
- the alteration of a responsible person code for 1 existing brand of a pharmaceutical item;
- the addition of 2 responsible persons to the list of responsible persons; and
- the deletion of 1 responsible person from the list of responsible persons.
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 November 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. 10)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10) and may also be cited as PB 102 of 2020.
Section 2 Commencement
This section provides that this Instrument commences on 1 November 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 the addition and deletion of drugs, the addition and deletion of forms of drugs, the addition and deletion of brands, the alteration of a responsible person code for one brand of a pharmaceutical benefit, the addition and deletion of responsible person codes from the list of responsible persons, 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 THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Methoxsalen |
Siponimod |
Listed Drugs Deleted
Listed Drug |
Aurothiomalate |
Lenograstim |
Pneumococcal vaccine - polyvalent |
Sofosbuvir |
Forms Added
Listed Drug | Form |
Glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine | Sachets containing oral powder 31 g, 30 (Tylactin Build 20) |
Topotecan | Solution concentrate for I.V. infusion 4 mg in 4 mL (as hydrochloride) |
Forms Deleted
Listed Drug | Form |
Darunavir | Tablet 150 mg (as ethanolate) |
Flucloxacillin | Capsule 250 mg (as sodium) |
| Capsule 500 mg (as sodium) |
Glyceryl trinitrate | Tablets 600 micrograms, 100 |
Ketoconazole | Shampoo 10 mg per g, 100 mL |
Nifedipine | Tablet 20 mg (controlled release) |
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL |
Periciazine | Tablet 2.5 mg, 84 |
| Tablet 10 mg, 84 |
Phenoxybenzamine | Capsule containing 10 mg phenoxybenzamine hydrochloride |
Quinagolide | Pack containing 3 tablets quinagolide 25 micrograms (as hydrochloride) and 3 tablets quinagolide 50 micrograms (as hydrochloride) |
Brands Added
Listed Drug | Form and Brand |
Amoxicillin | Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL (NOUMED AMOXICILLIN) |
Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL (NOUMED AMOXICILLIN) | |
Pioglitazone | Tablet 30 mg (as hydrochloride) (NOUMED PIOGLITAZONE) |
| Tablet 45 mg (as hydrochloride) (NOUMED PIOGLITAZONE) |
Quetiapine | Tablet 25 mg (as fumarate) (Quetiapine Sandoz Pharma) |
| Tablet 100 mg (as fumarate) (Quetiapine Sandoz Pharma) |
| Tablet 200 mg (as fumarate) (Quetiapine Sandoz Pharma) |
| Tablet 300 mg (as fumarate) (Quetiapine Sandoz Pharma) |
Salbutamol | Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) (Asmol CFC-Free with dose counter) |
Brands Deleted
Listed Drug | Form and Brand |
Amisulpride | Tablet 100 mg (Pharmacor Amisulpride) |
| Tablet 200 mg (Pharmacor Amisulpride) |
| Tablet 400 mg (Pharmacor Amisulpride) |
Amlodipine | Tablet 5 mg (as besilate) (Pharmacor Amlodipine) |
| Tablet 10 mg (as besilate) (Pharmacor Amlodipine) |
Amoxicillin with clavulanic acid | Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (Clavam 875 mg/125 mg) |
Cyproterone | Tablet containing cyproterone acetate 50 mg (Cyprostat) |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 50 mg (Pharmacor Diclofenac 50) |
Donepezil | Tablet containing donepezil hydrochloride 10 mg (Pharmacor Donepezil 10) |
Escitalopram | Tablet 10 mg (as oxalate) (Pharmacor Escitalopram 10) |
| Tablet 20 mg (as oxalate) (Pharmacor Escitalopram 20) |
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) (Pharmacor Esomeprazole) |
| Tablet (enteric coated) 40 mg (as magnesium trihydrate) (Pharmacor Esomeprazole) |
Famciclovir | Tablet 250 mg (Famciclovir SCP 250) |
Omeprazole | Tablet 20 mg (Pharmacor Omeprazole) |
Risperidone | Tablet 0.5 mg (Rispericor 0.5) |
| Tablet 1 mg (Rispericor 1) |
| Tablet 2 mg (Rispericor 2) |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (Tramadol SCP) |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
IncobotulinumtoxinA | Lyophilised powder for injection 100 units | Xeomin | From: EZ |
Addition of Responsible Person Code
Responsible Person and Code |
Encapsulate Pharma Pty Ltd (EJ) |
Terumo BCT Australia Pty Limited (TQ) |
Deletion of Responsible Person Code
Responsible Person and Code |
Merz Australia Pty Ltd (EZ) |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Armodafinil |
Atezolizumab |
Bevacizumab |
Codeine |
Dexamethasone |
Lenvatinib |
Modafinil |
Olaparib |
Sorafenib |
Topotecan |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Atezolizumab Lenvatinib Sorafenib | Child Pugh Score. 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 Child Pugh score assists health professionals to predict prognosis for people with chronic liver disease. | The Child Pugh Score is available for download for free from the NPS MedicineWise website: https://www.nps.org.au/australian-prescriber/articles/prescribing-in-liver-disease-1 |
Olaparib | Gynaecologic Cancer InterGroup (GCIG) guidelines/GCIG CA-125 response criteria. 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 GCIG guidelines/GCIG CA-125 response criteria are a set of criteria for defining response and progression of ovarian cancer. | The GCIG guidelines/GCIG CA-125 response criteria are available for download for free in references from the Oxford University Press website https://academic.oup.com/jnci/article/96/6/487/2606756
|
Olaparib | The Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. 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 RECIST guidelines are a tool used widely for defining when tumours in cancer patients respond, stabilise and/or progress during treatment. | The RECIST guidelines are available for download for free from the RECIST Working Group website: https://recist.eortc.org/ |
Armodafinil Cladribine Methoxsalen Modafinil | Therapeutic Goods Administration (TGA)‑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 |
Atezolizumab Lenvatinib Sorafenib | 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 |
Diagnostic tools referenced in the Instrument
The following standard medical diagnostic tools are referenced in the Instrument but are not intended to incorporate a document by reference.
Listed Drug | Diagnostic tool | Purpose and use in the Instrument | Reason why this reference does not serve to incorporate a document |
Dexamethasone | Early treatment diabetic retinopathy study chart (ETDRSC) and Snellen chart | The ETDRSC and Snellen chart are eye charts that are routinely used in clinical practice to measure visual acuity. | Measurement of visual acuity using the ETDRSC and/or Snellen chart is a process for obtaining physiological measurements and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met. It is part of the standard diagnostic work-up for macular oedema. |
Armodafinil Modafinil | Multiple Sleep Latency Test (MSLT) | The MSLT is a standard medical diagnostic tool used to measure excessive daytime sleepiness. The MSLT measures the individuals sleep latency and the presence or absence of sleep onset REM periods. | The MSLT is a process for obtaining physiological measurements and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met. The MSLT is part of the standard diagnostic work-up for narcolepsy. |
Armodafinil Modafinil | Polysomnography | Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography involves the recording of brain waves, blood oxygen levels, heart rate, breathing, and eye and leg movements during sleep for the purpose of monitoring sleep stages and cycles and identify if or when sleep patterns are disrupted and why. | Polysomnography is a process for obtaining physiological measurements and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met. Polysomnography is part of the standard diagnostic work-up for narcolepsy. |
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. 10)
(PB 102 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. 10) 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).
The amendments in Schedule 1 involve the addition and deletion of drugs, the addition and deletion of forms of drugs, the addition and deletion of brands, the alteration of a responsible person code for one brand of a pharmaceutical benefit, the addition and deletion of responsible person codes from the list of responsible persons, and the alteration of 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.
Paul Hansen
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health