National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
made under subsection 100(1) of the
National Health Act 1953
Compilation No. 104
Compilation date: 1 November 2020
Includes amendments up to: PB 107 of 2020
Registered: 17 November 2020
About this compilation
This compilation
This is a compilation of the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) that shows the text of the law as amended and in force on 1 November 2020 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
Part 1—General
Division 1—Preliminary
1 Name of Special Arrangement
3 Definitions
Division 2—Pharmaceutical benefits
4 Pharmaceutical benefits covered by this Special Arrangement
5 Application of Part VII of the Act
6 Responsible person
7 Authorised prescriber
8 Prescription circumstances
9 Maximum amount—chemotherapy drug
10 Maximum quantity—related pharmaceutical benefit
11 Maximum number of repeats—chemotherapy drug
12 Maximum number of repeats—related pharmaceutical benefit
13 Section 100 only supply
Part 2—Prescription
Division 1—Chemotherapy pharmaceutical benefits
14 Methods of prescribing chemotherapy pharmaceutical benefit
15 Information to be included in infusion prescription, other than chemotherapy medication chart prescription directing the supply of an infusion
16 Information to be included in chemotherapy medication chart prescription directing the supply of an infusion
17 Dose or number of repeats greater than maximum
18 Direction to vary dose of chemotherapy drug in infusion
Division 2—Related pharmaceutical benefits
19 Methods of prescribing related pharmaceutical benefit
20 Modified requirements for prescribing of related pharmaceutical benefits
Division 3—Authority required procedures
22 Authority required procedures to be followed
Part 3—Supply
30 Entitlement to infusion or related pharmaceutical benefit
31 Supply of infusion under this Special Arrangement
32 Supply of related pharmaceutical benefits under this Special Arrangement
33 Selection of chemotherapy pharmaceutical benefits to make infusion
34 Modified application of Act and Regulations
34A Modified application of paragraph 92A(1)(f) conditions of approval
Part 4—Claims, payment and provision of under co‑payment data
Division 1—Claims for payment and provision of under co‑payment data
36 How claims to be made
37 Modified references for claim and provision of under co‑payment data
39 Modified requirements for supply of infusion
Division 2—Payment of claim
41 Payment of approved pharmacist or approved medical practitioner for supply of infusion
42 Payment of approved hospital authority or HSD hospital authority for supply of infusion
43 Payment of participating hospital authority for supply of related pharmaceutical benefit
45 Method of working out dispensed price
46 No separate entitlement to payment for supply of diluent
Division 2A—Payments to TGA licensed compounders
46A Payments in relation to infusions prepared between 1 July 2015 and 30 November 2017
46B Payments in relation to infusions prepared on or after 1 December 2017
Division 3—Dispensed price of chemotherapy drug
47 Dispensed price if drug is in infusion supplied by approved pharmacist or approved medical practitioner
48 Mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab
49 Mark‑up for chemotherapy pharmaceutical benefit that has trastuzumab
50 Dispensed price if drug is in infusion supplied by approved private hospital authority
51 Dispensed price if drug is in infusion supplied by public hospital authority
Division 4—Dispensed price of related pharmaceutical benefit
52 Dispensed price for supply of related pharmaceutical benefit
53 Quantity less than manufacturer’s pack
Part 5—Patient contributions
54 Supply of infusion by approved pharmacist or approved medical practitioner
55 Supply of infusion by approved hospital authority or HSD hospital authority
57 Supply of related pharmaceutical benefit by participating hospital authority
58 Special patient contribution for Schedule 5 pharmaceutical benefit
59 Amounts taken into account for eligibility for concession and entitlement cards
Part 5A − Record keeping
59A Keeping documents ‑ chemotherapy medication chart prescriptions
Part 6—Transitional
60 Transitional provisions for existing medication chart prescribing
Schedule 1—Chemotherapy pharmaceutical benefits and chemotherapy drugs
Part 1—Chemotherapy pharmaceutical benefits and related information
Part 2—Chemotherapy drugs and related information
Schedule 2—Related pharmaceutical benefits
Schedule 3—Responsible Person Codes
Schedule 4—Circumstances and Purposes Codes
Schedule 5—Patient contributions
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
(1) This Special Arrangement is the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.
(2) This Special Arrangement may also be cited as PB 79 of 2011.
(1) In this Special Arrangement:
ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.
Act means the National Health Act 1953.
additional TGA licensed compounding fee, for the compounding of a dose of a chemotherapy drug for an infusion by a TGA licensed compounder – an amount of $20.
authorised prescriber means:
(a) for a chemotherapy pharmaceutical benefit—a kind of person identified by a prescriber code mentioned in the column in Part 1 of Schedule 1 headed ‘Authorised Prescriber’ for the benefit; or
(b) for a related pharmaceutical benefit—a kind of person identified by a prescriber code mentioned in the column in Schedule 2 headed ‘Authorised Prescriber’ for the benefit.
authority prescription means a prescription that has been authorised:
(a) in accordance with section 30 of the Regulations as modified by this Special Arrangement; or
(b) in accordance with Division 3 of Part 2 of this Special Arrangement.
benefit card means any of the following:
(a) a PBS Entitlement Card;
(b) a PBS Safety Net Concession Card;
(c) a Pensioner Concession Card;
(d) a Health Care Card (including Low Income Health Care Card and Foster Child Health Care Card);
(e) a Commonwealth Seniors Health Card;
(f) a cleft lip and cleft palate identification card;
(g) a DVA Gold Card;
(h) a DVA White Card;
(i) a DVA Orange Card;
(j) War Widow/Widower Transport Card;
(k) a card or voucher approved by the Chief Executive Medicare for this paragraph.
chemotherapy drug, means a drug that is mentioned in the column in Part 1 of Schedule 1 headed ‘Listed Drug’ for one or more chemotherapy pharmaceutical benefits.
Note: Each chemotherapy drug is also mentioned in Part 2 of Schedule 1.
chemotherapy medication chart prescription means a section of medication chart directing the supply of an infusion or a related pharmaceutical benefit.
chemotherapy pharmaceutical benefit means a pharmaceutical benefit that is mentioned in Part 1 of Schedule 1.
circumstances code means the letter ‘C’ followed by a number.
compounder means an entity (including a person, pharmacy, hospital or a body corporate) who undertakes and is responsible for the compounding of an infusion, so the infusion may be supplied by an approved supplier under this Special Arrangement.
compounder ID means the identification number allocated to a compounder by the Chemotherapy Compounding Payment Scheme Administration Agency in respect of a compounding site.
Note: Australian Healthcare Associates Pty Ltd is currently the Chemotherapy Compounding Payment Scheme Administration Agency.
diluent fee means an amount of $5.44.
dispensing fee means an amount of $7.74.
distribution fee means an amount of $27.45.
dose, for a chemotherapy drug, means the quantity of the drug contained in an infusion, including unit of use, such as international units, grams, micrograms, or milligrams.
electronic chemotherapy medication chart prescription means a chemotherapy medication chart directing the supply of an infusion or a related pharmaceutical benefit, prepared in an electronic medication chart system.
electronic medication chart system means a software system that is used for prescribing and recording the administration of medicines to persons receiving treatment in, at or from a public or private hospital.
eligible patient means a person who:
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is receiving treatment from an authorised prescriber.
eligible private hospital patient means an eligible patient who is receiving treatment at or from a private hospital.
eligible public hospital patient means an eligible patient who is receiving treatment at, or from, a public hospital as a non‑admitted patient, day admitted patient or patient on discharge.
entitlement number, for an eligible patient, means the number listed on the patient’s benefit card.
HSD hospital authority means a public hospital authority approved under section 52 of the National Health (Highly specialised drugs program) Special Arrangement 2010.
Human Services Department means the Department administered by the Human Services Minister.
infusion means a single treatment for a patient that is made from one or more chemotherapy pharmaceutical benefits.
infusion prescription means a prescription directing the supply of an infusion.
National Health Reform Agreement has the meaning given in the Federal Financial Relations Act 2009.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
participating hospital authority means an approved hospital authority for a public hospital that is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Health Reform Agreement.
preparation fee means an amount of $85.78.
Note: The preparation fee includes $40 for compounding the dose of chemotherapy drug in the infusion, which is not indexed annually. Where a TGA licensed compounder has compounded the dose of a chemotherapy drug, an additional TGA licensed compounding fee of $20 is payable to that TGA licensed compounder ‑ see section 46B.
prescriber code means any of the following codes identifying the kind of person mentioned for the code:
(a) MP—medical practitioner;
(b) PDP—participating dental practitioner;
(c) AO—authorised optometrist;
(d) MW—authorised midwife;
(e) NP—authorised nurse practitioner.
purposes code means the letter ‘P’ followed by a number.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
related pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 2.
residential care service has the meaning given by the Regulations.
supplier means a person who may supply an infusion or related pharmaceutical benefit under Part 3 of this Special Arrangement.
TGA licensed compounder means a compounder who holds a license issued under the Therapeutic Goods Act 1989 for aseptic compounding of sterile cytotoxic preparations.
under co‑payment data means information in relation to the supply under this Special Arrangement of:
(a) an infusion by an approved pharmacist, approved medical practitioner, approved hospital authority, or HSD hospital authority; or
(b) a related pharmaceutical benefit by a participating hospital authority;
where a claim is not payable as the dispensed price for the supply under this Special Arrangement does not exceed the amount that the supplier was entitled to charge under subsection 54(2) or 55(2) for supply of an infusion, or under subsection 57(2) for supply of a related pharmaceutical benefit.
Note: Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:
approved hospital authority
approved medical practitioner
approved pharmacist
approved supplier
pharmaceutical benefit
pharmaceutical item
public hospital authority.
(2) Subject to a contrary intention, in this Special Arrangement, a reference to a chemotherapy medication chart prescription includes a reference to an electronic chemotherapy medication chart prescription.
Division 2—Pharmaceutical benefits
4 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Part 1 of Schedule 1 or in Schedule 2.
(2) Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:
(a) in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and
(b) with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.
Note: Each listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Part 1 of Schedule 1 or in Schedule 2 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.
5 Application of Part VII of the Act
(1) Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
Note: Under this Special Arrangement, pharmaceutical benefits listed in Part 1 of Schedule 1 are supplied as an infusion made from one or more pharmaceutical benefits.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.
Note: See subsection 100(3) of the Act.
(1) If a code is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2)(a) is the responsible person for the brand of the pharmaceutical item.
(2) For subsection (1):
(a) the person is the person mentioned in Schedule 3 for the code, with the ABN, if any, mentioned in Schedule 3 for the person; and
(b) the pharmaceutical item is the listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:
(i) in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and
(ii) with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.
Note: A person identified by a code in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Responsible Person’ has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.
(1) Only an authorised prescriber for a chemotherapy pharmaceutical benefit may prescribe the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit to an eligible patient.
(2) Only an authorised prescriber for a related pharmaceutical benefit may prescribe the supply of the related pharmaceutical benefit to an eligible patient.
Note: Each person mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Authorised Prescriber’ is authorised by subsection 88(1) of the Act, or has been authorised by the Minister under section 88 of the Act, to prescribe the pharmaceutical benefit.
(1) If at least one circumstances code is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’ for a chemotherapy pharmaceutical benefit, the circumstances in Schedule 4 for a code are circumstances in which the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit may be prescribed.
(2) If each chemotherapy pharmaceutical benefit that has the same chemotherapy drug has at least one circumstances code, then the supply of an infusion that includes the chemotherapy drug may only be prescribed in circumstances mentioned for a circumstances code.
(3) If at least one circumstances code is mentioned in the column in Schedule 2 headed ‘Circumstances’ for a related pharmaceutical benefit:
(a) the circumstances mentioned in Schedule 4 for a code are circumstances in which the related pharmaceutical benefit may be prescribed; and
(b) the related pharmaceutical benefit may only be prescribed in circumstances mentioned for a circumstances code.
Note: Circumstances for a code mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Circumstances’ have been determined by the Minister under paragraph 85(7)(b) of the Act, except for circumstances in relation to chemotherapy pharmaceutical benefits containing trastuzumab or fluorouracil.
9 Maximum amount—chemotherapy drug
(1) This section applies subject to section 17.
(2) The maximum amount of a chemotherapy drug that an authorised prescriber may direct to be included in an infusion in one infusion prescription or chemotherapy medication chart prescription is the amount mentioned in the column in Part 2 of Schedule 1 headed ‘Maximum Amount’ for the chemotherapy drug.
(3) If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for a chemotherapy drug, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy drug.
10 Maximum quantity—related pharmaceutical benefit
(2) The maximum quantity or number of units of the pharmaceutical item in a related pharmaceutical benefit that an authorised prescriber may direct to be supplied in one prescription is the quantity or number of units mentioned in the column in Schedule 2 headed ‘Maximum Quantity’ for the pharmaceutical benefit.
(3) If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for a related pharmaceutical benefit, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same related pharmaceutical benefit.
(5) For subsection (2), the pharmaceutical item is the listed drug mentioned in Schedule 2:
(a) in the form mentioned in Schedule 2 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 2 for the form of the listed drug.
Note: The maximum quantities and numbers of units mentioned in the column in Schedule 2 headed ‘Maximum quantity’ have been determined by the Minister under paragraph 85A(2)(a) of the Act.
11 Maximum number of repeats—chemotherapy drug
(1) This section applies subject to section 17.
(2) The maximum number of occasions an authorised prescriber may, in one infusion prescription or chemotherapy medication chart prescription, direct that the supply of an infusion containing a chemotherapy drug be repeated is the number in the column in Part 2 of Schedule 1 headed ‘Number of Repeats’ for the chemotherapy drug.
(3) If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for the chemotherapy drug, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy drug.
(5) If an infusion contains more than one chemotherapy drug, the maximum number of repeats for the infusion is the smallest maximum number that applies in relation to one of the chemotherapy drugs.
12 Maximum number of repeats—related pharmaceutical benefit
(2) The maximum number of occasions an authorised prescriber may, in one prescription, direct that the supply of a related pharmaceutical benefit be repeated is the number in the column in Schedule 2 headed ‘Number of Repeats’ for the related pharmaceutical benefit.
(3) If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for the related pharmaceutical benefit, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same related pharmaceutical benefit.
Note: The numbers of repeats mentioned in the column in Schedule 2 headed ‘Number of Repeats’ have been determined by the Minister under paragraph 85A(2)(b) of the Act.
(1) If the letter ‘D’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.
(2) A pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has declared, under subsection 85(2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
(3) If the letters ‘PB’ are mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit, the pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.
(4) A pharmaceutical benefit mentioned in subsection (3) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has determined, under paragraph 85(8)(a) of the Act, that this pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.
(5) If the letter ‘C’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit and a code is mentioned in the column headed ‘Circumstances’, the pharmaceutical benefit may be supplied in the circumstances signified by the code only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.
(6) A pharmaceutical benefit mentioned in subsection (5) is not available in the circumstances mentioned in subsection (5) for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has determined, under paragraph 85(8)(b) of the Act, that one or more of the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.
Division 1—Chemotherapy pharmaceutical benefits
14 Methods of prescribing chemotherapy pharmaceutical benefit
(1) An authorised prescriber may prescribe a chemotherapy pharmaceutical benefit under this Special Arrangement by:
(a) writing an infusion prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with section 40 of the Regulations as modified by section 15 of this Special Arrangement; or
(b) preparing a chemotherapy medication chart prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with section 41 of the Regulations as modified by section 16 of this Special Arrangement.
(2) However, a chemotherapy medication chart prescription directing the supply of an infusion may only be prepared for an eligible public hospital patient or eligible private hospital patient.
(4) Where an infusion prescription is written in accordance with section 40 of the Regulations as modified by section 15, the prescription is taken to be written in accordance with section 40 of the Regulations.
(4A) Where a chemotherapy medication chart prescription is written in accordance with section 41 of the Regulations as modified by section 16, the prescription is taken to be written in accordance with section 41 of the Regulations and Parts 4 and 5 of the Regulations apply as if a reference to a medication chart prescription included a reference to a chemotherapy medication chart prescription.
(5) Paragraph 40(3)(a) of the Regulations does not apply to an infusion prescription.
Note: Section 41 of the Regulations does not prohibit same day prescribing for chemotherapy medication chart prescriptions.
(1) For paragraph 14(1)(a), this section modifies the requirements of section 40 of the Regulations.
(2) An infusion prescription must include the following information:
(a) the name of each chemotherapy drug included in the infusion;
(b) the dose of each chemotherapy drug;
(c) if supply of the infusion is to be repeated—the number of times it is to be repeated.
(3) An infusion prescription does not need to include the following information:
(a) the form of a chemotherapy drug to be supplied;
(b) the quantity or number of units of a pharmaceutical benefit to be supplied;
(c) the number of times supply of a pharmaceutical benefit is to be repeated.
Note: If the prescription does include this information, a supplier is not required to follow the prescriber’s directions—see section 33.
(1) For paragraph 14(1)(b), this section modifies the requirements of section 41 of the Regulations.
(2) A medication chart used to write a chemotherapy medication chart prescription directing the supply of an infusion is not required to be in a form approved by the Secretary under section 41(5) of the Regulations.
(3) A completed section of a chemotherapy medication chart prescription directing the supply of an infusion must include the following information:
(a) the name of each chemotherapy drug included in the infusion; and
(b) for each chemotherapy drug – the dose, the frequency of administration and the route of administration.
(4) However, a completed section of a chemotherapy medication chart prescription directing the supply of an infusion does not need to include the form of the chemotherapy drug to be supplied.
(5) Section 41 of the Regulations applies as if references to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital.
(6) For an electronic chemotherapy medication chart prescription:
(a) paragraph 41(2)(c) of the Regulations does not apply to the completion of a section of the chart; and
(b) the authorised prescriber must electronically approve the electronic chemotherapy medication chart prescription in the electronic medication chart system; and
(c) the section of the chemotherapy medication chart must include each authority approval number (if any) for the prescription.
Note: If the medication chart includes information about the form or brand of a chemotherapy drug to be supplied, or the quantity, number of units or number of repeats of a particular pharmaceutical benefit to be supplied, a supplier is not required to follow the prescriber's directions except if they relate to the method of administering the chemotherapy drug ‑ see section 33.
17 Dose or number of repeats greater than maximum
(1) If an authorised prescriber prescribes a dose of a chemotherapy drug that is greater than the maximum amount permitted under section 9, then:
(a) for an infusion prescription written in accordance with paragraph 14(1)(a); or
(b) for a chemotherapy medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in section 30 of the Regulations as modified by subsection (2).
(2) A reference in section 30 of the Regulations to:
(a) a determination in force under paragraph 85A(2)(a) of the Act is to be read as a reference to the maximum amount of the chemotherapy drug as described in section 9;
(b) compliance with subsection 41(2) of the Regulations is to be read as a reference to subsection 41(2) as modified by section 16;
(c) a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital; and
(d) an electronic prescription is to be read as reference to an electronic chemotherapy medication chart.
(3) If an authorised prescriber directs that the supply of an infusion be repeated more times than the maximum number of repeats permitted under section 11 for one or more of the chemotherapy drugs included in the infusion, then:
(a) for an infusion prescription written in accordance with paragraph 14(1)(a); or
(b) for a chemotherapy medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in section 30 of the Regulations as modified by subsection (4).
(4) A reference in section 30 of the Regulations to:
(a) a determination in force under paragraph 85A(2)(b) of the Act is to be read as a reference to the maximum number of repeats for a chemotherapy drug as described in section 11;
(b) compliance with subsection 41(2) of the Regulations is to be read as a reference to subsection 41(2) as modified by section 16;
(c) a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital; and
(d) an electronic prescription is to be read as reference to an electronic chemotherapy medication chart.
18 Direction to vary dose of chemotherapy drug in infusion
(1) An authorised prescriber may direct a supplier to increase or decrease the dose of a chemotherapy drug in a prescribed infusion, without writing a new infusion prescription or chemotherapy medication chart prescription, if the new dose of the drug is between 90% and 110% of the dose that was originally prescribed.
(2) A new dose directed under subsection (1) that is greater than the maximum amount for the chemotherapy drug does not require approval under section 17.
(3) If a supplier receives a direction in accordance with subsection (1), the supplier must record on the infusion prescription or chemotherapy medication chart prescription:
(a) the name of the authorised prescriber who gave the direction; and
(b) the means by which the supplier was notified of the direction (for example, by phone or by fax); and
(c) the date and time the supplier was notified.
Division 2—Related pharmaceutical benefits
19 Methods of prescribing related pharmaceutical benefit
(1) An authorised prescriber may prescribe a related pharmaceutical benefit under this Special Arrangement by:
(a) writing a prescription for the related pharmaceutical benefit in accordance with section 40 of the Regulations; or
(b) writing a chemotherapy medication chart prescription for the related pharmaceutical benefit in accordance with section 41 of the Regulations as modified by section 20.
(2) Where a chemotherapy medication chart prescription is written in accordance with section 41 of the Regulations as modified by section 20, it is taken to be written in accordance with section 41 of the Regulations and Parts 4 and 5 of the Regulations apply as if a reference to a medication chart prescription includes a reference to a chemotherapy medication chart prescription.
Note: Related pharmaceutical benefits can only be supplied under this Special Arrangement by a participating hospital authority to an eligible public hospital patient ‑ see section 32.
20 Modified requirements for prescribing of related pharmaceutical benefits
(1) For paragraph 19(1)(b), this section modifies the requirements of section 41 of the Regulations.
(2) A medication chart used to write a chemotherapy medication chart prescription directing the supply of a related pharmaceutical benefit is not required to be in a form approved by the Secretary under subsection 41(5) of the Regulations.
(3) Section 41 of the Regulations applies as if references to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital.
(4) For an electronic chemotherapy medication chart prescription:
(a) paragraph 41(2)(c) of the Regulations does not apply to the completion of a section of the chart; and
(b) the authorised prescriber must electronically approve the electronic chemotherapy medication chart prescription in the electronic medication chart system; and
(c) the section of the chemotherapy medication chart must include each authority approval number (if any) for the prescription.
Division 3—Authority required procedures
22 Authority required procedures to be followed
(1) This section applies to an infusion prescription or chemotherapy medication chart prescription used to direct the supply of an infusion if:
(a) a circumstances code is mentioned in Part 1 of Schedule 1 for a chemotherapy pharmaceutical benefit that has a chemotherapy drug included in the infusion; and
(b) the supply of the infusion is prescribed in the circumstances mentioned in Schedule 4 for the code; and
(c) the circumstances include one of the following statements:
(i) Compliance with Authority Required procedures;
(ii) Compliance with Written Authority Required procedures;
(iii) Compliance with Telephone Authority Required procedures;
(iv) Compliance with Written or Telephone Authority Required procedures.
Note: If at least one circumstances code is mentioned in Part 1 of Schedule 1 for each chemotherapy pharmaceutical benefit that has the same chemotherapy drug, supply of an infusion containing the chemotherapy drug may only be prescribed in one of the circumstances to which a code relates—see subsections 8(1) and (2).
(1A) If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with Authority Required Procedures’.
(2) This section applies to a prescription (including a chemotherapy medication chart prescription) for a related pharmaceutical benefit if:
(a) a circumstances code is mentioned in Schedule 2 for the related pharmaceutical benefit; and
(b) the related pharmaceutical benefit is prescribed in the circumstances mentioned in Schedule 4 for the code; and
(c) the circumstances include one of the following statements:
(i) Compliance with Authority Required procedures;
(ii) Compliance with Written Authority Required procedures;
(iii) Compliance with Telephone Authority Required procedures;
(iv) Compliance with Written or Telephone Authority Required procedures.
Note: If at least one circumstances code is mentioned in Schedule 2, the related pharmaceutical benefit may only be prescribed in one of the circumstances to which the code relates—see subsection 8(3).
(2A) If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with Authority Required Procedures’.
(3) The authority required procedures set out in sections 11 to 15 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, with the modifications set out in this section, are to be followed.
Note: See section 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 for Streamlined Authority Code.
(4) A reference to a medication chart prescription in sections 11 to 15 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 includes a reference to a chemotherapy medication chart prescription.
(5) An electronic chemotherapy medication chart prescription directing the supply of a written authority required pharmaceutical benefit may be authorised as set out in subsections (6) to (10).
Written authority required procedures ‑ submission of electronic chemotherapy medication chart prescription
(6) The authorised prescriber may submit to the Chief Executive Medicare:
(a) a copy of the electronic chemotherapy medication chart prescription; or
(b) details of the prescription, by means of electronic communication to obtain an electronic authority, in accordance with subsection (7).
Note: For an authority required prescription for a pharmaceutical benefit that is not a written authority required pharmaceutical benefit, the prescription may be submitted in accordance with the procedures set out in paragraph 12(1)(b), (c) or (d), as appropriate, of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.
(7) The details of the prescription submitted in accordance with paragraph (6)(b) must:
(a) be given to the Chief Executive Medicare in writing; and
(b) be given by means of an electronic communication; and
(c) encrypted when given to the Chief Executive Medicare; and
(d) be given in accordance with any other requirements that would need to be met in order for the requirements to give the information in writing to be taken to have been met under the Electronic Transactions Act 1999.
Written authority required procedures ‑ authorisation of electronic chemotherapy medication chart prescription
(8) An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (6)(a) may be authorised by the Chief Executive Medicare signing his or her authorisation on the copy of the prescription, and:
(a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — indicating this on the copy; and
(b) returning the copy to the authorised prescriber for alteration; and
(c) the authorised prescriber must enter the authorisation number into the electronic chemotherapy medication chart prescription.
(9) An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (6)(b) may be authorised by the Chief Executive Medicare sending his or her authorisation, by electronic communication, including computer automated electronic communication, to the authorised prescriber.
(10) If the Chief Executive Medicare authorises a prescription under subsection (9):
(a) the Chief Executive Medicare must tell the authorised prescriber, by telephone or electronic communication, the approval number that has been allotted to the electronic chemotherapy medication chart prescription; and
(b) the authorised prescriber must enter that number into the electronic chemotherapy medication chart prescription.
30 Entitlement to infusion or related pharmaceutical benefit
An eligible patient is entitled to receive an infusion or a related pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made under Part 5.
31 Supply of infusion under this Special Arrangement
(1) An infusion may be supplied under this Special Arrangement by any of the following:
(a) an approved pharmacist;
(b) an approved medical practitioner;
(c) an approved hospital authority for a private hospital; or
(d) a public hospital authority to an eligible public hospital patient.
(2) However, a public hospital authority that is not a participating hospital authority may only supply an infusion that contains trastuzumab and that does not contain any other chemotherapy drug.
(3) However, an infusion directed to be supplied under a chemotherapy medication chart prescription cannot be supplied by:
(a) an approved medical practitioner; or
(b) a public hospital authority that is not a participating hospital authority.
32 Supply of related pharmaceutical benefits under this Special Arrangement
A related pharmaceutical benefit may be supplied under this Special Arrangement by a participating hospital authority to an eligible public hospital patient.
33 Selection of chemotherapy pharmaceutical benefits to make infusion
Form, brand and method of administering
(1) If an authorised prescriber directs the supply of a form of a chemotherapy drug in an infusion prescription or chemotherapy medication chart prescription, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different form to make the infusion.
(2) If an authorised prescriber directs the supply of a listed brand of a chemotherapy drug in an infusion prescription or chemotherapy medication chart prescription, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different listed brand to make the infusion.
(3) If an authorised prescriber identifies a method of administering a chemotherapy drug in an infusion prescription or chemotherapy medication chart prescription, the supply of the infusion must be consistent with the method.
(4) Subsection (3) applies regardless of whether the method identified by the authorised prescriber is also a manner of administration for one or more chemotherapy pharmaceutical benefits containing the chemotherapy drug.
Note: Authorised prescribers are required to identify each chemotherapy drug in an infusion and the dose of each drug. They are not required to identify a particular chemotherapy pharmaceutical benefit by including the form, manner of administration or brand.
Quantity and number of repeats
(5) If an authorised prescriber directs the supply of a quantity or number of units of a particular chemotherapy pharmaceutical benefit, the supplier of the infusion may disregard the direction.
(6) If an authorised prescriber directs how many times the supply of a particular chemotherapy pharmaceutical benefit is to be repeated, the supplier of the infusion may disregard the direction.
Note: Authorised prescribers are required to identify the dose of each chemotherapy drug and for an infusion prescription the number of times that supply of the infusion is to be repeated. They are not required to identify the quantity or number of units of a pharmaceutical benefit to be supplied, or the number of times supply of a pharmaceutical benefit is to be repeated.
Circumstances
(7) If an infusion prescription or chemotherapy medication chart prescription has been authorised in circumstances mentioned in Schedule 4, the supplier must only use chemotherapy pharmaceutical benefits for which the circumstances code for those circumstances is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’.
34 Modified application of Act and Regulations
(1) A supply of an infusion under this Special Arrangement is not an early supply of a specified pharmaceutical benefit within the meaning of subsection 84AAA(1) of the Act.
(2) Subsections 51(2) to (4) of the Regulations do not apply to the supply of an infusion under this Special Arrangement.
Note: The effect of those subregulations is to restrict how soon a repeat supply may be made. There is no restriction on how soon a repeat supply of an infusion may be made under this Special Arrangement.
(3) Subsections 45(2) to (7) of the Regulations apply as if a reference to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital.
(3A) Section 49 of the Regulations does not apply in relation to the writing of an infusion prescription.
Note: Section 49 of the Regulations does not apply in relation to the writing of a chemotherapy medication chart prescription because of section 14.
(3B) Section 53 of the Regulations does not apply to the supply of an infusion on the basis of an infusion prescription.
Note: Section 53 of the Regulations does not apply to supplies on the basis of a chemotherapy medication chart prescription because of section 14.
(3C) For an electronic chemotherapy medication chart prescription:
(a) paragraph 45(2)(c) of the Regulations does not apply;
(b) the approved supplier or public hospital authority must verify in the electronic chemotherapy medication chart prescription that the pharmaceutical benefit has been supplied and the date on which is was supplied; and
(c) for section 51 of the Regulations, a reference to writing "immediate supply necessary" on the prescription is taken to be a reference to including those words in the electronic chemotherapy medication chart prescription.
(4) A reference elsewhere in the Regulations to the supply of a pharmaceutical benefit is taken to include the supply of an infusion under this Special Arrangement.
34A Modified application of paragraph 92A(1)(f) conditions of approval
a) Section 8 of the conditions of approval for approved pharmacists under paragraph 92A(1)(f) of the Act does not apply to the supply of an infusion, once prepared as a final product ready for infusion to a person, when the infusion has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.
b) For the purposes of this section, shelf life means the period of time that a medicine can be stored and still be considered safe and effective for use.
Part 4—Claims, payment and provision of under co‑payment data
Division 1—Claims for payment and provision of under co‑payment data
(1) The following may make a claim for payment for the supply of an infusion or related pharmaceutical benefit to an eligible patient under this Special Arrangement in accordance with section 99AAA of the Act, and the rules made under subsection 99AAA(8) of the Act, as modified by this Division:
(a) an approved supplier;
(b) an HSD hospital authority.
37 Modified references for claim and provision of under co‑payment data
(1) The rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act apply to a claim or provision of under co‑payment data as follows:
(a) a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority;
(ab) a reference to a medication chart prescription includes a reference to a chemotherapy medication chart prescription;
(b) a reference to a number allotted to an approval under section 16 of the Regulations includes a reference to a number allotted to an approval under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 for a HSD hospital authority; and
(c) the definition of under co‑payment data in section 4 of this Special Arrangement replaces the definition of under co‑payment data appearing in the rules made under subsection 98AC(4) of the Act.
39 Modified requirements for supply of infusion
For a claim or provision of under co‑payment data for supply of an infusion, the requirements in the rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act are modified as follows:
(a) a reference to a pharmaceutical benefit includes a reference to an infusion;
(b) a reference to an authority prescription in the rules includes a reference to an authority prescription within the meaning given by section 3 of this Special Arrangement;
(c) the claim or provision of under co‑payment data must include:
(i) a drug code for each chemotherapy drug in the infusion, being the code for the drug published in the Schedule of Pharmaceutical Benefits published by the Department; and
(ii) the dose of each chemotherapy drug in the infusion; and
(iii) the compounder ID of the site at which the compounder compounded the dose of a chemotherapy drug for the infusion; and
(d) the supplier is not required to include in the claim or provision of under co‑payment data:
(i) the PBS/RPBS Item Code for the supplied pharmaceutical benefit;
(ii) the brand of the supplied pharmaceutical item;
(iii) whether or not section 49 applies; or
(iv) whether or not immediate supply was necessary.
41 Payment of approved pharmacist or approved medical practitioner for supply of infusion
An approved pharmacist or approved medical practitioner who makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved pharmacist or approved medical practitioner was required to charge under subsection 54(2).
42 Payment of approved hospital authority or HSD hospital authority for supply of infusion
An approved hospital authority or HSD hospital authority that makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved hospital authority or HSD hospital authority was entitled to charge under subsection 55(2).
43 Payment of participating hospital authority for supply of related pharmaceutical benefit
A participating hospital authority that makes a claim under Division 1 for the supply of a related pharmaceutical benefit is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the related pharmaceutical benefit is greater than the amount that the supplier was entitled to charge under subsection 57(2).
45 Method of working out dispensed price
Infusion
(1) The dispensed price for the supply of an infusion is the sum of:
(a) the dispensed prices of the doses of chemotherapy drugs in the infusion; and
(b) if the supply is a repeated supply—an amount equivalent to the amount that may be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the eligible patient.
(2) The dispensed price for a dose of a chemotherapy drug is to be worked out under Division 3.
Related pharmaceutical benefit
(3) The dispensed price for the supply of a related pharmaceutical benefit is to be worked out under Division 4.
Rounding
(4) A dispensed price worked out under Division 3 or 4 is rounded to the nearest cent, with a half cent being rounded up.
46 No separate entitlement to payment for supply of diluent
(1) If a supplier adds a pharmaceutical benefit to an infusion supplied under this Special Arrangement as a diluent, no amount is payable under Part VII of the Act for supply of the pharmaceutical benefit.
(2) Subsection (1) applies regardless of whether the pharmaceutical benefit added as a diluent is one to which this Special Arrangement applies.
Note: For the application of this Special Arrangement to pharmaceutical benefits, see section 5.
Division 2A—Payments to TGA licensed compounders
46A Payments in relation to infusions prepared between 1 July 2015 and 30 November 2017
(1) A TGA licensed compounder may make a claim for payment for the compounding of a dose of a chemotherapy drug for an infusion prepared between 1 July 2015 and 30 November 2017.
(2) A claim under subsection (1) must:
(a) be in writing; and
(b) include a certification by the TGA licensed compounder that:
(i) each dose of a chemotherapy drug for the infusion to which the claim relates was prepared in accordance with a compounding order; and
(ii) the information provided in the claim is correct.
(3) If a claim is made under subsection (1), the Secretary may, at his or her discretion, if the Secretary is satisfied on reasonable grounds that it is appropriate to do so, pay an amount of $20 to the TGA licensed compounder for the compounding.
46B Payments in relation to infusions prepared on or after 1 December 2017
(1) If a TGA licensed compounder compounds a dose of a chemotherapy drug for an infusion prepared on or after 1 December 2017, the compounder is entitled to be paid an additional TGA licensed compounding fee by the Commonwealth.
(2) A TGA licensed compounder must not be paid more than one additional TGA licensed compounding fee for the compounding of a dose of a chemotherapy drug for a single infusion that is prepared in accordance with an infusion prescription for an individual patient.
Division 3—Dispensed price of chemotherapy drug
(1) For a dose of a chemotherapy drug in an infusion supplied by an approved pharmacist or an approved medical practitioner to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) the distribution fee;
(c) the dispensing fee;
(d) the preparation fee;
(e) the diluent fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:
(a) the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) the mark‑up for the chemotherapy pharmaceutical benefit worked out under:
(i) if the chemotherapy pharmaceutical benefit does not have trastuzumab—section 48; or
(ii) if the chemotherapy pharmaceutical benefit has trastuzumab—section 49.
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
48 Mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab
For subparagraph 47(4)(b)(i), the mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab is:
(mark‑up for maximum multiple) ÷ (maximum multiple of pharmaceutical benefit).
where:
mark‑up for maximum multiple means the administration, handling and infrastructure fee worked out under the determination made under paragraph 98B(1)(a) of the Act.
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of the chemotherapy drug in the benefit that is permitted under section 9.
Note: The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.
49 Mark‑up for chemotherapy pharmaceutical benefit that has trastuzumab
(1) For subparagraph 47(4)(b)(ii), the mark‑up for a chemotherapy pharmaceutical benefit that has trastuzumab is:
where:
mark‑up for maximum multiple means the amount worked out under subsection (2).
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of trastuzumab that is permitted under section 9.
Note: The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.
(2) The mark‑up for the maximum multiple of a chemotherapy pharmaceutical benefit with an ex‑manufacturer price mentioned in the table is the amount mentioned in the table.
Item | Ex‑manufacturer price for maximum multiple of pharmaceutical benefit | Mark‑up for maximum multiple |
1 | ≤ $40 | 10% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit |
2 | > $40, ≤ $100 | $4 |
3 | > $100, ≤ $1 000 | 4% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit |
4 | > $1 000 | $40 |
50 Dispensed price if drug is in infusion supplied by approved private hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by an approved hospital authority of a private hospital to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) for a drug other than trastuzumab—the distribution fee;
(c) the dispensing fee;
(d) the preparation fee;
(e) the diluent fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:
(a) the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) 1.4% of the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
51 Dispensed price if drug is in infusion supplied by public hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by a public hospital authority to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) the preparation fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up).
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
Division 4—Dispensed price of related pharmaceutical benefit
52 Dispensed price for supply of related pharmaceutical benefit
(1) For a related pharmaceutical benefit supplied by a participating hospital authority to an eligible public hospital patient, the dispensed price is as follows:
(a) if the quantity of the related pharmaceutical benefit that is ordered and supplied is equal to the quantity contained in the manufacturer’s pack—the ex‑manufacturer price for the pack;
(b) if the quantity of the related pharmaceutical benefit that is ordered and supplied is less than the quantity contained in the manufacturer’s pack—the amount worked out under section 53;
(c) if the quantity of the related pharmaceutical benefit that is ordered and supplied is more than the quantity contained in the manufacturer’s pack—the sum of:
(i) the ex‑manufacturer price for each complete pack in the quantity; and
(ii) the amount worked out under section 53 for any remainder.
(2) However, if there are 2 or more related pharmaceutical benefits that are different brands of the same pharmaceutical item, the dispensed price of those pharmaceutical benefits is to be based on the pharmaceutical benefit with the lowest ex‑manufacturer price.
53 Quantity less than manufacturer’s pack
For paragraph 52(1)(b) and subparagraph 52(1)(c)(ii), the amount for a quantity of a related pharmaceutical benefit that is less than the quantity contained in the manufacturer’s pack (a broken quantity) is worked out by:
(a) dividing the quantity or number of units in the broken quantity by the quantity or number of units in the manufacturer’s pack expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the ex‑manufacturer price for the complete pack.
54 Supply of infusion by approved pharmacist or approved medical practitioner
(1) The amount that an approved pharmacist or approved medical practitioner may or must charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.
Patient co‑payment for original supply
(2) For an original supply of an infusion, the approved pharmacist or approved medical practitioner must charge the eligible patient an amount that is equivalent to the amount that is required to be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the patient.
Note: This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.
(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the approved pharmacist or approved medical practitioner uses to make the infusion is mentioned in Schedule 5, the approved pharmacist or approved medical practitioner may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note: If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.
55 Supply of infusion by approved hospital authority or HSD hospital authority
(1) The amount that an approved hospital authority or HSD hospital authority may charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.
Patient co‑payment for original supply
(2) For an original supply of an infusion, the hospital authority may charge the eligible patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained a pharmaceutical benefit from an approved pharmacist.
Note: This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.
(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the hospital authority uses to make the infusion is mentioned in Schedule 5, the hospital authority may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note: If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.
57 Supply of related pharmaceutical benefit by participating hospital authority
(1) The amount that a participating hospital authority may charge an eligible public hospital patient for the supply of a related pharmaceutical benefit is the total of the amounts set out in this section.
Patient co‑payment
(2) The participating hospital authority may charge the eligible public hospital patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained the related pharmaceutical benefit from an approved pharmacist.
Special patient contribution for Schedule 5 pharmaceutical benefit
(3) If the related pharmaceutical benefit is mentioned in Schedule 5, the participating hospital authority may also charge the eligible public hospital patient an amount not exceeding the amount for the related pharmaceutical benefit worked out under section 58.
58 Special patient contribution for Schedule 5 pharmaceutical benefit
(1) The amount an eligible patient may be charged for a pharmaceutical benefit mentioned in Schedule 5 is worked out by subtracting the amount mentioned for the pharmaceutical benefit in the ‘Approved Ex‑manufacturer Price’ column in Schedule 5 from the amount mentioned for the pharmaceutical benefit in the ‘Claimed Ex‑manufacturer Price’ column in Schedule 5.
(2) However, the amounts mentioned in the ‘Approved Ex‑manufacturer price’ and ‘Claimed Ex‑manufacturer price’ columns must be adjusted proportionally if:
(a) for a chemotherapy pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit used to make the infusion is more or less than the number mentioned in the ‘Quantity or Number of Units’ column; and
(b) for a related pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit supplied is more or less than the number mentioned in the ‘Quantity or Number of Units’ column.
59 Amounts taken into account for eligibility for concession and entitlement cards
An amount charged under any of the following provisions is to be taken into account when determining a person’s eligibility for a concession card or entitlement card under section 84C of the Act:
(a) subsection 54(2);
(b) subsection 55(2);
(d) subsection 57(2).
59A Keeping documents ‑ chemotherapy medication chart prescriptions
(1) If an approved supplier or public hospital authority supplies an infusion or a related pharmaceutical benefit under this Special Arrangement on the basis of a chemotherapy medication chart prescription, the supplier must keep the chemotherapy medication chart, or a copy of the chemotherapy medication chart, on which the supplier wrote:
(a) the details required by paragraph 45(2)(c) of the Regulations; or
(b) for an electronic chemotherapy medication chart ‑ the verification required by subsection 34(3C) in relation to the prescription.
(2) The chemotherapy medication chart or copy of the chemotherapy medication chart must be kept for a period of at least 2 years from the date the infusion or related pharmaceutical benefit is supplied by the approved supplier or public hospital authority.
Note 1: The chemotherapy medication chart, or a copy of the chemotherapy medication chart, may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).
Note 2: Requirements to keep documents in relation to the supply of an infusion or a related pharmaceutical benefit on the basis of an infusion prescription are in section 59 of the Regulations.
60 Transitional provisions for existing medication chart prescribing
(1) This section applies where, before the commencement time, an authorised prescriber has written an infusion medication chart prescription or a medication chart prescription directing the supply of a related pharmaceutical benefit, in accordance with this Special Arrangement as in force immediately before that time (a relevant existing prescription).
(2) This Special Arrangement as in force immediately before commencement time continues to apply to:
(a) the prescribing of chemotherapy pharmaceutical benefits or related pharmaceutical benefits using the same chart used to write the relevant existing prescription, during the chart's period of validity under subsection 45(4) of the Regulations; and
(b) the supply of a chemotherapy pharmaceutical benefit or related pharmaceutical benefit made on the basis of that prescription and claims, payment and provisions of under co‑payment data in relation to such a supply.
(3) In this section:
commencement time means the commencement of the National Health (Efficient Funding of Chemotherapy) Amendment (COVID‑19 Simplified Prescribing) Special Arrangement 2020.
infusion medication chart prescription has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before the commencement time.
medication chart prescription has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before the commencement time.
Schedule 1—Chemotherapy pharmaceutical benefits and chemotherapy drugs
(sections 3, 4, 6, 8, 9, 11, 13, 22 and 33)
Part 1—Chemotherapy pharmaceutical benefits and related information
Listed Drug | Form | Manner of Administration | Brand | Responsible Person | Authorised Prescriber | Circumstances | Section 100 only |
Arsenic | Injection concentrate containing arsenic trioxide 10 mg in 10 mL | Injection | Phenasen | FF | MP | C4793 C5997 C6018 | D |
Atezolizumab | Solution concentrate for I.V. infusion 840 mg in 14 mL | Injection | Tecentriq | RO | MP | C10215 C10257 C10312 C10509 C10915 C10972 | D |
| Solution concentrate for I.V. infusion 1200 mg in 20 mL | Injection | Tecentriq | RO | MP | C9345 C10125 C10182 C10204 C10206 C10216 C10276 C10297 C10521 C10915 C10917 C10939 | D |
Avelumab | Solution concentrate for I.V. infusion 200 mg in 10 mL | Injection | Bavencio | SG | MP | C8947 C10023 | D |
Bendamustine | Powder for injection containing bendamustine hydrochloride 25 mg | Injection | Ribomustin | JC | MP | C7943 C7944 C7972 | D |
| Powder for injection containing bendamustine hydrochloride 100 mg | Injection | Ribomustin | JC | MP | C7943 C7944 C7972 | D |
Bevacizumab | Solution for I.V. infusion 100 mg in 4 mL | Injection | Avastin | RO | MP | C4584 C4587 C4594 C4814 C4939 C4968 C6337 C6353 C9102 C9149 C9166 C9346 C9347 C9454 C9566 C10959 | D |
| Solution for I.V. infusion 400 mg in 16 mL | Injection | Avastin | RO | MP | C4584 C4587 C4594 C4814 C4939 C4968 C6337 C6353 C9102 C9149 C9166 C9346 C9347 C9454 C9566 C10959 | D |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. | Injection | CIPLA BLEOMYCIN | LR | MP | C6224 C6275 | D |
|
|
| DBL Bleomycin Sulfate | PF | MP | C6224 C6275 | D |
| Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial | Injection | Bleomycin for Injection, USP | QY | MP | C6224 C6275 | D |
Blinatumomab | Powder for I.V. infusion 38.5 micrograms | Injection | Blincyto | AN | MP | C9369 C9519 C9878 C9911 C9936 C9937 | D |
Bortezomib | Powder for injection 1 mg | Injection | Velcade | JC | MP | C7940 C7941 C10338 C10426 C10454 C10455 | D |
| Powder for injection 3 mg | Injection | Velcade | JC | MP | C7938 C7939 C7940 C7941 C7960 C7961 C7962 C7974 C10338 C10426 C10454 C10455 | D |
| Powder for injection 3.5 mg | Injection | Velcade | JC | MP | C7938 C7939 C7960 C7961 C7962 C7974 | D |
Brentuximab vedotin | Powder for I.V. infusion 50 mg | Injection | Adcetris | TK | MP | C4675 C7616 C8722 C8736 C10519 C10524 C10811 C10902 | D |
Cabazitaxel | Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent | Injection | Jevtana | SW | MP | C4662 | D |
Carboplatin | Solution for I.V. injection 150 mg in 15 mL | Injection | DBL Carboplatin | PF | MP |
| D |
| Solution for I.V. injection 450 mg in 45 mL | Injection | Carboplatin Accord | OC | MP |
| D |
|
|
| DBL Carboplatin | PF | MP |
| D |
Carfilzomib | Powder for injection 10 mg | Injection | Kyprolis | AN | MP | C7348 C10855 | D |
| Powder for injection 30 mg | Injection | Kyprolis | AN | MP | C7348 C10855 | D |
| Powder for injection 60 mg | Injection | Kyprolis | AN | MP | C7348 C10855 | D |
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | SG | MP | C4785 C4788 C4794 C4908 C4912 C4945 C4965 | D |
| Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | SG | MP | C4785 C4788 C4794 C4908 C4912 C4945 C4965 | D |
Cisplatin | I.V. injection 50 mg in 50 mL | Injection | Cisplatin Accord | OC | MP |
| D |
| I.V. injection 100 mg in 100 mL | Injection | Cisplatin Accord | OC | MP |
| D |
Cladribine | Injection 10 mg in 5 mL | Injection | Litak | AF | MP | C6265 | D |
| Solution for I.V. infusion 10 mg in 10 mL single use vial | Injection | Leustatin | JC | MP | C6265 | D |
Cyclophosphamide | Powder for injection 500 mg (anhydrous) | Injection | Endoxan | BX | MP |
| PB |
| Powder for injection 1 g (anhydrous) | Injection | Endoxan | BX | MP |
| PB |
| Powder for injection 2 g (anhydrous) | Injection | Endoxan | BX | MP |
| PB |
Cytarabine | Injection 100 mg in 5 mL vial | Injection | Pfizer Australia Pty Ltd | PF | MP |
| D |
Docetaxel | Solution concentrate for I.V. infusion 80 mg in 4 mL | Injection | Docetaxel Accord | OC | MP |
| D |
| Solution concentrate for I.V. infusion 80 mg in 8 mL | Injection | DBL Docetaxel Concentrated Injection | PF | MP |
| D |
| Solution concentrate for I.V. infusion 160 mg in 8 mL | Injection | Docetaxel Accord | OC | MP |
| D |
| Solution concentrate for I.V. infusion 160 mg in 16 mL | Injection | DBL Docetaxel Concentrated Injection | PF | MP |
| D |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial | Injection/ | Adriamycin | PF | MP |
| D |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial | Injection/ | Adriamycin | PF | MP |
| D |
|
|
| Doxorubicin ACC | OC | MP |
| D |
Doxorubicin ‑ pegylated liposomal | Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL | Injection | Caelyx | JC | MP | C4786 C4787 C4791 | D |
|
|
| Liposomal Doxorubicin SUN | RA | MP | C4786 C4787 C4791 | D |
| Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL | Injection | Caelyx | JC | MP | C4786 C4787 C4791 | D |
|
|
| Liposomal Doxorubicin SUN | RA | MP | C4786 C4787 C4791 | D |
Durvalumab | Solution concentrate for I.V. infusion 120 mg in 2.4 mL | Injection | Imfinzi | AP | MP | C10126 C10145 C10174 | D |
| Solution concentrate for I.V. infusion 500 mg in 10 mL | Injection | Imfinzi | AP | MP | C10126 C10145 C10174 | D |
Epirubicin | Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL | Injection/ | Epirube | TB | MP |
| D |
|
|
| Epirubicin ACT | JU | MP |
| D |
| Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL | Injection/ | Epirubicin ACT | JU | MP |
| D |
| Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL | Injection/ | Epirube | TB | MP |
| D |
|
|
| Epirubicin Accord | OC | MP |
| D |
|
|
| Epirubicin ACT | JU | MP |
| D |
Eribulin | Solution for I.V. injection containing eribulin mesilate 1 mg in 2 mL | Injection | Halaven | EI | MP | C4649 C7258 C7280 | D |
Etoposide | Powder for I.V. infusion 1 g (as phosphate) | Injection | Etopophos | LM | MP |
| PB |
| Solution for I.V. infusion 100 mg in 5 mL | Injection | Etoposide Ebewe | SZ | MP |
| PB |
|
|
| Pfizer Australia Pty Ltd | PF | MP |
| PB |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg | Injection | Fludarabine AMNEAL | JU | MP |
| PB |
|
|
| Fludarabine Juno | JO | MP |
| PB |
| Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL | Injection | Fludarabine Ebewe | SZ | MP |
| PB |
Fluorouracil | Injection 500 mg in 10 mL | Injection | DBL Fluorouracil Injection BP | PF | MP | C6266 C6297 | D |
|
|
| Fluorouracil Accord | OC | MP | C6266 C6297 | D |
| Injection 1000 mg in 20 mL | Injection | Fluorouracil Accord | OC | MP | C6266 C6297 | D |
|
|
| Fluorouracil Ebewe | SZ | MP | C6266 C6297 | D |
| Injection 2500 mg in 50 mL | Injection | DBL Fluorouracil Injection BP | PF | MP | C6266 C6297 | D |
|
|
| Fluorouracil Accord | OC | MP | C6266 C6297 | D |
| Injection 5000 mg in 100 mL | Injection | Fluorouracil Accord | OC | MP | C6266 C6297 | D |
|
|
| Fluorouracil Ebewe | SZ | MP | C6266 C6297 | D |
Fotemustine | Powder for injection 208 mg with solvent | Injection | Muphoran | SE | MP | C6288 | D |
Gemcitabine | Solution for injection 1 g (as hydrochloride) in 26.3 mL | Injection | DBL Gemcitabine Injection | PF | MP |
| D |
| Solution for injection 2 g (as hydrochloride) in 52.6 mL | Injection | DBL Gemcitabine Injection | PF | MP |
| D |
Idarubicin | Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL | Injection | Zavedos Solution | PF | MP | C6247 | PB |
| Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL | Injection | Zavedos Solution | PF | MP | C6247 | PB |
Ifosfamide | Powder for I.V. injection 1 g | Injection | Holoxan | BX | MP |
| D |
| Powder for I.V. injection 2 g | Injection | Holoxan | BX | MP |
| D |
Inotuzumab ozogamicin | Powder for I.V. infusion 1 mg | Injection | Besponsa | PF | MP | C9470 C9601 | D |
Ipilimumab | Injection concentrate for I.V. infusion 50 mg in 10 mL | Injection | Yervoy | BQ | MP | C6562 C6585 C8555 C10122 | D |
| Injection concentrate for I.V. infusion 200 mg in 40 mL | Injection | Yervoy | BQ | MP | C6562 C6585 C10122 | D |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Injection | MEDITAB IRINOTECAN | LR | MP |
| D |
|
|
| Omegapharm Irinotecan | OE | MP |
| D |
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Injection | Irinotecan Accord | OC | MP |
| D |
|
|
| Irinotecan Alphapharm | AF | MP |
| D |
|
|
| Irinotecan Kabi | PK | MP |
| D |
|
|
| MEDITAB IRINOTECAN | LR | MP |
| D |
|
|
| Omegapharm Irinotecan | OE | MP |
| D |
| I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL | Injection | Irinotecan Alphapharm | AF | MP |
| D |
Methotrexate | Injection 5 mg in 2 mL vial | Injection | DBL Methotrexate | PF | MP |
| C |
| Injection 50 mg in 2 mL vial | Injection | DBL Methotrexate | PF | MP |
| C |
|
|
| Methotrexate Accord | OD | MP |
| C |
| Solution concentrate for I.V. infusion 500 mg in 20 mL vial | Injection | DBL Methotrexate | PF | MP |
| C |
| Solution concentrate for I.V. infusion 1000 mg in 10 mL vial | Injection | DBL Methotrexate | PF | MP |
| PB |
|
|
| Methaccord | EA | MP |
| PB |
|
|
| Methotrexate Accord | OD | MP |
| PB |
|
|
| Pfizer Australia Pty Ltd | PF | MP |
| PB |
| Solution concentrate for I.V. infusion 5000 mg in 50 mL vial | Injection | Methotrexate Ebewe | SZ | MP |
| PB |
Mitozantrone | Injection 20 mg (as hydrochloride) in 10 mL | Injection | Mitozantrone Ebewe | SZ | MP |
| D |
|
|
| Onkotrone | BX | MP |
| D |
| Injection 25 mg (as hydrochloride) in 12.5 mL | Injection | Onkotrone | BX | MP |
| D |
Nivolumab | Injection concentrate for I.V. infusion 40 mg in 4 mL | Injection | Opdivo | BQ | MP | C8573 C9214 C9216 C9252 C9298 C9299 C9312 C9321 C10117 C10118 C10119 C10120 C10155 C10156 C10165 C10195 | D |
| Injection concentrate for I.V. infusion 100 mg in 10 mL | Injection | Opdivo | BQ | MP | C8573 C9214 C9216 C9252 C9298 C9299 C9312 C9321 C10117 C10118 C10119 C10120 C10155 C10156 C10165 C10195 | D |
Obinutuzumab | Solution for I.V. infusion 1000 mg in 40 mL | Injection | Gazyva | RO | MP | C7935 C7936 C7950 C7959 C7968 C7981 C8184 | D |
Oxaliplatin | Solution concentrate for I.V. infusion 100 mg in 20 mL | Injection | DBL Oxaliplatin Concentrate | PF | MP |
| D |
|
|
| Oxaliplatin Accord | OC | MP |
| D |
|
|
| Oxaliplatin SUN | RA | MP |
| D |
| Solution concentrate for I.V. infusion 200 mg in 40 mL | Injection | Oxaliplatin SUN | RA | MP |
| D |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | Paclitaxel Kabi | PK | MP |
| D |
|
|
| Paclitaxin | TB | MP |
| D |
| Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | Anzatax | PF | MP |
| D |
|
|
| Paclitaxin | TB | MP |
| D |
| Solution concentrate for I.V. infusion 150 mg in 25 mL | Injection | Anzatax | PF | MP |
| D |
|
|
| Paclitaxin | TB | MP |
| D |
| Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | Anzatax | PF | MP |
| D |
|
|
| Paclitaxel Accord | OC | MP |
| D |
|
|
| Paclitaxel Ebewe | SZ | MP |
| D |
|
|
| Paclitaxel Kabi | PK | MP |
| D |
|
|
| Paclitaxin | TB | MP |
| D |
Paclitaxel, nanoparticle albumin‑bound | Powder for I.V. injection containing 100 mg paclitaxel | Injection | Abraxane | TS | MP | C4657 C6106 C6119 | D |
Panitumumab | Solution concentrate for I.V. infusion 100 mg in 5 mL | Injection | Vectibix | AN | MP | C5439 C5447 C5452 C5526 | D |
| Solution concentrate for I.V. infusion 400 mg in 20 mL | Injection | Vectibix | AN | MP | C5439 C5447 C5452 C5526 | D |
Pembrolizumab | Solution concentrate for I.V. infusion 100 mg in 4 mL | Injection | Keytruda | MK | MP | C9863 C9864 C9894 C9921 C10676 C10678 C10679 C10681 C10682 C10683 C10687 C10688 C10689 C10693 C10695 C10696 C10697 C10701 C10702 C10704 C10705 C10809 C10888 | D |
Pemetrexed | Powder for I.V. infusion 100 mg (as disodium) | Injection | Alimta | LY | MP |
| D |
|
|
| Pemetrexed Accord | OD | MP |
| D |
|
|
| Pemetrexed SUN | RA | MP |
| D |
|
|
| Reladdin | AF | MP |
| D |
|
|
| Tevatrexed | TB | MP |
| D |
| Powder for I.V. infusion 500 mg (as disodium) | Injection | Alimta | LY | MP |
| D |
|
|
| Pemetrexed Accord | OD | MP |
| D |
|
|
| Pemetrexed APOTEX | TX | MP |
| D |
|
|
| Pemetrexed SUN | RA | MP |
| D |
|
|
| Reladdin | AF | MP |
| D |
|
|
| Tevatrexed | TB | MP |
| D |
| Powder for I.V. infusion 1 g (as disodium) | Injection | Pemetrexed Accord | OD | MP |
| D |
|
|
| Pemetrexed SUN | RA | MP |
| D |
Pertuzumab | Solution for I.V. infusion 420 mg in 14 mL | Injection | Perjeta | RO | MP | C10275 C10414 | D |
Pralatrexate | Solution for I.V. infusion 20 mg in 1 mL | Injection | Folotyn | MF | MP | C7526 C7558 | D |
Raltitrexed | Powder for I.V. infusion 2 mg in single use vial | Injection | Tomudex | PF | MP | C6228 | D |
Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | Mabthera | RO | MP | C7399 C7400 C9451 C9542 C10227 | PB |
|
|
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 C10227 | PB |
|
|
| Truxima | EW | MP | C7399 C7400 C9451 C9542 C10227 | PB |
| Solution for I.V. infusion 500 mg in 50 mL | Injection | Mabthera | RO | MP | C7399 C7400 C9451 C9542 C10227 | PB |
|
|
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 C10227 | PB |
|
|
| Truxima | EW | MP | C7399 C7400 C9451 C9542 C10227 | PB |
Topotecan | Powder for I.V. infusion 4 mg (as hydrochloride) | Injection | Hycamtin | SZ | MP |
| D |
| Solution concentrate for I.V. infusion 4 mg in 4 mL (as hydrochloride) | Injection | Topotecan Accord | OC | MP |
| D |
Trastuzumab | Powder for I.V. infusion 60 mg | Injection | Herceptin | RO | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
|
|
| Trazimera | PF | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
| Powder for I.V. infusion 150 mg | Injection | Herceptin | RO | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
|
|
| Herzuma | EW | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
|
|
| Kanjinti | AN | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
|
|
| Ogivri | AF | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
|
|
| Ontruzant | MK | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
|
|
| Trazimera | PF | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
| Powder for I.V. infusion 420 mg | Injection | Kanjinti | AN | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
Trastuzumab emtansine | Powder for I.V. infusion 100 mg | Injection | Kadcyla | RO | MP | C10214 C10255 C10273 C10295 C10510 | D |
| Powder for I.V. infusion 160 mg | Injection | Kadcyla | RO | MP | C10214 C10255 C10273 C10295 C10510 | D |
Vinblastine | Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL | Injection | DBL Vinblastine | PF | MP |
| D |
Vincristine | I.V. injection containing vincristine sulfate 1 mg in 1 mL | Injection | DBL Vincristine Sulfate | PF | MP |
| D |
Vinorelbine | Solution for I.V. infusion 10 mg (as tartrate) in 1 mL | Injection | Navelbine | FB | MP |
| PB |
|
|
| Vinorelbine Ebewe | SZ | MP |
| PB |
| Solution for I.V. infusion 50 mg (as tartrate) in 5 mL | Injection | Navelbine | FB | MP |
| PB |
|
|
| Vinorelbine Ebewe | SZ | MP |
| PB |
Part 2—Chemotherapy drugs and related information
Listed Drug | Purposes | Maximum Amount | Number of Repeats |
Arsenic | P4793 P5997 | 18 | 89 |
| P6018 | 18 | 140 |
Atezolizumab | P10206 P10939 | 1200 | 3 |
| P10204 P10521 | 1200 | 4 |
| P10125 P10182 P10276 | 1200 | 5 |
| P9345 P10216 P10297 | 1200 | 7 |
| P10917 | 1200 | 8 |
| P10312 P10509 | 1680 | 3 |
| P10215 P10257 P10915 P10972 | 1680 | 5 |
Avelumab | P8947 | 1200 | 8 |
| P10023 | 1200 | 11 |
Bendamustine |
| 200 | 11 |
Bevacizumab | P4814 | 900 | 5 |
| P4584 P4587 P4594 P4939 P4968 | 900 | 11 |
| P9166 | 1800 | 3 |
| P9102 P9149 P9346 P9347 | 1800 | 5 |
| P6337 P6353 P9454 P9566 | 1800 | 7 |
| P10959 | 1800 | 8 |
Bleomycin |
| 30000 | 11 |
Blinatumomab | P9878 P9911 | 651 | 0 |
| P9519 | 784 | 0 |
| P9936 P9937 | 784 | 1 |
| P9369 | 784 | 2 |
Bortezomib | P7960 P7962 | 3000 | 11 |
| P7938 P7939 P7961 P7974 P10338 | 3000 | 15 |
| P7940 P7941 | 3000 | 19 |
| P10426 P10454 P10455 | 3000 | 31 |
Brentuximab vedotin | P8722 | 180 | 3 |
| P8736 | 180 | 11 |
| P7616 P10811 P10902 | 200 | 3 |
| P4675 P10519 P10524 | 200 | 11 |
Cabazitaxel |
| 55 | 5 |
Carboplatin |
| 900 | 5 |
Carfilzomib |
| 120 | 17 |
Cetuximab | P4788 | 550 | 5 |
| P4945 | 550 | 11 |
| P4912 | 550 | 18 |
| P4785 P4794 P4908 P4965 | 880 | 0 |
Cisplatin |
| 220 | 14 |
Cladribine |
| 17 | 6 |
Cyclophosphamide |
| 2800 | 17 |
Cytarabine |
| 7000 | 15 |
Docetaxel |
| 250 | 5 |
Doxorubicin |
| 135 | 11 |
Doxorubicin ‑ pegylated liposomal |
| 100 | 5 |
Durvalumab |
| 1200 | 8 |
Epirubicin |
| 220 | 5 |
Eribulin | P7258 P7280 | 3 | 7 |
| P4649 | 3 | 13 |
Etoposide |
| 440 | 14 |
Fludarabine |
| 55 | 29 |
Fluorouracil | P6297 | 1000 | 23 |
| P6266 | 5500 | 11 |
Fotemustine |
| 220 | 8 |
Gemcitabine |
| 3000 | 17 |
Idarubicin |
| 30 | 5 |
Ifosfamide |
| 4000 | 19 |
Inotuzumab ozogamicin | P9601 | 2820 | 4 |
| P9470 | 3384 | 2 |
Ipilimumab | P8555 | 120 | 3 |
| P6562 P6585 P10122 | 360 | 3 |
Irinotecan |
| 800 | 11 |
Methotrexate |
| 250 | 5 |
| P6276 | 20000 | 0 |
Mitozantrone |
| 30 | 5 |
Nivolumab | P10156 P10195 | 120 | 3 |
| P8573 | 360 | 3 |
| P10118 P10119 P10120 | 480 | 5 |
| P9216 P9312 P10155 P10165 | 480 | 8 |
| P9214 P9252 P9298 P9299 P9321 P10117 | 480 | 11 |
Obinutuzumab | P7935 P7950 | 1000 | 5 |
| P7959 P7968 P8184 | 1000 | 7 |
| P7936 P7981 | 1000 | 9 |
Oxaliplatin |
| 300 | 11 |
Paclitaxel |
| 450 | 3 |
Paclitaxel, nanoparticle albumin‑bound | P4657 | 275 | 11 |
| P6106 P6119 | 580 | 5 |
Panitumumab | P5439 P5447 | 720 | 5 |
| P5452 P5526 | 720 | 9 |
Pembrolizumab | P10696 | 200 | 5 |
| P9863 P9864 P9894 P9921 P10678 P10679 P10681 P10682 P10697 P10702 | 200 | 6 |
| P10687 P10695 P10705 P10888 | 200 | 7 |
| P10689 | 400 | 2 |
| P10676 P10683 P10688 P10693 P10701 P10704 P10809 | 400 | 3 |
Pemetrexed |
| 1100 | 5 |
Pertuzumab | P10414 | 420 | 3 |
| P10275 | 840 | 0 |
Pralatrexate | P7558 | 80 | 5 |
| P7526 | 80 | 11 |
Raltitrexed |
| 7 | 8 |
Rituximab | P10227 | 800 | 3 |
| P7399 | 800 | 5 |
| P7400 P9542 | 800 | 7 |
| P9451 | 800 | 11 |
Topotecan |
| 3500 | 17 |
Trastuzumab | P10213 | 250 | 9 |
| P10296 | 500 | 0 |
| P9349 P9571 P10294 | 750 | 3 |
| P9353 P9573 P10293 | 1000 | 0 |
Trastuzumab emtansine | P10255 P10273 P10295 | 450 | 6 |
| P10214 P10510 | 450 | 8 |
Vinblastine |
| 20 | 17 |
Vincristine |
| 2 | 7 |
Vinorelbine |
| 70 | 7 |
Schedule 2—Related pharmaceutical benefits
(sections 3, 4, 6, 8, 10, 12, 13 and 22)
Listed Drug | Form | Manner of Administration | Brand | Responsible Person | Authorised Prescriber | Circumstances | Purposes | Maximum Quantity | Number of Repeats | Section 100 only |
Aprepitant | Capsule 165 mg | Oral | Aprepitant APOTEX | TX | MP | C4216 C4223 C6383 C6464 |
| 1 | 5 | C |
Folinic acid | Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL | Injection | Leucovorin Calcium (Hospira Pty Limited) | PF | MP |
|
| 10 | 2 |
|
|
|
| Leucovorin Calcium (Pfizer Australia Pty Ltd) | PF | MP |
|
| 10 | 2 |
|
| Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL | Injection | Leucovorin Calcium (Pfizer Australia Pty Ltd) | PF | MP |
|
| 10 | 1 |
|
| Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL | Injection | Leucovorin Calcium (Hospira Pty Limited) | PF | MP |
|
| 4 | 1 |
|
| Tablet containing calcium folinate equivalent to 15 mg folinic acid | Oral | Leucovorin Calcium (Hospira Pty Limited) | PF | MP | C5973 |
| 10 | 0 | C |
Fosaprepitant | Powder for I.V. infusion 150 mg | Injection | Emend IV | MK | MP | C6852 C6886 C6887 C6891 |
| 1 | 5 |
|
Granisetron | Concentrated injection 3 mg (as hydrochloride) in 3 mL | Injection | Granisetron Kabi | PK | MP | C4139 |
| 1 | 0 | C |
|
|
| Granisetron‑AFT | AE | MP | C4139 |
| 1 | 0 | C |
|
|
| Kytril | IX | MP | C4139 |
| 1 | 0 | C |
| Tablet 2 mg (as hydrochloride) | Oral | Kytril | IX | MP | C4139 |
| 2 | 0 | C |
Interferon alfa‑2a | Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | Roferon‑A | RO | MP | C6661 C6662 C6678 | P6662 P6678 | 15 | 4 | C |
|
|
|
|
| MP | C6661 C6662 C6678 | P6661 | 15 | 5 | C |
| Injection 9,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | Roferon‑A | RO | MP | C6661 C6678 | P6678 | 5 | 4 | C |
|
|
|
|
| MP | C6661 C6678 | P6661 | 5 | 5 | C |
Mesna | Solution for I.V. injection 400 mg in 4 mL ampoule | Injection | Uromitexan | BX | MP | C5130 |
| 15 | 5 | C |
| Solution for I.V. injection 1 g in 10 mL ampoule | Injection | Uromitexan | BX | MP | C5130 |
| 15 | 5 | C |
Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain | Vial containing powder for intravesical administration approximately 5 x 108 CFU | Intravesical | OncoTICE | MK | MP | C5597 |
| 3 | 1 | C |
Netupitant with Palonosetron | Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride) | Oral | Akynzeo | MF | MP | C5991 C5994 C6879 C6937 |
| 1 | 5 |
|
Ondansetron | Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL | Oral | Zofran syrup 50 mL | AS | MP | C5778 |
| 1 | 0 | C |
| Tablet (orally disintegrating) 4 mg | Oral | APO‑Ondansetron ODT | TX | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron AN ODT | EA | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron Mylan ODT | AF | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron ODT GH | GQ | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron ODT‑DRLA | RZ | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron SZ ODT | HX | MP | C5743 |
| 4 | 0 | C |
|
|
| Zotren ODT | RF | MP | C5743 |
| 4 | 0 | C |
| Tablet 4 mg (as hydrochloride dihydrate) | Oral | APO‑Ondansetron | TX | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron AN | EA | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron APOTEX | GX | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron Mylan Tablets | AF | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron SZ | HX | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron‑DRLA | RZ | MP | C5778 |
| 4 | 0 | C |
|
|
| Zofran | AS | MP | C5778 |
| 4 | 0 | C |
| Tablet (orally disintegrating) 8 mg | Oral | APO‑Ondansetron ODT | TX | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron AN ODT | EA | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron Mylan ODT | AF | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron ODT GH | GQ | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron ODT‑DRLA | RZ | MP | C5743 |
| 4 | 0 | C |
|
|
| Ondansetron SZ ODT | HX | MP | C5743 |
| 4 | 0 | C |
|
|
| Zotren ODT | RF | MP | C5743 |
| 4 | 0 | C |
| Tablet 8 mg (as hydrochloride dihydrate) | Oral | APO‑Ondansetron | TX | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron AN | EA | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron APOTEX | GX | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron Mylan Tablets | AF | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron SZ | HX | MP | C5778 |
| 4 | 0 | C |
|
|
| Ondansetron‑DRLA | RZ | MP | C5778 |
| 4 | 0 | C |
|
|
| Zofran | AS | MP | C5778 |
| 4 | 0 | C |
| Wafer 4 mg | Oral | Zofran Zydis | AS | MP | C5743 |
| 4 | 0 | C |
| Wafer 8 mg | Oral | Zofran Zydis | AS | MP | C5743 |
| 4 | 0 | C |
Palonosetron | Injection 250 micrograms (as hydrochloride) in 5 mL | Injection | Aloxi | MF | MP | C5805 |
| 1 | 0 | C |
Rituximab | Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL | Injection | Mabthera SC | RO | MP | C6011 C6161 C7399 C7400 C10227 | P10227 | 1 | 2 |
|
|
|
|
|
| MP | C6011 C6161 C7399 C7400 C10227 | P7399 | 1 | 5 |
|
|
|
|
|
| MP | C6011 C6161 C7399 C7400 C10227 | P7400 | 1 | 6 |
|
|
|
|
|
| MP | C6011 C6161 C7399 C7400 C10227 | P6011 | 1 | 7 |
|
|
|
|
|
| MP | C6011 C6161 C7399 C7400 C10227 | P6161 | 1 | 11 |
|
Trastuzumab | Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL | Injection | Herceptin SC | RO | MP | C9353 C9462 C10212 | P9353 | 1 | 0 |
|
|
|
|
|
| MP | C9353 C9462 C10212 | P9462 P10212 | 1 | 3 |
|
Tropisetron | I.V. injection 5 mg (as hydrochloride) in 5 mL | Injection | Tropisetron‑AFT | AE | MP | C5749 |
| 1 | 0 | C |
Schedule 3—Responsible Person Codes
(section 6)
Code | Responsible Person | ABN |
AE | AFT Pharmaceuticals (AU) Pty Ltd | 29 105 636 413 |
AF | Alphapharm Pty Ltd | 93 002 359 739 |
AN | Amgen Australia Pty Ltd | 31 051 057 428 |
AP | AstraZeneca Pty Ltd | 54 009 682 311 |
AS | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
BQ | Bristol‑Myers Squibb Australia Pty Ltd | 33 004 333 322 |
BX | Baxter Healthcare Pty Ltd | 43 000 392 781 |
EA | Amneal Pharmaceuticals Pty Ltd | 11 163 167 851 |
EI | Eisai Australia Pty Ltd | 73 117 970 993 |
EW | Celltrion Healthcare Australia Pty Ltd | 66 625 407 105 |
FB | Pierre Fabre Australia Pty Ltd | 30 098 999 850 |
FF | Phebra Pty Ltd | 99 059 357 890 |
GQ | Generic Health Pty Ltd | 93 110 617 859 |
GX | Apotex Pty Ltd | 52 096 916 148 |
HX | Sandoz Pty Ltd | 60 075 449 553 |
IX | Clinect Pty Ltd | 76 150 558 473 |
JC | Janssen‑Cilag Pty Ltd | 47 000 129 975 |
JO | Juno Pharmaceuticals Pty Ltd | 55 156 303 650 |
JU | Juno Pharmaceuticals Pty Ltd | 55 156 303 650 |
LM | Link Medical Products Pty Ltd | 73 010 971 516 |
LR | Cipla Australia Pty Ltd | 46 132 155 063 |
LY | Eli Lilly Australia Pty Ltd | 39 000 233 992 |
MF | Mundipharma Pty Limited | 87 081 322 509 |
MK | Merck Sharp & Dohme (Australia) Pty Ltd | 14 000 173 508 |
OC | Accord Healthcare Pty Ltd | 49 110 502 513 |
OD | Accord Healthcare Pty Ltd | 49 110 502 513 |
OE | Omegapharm Pty Ltd | 86 128 078 151 |
PF | Pfizer Australia Pty Ltd | 50 008 422 348 |
PK | Fresenius Kabi Australia Pty Limited | 39 109 383 593 |
QY | Pro Pharmaceuticals Group Pty Ltd | 20 605 457 430 |
RA | Sun Pharma ANZ Pty Ltd | 17 110 871 826 |
RF | Arrow Pharma Pty Ltd | 35 605 909 920 |
RO | Roche Products Pty Ltd | 70 000 132 865 |
RZ | Dr Reddy’s Laboratories (Australia) Pty Ltd | 16 120 092 408 |
SE | Servier Laboratories (Aust.) Pty Ltd | 54 004 838 500 |
SG | Merck Serono Australia Pty Ltd | 72 006 900 830 |
SW | sanofi‑aventis Australia Pty Ltd | 31 008 558 807 |
SZ | Sandoz Pty Ltd | 60 075 449 553 |
TB | Teva Pharma Australia Pty Limited | 41 169 715 664 |
TK | Takeda Pharmaceuticals Australia Pty Ltd | 71 095 610 870 |
TS | Specialised Therapeutics Australia Pty Ltd | 73 124 031 241 |
TX | Apotex Pty Ltd | 52 096 916 148 |
Schedule 4—Circumstances and Purposes Codes
(sections 8 to 12, 22 and 24)
Listed Drug | Circumstances Code | Purposes Code | Circumstances and Purposes | Authority Requirements |
Aprepitant
| C4216 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND The treatment must be in combination with a 5‑hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND Patient must be scheduled to be co‑administered cyclophosphamide and an anthracycline. No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4216 |
C4223 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND The treatment must be in combination with a 5‑hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin. No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4223 | |
C6383 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND The treatment must be in combination with a 5‑hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin. No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy. Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6383 | |
C6464 |
| Nausea and vomiting The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND The treatment must be in combination with a 5‑hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed. No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy. Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6464 | |
Arsenic | C4793 | P4793 | Acute promyelocytic leukaemia Induction and consolidation treatment The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR‑alpha fusion gene transcript; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4793 |
C5997 | P5997 | Acute promyelocytic leukaemia The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR‑alpha fusion gene transcript. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5997 | |
C6018 | P6018 | Acute promyelocytic leukaemia Induction and consolidation treatment The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR‑alpha fusion gene transcript. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6018 | |
Atezolizumab | C9345 | P9345 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Grandfathering treatment Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated. The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND Patient must have stable or responding disease; AND Patient must have a WHO performance status of 0 or 1. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9345 |
| C10125 | P10125 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10125 |
| C10182 | P10182 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10182 |
| C10204 | P10204 | Extensive‑stage small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10204 |
| C10206 | P10206 | Extensive‑stage small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10206 |
| C10215 | P10215 | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10215 |
| C10216 | P10216 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10216 |
| C10257 | P10257 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10257 |
| C10276 | P10276 | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10276 |
| C10297 | P10297 | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10297 |
| C10312 | P10312 | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10312 |
| C10509 | P10509 | Extensive‑stage small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10509 |
| C10521 | P10521 | Extensive‑stage small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10521 |
| C10915 | P10915 | Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma | Compliance with Authority Required procedures - Streamlined Authority Code 10915 |
| C10917 | P10917 | Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma | Compliance with Authority Required procedures - Streamlined Authority Code 10917 |
| C10939 | P10939 | Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma | Compliance with Authority Required procedures - Streamlined Authority Code 10939 |
| C10972 | P10972 | Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma | Compliance with Authority Required procedures - Streamlined Authority Code 10972 |
Avelumab | C8947 | P8947 | Stage IV (metastatic) Merkel Cell Carcinoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8947 |
| C10023 | P10023 | Stage IV (metastatic) Merkel Cell Carcinoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10023 |
Bendamustine | C7943 |
| Previously untreated stage II bulky or stage III or IV indolent non‑Hodgkin's lymphoma Induction treatment The condition must be CD20 positive; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7943 |
| C7944 |
| Follicular lymphoma Re‑induction treatment The condition must be CD20 positive; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7944 |
| C7972 |
| Previously untreated stage III or IV mantle cell lymphoma Induction treatment The condition must be CD20 positive; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7972 |
Bevacizumab | C4584 | P4584 | Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer Continuing treatment Patient must have previously received PBS‑subsidised treatment with bevacizumab for this condition; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4584 |
C4587 | P4587 | Metastatic colorectal cancer Continuing treatment Patient must have previously received PBS‑subsidised treatment with bevacizumab for this condition; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4587 | |
C4594 | P4594 | Metastatic colorectal cancer Initial treatment The condition must be previously untreated; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4594 | |
C4814 | P4814 | Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial treatment The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm) only if the patient presents with Stage IIIB or Stage IIIC disease; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4814 | |
C4939 | P4939 | Metastatic colorectal cancer Initial treatment Patient must have RAS wild‑type metastatic colorectal cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4939 | |
C4968 | P4968 | Metastatic colorectal cancer Continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4968 | |
C6337 | P6337 | Advanced carcinoma of cervix Initial treatment Patient must have a Gynaecologic Oncology Group (GOG) performance status of 0 or 1; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6337 | |
C6353 | P6353 | Advanced carcinoma of cervix Continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6353 | |
| C9102 | P9102 | Relapsed or recurrent glioblastoma | Compliance with Authority Required procedures |
C9149 | P9149 | Relapsed or recurrent glioblastoma | Compliance with Written Authority Required procedures | |
C9166 | P9166 | Relapsed or recurrent glioblastoma | Compliance with Written Authority Required procedures | |
| C9346 | P9346 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Initial treatment 1 Patient must be undergoing combination treatment with atezolizumab and platinum‑doublet chemotherapy. The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND Patient must not have previously been treated for this condition in the metastatic setting; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9346 |
| C9347 | P9347 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Initial treatment 2 Patient must be undergoing combination treatment with atezolizumab and platinum‑doublet chemotherapy. The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND Patient must have a WHO performance status of 0 or 1; AND Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9347 |
| C9454 | P9454 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Grandfathering treatment Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated. The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND Patient must have stable or responding disease; AND Patient must have a WHO performance status of 0 or 1. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9454 |
| C9566 | P9566 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Continuing treatment Patient must be undergoing combination treatment with atezolizumab until disease progression, unless not tolerated. The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9566 |
| C10959 | P10959 | Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma | Compliance with Authority Required procedures - Streamlined Authority Code 10959 |
Bleomycin | C6224 |
| Lymphoma |
|
C6275 |
| Germ cell neoplasms |
| |
Blinatumomab | C9369 | P9369 | Acute lymphoblastic leukaemia Consolidation treatment Patient must have previously received PBS‑subsidised induction treatment with this drug for this condition; AND Patient must have achieved a complete remission; OR Patient must have achieved a complete remission with partial haematological recovery; AND The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug. | Compliance with Authority Required procedures |
| C9519 | P9519 | Acute lymphoblastic leukaemia Induction treatment ‑ balance of supply The condition must be relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND The condition must not be present in the central nervous system or testis; AND Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime. According to the TGA‑approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re‑initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended. An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2. Blinatumomab is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures |
| C9878 | P9878 | Acute lymphoblastic leukaemia | Compliance with Written Authority Required procedures |
| C9911 | P9911 | Acute lymphoblastic leukaemia | Compliance with Written Authority Required procedures |
| C9936 | P9936 | Minimal residual disease of precursor B‑cell acute lymphoblastic leukaemia (Pre‑B‑cell ALL) | Compliance with Authority Required procedures |
| C9937 | P9937 | Minimal residual disease of precursor B‑cell acute lymphoblastic leukaemia (Pre‑B‑cell ALL) | Compliance with Written Authority Required procedures |
Bortezomib | C7938 | P7938 | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7938 |
| C7939 | P7939 | Multiple myeloma Retreatment of Progressive disease ‑ Continuing PBS‑subsidised treatment The treatment must be as monotherapy; OR | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7939 |
| C7940 | P7940 | Symptomatic multiple myeloma Continuing PBS‑subsidised treatment Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and be ineligible for high dose chemotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7940 |
| C7941 | P7941 | Symptomatic multiple myeloma Continuing PBS‑subsidised treatment Patient must have previously received PBS‑subsidised treatment with this drug for newly diagnosed symptomatic multiple myeloma; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7941 |
| C7960 | P7960 | Multiple myeloma Retreatment of Progressive disease ‑ Continuing PBS‑subsidised treatment The treatment must be as monotherapy; OR | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7960 |
| C7961 | P7961 | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7961 |
| C7962 | P7962 | Multiple myeloma Treatment of Progressive disease ‑ Continuing PBS‑subsidised treatment The treatment must be as monotherapy; OR | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7962 |
| C7974 | P7974 | Multiple myeloma Treatment of Progressive disease ‑ Continuing PBS‑subsidised treatment The treatment must be as monotherapy; OR | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7974 |
| C10338 | P10338 | Symptomatic multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10338 |
| C10426 | P10426 | Symptomatic multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10426 |
| C10454 | P10454 | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10454 |
| C10455 | P10455 | Symptomatic multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10455 |
Brentuximab vedotin | C4675 | P4675 | CD30 positive systemic anaplastic large cell lymphoma Continuing treatment Patient must not have progressive disease; AND | Compliance with Authority Required procedures |
| C7616 | P7616 | CD30 positive systemic anaplastic large cell lymphoma Initial treatment The treatment must be for curative intent; AND | Compliance with Written Authority Required procedures |
| C8722 | P8722 | CD30 positive cutaneous T‑cell lymphoma | Compliance with Written Authority Required procedures |
| C8736 | P8736 | CD30 positive cutaneous T‑cell lymphoma | Compliance with Authority Required procedures |
| C10519 | P10519 | Relapsed or Refractory Hodgkin lymphoma | Compliance with Authority Required procedures |
| C10524 | P10524 | Relapsed or Refractory Hodgkin lymphoma | Compliance with Authority Required procedures |
| C10811 | P10811 | Relapsed or Refractory Hodgkin lymphoma | Compliance with Written Authority Required procedures |
| C10902 | P10902 | Relapsed or Refractory Hodgkin lymphoma | Compliance with Written Authority Required procedures |
Cabazitaxel | C4662 |
| Castration resistant metastatic carcinoma of the prostate The treatment must be in combination with prednisone or prednisolone; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4662 |
Carfilzomib | C7348 |
| Multiple myeloma | Compliance with Authority Required procedures |
| C10855 |
| Multiple myeloma | Compliance with Authority Required procedures |
Cetuximab | C4785 | P4785 | Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx Initial treatment The treatment must be in combination with radiotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4785 |
C4788 | P4788 | Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx Continuing treatment The treatment must be in combination with radiotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4788 | |
C4794 | P4794 | Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx Initial treatment The treatment must be for the week prior to radiotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4794 | |
C4908 | P4908 | Metastatic colorectal cancer Initial treatment Patient must have RAS wild‑type metastatic colorectal cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4908 | |
C4912 | P4912 | Metastatic colorectal cancer Continuing treatment Patient must have received an initial authority prescription for this drug for first‑line treatment of RAS wild‑type metastatic colorectal cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4912 | |
C4945 | P4945 | Metastatic colorectal cancer Continuing treatment Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of first‑line chemotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4945 | |
C4965 | P4965 | Metastatic colorectal cancer Initial treatment Patient must have RAS wild‑type metastatic colorectal cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4965 | |
Cladribine | C6265 |
| Hairy cell leukaemia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6265 |
Doxorubicin ‑ pegylated liposomal | C4786 |
| Advanced epithelial ovarian cancer Patient must have failed a first‑line platinum‑based chemotherapy regimen. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4786 |
C4787 |
| Metastatic breast cancer The treatment must be as monotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4787 | |
C4791 |
| Metastatic breast cancer The treatment must be as monotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4791 | |
Durvalumab | C10126 |
| Unresectable Stage III non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10126 |
| C10145 |
| Unresectable Stage III non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10145 |
| C10174 |
| Unresectable Stage III non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10174 |
Eribulin | C4649 | P4649 | Locally advanced or metastatic breast cancer Patient must have progressive disease; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4649 |
| C7258 | P7258 | Advanced (unresectable and/or metastatic) liposarcoma Initial treatment Patient must have an ECOG performance status of 2 or less; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7258 |
| C7280 | P7280 | Advanced (unresectable and/or metastatic) liposarcoma Continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7280 |
Fluorouracil | C6266 | P6266 | Patients requiring administration of fluorouracil by intravenous infusion |
|
C6297 | P6297 | Patients requiring administration of fluorouracil by intravenous injection |
| |
Folinic acid | C5973 |
| Megaloblastic anaemias The condition must be a result of folic acid deficiency from the use of folic acid antagonists. |
|
Fosaprepitant | C6852 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6852 |
C6886 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6886 | |
C6887 |
| Nausea and vomiting The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6887 | |
C6891 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6891 | |
Fotemustine | C6288 |
| Metastatic malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6288 |
Granisetron | C4139 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. |
|
Idarubicin | C6247 |
| Acute myelogenous leukaemia (AML) |
|
Inotuzumab ozogamicin | C9470 | P9470 | Acute lymphoblastic leukaemia Induction treatment The condition must be relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND Patient must not have received more than 1 line of salvage therapy; AND Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND The condition must be CD22‑positive; AND The condition must have more than 5% blasts in bone marrow; AND The treatment must not be more than 3 treatment cycles under this restriction in a lifetime. This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting. The authority application must be made in writing and must include: (1) two completed authority prescription forms; (2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application ‑ Supporting Information Form; and (3) evidence that the condition is CD22‑positive; and (4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and (5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application. The treatment must not exceed 0.8mg per m2for the first dose of a treatment cycle (Day 1), and 0.5mg per m2for subsequent doses (Days 8 and 15) within a treatment cycle. Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime. | Compliance with Written Authority Required procedures |
| C9601 | P9601 | Acute lymphoblastic leukaemia Consolidation treatment Patient must have previously received PBS‑subsidised induction treatment with this drug for this condition; AND Patient must have achieved a complete remission; OR Patient must have achieved a complete remission with partial haematological recovery; AND The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug. This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting. The treatment must not exceed 0.5mg per m2for all doses within a treatment cycle Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime. | Compliance with Authority Required procedures |
Interferon alfa‑2a | C6661 | P6661 | Low grade non‑Hodgkin's lymphoma The condition must have clinical features suggestive of a poor prognosis; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6661 |
C6662 | P6662 | Hairy cell leukaemia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6662 | |
C6678 | P6678 | Myeloproliferative disease Patient must have excessive thrombocytosis. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6678 | |
Ipilimumab | C6562 | P6562 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment The treatment must be the sole PBS‑subsidised therapy for this condition; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6562 |
C6585 | P6585 | Unresectable Stage III or Stage IV malignant melanoma Re‑induction treatment The treatment must be the sole PBS‑subsidised therapy for this condition; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6585 | |
| C8555 | P8555 | Stage IV clear cell variant renal cell carcinoma (RCC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8555 |
| C10122 | P10122 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10122 |
Mesna | C5130 |
| Urothelial toxicity Prophylaxis or reduction of toxicity |
|
Methotrexate |
| P6276 | Patients receiving treatment with a high dose regimen |
|
Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain | C5597 |
| Primary and relapsing superficial urothelial carcinoma of the bladder |
|
Netupitant with Palonosetron | C5991 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5991 |
C5994 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5994 | |
C6879 |
| Nausea and vomiting The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6879 | |
C6937 |
| Nausea and vomiting The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6937 | |
Nivolumab | C8573 | P8573 | Stage IV clear cell variant renal cell carcinoma (RCC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8573 |
| C9214 | P9214 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9214 |
| C9216 | P9216 | Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9216 |
| C9252 | P9252 | Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9252 |
| C9298 | P9298 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9298 |
| C9299 | P9299 | Stage IV clear cell variant renal cell carcinoma (RCC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9299 |
| C9312 | P9312 | Stage IV clear cell variant renal cell carcinoma (RCC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9312 |
| C9321 | P9321 | Stage IV clear cell variant renal cell carcinoma (RCC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9321 |
| C10117 | P10117 | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10117 |
| C10118 | P10118 | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma | Compliance with Authority Required procedures |
| C10119 | P10119 | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma | Compliance with Authority Required procedures |
| C10120 | P10120 | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma | Compliance with Authority Required procedures |
| C10155 | P10155 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10155 |
| C10156 | P10156 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10156 |
| C10165 | P10165 | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10165 |
| C10195 | P10195 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10195 |
Obinutuzumab | C7935 | P7935 | Stage II bulky or Stage III/IV follicular lymphoma Maintenance therapy Patient must have previously received PBS‑subsidised treatment with this drug under the previously untreated initial restriction; OR | Compliance with Authority Required procedures |
| C7936 | P7936 | Stage II bulky or Stage III/IV follicular lymphoma | Compliance with Authority Required procedures |
| C7950 | P7950 | Follicular lymphoma Maintenance therapy Patient must have previously received PBS‑subsidised treatment with this drug under the rituximab refractory initial restriction; OR | Compliance with Authority Required procedures |
| C7959 | P7959 | Follicular lymphoma Re‑induction treatment Patient must not have previously received PBS subsidised obinutuzumab; AND | Compliance with Authority Required procedures |
| C7968 | P7968 | Follicular lymphoma Grandfather treatment ‑ rituximab refractory Patient must have received non‑PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND | Compliance with Authority Required procedures |
| C7981 | P7981 | Stage II bulky or Stage III/IV follicular lymphoma Induction treatment The condition must be CD20 positive; AND | Compliance with Authority Required procedures |
| C8184 | P8184 | Chronic lymphocytic leukaemia (CLL) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8184 |
Ondansetron | C5743 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. |
|
C5778 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. |
| |
Paclitaxel, nanoparticle albumin‑bound | C4657 | P4657 | Stage IV (metastatic) adenocarcinoma of the pancreas The treatment must be in combination with gemcitabine; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4657 |
C6106 | P6106 | Metastatic breast cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6106 | |
C6119 | P6119 | HER2 positive breast cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6119 | |
Palonosetron | C5805 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. |
|
Panitumumab | C5439 | P5439 | Metastatic colorectal cancer Initial treatment Patient must have RAS wild‑type metastatic colorectal cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5439 |
C5447 | P5447 | Metastatic colorectal cancer Continuing treatment Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of first‑line chemotherapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5447 | |
C5452 | P5452 | Metastatic colorectal cancer Continuing treatment Patient must have received an initial authority prescription for panitumumab for first‑line treatment of RAS wild‑type metastatic colorectal cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5452 | |
C5526 | P5526 | Metastatic colorectal cancer Initial Treatment Patient must have RAS wild‑type metastatic colorectal cancer; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5526 | |
Pembrolizumab | C9863 | P9863 | Relapsed or Refractory Hodgkin lymphoma | Compliance with Written Authority Required procedures |
| C9864 | P9864 | Relapsed or Refractory Hodgkin lymphoma | Compliance with Authority Required procedures |
| C9894 | P9894 | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9894 |
| C9921 | P9921 | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9921 |
| C10676 | P10676 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma | Compliance with Authority Required procedures |
| C10678 | P10678 | Relapsed or refractory primary mediastinal B‑cell lymphoma | Compliance with Written Authority Required procedures |
| C10679 | P10679 | Relapsed or refractory primary mediastinal B‑cell lymphoma | Compliance with Authority Required procedures |
| C10681 | P10681 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10681 |
| C10682 | P10682 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10682 |
| C10683 | P10683 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10683 |
| C10687 | P10687 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma | Compliance with Authority Required procedures |
| C10688 | P10688 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma | Compliance with Authority Required procedures |
| C10689 | P10689 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10689 |
| C10693 | P10693 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10693 |
| C10695 | P10695 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma | Compliance with Authority Required procedures |
| C10696 | P10696 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10696 |
| C10697 | P10697 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10697 |
| C10701 | P10701 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10701 |
| C10702 | P10702 | Relapsed or refractory primary mediastinal B‑cell lymphoma | Compliance with Written Authority Required procedures |
| C10704 | P10704 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10704 |
| C10705 | P10705 | Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10705 |
| C10809 | P10809 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma | Compliance with Authority Required procedures |
| C10888 | P10888 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma | Compliance with Authority Required procedures |
Pertuzumab | C10275 | P10275 | Metastatic (Stage IV) HER2 positive breast cancer | Compliance with Written Authority Required procedures |
| C10414 | P10414 | Metastatic (Stage IV) HER2 positive breast cancer | Compliance with Authority Required procedures |
Pralatrexate | C7526 | P7526 | Relapsed or chemotherapy refractory Peripheral T‑cell Lymphoma Continuing treatment The condition must be relapsed or chemotherapy refractory; AND | Compliance with Authority Required procedures |
C7558 | P7558 | Relapsed or chemotherapy refractory Peripheral T‑cell Lymphoma Initial treatment The condition must be relapsed or chemotherapy refractory; AND | Compliance with Authority Required procedures | |
Raltitrexed | C6228 |
| Advanced colorectal cancer The treatment must only be used as a single agent in the treatment of this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6228 |
Rituximab | C6011 | P6011 | Relapsed or refractory Stage III or IV CD20 positive follicular B‑cell non‑Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6011 |
C6161 | P6161 | Stage III or IV CD20 positive follicular B‑cell non‑Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to induction treatment with either R‑CHOP or R‑CVP regimens for previously untreated follicular B‑cell Non‑Hodgkin's lymphoma, received immediately prior to this current Authority application; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6161 | |
| C7399 | P7399 | Previously untreated or Relapsed/refractory CD20 positive acute lymphoblastic leukaemia Maintenance therapy The treatment must be maintenance therapy; AND | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7399 |
| C7400 | P7400 | Previously untreated or relapsed/refractory CD20 positive lymphoid cancer Induction or re‑induction therapy The treatment must be for induction or re‑induction for CD20 positive lymphoma; OR | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7400 |
| C9451 | P9451 | Stage III or IV CD20 positive follicular B‑cell non‑Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to induction treatment with either R‑CHOP or R‑CVP regimens for previously untreated follicular B‑cell Non‑Hodgkin's lymphoma, received immediately prior to this current treatment with this drug for this condition; AND Patient must not have received bendamustine induction therapy; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9451 |
| C9542 | P9542 | Relapsed or refractory Stage III or IV CD20 positive follicular B‑cell non‑Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re‑induction treatment received immediately prior to this current treatment with this drug for this condition; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9542 |
| C10227 | P10227 | Relapsed or refractory follicular B‑cell non‑Hodgkin's lymphoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10227 |
Trastuzumab | C9349 | P9349 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, a new loading dose may be required. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9349 |
| C9353 | P9353 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND The treatment must not be in combination with nab‑paclitaxel; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9353 |
| C9462 | P9462 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9462 |
| C9571 | P9571 | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro‑oesophageal junction Continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must not have progressive disease; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9571 |
| C9573 | P9573 | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro‑oesophageal junction Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND Patient must commence treatment in combination with platinum based chemotherapy and capecitabine; OR Patient must commence treatment in combination with platinum based chemotherapy and 5 fluorouracil; AND Patient must not have previously received this drug for this condition; AND Patient must not have received prior chemotherapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9573 |
| C10212 | P10212 | Early HER2 positive breast cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10212 |
| C10213 | P10213 | Early HER2 positive breast cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10213 |
| C10293 | P10293 | Early HER2 positive breast cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10293 |
| C10294 | P10294 | Early HER2 positive breast cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10294 |
| C10296 | P10296 | Early HER2 positive breast cancer | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10296 |
Trastuzumab emtansine | C10214 | P10214 | Metastatic (Stage IV) HER2 positive breast cancer | Compliance with Authority Required procedures |
| C10255 | P10255 | Early HER2 positive breast cancer | Compliance with Written Authority Required procedures |
| C10273 | P10273 | Early HER2 positive breast cancer | Compliance with Written Authority Required procedures |
| C10295 | P10295 | Early HER2 positive breast cancer | Compliance with Authority Required procedures |
| C10510 | P10510 | Metastatic (Stage IV) HER2 positive breast cancer | Compliance with Written Authority Required procedures |
Tropisetron | C5749 |
| Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. |
|
Schedule 5—Patient contributions
(sections 54 to 58)
Listed Drug | Form | Manner of Administration | Brand | Quantity or Number of Units | Approved Ex‑manufacturer Price | Claimed Ex‑manufacturer Price |
Ondansetron | Wafer 4 mg | Oral | Zofran Zydis | 4 | $3.41 | $5.69 |
Ondansetron | Wafer 8 mg | Oral | Zofran Zydis | 4 | $5.35 | $7.63 |
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
ad = added or inserted | o = order(s) |
am = amended | Ord = Ordinance |
amdt = amendment | orig = original |
c = clause(s) | par = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
Ch = Chapter(s) | pres = present |
def = definition(s) | prev = previous |
Dict = Dictionary | (prev…) = previously |
disallowed = disallowed by Parliament | Pt = Part(s) |
Div = Division(s) | r = regulation(s)/rule(s) |
ed = editorial change | reloc = relocated |
exp = expires/expired or ceases/ceased to have | renum = renumbered |
effect | rep = repealed |
F = Federal Register of Legislation | rs = repealed and substituted |
gaz = gazette | s = section(s)/subsection(s) |
LA = Legislation Act 2003 | Sch = Schedule(s) |
LIA = Legislative Instruments Act 2003 | Sdiv = Subdivision(s) |
(md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
effect | SR = Statutory Rules |
(md not incorp) = misdescribed amendment | Sub‑Ch = Sub‑Chapter(s) |
cannot be given effect | SubPt = Subpart(s) |
mod = modified/modification | underlining = whole or part not |
No. = Number(s) | commenced or to be commenced |
Name | Registration | Commencement | Application, saving and transitional provisions |
PB 79 of 2011 | 29 Nov 2011 (F2011L02491) | 1 Dec 2011 |
|
PB 100 of 2011 | 20 Dec 2011 (F2011L02756) | 1 Jan 2012 | — |
PB 4 of 2012 | 23 Feb 2012 (F2012L00379) | 1 Mar 2012 | — |
PB 18 of 2012 | 29 Mar 2012 (F2012L00721) | 1 Apr 2012 | — |
PB 32 of 2012 | 30 Apr 2012 (F2012L00951) | 1 May 2012 | — |
PB 36 of 2012 | 30 May 2012 (F2012L01118) | 1 June 2012 | — |
PB 40 of 2012 | 25 June 2012 (F2012L01332) | 1 July 2012 | — |
PB 48 of 2012 | 27 July 2012 (F2012L01616) | 1 Aug 2012 | — |
PB 65 of 2012 | 21 Aug 2012 (F2012L01730) | 1 Sept 2012 | — |
PB 77 of 2012 | 28 Sept 2012 (F2012L01966) | 1 Oct 2012 | — |
PB 97 of 2012 | 29 Nov 2012 (F2012L02290) | 1 Dec 2012 | — |
PB 3 of 2013 | 14 Jan 2013 (F2013L00046) | 1 Feb 2013 | — |
PB 11 of 2013 | 21 Feb 2013 (F2013L00254) | 1 Mar 2013 | — |
PB 17 of 2013 | 27 Mar 2013 (F2013L00563) | 1 Apr 2013 | — |
PB 25 of 2013 | 26 Apr 2013 (F2013L00691) | 1 May 2013 | — |
PB 31 of 2013 | 24 May 2013 (F2013L00842) | 1 June 2013 | — |
PB 36 of 2013 | 18 June 2013 (F2013L01039) | 1 July 2013 | — |
PB 43 of 2013 | 29 July 2013 (F2013L01453) | 1 Aug 2013 | — |
PB 57 of 2013 | 28 Aug 2013 (F2013L01631) | 1 Sept 2013 | — |
PB 64 of 2013 | 24 Sept 2013 (F2013L01735) | 1 Oct 2013 | — |
PB 71 of 2013 | 18 Oct 2013 (F2013L01813) | 1 Nov 2013 | — |
PB 79 of 2013 | 29 Nov 2013 (F2013L02023) | 1 Dec 2013 | — |
PB 93 of 2013 | 24 Dec 2013 (F2013L02195) | 1 Jan 2014 | — |
PB 5 of 2014 | 23 Jan 2014 (F2014L00079) | 1 Feb 2014 | — |
PB 12 of 2014 | 26 Feb 2014 (F2014L00191) | 1 Mar 2014 | — |
PB 21 of 2014 | 27 Mar 2014 (F2014L00360) | 1 Apr 2014 | — |
PB 31 of 2014 | 28 Apr 2014 (F2014L00438) | 1 May 2014 | — |
PB 41 of 2014 | 21 May 2014 (F2014L00578) | 1 June 2014 | — |
PB 49 of 2014 | 1 July 2014 (F2014L00919) | 1 July 2014 | — |
PB 56 of 2014 | 30 July 2014 (F2014L01053) | 1 Aug 2014 | — |
PB 64 of 2014 | 25 Aug 2014 (F2014L01124) | 1 Sept 2014 | — |
PB 78 of 2014 | 26 Sept 2014 (F2014L01291) | 1 Oct 2014 | — |
PB 86 of 2014 | 29 Oct 2014 (F2014L01439) | 1 Nov 2014 (s 2) | — |
PB 94 of 2014 | 1 Dec 2014 (F2014L01615) | 1 Dec 2014 (s 2) | — |
PB 104 of 2014 | 24 Dec 2014 (F2014L01834) | 1 Jan 2015 (s 2) | — |
PB 4 of 2015 | 30 Jan 2015 (F2015L00083) | 1 Feb 2015 (s 2) | — |
PB 13 of 2015 | 27 Feb 2015 (F2015L00230) | 1 Mar 2015 (s 2) | — |
PB 31 of 2015 | 1 Apr 2015 (F2015L00434) | 1 Apr 2015 (s 2) | — |
PB 44 of 2015 | 29 Apr 2015 (F2015L00604) | 1 May 2015 (s 2) | — |
PB 51 of 2015 | 1 June 2015 (F2015L00769) | 1 June 2015 (s 2) | — |
PB 59 of 2015 | 30 June 2015 (F2015L01060) | 1 July 2015 (s 2) | — |
PB 73 of 2015 | 31 July 2015 (F2015L01200) | 1 Aug 2015 (s 2) | — |
PB 84 of 2015 | 31 Aug 2015 (F2015L01361) | 1 Sept 2015 (s 2) | — |
PB 95 of 2015 | 1 Oct 2015 (F2015L01604) | 1 Oct 2015 (s 2) | — |
PB 105 of 2015 | 29 Oct 2015 (F2015L01715) | 1 Nov 2015 (s 2) | — |
PB 112 of 2015 | 1 Dec 2015 (F2015L01898) | 1 Dec 2015 (s 2) | — |
PB 122 of 2015 | 24 Dec 2015 (F2015L02132) | 1 Jan 2016 (s 2) | — |
PB 6 of 2016 | 1 Feb 2016 (F2016L00080) | 1 Feb 2016 (s 2) | — |
PB 14 of 2016 | 1 Mar 2016 (F2016L00213) | 1 Mar 2016 (s 2) | — |
PB 23 of 2016 | 1 Apr 2016 (F2016L00483) | 1 Apr 2016 (s 2) | — |
PB 34 of 2016 | 29 Apr 2016 (F2016L00605) | 1 May 2016 (s 2) | — |
PB 46 of 2016 | 31 May 2016 (F2016L00920) | 1 June 2016 (s 2) | — |
PB 56 of 2016 | 28 June 2016 (F2016L01092) | 1 July 2016 (s 2) | — |
PB 61 of 2016 | 1 July 2016 (F2016L01132) | 1 July 2016 (s 2) | — |
PB 68 of 2016 | 28 July 2016 (F2016L01241) | 1 Aug 2016 (s 2) | — |
PB 77 of 2016 | 31 Aug 2016 (F2016L01369) | 1 Sept 2016 (s 2) | — |
PB 85 of 2016 | 30 Sept 2016 (F2016L01567) | 1 Oct 2016 (s 2) | — |
PB 101 of 2016 | 30 Nov 2016 (F2016L01836) | 1 Dec 2016 (s 2) | — |
PB 114 of 2016 | 22 Dec 2016 (F2016L02032) | 1 Jan 2017 (s 2) | — |
PB 6 of 2017 | 27 Jan 2017 (F2017L00074) | 1 Feb 2017 (s 2) | — |
PB 13 of 2017 | 15 Mar 2017 (F2017L00226) | 16 Mar 2017 (s 2) | — |
PB 21 of 2017 | 31 Mar 2017 (F2017L00376) | 1 Apr 2017 (s 2) | — |
PB 31 of 2017 | 28 Apr 2017 (F2017L00490) | Sch 1: 1 May 2017 (s 2(1) item 2) | — |
PB 40 of 2017 | 31 May 2017 (F2017L00624) | 1 June 2017 (s 2) | — |
PB 48 of 2017 | 30 June 2017 (F2017L00860) | 1 July 2017 (s 2) | — |
PB 58 of 2017 | 28 July 2017 (F2017L00963) | 1 Aug 2017 (s 2) | — |
PB 67 of 2017 | 31 Aug 2017 (F2017L01120) | 1 Sept 2017 (s 2) | — |
PB 76 of 2017 | 26 Sept 2017 (F2017L01261) | 1 Oct 2017 (s 2) | — |
PB 89 of 2017 | 30 Oct 2017 (F2017L01402) | 1 Nov 2017 (s 2) | — |
PB 96 of 2017 | 1 Dec 2017 (F2017L01557) | 1 Dec 2017 (s 1) | — |
PB 105 of 2017 | 18 Dec 2017 (F2017L01640) | 1 Jan 2018 (s 2) | — |
PB 7 of 2018 | 30 Jan 2018 (F2018L00066) | 1 Feb 2018 (s 2) | — |
PB 17 of 2018 | 28 Feb 2018 (F2018L00169) | 1 Mar 2018 (s 2) | — |
PB 23 of 2018 | 28 Mar 2018 (F2018L00424) | 1 Apr 2018 (s 2) | — |
PB 33 of 2018 | 30 Apr 2018 (F2018L00549) | 1 May 2018 (s 2) | — |
PB 41 of 2018 | 31 May 2018 (F2018L00682) | 1 June 2018 (s 2) | — |
PB 55 of 2018 | 29 June 2018 (F2018L00953) | 1 July 2018 (s 2) | — |
PB 68 of 2018 | 31 July 2018 (F2018L01067) | 1 Aug 2018 (s 2) | — |
PB 78 of 2018 | 30 Aug 2018 (F2018L01212) | 1 Sept 2018 (s 2) | — |
PB 86 of 2018 | 27 Sept 2018 (F2018L01362) | 1 Oct 2018 (s 2) | — |
PB 95 of 2018 | 29 Oct 2018 (F2018L01500) | 1 Nov 2018 (s 2) | — |
PB 103 of 2018 | 30 Nov 2018 (F2018L01638) | 1 Dec 2018 (s 2) | — |
PB 112 of 2018 | 21 Dec 2018 (F2018L01818) | 1 Jan 2019 (s 2) | — |
PB 4 of 2019 | 31 Jan 2019 (F2019L00074) | 1 Feb 2019 (s 2) | — |
PB 14 of 2019 | 28 Feb 2019 (F2019L00218) | 1 Mar 2019 (s 2) | — |
PB 21 of 2019 | 29 Mar 2019 (F2019L00469) | 1 Apr 2019 (s 2) | — |
PB 32 of 2019 | 30 Apr 2019 (F2019L00664) | 1 May 2019 (s 2) | — |
PB 40 of 2019 | 30 May 2019 (F2019L00699) | 1 June 2019 (s 2) | — |
PB 49 of 2019 | 28 June 2019 (F2019L00924) | 1 July 2019 (s 2) | — |
PB 62 of 2019 | 31 July 2019 (F2019L01025) | 1 Aug 2019 (s 2) | — |
PB 71 of 2019 | 30 Aug 2019 (F2019L01125) | 1 Sept 2019 (s 2) | — |
PB 79 of 2019 | 30 Sept 2019 (F2019L01296) | 1 Oct 2019 (s 2) | — |
PB 88 of 2019 | 31 Oct 2019 (F2019L01390) | 1 Nov 2019 (s 2) | — |
PB 96 of 2019 | 29 Nov 2019 (F2019L01527) | 1 Dec 2019 (s 2) | — |
PB 107 of 2019 | 23 Dec 2019 (F2019L01702) | 1 Jan 2020 (s 2) | — |
PB 5 of 2020 | 31 Jan 2020 (F2020L00072) | 1 Feb 2020 (s 2) | — |
PB 18 of 2020 | 28 Feb 2020 (F2020L00187) | 1 Mar 2020 (s 2) | — |
PB 25 of 2020 | 31 Mar 2020 (F2020L00364) | 1 Apr 2020 (s 2) | — |
PB 38 of 2020 | 30 Apr 2020 (F2020L00525) | 1 May 2020 (s 2) | — |
PB 47 of 2020 | 29 May 2020 (F2020L00649) | 1 June 2020 (s 2) | — |
PB 60 of 2020 | 30 June 2020 (F2020L00852) | 1 July 2020 (s 2) | — |
PB 53 of 2020 | 20 Aug 2020 (F2020L01037) | 21 Aug 2020 (s 2(1) item 1) | — |
PB 83 of 2020 | 28 Aug 2020 (F2020L01091) | 1 Sept 2020 (s 2) | — |
PB 94 of 2020 | 30 Sept 2020 (F2020L01262) | 1 Oct 2020 (s 2) | — |
PB 107 of 2020 | 30 Oct 2020 (F2020L01369) | 1 Nov 2020 (s 2) | — |
Provision affected | How affected |
Part 1 |
|
Division 1 |
|
s 2..................... | rep LA s 48D |
s 3..................... | am PB 18, 40 and 48 of 2012; PB 36 of 2013; PB 49 of 2014; PB 31 and 59 of 2015; PB 56, 61 and 77 of 2016; PB 48 of 2017; PB 96 of 2017; PB 55 of 2018; PB 103 of 2018; PB 49 of 2019; PB 60 of 2020; PB 53 of 2020 |
Division 2 |
|
s 9..................... | am PB 31 of 2015; PB 53 of 2020 |
s 10.................... | am PB 31 of 2015 |
s 11.................... | am PB 31 of 2015; PB 53 of 2020 |
s 12.................... | am PB 31 of 2015 |
Part 2 |
|
Division 1 |
|
s 14.................... | am PB 31 of 2015; PB 96 of 2017; PB 53 of 2020 |
| ed C101 |
s 15.................... | am PB 31 of 2015; PB 96 of 2017; PB 53 of 2020 |
s 16.................... | rs PB 31 of 2015 |
| am PB 96 of 2017; PB 53 of 2020 |
s 17.................... | am PB 31 of 2015; PB 96 of 2017; PB 53 of 2020 |
s 18.................... | am PB 31 of 2015; PB 53 of 2020 |
Division 2 |
|
s 19.................... | am PB 31 of 2015; PB 96 of 2017; PB 53 of 2020 |
s 20.................... | rep PB 31 of 2015 |
| ad PB 53 of 2020 |
s 21.................... | rep PB 31 of 2015 |
Division 3 |
|
s 22.................... | am PB 31 of 2015; PB 34 of 2016; PB 53 of 2020 |
s 23.................... | rep PB 31 of 2015 |
s 24.................... | rep PB 31 of 2015 |
s 25.................... | rep PB 31 of 2015 |
s 26.................... | rep PB 31 of 2015 |
s 27.................... | rep PB 31 of 2015 |
s 28.................... | rep PB 31 of 2015 |
s 29.................... | rep PB 31 of 2015 |
Part 3 |
|
s 31.................... | am PB 31 of 2015; PB 53 of 2020 |
s 33.................... | am PB 31 of 2015; PB 53 of 2020 |
s 34.................... | am PB 31 of 2015; PB 96 of 2017; PB 53 of 2020 |
s 35.................... | am PB 31 of 2015 |
s 34A................... | ad PB 94, 2014 |
s 35.................... | rep PB 31 of 2015 |
Part 4 |
|
Part 4 heading............. | rs PB 18 of 2012 |
Division 1 |
|
Division 1 heading.......... | rs PB 18 of 2012 |
s 36.................... | am PB 31 of 2015 |
s 37.................... | rs PB 18 of 2012 |
| am PB 96 of 2017; PB 53 of 2020 |
s 38.................... | rep PB 31 of 2015 |
s 39.................... | rs PB 18 of 2012 |
| am PB 31 of 2015; PB 96 of 2017 |
s 40.................... | rep PB 31 of 2015 |
Division 2 |
|
s 44.................... | rep PB 31 of 2015 |
Division 2A |
|
Division 2A............... | ad PB 59 of 2015 |
| rs PB 77 of 2016 |
s 46A................... | ad PB 59 of 2015 |
| rs PB 77 of 2016 |
| am PB 13 of 2017; PB 96 of 2017 |
s 46B................... | ad PB 59 of 2015 |
| rs PB 77 of 2016 |
| am PB 13 of 2017; PB 96 of 2017 |
s 46C................... | ad PB 59 of 2015 |
| rep PB 77 of 2016 |
Division 3 |
|
s 48.................... | rs PB 59 of 2015 |
| am PB 53 of 2020 |
Division 4 |
|
s 52.................... | am PB 31 of 2015 |
Part 5 |
|
s 56.................... | rep PB 31 of 2015 |
s 57.................... | am PB 31 of 2015 |
s 59.................... | am PB 31 of 2015 |
Part 5A |
|
Part 5A.................. | ad PB 53 of 2020 |
s 59A................... | ad PB 53 of 2020 |
Part 6 |
|
s 60.................... | rs PB 31 of 2015 |
| am PB 21 of 2017; PB 96 of 2017; PB 53 of 2020 |
s 61.................... | ad PB 59 of 2015 |
| exp 1 Nov 2015 (s 61(3)) |
| rep PB 77 of 2016 |
Schedule 1 |
|
Schedule 1................ | am PB 100 of 2011; PB 4, 18, 32, 36, 40, 48, 65, 77 and 97 of 2012; PB 3, 11, 17, 25, 31, 36, 43, 57, 64, 71 and 79 of 2013; PB 5, 12, 21, 31, 41, 49, 56, 64, 78, 86, 94 and 104 (Sch 1 item 1 md) of 2014; PB 4, 13, 31, 44, 51, 59 (Sch 1 item 19 md), 73, 84 (Sch 1 item 1 md), 95, 105, 112 and 122 of 2015; PB 6, 14, 23 (Sch 1 item 15 md), 34, 46, 56, 68, 77, 85, 101 and 114 of 2016; PB 6 of 2017; PB 21 of 2017; PB 31 of 2017; PB 40 of 2017; PB 48 of 2017; PB 58 of 2017; PB 67 of 2017; PB 76 of 2017; PB 89 of 2017; PB 96 of 2017; PB 105 of 2017; PB 7 of 2018; PB 17 of 2018; PB 23 of 2018; PB 33 of 2018; PB 55 of 2018; PB 68 of 2018; PB 78 of 2018; PB 86 of 2018; PB 95 of 2018; PB 103 of 2018; PB 112 of 2018 |
| ed C82 |
| am PB 4 of 2019; PB 14 of 2019; PB 21 of 2019; PB 32 of 2019; PB 40 of 2019; PB 49 of 2019; PB 62 of 2019; PB 71 of 2019; PB 79 of 2019; PB 88 of 2019; PB 96 of 2019; PB 107 of 2019; PB 5 of 2020; PB 18 of 2020; PB 25 of 2020; PB 38 of 2020; PB 47 of 2020; PB 60 of 2020; PB 83 of 2020; PB 94 of 2020, PB 107 of 2020 |
Schedule 2 |
|
Schedule 2................ | am PB 40, 77 and 97 of 2012; PB 17, 25, 43, 57, 64 and 93 of 2013; PB 21 and 64 of 2014; PB 31, 51, 73, 95, 105 and 112 of 2015; PB 14, 23, 34, 46, 56, 68, 85 and 114 of 2016; PB 31 of 2017; PB 40 of 2017; PB 67 of 2017; PB 89 of 2017; PB 7 of 2018; PB 41 of 2018; PB 55 of 2018; PB 32 of 2019; PB 62 of 2019; PB 79 of 2019; PB 88 of 2019; PB 18 of 2020; PB 25 of 2020; PB 38 of 2020; PB 60 of 2020; PB 94 of 2020 |
Schedule 3 |
|
Schedule 3................ | am PB 32 and 40 of 2012; PB 3, 17 and 64 of 2013; PB 21, 31, 41, 49, 64, 78 and 94 of 2014; PB 59, 95 and 112 of 2015; PB 6, 14, 23, 34, 46, 68 and 114 of 2016; PB 6 of 2017; PB 40 of 2017; PB 58 of 2017; PB 89 of 2017; PB 33 of 2018; PB 78 of 2018; PB 86 of 2018; PB 103 of 2018; PB 112 of 2018; PB 4 of 2019; PB 32 of 2019; PB 40 of 2019; PB 71 of 2019; PB 79 of 2019; PB 88 of 2019; PB 107 of 2019; PB 18 of 2020; PB 94 of 2020 |
Schedule 4 |
|
Schedule 4................ | am PB 100 of 2011; PB 4, 48, 77 and 97 of 2012; PB 25, 43, 79 and 93 of 2013; PB 21, 56, 78, 86, 94 and 104 of 2014; PB 4, 13, 31, 51, 59, 73, 84, 95, 105, 112 and 122 of 2015; PB 14, 23 (Sch 1 item 15 md), 34, 46, 56, 68, 85, 101 and 114 of 2016; PB 21 of 2017; PB 31 of 2017; PB 40 of 2017; PB 48 of 2017; PB 58 of 2017; PB 89 of 2017; PB 96 of 2017; PB 105 of 2017; PB 7 of 2018; PB 17 of 2018; PB 23 of 2018; PB 33 of 2018; PB 41 of 2018; PB 55 of 2018; PB 68 of 2018; PB 78 of 2018; PB 86 of 2018; PB 95 of 2018; PB 103 of 2018; PB 14 of 2019; PB 21 of 2019 |
| ed C85 |
| am PB 32 of 2019; PB 49 of 2019; PB 62 of 2019; PB 71 of 2019; PB 79 of 2019 |
| ed C91 |
| am PB 88 of 2019; PB 96 of 2019; PB 107 of 2019; PB 18 of 2020; PB 25 of 2020; PB 38 of 2020; PB 47 of 2020; PB 60 of 2020; PB 83 of 2020; PB 94 of 2020; PB 107 of 2020 |
Schedule 5 |
|
Schedule 5................ | am PB 18 and 32 of 2012; PB 94 of 2014; PB 95 of 2015; PB 101 of 2016; PB 76 of 2017 |