Commonwealth Coat of Arms of Australia

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. 143

Compilation date: 1 February 2024

Includes amendments: F2024L00122

Registered: 16 February 2024

About this compilation

This compilation

This is a compilation of the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 that shows the text of the law as amended and in force on 1 February 2024 (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 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 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 Register for the compiled law.

Selfrepealing 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 Conditions for approved pharmacists do not apply to infusions and certain related pharmaceutical benefits

Part 4Claims, payment and provision of under copayment data

Division 1Claims for payment and provision of under copayment data

36 How claims to be made

37 Modified references for claim and provision of under copayment 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

41A Paragraph 99(3)(b) of the Act does not apply to infusions and certain related pharmaceutical benefits

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 Markup for a chemotherapy pharmaceutical benefit that does not have trastuzumab

49 Markup 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

Part 1General

Division 1Preliminary

1  Name of Special Arrangement

 (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.

3  Definitions

 (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 $5.77.

dispensing fee means an amount of $8.37.

distribution fee means an amount of $29.15.

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 nonadmitted 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 10 of the National Health (Highly Specialised Drugs Program) Special Arrangement 2021.

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 $88.62.

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 copayment 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 2Pharmaceutical 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.

6  Responsible person

 (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.

7  Authorised prescriber

 (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 unless the pharmaceutical benefit is mentioned in Part 2 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (readyprepared pharmaceutical benefits for supply only).

8  Prescription circumstances

 (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.

13  Section 100 only supply

 (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.

Part 2Prescription

Division 1Chemotherapy 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.

15  Information to be included in infusion prescription, other than chemotherapy medication chart prescription directing the supply of an infusion

 (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.

16  Information to be included in chemotherapy medication chart prescription directing the supply of an infusion

 (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 2Related 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 3Authority 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)(a), (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.

Part 3Supply

 

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  Conditions for approved pharmacists do not apply to infusions and certain related pharmaceutical benefits

  The National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017 does not apply to the dispensing or supply of:

 (a) an infusion; or

 (b) a pharmaceutical benefit mentioned in Schedule 2 for which the manner of administration is injection or intravesical;

that is supplied under this Special Arrangement.

Part 4Claims, payment and provision of under copayment data

Division 1Claims for payment and provision of under copayment data

36  How claims to be made

 (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 copayment 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 copayment 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 10 of the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 for a HSD hospital authority; and

 (c) the definition of under copayment data in section 4 of this Special Arrangement replaces the definition of under copayment 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 copayment 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 copayment 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 copayment 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.

Division 2Payment of claim

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).

41A  Paragraph 99(3)(b) of the Act does not apply to infusions and certain related pharmaceutical benefits

  Paragraph 99(3)(b) of the Act does not apply to the supply of:

 (a) an infusion; or

 (b) a pharmaceutical benefit mentioned in Schedule 2 for which the manner of administration is injection or intravesical;

under this Special Arrangement.

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 2APayments 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 3Dispensed price of chemotherapy drug

47  Dispensed price if drug is in infusion supplied by approved pharmacist or approved medical practitioner

 (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 exmanufacturer 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 markup 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 exmanufacturer 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 exmanufacturer price of the pack would be divided by 3 to obtain the exmanufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

48  Markup for a chemotherapy pharmaceutical benefit that does not have trastuzumab

  For subparagraph 47(4)(b)(i), the markup for a chemotherapy pharmaceutical benefit that does not have trastuzumab is:

 (markup for maximum multiple) ÷ (maximum multiple of pharmaceutical benefit).

where:

markup 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  Markup for chemotherapy pharmaceutical benefit that has trastuzumab

 (1) For subparagraph 47(4)(b)(ii), the markup for a chemotherapy pharmaceutical benefit that has trastuzumab is:

Start formula open bracket mark-up for maximum multiple close bracket divided by open bracket maximum multiple of pharmaceutical benefit close bracket end formula

where:

markup 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 markup for the maximum multiple of a chemotherapy pharmaceutical benefit with an exmanufacturer price mentioned in the table is the amount mentioned in the table.

 

Item

Exmanufacturer price for maximum multiple of pharmaceutical benefit

Markup for maximum multiple

1

≤ $40

10% of exmanufacturer price for maximum multiple of pharmaceutical benefit

2

> $40, ≤ $100

$4

3

> $100, ≤ $1 000

4% of exmanufacturer 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 exmanufacturer 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 exmanufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

Note: The reference price and the exmanufacturer 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 exmanufacturer price of the pack would be divided by 3 to obtain the exmanufacturer 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 exmanufacturer 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 exmanufacturer 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 exmanufacturer price of the pack would be divided by 3 to obtain the exmanufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

Division 4Dispensed 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 exmanufacturer 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 exmanufacturer 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 exmanufacturer 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 exmanufacturer price for the complete pack.

Part 5Patient contributions

 

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 copayment 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 copayment 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 copayment

 (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 Exmanufacturer Price’ column in Schedule 5 from the amount mentioned for the pharmaceutical benefit in the ‘Claimed Exmanufacturer Price’ column in Schedule 5.

 (2) However, the amounts mentioned in the ‘Approved Exmanufacturer price’ and ‘Claimed Exmanufacturer 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).

Part 5ARecord keeping

 

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.

Part 6Transitional

 

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 copayment 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 (COVID19 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 1Chemotherapy pharmaceutical benefits and chemotherapy drugs

(sections 3, 4, 6, 8, 9, 11, 13, 22 and 33)

Part 1Chemotherapy 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

Arsenic Trioxide Accord

OC

MP

C4793 C5997 C6018

D

 

 

 

Arsenic TrioxideAFT

AE

MP

C4793 C5997 C6018

D

 

 

 

Arsenic Trioxide Juno

JU

MP

C4793 C5997 C6018

D

 

 

 

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 C10509 C10972 C13446 C13451

D

 

Solution concentrate for I.V. infusion 1200 mg in 20 mL

Injection

Tecentriq

RO

MP

C10125 C10206 C10216 C10297 C10521 C10917 C10939 C13442 C13443 C13448

D

Avelumab

Solution concentrate for I.V. infusion 200 mg in 10 mL

Injection

Bavencio

SG

MP

C8947 C10023 C13290 C13303 C13313

D

Bendamustine

Powder for injection containing bendamustine hydrochloride 25 mg

Injection

Bendamustine Juno

JU

MP

C7943 C7944 C7972

D

 

 

 

Bendamustine Sandoz

SZ

MP

C7943 C7944 C7972

D

 

 

 

Bendamustine Viatris

AF

MP

C7943 C7944 C7972

D

 

 

 

Ribomustin

JC

MP

C7943 C7944 C7972

D

 

Powder for injection containing bendamustine hydrochloride 100 mg

Injection

Bendamustine Juno

JU

MP

C7943 C7944 C7972

D

 

 

 

Bendamustine Sandoz

SZ

MP

C7943 C7944 C7972

D

 

 

 

Bendamustine Viatris

AF

MP

C7943 C7944 C7972

D

 

 

 

Ribomustin

JC

MP

C7943 C7944 C7972

D

Bevacizumab

Solution for I.V. infusion 100 mg in 4 mL

Injection

Abevmy

AF

MP12479T(IP);12508H(IN)

 

D

 

 

 

Bevaciptin

LR

MP

 

D

 

 

 

Mvasi

AN

MP

 

D

 

Solution for I.V. infusion 400 mg in 16 mL

Injection

Abevmy

AF

MP12479T(IP);12508H(IN)

 

D

 

 

 

Bevaciptin

LR

MP

 

D

 

 

 

Mvasi

AN

MP

 

D

Bleomycin

Powder for injection containing bleomycin sulfate 15,000 I.U.

Injection

DBL Bleomycin Sulfate

PF

MP

C6224 C6275

D

Blinatumomab

Powder for I.V. infusion 38.5 micrograms

Injection

Blincyto

AN

MP

C9369 C9519 C14587 C14588 C14631

D

Bortezomib

Powder for injection 1 mg

Injection

Bortezomib Accord

OC

MP

C11099 C13745

D

 

 

 

DBL Bortezomib

PF

MP

C11099 C13745

D

 

 

 

Velcade

JC

MP

C11099 C13745

D

 

Powder for injection 2.5 mg

Injection

Bortezomib Juno

JU

MP

C11099 C13745

D

 

 

 

DBL Bortezomib

PF

MP

C11099 C13745

D

 

Powder for injection 3 mg

Injection

DBL Bortezomib

PF

MP

C11099 C13745

D

 

 

 

Velcade

JC

MP

C11099 C13745

D

 

Powder for injection 3.5 mg

Injection

Bortezom

CR

MP

C11099 C13745

D

 

 

 

Bortezomib Accord

OC

MP

C11099 C13745

D

 

 

 

Bortezomib Baxter

BX

MP

C11099 C13745

D

 

 

 

Bortezomib Juno

JU

MP

C11099 C13745

D

 

 

 

Bortezomib Sandoz

SZ

MP

C11099 C13745

D

 

 

 

BORTEZOMIBTEVA

TB

MP

C11099 C13745

D

 

 

 

DBL Bortezomib

PF

MP

C11099 C13745

D

 

 

 

Velcade

JC

MP

C11099 C13745

D

 

Solution for injection 2.5 mg in 1 mL

Injection

Bortezomib Accord

OC

MP

C11099 C13745

D

 

 

 

Bortezomib Ever Pharma

IT

MP

C11099 C13745

D

 

Solution for injection 3.5 mg in 1.4 mL

Injection

Bortezomib Accord

OC

MP

C11099 C13745

D

 

 

 

Bortezomib Ever Pharma

IT

MP

C11099 C13745

D

Brentuximab vedotin

Powder for I.V. infusion 50 mg

Injection

Adcetris

TK

MP

C13134 C13179 C13181 C13182 C13208 C13209 C13212 C13231 C13259 C13261

D

Cabazitaxel

Concentrated injection 60 mg in 1.5 mL, with diluent

Injection

Cabazitaxel Juno

JU

MP

C13207

D

 

 

 

MSN Cabazitaxel

RQ

MP

C13207

D

 

Solution concentrate for I.V. infusion 60 mg in 3 mL

Injection

Cabazitaxel Accord

OC

MP

C13207

D

 

Solution concentrate for I.V. infusion 60 mg in 6 mL

Injection

Cabazitaxel Ever Pharma

IT

MP

C13207

D

Carboplatin

Solution for I.V. injection 450 mg in 45 mL

Injection

Carboplatin Accord

OC

MP

 

D

Carfilzomib

Powder for injection 10 mg

Injection

Kyprolis

AN

MP

C12694 C12849 C12930 C12934 C14363 C14364 C14389

D

 

Powder for injection 30 mg

Injection

Kyprolis

AN

MP

C12694 C12849 C12930 C12934 C14363 C14364 C14389

D

 

Powder for injection 60 mg

Injection

Kyprolis

AN

MP

C12694 C12849 C12930 C12934 C14363 C14364 C14389

D

Cemiplimab

Solution concentrate for I.V. infusion 350 mg in 7 mL

Injection

Libtayo

SW

MP

C13322 C13373 C13411 C13419 C13766

D

Cetuximab

Solution for I.V. infusion 100 mg in 20 mL

Injection

Erbitux

SG

MP

C4785 C4788 C4794 C4908 C4912 C12016 C12045 C12470 C12483

D

 

Solution for I.V. infusion 500 mg in 100 mL

Injection

Erbitux

SG

MP

C4785 C4788 C4794 C4908 C4912 C12016 C12045 C12470 C12483

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

IX

MP

C6265

D

Cyclophosphamide

Powder for injection 500 mg (anhydrous)

Injection

CYCLOPHOSPHAMIDEREACH

RQ

MP

 

PB

 

 

 

Endoxan

BX

MP

 

PB

 

Powder for injection 1 g (anhydrous)

Injection

CYCLOPHOSPHAMIDEREACH

RQ

MP

 

PB

 

 

 

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

Daratumumab

Solution concentrate for I.V. infusion 100 mg in 5 mL

Injection

Darzalex

JC

MP

C12691 C12844 C12845 C13752

PB

 

Solution concentrate for I.V. infusion 400 mg in
20 mL

Injection

Darzalex

JC

MP

C12691 C12844 C12845 C13752

PB

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/
intravesical

Adriamycin

PF

MP

 

D

 

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

Injection/
intravesical

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

BX

MP

 

D

 

 

 

Liposomal Doxorubicin SUN

RA

MP

 

D

 

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL

Injection

Caelyx

BX

MP

 

D

 

 

 

Liposomal Doxorubicin SUN

RA

MP

 

D

Durvalumab

Solution concentrate for I.V. infusion 120 mg in 2.4 mL

Injection

Imfinzi

AP

MP

C10126 C10206 C10509 C12271 C14708

D

 

Solution concentrate for I.V. infusion 500 mg in 10 mL

Injection

Imfinzi

AP

MP

C10126 C10206 C10509 C12271 C14708

D

Elotuzumab

Powder for injection 300 mg

Injection

Empliciti

BQ

MP

C12847 C12891

D

 

Powder for injection 400 mg

Injection

Empliciti

BQ

MP

C12847 C12891

D

Enfortumab vedotin

Powder for I.V. infusion 20 mg

Injection

Padcev

LL

MP

C14416

D

 

Powder for I.V. infusion 30 mg

Injection

Padcev

LL

MP

C14416

D

Epirubicin

Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

Injection/
intravesical

Epirubicin Accord

OC

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

Fludarabine

Powder for I.V. injection containing fludarabine phosphate 50 mg

Injection

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

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

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

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

Gemtuzumab ozogamicin

Powder for injection 5 mg

Injection

Mylotarg

PF

MP

C12559 C12566

D

Idarubicin

Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 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 C11391 C11478 C11930 C14808

D

 

Injection concentrate for I.V. infusion 200 mg in 40 mL

Injection

Yervoy

BQ

MP

C6562 C6585 C14808

D

Irinotecan

I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

Injection

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 BAXTER

BX

MP

 

D

 

 

 

Omegapharm Irinotecan

OE

MP

 

D

 

I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

Injection

Irinotecan Accord

OC

MP

 

D

 

 

 

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

 

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

 

 

 

Methotrexate Accord

OD

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

C9216 C9252 C9298 C9299 C9312 C9321 C10119 C10120 C11468 C11477 C11985 C13433 C13445 C13839 C13852 C13863 C13900 C14001 C14676 C14816 C14830

D

 

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

BQ

MP

C9216 C9252 C9298 C9299 C9312 C9321 C10119 C10120 C11468 C11477 C11985 C13433 C13445 C13839 C13852 C13863 C13900 C14001 C14676 C14816 C14830

D

Obinutuzumab

Solution for I.V. infusion 1000 mg in 40 mL

Injection

Gazyva

RO

MP

C11015 C11755 C11785 C11787 C11815 C14326 C14764

D

Oxaliplatin

Solution concentrate for I.V. infusion 100 mg in 20 mL

Injection

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 300 mg in 50 mL

Injection

Paclitaxel Accord

OC

MP

 

D

 

 

 

Paclitaxel Ebewe

SZ

MP

 

D

Paclitaxel, nanoparticle albuminbound

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

C5452 C5526 C12035 C12066

D

 

Solution concentrate for I.V. infusion 400 mg in 20 mL

Injection

Vectibix

AN

MP

C5452 C5526 C12035 C12066

D

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

MK

MP

C10676 C10688 C10701 C10705 C13431 C13432 C13436 C13437 C13726 C13727 C13728 C13730 C13731 C13732 C13735 C13736 C13738 C13739 C13741 C13948 C13949 C13986 C14027 C14028 C14044 C14324 C14403 C14404 C14405 C14727 C14770 C14786 C14817 C14818

D

Pemetrexed

Powder for I.V. infusion 100 mg (as disodium)

Injection

Pemetrexed Accord

OD

MP

 

D

 

 

 

Pemetrexed SUN

RA

MP

 

D

 

Powder for I.V. infusion 500 mg (as disodium)

Injection

Pemetrexed Accord

OD

MP

 

D

 

 

 

Pemetrexed APOTEX

TX

MP

 

D

 

 

 

Pemetrexed SUN

RA

MP

 

D

 

Powder for I.V. infusion 1 g (as disodium)

Injection

Pemetrexed Accord

OD

MP

 

D

 

 

 

Pemetrexed SUN

RA

MP

 

D

 

Solution concentrate for I.V. infusion 100 mg (as disodium) in 4 mL

Injection

Pemetrexed Ever Pharma

IT

MP

 

D

 

Solution concentrate for I.V. infusion 500 mg (as disodium) in 20mL

Injection

Pemetrexed Ever Pharma

IT

MP

 

D

 

Solution concentrate for I.V. infusion 1 g (as disodium) in 40 mL

Injection

Pemetrexed Ever Pharma

IT

MP

 

D

Pertuzumab

Solution for I.V. infusion 420 mg in 14 mL

Injection

Perjeta

RO

MP

C10414 C13018

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

 

D

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Riximyo

SZ

MP

 

D

 

 

 

Ruxience

PF

MP

 

D

 

 

 

Truxima

EW

MP

 

D

 

Solution for I.V. infusion 500 mg in 50 mL

Injection

Riximyo

SZ

MP

 

D

 

 

 

Ruxience

PF

MP

 

D

 

 

 

Truxima

EW

MP

 

D

Sacituzumab govitecan

Powder for injection 180 mg

Injection

Trodelvy

GI

MP

C12656 C12669

D

Tebentafusp

Solution concentrate for I.V. infusion 100 micrograms in 0.5 mL

Injection

Kimmtrak

WM

MP

C14813 C14821 C14822 C14825

D

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

Trabectedin

Powder for I.V. infusion 1 mg

Injection

Yondelis

ZL

MP

C14188 C14196 C14197

D

Trastuzumab

Powder for I.V. infusion 60 mg

Injection

Trazimera

PF

MP

C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296

PB

 

Powder for I.V. infusion 150 mg

Injection

Herzuma

EW

MP

C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296

PB

 

 

 

Kanjinti

JU

MP

C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296

PB

 

 

 

Ogivri

AF

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

JU

MP

C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296

PB

 

Powder for I.V. infusion 440 mg with diluent

Injection

Herzuma

EW

MP

C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296

PB

Trastuzumab deruxtecan

Powder for I.V. infusion 100 mg

Injection

Enhertu

AP

MP

C14470

D

Trastuzumab emtansine

Powder for I.V. infusion 100 mg

Injection

Kadcyla

RO

MP

C10295 C12989 C13004 C13017

D

 

Powder for I.V. infusion 160 mg

Injection

Kadcyla

RO

MP

C10295 C12989 C13004 C13017

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 2Chemotherapy drugs and related information

 

Listed Drug

Purposes

Maximum Amount

Number of Repeats

Arsenic

P4793 P5997

18 mg

89

 

P6018

18 mg

140

Atezolizumab

P10206 P10939

1200 mg

3

 

P10521

1200 mg

4

 

P10125 P13443 P13448

1200 mg

5

 

P10216 P10297 P13442

1200 mg

7

 

P10917

1200 mg

8

 

P10509 P13446

1680 mg

3

 

P10215 P10257 P10972 P13451

1680 mg

5

Avelumab

P13303 P13313

800 mg

7

 

P13290

800 mg

11

 

P8947

1200 mg

8

 

P10023

1200 mg

11

Bendamustine

 

200 mg

11

Bevacizumab

 

1800 mg

7

Bleomycin

 

30000 iu

11

Blinatumomab

P14588

651 mcg

0

 

P9519

784 mcg

0

 

P14587 P14631

784 mcg

1

 

P9369

784 mcg

2

Bortezomib

 

3000 mcg

15

Brentuximab vedotin

P13179

180 mg

3

 

P13181

180 mg

11

 

P13212

200 mg

1

 

P13182 P13209 P13259

200 mg

3

 

P13134

200 mg

5

 

P13208 P13231 P13261

200 mg

11

Cabazitaxel

 

55 mg

5

Carboplatin

 

900 mg

5

Carfilzomib

P14363 P14364 P14389

60 mg

17

 

P12930 P12934

120 mg

17

 

P12694 P12849

160 mg

8

Cemiplimab

P13419

350 mg

2

 

P13373 P13766

350 mg

6

 

P13322 P13411

350 mg

7

Cetuximab

P4788

550 mg

5

 

P12016 P12470

550 mg

11

 

P4912

550 mg

18

 

P4785 P4794 P4908 P12045 P12483

880 mg

0

Cisplatin

 

220 mg

14

Cladribine

 

17 mg

6

Cyclophosphamide

 

2800 mg

17

Cytarabine

 

7000 mg

15

Daratumumab

P12845

1920 mg

4

 

P12691

1920 mg

5

 

P12844

1920 mg

7

 

P13752

1920 mg

8

Docetaxel

 

250 mg

5

Doxorubicin

 

135 mg

11

Doxorubicin pegylated liposomal

 

100 mg

5

Durvalumab

P10206

1500 mg

3

 

P10126 P12271

1500 mg

4

 

P10509 P14708

1500 mg

5

Elotuzumab

P12847

1200 mg

5

 

P12891

1200 mg

9

Enfortumab vedotin

 

125 mg

8

Epirubicin

 

220 mg

5

Eribulin

P7258 P7280

3 mg

7

 

P4649

3 mg

13

Etoposide

 

440 mg

14

Fludarabine

 

55 mg

29

Fluorouracil

P6297

1000 mg

23

 

P6266

5500 mg

11

Gemcitabine

 

3000 mg

17

Gemtuzumab ozogamicin

P12566

5 mg

1

 

P12559

5 mg

2

Idarubicin

 

30 mg

5

Ifosfamide

 

4000 mg

19

Inotuzumab ozogamicin

P9601

2820 mcg

4

 

P9470

3384 mcg

2

Ipilimumab

P8555 P11930

120 mg

3

 

P11391 P11478

120 mg

4

 

P6562 P6585 P14808

360 mg

3

Irinotecan

 

800 mg

11

Methotrexate

 

250 mg

5

 

P6276

20000 mg

0

Mitozantrone

 

30 mg

5

Nivolumab

P13852 P14830

120 mg

3

 

P14001

360 mg

3

 

P11985

360 mg

8

 

P11468 P13433

360 mg 

13

 

P10119 P10120 P13900

480 mg

5

 

P9216 P9312 P13445 P14816

480 mg

8

 

P9252 P9298 P9299 P9321 P11477 P13839 P13863

480 mg

11

 

P14676

480 mg

13

Obinutuzumab

P11785 P11787 P14764

1000 mg

5

 

P11755 P14326

1000 mg

7

 

P11015

1000 mg

8

 

P11815

1000 mg

9

Oxaliplatin

 

300 mg

11

Paclitaxel

 

450 mg

3

Paclitaxel, nanoparticle albuminbound

P4657

275 mg

11

 

P6106 P6119

580 mg

5

Panitumumab

P12035 P12066

720 mg

5

 

P5452 P5526

720 mg

9

Pembrolizumab

P14818

200 mg

5

 

P13431 P13432

200 mg

6

 

P10705 P14770 P14786

200 mg

7

 

P14817

400 mg

2

 

P10676 P10688 P10701 P13436 P13437

400 mg

3

 

P13726 P13727 P13728 P13730 P13731 P13732 P13735 P13736 P13738 P13739 P13741 P13948 P13949 P13986 P14027 P14028 P14044 P14324 P14403 P14404 P14405

400 mg

6

 

P14727

400 mg

7

Pemetrexed

 

1100 mg

5

Pertuzumab

P10414

420 mg

3

 

P13018

840 mg

0

Pralatrexate

P7558

80 mg

5

 

P7526

80 mg

11

Raltitrexed

 

7 mg

8

Rituximab

 

800 mg

11

Sacituzumab govitecan

P12656

1200 mg

7

 

P12669

1200 mg

13

Tebentafusp

P14813

20 mcg

0

 

P14821

30 mcg

0

 

P14825

68 mcg

0

 

P14822

136 mcg

7

Topotecan

 

3500 mcg

17

Trabectedin

P14196

3250 mcg

3

 

P14188 P14197

3250 mcg

7

Trastuzumab

P10213

250 mg

9

 

P10296

500 mg

0

 

P9349 P9571 P10294

750 mg

3

 

P9353 P9573 P10293

1000 mg

0

Trastuzumab deruxtecan

 

675 mg

8

Trastuzumab emtansine

P10295 P13004

450 mg

6

 

P12989 P13017

450 mg

8

Vinblastine

 

20 mg

17

Vincristine

 

2 mg

7

Vinorelbine

 

70 mg

7

Schedule 2Related 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

 

 

 

APREPITANT SCP

XC

MP

C4216 C4223 C6383 C6464

 

1

5

C

Daratumumab

Solution for subcutaneous injection containing daratumumab 1800 mg in 15 mL

Injection

Darzalex SC

JC

MP

C12691 C12842 C12845 C13752 C13774 C13944 C14015

P12845

1

4

 

 

 

 

 

 

MP

C12691 C12842 C12845 C13752 C13774 C13944 C14015

P12691 P13774

1

5

 

 

 

 

 

 

MP

C12691 C12842 C12845 C13752 C13774 C13944 C14015

P12842

1

7

 

 

 

 

 

 

MP

C12691 C12842 C12845 C13752 C13774 C13944 C14015

P13752

1

8

 

 

 

 

 

 

MP

C12691 C12842 C12845 C13752 C13774 C13944 C14015

P13944 P14015

1

15

 

Folinic acid

Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

 

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

 

 

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

 

 

 

 

FOSAPREPITANTAFT

AE

MP

C6852 C6886 C6887 C6891

 

1

5

 

 

 

 

FOSAPREPITANT MSN

RQ

MP

C6852 C6886 C6887 C6891

 

1

5

 

Fosnetupitant with palonosetron

Solution concentrate for I.V. infusion containing fosnetupitant 235 mg (as chloride hydrochloride) and palonosetron 250 microgram (as hydrochloride)

Injection

Akynzeo IV

JZ

MP

C14387

 

1

5

C

Granisetron

Concentrated injection 3 mg (as hydrochloride) in 3 mL

Injection

Granisetron Kabi

PK

MP

C4139

 

1

0

C

 

 

 

GranisetronAFT

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

 

 

 

 

 

MP

C6661 C6662 C6678

P6661

15

5

C

 

Injection 9,000,000 I.U. in 0.5 mL single dose prefilled syringe

Injection

RoferonA

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 (BCG)) Danish 1331 strain

Single dose pack containing powder for irrigation 30 mg, 4 vials

Intravesical

VesiCulture

LM

MP

C5597

 

3

1

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

JZ

MP

C14443

 

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

APXOndansetron ODT

TY

MP

C5743

 

4

0

C

 

 

 

Ondansetron Mylan ODT

AF

MP

C5743

 

4

0

C

 

 

 

Ondansetron ODTDRLA

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

APOOndansetron

TX

MP

C5778

 

4

0

C

 

 

 

APXOndansetron

TY

MP

C5778

 

4

0

C

 

 

 

Ondansetron Mylan Tablets

AF

MP

C5778

 

4

0

C

 

 

 

Ondansetron SZ

HX

MP

C5778

 

4

0

C

 

 

 

OndansetronDRLA

RZ

MP

C5778

 

4

0

C

 

 

 

Zofran

AS

MP

C5778

 

4

0

C

 

 

 

Zotren 4

RF

MP

C5778

 

4

0

C

 

Tablet (orally disintegrating) 8 mg

Oral

APXOndansetron ODT

TY

MP

C5743

 

4

0

C

 

 

 

Ondansetron Mylan ODT

AF

MP

C5743

 

4

0

C

 

 

 

Ondansetron ODTDRLA

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

APOOndansetron

TX

MP

C5778

 

4

0

C

 

 

 

APXOndansetron

TY

MP

C5778

 

4

0

C

 

 

 

Ondansetron Mylan Tablets

AF

MP

C5778

 

4

0

C

 

 

 

Ondansetron SZ

HX

MP

C5778

 

4

0

C

 

 

 

OndansetronDRLA

RZ

MP

C5778

 

4

0

C

 

 

 

Zofran

AS

MP

C5778

 

4

0

C

 

 

 

Zotren 8

RF

MP

C5778

 

4

0

C

Palonosetron

Injection 250 micrograms (as hydrochloride) in 5 mL

Injection

Aloxi

MF

MP

C5805

 

1

0

C

 

 

 

Palonosetron Dr.Reddy's

RZ

MP

C5805

 

1

0

C

 

 

 

PALONOSETRON Medsurge

DZ

MP

C5805

 

1

0

C

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

TropisetronAFT

AE

MP

C5749

 

1

0

C

Schedule 3Responsible 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

BristolMyers Squibb Australia Pty Ltd

33 004 333 322

BX

Baxter Healthcare Pty Ltd

43 000 392 781

CR

Pharmacor Pty Limited

58 121 020 835

DZ

Medsurge Healthcare Pty Ltd

92 124 728 892

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

GI

Gilead Sciences Pty Limited

71 072 611 708

HX

Sandoz Pty Ltd

60 075 449 553

IT

InterPharma Pty Ltd

19 99 877 899

IX

Clinect Pty Ltd

76 150 558 473

JC

JanssenCilag Pty Ltd

47 000 129 975

JO

Juno Pharmaceuticals Pty Ltd

55 156 303 650

JU

Juno Pharmaceuticals Pty Ltd

55 156 303 650

JZ

Juniper Biologics Pty Ltd

97 655 479 897

LL

Astellas Pharma Australia Pty Ltd

81 147 915 482

LM

Link Medical Products Pty Ltd

73 010 971 516

LR

Cipla Australia Pty Ltd

46 132 155 063

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

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

RQ

Reach Pharmaceuticals Pty Ltd

25 623 897 183

RZ

Dr Reddy’s Laboratories (Australia) Pty Ltd

16 120 092 408

SG

Merck Serono Australia Pty Ltd

72 006 900 830

SW

sanofiaventis Australia Pty Ltd

31 008 558 807

SZ

Sandoz Pty Ltd

60 075 449 553

TB

Teva Pharma Australia Pty Ltd

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

TY

Apotex Pty Ltd

52 096 916 148

WM

MEDISON PHARMA AUSTRALIA PTY LIMITED

19 659 723 403

XC

Southern Cross Pharma Pty Ltd

47 094 447 677

ZL

Specialised Therapeutics Pharma Pty Ltd

77 609 261 430

Schedule 4Circumstances and Purposes Codes

(sections 8 to 12, 22 and 24)

 

 

Listed Drug

Circumstances Code

Purposes Code

Circumstances and Purposes

Authority Requirements
(part of Circumstances)

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 5hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND

Patient must be scheduled to be coadministered 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 5hydroxytryptamine 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 5hydroxytryptamine 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 5hydroxytryptamine 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/RARalpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction.

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/RARalpha 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/RARalpha fusion gene transcript.

Compliance with Authority Required procedures Streamlined Authority Code 6018

Atezolizumab

C10125

P10125

Stage IV (metastatic) nonsmall cell lung cancer (NSCLC)
Initial treatment 2
Patient must be undergoing combination treatment with bevacizumab and platinumdoublet chemotherapy.
The condition must be nonsquamous type nonsmall 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 death1 (PD1) inhibitor or a programmed cell death ligand1 (PDL1) inhibitor for nonsmall cell lung cancer.

Compliance with Authority Required procedures Streamlined Authority Code 10125

 

C10206

P10206

Extensivestage small cell lung cancer
Initial treatment
The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with etoposide and a platinumbased antineoplastic drug.

Compliance with Authority Required procedures Streamlined Authority Code 10206

 

C10215

P10215

Locally advanced or metastatic nonsmall cell lung cancer
Continuing treatment 4 weekly treatment regimen
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
The treatment must be the sole PBSsubsidised therapy for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures Streamlined Authority Code 10215

 

C10216

P10216

Stage IV (metastatic) nonsmall cell lung cancer (NSCLC)
Continuing firstline treatment of metastatic disease 3 weekly treatment regimen
Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
Patient must have previously received PBSsubsidised treatment with this drug in this line of treatment; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures Streamlined Authority Code 10216

 

C10257

P10257

Stage IV (metastatic) nonsmall cell lung cancer (NSCLC)
Continuing firstline treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance 4 weekly treatment regimen
Patient must have experienced intolerance to combination treatment with bevacizumab; AND
Patient must have previously received PBSsubsidised treatment with this drug in this line of treatment; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBSsubsidised therapy for this condition.

Compliance with Authority Required procedures Streamlined Authority Code 10257

 

C10297

P10297

Locally advanced or metastatic nonsmall cell lung cancer
Continuing treatment 3 weekly treatment regimen
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
The treatment must be the sole PBSsubsidised systemic anticancer therapy for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures Streamlined Authority Code 10297

 

C10509

P10509

Extensivestage small cell lung cancer
Continuing treatment 4 weekly treatment regimen
The treatment must be as monotherapy; AND
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures Streamlined Authority Code 10509

 

C10521

P10521

Extensivestage small cell lung cancer
Continuing treatment 3 weekly treatment regimen
The treatment must be as monotherapy; AND
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures Streamlined Authority Code 10521

 

C10917

P10917

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Continuing treatment of hepatocellular carcinoma 3 weekly treatment regimen
Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.
PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time

Compliance with Authority Required procedures Streamlined Authority Code 10917

 

C10939

P10939

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Initial treatment
Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.
Patient must have a WHO performance status of 0 or 1; AND
Patient must not be suitable for transarterial chemoembolisation; AND
Patient must have Child Pugh class A; AND
The condition must be untreated with systemic therapy; OR
Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.

Compliance with Authority Required procedures Streamlined Authority Code 10939

 

C10972

P10972

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Continuing treatment where bevacizumab is discontinued 4 weekly treatment regimen
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.
PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time

Compliance with Authority Required procedures Streamlined Authority Code 10972

 

C13442

P13442

Resected early stage (Stage II to IIIA) nonsmall cell lung cancer (NSCLC)
1,200 mg administered once every 3 weeks
Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death1/ligand 1 (PD1/PDL1) inhibitor therapy; OR
Patient must be continuing existing PBSsubsidised treatment with this drug; OR
Patient must be both: (i) transitioning from existing nonPBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death1/ligand 1 (PD1/PDL1) inhibitor therapy at the time this drug was initiated.
Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.
The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinumbased chemotherapy; AND
The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND
The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PDL1) expression on at least 50% of tumour cells; AND
The treatment must be the sole PBSsubsidised systemic anticancer therapy for this condition.
Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.

Compliance with Authority Required procedures Streamlined Authority Code 13442

 

C13443

P13443

Locally advanced or metastatic nonsmall cell lung cancer
Initial treatment 3 weekly treatment regimen
Patient must not have received prior treatment with a programmed cell death1 (PD1) inhibitor or a programmed cell death ligand1 (PDL1) inhibitor for nonsmall cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBSsubsidised systemic anticancer therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy; OR
The condition must have progressed after treatment with tepotinib.

Compliance with Authority Required procedures Streamlined Authority Code 13443

 

C13446

P13446

Locally advanced or metastatic nonsmall cell lung cancer
Initial treatment 4 weekly treatment regimen
Patient must not have received prior treatment with a programmed cell death1 (PD1) inhibitor or a programmed cell death ligand1 (PDL1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBSsubsidised therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy; OR
The condition must have progressed after treatment with tepotinib.

Compliance with Authority Required procedures Streamlined Authority Code 13446

 

C13448

P13448

Stage IV (metastatic) nonsmall cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with bevacizumab and platinumdoublet chemotherapy.
The condition must be nonsquamous type nonsmall cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; OR
The condition must have progressed after treatment with tepotinib; AND
Patient must not have received prior treatment with a programmed cell death1 (PD1) inhibitor or a programmed cell death ligand1 (PDL1) inhibitor for nonsmall cell lung cancer; 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 13448

 

C13451

P13451

Resected early stage (Stage II to IIIA) nonsmall cell lung cancer (NSCLC)
1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks
Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death1/ligand 1 (PD1/PDL1) inhibitor therapy; OR
Patient must be continuing existing PBSsubsidised treatment with this drug; OR
Patient must be both: (i) transitioning from existing nonPBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death1/ligand 1 (PD1/PDL1) inhibitor therapy at the time this drug was initiated.
Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.
The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinumbased chemotherapy; AND
The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND
The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PDL1) expression on at least 50% of tumour cells; AND
The treatment must be the sole PBSsubsidised systemic anticancer therapy for this condition.
Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.

Compliance with Authority Required procedures Streamlined Authority Code 13451

Avelumab

C8947

P8947

Stage IV (metastatic) Merkel Cell Carcinoma
Initial treatment
The treatment must be the sole PBSsubsidised therapy for this condition; AND
The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures Streamlined Authority Code 8947

 

C10023

P10023

Stage IV (metastatic) Merkel Cell Carcinoma
Continuing treatment
The treatment must be the sole PBSsubsidised therapy for this condition; AND
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction.

Compliance with Authority Required procedures Streamlined Authority Code 10023

 

C13290

P13290

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy Continuing treatment
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBSsubsidised therapy for this condition.

Compliance with Authority Required procedures Streamlined Authority Code 13290

 

C13303

P13303

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy Grandfathering treatment
Patient must have received nonPBSsubsidised treatment with this drug for this PBS indication prior to 1 October 2022; AND
Patient must have received firstline platinumbased chemotherapy prior to initiation of nonPBSsubsidised treatment with this drug for this condition; AND
Patient must not have progressive disease following firstline platinumbased chemotherapy; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of nonPBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBSsubsidised therapy for this condition.
A patient may qualify for PBSsubsidised treatment under this restriction once only. For continuing PBSsubsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures Streamlined Authority Code 13303

 

C13313

P13313

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy Initial treatment
Patient must have received firstline platinumbased chemotherapy; AND
Patient must not have progressive disease following firstline platinumbased chemotherapy; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBSsubsidised therapy for this condition.

Compliance with Authority Required procedures Streamlined Authority Code 13313

Bendamustine

C7943

 

Previously untreated stage II bulky or stage III or IV indolent nonHodgkin's lymphoma

Induction treatment

The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
The treatment must be in combination with rituximab or obinutuzumab; AND
The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.

Compliance with Authority Required procedures Streamlined Authority Code 7943

 

C7944

 

Follicular lymphoma

Reinduction treatment

The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for reinduction treatment purposes only; AND
The treatment must be in combination with obinutuzumab; AND
The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
The condition is considered rituximabrefractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximabcontaining regimen.

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
The treatment must be in combination with rituximab; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND
Patient must not be eligible for stem cell transplantation.

Compliance with Authority Required procedures Streamlined Authority Code 7972

Bleomycin

C6224

 

Lymphoma

 

C6275

 

Germ cell neoplasms

 

Blinatumomab

C9369

P9369

Acute lymphoblastic leukaemia

Consolidation treatment

Patient must have previously received PBSsubsidised 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 PBSsubsidised 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 Bprecursor 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 TGAapproved 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 reinitiation (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 PBSsubsidised if it is administered to an inpatient in a public hospital setting.

Compliance with Authority Required procedures

 

C14587

P14587

Measurable residual disease of precursor Bcell acute lymphoblastic leukaemia (PreBcell ALL)
Continuing treatment of previously measurable residual disease of PreBcell ALL
Must be treated by a physician experienced in the treatment of haematological malignancies.
Patient must have previously received PBSsubsidised initial treatment with this drug for this condition; AND
Patient must have achieved a complete remission; AND
The condition must be negative for measurable residual disease using the same method used to determine initial PBS eligibility; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
For all subsequent cycle starts and reinitiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
Blinatumomab is not PBSsubsidised if it is administered to an inpatient in a public hospital setting.
Patients who fail to demonstrate a response to PBSsubsidised treatment with this agent at the time where an assessment is required must cease PBSsubsidised therapy with this agent.

 

 

C14588

P14588

Acute lymphoblastic leukaemia
Induction treatment
The condition must be relapsed or refractory Bprecursor 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 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
The condition must be one of the following: (i) untreated with this drug for measurable residual disease, (ii) treated with this drug for measurable residual disease, but the condition has not relapsed within 6 months of completing that course of treatment; AND
The condition must have more than 5% blasts in bone marrow; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
According to the TGAapproved 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 reinitiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBSsubsidised if it is administered to an inpatient in a public hospital setting.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application Supporting Information Form; and
(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(4) if applicable, the date of completion of blinatumomab treatment for measurable residual disease and the date of the patient's subsequent relapse; and
(5) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.

 

 

C14631

P14631

Measurable residual disease of precursor Bcell acute lymphoblastic leukaemia (PreBcell ALL)
Initial treatment of measurable residual disease of PreBcell ALL
Must be treated by a physician experienced in the treatment of haematological malignancies.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be present in the central nervous system or testis; AND
Patient must have achieved complete remission following intensive combination chemotherapy for initial treatment of acute lymphoblastic leukaemia (ALL) or for subsequent salvage therapy; AND
Patient must have measurable residual disease based on measurement in bone marrow, documented after an interval of at least 2 weeks from the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL/as subsequent salvage therapy, whichever was the later, measured using flow cytometry/molecular methods; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
According to the TGAapproved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle.
For all subsequent cycle starts and reinitiation (e.g. if treatment is interrupted for four 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 each cycle.
Blinatumomab is not PBSsubsidised if it is administered to an inpatient in a public hospital setting.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Measurable residual disease positive Acute Lymphoblastic Leukaemia PBS Authority Application Supporting Information Form; and
(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
(4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.
Patients who fail to demonstrate a response to PBSsubsidised treatment with this agent at the time where an assessment is required must cease PBSsubsidised therapy with this agent.

 

Bortezomib

C11099

 

Multiple myeloma

 

 

C13745

 

Newly diagnosed systemic light chain amyloidosis
Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total
Patient must be undergoing concurrent treatment with PBSsubsidised daratumumab for this PBS indication.

 

Brentuximab vedotin

C13134

P13134

CD30 positive peripheral Tcell lymphoma, noncutaneous type
Initial treatment
Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND
The treatment must be for first line therapy for this condition; AND
The treatment must be for curative intent; AND
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and
(b) The date of initial diagnosis of Peripheral Tcell lymphoma.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

 

C13179

P13179

CD30 positive cutaneous Tcell lymphoma
Initial treatment
Patient must have pathologically confirmed CD30 positive cutaneous Tcell lymphoma; AND
Patient must have CD30 positivity of at least 3% of malignant cells; AND
Patient must have a diagnosis of mycosis fungoides; OR
Patient must have a diagnosis of Sezary syndrome; OR
Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND
Patient must have received prior systemic treatment for this condition; AND
The condition must be relapsed or refractory; AND
The treatment must not exceed 4 cycles under this restriction in a lifetime; AND
The treatment must be the sole PBSsubsidised systemic anticancer therapy for this condition.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and
(b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and
(c) Date of commencement and completion of the most recent prior systemic treatment.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

 

C13181

P13181

CD30 positive cutaneous Tcell lymphoma
Continuing treatment
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must have achieved an objective response with this drug; AND
Patient must not have developed disease progression while receiving PBSsubsidised treatment with this drug for this condition; AND
The treatment must be the sole PBSsubsidised systemic anticancer therapy for this condition; AND
The treatment must not exceed 12 cycles under this restriction in a lifetime.
An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positronemission tomography (PET) and/or computed tomography (CT) standard criteria.

Compliance with Authority Required procedures

 

C13182

P13182

CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior frontline curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapyrefractory disease; AND
Patient must have responded to PBSsubsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral Tcell lymphoma, noncutaneous type; AND
The treatment must not exceed 4 cycles under this restriction.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and
(b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and
(c) Dates of commencement and completion of frontline curative intent chemotherapy; and
(d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

 

C13208

P13208

Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND
Patient must have previously received PBSsubsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBSsubsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime.

Compliance with Authority Required procedures

 

C13209

P13209

Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multiagent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

 

C13212

P13212

CD30 positive peripheral Tcell lymphoma, noncutaneous type
Continuing treatment
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
Patient must have completed 6 initial cycles of PBSsubsidised treatment with this drug for this indication; AND
Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND
Patient must not have developed disease progression while receiving PBSsubsidised treatment with this drug for this condition; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
Partial response is defined using Lugano Response Criteria for NonHodgkin Lymphoma as:
(a) Positron emission tomographybased response: lymph nodes and extralymphatic sites a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions not applicable; organ enlargement not applicable; new lesions none; bone marrow residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR
(b) Computed tomographybased response: lymph nodes and extralymphatic sites greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; nonmeasured lesions absent/normal, regressed but no increase; new lesions none; bone marrow not applicable.

Compliance with Authority Required procedures