National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (No. PB 79 of 2011) (Cth)

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. 52

Compilation date: 1 July 2016

Includes amendments up to: PB 56 of 2016

Registered: 1 July 2016

About this compilation

This compilation

This is a compilation of the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) that shows the text of the law as amended and in force on 1 July 2016 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1—General 1
Division 1—Preliminary 1
1............ Name of Special Arrangement....................................................................................... 1
2............ Commencement............................................................................................................. 1
3............ Definitions..................................................................................................................... 1

Division 2—Pharmaceutical benefits 5
4............ Pharmaceutical benefits covered by this Special Arrangement...................................... 5
5............ Application of Part VII of the Act................................................................................. 5
6............ Responsible person....................................................................................................... 5
7............ Authorised prescriber.................................................................................................... 6
8............ Prescription circumstances............................................................................................ 6
9............ Maximum amount—chemotherapy drug....................................................................... 6
10.......... Maximum quantity—related pharmaceutical benefit...................................................... 7
11.......... Maximum number of repeats—chemotherapy drug...................................................... 7
12.......... Maximum number of repeats—related pharmaceutical benefit...................................... 8
13.......... Section 100 only supply................................................................................................ 8

Part 2—Prescription 10
Division 1—Chemotherapy pharmaceutical benefits 10
14.......... Methods of prescribing chemotherapy pharmaceutical benefit.................................... 10
15.......... Information to be included in infusion prescription, other than infusion medication chart prescriptions 10
16.......... Information to be included in infusion medication chart prescription.......................... 11
17.......... Dose or number of repeats greater than maximum...................................................... 11
18.......... Direction to vary dose of chemotherapy drug in infusion............................................ 12

Division 2—Related pharmaceutical benefits 13
19.......... Methods of prescribing related pharmaceutical benefit................................................ 13

Division 3—Authority required procedures 14
22.......... Authority required procedures to be followed............................................................. 14

Part 3—Supply 16
30.......... Entitlement to infusion or related pharmaceutical benefit............................................. 16
31.......... Supply of infusion under this Special Arrangement.................................................... 16
32.......... Supply of related pharmaceutical benefits under this Special Arrangement................. 16
33.......... Selection of chemotherapy pharmaceutical benefits to make infusion.......................... 16
34.......... Modified application of Act and Regulations.............................................................. 17
34A....... Modified application of paragraph 92A(1)(f) conditions of approval.......................... 18

Part 4—Claims, payment and provision of under co‑payment data 19
Division 1—Claims for payment and provision of under co‑payment data 19
36.......... How claims to be made............................................................................................... 19
37.......... Modified references for claim and provision of under co‑payment data...................... 19
39.......... Modified requirements for supply of infusion............................................................. 19

Division 2—Payment of claim  21
41.......... Payment of approved pharmacist or approved medical practitioner for supply of infusion      21
42.......... Payment of approved hospital authority or HSD hospital authority for supply of infusion      21
43.......... Payment of participating hospital authority for supply of related pharmaceutical benefit 21
45.......... Method of working out dispensed price...................................................................... 21
46.......... No separate entitlement to payment for supply of diluent............................................ 22

Division 2A—Payments to compounders 23
46A....... Fee payment to TGA licensed compounder between 1 July and the day before the start date 23
46B....... Compound fee payment to compounder on and after the start date.............................. 23
46C....... How claims are to be made - compounders................................................................. 23

Division 3—Dispensed price of chemotherapy drug 24
47.......... Dispensed price if drug is in infusion supplied by approved pharmacist or approved medical practitioner 24
48.......... Mark-up for a chemotherapy pharmaceutical benefit that does not have trastuzumab.. 25
49.......... Mark‑up for chemotherapy pharmaceutical benefit that has trastuzumab..................... 25
50.......... Dispensed price if drug is in infusion supplied by approved private hospital authority 26
51.......... Dispensed price if drug is in infusion supplied by public hospital authority............... 27

Division 4—Dispensed price of related pharmaceutical benefit 28
52.......... Dispensed price for supply of related pharmaceutical benefit...................................... 28
53.......... Quantity less than manufacturer’s pack....................................................................... 28

Part 5—Patient contributions 29
54.......... Supply of infusion by approved pharmacist or approved medical practitioner............ 29
55.......... Supply of infusion by approved hospital authority or HSD hospital authority............ 29
57.......... Supply of related pharmaceutical benefit by participating hospital authority................ 30
58.......... Special patient contribution for Schedule 5 pharmaceutical benefit.............................. 30
59.......... Amounts taken into account for eligibility for concession and entitlement cards......... 31

Part 6—Transitional 32
60.......... Transitional provisions for existing medication chart prescribing................................ 32
61.......... Transitional provisions for fees................................................................................... 32

Schedule 1—Chemotherapy pharmaceutical benefits and chemotherapy drugs 33

Part 1—Chemotherapy pharmaceutical benefits and related information 33
Part 2—Chemotherapy drugs and related information 55

Schedule 2—Related pharmaceutical benefits 59

Schedule 3—Responsible Person Codes 67

Schedule 4—Circumstances and Purposes Codes 69

Schedule 5—Patient contributions 135

Endnotes136
Endnote 1—About the endnotes  136
Endnote 2—Abbreviation key  137
Endnote 3—Legislation history  138
Endnote 4—Amendment history  141

Part 1—General

Division 1—Preliminary

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.

2 Commencement
This Special Arrangement commences on 1 December 2011.

3 Definitions
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.
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 regulation 13 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 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.
compound fee means an amount of:
a) $60 for a TGA licensed compounder; or
b) $40 for a compounder

diluent fee means an amount of $5.14.
dispensing fee means an amount of $7.02.
distribution fee means an amount of $26.08.
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.
eligible patient means a person who:
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is receiving treatment from an authorised prescriber.

eligible private hospital patient means an eligible patient who is receiving treatment at or from a private hospital.
eligible public hospital patient means an eligible patient who is receiving treatment at, or from, a public hospital as a non‑admitted patient, day admitted patient or patient on discharge.
entitlement number, for an eligible patient, means the number listed on the patient’s benefit card.
HSD hospital authority means a public hospital authority approved by the Chief Executive Medicare under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010.
Human Services Department means the Department administered by the Human Services Minister.
infusion means a single treatment for a patient that is made from one or more chemotherapy pharmaceutical benefits.
infusion medication chart prescription means a medication chart directing the supply of an infusion.
infusion prescription means a prescription directing the supply of an infusion.
medication chart prescription has the meaning given by the Regulations, but does not include a medication chart prescription for a person receiving treatment in a residential care service.
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 $83.22.
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 1960.
related pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 2.
residential care service has the meaning given by the Regulations.
start date means the earlier of:
a) 1 September 2016; or
b) the day the Secretary decides a compounding fee payment computer system is operational.

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.
under co‑payment data means information in relation to the supply under this Special Arrangement of:
(a) an infusion by an approved pharmacist, approved medical practitioner, approved hospital authority, or HSD hospital authority; or
(b) a related pharmaceutical benefit by a participating hospital authority;

where a claim is not payable as the dispensed price for the supply under this Special Arrangement does not exceed the amount that the supplier was entitled to charge under subsection 54(2) or 55(2) for supply of an infusion, or under subsection 57(2) for supply of a related pharmaceutical benefit.
Note: Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:
·      approved hospital authority
·      approved medical practitioner
·      approved pharmacist
·      approved supplier
·      pharmaceutical benefit
·      pharmaceutical item
·      public hospital authority.

Division 2—Pharmaceutical benefits

4 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Part 1 of Schedule 1 or in Schedule 2.
(2) Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:
(a) in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and
(b) with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.
Note: Each listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Part 1 of Schedule 1 or in Schedule 2 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

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.

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 infusion 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 infusion 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.

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 2—Prescription

Division 1—Chemotherapy pharmaceutical benefits

14 Methods of prescribing chemotherapy pharmaceutical benefit
(1) An authorised prescriber may prescribe a chemotherapy pharmaceutical benefit under this Special Arrangement by:
(a) writing an infusion prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with regulation 19 of the Regulations as modified by section 15; or
(b) preparing an infusion medication chart prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with regulation 19AA of the Regulations as modified by section 16.

(2) However, an infusion medication chart prescription may only be prepared for an eligible public hospital patient or eligible private hospital patient.
(3) However, chemotherapy pharmaceutical benefits containing the following chemotherapy drugs may only be prescribed by writing an infusion prescription:
(a) bortezomib;
(b) trastuzumab.

(4) An infusion prescription written in accordance with section 15 or an infusion medication chart prescription written in accordance with section 16 is taken to be a duly written prescription for regulation 19 or 19AA of the Regulations.
(5) Paragraph 19(2)(a) of the Regulations does not apply to an infusion prescription.
Note: Regulation 19AA does not prohibit same day prescribing for infusion medication chart prescriptions.

15 Information to be included in infusion prescription, other than infusion medication chart prescriptions
(1) For paragraph 14(1)(a), this section modifies the requirements of regulation 19 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 infusion medication chart prescription
(1) For paragraph 14(1)(b) this section modifies the requirements of regulation 19AA of the Regulations.
(2) An infusion medication chart prescription 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.

(3) An infusion medication chart prescription does not need to include the form of the chemotherapy drug supplied.
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 an infusion medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in regulation 13 of the Regulations as modified by subsection (2).
(2) A reference in regulation 13 of the Regulations to 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.
(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 an infusion medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in regulation 13 of the Regulations as modified by subsection (4).
(4) A reference in regulation 13 of the Regulations to 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.

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 infusion 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 infusion medication chart prescription:
(a) the name of the authorised prescriber who gave the direction; and
(b) the means by which the supplier was notified of the direction (for example, by phone or by fax); and
(c) the date and time the supplier was notified.

Division 2—Related pharmaceutical benefits

19 Methods of prescribing related pharmaceutical benefit
(1) An authorised prescriber may prescribe a related pharmaceutical benefit under this Special Arrangement by:
(a) writing a prescription for the related pharmaceutical benefit in accordance with regulation 19 of the Regulations; or
(b) writing a medication chart prescription for the related pharmaceutical benefit in accordance with regulation 19AA of the Regulations.
Note: Related pharmaceutical benefits can only be supplied under this Special Arrangement by a participating hospital authority to eligible public hospital patients—see section 32.

Division 3—Authority required procedures

22 Authority required procedures to be followed
(1) This section applies to an infusion prescription or infusion medication chart prescription 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;
(v) Compliance with modified Written 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 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;
(v) Compliance with modified Written 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 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 are to be followed.
Note: See section 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 for Streamlined Authority Code.

(4) In addition to the requirements of subsection (3) where ‘Compliance with modified Written Authority Required procedures’ appears in the circumstances mentioned in Schedule 4 for the code, any other requirement included in the circumstances is to be followed as part of the authority required procedures.
Example: The circumstances in Schedule 4 may require additional documents to be submitted along with the prescription.

Part 3—Supply

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 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 infusion 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 infusion 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 infusion 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 infusion 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
Infusions
(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) Subregulations 25(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) Regulations 24 and 26A of the Regulations do not apply to the supply of an infusion for an infusion prescription under this Special Arrangement.
Note: Regulations 24 and 26A already do not apply to infusion medication chart prescriptions.

(4) A reference elsewhere in the Regulations to the supply of a pharmaceutical benefit is taken to include the supply of an infusion under this Special Arrangement.

34A Modified application of paragraph 92A(1)(f) conditions of approval
a) Section 8 of the conditions of approval for approved pharmacists under paragraph 92A(1)(f) of the Act does not apply to the supply of an infusion, once prepared as a final product ready for infusion to a person, when the infusion has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.
b) For the purposes of this section, shelf life means the period of time that a medicine can be stored and still be considered safe and effective for use.

Part 4—Claims, payment and provision of under co‑payment data

Division 1—Claims for payment and provision of under co‑payment data

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 co‑payment data
(1) The rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act apply to a claim or provision of under co‑payment data as follows:
(a) a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority;
(b) a reference to a number allotted to an approval under regulation 8A of the Regulations includes a reference to a number allotted to an approval under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 for a HSD hospital authority; and
(c) the definition of under co‑payment data in section 4 of this Special Arrangement replaces the definition of under co‑payment data appearing in the rules made under subsection 98AC(4) of the Act.

39 Modified requirements for supply of infusion
For a claim or provision of under co‑payment data for supply of an infusion, the requirements in the rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act are modified as follows:
(a) a reference to a pharmaceutical benefit includes a reference to an infusion;
(b) a reference to an authority prescription in the rules includes a reference to an authority prescription within the meaning given by section 3 of this Special Arrangement;
(c) the claim or provision of under co‑payment data must include:
(i) a drug code for each chemotherapy drug in the infusion, being the code for the drug published in the Schedule of Pharmaceutical Benefits published by the Department; and
(ii) the dose of each chemotherapy drug in the infusion; and
(d) the supplier is not required to include in the claim or provision of under co‑payment data:
(i) the PBS/RPBS Item Code for the supplied pharmaceutical benefit;
(ii) the brand of the supplied pharmaceutical item;
(iii) whether or not regulation 24 applies; or
(iv) whether or not immediate supply was necessary.

Division 2—Payment 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).

42 Payment of approved hospital authority or HSD hospital authority for supply of infusion
An approved hospital authority or HSD hospital authority that makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved hospital authority or HSD hospital authority was entitled to charge under subsection 55(2).

43 Payment of participating hospital authority for supply of related pharmaceutical benefit
A participating hospital authority that makes a claim under Division 1 for the supply of a related pharmaceutical benefit is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the related pharmaceutical benefit is greater than the amount that the supplier was entitled to charge under subsection 57(2).

45 Method of working out dispensed price
Infusion
(1) The dispensed price for the supply of an infusion is the sum of:
(a) the dispensed prices of the doses of chemotherapy drugs in the infusion; and
(b) if the supply is a repeated supply—an amount equivalent to the amount that may be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the eligible patient.

(2) The dispensed price for a dose of a chemotherapy drug is to be worked out under Division 3.
Related pharmaceutical benefit
(3) The dispensed price for the supply of a related pharmaceutical benefit is to be worked out under Division 4.
Rounding
(4) A dispensed price worked out under Division 3 or 4 is rounded to the nearest cent, with a half cent being rounded up.

46 No separate entitlement to payment for supply of diluent
(1) If a supplier adds a pharmaceutical benefit to an infusion supplied under this Special Arrangement as a diluent, no amount is payable under Part VII of the Act for supply of the pharmaceutical benefit.
(2) Subsection (1) applies regardless of whether the pharmaceutical benefit added as a diluent is one to which this Special Arrangement applies.
Note: For the application of this Special Arrangement to pharmaceutical benefits, see section 5.

Division 2A—Payments to compounders

46A Fee payment to TGA licensed compounder between 1 July and the day before the start date
(1) A TGA licensed compounder may make a claim for payment for the compounding of an infusion prepared between 1 July 2015 and the day before the start date.
(2) If a claim for a fee is made under subsection (1), the Secretary may, at his or her discretion, pay an amount of $20 to a TGA licensed compounder for the compounding of the infusion.

46B Compound fee payment to compounder on and after the start date
(1) Subject to subsections (2) and (3), a compounder, who makes a claim under this Division for the compounding of an infusion, is entitled to be paid a compound fee by the Commonwealth.
(2) A compounder must not be paid a compounding fee for the compounding of an infusion prepared between 1 July 2015 and the start date.
(3) Only a single compound fee can be paid for the compounding of an infusion prepared in accordance with an infusion prescription for an individual patient.

46C How claims are to be made - compounders
(1) A compounder must submit a claim for payment on an approved form when seeking payment from the Commonwealth for a fee under sections 46A and 46B.
(2) The compounder must certify with each claim:
(a) that each infusion to which the claim relates was prepared in accordance with a compounding order; and
(b) that the information in the claim form is correct.

Division 3—Dispensed 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 ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) the mark‑up for the chemotherapy pharmaceutical benefit worked out under:
(i) if the chemotherapy pharmaceutical benefit does not have trastuzumab—section 48; or
(ii) if the chemotherapy pharmaceutical benefit has trastuzumab—section 49.
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

48 Mark-up for a chemotherapy pharmaceutical benefit that does not have trastuzumab
For subparagraph 47(4)(b)(i), the mark-up for a chemotherapy pharmaceutical benefit that does not have trastuzumab is:

(mark-up for maximum multiple) divided by (maximum multiple of pharmaceutical benefit).
where:
mark-up for maximum multiple means the administration, handling and infrastructure fee worked out under the determination made under paragraph 98B(1)(a) of the Act.
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of the chemotherapy drug in the benefit that is permitted under section 9.
Note: The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.

49 Mark‑up for chemotherapy pharmaceutical benefit that has trastuzumab
(1) For subparagraph 47(4)(b)(ii), the mark‑up for a chemotherapy pharmaceutical benefit that has trastuzumab is:

where:
mark‑up for maximum multiple means the amount worked out under subsection (2).
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of trastuzumab that is permitted under section 9.
Note: The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.

(2) The mark‑up for the maximum multiple of a chemotherapy pharmaceutical benefit with an ex‑manufacturer price mentioned in the table is the amount mentioned in the table.

Item Ex‑manufacturer price for maximum multiple of pharmaceutical benefit Mark‑up for maximum multiple

1 ≤ $40 10% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit

2 > $40, ≤ $100 $4

3 > $100, ≤ $1 000 4% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit

4 > $1 000 $40
50 Dispensed price if drug is in infusion supplied by approved private hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by an approved hospital authority of a private hospital to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) for a drug other than trastuzumab—the distribution fee;
(c) the dispensing fee;
(d) the preparation fee;
(e) the diluent fee.

Item	Ex‑manufacturer price for maximum multiple of pharmaceutical benefit	Mark‑up for maximum multiple
1	≤ $40	10% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit
2	> $40, ≤ $100	$4
3	> $100, ≤ $1 000	4% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit
4	> $1 000	$40

(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.

(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.

(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:
(a) the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) 1.4% of the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

51 Dispensed price if drug is in infusion supplied by public hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by a public hospital authority to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) the preparation fee.

(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.

(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.

(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up).
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

Division 4—Dispensed price of related pharmaceutical benefit

52 Dispensed price for supply of related pharmaceutical benefit
(1) For a related pharmaceutical benefit supplied by a participating hospital authority to an eligible public hospital patient, the dispensed price is as follows:
(a) if the quantity of the related pharmaceutical benefit that is ordered and supplied is equal to the quantity contained in the manufacturer’s pack—the ex‑manufacturer price for the pack;
(b) if the quantity of the related pharmaceutical benefit that is ordered and supplied is less than the quantity contained in the manufacturer’s pack—the amount worked out under section 53;
(c) if the quantity of the related pharmaceutical benefit that is ordered and supplied is more than the quantity contained in the manufacturer’s pack—the sum of:
(i) the ex‑manufacturer price for each complete pack in the quantity; and
(ii) the amount worked out under section 53 for any remainder.

(2) However, if there are 2 or more related pharmaceutical benefits that are different brands of the same pharmaceutical item, the dispensed price of those pharmaceutical benefits is to be based on the pharmaceutical benefit with the lowest ex‑manufacturer price.

53 Quantity less than manufacturer’s pack
For paragraph 52(1)(b) and subparagraph 52(1)(c)(ii), the amount for a quantity of a related pharmaceutical benefit that is less than the quantity contained in the manufacturer’s pack (a broken quantity) is worked out by:

(a) dividing the quantity or number of units in the broken quantity by the quantity or number of units in the manufacturer’s pack expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the ex‑manufacturer price for the complete pack.

Part 5—Patient 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 co‑payment for original supply
(2) For an original supply of an infusion, the approved pharmacist or approved medical practitioner must charge the eligible patient an amount that is equivalent to the amount that is required to be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the patient.
Note: This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.

(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the approved pharmacist or approved medical practitioner uses to make the infusion is mentioned in Schedule 5, the approved pharmacist or approved medical practitioner may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note: If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.

55 Supply of infusion by approved hospital authority or HSD hospital authority
(1) The amount that an approved hospital authority or HSD hospital authority may charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.
Patient co‑payment for original supply
(2) For an original supply of an infusion, the hospital authority may charge the eligible patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained a pharmaceutical benefit from an approved pharmacist.
Note: This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.

(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the hospital authority uses to make the infusion is mentioned in Schedule 5, the hospital authority may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note: If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.

57 Supply of related pharmaceutical benefit by participating hospital authority
(1) The amount that a participating hospital authority may charge an eligible public hospital patient for the supply of a related pharmaceutical benefit is the total of the amounts set out in this section.
Patient co‑payment
(2) The participating hospital authority may charge the eligible public hospital patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained the related pharmaceutical benefit from an approved pharmacist.
Special patient contribution for Schedule 5 pharmaceutical benefit
(3) If the related pharmaceutical benefit is mentioned in Schedule 5, the participating hospital authority may also charge the eligible public hospital patient an amount not exceeding the amount for the related pharmaceutical benefit worked out under section 58.

Special patient contribution for Schedule 5 pharmaceutical benefit
(1) The amount an eligible patient may be charged for a pharmaceutical benefit mentioned in Schedule 5 is worked out by subtracting the amount mentioned for the pharmaceutical benefit in the ‘Approved Ex‑manufacturer Price’ column in Schedule 5 from the amount mentioned for the pharmaceutical benefit in the ‘Claimed Ex‑manufacturer Price’ column in Schedule 5.
(2) However, the amounts mentioned in the ‘Approved Ex‑manufacturer price’ and ‘Claimed Ex‑manufacturer price’ columns must be adjusted proportionally if:
(a) for a chemotherapy pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit used to make the infusion is more or less than the number mentioned in the ‘Quantity or Number of Units’ column; and
(b) for a related pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit supplied is more or less than the number mentioned in the ‘Quantity or Number of Units’ column.

59 Amounts taken into account for eligibility for concession and entitlement cards
An amount charged under any of the following provisions is to be taken into account when determining a person’s eligibility for a concession card or entitlement card under section 84C of the Act:
(a) subsection 54(2);
(b) subsection 55(2);
(d) subsection 57(2).

Part 6—Transitional

60 Transitional provisions for existing medication chart prescribing
(1) An authorised prescriber may prescribe a pharmaceutical benefit for an eligible public hospital patient by writing:
(a) an infusion medication chart, or
(b) a medication chart,

before 1 April 2017, by following the requirements for prescribing from an infusion medication chart or medication chart in the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before 1 April 2015.
(2) A participating hospital authority can supply a pharmaceutical benefit prescribed under subsection (1).
(3) The provisions for prescribing, supplying and claiming from an infusion medication chart or medication chart set out in the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before 1 April 2015, continue to apply in relation to an infusion medication chart or a medication chart written under subsection (1).
(4) However, this section does not apply if the participating hospital authority referred to in subsection (2) is a listed approved hospital under regulation 59 of the Regulations and supplying from infusion medication chart prescriptions under this Special Arrangement.
(5) If this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules.

61 Transitional provisions for fees
(1) If a claim is made for the supply of an infusion under section 41 or 42, where the approved pharmacist, approved medical practitioner, approved hospital authority or HSD hospital authority has already directly paid a compounder to prepare the infusion, the compounder is not entitled to be paid a compound fee.
(2) If section 61(1) applies, the preparation fee to be paid under Division 2 to the approved pharmacist, approved medical practitioner, approved hospital authority or HSD hospital authority, is an amount of $82.67.
(3) This section ceases to operate on and from 1 November 2015.

Schedule 1—Chemotherapy pharmaceutical benefits and chemotherapy drugs

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

Part 1—Chemotherapy pharmaceutical benefits and related information

Listed Drug	Form	Manner of Administration	Brand	Responsible Person	Authorised Prescriber	Circumstances	Section 100 only
Arsenic	Injection concentrate containing arsenic trioxide 10 mg in 10 mL	Injection	Phenasen	PL	MP	C4793C5997 C6018	D
Bendamustine	Powder for injection containing bendamustine hydrochloride 25 mg	Injection	Ribomustin	JC	MP	C6075 C6124	D
Powder for injection containing bendamustine hydrochloride 100 mg	Injection	Ribomustin	JC	MP	C6075 C6124	D
Bevacizumab	Solution for I.V. infusion 100 mg in 4 mL	Injection	Avastin	RO	MP	C4584 C4587 C4594 C4814 C4939 C4968	D
Solution for I.V. infusion 400 mg in 16 mL	Injection	Avastin	RO	MP	C4584 C4587 C4594 C4814 C4939 C4968	D
Bleomycin	Powder for injection containing bleomycin sulfate 15,000 I.U.	Injection	Bleo 15K	EA	MP	C6224 C6275	D
CIPLA BLEOMYCIN	LR	MP	C6224 C6275	D
Hospira Pty Limited	HH	MP	C6224 C6275	D
Bortezomib	Powder for injection 3.5 mg	Injection	Velcade	JC	MP	C4079 C4080 C4081 C4126 C4161 C4162	D
Powder for Injection 1mg	Injection	Velcade	JC	MP	C4082 C4103 C4127 C4141 C4163	D
Brentuximab Vedotin	Powder for I.V. Infusion 50 mg	Injection	Adcetris	TK	MP	C4675 C4719	D
Cabazitaxel	Concentrated injection 60mg (as acetone solvate) in 1.5 mL, with diluent	Injection	Jevtana	SW	MP	C4662	D
Carboplatin	Solution for I.V. injection 150 mg in 15 mL	Injection	Carbaccord	EA	MP	D
Hospira Pty Limited	HH	MP	D
Solution for I.V. injection 450 mg in 45 mL	Injection	Carboplatin Kabi	PK	MP	D
Hospira Pty Limited	HH	MP	D
Solution for I.V. injection 50 mg in 5 mL	Injection	Carbaccord	EA	MP	D
Hospira Pty Limited	HH	MP	D
Cetuximab	Solution for I.V. infusion 100 mg in 20 mL	Injection	Erbitux	SG	MP	C4785 C4788 C4794 C4908 C4912 C4945 C4965	D
Solution for I.V. infusion 500 mg in 100 mL	Injection	Erbitux	SG	MP	C4785 C4788 C4794 C4908 C4912 C4945 C4965	D
Cisplatin	I.V. injection 100 mg in 100 mL	Injection	Cisplatin Ebewe	SZ	MP	D
Hospira Pty Limited	HH	MP	D
I.V. injection 50 mg in 50 mL	Injection	Hospira Pty Limited	HH	MP	D
Cladribine	Injection 10 mg in 5 mL	Injection	Litak	OA	MP	C6265	D
Solution for I.V. infusion 10 mg in 10 mL single use vial	Injection	Leustatin	JC	MP	C6265	D
Cyclophosphamide	Powder for injection 1 g (anhydrous)	Injection	Endoxan	BX	MP	PB
Powder for injection 2 g (anhydrous)	Injection	Endoxan	BX	MP	PB
Powder for injection 500 mg (anhydrous)	Injection	Endoxan	BX	MP	PB
Cytarabine	Injection 100 mg in 5 mL vial	Injection	Pfizer Australia Pty Ltd	PF	MP	D
Docetaxel	Solution concentrate for I.V. infusion 140 mg in 7 mL	Injection	Oncotaxel 140	EA	MP	D
Solution concentrate for I.V. infusion 160 mg in 16 mL	Injection	DBL Docetaxel Concentrated Injection	HH	MP	D
Solution concentrate for I.V. infusion 20 mg in 2 mL	Injection	DBL Docetaxel Concentrated Injection	HH	MP	D
Solution concentrate for I.V. infusion 80 mg in 4 mL	Injection	Oncotaxel 80	EA	MP	D
Solution concentrate for I.V. infusion 80 mg in 8 mL	Injection	DBL Docetaxel Concentrated Injection	HH	MP	D
Docetaxel Sandoz	SZ	MP	D
Doxorubicin	Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial	Injection/ intravesical	Doxorubicin SZ	HX	MP	D
Hospira Pty Limited	HH	MP	D
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial	Injection/ intravesical	Doxorubicin Ebewe	SZ	MP	D
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial	Injection/ intravesical	Accord Doxorubicin	EA	MP	D
Doxorubicin MYX	OC	MP	D
Doxorubicin SZ	HX	MP	D
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial	Injection/ intravesical	Hospira Pty Limited	HH	MP	D
Doxorubicin ‑ Pegylated Liposomal	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL	Injection	Caelyx	JC	MP	C4786 C4787 C4791	D
Liposomal Doxorubicin SUN	RA	MP	C4786 C4787 C4791	D
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL	Injection	Caelyx	JC	MP	C1568 C1795 C1796 C3905 C3910 C3911	D
Liposomal Doxorubicin SUN	RA	MP	C1568 C1795 C1796 C3905 C3910 C3911	D
Epirubicin	Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL	Injection/ intravesical	Epirubicin ACT	EA	MP	D
Hospira Pty Limited	HH	MP	D
Pharmorubicin	PF	MP	D
Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL	Injection/ intravesical	DBL Epirubicin Hydrochloride Injection	HH	MP	D
Epirubicin ACT	EA	MP	D
Epirubicin Kabi	PK	MP	D
Pharmorubicin	PF	MP	D
Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL	Injection/ intravesical	Epirubicin ACT	EA	MP	D
Epirubicin SZ	HX	MP	D
Hospira Pty Limited	HH	MP	D
Pharmorubicin	PF	MP	D
Eribulin	Solution for I.V. injection containing eribulin mesilate 1 mg in 2 mL	Injection	Halaven	EI	MP	C4649	D
Etoposide	Powder for I.V. infusion 1 g (as phosphate)	Injection	Etopophos	BQ	MP	PB
Powder for I.V. infusion 100 mg (as phosphate)	Injection	Etopophos	BQ	MP	PB
Solution for I.V. infusion 100 mg in 5 mL vial	Injection	Etoposide Ebewe	SZ	MP	PB
Fludarabine	Powder for I.V. injection containing fludarabine phosphate 50 mg	Injection	Fludarabine ACT	EA	MP	C6248	PB
Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL	Injection	Fludarabine‑Ebewe	SZ	MP	C6248	PB
Fluorouracil	Injection 1000 mg in 20 mL	Injection	DBL Fluorouracil Injection BP	HH	MP	C6266 C6297	D
Fluorouracil Ebewe	SZ	MP	C6266 C6297	D
Injection 2500 mg in 50 mL	Injection	DBL Fluorouracil Injection BP	HH	MP	C6266 C6297	D
Fluorouracil Ebewe	SZ	MP	C6266 C6297	D
Injection 500 mg in 10 mL	Injection	Hospira Pty Limited	HH	MP	C6266 C6297	D
Injection 5000 mg in 100 mL	Injection	Fluorouracil Ebewe	SZ	MP	C6266 C6297	D
Fotemustine	Powder for injection 208 mg with solvent	Injection	Muphoran	SE	MP	C6288	D
Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	DBL Gemcitabine for Injection	HH	MP	D
Gemaccord	EA	MP	D
Gemcitabine Ebewe	SZ	MP	D
Gemcitabine Kabi	PK	MP	D
Gemcitabine Sun	RA	MP	D
Powder for I.V. infusion 2 g (as hydrochloride)	Injection	DBL Gemcitabine for Injection	HH	MP	D
Gemcitabine Actavis 2000	EA	MP	D
Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	DBL Gemcitabine for Injection	HH	MP	D
Gemaccord	EA	MP	D
Gemcitabine Ebewe	SZ	MP	D
Gemcitabine Sun	RA	MP	D
Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL	Injection	Gemcitabine Ebewe	SZ	MP	D
Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL	Injection	Gemcitabine Ebewe	SZ	MP	D
Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL	Injection	Gemcitabine Ebewe	SZ	MP	D
Solution for injection 1 g (as hydrochloride) in 26.3 mL	Injection	DBL Gemcitabine Injection	HH	MP	D
Solution for injection 2 g (as hydrochloride) in 52.6 mL	Injection	DBL Gemcitabine Injection	HH	MP	D
Solution for injection 200 mg (as hydrochloride) in 5.3 mL	Injection	DBL Gemcitabine Injection	HH	MP	D
Idarubicin	Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL	Injection	Idarubicin Ebewe	SZ	MP	C6247	PB
Zavedos Solution	PF	MP	C6247	PB
Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL	Injection	Idarubicin Ebewe	SZ	MP	C6247	PB
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
Ipilimumab	Injection concentrate for I.V. infusion 50 mg in 10 mL	Injection	Yervoy	BQ	MP	C4251 C4252 C4254 C4261	D
Injection concentrate for I.V. infusion 200 mg in 40 mL	Injection	Yervoy	BQ	MP	C4251 C4252 C4254 C4261	D
Irinotecan	I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Hospira Pty Limited	HH	MP	D
IRINOTECAN ACT	ED	MP	D
Irinoccord	EA	MP	D
Irinotecan Alphapharm	AF	MP	D
Irinotecan Ebewe	SZ	MP	D
Irinotecan Kabi	PK	MP	D
Irinotecan MYX	OC	MP	D
MEDITAB IRINOTECAN	LR	MP	D
Omegapharm Irinotecan	OE	MP	D
I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL	Injection	Irinotecan Ebewe	SZ	MP	D
I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Irinoccord	EA	MP	D
IRINOTECAN ACT	ED	MP	D
Irinotecan Alphapharm	AF	MP	D
Irinotecan Ebewe	SZ	MP	D
MEDITAB IRINOTECAN	LR	MP	D
Omegapharm Irinotecan	OE	MP	D
I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL	Injection	Hospira Pty Limited	HH	MP	D
IRINOTECAN ACT	ED	MP	D
Irinotecan Actavis 500	EA	MP	D
Irinotecan Alphapharm	AF	MP	D
Irinotecan Ebewe	SZ	MP	D
Methotrexate		Injection 5 mg in 2 mL vial	Injection	Hospira Pty Limited	HH	MP
Pfizer Australia Pty Ltd	PF	MP
Injection 50 mg in 2 mL vial	Injection	Hospira Pty Limited	HH	MP
Methaccord	EA	MP
Methotrexate MYX	OC	MP	D
Pfizer Australia Pty Ltd	PF	MP
Solution concentrate for I.V. infusion 1000 mg in 10 mL vial	Injection	Hospira Pty Limited	HH	MP	PB
Methaccord	EA	MP	PB
Methotrexate MYX	OC	MP	D
Pfizer Australia Pty Ltd	PF	MP
Solution concentrate for I.V. infusion 500 mg in 20 mL vial	Injection	Hospira Pty Limited	HH	MP	PB
Pfizer Australia Pty Ltd	PF	MP
Solution concentrate for I.V. infusion 5000 mg in 50 mL vial	Injection	Methotrexate Ebewe	SZ	MP	PB
Pfizer Australia Pty Ltd	PF	MP
Mitozantrone	Injection 20 mg (as hydrochloride) in 10 mL	Injection	Hospira Pty Limited	HH	MP	D
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	C6070 C6083 C6095 C6111 C6116	D
Injection concentrate for I.V. infusion 100 mg in 10 mL	Injection	Opdivo	BQ	MP	C6070 C6083 C6095 C6111 C6116	D
Obinutuzumab	Solution for I.V. infusion 1000 mg in 40 mL	Injection	Gazyva	RO	MP	C5126	D
Ofatumumab	Solution concentrate for I.V. 100 mg in 5 mL	Injection	Arzerra	NV	MP	C4828	D
Solution concentrate for I.V. 1000 mg in 50 mL	Injection	Arzerra	NV	MP	C4828 C4858	D
Oxaliplatin	Solution concentrate for I.V. infusion 100 mg in 20 mL	Injection	DBL Oxaliplatin Concentrate	HH	MP	D
Oxaliccord	EA	MP	D
Oxaliplatin Kabi	PK	MP	D
Oxaliplatin SUN	RA	MP	D
Oxaliplatin SZ	HX	MP	D
Solution concentrate for I.V. infusion 200 mg in 40 mL	Injection	Oxaliplatin SUN	RA	MP	D
Solution concentrate for I.V. infusion 50 mg in 10 mL	Injection	DBL Oxaliplatin Concentrate	HH	MP	D
Oxaliplatin SUN	RA	MP	D
Paclitaxel	Solution concentrate for I.V. infusion 100 mg in 16.7 mL	Injection	Anzatax	HH	MP	D
Paclitaxel ACT	EF	MP	D
Paclitaxel Actavis	EA	MP	D
Plaxel	ED	MP	D
Solution concentrate for I.V. infusion 150 mg in 25 mL	Injection	Anzatax	HH	MP	D
Paclitaxel ACT	EF	MP	D
Paclitaxel Actavis	EA	MP	D
Paclitaxel Ebewe	SZ	MP	D
Plaxel	ED	MP	D
Solution concentrate for I.V. infusion 30 mg in 5 mL	Injection	Anzatax	HH	MP	D
Paclitaxel ACT	EF	MP	D
Paclitaxel Actavis	EA	MP	D
Paclitaxel Ebewe	SZ	MP	D
Paclitaxel Kabi	PK	MP	D
Plaxel	ED	MP	D
Solution concentrate for I.V. infusion 300 mg in 50 mL	Injection	Anzatax	HH	MP	D
Paclitaxel ACT	EF	MP	D
Paclitaxel Actavis	EA	MP	D
Paclitaxel Ebewe	SZ	MP	D
Paclitaxel Kabi	PK	MP	D
Plaxel	ED	MP	D
Paclitaxel, nanoparticle albumin‑bound	Powder for I.V. injection containing 100 mg paclitaxel	Injection	Abraxane	TS	MP	C4657 C6106 C6119	D
Panitumumab	Solution concentrate for I.V. infusion 100 mg in 5 mL	Injection	Vectibix	AN	MP	C5439 C5447 C5452 C5526	D
Solution concentrate for I.V. infusion 400 mg in 20 mL	Injection	Vectibix	AN	MP	C5439 C5447 C5452 C5526	D
Pembrolizumab	Powder for injection 50 mg	Injection	Keytruda	MK	MP	C5362 C6093 C6094 C6103 C6104	D
Pemetrexed	Powder for I.V. infusion 100 mg (as disodium heptahydrate)	Injection	Alimta	LY	MP	C4789 C4792	D
DBL Pemetrexed	HH	MP	C4789 C4792	D
Pemetrexed APOTEX	TX	MP	C4789 C4792	D
Pemetrexed Juno	JU	MP	C4789 C4792	D
Pemetrexed MYX	OC	MP	C4789 C4792	D
Reladdin	AF	MP	C4789 C4792	D
Powder for I.V. infusion 500 mg (as disodium heptahydrate)	Injection	Alimta	LY	MP	C4789 C4792	D
DBL Pemetrexed	HH	MP	C4789 C4792	D
Pemetrexed APOTEX	TX	MP	C4789 C4792	D
Pemetrexed DRLA	RZ	MP	C4789 C4792	D
Pemetrexed Juno	JU	MP	C4789 C4792	D
Pemetrexed MYX	OC	MP	C4789 C4792	D
Pemetrexed Sandoz	SZ	MP	C4789 C4792	D
Reladdin	AF	MP	C4789 C4792	D
Powder for I.V. infusion 1 g (as disodium)	Injection	DBL Pemetrexed	HH	MP	C4789 C4792	D
Pemetrexed MYX	YN	MP	C4789 C4792	D
Pertuzumab	Solution for I.V. infusion 420 mg in 14 mL	Injection	Perjeta	RO	MP	C4971 C5013 C5023	D
Raltitrexed	Powder for I.V. infusion 2 mg in single use vial	Injection	Tomudex	HH	MP	C6228	D
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Mabthera	RO	MP	C4706 C5998 C6009 C6034 C6039 C6161 C6162 C6187	D
Solution for I.V. infusion 500 mg in 50 mL	Injection	Mabthera	RO	MP	C4706 C5998 C6009 C6034 C6039 C6161 C6162 C6187	D
Topotecan	Powder for I.V. infusion 4 mg (as hydrochloride)	Injection	Hycamtin	NV	MP	C6238	D
Topotecan Agila	YA	MP	C6238	D
Topotecan Kabi	PK	MP	C6238	D
Trastuzumab	Powder for I.V. infusion 150 mg	Injection	Herceptin	RO	MP	C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041C5825C5834C5844	D
Powder for I.V. infusion 60 mg	Injection	Herceptin	RO	MP	C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164C5024 C5032 C5041C5825C5834C5844	D
Trastuzumab emtansine	Powder for I.V. infusion 100 mg	Injection	Kadcyla	RO	MP	C4978 C4986 C6096 C6129	D
Powder for I.V. infusion 160 mg	Injection	Kadcyla	RO	MP	C4978 C4986 C4987	D
Vinblastine	Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL	Injection	Hospira Pty Limited	HH	MP	D
Vincristine	I.V. injection containing vincristine sulfate 1 mg in 1 mL	Injection	Hospira Pty Limited	HH	MP	D
Vinorelbine	Solution for I.V. infusion 10 mg (as tartrate) in 1 mL	Injection	Hospira Pty Limited	HH	MP	PB
Navelbine	FB	MP	PB
Vinorelbine Ebewe	SZ	MP	PB
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL	Injection	Hospira Pty Limited	HH	MP	PB
Navelbine	FB	MP	PB
Vinorelbine Ebewe	SZ	MP	PB
Vinorelbine Kabi	PK	MP	PB

Pemetrexed	C4789	Mesothelioma. Treatment must be in combination with cisplatin. The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated. Doses greater than 500 mg per metre squared BSA are not PBS-subsidised.	Compliance with Authority Required procedures - Streamlined Authority Code 4789
C4792	Locally advanced or metastatic non-small cell lung cancer. Patient must have received prior treatment with platinum-based chemotherapy. The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated. Doses greater than 500 mg per metre squared BSA are not PBS-subsidised	Compliance with Authority Required procedures - Streamlined Authority Code 4792
Pertuzumab	C4971	P4971	Metastatic (Stage IV) HER2 positive breast cancer Treatment Phase: Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition, AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, AND The treatment must be in combination with trastuzumab, AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course. However, short treatment breaks are permitted. A patient who has a treatment break of less than 6 weeks in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug. A patient who has a treatment break of more than 6 weeks in PBS-subsidised treatment with this drug is not eligible to receive PBS-subsidised treatment with this drug. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.	Compliance with Written or Telephone Authority Required procedures
C5013	P5013	Metastatic (Stage IV) HER2 positive breast cancer Treatment Phase: Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, AND Patient must have a WHO performance status of 0 or 1, AND Patient must not have received prior anti-HER2 therapy for this condition, AND Patient must not have received prior chemotherapy for this condition, AND The treatment must be in combination with trastuzumab and a taxane, AND The treatment must not be in combination with nab-paclitaxel, AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease; and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
C5023	P5023	HER2 positive breast cancer Treatment Phase: Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015, AND Patient must not have received non-PBS-subsidised treatment with trastuzumab for this condition before 1 July 2014, AND Patient must not have received prior therapy with trastuzumab emtansine or lapatinib for this condition, AND The treatment must be in combination with trastuzumab, AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
Raltitrexed	C6228	Advanced colorectal cancer The treatment must only be used as a single agent in the treatment of this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 6228
Rituximab	C4706	P4706	Chronic lymphocytic leukaemia (CLL) The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND The treatment must be in combination with chemotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 4706
C5998	P5998	Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma Re-induction treatment The treatment must be for re-induction treatment purposes only; AND The condition must have relapsed or be refractory to treatment; AND Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction. An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.	Compliance with Authority Required procedures - Streamlined Authority Code 5998
C6008	P6008	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6008
C6009	P6009	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6009
C6034	P6034	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6034
C6039	P6039	Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma Re-induction treatment The treatment must be for re-induction treatment purposes only; AND The condition must have relapsed or be refractory to treatment; AND Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction. An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.	Compliance with Authority Required procedures - Streamlined Authority Code 6039
C6161	P6161	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to induction treatment with either R-CHOP or R-CVP regimens for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND Patient must not have received bendamustine induction therapy; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 6161
C6162	P6162	Previously untreated symptomatic indolent CD20 positive non-Hodgkin's lymphoma in combination with chemotherapy Induction treatment The treatment must be in combination with PBS-subsidised chemotherapy; 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 the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction. An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.	Compliance with Authority Required procedures - Streamlined Authority Code 6162
C6187	P6187	Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with PBS-subsidised chemotherapy; AND The condition must be previously untreated; AND The treatment must be for induction treatment purposes only; AND Patient must not be eligible for stem cell transplantation if they have mantle cell lymphoma. An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.	Compliance with Authority Required procedures - Streamlined Authority Code 6187
Topotecan	C6238	Advanced metastatic ovarian cancer Patient must have failed prior therapy which included a platinum compound.	Compliance with Authority Required procedures - Streamlined Authority Code 6238
Trastuzumab	C4083	P4083	Locally advanced HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures
C4093	P4093	Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures
C4104	P4104	Locally advanced HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures
C4142	P4142	Locally advanced HER2 positive breast cancer Initial treatment (weekly regimen) Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg.	Compliance with Written Authority Required procedures
C4143	P4143	Locally advanced HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg.	Compliance with Written Authority Required procedures
C4144	P4144	Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with adjuvant chemotherapy; AND Patient must have undergone surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg.	Compliance with Written Authority Required procedures
C4156	P4156	Early HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures
C4164	P4164	Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must commence treatment concurrently with adjuvant chemotherapy; AND Patient must have undergone surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg.	Compliance with Written Authority Required procedures
C5024	P5024	Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, authority approval will be granted for a new loading dose. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.	Compliance with Written or Telephone Authority Required procedures
C5032	P5032	Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND The treatment must not be in combination with nab-paclitaxel; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the patient has Stage IV disease. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
C5041	P5041	HER2 positive breast cancer Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.	Compliance with Written or Telephone Authority Required procedures
C5825	P5825	Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Initial PBS-subsidised treatment (Grandfather patient) Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity; AND Patient must have been treated with this drug for this condition prior to 1 January 2016; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) positivity.	Compliance with Written Authority Required procedures
C5834	P5834	Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must not have progressive disease; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.	Compliance with Written or Telephone Authority Required procedures
C5844	P5844	Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND Patient must commence treatment in combination with cisplatin and capecitabine; OR Patient must commence treatment in combination with cisplatin and 5 fluorouracil; AND Patient must not have previously received this drug for this condition; AND Patient must not have received prior chemotherapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated in tumour material by both (i) immunohistochemistry (IHC) 2+ or IHC 3+ AND (ii) in situ hybridisation (ISH) results based on both more than 6 copies of HER2 AND the ratio of HER2: chromosome 17 being more than 2 in the same tumour tissue sample Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment	Compliance with Written Authority Required procedures
C6059	P6059	Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with adjuvant chemotherapy; AND Patient must have undergone surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
C6060	P6060	Locally advanced HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
C6061	P6061	Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures
C6062	P6062	Locally advanced HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.	Compliance with Written or Telephone Authority Required procedures
Trastuzumab emtansine	C4978	P4978	Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course.	Compliance with Written or Telephone Authority Required procedures
C4986	P4986	Metastatic (Stage IV) HER2 positive breast cancer Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures
C6096	P6096	Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease; (ii) a copy of the signed patient acknowledgement form; (iii) dates of treatment with trastuzumab and pertuzumab; and (iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or (v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.	Compliance with Written Authority Required procedures
C6129	P6129	Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease; (ii) a copy of the signed patient acknowledgement form; (iii) dates of treatment with trastuzumab and pertuzumab; and (iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or (v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.	Compliance with Written Authority Required procedures
Tropisetron	C5749	Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle

Schedule 5—Patient contributions

(sections 54 to 58)

Listed Drug	Form	Manner of Administration			Brand	Quantity or Number of Units	Approved Ex‑manufacturer Price	Claimed Ex‑manufacturer Price
Nil entry

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

ad = added or inserted	o = order(s)
am = amended	Ord = Ordinance
amdt = amendment	orig = original
c = clause(s)	par = paragraph(s)/subparagraph(s)
C[x] = Compilation No. x	/sub‑subparagraph(s)
Ch = Chapter(s)	pres = present
def = definition(s)	prev = previous
Dict = Dictionary	(prev…) = previously
disallowed = disallowed by Parliament	Pt = Part(s)
Div = Division(s)	r = regulation(s)/rule(s)
ed = editorial change	reloc = relocated
exp = expires/expired or ceases/ceased to have	renum = renumbered
effect	rep = repealed
F = Federal Register of Legislation	rs = repealed and substituted
gaz = gazette	s = section(s)/subsection(s)
LA = Legislation Act 2003	Sch = Schedule(s)
LIA = Legislative Instruments Act 2003	Sdiv = Subdivision(s)
(md) = misdescribed amendment can be given	SLI = Select Legislative Instrument
effect	SR = Statutory Rules
(md not incorp) = misdescribed amendment	Sub‑Ch = Sub‑Chapter(s)
cannot be given effect	SubPt = Subpart(s)
mod = modified/modification	underlining = whole or part not
No. = Number(s)	commenced or to be commenced

Endnote 3—Legislation history

Name	Registration	Commencement	Application, saving and transitional provisions
PB 79 of 2011	29 Nov 2011 (F2011L02491)	1 Dec 2011
PB 100 of 2011	20 Dec 2011 (F2011L02756)	1 Jan 2012	—
PB 4 of 2012	23 Feb 2012 (F2012L00379)	1 Mar 2012	—
PB 18 of 2012	29 Mar 2012 (F2012L00721)	1 Apr 2012	—
PB 32 of 2012	30 Apr 2012 (F2012L00951)	1 May 2012	—
PB 36 of 2012	30 May 2012 (F2012L01118)	1 June 2012	—
PB 40 of 2012	25 June 2012 (F2012L01332)	1 July 2012	—
PB 48 of 2012	27 July 2012 (F2012L01616)	1 Aug 2012	—
PB 65 of 2012	21 Aug 2012 (F2012L01730)	1 Sept 2012	—
PB 77 of 2012	28 Sept 2012 (F2012L01966)	1 Oct 2012	—
PB 97 of 2012	29 Nov 2012 (F2012L02290)	1 Dec 2012	—
PB 3 of 2013	14 Jan 2013 (F2013L00046)	1 Feb 2013	—
PB 11 of 2013	21 Feb 2013 (F2013L00254)	1 Mar 2013	—
PB 17 of 2013	27 Mar 2013 (F2013L00563)	1 Apr 2013	—
PB 25 of 2013	26 Apr 2013 (F2013L00691)	1 May 2013	—
PB 31 of 2013	24 May 2013 (F2013L00842)	1 June 2013	—
PB 36 of 2013	18 June 2013 (F2013L01039)	1 July 2013	—
PB 43 of 2013	29 July 2013 (F2013L01453	1 Aug 2013	—
PB 57 of 2013	28 Aug 2013 (F2013L01631	1 Sept 2013	—
PB 64 of 2013	24 Sept 2013 (F2013L01735)	1 Oct 2013	—
PB 71 of 2013	18 Oct 2013 (F2013L01813)	1 Nov 2013	—
PB 79 of 2013	29 Nov 2013 (F2013L02023)	1 Dec 2013	—
PB 93 of 2013	24 Dec 2013 (F2013L02195)	1 Jan 2014	—
PB 5 of 2014	23 Jan 2014 (F2014L00079)	1 Feb 2014	—
PB 12 of 2014	26 Feb 2014 (F2014L00191)	1 Mar 2014	—
PB 21 of 2014	27 Mar 2014 (F2014L00360)	1 Apr 2014	—
PB 31 of 2014	28 Apr 2014 (F2014L00438)	1 May 2014	—
PB 41 of 2014	21 May 2014 (F2014L00578)	1 June 2014	—
PB 49 of 2014	1 July 2014 (F2014L00919)	1 July 2014	—
PB 56 of 2014	30 July 2014 (F2014L01053)	1 Aug 2014	—
PB 64 of 2014	25 Aug 2014 (F2014L01124)	1 Sept 2014	—
PB 78 of 2014	26 Sept 2014 (F2014L01291)	1 Oct 2014	—
PB 86 of 2014	29 Oct 2014 (F2014L01439)	1 Nov 2014 (s 2)	—
PB 94 of 2014	1 Dec 2014 (F2014L01615)	1 Dec 2014 (s 2)	—
PB 104 of 2014	24 Dec 2014 (F2014L01834)	1 Jan 2015 (s 2)	—
PB 4 of 2015	30 Jan 2015 (F2015L00083)	1 Feb 2015 (s 2)	—
PB 13 of 2015	27 Feb 2015 (F2015L00230)	1 Mar 2015 (s 2)	—
PB 31 of 2015	1 Apr 2015 (F2015L00434)	1 Apr 2015 (s 2)	—
PB 44 of 2015	29 Apr 2015 (F2015L00604)	1 May 2015 (s 2)	—
PB 51 of 2015	1 June 2015 (F2015L00769)	1 June 2015 (s 2)	—
PB 59 of 2015	30 June 2015 (F2015L01060)	1 July 2015 (s 2)	—
PB 73 of 2015	31 July 2015 (F2015L01200)	1 Aug 2015 (s 2)	—
PB 84 of 2015	31 Aug 2015 (F2015L01361)	1 Sept 2015 (s 2)	—
PB 95 of 2015	1 Oct 2015 (F2015L01604)	1 Oct 2015 (s 2)	—
PB 105 of 2015	29 Oct 2015 (F2015L01715)	1 Nov 2015 (s 2)	—
PB 112 of 2015	1 Dec 2015 (F2015L01898)	1 Dec 2015 (s 2)	—
PB 122 of 2015	24 Dec 2015 (F2015L02132)	1 Jan 2016 (s 2)	—
PB 6 of 2016	1 Feb 2016 (F2016L00080)	1 Feb 2016 (s 2)	—
PB 14 of 2016	1 Mar 2016 (F2016L00213)	1 Mar 2016 (s 2)	—
PB 23 of 2016	1 Apr 2016 (F2016L00483)	1 Apr 2016 (s 2)	—
PB 34 of 2016	29 Apr 2016 (F2016L00605)	1 May 2016 (s 2)	—
PB 46 of 2016	31 May 2016 (F2016L00920)	1 June 2016 (s 2)	—
PB 56 of 2016	28 June 2016 (F2016L01092)	1 July 2016 (s 2)	—

Endnote 4—Amendment history

Provision affected	How affected
Part 1
Division 1
s. 3.......................................	am. PB 18, 40 and 48 of 2012; PB 36 of 2013; PB 49 of 2014; PB 31 and 59 of 2015; PB 56 of 2016
Division 2
s 9........................................	am PB 31 of 2015
s 10......................................	am PB 31 of 2015
s 11......................................	am PB 31 of 2015
s 12......................................	am PB 31 of 2015
Part 2
Division 1
s 14......................................	am PB 31 of 2015
s 15......................................	am PB 31 of 2015
s 16......................................	rs PB 31 of 2015
s 17......................................	am PB 31 of 2015
s 18......................................	am PB 31 of 2015
Division 2
s 19......................................	am PB 31 of 2015
s 20......................................	rep PB 31 of 2015
s 21......................................	rep PB 31 of 2015
Division 3
s 22......................................	am PB 31 of 2015; PB 34 of 2016
s 23......................................	rep PB 31 of 2015
s 24......................................	rep PB 31 of 2015
s 25......................................	rep PB 31 of 2015
s 26......................................	rep PB 31 of 2015
s 27......................................	rep PB 31 of 2015
s 28......................................	rep PB 31 of 2015
s 29......................................	rep PB 31 of 2015
Part 3
s 31......................................	am PB 31 of 2015
s 33......................................	am PB 31 of 2015
s 34......................................	am PB 31 of 2015
s 35......................................	am PB 31 of 2015
s 34A...................................	ad PB 94, 2014
s 35......................................	rep PB 31 of 2015
Part 4
Part 4 heading......................	rs. PB 18 of 2012
Division 1
Division 1 heading...............	rs. PB 18 of 2012
s 36......................................	am PB 31 of 2015
s. 37.....................................	rs. PB 18 of 2012
s 38......................................	rep PB 31 of 2015
s. 39.....................................	rs. PB 18 of 2012
am PB 31 of 2015
s 40......................................	rep PB 31 of 2015
Division 2
s 44......................................	rep PB 31 of 2015
Division 2A
Division 2A.........................	ad PB 59 of 2015
s 46A...................................	ad PB 59 of 2015
s 46B...................................	ad PB 59 of 2015
s 46C...................................	ad PB 59 of 2015
Division 3
s 48......................................	rs PB 59 of 2015
Division 4
s 52......................................	am PB 31 of 2015
Part 5
s 56......................................	rep PB 31 of 2015
s 57......................................	am PB 31 of 2015
s 59......................................	am PB 31 of 2015
Part 6
s 60......................................	rs PB 31 of 2015
s 61......................................	ad PB 59 of 2015
exp 1 Nov 2015 (s 61(3))
Schedule 1
Schedule 1........................... ............................................	am. PB 100 of 2011; PB 4, 18, 32, 36, 40, 48, 65, 77 and 97 of 2012; PB 3, 11, 17, 25, 31, 36, 43, 57, 64, 71 and 79 of 2013; PB 5, 12, 21, 31, 41, 49, 56, 64, 78, 86, 94 and 104 (Sch 1 item 1 (md)) of 2014; PB 4, 13, 31, 44, 51, 59 (Sch 1 item 19 (md)), 73, 84 (Sch 1 item 1 (md)), 95, 105, 112 and 122 of 2015; PB 6, 14, 23 (item 15 (md)), 34, 46 and 56 of 2016
Schedule 2
Schedule 2........................... ............................................	am. PB 40, 77 and 97 of 2012; PB 17, 25, 43, 57, 64 and 93 of 2013; PB 21 and 64 of 2014; PB 31, 51, 73, 95, 105 and 112 of 2015; PB 14, 23, 34 (Sch 2 item 17 md not incorp), 46 and 56 of 2016
Schedule 3
Schedule 3...........................	am. PB 32 and 40 of 2012; PB 3, 17 and 64 of 2013; PB 21, 31, 41, 49, 64, 78 and 94 of 2014; PB 59, 95 and 112 of 2015; PB 6, 14, 23, 34 and 46 of 2016
Schedule 4
Schedule 4...........................	am. PB 100 of 2011; PB 4, 48, 77 and 97 of 2012; PB 25, 43, 79 and 93 of 2013; PB 21, 56, 78, 86, 94 and 104 of 2014; PB 4, 13, 31, 51, 59, 73, 84, 95, 105, 112 and 122 of 2015; PB 14, 23 (Sch 1 item 15 md), 34, 46 and 56 of 2016
Schedule 5
Schedule 5...........................	am. PB 18 and 32 of 2012; PB 94 of 2014; PB 95 of 2015