PB 31 of 2024

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024

I, David Laffan, as delegate of the Minister for Health and Aged Care, make the following special arrangement.

Dated  26 March 2024

David Laffan
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division

Department of Health and Aged Care

Contents

Part 1—Preliminary

1 Name

2 Commencement

3 Authority

4 Simplified outline

5 Definitions

6 Definition of authorised prescriber

7 Definition of eligible patient

8 Application of Act and instruments in relation to special arrangement supplies to patients receiving treatment from hospitals

9 Application of Act and instruments in relation to chemotherapy prescriptions and special arrangement supplies of doses of chemotherapy drugs

Part 2—Special arrangement supplies

Division 1—Preliminary

10 Definition of special arrangement supply

Division 2—Prescribing doses of chemotherapy drugs and related pharmaceutical benefits

11 Prescribing chemotherapy drugs

12 Prescription circumstances—general

13 Prescription circumstances—authority required procedures

14 Maximum amount—chemotherapy drugs

15 Maximum quantity (number of units)—related pharmaceutical benefits

16 Maximum number of repeats—chemotherapy drugs

17 Maximum number of repeats—related pharmaceutical benefits

18 Variation of maximum amount or quantity or maximum number of repeats

19 Writing chemotherapy prescriptions that are not medication chart prescriptions

20 Writing medication chart prescriptions

21 Direction to vary prescribed dose of chemotherapy drug

Division 3—Supplying doses of chemotherapy drugs and related pharmaceutical benefits

22 Entitlement to receive special arrangement supplies

23 Special arrangement supplies of doses of chemotherapy drugs

24 Rules not applicable to special arrangement supplies of chemotherapy drugs

25 Modified rules for special arrangement supplies on the basis of an electronic medication chart prescription

Part 3—Claims, information and payment

Division 1—Claims for payment and giving information

26 Modified requirements for claims or giving information

Division 2—Payment of claims

27 Payment of approved pharmacists and approved medical practitioners for supplies of doses of chemotherapy drugs

28 Payment of approved hospital authorities for supplies

29 No separate entitlement to payment for supplies of diluent

30 Payment of TGA‑licensed compounders

Division 3—Dispensed price for dose of chemotherapy drug

31 Dispensed price for doses supplied by approved pharmacists and approved medical practitioners

32 Mark‑up for a chemotherapy pharmaceutical benefit

33 Dispensed price if dose is supplied by approved private hospital authority

34 Dispensed price if dose is supplied by approved public hospital authority

Division 4—Dispensed price for related pharmaceutical benefit

35 Dispensed price for supply of related pharmaceutical benefit

Part 4—Patient contributions

36 Supplies of doses of chemotherapy drugs by approved pharmacists and approved medical practitioners

37 Supplies of doses of chemotherapy drugs by approved hospital authorities

38 Supplies of related pharmaceutical benefits—special patient contribution

39 Application of safety net provisions

Schedule 1—Chemotherapy pharmaceutical benefits and chemotherapy drugs

Part 1—Chemotherapy pharmaceutical benefits

1 Chemotherapy pharmaceutical drugs and chemotherapy pharmaceutical benefits

Part 2—Maximum amounts and number of repeats for chemotherapy drugs 38

2 Maximum amounts and number of repeats.........................38

Schedule 2—Related pharmaceutical benefits

1 Related pharmaceutical benefits and related information

Schedule 3—Circumstances, purposes and variations 48

Part 1—Circumstances and purposes 48

1 Circumstances and purposes.................................48

Part 2—Variation rules 136

2 Variation rules........................................136

Part 1—Preliminary

1  Name

 (1) This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024.

 (2) This instrument may also be cited as PB 31 of 2024.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under sections 85, 85A, 99 and 100 of the National Health Act 1953.

4  Simplified outline

Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

5  Definitions

Note 1: A number of expressions used in this instrument are defined in the Act, including the following:

(a) hospital;

(b) public hospital.

Note 2: Under subsection 4(1A) of the Act, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that are defined in that Act include the following:

(a) eligible person;

(b) medical practitioner;

(c) private hospital;

(d) specialist.

Note 3: A reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority within the meaning of the National Health (Highly Specialised Drugs Program) Special Arrangement 2021: see section 11 of that instrument.

  In this instrument:

Act means the National Health Act 1953.

approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

approved hospital authority has the same meaning as in Part VII of the Act.

approved medical practitioner has the same meaning as in Part VII of the Act.

approved pharmacist has the same meaning as in Part VII of the Act.

approved supplier has the same meaning as in Part VII of the Act.

authorised prescriber has the meaning given by section 6.

authority prescription means a prescription that has been authorised:

 (a) in accordance with section 30 of the Regulations as modified by this instrument; or

 (b) in accordance with section 19 of the Listing Instrument as modified by this instrument.

chemotherapy drug means a listed drug that is mentioned in Part 1 of Schedule 1.

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.

chemotherapy prescription has the meaning given by subsection 11(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 doses of chemotherapy drugs.

compounder ID means the identification number allocated to a compounder by the Chemotherapy Compounding Payment Scheme Administration Agency in respect of a compounding site.

Note: At the commencement of this instrument, Australian Healthcare Associates Pty Ltd was the Chemotherapy Compounding Payment Scheme Administration Agency.

diluent fee means an amount of $5.77.

dispensed price:

 (a) for a special arrangement supply of a dose of a chemotherapy drug by an approved pharmacist or an approved medical practitioner—has the meaning given by section 31; and

 (b) for a special arrangement supply of a dose of a chemotherapy drug by an approved hospital authority of a private hospital—has the meaning given by section 33; and

 (c) for a special arrangement supply of a dose of a chemotherapy drug by an approved hospital authority of a public hospital—has the meaning given by section 34; and

 (d) for a special arrangement supply of a related pharmaceutical benefit—has the meaning given by section 35.

dispensing fee means an amount of $8.37.

distribution fee means an amount of $29.15.

dose, of a chemotherapy drug, means a quantity of the drug for a single treatment of a patient that is made from one or more chemotherapy pharmaceutical benefits.

electronic medication chart prescription means a medication chart prescription prepared, in electronic form, in a software system that is used for prescribing and recording the administration of medicines to persons receiving treatment in, at or from a hospital.

eligible patient has the meaning given by section 7.

listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

listed drug has the same meaning as in Part VII of the Act.

Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.

medication chart has a meaning affected by subsection 20(1).

medication chart prescription has the same meaning as in the Regulations.

National Health Reform Agreement has the same meaning as in the Federal Financial Relations Act 2009.

pack quantity of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

participating hospital authority means an approved hospital authority of a public hospital that is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Health Reform Agreement.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.

pharmaceutical item has the same meaning as in Part VII of the Act.

preparation fee means an amount of $88.62.

pricing quantity of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

proportional ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

purposes code means the letter “P” followed by a number.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

related pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 2.

restricted drug has the meaning given by subsection 12(1).

single unit ex‑manufacturer price, for a chemotherapy pharmaceutical benefit that is a listed brand of a pharmaceutical item, means the approved ex‑manufacturer price for the chemotherapy pharmaceutical benefit divided by the pricing quantity for the chemotherapy pharmaceutical benefit.

Note: This price is 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 the pricing quantity is 5 units of “Injection 500 mg in 10 mL”, the approved ex‑manufacturer price would be divided by 5 to obtain the single unit ex‑manufacturer price.

special arrangement supply has the meaning given by section 10.

TGA‑licensed compounder means a compounder who holds a licence issued under the Therapeutic Goods Act 1989 that authorises the aseptic compounding of sterile chemotherapy drugs.

TGA‑licensed compounding fee means an amount of $20.

variation code means the letter “V” followed by a number.

6  Definition of authorised prescriber

 (1) A medical practitioner is an authorised prescriber for a chemotherapy drug.

 (2) A medical practitioner is an authorised prescriber for a related pharmaceutical benefit.

7  Definition of eligible patient

 (1) A person is an eligible patient for a chemotherapy drug if:

 (a) the person is, or is to be treated as, an eligible person; and

 (b) a dose of the drug is or will be prescribed to the person for the purposes of treatment for cancer or a cancer‑related condition.

 (2) A person is an eligible patient for a related pharmaceutical benefit if:

 (a) the person is, or is to be treated as, an eligible person; and

 (b) the benefit is or will be prescribed to the person for the purposes of treatment for cancer or a cancer‑related condition.

8  Application of Act and instruments in relation to special arrangement supplies to patients receiving treatment from hospitals

 (1) In the application of Part VII of the Act, and regulations or other instruments made for the purposes of that Part, to special arrangement supplies, a reference to a person receiving treatment in or at an approved hospital is taken to include a reference to a person receiving treatment from an approved hospital.

 (2) In Part VII of the Act, and regulations or other instruments made for the purposes of that Part, a reference to an approved hospital authority supplying pharmaceutical benefits to patients receiving treatment in or at a hospital is taken to include a reference to an approved hospital authority supplying doses of chemotherapy drugs or related pharmaceutical benefits to patients receiving treatment from a hospital.

9  Application of Act and instruments in relation to chemotherapy prescriptions and special arrangement supplies of doses of chemotherapy drugs

 (1) Subject to this instrument, a reference in Part VII of the Act, or regulations or other instruments made for the purposes of that Part, to a prescription for the supply of a pharmaceutical benefit is taken to include a reference to a chemotherapy prescription.

 (2) Subject to this instrument, a reference in Part VII of the Act, or regulations and other instruments made for the purposes of that Part, to a supply of a pharmaceutical benefit is taken to include a special arrangement supply of a dose of a chemotherapy drug.

Part 2—Special arrangement supplies

Division 1—Preliminary

10  Definition of special arrangement supply

Doses of chemotherapy drugs supplied by approved pharmacists

 (1) A supply of a dose of a chemotherapy drug to a person is a special arrangement supply of the dose if:

 (a) the person is an eligible patient for the drug; and

 (b) the dose is supplied by an approved pharmacist; and

 (c) the dose is supplied on the basis of a chemotherapy prescription written by an authorised prescriber for the drug in accordance with Division 2.

Doses of chemotherapy drugs supplied by approved medical practitioners

 (2) A supply of a dose of a chemotherapy drug to a person is a special arrangement supply of the dose if:

 (a) the person is an eligible patient for the drug; and

 (b) the dose is supplied by an approved medical practitioner; and

 (c) the dose is supplied on the basis of a chemotherapy prescription written by an authorised prescriber for the drug in accordance with Division 2; and

 (d) the prescription is not a medication chart prescription.

Doses of chemotherapy drugs supplied by private hospitals

 (3) A supply of a dose of a chemotherapy drug to a person is a special arrangement supply of the dose if:

 (a) the person is an eligible patient for the drug; and

 (b) the dose is supplied by an approved hospital authority of a private hospital; and

 (c) the dose is supplied on the basis of a chemotherapy prescription written:

 (i) when the person was receiving medical treatment at or from a private hospital; and

 (ii) by an authorised prescriber for the drug in accordance with Division 2.

Doses of chemotherapy drugs supplied by public hospitals

 (4) A supply of a dose of a chemotherapy drug to a person is a special arrangement supply of the dose if:

 (a) the person is an eligible patient for the drug; and

 (b) the dose is supplied by a participating hospital authority; and

 (c) the dose is supplied on the basis of a chemotherapy prescription written:

 (i) when the person was receiving medical treatment at or from a public hospital as a non‑admitted patient, day admitted patient or patient on discharge; and

 (ii) by an authorised prescriber for the drug in accordance with Division 2.

 (5) A supply of a dose of the chemotherapy drug trastuzumab to a person is a special arrangement supply of the dose if:

 (a) the person is an eligible patient for the drug; and

 (b) the dose is supplied by an approved hospital authority of a public hospital that is not a participating hospital authority; and

 (c) the dose is supplied on the basis of a prescription written:

 (i) when the person was receiving medical treatment at or from a public hospital as a non‑admitted patient, day admitted patient or patient on discharge; and

 (ii) by an authorised prescriber for the drug in accordance with Division 2; and

 (d) the prescription is not a medication chart prescription.

Related pharmaceutical benefits

 (6) A supply of a related pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

 (a) the person is an eligible patient for the benefit; and

 (b) the benefit is supplied by a participating hospital authority; and

 (c) the benefit is supplied on the basis of a prescription written:

 (i) when the person was receiving medical treatment at or from a public hospital as a non‑admitted patient, day admitted patient or patient on discharge; and

 (ii) by an authorised prescriber for the benefit; and

 (iii) if the benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act—in circumstances determined by subsection 12(3) of this instrument.

Division 2—Prescribing doses of chemotherapy drugs and related pharmaceutical benefits

11  Prescribing chemotherapy drugs

 (1) Subject to this Division, an authorised prescriber for a chemotherapy drug is authorised to write a prescription (a chemotherapy prescription) for the special arrangement supply of a dose of the drug.

 (2) This section applies in addition to authorisations to write prescriptions under section 88 of the Act.

12  Prescription circumstances—general

Chemotherapy drugs

 (1) A chemotherapy drug is a restricted drug if there are one or more circumstances codes mentioned in the column of the table in Part 1 of Schedule 1 headed “Circumstances” in relation to each chemotherapy pharmaceutical benefit that has the chemotherapy drug.

Note: Different chemotherapy pharmaceutical benefits having the same drug may have different circumstances codes. For the purposes of this subsection, it does not matter which circumstances code is mentioned.

 (2) A chemotherapy prescription for a dose of a restricted drug may only be written in circumstances mentioned in the column of the table in Part 1 of Schedule 3 headed “Circumstances and Purposes” in relation to any of the circumstances codes that relate to chemotherapy pharmaceutical benefits that have the drug.

Related pharmaceutical benefits

 (3) For the purposes of paragraphs 85(7)(a) and (b) of the Act, if a circumstances code is mentioned in the column of the table in Schedule 2 headed “Circumstances” in relation to a related pharmaceutical benefit:

 (a) the pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act; and

 (b) the circumstances mentioned in the column of the table in Part 1 of Schedule 3 headed “Circumstances and Purposes” in relation to the circumstances code are circumstances in which a prescription for a special arrangement supply of the pharmaceutical benefit may be written.

Application of this section

 (4) This section applies in addition to section 13 of the Listing Instrument.

13  Prescription circumstances—authority required procedures

Restricted drugs

 (1) Subsection (3) applies to a chemotherapy prescription for a dose of a restricted drug if the circumstances mentioned in Part 1 of Schedule 3 that apply to the writing of the prescription include:

 (a) Compliance with Authority Required procedures; or

 (b) Compliance with Written Authority Required procedures.

Related pharmaceutical benefits

 (2) Subsection (3) applies to a prescription for a special arrangement supply of a related pharmaceutical benefit if the circumstances mentioned in Part 1 of Schedule 3 (if any) in which the prescription is written include:

 (a) Compliance with Authority Required procedures; or

 (b) Compliance with Written Authority Required procedures.

Modified application of Listing Instrument

 (3) Section 19 of the Listing Instrument applies to the prescription as if:

 (a) a reference to Part 1 of Schedule 4 to that instrument were a reference to Part 1 of Schedule 3 to this instrument; and

 (b) a reference to an authorised prescriber were a reference to an authorised prescriber within the meaning of this instrument.

14  Maximum amount—chemotherapy drugs

 (1) This section determines the maximum amount of a chemotherapy drug that an authorised prescriber may, in one chemotherapy prescription, direct to be supplied in a dose of the drug.

 (2) If only one amount is mentioned in the column of the table in Part 2 of Schedule 1 headed “Maximum Amount” in relation to a chemotherapy drug, that amount is the maximum amount of the chemotherapy drug for all purposes.

 (3) If more than one amount is mentioned in the column of the table in Part 2 of Schedule 1 headed “Maximum Amount” in relation to a chemotherapy drug, then:

 (a) if a purposes code is mentioned in the column of the table headed “Purposes” in relation to an amount—that amount is the maximum amount of the chemotherapy drug for the purposes mentioned in the table in Part 1 of Schedule 3 for that purposes code; and

 (b) if no purposes code is mentioned in the column in relation to an amount—that amount is the maximum amount for all purposes other than purposes to which paragraph (a) applies.

15  Maximum quantity (number of units)—related pharmaceutical benefits

 (1) For the purposes of paragraph 85A(2)(a) of the Act, this section determines the maximum number of units of the pharmaceutical item in a related pharmaceutical benefit that an authorised prescriber may, in one prescription for a special arrangement supply of the benefit, direct to be supplied on any one occasion.

 (2) If only one number of units is mentioned in the column of the table in Schedule 2 headed “Maximum Quantity” in relation to brands of the pharmaceutical item, that number of units is the maximum number of units of the pharmaceutical item for all purposes.

 (3) If more than one number of units is mentioned in the column of the table in Schedule 2 headed “Maximum Quantity” in relation to brands of the pharmaceutical item, then:

 (a) if a purposes code is mentioned in the column of the table headed “Purposes” in relation to a number of units—that number is the maximum number of units of the pharmaceutical item for the purposes mentioned in the table in Part 1 of Schedule 3 for that purposes code; and

 (b) if no purposes code is mentioned in the column in relation to a number of units—that number is the maximum number of units of the pharmaceutical item for all purposes other than purposes to which paragraph (a) applies.

Application of this section

 (4) To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

 (5) To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

16  Maximum number of repeats—chemotherapy drugs

 (1) This section determines the maximum number of occasions an authorised prescriber may, in one chemotherapy prescription, direct that a special arrangement supply of a dose of a chemotherapy drug be repeated.

 (2) If only one number is mentioned in the column of the table in Part 2 of Schedule 1 headed “Number of Repeats” in relation to the chemotherapy drug, that number is the maximum number of occasions for all purposes.

 (3) If more than one number is mentioned in the column of the table in Part 2 of Schedule 1 headed “Number of Repeats” in relation to the chemotherapy drug, then:

 (a) if a purposes code is mentioned in the column of the table headed “Purposes” in relation to a number—that number is the maximum number of occasions for the purposes mentioned in the table in Part 1 of Schedule 3 for that purposes code; and

 (b) if no purposes code is mentioned in the column in relation to a number—that number is the maximum number of occasions for all purposes other than purposes to which paragraph (a) applies.

17  Maximum number of repeats—related pharmaceutical benefits

 (1) For the purposes of paragraph 85A(2)(b) of the Act, this section determines the maximum number of occasions an authorised prescriber may, in one prescription, direct that a special arrangement supply of a related pharmaceutical benefit be repeated.

 (2) If only one number is mentioned in the column of the table in Schedule 2 headed “Number of Repeats” in relation to the related pharmaceutical benefit, that number is the maximum number of occasions for all purposes.

 (3) If more than one number is mentioned in the column of the table in Schedule 2 headed “Number of Repeats” in relation to the related pharmaceutical benefit, then:

 (a) if a purposes code is mentioned in the column of the table headed “Purposes” in relation to a number—that number is the maximum number of occasions for the purposes mentioned in the table in Part 1 of Schedule 3 for that purposes code; and

 (b) if no purposes code is mentioned in the column in relation to a number—that number is the maximum number of occasions for all purposes other than purposes to which paragraph (a) applies.

Application of this section

 (4) To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

 (5) To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

18  Variation of maximum amount or quantity or maximum number of repeats

Modified application of section 30 of the Regulations for chemotherapy prescriptions

 (1) Section 30 of the Regulations applies in relation to a chemotherapy prescription as if:

 (a) a reference to a determination under paragraph 85A(2)(a) of the Act were a reference to a determination of the maximum amount of a chemotherapy drug by section 14 of this instrument; and

 (b) a reference to a determination under paragraph 85A(2)(b) of the Act were a reference to a determination by section 16 of this instrument.

Rules for related pharmaceutical benefits

 (2) For the purposes of subsection 85A(3A) of the Act, this section determines rules that must be applied when deciding whether to authorise a variation of the application of a determination of the maximum number of units or maximum number of repeats in relation to a prescription for a special arrangement supply of a related pharmaceutical benefit.

 (3) If the column of the table in Schedule 2 headed “Variations” includes a variation code in relation to a maximum number of units, the rules mentioned in the column of the table in Part 2 of Schedule 3 headed “Variation Rules” in relation to the variation code must be applied when deciding whether to authorise a variation of that maximum (to the extent that those rules relate to the number of units).

 (4) If the column of the table in Schedule 2 headed “Variations” includes a variation code in relation to a maximum number of repeats, the rules mentioned in the column of the table in Part 2 of Schedule 3 headed “Variation Rules” in relation to the variation code must be applied when deciding whether to authorise a variation of that maximum (to the extent that those rules relate to the number of repeats).

Note: Rules may relate to the maximum number of units, the maximum number of repeats or both.

Application of this section

 (5) To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

 (6) To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

19  Writing chemotherapy prescriptions that are not medication chart prescriptions

 (1) This section applies in relation to a chemotherapy prescription that is not a medication chart prescription.

 (2) The prescription must include the following information:

 (a) the name of the chemotherapy drug directed to be supplied;

 (b) the dose of the drug directed to be supplied;

 (c) if supply of the dose of the drug is to be repeated—the number of times it is to be repeated.

 (3) The following provisions of the Regulations do not apply in relation to the writing of the prescription:

 (a) paragraph 40(1)(d) and subsection 40(2A);

 (b) paragraph 40(1)(e);

 (c) paragraph 40(1)(j) and section 49;

 (d) paragraph 40(3)(a).

Note: If the prescription includes directions about particular pharmaceutical benefits to be supplied, an approved supplier is not required to follow the prescriber’s directions—see subsection 23(8).

20  Writing medication chart prescriptions

Chart is not required to be in approved form

 (1) A chart used to write a chemotherapy prescription or a prescription for a special arrangement supply of a related pharmaceutical benefit:

 (a) is not required to be in a form approved under paragraph 41(5)(a) of the Regulations or meet the information requirements approved under paragraph 41(5)(b) of the Regulations; and

 (b) is taken to be a medication chart for the purposes of the Regulations despite paragraphs 41(4)(a) and (b) of the Regulations.

No application to persons receiving treatment in or at residential care services

 (2) Subparagraph 41(1)(a)(i) of the Regulations does not apply to a medication chart prescription that is:

 (a) a chemotherapy prescription; or

 (b) a prescription for a special arrangement supply of a related pharmaceutical benefit.

Modified application of section 41 of the Regulations—electronic medication chart prescriptions

 (3) For an electronic medication chart prescription that is a chemotherapy prescription or a prescription for a special arrangement supply of a related pharmaceutical benefit:

 (a) paragraph 41(2)(c) of the Regulations does not apply; and

 (b) the authorised prescriber must approve the prescription in the electronic system used to write the prescription; and

 (c) paragraph 104(3)(b) of the Regulations does not apply.

Modifications for chemotherapy drugs only

 (4) A medication chart prescription that is a chemotherapy prescription must include the following information:

 (a) the name of the chemotherapy drug directed to be supplied;

 (b) the dose of the chemotherapy drug directed to be supplied;

 (c) the frequency of administration and route of administration of the dose;

 (d) the date of the prescription.

 (5) The following provisions of the Regulations do not apply in relation to the writing of a medication chart prescription that is a chemotherapy prescription:

 (a) subparagraph 41(2)(a)(i) and subsection 41(2A);

 (b) subparagraph 41(2)(a)(ii);

 (c) subparagraph 41(2)(a)(iii).

Note: If the prescription does include directions about particular pharmaceutical benefits to be supplied, an approved supplier is not required to follow the prescriber’s directions—see subsection 23(8).

21  Direction to vary prescribed dose of chemotherapy drug

 (1) An authorised prescriber who has written a chemotherapy prescription for a dose of a chemotherapy drug may direct an approved supplier that is to supply the dose on the basis of the prescription to increase or decrease the dose to be supplied, without writing a new prescription, if the new dose is between 90% and 110% of the dose that was originally prescribed.

 (2) A new dose directed in accordance with subsection (1) that is greater than the maximum amount for the chemotherapy drug determined by section 14 of this instrument does not require approval under section 30 of the Regulations as modified by subsection 18(1) of this instrument.

 (3) If an approved supplier receives a direction in accordance with subsection (1), the supplier must record on the chemotherapy prescription:

 (a) the new dose of the chemotherapy drug as directed;

 (b) the name of the authorised prescriber who gave the direction; and

 (c) the means by which the supplier received the direction (for example, by phone or by fax); and

 (d) the date and time the supplier received the direction.

 (4) If an approved supplier records the information mentioned in subsection (3) on a chemotherapy prescription, the prescription is taken to be varied accordingly.

Division 3—Supplying doses of chemotherapy drugs and related pharmaceutical benefits

22  Entitlement to receive special arrangement supplies

 (1) A person is entitled to receive a special arrangement supply of a dose of a chemotherapy drug or of a related pharmaceutical benefit without payment or other consideration, other than a charge made under Part 4, if the person is an eligible patient for the chemotherapy drug or related pharmaceutical benefit.

 (2) A person is not entitled to receive a special arrangement supply of a dose of a chemotherapy drug unless it is supplied by an approved supplier on presentation of a chemotherapy prescription written in accordance with Division 2.

 (3) This section has effect in addition to sections 86 and 89 of the Act.

23  Special arrangement supplies of doses of chemotherapy drugs

 (1) Subject to this section, an approved supplier may make a special arrangement supply of a dose of a chemotherapy drug on presentation of a chemotherapy prescription for the dose.

 (2) The supply of the dose must be made from chemotherapy pharmaceutical benefits.

Rules for approved pharmacists modified

 (3) Despite sections 89 and 90 of the Act, an approved pharmacist may make the supply of the dose other than at or from the premises in respect of which the pharmacist is for the time being approved.

 (4) The National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017, other than sections 6 and 7, does not apply to the supply of the dose.

Method of administration and circumstances must be complied with

 (5) If the prescription directs the dose of the chemotherapy drug to be administered by a particular method, the supply of the dose must be able to be administered by that method.

 (6) Subsection (5) applies regardless of whether the method directed by the prescription is also a manner of administration for a chemotherapy pharmaceutical benefit that has the chemotherapy drug.

 (7) If the prescription was authorised in circumstances mentioned in Part 1 of Schedule 3 in relation to the chemotherapy drug, the supply of the dose must be made only from chemotherapy pharmaceutical benefits for which the circumstances code for those circumstances is mentioned in the column in Part 1 of Schedule 1 headed “Circumstances”.

Directions as to form, brand, quantity of benefits and number of repeats of benefits may be disregarded

 (8) The approved supplier may disregard any directions as to the following that are included in the prescription:

 (a) the supply of a form of the chemotherapy drug;

 (b) the supply of a listed brand of a pharmaceutical item;

 (c) the supply of a quantity or number of units of a particular chemotherapy pharmaceutical benefit;

 (d) the number of times the supply of a particular chemotherapy pharmaceutical benefit is to be repeated.

Note: The matters in subsection (8) are not required to be included in chemotherapy prescriptions (see sections 19 and 20).

24  Rules not applicable to special arrangement supplies of chemotherapy drugs

Early supply of pharmaceutical benefit not applicable

 (1) A special arrangement supply of a dose of a chemotherapy drug is not an early supply of a specified pharmaceutical benefit within the meaning of subsection 84AAA(1) of the Act.

Restrictions on frequency of repeated supplies not applicable

 (2) Subsections 51(2) to (4) of the Regulations do not apply to a special arrangement supply of a dose of a chemotherapy drug.

Note: The effect of those subsections is to restrict how soon a repeat supply may be made. There is no restriction on how soon a repeat supply of a chemotherapy drug may be made under this instrument.

Deferred supply authorisations not applicable

 (3) Section 53 of the Regulations does not apply in relation to a special arrangement supply of a dose of a chemotherapy drug.

25  Modified rules for special arrangement supplies on the basis of an electronic medication chart prescription

  For a special arrangement supply of a dose of a chemotherapy drug or of a related pharmaceutical benefit on the basis of an electronic medication chart prescription:

 (a) paragraph 45(2)(c) of the Regulations does not apply; and

 (b) the supplier must verify the supply and the date of supply in the electronic system used to write the prescription; and

 (c) section 61 of the Regulations applies as if the reference to the details referred to in paragraph 45(2)(c) of the Regulations includes a reference to the verification required by paragraph (b) of this section.

Part 3—Claims, information and payment

Division 1—Claims for payment and giving information

26  Modified requirements for claims or giving information

Under co‑payment data

 (1) A reference in the rules made by the Minister under subsections 98AC(4) and 99AAA(8) of the Act to under co‑payment data is taken to include a reference to information relating to the special arrangement supply of a dose of a chemotherapy drug or of a related pharmaceutical benefit where the amount payable to the supplier under Division 2 of this Part is nil.

Supplies of doses of chemotherapy drugs

 (2) For a claim or giving of information in relation to a special arrangement supply of a dose of a chemotherapy drug, the requirements in the rules made by the Minister under subsections 98AC(4) and 99AAA(8) of the Act are modified as follows:

 (a) a reference to a pharmaceutical benefit includes a reference to a dose of a chemotherapy drug;

 (b) a reference to an authority prescription in the rules includes a reference to an authority prescription within the meaning of this instrument;

 (c) the claim or information must include the following:

 (i) an identifying code for the chemotherapy drug;

 (ii) the dose of the drug supplied;

 (iii) the compounder ID of the site at which the compounder compounded the dose of the drug;

 (d) the supplier is not required to include the following in the claim or information:

 (i) the PBS/RPBS Item Code for the supplied pharmaceutical benefit;

 (ii) the brand of the supplied pharmaceutical item;

 (iii) whether or not section 49 of the Regulations applies;

 (iv) whether or not immediate supply was necessary.

Note: A special arrangement supply of a dose of a chemotherapy drug is taken to be a supply of a pharmaceutical benefit (see subsection 9(2) of this instrument).

Division 2—Payment of claims

27  Payment of approved pharmacists and approved medical practitioners for supplies of doses of chemotherapy drugs

 (1) An approved pharmacist or approved medical practitioner who makes a special arrangement supply of a dose of a chemotherapy drug to a patient is, subject to section 99AAA of the Act and the conditions determined under section 98C of the Act that are applicable at the time of supply, entitled to be paid by the Commonwealth:

 (a) for an original supply—the amount, if any, by which the dispensed price for the dose exceeds the amount that the approved pharmacist or approved medical practitioner was required to charge the patient under subsection 36(2) of this instrument for the supply; and

 (b) for a repeated supply—the dispensed price for the dose.

 (2) Subsection (1) applies despite subsections 99(2) and (2AA) of the Act.

 (3) Paragraph 99(3)(b) of the Act does not apply to a special arrangement supply of a dose of a chemotherapy drug by an approved pharmacist.

28  Payment of approved hospital authorities for supplies

Purpose of section

 (1) This section determines, for the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority in respect of a special arrangement supply of a dose of a chemotherapy drug or of a related pharmaceutical benefit.

Note: Under this instrument, subsection 99(4) of the Act applies as if it includes a reference to patients receiving treatment from a hospital (see section 8 of this instrument).

 (2) This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017) and the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020 (PB 99 of 2020).

Supplies of doses of chemotherapy drugs

 (3) The amount payable to an approved hospital authority in respect of a special arrangement supply of a dose of a chemotherapy drug to a patient is:

 (a) for an original supply—the amount, if any, by which the dispensed price for the dose exceeds the amount that the hospital authority was entitled to charge the patient under subsection 37(2) of this instrument for the supply; and

 (b) for a repeat supply—the dispensed price for the dose.

Supplies of related pharmaceutical benefit

 (4) The amount payable to a participating hospital authority in respect of a special arrangement supply of a related pharmaceutical benefit to a patient is the amount, if any, by which the dispensed price for the pharmaceutical benefit exceeds the amount the patient could have been required to pay in accordance with subsection 87(2) of the Act if the patient had obtained the related pharmaceutical benefit from an approved pharmacist.

Note:  The participating hospital authority may charge the patient the amount mentioned in subsection 87(2) of the Act (see subsection 87(5) of the Act).

29  No separate entitlement to payment for supplies of diluent

 (1) If an approved supplier adds a pharmaceutical benefit to the supply of a dose of a chemotherapy drug as a diluent, then despite section 99 of the Act no amount is payable for supply of the pharmaceutical benefit.

 (2) Subsection (1) applies regardless of whether the pharmaceutical benefit added as a diluent is a related pharmaceutical benefit.

30  Payment of TGA‑licensed compounders

  If a TGA‑licensed compounder compounds a dose of a chemotherapy drug for a special arrangement supply of the dose, the compounder is entitled to be paid a TGA‑licensed compounding fee by the Commonwealth for compounding the dose.

Note: Information about the compounder is included in the claim by the supplier of the chemotherapy drug or in information about the supply: see subsection 26(2).

Division 3—Dispensed price for dose of chemotherapy drug

31  Dispensed price for doses supplied by approved pharmacists and approved medical practitioners

 (1) For a dose of a chemotherapy drug supplied by an approved pharmacist or an approved medical practitioner, 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 for 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.

 (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 single unit ex‑manufacturer price for 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 section 32.

32  Mark‑up for a chemotherapy pharmaceutical benefit

 (1) For the purposes of paragraph 31(4)(b), the mark‑up for a chemotherapy pharmaceutical benefit is:

  where:

mark‑up for maximum units means the amount worked out:

 (a) if the chemotherapy pharmaceutical benefit does not have trastuzumab—under subsection (2); or

 (b) if the chemotherapy pharmaceutical benefit has trastuzumab—under subsection (3).

maximum units of pharmaceutical benefit is the whole number of units of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of the chemotherapy drug in the benefit that is determined by section 14.

 (2) The following table sets out how to work out the mark‑up for maximum units for a chemotherapy pharmaceutical benefit that does not have trastuzumab.

 (3) The following table sets out how to work out the mark‑up for maximum units for a chemotherapy pharmaceutical benefit that has trastuzumab.

 (4) For the purposes of subsections (2) and (3), the maximum units ex‑manufacturer price of a chemotherapy pharmaceutical benefit that is a listed brand of a pharmaceutical item is:

where:

AEMP means the approved ex‑manufacturer price of the chemotherapy pharmaceutical benefit.

maximum units of pharmaceutical benefit has the meaning given by subsection (1).

pricing quantity means the pricing quantity of the chemotherapy pharmaceutical benefit.

33  Dispensed price if dose is supplied by approved private hospital authority

 (1) For a dose of a chemotherapy drug supplied by an approved hospital authority of a private hospital, the dispensed price is the sum of the following amounts:

 (a) the base price for the dose worked out under subsection (2);

 (b) for a drug other than trastuzumab—the distribution fee;

 (c) the dispensing fee;

 (d) the preparation fee;

 (e) the diluent fee.

 (2) The base price for 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.

 (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 single unit ex‑manufacturer price for the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and

 (b) 1.4% of the single unit ex‑manufacturer price for the chemotherapy pharmaceutical benefit.

34  Dispensed price if dose is supplied by approved public hospital authority

 (1) For a dose of a chemotherapy drug supplied by an approved hospital authority of a public hospital, 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 for 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.

 (4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the single unit ex‑manufacturer price for the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up).

Division 4—Dispensed price for related pharmaceutical benefit

35  Dispensed price for supply of related pharmaceutical benefit

 (1) The dispensed price for a special arrangement supply of a related pharmaceutical benefit that is a listed brand of a pharmaceutical item is as follows:

 (a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity;

 (b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the amount worked out in accordance with subsection (2);

 (c) if neither paragraph (a) or (b) applies to the quantity of the benefit supplied—the sum of:

 (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

 (ii) the amount calculated in accordance with subsection (2) for the remainder of the quantity that is a broken quantity.

 (2) For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out by:

 (a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

 (b)  applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price (as applicable) for the pack quantity.

 (3) The dispensed price under subsection (1) is rounded to the nearest cent (with a half cent being rounded up).

Part 4—Patient contributions

36  Supplies of doses of chemotherapy drugs by approved pharmacists and approved medical practitioners

 (1) This section sets out amounts that an approved pharmacist or approved medical practitioner must or may charge an eligible patient for a special arrangement supply of a dose of a chemotherapy drug.

Patient co‑payment must be charged for original supply only

 (2) For an original supply of a dose, the approved pharmacist or approved medical practitioner must charge the patient an amount that is equivalent to the amount that may 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 dose, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the dose.

 (3) No amount may be charged under subsection (2) for a repeated supply.

Special patient contribution for original or repeated supply

 (4) If a determination under subsection 85B(3) of the Act is in force in relation to a chemotherapy pharmaceutical benefit used to make the dose:

 (a) the approved pharmacist or approved medical practitioner may charge a special patient contribution in accordance with the Act for supply of the benefit; and

 (b) subsection 85B(5) of the Act applies as if a reference to the Commonwealth price for a quantity or number of units of a listed brand of a pharmaceutical item were a reference to the dispensed price for a dose of a chemotherapy drug made using a quantity or number of units of a listed brand of a pharmaceutical item.

37  Supplies of doses of chemotherapy drugs by approved hospital authorities

 (1) This section sets out amounts that an approved hospital authority may charge an eligible patient for a special arrangement supply of a dose of a chemotherapy drug.

Patient co‑payment may be charged for original supply only

 (2) For an original supply of a dose, the hospital authority may charge the 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 dose, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the dose.

 (3) No amount may be charged under subsection (2) for a repeated supply.

Special patient contribution for original or repeated supply

 (4) If a determination under subsection 85B(3) of the Act is in force in relation to a chemotherapy pharmaceutical benefit used to make the dose:

 (a) the hospital authority may charge a special patient contribution in accordance with the Act for supply of the benefit; and

 (b) subsection 85B(5) of the Act applies as if a reference to the Commonwealth price for a quantity or number of units of a listed brand of a pharmaceutical item were a reference to the dispensed price for a dose of a chemotherapy drug made using a quantity or number of units of a listed brand of a pharmaceutical item.

38  Supplies of related pharmaceutical benefits—special patient contribution

  If a determination under subsection 85B(3) of the Act is in force in relation to a related pharmaceutical benefit, subsection 85B(5) of the Act applies to a special arrangement supply of the related pharmaceutical benefit as if a reference to the Commonwealth price were a reference to the dispensed price.

39  Application of safety net provisions

 (1) Subparagraph 84C(4)(a)(i) of the Act applies to a special arrangement supply of a dose of a chemotherapy drug or of a related pharmaceutical benefit as if the words “at or from premises in respect of which the pharmacist is for the time being approved” were omitted.

 (2) The value for safety net purposes for an original special arrangement supply of a dose of a chemotherapy drug to a person is the amount paid by the person for the supply of the dose under subsection 36(2) or 37(2).

Note: A special arrangement supply of a dose of a chemotherapy drug is taken to be a supply of a pharmaceutical benefit (see subsection 9(2) of this instrument).

 (3) The value for safety net purposes for a repeated special arrangement supply of a dose of a chemotherapy drug to a person is zero.

Note: A person must not be charged a patient co‑payment for a repeat supply but may be charged a special patient contribution if applicable (see sections 36 and 37).

 (4) This section applies despite section 17A of the Regulations.

Schedule 1—Chemotherapy pharmaceutical benefits and chemotherapy drugs

Note: See the definitions of chemotherapy drug and chemotherapy pharmaceutical benefit in section 5, and sections 12, 14, 16 and 23.

Part 1—Chemotherapy pharmaceutical benefits

1  Chemotherapy pharmaceutical drugs and chemotherapy pharmaceutical benefits

 (1) Each listed drug specified in the following table is a chemotherapy drug.

 (2) Each pharmaceutical benefit specified in the following table is a chemotherapy pharmaceutical benefit.

 (3) The following table also specifies circumstances for chemotherapy pharmaceutical benefits.

Note: The drugs mentioned in the table have been declared by the Minister under subsection 85(2) of the Act. The forms, manners of administrations and brands mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

Part 2—Maximum amounts and number of repeats for chemotherapy drugs

2  Maximum amounts and number of repeats

  For each chemotherapy drug, the following table specifies:

 (a) the maximum amount of the drug that may be directed to be supplied on any one occasion; and

 (b) the maximum number of occasions that, in one chemotherapy prescription, supply of a dose of the drug may be directed to be repeated.

Schedule 2—Related pharmaceutical benefits

Note: See the definition of related pharmaceutical benefit in section 5, and sections 12, 15 and 17.

1  Related pharmaceutical benefits and related information

 (1) Each pharmaceutical benefit specified in the following table is a related pharmaceutical benefit.

 (2) The following table also specifies circumstances, purposes, maximum quantities and maximum repeats for related pharmaceutical benefits.

Note: The drugs mentioned in the table have been declared by the Minister under subsection 85(2) of the Act. The forms, manners of administration and brands mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.