PB 26 of 2024

National Health (Listing of Pharmaceutical Benefits) Instrument 2024

I, Nikolai Tsyganov, as delegate for the Minister for Health and Aged Care, make the following instrument.

Dated  28 March 2024

Nikolai Tsyganov

Assistant Secretary
Pricing and PBS Policy 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

Part 2—Pharmaceutical benefits

6  Drugs and medicinal preparations to which Part VII of the Act applies (Act s 85(2))

7  Form or forms of a listed drug (Act s 85(3))

8  Manner of administration of a form of a listed drug (Act s 85(5))

9  Brand of a pharmaceutical item (Act s 85(6))

10  Responsible person for a brand of a pharmaceutical item (Act s 84AF(1))

11  Schedule equivalents of brands of pharmaceutical items (Act s 85(6A))

Part 3—Prescription of pharmaceutical benefits

Division 1—Authorised prescribers and prescription circumstances

12  Authorised prescribers (Act s 88)

13  Prescription of ready‑prepared pharmaceutical benefits in certain circumstances (Act s 85(7))

14  Prescription of extemporaneously‑prepared pharmaceutical benefits in certain circumstances (Act s 85(7))

Division 2—Maximum quantities and repeats

15  Maximum quantity (number of units)—ready‑prepared pharmaceutical benefits (Act s 85A(2)(a), (2A) and (3A))

16  Maximum number of repeats—ready‑prepared pharmaceutical benefits (Act s 85A(2)(b), (2A) and (3A))

17  Maximum quantity—extemporaneously‑prepared pharmaceutical benefits (Act s 85A(2)(a))

18  Maximum number of repeats—extemporaneously‑prepared pharmaceutical benefits (Act s 85A(2)(b))

Division 3—Authorisation of prescriptions

19  Authority required procedures

Part 4—Quantities of pharmaceutical items

20  Pack quantity (Act s 84AK(2))

21  Determined quantity (Act s 84AK(3))

Part 5—Supply of pharmaceutical benefits

22  Listed drugs and pharmaceutical benefits that can only be supplied under the prescriber bag provisions (Act s 85(2AA) and (7A))

23  Listed drugs and pharmaceutical benefits that can be supplied only under special arrangements (Act s 85(2A) and (8))

Part 6—Application, saving and transitional provisions

24  Transitional provision—authorisation of prescriptions

Schedule 1—Ready‑prepared pharmaceutical benefits

Part 1—Ready‑prepared pharmaceutical benefits for prescription and supply

1  Matters relating to pharmaceutical benefits

Part 1—Preliminary

1  Name

 (1) This instrument is the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.

 (2) This instrument may also be cited as PB 26 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 84AF, 84AK, 85, 85A and 88 of the National Health Act 1953.

4  Simplified outline

5  Definitions

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

(a) Chief Executive Medicare;

(b) 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) medical practitioner;

(b) medicare benefit.

  In this instrument:

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 midwife has the same meaning as in Part VII of the Act.

authorised nurse practitioner has the same meaning as in Part VII of the Act.

authorised optometrist has the same meaning as in Part VII of the Act.

authorised prescriber, of a pharmaceutical benefit, means a PBS prescriber (within the meaning of Part VII of the Act) who is authorised under section 12 of this instrument to write a prescription for the supply of the benefit.

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

CFC is short for chlorofluorocarbon.

CFU is short for colony forming unit.

circumstances code means the letter “C” followed by a number.

conditions code means the letters “CN” followed by a number.

extemporaneously‑prepared pharmaceutical benefit means a pharmaceutical benefit that:

 (a) is a listed drug mentioned in column 1 of the table in Part 1 of Schedule 2; or

 (b) contains such a listed drug.

General statement for drugs for the treatment of hepatitis C means the statement set out in Schedule 6.

GP Management Plan means a comprehensive written plan for the treatment of a patient:

 (a) that is prepared by a medical practitioner; and

 (b) for the preparation of which a medicare benefit is payable; and

 (c) that includes a description of the patient’s health care needs, management goals, actions to be taken by the patient, and treatment and services the patient is likely to need.

I.M. is short for intramuscular.

I.U. is short for international unit.

I.V. is short for intravenous.

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

Medicare Benefits Schedule means:

 (a) the table, within the meaning of subsection 3(1) of the Health Insurance Act 1973; or

 (b) any determination made under subsection 3C(1) of that Act.

palliative care patient means a patient with an active, progressive, far‑advanced disease for whom the prognosis is limited and the focus of care is the quality of life.

participating dental practitioner has the same meaning as in Part VII of the Act.

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

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

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

ready‑prepared pharmaceutical benefit means a pharmaceutical benefit that is mentioned in a table in Schedule 1.

streamlined authority code means the words “Streamlined Authority Code” followed by a number.

Team Care Arrangements means arrangements:

 (a) that are coordinated by a medical practitioner; and

 (b) for the coordination of which a medicare benefit is payable; and

 (c) that, following consultation with collaborating providers, are documented in a plan that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide, and the actions to be taken by the patient.

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

Part 2—Pharmaceutical benefits

6  Drugs and medicinal preparations to which Part VII of the Act applies (Act s 85(2))

Drugs and medicinal preparations—Schedule 1

 (1) For the purposes of paragraph 85(2)(a) of the Act, Part VII of the Act applies to a drug or medicinal preparation mentioned in the column of a table in Schedule 1 to this instrument headed “Listed Drug”.

Drugs and medicinal preparations—Schedule 2

 (2) For the purposes of paragraph 85(2)(a) of the Act, Part VII of the Act applies to:

 (a) a drug or medicinal preparation mentioned in column 1 of the table in Part 1 of Schedule 2 to this instrument; and

 (b) a medicinal preparation composed of one or more drugs or medicinal preparations mentioned in that column.

 (3) For the purposes of paragraph 85(2)(b) of the Act, that paragraph applies to:

 (a) the class of drugs and medicinal preparations consisting of the drugs and medicinal preparations mentioned in column 1 of the table in Part 1 of Schedule 2 to this instrument; and

 (b) additives mentioned in the table in Part 2 of that Schedule.

Note: Part VII of the Act applies to medicinal preparations composed of one or more of the drugs and medicinal preparations included in the class mentioned in paragraph (a) of this subsection and one or more additives mentioned in paragraph (b) of this subsection—see paragraph 85(2)(b) of the Act.

7  Form or forms of a listed drug (Act s 85(3))

  For the purposes of subsection 85(3) of the Act, the form or forms of a listed drug mentioned in a table in Schedule 1 to this instrument are the form or forms mentioned in relation to the listed drug in the column of the table headed “Form”.

8  Manner of administration of a form of a listed drug (Act s 85(5))

  For the purposes of subsection 85(5) of the Act, the manner of administration of a form of a listed drug mentioned in a table in Schedule 1 to this instrument is the manner of administration mentioned in relation to the form of the drug in the column of the table headed “Manner of Administration”.

9  Brand of a pharmaceutical item (Act s 85(6))

  For the purposes of subsection 85(6) of the Act, each brand mentioned in the column of a table in Schedule 1 to this instrument headed “Brand” in relation to a pharmaceutical item is a brand of the pharmaceutical item.

10  Responsible person for a brand of a pharmaceutical item (Act s 84AF(1))

  For the purposes of subsection 84AF(1) of the Act, the responsible person for a brand of a pharmaceutical item mentioned in a table in Schedule 1 to this instrument is the person represented, in accordance with the table in Schedule 3, by the code mentioned in relation to the brand in the column of the table in Schedule 1 headed “Responsible Person”.

11  Schedule equivalents of brands of pharmaceutical items (Act s 85(6A))

  For the purposes of subsection 85(6A) of the Act, a brand of a pharmaceutical item included in a schedule equivalent group in the table in Schedule 5 to this instrument is, for the purposes of paragraph 103(2A)(b) of the Act, to be treated as equivalent to each other brand of a pharmaceutical item that is included in that schedule equivalent group.

Part 3—Prescription of pharmaceutical benefits

Division 1—Authorised prescribers and prescription circumstances

12  Authorised prescribers (Act s 88)

Ready‑prepared pharmaceutical benefits

 (1) The following table has effect.

Extemporaneously‑prepared pharmaceutical benefits

 (2) For the purposes of subsection 88(1) of the Act, a medical practitioner is authorised to write a prescription for the supply of an extemporaneously‑prepared pharmaceutical benefit.

13  Prescription of ready‑prepared pharmaceutical benefits in certain circumstances (Act s 85(7))

  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 Part 1 of Schedule 1 to this instrument headed “Circumstances” in relation to a 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 4 to this instrument headed “Circumstances and Purposes” in relation to the circumstances code are circumstances in which a prescription for the supply of the pharmaceutical benefit may be written; and

 (c) if the column of the table in Part 1 of Schedule 4 to this instrument headed “Authority Requirements” in relation to the circumstances code is not blank—it is part of the circumstances that writing the prescription must be authorised by the Chief Executive Medicare in accordance with section 19 of this instrument.

14  Prescription of extemporaneously‑prepared pharmaceutical benefits in certain circumstances (Act s 85(7))

 (1) If circumstances are mentioned in column 2 of an item in the table in Part 1 of Schedule 2, then:

 (a) for the purposes of paragraph 85(7)(a) of the Act:

 (i) the listed drug mentioned in column 1 of the item is a relevant pharmaceutical benefit for the purposes of section 88A of the Act; and

 (ii) an extemporaneously‑prepared pharmaceutical benefit that contains the listed drug is a relevant pharmaceutical benefit for the purposes of section 88A of the Act; and

 (b) for the purposes of paragraph 85(7)(b) of the Act, the circumstances are circumstances in which a prescription may be written:

 (i) for the supply of the listed drug; or

 (ii) for the supply of a pharmaceutical benefit that is a relevant pharmaceutical benefit under subparagraph (a)(ii) of this subsection only because it contains the listed drug.

 (2) If a pharmaceutical benefit contains 2 or more listed drugs that are relevant pharmaceutical benefits under subparagraph (1)(a)(i) (the component drugs), then, for the purposes of paragraph 85(7)(b) of the Act, a prescription for the supply of the pharmaceutical benefit may be written only if the circumstances mentioned in column 2 of the table in Part 1 of Schedule 2 to this instrument for every component drug exist.

Division 2—Maximum quantities and repeats

15  Maximum quantity (number of units)—ready‑prepared pharmaceutical benefits (Act s 85A(2)(a), (2A) and (3A))

Purpose of section

 (1) This section determines, with respect to the writing of prescriptions for the supply of a ready‑prepared pharmaceutical benefit having a pharmaceutical item by authorised prescribers of the benefit:

 (a) for the purposes of paragraph 85A(2)(a) of the Act—the maximum number of units of the pharmaceutical item that may, in one prescription, be directed to be supplied on any one occasion; and

 (b) for the purposes of subsection 85A(2A) of the Act—conditions that must be satisfied when writing a prescription; and

 (c) for the purposes of subsection 85A(3A) of the Act—rules that must be applied when deciding whether to authorise a variation of the application of a determination referred to in paragraph (a) of this subsection.

Determination of maximum number of units

 (2) If only one number of units is mentioned in the column of the table in Part 1 of Schedule 1 to this instrument headed “Maximum Quantity” in relation to brands of the pharmaceutical item and a kind of authorised prescriber, that number of units is the maximum number of units of the pharmaceutical item for that kind of authorised prescriber for all purposes.

 (3) If more than one number of units is mentioned in the column of the table in Part 1 of Schedule 1 headed “Maximum Quantity” in relation to brands of the pharmaceutical item and a kind of authorised prescriber, 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 that kind of authorised prescriber for the purposes mentioned in the table in Part 1 of Schedule 4 for that purposes code; and

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

Conditions for writing prescription

 (4) If the column of the table in Part 1 of Schedule 1 headed “Maximum Quantity” includes a conditions code together with a maximum number of units, it is a condition when writing a prescription to which that maximum applies that writing the prescription must be authorised by the Chief Executive Medicare in accordance with section 19 of this instrument.

Rules for authorising variation of maximum number of units

 (5) If the column of the table in Part 1 of Schedule 1 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 4 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).

Note: Rules may also relate to the maximum number of repeats.

16  Maximum number of repeats—ready‑prepared pharmaceutical benefits (Act s 85A(2)(b), (2A) and (3A))

Purpose of section

 (1) This section determines, with respect to the writing of prescriptions for the supply of a ready‑prepared pharmaceutical benefit by authorised prescribers of the benefit:

 (a) for the purposes of paragraph 85A(2)(b) of the Act—the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated; and

 (b) for the purposes of subsection 85A(2A) of the Act—conditions that must be satisfied when writing a prescription; and

 (c) for the purposes of subsection 85A(3A) of the Act—rules that must be applied when deciding whether to authorise a variation of the application of a determination referred to in paragraph (a) of this subsection.

Determination of maximum number of repeats

 (2) If only one number is mentioned in the column of the table in Part 1 of Schedule 1 to this instrument headed “Number of Repeats” in relation to the pharmaceutical benefit and a kind of authorised prescriber, that number is the maximum number of occasions for that kind of authorised prescriber for all purposes.

 (3) If more than one number is mentioned in the column of the table in Part 1 of Schedule 1 headed “Number of Repeats” in relation to the pharmaceutical benefit and a kind of authorised prescriber, 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 that kind of authorised prescriber for the purposes mentioned in the table in Part 1 of Schedule 4 for that purposes code; and

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

Conditions for writing prescription

 (4) If the column of the table in Part 1 of Schedule 1 headed “Number of Repeats” includes a conditions code together with a maximum number of occasions that supply may be directed to be repeated, it is a condition when writing a prescription to which that maximum applies that writing the prescription must be authorised by the Chief Executive Medicare in accordance with section 19 of this instrument.

Rules for authorising variation of maximum number of repeats

 (5) If the column of the table in Part 1 of Schedule 1 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 4 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 also relate to the maximum number of units.

17  Maximum quantity—extemporaneously‑prepared pharmaceutical benefits (Act s 85A(2)(a))

  For the purposes of paragraph 85A(2)(a) of the Act, the maximum quantity of an extemporaneously‑prepared pharmaceutical benefit, of a type mentioned in column 1 of an item in the table in Part 3 of Schedule 2 to this instrument, that a medical practitioner may, in one prescription, direct to be supplied on any one occasion is the quantity mentioned in column 2 of the item.

18  Maximum number of repeats—extemporaneously‑prepared pharmaceutical benefits (Act s 85A(2)(b))

  For the purposes of paragraph 85A(2)(b) of the Act, the maximum number of occasions that a medical practitioner may, in one prescription, direct that the supply of an extemporaneously‑prepared pharmaceutical benefit, of a type mentioned in column 1 of an item in the table in Part 3 of Schedule 2 to this instrument, be repeated is the number mentioned in column 3 of the item.

Division 3—Authorisation of prescriptions

19  Authority required procedures

 (1) This section applies if:

 (a) the circumstances under paragraph 85(7)(b) of the Act in which a prescription for the supply of a pharmaceutical benefit may be written; or

 (b) the conditions under subsection 85A(2A) of the Act for writing a prescription for the supply of a pharmaceutical benefit;

include a requirement that writing the prescription must be authorised by the Chief Executive Medicare.

Obtaining authority

 (2) When requesting authority to write a prescription, an authorised prescriber must provide details of the proposed prescription to the Chief Executive Medicare.

 (3) If the column of the table in Part 1 of Schedule 4 to this instrument headed “Authority Requirements” contains the statement “Compliance with Written Authority Required procedures”, the details must be provided in writing.

 (4) If the Chief Executive Medicare gives authority to write the prescription, the Chief Executive Medicare must allot a number to the prescription and tell the authorised prescriber that number.

Note: For requirements to write the allotted number on the prescription, see sections 40 and 41 of the National Health (Pharmaceutical Benefits) Regulations 2017.

Deemed authority

 (5) If the column of the table in Part 1 of Schedule 4 headed “Authority Requirements” includes a streamlined authority code, writing the prescription is taken to have been authorised by the Chief Executive Medicare.

Note: For requirements to write the streamlined authority code on the prescription, see sections 40 and 41 of the National Health (Pharmaceutical Benefits) Regulations 2017.

Part 4—Quantities of pharmaceutical items

20  Pack quantity (Act s 84AK(2))

  For the purposes of subsection 84AK(2) of the Act, a number of units of a pharmaceutical item mentioned in the column of a table in Schedule 1 to this instrument headed “Pack Quantity” in relation to a brand of the pharmaceutical item is a pack quantity of the brand.

21  Determined quantity (Act s 84AK(3))

  For the purposes of subsection 84AK(3) of the Act, a number of units of a pharmaceutical item mentioned in the column of a table in Schedule 1 to this instrument headed “Determined Quantity” in relation to a brand of the pharmaceutical item is a determined quantity of the brand.

Part 5—Supply of pharmaceutical benefits

22  Listed drugs and pharmaceutical benefits that can only be supplied under the prescriber bag provisions (Act s 85(2AA) and (7A))

Listed drugs

 (1) For the purposes of subsection 85(2AA) of the Act, if one or more of the codes “D(MP)”, “D(MW)” and “D(NP)” are mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to a listed drug, then the listed drug can only be supplied under:

 (a) if the code D(MP) is mentioned—section 93 of the Act (prescriber bag supplies—medical practitioners); and

 (b) if the code D(MW) is mentioned—section 93AA of the Act (prescriber bag supplies—authorised midwives); and

 (c) if the code D(NP) is mentioned—section 93AB of the Act (prescriber bag supplies—authorised nurse practitioners).

Pharmaceutical benefits

 (2) For the purposes of subsection 85(7A) of the Act, if one or more of the codes “PB(MP)”, “PB(MW)” and “PB(NP)” are mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to a pharmaceutical benefit, then the pharmaceutical benefit can only be supplied in accordance with the following:

 (a) if the code PB(MP) is mentioned—section 93 of the Act (prescriber bag supplies—medical practitioners);

 (b) if the code PB(MW) is mentioned—section 93AA of the Act (prescriber bag supplies—authorised midwives);

 (c) if the code PB(NP) is mentioned—section 93AB of the Act (prescriber bag supplies—authorised nurse practitioners).

Note: For the interaction between a declaration under subsection 85(2AA) of the Act in relation to a drug and a declaration under subsection 85(7A) of the Act in relation to a pharmaceutical benefit that has the drug, see subsection 85AAA(3) of the Act.

23  Listed drugs and pharmaceutical benefits that can be supplied only under special arrangements (Act s 85(2A) and (8))

Listed drugs

 (1) For the purposes of subsection 85(2A) of the Act, a listed drug can be supplied only under special arrangements under section 100 of the Act if the code “D(100)” is mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to the drug.

Pharmaceutical benefits

 (2) For the purposes of paragraph 85(8)(a) of the Act, a ready‑prepared pharmaceutical benefit can be supplied only under special arrangements under section 100 of the Act if the code “PB(100)” is mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to the pharmaceutical benefit.

Circumstances

 (3) For the purposes of paragraph 85(8)(b) of the Act, if the code “C(100)” is mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to a pharmaceutical benefit and a circumstances code, the circumstances mentioned in the table in Part 1 of Schedule 4 for the circumstances code are circumstances in which the pharmaceutical benefit can be supplied only under special arrangements under section 100 of the Act.

Part 6—Application, saving and transitional provisions

24  Transitional provision—authorisation of prescriptions

 (1) This section applies in relation to prescriptions for the supply of pharmaceutical benefits written before 1 July 2024.

 (2) Despite the repeal of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012:

 (a) an authorised prescriber may submit a prescription to the Chief Executive Medicare in accordance with section 12 of that instrument as in force immediately before 1 April 2024; and

 (b) the Chief Executive Medicare may authorise the prescription in accordance with section 13 of that instrument as in force immediately before 1 April 2024; and

 (c) if the prescription is so authorised, writing the prescription is taken to have been authorised in accordance with section 19 of this instrument.

 (3) If the Chief Executive Medicare authorises a prescription under subsection 13(1), (1A) or (1B) of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 as in force immediately before 1 April 2024, the authorised prescriber is not required to comply with the following provisions of the National Health (Pharmaceutical Benefits) Regulations 2017 in relation to the prescription:

 (a) paragraph 40(1)(i);

 (b) paragraph 41(3)(a).

Schedule 1—Ready‑prepared pharmaceutical benefits

Note: See the definition of ready‑prepared pharmaceutical benefit in section 5, and sections 6 to 10, 12, 13, 15, 16 and 20 to 23.

Part 1—Ready‑prepared pharmaceutical benefits for prescription and supply

1  Matters relating to pharmaceutical benefits

  The following table sets out pharmaceutical benefits and matters relating to pharmaceutical benefits and their prescription and supply, for the purposes of sections 6 to 10, 12, 13, 15, 16 and 20 to 23.