Part 1—Preliminary
Division 1—General
1 Name
(1) This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement 2021.
(2) This instrument may also be cited as PB 27 of 2021.
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.
| Commencement information |
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 April 2021. | 1 April 2021 |
Note: This table relates only to the provisions of this instrument as originally made.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, 88, 99 and 100 of the National Health Act 1953.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
5 Simplified outline of this instrument
This instrument makes a special arrangement for the supply of pharmaceutical benefits that contain highly specialised drugs for the treatment of chronic conditions.
Restrictions apply to the prescribing and supply of these benefits because of their clinical use and other special features.
The prescribing of these benefits is in most cases limited to practitioners who have undertaken particular training or are affiliated with a specialised hospital unit.
The supply of these benefits is restricted to persons who are receiving treatment by medical practitioners and authorised nurse practitioners.
These benefits will be supplied by approved suppliers (public and private hospitals, community pharmacies and certain medical practitioners).
This instrument also deals with payments for supplies of these pharmaceutical benefits.
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).
6 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;
(c) 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.
In this instrument:
accredited prescriber of medication for the treatment of hepatitis B means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis B in accordance with this instrument.
accredited prescriber of medication for the treatment of hepatitis C means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis C in accordance with this instrument.
accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS in accordance with this instrument.
accredited prescriber of medication for the treatment of schizophrenia means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of schizophrenia in accordance with this instrument.
Act means the National Health Act 1953.
affiliated: a specialist is affiliated with a hospital if the specialist is:
(a) a staff specialist of the hospital; or
(b) a visiting or consulting specialist of the hospital.
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, as affected by section 11 of this instrument.
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, as affected by section 11 of this instrument.
authorised nurse practitioner has the same meaning as in Part VII of the Act.
authorised prescriber has the meaning given by section 7.
CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:
(a) abatacept;
(b) adalimumab;
(c) ambrisentan;
(d) azacitidine;
(e) benralizumab;
(f) bosentan;
(g) eculizumab;
(h) eltrombopag;
(i) epoprostenol;
(j) etanercept;
(k) iloprost;
(l) infliximab;
(m) ivacaftor;
(n) lenalidomide;
(o) lumacaftor with ivacaftor;
(p) macitentan;
(q) mepolizumab;
(r) midostaurin;
(s) nusinersen;
(t) omalizumab;
(u) pasireotide;
(v) pegvisomant;
(w) pomalidomide;
(x) riociguat;
(y) rituximab;
(z) romiplostim;
(za) sildenafil;
(zb) tadalafil;
(zc) teduglutide;
(zd) tezacaftor with ivacaftor and ivacaftor;
(ze) tocilizumab;
(zf) ustekinumab;
(zg) vedolizumab.
circumstances code means the letter “C” followed by a number.
community access medication means any of the following:
(a) medication for the treatment of hepatitis B;
(b) medication for the treatment of HIV or AIDS, other than a pharmaceutical benefit that has the drug:
(i) azithromycin; or
(ii) doxorubicin ‑ pegylated liposomal; or
(iii) rifabutin;
(c) medication for continuing treatment of schizophrenia;
(d) lanreotide, if:
(i) the description of its form does not include “Powder for suspension for injection”; and
(ii) it is for continuing treatment;
(e) octreotide, if:
(i) the description of its form includes “Injection (modified release)”; and
(ii) it is for continuing treatment.
day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:
(a) is admitted to the hospital (other than through the hospital’s emergency department); and
(b) receives treatment; and
(c) is discharged from the hospital;
in accordance with a pre‑existing plan for the person’s treatment.
dispensed price:
(a) for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 29; and
(b) for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital—has the meaning given by section 32.
eligible patient has the meaning given by section 8.
highly specialised drug means a listed drug mentioned in Schedule 1.
hospital authority has the same meaning as in Part VII of the Act.
HSD hospital authority means a hospital authority for which:
(a) an approval under section 94 of the Act, as modified by section 10 of this instrument, is in force; or
(b) an approval mentioned in section 38 of this instrument is in force.
HSD pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
listed drug has the same meaning as in Part VII of the Act.
Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
medication chart prescription has the same meaning as in the Regulations.
medication for the treatment of hepatitis B means any of the following:
(a) adefovir;
(b) entecavir;
(c) interferon alfa‑2a;
(d) lamivudine;
(e) tenofovir.
medication for the treatment of hepatitis C means medication mentioned in the table in paragraph 3 of the General Statement for drugs for the treatment of hepatitis C set out in Part 3 of Schedule 4 to the Listing Instrument.
medication for the treatment of HIV or AIDS means any of the following:
(a) abacavir;
(b) abacavir with lamivudine;
(c) abacavir with lamivudine and zidovudine;
(d) atazanavir;
(e) atazanavir with cobicistat;
(f) azithromycin;
(g) bictegravir with emtricitabine with tenofovir alafenamide;
(h) darunavir;
(i) darunavir with cobicistat;
(j) dolutegravir;
(k) dolutegravir with abacavir and lamivudine;
(l) dolutegravir with lamivudine;
(m) dolutegravir with rilpivirine;
(n) doxorubicin ‑ pegylated liposomal;
(o) efavirenz;
(p) emtricitabine with rilpivirine with tenofovir alafenamide;
(q) emtricitabine with tenofovir alafenamide;
(r) enfuvirtide;
(s) etravirine;
(t) fosamprenavir;
(u) ganciclovir;
(v) lamivudine;
(w) lamivudine with zidovudine;
(x) lopinavir with ritonavir;
(y) maraviroc;
(z) nevirapine;
(za) raltegravir;
(zb) rifabutin;
(zc) rilpivirine;
(zd) ritonavir;
(ze) saquinavir;
(zf) tenofovir;
(zg) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;
(zh) tenofovir with emtricitabine;
(zi) tenofovir with emtricitabine and efavirenz;
(zj) tipranavir;
(zk) valganciclovir;
(zl) zidovudine.
medication for the treatment of schizophrenia means clozapine.
non‑CAR drug means a highly specialised drug that is not a CAR drug.
pack quantity 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.
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 Benefit) Regulations 2017.
residential care service has the same meaning as in the Regulations.
shelf life, of a medicine, means the period of time that the medicine can be stored and still be considered safe and effective for use.
special arrangement supply has the meaning given by section 13.
7 Definition of authorised prescriber
Specialists affiliated with hospitals
(1) A specialist is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if the specialist is affiliated with the hospital.
Medical practitioners—with the agreement of specialists
(2) A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if all of the following apply:
(a) the benefit is for continuing treatment for the patient;
(b) the patient’s treatment is being managed by a specialist;
(c) it is impractical for the patient to obtain a prescription for the benefit from the specialist;
(d) the specialist has agreed to the prescribing of the benefit for the patient by the medical practitioner.
Medical practitioners—if authorised by Commonwealth and State authorities
(3) A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient if all of the following apply:
(a) the HSD pharmaceutical benefit is for continuing treatment for the patient;
(b) the medical practitioner is authorised (however described) by an authority of the Commonwealth for the purposes of this provision;
(c) the medical practitioner is authorised (however described) by an authority of the State or Territory in which the hospital is located for the purposes of this provision.
Medical practitioners—medication for the treatment of hepatitis C, lanreotide and octreotide
(4) A medical practitioner is an authorised prescriber for the following HSD pharmaceutical benefits:
(a) a medication for the treatment of hepatitis C;
(b) lanreotide, if:
(i) the description of its form does not include “Powder for suspension for injection”; and
(ii) it is for continuing treatment;
(c) octreotide, if:
(i) the description of its form includes “Injection (modified release)”; and
(ii) it is for continuing treatment.
Accredited prescribers—for HSD pharmaceutical benefits for the treatment of hepatitis B, hepatitis C, HIV or AIDS, and schizophrenia
(5) A person mentioned in column 1 of an item of the following table is an authorised prescriber for an HSD pharmaceutical benefit mentioned in column 2 of the item.
| Authorised prescribers for certain HSD pharmaceutical benefits |
| Item | Column 1
Person | Column 2
HSD pharmaceutical benefit |
| 1 | An accredited prescriber of medication for the treatment of hepatitis B | A medication for the treatment of hepatitis B |
| 2 | An accredited prescriber of medication for the treatment of hepatitis C | A medication for the treatment of hepatitis C |
| 3 | An accredited prescriber of medication for the treatment of HIV or AIDS | A medication for the treatment of HIV or AIDS |
| 4 | An accredited prescriber of medication for the treatment of schizophrenia | A medication for the treatment of schizophrenia |
8 Definition of eligible patient
Persons receiving treatment by medical practitioners at or from public hospitals other than as admitted patients
(1) A person is an eligible patient for an HSD pharmaceutical benefit if the person:
(a) is, or is to be treated as, an eligible person; and
(b) is receiving medical treatment by a medical practitioner at or from a public hospital; and
(c) is receiving that treatment as:
(i) a non‑admitted patient of the hospital; or
(ii) a day admitted patient of the hospital; or
(iii) a patient on discharge from the hospital.
Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—medication for the treatment of hepatitis C
(2) A person is an eligible patient for an HSD pharmaceutical benefit that is a medication for the treatment of hepatitis C if the person:
(a) is, or is to be treated as, an eligible person; and
(b) is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and
(c) is receiving that treatment as:
(i) a non‑admitted patient of the hospital; or
(ii) a day admitted patient of the hospital; or
(iii) a patient on discharge from the hospital.
Persons receiving treatment by medical practitioners in public hospitals as admitted patients—HSD pharmaceutical benefits that contain eculizumab
(3) A person is an eligible patient for an HSD pharmaceutical benefit that contains eculizumab if the person:
(a) is, or is to be treated as, an eligible person; and
(b) is receiving medical treatment by a medical practitioner in a public hospital;
(c) is receiving that treatment as an admitted patient (other than a day admitted patient) of the hospital.
Persons receiving treatment by medical practitioners in, at or from private hospitals
(4) A person is an eligible patient for an HSD pharmaceutical benefit if the person:
(a) is, or is to be treated as, an eligible person; and
(b) is receiving medical treatment by a medical practitioner in, at or from a private hospital.
Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—medication for the treatment of hepatitis C
(5) A person is an eligible patient for an HSD pharmaceutical benefit that is a medication for the treatment of hepatitis C if the person:
(a) is, or is to be treated as, an eligible person; and
(b) is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.
Persons receiving HSD pharmaceutical benefits that are community access medications
(6) A person is an eligible patient for an HSD pharmaceutical benefit if:
(a) the benefit is a community access medication; and
(b) the person is, or is to be treated as, an eligible person.
Division 2—Supplies of HSD pharmaceutical benefits from hospitals
9 Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals
(1) In this instrument, and 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 the hospital of which it is the governing body or proprietor includes a reference to the hospital authority supplying HSD pharmaceutical benefits to patients receiving treatment from the hospital.
(2) This section applies in addition to section 94 of the Act.
Division 3—HSD hospital authorities
10 HSD hospital authorities
(1) Section 94 of the Act applies as if that section permitted the Minister to approve a hospital authority for the purpose of its supplying HSD pharmaceutical benefits to patients receiving treatment in, at or from the hospital of which it is the governing body or proprietor if the dispensing of those benefits is performed:
(a) other than at the hospital; and
(b) by or under the direct supervision of a medical practitioner or pharmacist.
(2) Subsection (1) applies despite subsection 94(5) of the Act.
11 References to approved suppliers and approved hospital authorities
In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority.
12 Numbers allotted to HSD hospital authorities
For the purposes of Part VII of the Act and regulations or other instruments made for the purposes of that Part, a number allotted to an HSD hospital authority under either of the following provisions is taken to have been allotted by the Minister under subsection 16(4) of the Regulations:
(a) subsection 52(3) of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010);
(b) subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010).
Part 2—Special arrangement supplies of HSD pharmaceutical benefits
Division 1—Preliminary
13 Definition of special arrangement supply
Prescriptions written for public hospital patients
(1) A supply of an HSD 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:
(i) for any benefit—an approved hospital authority for a public hospital; or
(ii) for a benefit that has a CAR drug—an approved pharmacist; and
(c) the benefit is supplied on the basis of a prescription written:
(i) when the person was receiving medical treatment in, at or from a public hospital; and
(ii) by an authorised prescriber for the benefit; and
(iii) in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.
Prescriptions written for private hospital patients
(2) A supply of an HSD 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:
(i) an approved hospital authority for a private hospital; or
(ii) an approved pharmacist; and
(c) the benefit is supplied on the basis of a prescription written:
(i) when the person was receiving medical treatment in, at or from a private hospital; and
(ii) by an authorised prescriber for the benefit; and
(iii) in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.
Community access arrangements
(3) A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:
(a) the benefit is a community access medication; and
(b) the person is an eligible patient for the benefit; and
(c) the benefit is supplied by an approved supplier; and
(d) the benefit is supplied on the basis of a prescription written:
(i) by an authorised prescriber for the benefit; and
(ii) in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.
Division 2—Prescribing of HSD pharmaceutical benefits
14 Prescribing of HSD pharmaceutical benefits—authorised prescribers (Act s 88(1) and (1E))
Medical practitioners
(1) For the purposes of subsection 88(1) of the Act applying to a medical practitioner who is an authorised prescriber for an HSD pharmaceutical benefit, the benefit is determined.
(2) Subsection 9(1A) of the Listing Instrument (which provides for the pharmaceutical benefits for which medical practitioners are authorised to write prescriptions) does not apply to an HSD pharmaceutical benefit other than a medication for the treatment of hepatitis C.
Authorised nurse practitioners
(3) For the purposes of subsection 88(1E) of the Act applying to an authorised nurse practitioner who is an authorised prescriber for an HSD pharmaceutical benefit, the benefit is determined.
“Supply only” pharmaceutical benefits
(4) Subsections (1) and (3) do not apply to an HSD pharmaceutical benefit mentioned in Part 2 of Schedule 1 to the Listing Instrument (ready‑prepared pharmaceutical benefits for supply only).
15 Prescription circumstances—general (Act s 85(7)(a) and (b))
(1) For the purposes of paragraph 85(7)(a) of the Act, an HSD pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.
(2) For the purposes of paragraph 85(7)(b) of the Act, the circumstances in which a prescription for a special arrangement supply of an HSD pharmaceutical benefit may be written are the circumstances mentioned in Schedule 3 to this instrument for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 to this instrument for the benefit.
(3) This section applies in addition to section 10 of the Listing Instrument.
(4) This section has effect subject to section 17 (which temporarily modifies the circumstances mentioned in Schedule 3 for circumstances codes for HSD pharmaceutical benefits that are pharmaceutical items described in Schedule 4).
16 Prescription circumstances—authority required procedures
(1) This section applies to a prescription for a special arrangement supply of an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 in which the prescription is written include:
(a) Compliance with Authority Required procedures; or
(b) Compliance with Written Authority Required procedures.
(2) Sections 11 to 14 of the Listing Instrument apply to the prescription as if:
(a) a reference in those provisions to “Part 1 of Schedule 4” or “Schedule 4” were a reference to Schedule 3 to this instrument; and
(b) a reference in those provisions to an “authorised prescriber” were a reference to an authorised prescriber within the meaning of this instrument.
17 Prescription circumstances—modifications during COVID‑19 pandemic (Act s 85(7)(a) and (b))
(1) This section affects the circumstances in which a prescription may be written by an authorised prescriber for the supply of an HSD pharmaceutical benefit that is a listed brand of a pharmaceutical item described in Schedule 4 to a person (the patient) if the authorised prescriber is satisfied the patient has, in accordance with this instrument, already been supplied with the benefit on the basis of a prescription:
(a) written, on or after 1 April 2021, in circumstances determined by subsection 10(1) of the Listing Instrument unaffected by this section; or
(b) written, before 1 April 2021, in circumstances determined by subsection 9(1) of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) unaffected by section 9AA of that instrument.
(2) For the purposes of subsection 10(1) of the Listing Instrument and subsection 15(2) of this instrument, Part 1 of Schedule 4 to the Listing Instrument and Schedule 3 to this instrument have effect as if each circumstances code for the HSD pharmaceutical benefit:
(a) did not mention any circumstance that, having regard to the patient’s situation and the state of affairs associated with precautions against the spread of the coronavirus known as COVID‑19, it is not reasonably practicable to establish in relation to the patient; and
(b) mentioned the circumstance that the authorised prescriber keeps a written record of the reason it is not practicable to establish the circumstance described in paragraph (a).
(3) This section, subsection 15(4) and Schedule 4 to this instrument are repealed at the start of 1 January 2022.
18 When medication chart prescriptions not to be written
HSD pharmaceutical benefits that have CAR drugs
(1) Subparagraph 39(a)(ii) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug.
Persons receiving treatment in residential care services
(2) Subparagraph 41(1)(a)(i) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit.
19 Prescriptions not to direct repeated supplies for visitors to Australia
(1) An authorised prescriber for an HSD pharmaceutical benefit must not write a prescription directing a repeated supply of an HSD pharmaceutical benefit to a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.
(2) This section applies despite section 85A of the Act.
20 Maximum quantity or number of units (Act s 85A(2)(a))
(1) For the purposes of paragraph 85A(2)(a) of the Act, this section sets out the maximum quantity or number of units of the pharmaceutical item in an HSD pharmaceutical benefit that may, in one prescription for a special arrangement supply of the benefit, be directed by an authorised prescriber to be supplied on any one occasion.
Supply for particular purposes
(2) If:
(a) a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and
(b) the supply of the benefit is for purposes mentioned in Schedule 3 to this instrument for the purposes code;
the maximum quantity or number of units is the quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit and the purposes code.
Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2
(3) If:
(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and
(a) a quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit;
the maximum quantity or number of units is that quantity or number of units.
Supply for all purposes—HSD pharmaceutical benefits in Schedule 2
(4) If:
(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and
(b) the words “See Schedule 2” appear in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit; and
(c) the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;
the maximum quantity or number of units is the quantity or number of units that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.
(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.
21 Maximum number of repeats (Act s 85A(2)(b))
(1) For the purposes of paragraph 85A(2)(b) of the Act, this section sets out the maximum number of occasions an authorised prescriber may, in one prescription, direct that a special arrangement supply of an HSD pharmaceutical benefit be repeated.
Supply for particular purposes
(2) If:
(a) a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and
(b) the supply is for purposes mentioned in Schedule 3 to this instrument for the purposes code;
the maximum number is the number mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit and the purposes code.
Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2
(3) If:
(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and
(b) a number is mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit;
the maximum number is that number.
Supply for all purposes—HSD pharmaceutical benefits in Schedule 2
(4) If:
(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and
(b) the words “See Schedule 2” appear in the column headed “Maximum repeats” in Schedule 1 for the benefit; and
(c) the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;
the maximum number is the number that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.
(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.
22 No variation of application of determination of maximum number of repeats or maximum number or quantity of units—HSD pharmaceutical benefits that have CAR drugs
Section 30 of the Regulations does not apply in relation to a practitioner (within the meaning of section 29 of the Regulations) who has written a prescription for a special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug.
Note: Section 30 of the Regulations allows the Minister to vary the application of a determination under paragraph 85A(2)(a) or (b) of the Act in certain circumstances.
23 Records to be kept—prescriptions for HSD pharmaceutical benefits that contain eculizumab
(1) If an authorised prescriber for an HSD pharmaceutical benefit that contains eculizumab writes a prescription for a special arrangement supply of the benefit, a copy of any clinical records relating to the prescription, including records required to demonstrate that the prescription was written in compliance with the circumstances and purposes determined in relation to the benefit under subsection 85(7) of the Act, must be kept by:
(a) the approved hospital authority for the hospital in, at or from which the eligible patient is receiving treatment; or
(b) if the approved hospital authority is not able to keep the records—the authorised prescriber.
(2) The records must be kept for 2 years after the date the prescription to which the records relate is written.
Division 3—Supplying HSD pharmaceutical benefits
24 Special patient contribution for certain HSD pharmaceutical benefits
(1) This section applies to a special arrangement supply of an HSD pharmaceutical benefit mentioned in the following table.
| Special patient contribution for certain HSD pharmaceutical benefits |
| Item | Drug | Form | Manner of administration | Brand | Pack quantity | Claimed price ($) |
| 1 | Lamivudine | Tablet 100 mg | Oral | Zeffix | 28 | 35.30 |
| 2 | Valaciclovir | Tablet 500 mg (as hydrochloride) | Oral | Valtrex | 100 | 44.64 |
(2) The special patient contribution for a pack quantity of a listed brand of a pharmaceutical item mentioned in the table is the amount that is the difference between:
(a) the price that would have been the dispensed price for that quantity of the brand of the pharmaceutical item if that dispensed price had been based on the claimed price (within the meaning of Part VII of the Act) mentioned in the table for that quantity; and
(b) the dispensed price for that quantity of the brand of the pharmaceutical item.
(3) This section applies despite subsection 85B(5) of the Act.
25 Modified application of conditions of approval of approved pharmacists
Section 8 of the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2017 (PB 70 of 2017) does not apply to a special arrangement supply of an HSD pharmaceutical benefit, once prepared as a final product ready for infusion to a person, if the benefit has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.
26 Supplies by HSD hospital authorities need not be directly to persons
(1) An HSD hospital authority may make a special arrangement supply of an HSD pharmaceutical benefit to a person:
(a) other than directly to the person; or
(b) through an agent.
(2) This section applies in addition to section 94 of the Act.
27 Repeated supplies of pharmaceutical benefits
Section 51 of the Regulations does not apply to a special arrangement supply of HSD pharmaceutical benefits.
Part 3—Payment for special arrangement supplies of HSD pharmaceutical benefits
Division 1—Supplies by approved hospital authorities for public hospitals
28 Rates of payment for approved hospital authorities for public hospitals (Act s 99(4))
(1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a public hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the hospital authority was entitled to charge under section 87 of the Act in respect of the supply.
(2) This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017).
Note: See subsection 99(4) of the Act (read with section 9 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.
29 Dispensed price for approved hospital authorities for public hospitals
(1) The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital 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 the quantity of the benefit supplied is more than a multiple of a pack quantity of the benefit—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.
Broken quantities
(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.
Rounding
(3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).
Division 2—Supplies by other approved suppliers
30 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners
(1) This section applies if:
(a) an approved pharmacist or approved medical practitioner has supplied an HSD pharmaceutical benefit; and
(b) the supply is a special arrangement supply of the benefit.
(2) The approved pharmacist or approved medical practitioner 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 the supply, entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 87 of the Act in respect of the supply.
(3) This section applies despite subsections 99(2) and (2AA) of the Act.
31 Rates of payment for approved hospital authorities for private hospitals (Act s 99(4))
(1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a private hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the authority was entitled to charge under section 87 of the Act in respect of the supply.
(2) This section applies despite the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020 (PB 99 of 2020).
Note: See subsection 99(4) of the Act (read with section 9 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.
32 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals
(1) The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital 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:
(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and
(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and
(iii) the dispensing fee for the benefit in accordance with section 34;
(b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the sum of:
(i) the amount worked out in accordance with subsection (2); and
(ii) the dispensing fee for the benefit in accordance with section 34;
(c) if the quantity of the benefit supplied is more than a multiple of a pack quantity of the benefit—the sum of:
(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and
(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and
(iii) the amount worked out in accordance with subsection (2) for the remainder of the quantity that is a broken quantity; and
(iv) the dispensing fee for the benefit in accordance with section 34.
Broken quantities
(2) For the purposes of subparagraphs (1)(b)(i) and (c)(iii), 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 sum of:
(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and
(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards).
Rounding
(3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).
33 Mark‑up for ready‑prepared pharmaceutical benefits
For the purposes of subparagraphs 32(1)(a)(ii), (c)(ii) and (2)(b)(ii), the mark‑up for a pack quantity of an HSD pharmaceutical benefit that is a ready‑prepared pharmaceutical benefit is:
(a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit mentioned in section 20—the amount mentioned in the following table for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer price (PEMP) (as applicable) for that quantity; or
(b) if the pack quantity of the benefit is less than the maximum quantity of the benefit mentioned in section 20:
(i) if the mark‑up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or
(ii) if the mark‑up mentioned in the following table for the maximum quantity is a percentage of the AEMP or PEMP (as applicable)—that percentage of the AEMP or PEMP for the pack quantity.
| Mark‑up for ready‑prepared pharmaceutical benefits |
| Item | If the AEMP or PEMP (as applicable) for the maximum quantity is … | the mark‑up for the maximum quantity is … |
| 1 | less than $40 | 10% of the AEMP or PEMP |
| 2 | at least $40 but not more than $100 | $4 |
| 3 | more than $100 but not more than $1,000 | 4% of the AEMP or PEMP |
| 4 | more than $1,000 | $40 |
34 Dispensing fee
(1) For the purposes of subparagraphs 32(1)(a)(iii), (b)(ii) and (c)(iv):
(a) the dispensing fee for the supply of an HSD pharmaceutical benefit is:
(i) if the benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee (within the meaning of the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020 (PB 66 of 2020)); or
(ii) if subparagraph (i) does not apply—the ready‑prepared dispensing fee (within the meaning of that determination); and
(b) if the authorised prescriber who prescribed the benefit, instead of directing a repeated supply of the benefit, directed the supply on one occasion of a quantity or number of units of the benefit, not exceeding the total quantity or number of units that could be prescribed if the authorised prescriber directed a repeated supply, only one dispensing fee is included in the dispensed price for the supply of the benefit.
Note: See section 49 of the Regulations for the circumstances in which such a supply may be directed.
(2) For the purpose of subparagraph (1)(a)(i), the drugs and the forms for the drugs are as follows:
(a) mycophenolic acid as a powder for oral suspension containing mycophenolate mofetil 1g per 5 mL, 165mL;
(b) valganciclovir as a powder for oral solution 50mg (as hydrochloride) per mL, 100 mL.
Part 4—Claims for payment for special arrangement supplies of HSD pharmaceutical benefits
35 Rules for providing information about supplies—definition of under co‑payment data
The National Health (Claims and under co‑payment data) Rules 2012 (PB 19 of 2012) apply to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier as if the definition of under co‑payment data in that instrument were replaced with the following definition:
under co‑payment data means information relating to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier where the amount payable by the Commonwealth is nil because the dispensed price for the supply of the benefit does not exceed the amount that the supplier was entitled to charge under section 87 of the Act in respect of the supply.
Part 5—Miscellaneous
36 Compliance and audit arrangements
(1) If an approved supplier makes a special arrangement supply of an HSD pharmaceutical benefit, the approved supplier must keep adequate, secure and auditable records of all supplied HSD pharmaceutical benefits for which a claim is made.
(2) The records must be kept in systems that are able to be audited by the Chief Executive Medicare on reasonable notice being given to the approved supplier.
37 Value for safety net purposes for supplies
Supplies by approved hospital authorities
(1) The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved hospital authority is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under subsection 87(5) of the Act for the supply of the benefit less the amount chargeable under that subsection because of subsection 87(2A) of the Act.
Supplies by approved pharmacists and approved medical practitioners
(2) The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved pharmacist or approved medical practitioner is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under section 87 of the Act for the supply of the benefit less the amount chargeable under subsection 87(2A) of the Act.
(3) This section applies despite regulation 17A of the Regulations.
Part 6—Application, saving and transitional provisions
Division 1—Provisions relating to this instrument as made
38 HSD hospital authorities
Despite the repeal of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010):
(a) an approval that was in force under subsection 52(2) of that instrument immediately before 1 April 2021; and
(b) an approval that was continued in force under section 53 of that instrument as if it were an approval under subsection 52(2) of that instrument, and was in force immediately before 1 April 2021;
continues in force as if it were an approval under section 94 of the Act, as modified by section 10 of this instrument.