Part 1—Preliminary
Division 1—General
1 Name of Special Arrangement
(1) This Special Arrangement is the National Health (Highly specialised drugs program) Special Arrangement 2010.
(2) This Special Arrangement may also be cited as PB 116 of 2010.
4 Definitions
In this Special Arrangement:
ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.
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 for this Special Arrangement.
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 for this Special Arrangement.
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 for this Special Arrangement.
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 for this Special Arrangement.
Act means the National Health Act 1953.
affiliated specialist medical practitioner means a medical practitioner who:
(a) is affiliated with the hospital at or from which the patient is receiving treatment; and
(b) is either:
(i) a staff hospital specialist; or
(ii) a visiting or consulting specialist of the hospital.
approved hospital authority, for a hospital, means the hospital authority for the hospital that:
(a) is approved:
(i) by the Minister under section 94 of the Act; or
(ii) by the Secretary under section 52 of this Special Arrangement; or
(b) was approved under section 52 of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 and the approval:
(i) is not suspended; or
(ii) has not been revoked.
Note: The Instrument mentioned in paragraph (b) is also known as PB 63 of 2010.
approved private hospital means a private hospital that has an approved hospital authority.
approved public hospital means a public hospital that has an approved hospital authority.
authorised nurse practitioner has the same meaning as in Part VII of the Act.
authorised prescriber has the meaning given by section 4A.
benefit card means any of the following:
(a) a PBS Entitlement Card;
(b) a PBS Safety Net Concession Card;
(c) a Pensioner Concession Card;
(d) a Health Care Card (including Low Income Health Care Card and Foster Child Health Care Card);
(e) a Commonwealth Seniors Health Card;
(f) a Cleft Lip and Palate Card;
(g) a DVA Gold Card;
(h) a DVA White Card;
(i) a DVA Orange Card;
(j) War Widow/Widower Transport Card;
(k) a card or voucher approved by the Chief Executive Medicare for this paragraph.
CAR drug (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
(aa) sildenafil
(bb) tadalafil
(cc) teduglutide
(dd) tezacaftor with ivacaftor and ivacaftor
(ee) tocilizumab
(ff) ustekinumab
(gg) vedolizumab
circumstances code means the letter ‘C’ followed by a number.
Department means the Department administered by the Minister who administers the National Health Act 1953.
dispensed price:
(a) for the supply of an HSD pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 37; and
(b) for the supply of an HSD pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist—has the meaning given by section 39.
eligible medical practitioner, for the prescription of an HSD pharmaceutical benefit under this Special Arrangement to an eligible patient, means a person:
(a) who is an affiliated specialist medical practitioner; or
(bb) who is, for the prescription of medication for the treatment of schizophrenia—an accredited prescriber of medication for the treatment of schizophrenia; or
(d) who is, for the prescription of medication for maintenance therapy if it is impractical to obtain a prescription from the treating affiliated specialist medical practitioner and the treating staff hospital specialist has agreed to the prescription—a medical practitioner; or
(e) who is, for the prescription of medication for maintenance therapy—a medical practitioner whom the Commonwealth and the State or Territory Government has agreed may give such a prescription.
eligible patient means a person who
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) if receiving treatment at or from a public hospital, is receiving medical treatment by a medical practitioner as:
(i) a non‑admitted patient; or
(ii) a day admitted patient; or
(iii) a patient on discharge; or
(iv) an admitted patient who has been prescribed a HSD pharmaceutical benefit referred to in section 9A.
entitlement number, for a patient, means the number listed on the patient’s benefit card.
General Statement for drugs for the treatment of hepatitis C means the statement set out in Schedule 3 Part 1.
highly specialised drug means a listed drug mentioned in Schedule 1.
Note: Special Arrangements under section 100 of the Act apply to pharmaceutical benefits with drugs that have been declared by the Minister under subsection 85(2) of the Act. The drugs in Schedule 1 have all been so declared.
hospital authority means:
(a) for a public hospital—the governing body of the hospital; or
(b) for a private hospital—the proprietor of the hospital.
HSD pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
item code, for a drug that has a particular form, manner of administration and brand, means the code for the form, manner of administration and brand for the drug set out in the Department’s website.
Note: The website address is http://www.pbs.gov.au.
medication chart prescription has the meaning given in the Regulations, but does not include a medication chart prescription for a person receiving treatment in a residential care service.
medication for the treatment of hepatitis B means any of the following:
(a) adefovir
(b) entecavir
(c) interferon alfa‑2a
(e) lamivudine
(g) 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.
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
(aa) raltegravir
(bb) rifabutin
(cc) rilpivirine
(dd) ritonavir
(ee) saquinavir
(ff) tenofovir
(gg) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat
(hh) tenofovir with emtricitabine
(ii) tenofovir with emtricitabine and efavirenz
(jj) tipranavir
(kk) valganciclovir
(ll) zidovudine
medication for the treatment of schizophrenia means clozapine.
non‑CAR drug means a highly specialised drug that is not a complex authority required (CAR) drug.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
purposes code means the letter ‘P’ followed by a number.
residential care service has the meaning given by the Regulations.
Regulations means the National Health (Pharmaceutical Benefit) Regulations 2017.
streamlined authority code means the number mentioned in subsection 13(1).
under co‑payment data means information relating to a supply of a HSD pharmaceutical benefit by an approved pharmacist, approved medical practitioner or approved hospital authority for a hospital where a claim is not payable as the dispensed price for the supply of the HSD pharmaceutical benefit does not exceed the amount that the supplier was entitled to charge under subsection 46(2) or subsection 47(2) of this Special Arrangement.
Note: Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:
· approved ex‑manufacturer price
· approved medical practitioner
· approved pharmacist
· claimed price
· hospital
· medical practitioner
· Chief Executive Medicare
· pack quantity
· pharmaceutical benefit
· pharmaceutical item
· private hospital
· proportional ex‑manufacturer price
· public hospital.
4A Definition of authorised prescriber
(1) An eligible medical practitioner for the prescription of an HSD pharmaceutical benefit under this Special Arrangement to an eligible patient is an authorised prescriber for the HSD pharmaceutical benefit.
(2) A medical practitioner is an authorised prescriber for each of the following HSD pharmaceutical benefits for the purpose of the treatment of hepatitis C:
(a) grazoprevir with elbasvir;
(b) ledipasvir with sofosbuvir; and
(c) ribavirin.
(3) 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 |
Division 2—HSD pharmaceutical benefits
5 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each HSD pharmaceutical benefit mentioned in Schedule 1.
(2) Each HSD pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note: Each listed drug mentioned in Schedule 1 is a highly specialised drug—see definition of highly specialised drug in section 4. Each listed drug has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.
6 Application of Part VII of the Act
(1) Each HSD pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.
Note: See subsection 100(3) of the Act.
7 Responsible person
(1) If a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2)(a) is the responsible person for the brand of the pharmaceutical item.
(2) For subsection (1):
(a) the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and
(b) the pharmaceutical item is the listed drug mentioned in Schedule 1:
(i) in the form mentioned in Schedule 1 for the listed drug; and
(ii) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note: An HSD pharmaceutical benefit mentioned in Schedule 1 is a brand of a pharmaceutical item.
Note: A person identified by a code in the column headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.
8 Prescribing of HSD pharmaceutical benefits—authorised prescribers
(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) 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.
(4) For subsection (1), the HSD pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
(5) Subsection 9(1A) of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (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.
(6) Subsections (1) and (2) do not apply to an HSD pharmaceutical benefit mentioned in Part 2 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (ready‑prepared pharmaceutical benefits for supply only).
9 Prescription circumstances
(1) If at least 1 circumstances code is mentioned in the column in Schedule 1 headed ‘Circumstances’ for an HSD pharmaceutical benefit, the circumstances mentioned in Schedule 3 for the code are the circumstances in which a prescription for the supply of the HSD pharmaceutical benefit may be written.
(2) For subsection (1), the HSD pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
(3) This section has effect subject to section 9AA (which temporarily modifies the circumstances mentioned in Schedule 3 for circumstances codes for HSD pharmaceutical benefits that are pharmaceutical items described in Schedule 5).
9AA Modified prescription circumstances during COVID‑19 pandemic
(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 5 to a person (the patient) if the authorised prescriber is satisfied the patient has, in accordance with this Special Arrangement, already been supplied with the benefit on the basis of a prescription written in circumstances determined by subsection 9(1) unaffected by this section.
(2) For the purposes of subsection 9(1), Schedule 3 has 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 9(3) and Schedule 5 are repealed at the start of 1 April 2021.
9A HSD pharmaceutical benefits which may be supplied to public hospital admitted patients
The HSD pharmaceutical benefits which may be supplied to public hospital admitted patients under this Special Arrangement are referred to in the table below:
(a) if a drug is referred to in the table below and paragraphs (b), (c) and (d) do not apply – all HSD pharmaceutical benefits containing that drug;
(b) if a form of the drug is referred to in the table below and paragraphs (c) and (d) do not apply – all HSD pharmaceutical benefits containing that drug in that form;
(c) if a manner of administration of that form of the drug is referred to in the table below and paragraph (d) does not apply – all HSD pharmaceutical benefits containing that drug in that form with that manner of administration;
(d) if a brand of a drug in that form with that manner of administration is referred to in the table below – that brand of HSD pharmaceutical benefit containing that drug in that form with that manner of administration;
(e) if one or more circumstances and/or purposes code is identified in the table below – the HSD pharmaceutical benefit must be prescribed for one of those circumstances and/or purposes.
| Drug | Form | Manner of Administration | Brand | Circumstances Code | Purposes Code |
| eculizumab | | | | | |
Note: A circumstances and/or purposes code mentioned in the above table is the same circumstances and/or purposes code referred to in section 9 (circumstances code) or section 14 or section 15 (purposes code).
Division 3—HSD Authority Required procedures
10 HSD Authority Required procedures
(1) This section applies to an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 for a circumstances code mentioned in Schedule 1 for the HSD pharmaceutical benefit includes:
(a) Compliance with Authority Required procedures;
(b) Compliance with Written Authority Required procedures;
(c) Compliance with Written or Telephone Authority Required procedures;
(d) Compliance with modified Authority Required procedures.
(1A) If the circumstances mentioned in Schedule 3 for a circumstances code mentioned in Schedule 1 for a HSD pharmaceutical benefit include ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with Authority Required procedures’.
(2) The Authority Required procedures as provided for in sections 11 to 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 are to be followed.
(3) In addition to the requirements of subsection (2), where ‘Compliance with modified Authority Required procedures’ appears in the circumstances mentioned in Schedule 3 for the code, in addition to ‘Compliance with Written or Telephone Authority Required procedures’, any other requirement included in the circumstances is to be followed as part of the Authority Required procedures.
Division 4—Maximum quantity and maximum number of repeats
14 Maximum quantity
(1) The maximum quantity or number of units of the pharmaceutical item in an HSD pharmaceutical benefit that may, in 1 prescription for the supply of the HSD pharmaceutical benefit, be directed to be supplied by an authorised prescriber for the HSD pharmaceutical benefit is the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for the HSD pharmaceutical benefit.
(2) If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for an HSD pharmaceutical benefit, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 3 for each code.
(3) If no purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’, the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same HSD pharmaceutical benefit.
(4) For subsection (1), the pharmaceutical item is the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
(5) For this section, the HSD pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
(6) Subsection (1) applies, in relation to an HSD pharmaceutical benefit that has a CAR drug, subject to section 24.
Note: The maximum quantities and numbers of units mentioned in the column headed ‘Maximum quantity’ in Schedule 1 have been determined by the Minister under paragraph 85A(2)(a) of the Act.
Note: See also section 26.
(7) A determination made under paragraph 85A(2)(a) of the Act does not apply to an HSD pharmaceutical benefit supplied in accordance with this Special Arrangement in relation to the maximum quantity of the HSD pharmaceutical benefit that can be supplied under this Special Arrangement if the maximum quantity mentioned in the determination differs from the maximum quantity mentioned in this section.
15 Maximum number of repeats
(1) The maximum number of occasions an authorised prescriber for the HSD pharmaceutical benefit may, in 1 prescription, direct that the supply of the pharmaceutical benefit be repeated is the number in the column in Schedule 1 headed ‘Number of Repeats’ for the pharmaceutical benefit.
(2) If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for the pharmaceutical benefit, the number of repeats mentioned in the column in Schedule 1 headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 3 for each code.
(3) If no purposes code is mentioned in the column headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.
(4) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
(5) Subsection (1) applies, in relation to an HSD pharmaceutical benefit that has a CAR drug, subject to section 25.
Note: See also section 26.
(6) A determination made under paragraph 85A(2)(b) of the Act does not apply to an HSD pharmaceutical benefit supplied in accordance with this Special Arrangement in relation to the maximum number of occasions an authorised prescriber for the HSD pharmaceutical benefit may, in 1 prescription, direct, under this Special Arrangement, that the supply of the HSD pharmaceutical benefit be repeated if the maximum number mentioned in the determination differs from the maximum number mentioned in this section.
Division 5—Section 100 only
16 Section 100 only supply
(1) If the letter ‘D’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.
(2) An HSD pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has declared, under subsection 85(2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
(3) If the letters ‘PB’ are mentioned in the column in Schedule 1 headed ‘Section 100 only’ for an HSD pharmaceutical benefit, the HSD pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.
(4) An HSD pharmaceutical benefit mentioned in subsection (3) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has determined, under paragraph 85(8)(a) of the Act, that this HSD pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.
(5) If the letter ‘C’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for an HSD pharmaceutical benefit, the HSD pharmaceutical benefit may be supplied in the circumstances mentioned in Schedule 3 for the circumstances code in the column headed ‘Circumstances’ only in accordance with this Special Arrangement and any other Special Arrangement relating to the HSD pharmaceutical benefit.
(6) An HSD pharmaceutical benefit mentioned in subsection (5) is not available in the circumstances mentioned in subsection (5) for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has determined, under paragraph 85(8)(b) of the Act, that 1 or more of the circumstances in which a prescription for the supply of the HSD pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.
Part 2—Supply of HSD pharmaceutical benefits
Division 1—General requirements for supply
17 Entitlement to HSD pharmaceutical benefits
Subject to this Special Arrangement, an eligible patient is entitled to be supplied an HSD pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made in accordance with Part 6.
17A Modified application of paragraph 92A(1)(f) conditions of approval
(1) Section 8 of the conditions of approval for approved pharmacists under paragraph 92A(1)(f) of the Act does not apply to the supply of a HSD pharmaceutical benefit, once prepared as a final product ready for infusion to a person, when the HSD pharmaceutical benefit has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.
(2) For the purposes of this section, shelf life means the period of time that a medicine can be stored and still be considered safe and effective for use.
18 Supply of HSD pharmaceutical benefits under this Special Arrangement
(1) Subject to subsection (2), this Special Arrangement only applies to the supply of an HSD pharmaceutical benefit:
(a) by an approved hospital authority for a public hospital to an eligible patient receiving treatment at or from an approved public hospital; or
(b) by an approved hospital authority for a private hospital to an eligible patient receiving treatment at or from an approved private hospital; or
(c) by an approved pharmacist to an eligible patient receiving treatment at or from a private hospital; or
(d) if the HSD pharmaceutical benefit has a CAR drug—by an approved pharmacist to an eligible patient receiving treatment at or from an approved public hospital or an approved private hospital.
(2) Where an eligible patient receives treatment in or at or outside of an approved public hospital or an approved private hospital, then a supplier listed in paragraph (a) may supply, to the eligible patient, HSD pharmaceutical benefits that are referred to in paragraph (b):
(a) The suppliers are:
i. an approved pharmacist; or
ii. an approved medical practitioner; or
iii. an approved hospital authority;
(b) The HSD pharmaceutical benefits are:
i. medication for the treatment of hepatitis B;
ii. medication for the treatment of HIV or AIDS, other than the pharmaceutical benefits containing the drugs azithromycin, doxorubicin ‑ pegylated liposomal and rifabutin; and
iii. medication for the treatment of schizophrenia when used in continuing therapy.
(3) This section does not require an approved hospital authority or an approved pharmacist to supply the HSD pharmaceutical benefit directly to a patient.
(4) The HSD pharmaceutical benefit may be supplied by the approved hospital authority or approved pharmacist through an agent.
(5) Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied by an approved hospital authority under this Special Arrangement.
Division 2—Repeat prescriptions
19 Application of section 51 of the Regulations
Section 51 of the Regulations does not apply to the supply of HSD pharmaceutical benefits.
20 No repeats for visitors
An authorised prescriber for an HSD pharmaceutical benefit must not write a repeat prescription for the HSD pharmaceutical benefit for 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.
Division 3—Prescribing HSD pharmaceutical benefits that have non‑CAR drugs
21 Methods of prescribing HSD pharmaceutical benefits that have non‑CAR drugs
An authorised prescriber for an HSD pharmaceutical benefit that has a non‑CAR drug may prescribe the HSD pharmaceutical benefit under this Special Arrangement by:
(a) writing a prescription for the HSD pharmaceutical benefit in accordance with section 40 of the Regulations; or
(b) preparing a medication chart prescription for the HSD pharmaceutical benefit in accordance with section 41 of the Regulations.
Note: An authorised prescriber for an HSD pharmaceutical benefit that has a non‑CAR drug may prescribe more than the maximum quantity, or more than the maximum number of repeats, of the HSD pharmaceutical benefit only in accordance with section 30 of the Regulations.
22A Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have non‑CAR drugs
(1) If an authorised prescriber for an HSD pharmaceutical benefit referred to in section 9A prescribes the HSD pharmaceutical benefit for supply under Part VII of the Act, and the HSD pharmaceutical benefit has a non‑CAR drug, then either the:
(a) authorised prescriber; or
(b) approved hospital authority treating the eligible patient;
must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes.
(2) These records must be kept for 2 years after the date the prescription to which the records relate is written.
Division 4—Prescribing HSD pharmaceutical benefits that have CAR drugs
23 Prescriptions for HSD pharmaceutical benefits that have CAR drugs
An authorised prescriber for an HSD pharmaceutical benefit that has a CAR drug may prescribe the HSD pharmaceutical benefit by writing a prescription for the HSD pharmaceutical benefit in accordance with section 40 of the Regulations.
23A Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have CAR drugs
(1) If an authorised prescriber for an HSD pharmaceutical benefit referred to in section 9A prescribes the HSD pharmaceutical benefit for supply under Part VII of the Act, and the HSD pharmaceutical benefit has a CAR drug, then either the:
(a) authorised prescriber; or
(b) approved hospital authority treating the eligible patient;
must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes.
(2) These records must be kept for 2 years after the date the prescription to which the records relate is written.
24 HSD pharmaceutical benefits that have CAR drugs—quantity exceptions
(1) An authorised prescriber for an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) may write a prescription for the HSD pharmaceutical benefit to be supplied to an eligible patient on any one occasion only in accordance with the limitation mentioned in subsection (2) for the drug.
(2) The drugs and limitations are as follows:
(a) for HSD pharmaceutical benefits that have the drug ambrisentan, bosentan, epoprostenol, etanercept, iloprost, sildenafil or tadalafil—a quantity of units sufficient for up to 1 month of treatment with the drug;
(b) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with severe active rheumatoid arthritis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 3 milligrams per kilogram;
(c) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with active ankylosing spondylitis, severe active psoriatic arthritis or severe chronic plaque psoriasis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram;
(d) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of a patient with refractory Crohn disease or fistulating Crohn disease—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram;
(da) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of a patient with moderate to severe ulcerative colitis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram.
(db) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with severe Crohn disease—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram.
(e) for HSD pharmaceutical benefits that have the drug rituximab—a quantity of units sufficient to provide for a single dose;
(f) for HSD pharmaceutical benefits that have the drug abatacept—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose;
(g) for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of adult patients with severe active rheumatoid arthritis—a quantity of units that are sufficient, based on the weight of the patient and taking into account whether any other strength injections will contribute part of the dose, to provide for the whole or part of a single dose of 8 mg per kg;
(h) for HSD pharmaceutical benefits that have the drug adalimumab—a quantity of units that are sufficient, based on the weight of the patient, to provide for 2 doses;
(i) for HSD pharmaceutical benefits that have the drug lenalidomide, for the treatment of a patient with multiple myeloma:
(i) with the form Capsule 5 mg—up to 84 tablets;
(ii) with the form Capsule 10 mg—up to 42 tablets;
(iii) with the form Capsule 15 mg—up to 21 tablets;
(iv) with the form Capsule 25 mg—up to 21 tablets;
(j) for HSD pharmaceutical benefits that have the drug lenalidomide, for the treatment of a patient with myelodysplastic syndrome:
(i) with the form Capsule 5 mg—up to 21 tablets;
(ii) with the form Capsule 10 mg—up to 21 tablets;
(k) for HSD pharmaceutical benefits that have the drug azacitidine with the form Powder for injection 100mg—up to 14 units.
(l) for HSD pharmaceutical benefits that have the drug romiplostim, for initial treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) at the time of the initial written authority application—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;
(ii) during the initial period of dose titration—a quantity of units sufficient to provide for a single dose;
(iii) for a patient whose dose has been stable for a period of 4 weeks—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(m) for HSD pharmaceutical benefits that have the drug romiplostim, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Romiplostim was commenced:
(i) at the time of the initial written authority application—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;
(ii) during the initial period of dose titration—a quantity of units sufficient to provide for a single dose;
(iii) for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks;
(iv) for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS‑subsidy—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.
(n) for HSD pharmaceutical benefits that have the drug romiplostim, for the first period of continuing treatment or re‑initiation of interrupted PBS subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS‑subsidised treatment—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks treatment.
(o) for HSD pharmaceutical benefits that have the drug romiplostim, for the second and subsequent periods of continuing treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Romiplostim—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.
(p) for HSD pharmaceutical benefits that have the drug omalizumab, for initial treatment of uncontrolled severe allergic asthma—a quantity of units that are sufficient to provide for 28 weeks treatment;
(r) for HSD pharmaceutical benefits that have the drug omalizumab, for continuing treatment—a quantity of units that are sufficient to provide for 24 weeks treatment.
(ra) for HSD pharmaceutical benefits that have the drug omalizumab, for the treatment of severe chronic spontaneous urticaria:
(i) for initial treatment—a quantity of units that are sufficient to provide for 12 weeks treatment;
(ii) for initial PBS‑subsidised treatment in a patient who has previously received non‑PBS‑subsidised therapy with omalizumab (grandfathered patients)—a quantity of units that are sufficient to provide for 24 weeks treatment;
(iii) for continuing treatment—a quantity of units that are sufficient to provide for 24 weeks treatment.
(s) for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) with the form Tablet 25 mg (as olamine)—up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine)—up to 28 tablets;
—a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(t) for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Eltrombopag was commenced):
(i) with the form Tablet 25 mg (as olamine)—up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine)—up to 28 tablets;
—a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(u) for HSD pharmaceutical benefits that have the drug eltrombopag, for the first period of continuing treatment or re‑initiation of interrupted PBS subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Eltrombopag during the initial period of PBS‑subsidised treatment:
(i) with the form Tablet 25 mg (as olamine)—up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine)—up to 28 tablets;
—a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(v) for HSD pharmaceutical benefits that have the drug eltrombopag, for the second and subsequent periods of continuing treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Eltrombopag:
(i) with the form Tablet 25 mg (as olamine)—up to 28 tablets;
(ii) with the form Tablet 50 mg (as olamine)—up to 28 tablets;
—a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.
(w) for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis—a quantity of units sufficient for up to 1 month of treatment with the drug.
(x) for HSD pharmaceutical benefits that have the drug riociguat, for the treatment of Chronic thromboembolic pulmonary hypertension (CTEPH):
(ii) for Initial treatment—prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2‑week intervals to achieve up to a maximum of 2.5 mg three times daily. Approvals for subsequent authority prescriptions will be limited to 1 month of treatment.
(iii) for Continuing treatment—the maximum quantity per prescription will be limited to provide sufficient supply for 1 month of treatment.
(y) for HSD pharmaceutical benefits that have the drug riociguat, for balance of supply for patient who has received insufficient therapy with this agent:
(ii) for Initial treatment—maximum of 20 weeks of treatment.
(iii) for Continuing treatment—maximum of 24 weeks of treatment—the treatment must provide no more than the balance up to 20 or 24 weeks of treatment available under the above respective restriction.
(z) for HSD pharmaceutical benefits that have the drug riociguat, for the treatment of Pulmonary arterial hypertension (PAH):
(i) for Initial 1(new patients), Initial 2 (new patients) and Initial 3 (change or re‑commencement of therapy for all patients) – prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2‑week intervals to achieve up to a maximum of 2.5 mg three times daily. Approvals for subsequent authority prescriptions will be limited to 1 month of treatment.
(ii) for First Continuing treatment and Subsequent Continuing treatment – the maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment.
(iii) for Initial 1 (new patients) or Initial 2 (new patients) or Initial 3 (change or re‑commencement of therapy for all patients) or First Continuing treatment – Balance of supply – the treatment must provide no more than the balance of up to six months treatment.
(za) for HSD pharmaceutical benefits that have the drug pasireotide, for the treatment of acromegaly:
(i) with the form Injection (modified release) 20 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes;
(ii) with the form Injection (modified release) 40 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes;
(iii) with the form Injection (modified release) 60 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes.
(zb) for HSD pharmaceutical benefits that have the drug pegvisomant, for the treatment of acromegaly:
(i) for initial treatment, for the 80 mg loading dose—4 x injection set containing powder for injection 20 mg, 1 and diluent, 1;
(ii) for initial treatment (subsequent doses)—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30;
(iii) for initial PBS‑subsidised treatment in a patient who has previously received non‑PBS‑subsidised therapy with pegvisomant—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30;
(iv) for continuing treatment—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30.
(zc) for HSD pharmaceutical benefits that have the drug ustekinumab, for the treatment of severe Crohn disease:
(i) for initial treatment, for a weight‑based loading dose—up to 4 vials of Solution for I.V. infusion 130 mg in 26 mL;
(ii) for a change or re‑commencement of treatment, for a weight‑based loading dose—up to 4 vials of Solution for I.V. infusion 130 mg in 26 mL.
(zd) for HSD pharmaceutical benefits that have the drug vedolizumab, for the treatment of moderate to severe ulcerative colitis—the appropriate number of vials to provide for a single infusion of 300 mg per dose.
(ze) for HSD pharmaceutical benefits that have the drug vedolizumab, for the treatment of severe Crohn disease— the appropriate number of vials to provide for a single infusion of 300 mg.
(zf) for HSD pharmaceutical benefits that have the drug nusinersen, for PBS‑subsidised treatment of spinal muscular atrophy:
(i) for initial treatment with loading doses at days 0, 14, 28 and 63—up to 2 x solution for injection 12 mg in 5 mL for days 0 and 14; up to 1 x solution for injection 12 mg in 5 mL for day 28 or 63.
(ii) for continuing treatment—0 repeat supplies
25 HSD pharmaceutical benefits that have CAR drugs—repeat exceptions
(1) An authorised prescriber for an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) may authorise the repeat supply of the HSD pharmaceutical benefit only in accordance with the limitations mentioned in subsection (2) for the drug.
(2) The drugs and limitations are as follows:
(a) for bosentan:
(i) if the prescription is for the balance of a 6 month course of initial treatment for a patient who has been issued with an authority prescription for the first month of the 6 month course—up to 4 repeat supplies; or
(ii) if the prescription is for continuing treatment of a patient who has achieved a response to his or her most recent course of PBS‑subsidised treatment—up to 5 repeat supplies;
(b) for etanercept:
(i) for the initial treatment of severe polyarticular course juvenile chronic arthritis—up to 3 repeat supplies; or
(ii) for the continuing treatment of severe polyarticular course juvenile chronic arthritis—up to 5 repeat supplies;
(c) for infliximab, for the treatment of an adult with severe active rheumatoid arthritis:
(i) if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;
(d) for infliximab, for the treatment of an adult with severe active psoriatic arthritis:
(i) if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;
(e) for infliximab, for the treatment of an adult with active ankylosing spondylitis—up to 3 repeat supplies;
(f) for infliximab, for the treatment of a patient with refractory Crohn disease or fistulating Crohn disease—up to 2 repeat supplies;
(g) for infliximab, for the treatment of an adult with severe chronic plaque psoriasis:
(i) if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;
(ga) for infliximab, for the treatment of a patient with moderate to severe ulcerative colitis:
(i) for initial treatment (new patient or re‑commencement of treatment after more than 5 years break in therapy)—up to 2 repeat supplies;
(ii) for a change or re‑commencement of treatment after a break in therapy—up to 2 repeat supplies;
(iii) for continuing treatment—up to 2 repeat supplies.
(gb) for infliximab, for the treatment of an adult with severe Crohn disease:
(i) for initial treatment (new patient – initial 1)—up to 2 repeat supplies;
(ii) for a change or re‑commencement of treatment (initial 2)—up to 2 repeat supplies;
(iii) for continuing treatment—up to 2 repeat supplies.
(h) for abatacept, for the treatment of an adult with severe active rheumatoid arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 4 repeat supplies; or
(ii) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;
(i) for rituximab—1 repeat supply;
(j) for ambrisentan:
(i) for the initial PBS‑subsidised treatment of a patient who was receiving non‑PBS‑subsidised treatment with ambrisentan for less than 6 months before 1 December 2009—sufficient repeat supplies to allow the patient to complete a period of combined PBS‑subsidised and non‑PBS‑subsidised therapy of up to 6 months duration in total; or
(ii) if subparagraph (i) does not apply—up to 5 repeat supplies;
(k) for lenalidomide, for the treatment of a patient with multiple myeloma—up to 2 repeat supplies;
(l) for lenalidomide, for the treatment of a patient with myelodysplastic syndrome—up to 3 repeat supplies;
(m) for epoprostenol, iloprost, sildenafil, or tadalafil—up to 5 repeat supplies;
(n) for tocilizumab, for the treatment of adults with severe active rheumatoid arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;
(ii) If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;
(o) for adalimumab for the treatment of a patient with juvenile idiopathic arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;
(ii) if the circumstances permit a course of up to a maximum of 24 weeks treatment to be authorised—up to 5 repeat supplies;
(p) for azacitidine:
(i) for initial treatment—up to 2 repeat supplies;
(ii) for continuing treatment—up to 5 repeat supplies.
(q) for romiplostim for initial treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) at the time of the initial written authority application—1 repeat supply;
(ii) during the initial period of dose titration—1 repeat supply;
(iii) for a patient whose dose has been stable for a period of 4 weeks—up to 4 repeat supplies.
(r) for romiplostim for initial PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with romplostin was commenced:
(i) at the time of the initial written authority application—1 repeat supply;
(ii) during the initial period of dose titration—1 repeat supply;
(iii) for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks—up to 4 repeat supplies;
(iv) for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS‑subsidy—up to 5 repeat supplies.
(s) for romiplostim for the first period of continuing treatment or re‑initiation of interrupted PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS‑subsidised treatment:
(i) at the time of the initial written authority application—up to 5 repeat supplies;
(ii) where less than 5 repeat supplies are requested in the initial written authority application—sufficient repeat supplies to complete a maximum of 24 weeks treatment.
(t) for romiplostim for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with Romiplostim—up to 5 repeat supplies.
(u) for omalizumab—where fewer than the required number of repeats to complete 24 weeks of treatment are requested at the time of the authority application—sufficient repeat supplies to complete 24 weeks of treatment.
(v) for omalizumab—where at least 24 weeks treatment was requested at the time of the application—0 repeat supplies.
(va) for omalizumab, for the treatment of severe chronic spontaneous urticaria:
(i) for initial treatment—where the patient has received a quantity of units that are sufficient to provide for 12 weeks treatment—0 repeat supplies;
(ii) for initial PBS‑subsidised treatment in a patient who has previously received non‑PBS‑subsidised therapy with omalizumab (grandfathered patients)—where the patient has received a quantity of units that are sufficient to provide for 24 weeks treatment—0 repeat supplies;
(iii) for continuing treatment—where the patient has received a quantity of units that are sufficient to provide for 24 weeks treatment—0 repeat supplies;
(w) for eltrombopag for initial treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):
(i) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.
(x) for eltrombopag for initial PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with eltrombopag was commenced:
(i) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.
(y) for eltrombopag for the first period of continuing treatment or re‑initiation of interrupted PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with eltrombopag during the initial period of PBS‑subsidised treatment:
(i) if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;
(ii) where less than 5 repeat supplies are requested in the initial written authority application—sufficient repeat supplies to complete a maximum of 24 weeks treatment.
(z) for eltrombopag for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with eltrombopag—up to 5 repeat supplies.
(za) for tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis:
(i) if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;
(ii) If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.
(zb) for riociguat, for the treatment of Chronic thromboembolic pulmonary hypertension (CTEPH):
(ii) for initial treatment—up to 3 repeat supplies.
(iii) for continuing treatment—up to 5 repeat supplies.
(zc) for riociguat, for the treatment of Pulmonary arterial hypertension (PAH):
(i) for Initial 1 (new patients), Initial 2 (new patients) and Initial 3 (change or re‑commencement of therapy for all patients) – up to 4 repeat supplies.
(ii) for First Continuing treatment and Subsequent Continuing treatment – up to 5 repeat supplies.
(zd) for pasireotide—up to 5 repeat supplies.
(ze) for pegvisomant:
(i) for initial treatment, for the 80 mg loading dose—0 repeat supplies;
(ii) for intitial treatment (subsequent doses)—up to 5 repeat supplies;
(iii) for initial PBS‑subsidised treatment in a patient who has previously received non‑PBS‑subsidised therapy with pegvisomant—up to 5 repeat supplies;
(iv) for continuing treatment—up to 5 repeat supplies.
(zf) for ustekinumab:
(i) for initial treatment, for a weight‑based loading dose—0 repeat supplies;
(ii) for a change or re‑commencement of treatment, for a weight‑based loading dose——0 repeat supplies.
(zg) for vedolizumab, for the treatment of severe Crohn disease:
(i) for initial treatment (new patient – initial 1)—up to 2 repeat supplies;
(ii) for a change or re‑commencement of treatment (initial 2)—up to 2 repeat supplies;
(iii) for initial PBS‑subsidised treatment (grandfather)—up to 2 repeat supplies;
(iv) for continuing treatment—up to 2 repeat supplies.
(zh) for vedolizumab, for the treatment of moderate to severe ulcerative colitis:
(i) for initial treatment (new patient – initial 1)—up to 2 repeat supplies;
(ii) for a change or re‑commencement of treatment after a break in therapy (initial 2)—up to 2 repeat supplies;
(iii) for initial PBS‑subsidised treatment (grandfather patient)—up to 2 repeat supplies;
(iv) for continuing treatment—up to 2 repeat supplies.
(zi) for nusinersen, for the treatment of spinal muscular atrophy:
(i) for initial treatment loading doses —up to 1 x solution for injection 12 mg in 5 mL
(ii) for continuing treatment—up to 1 x solution for injection 12 mg in 5 mL
(3) In this section, circumstances means circumstances mentioned in Schedule 3 for the circumstances code mentioned in the column in Schedule 1 headed ‘Circumstances’ for the HSD pharmaceutical benefit that has the drug.
26 Application of section 30 of the Regulations in relation to CAR drugs
Section 30 of the Regulations does not apply in relation to a prescription for an HSD pharmaceutical benefit that has a CAR drug supplied under this Special Arrangement.
Part 4—Claiming procedures and payment amounts
Division 2—Modified section 99AAA claims by approved public hospitals
Subdivision 1—General requirements
30 How claims to be made—modified section 99AAA claiming
An approved hospital authority for a public hospital may make a claim for payment for the supply of an HSD pharmaceutical benefit in accordance with the rules made by the Minister under subsection 99AAA(8) of the Act, as modified by this Division.
Note: An approved hospital authority for a public hospital that may make a modified section 99AAA claim may choose instead to make the claim in accordance with the rules made by the Minister under subsection 99AAA(8) of the Act.
31 Limit on number of prescriptions in one claim
The claim for payment must not contain more than 3 500 prescriptions.
Subdivision 3—Payment of claims
35 Payments to suppliers that are approved hospital authorities for public hospitals
(1) An approved hospital authority for a public hospital is entitled to be paid the amount, if any, by which the dispensed price for the supply of the HSD pharmaceutical benefit exceeds the amount that the approved hospital authority was entitled to charge under subsection 46(2).
(2) The dispensed price is to be worked out in accordance with Division 1 of Part 5.
(3) No mark ups may be added to the cost of an HSD pharmaceutical benefit for which payment is claimed under this Division.
Division 3—Payments to suppliers of HSD pharmaceutical benefits that are approved hospital authorities for private hospitals or approved pharmacists or approved medical practitioners
36 Payments to certain suppliers of HSD pharmaceutical benefits
(1) An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the HSD pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under subsection 46(2).
(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of an HSD pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under subsection 47(2).
(3) The dispensed price for the supply of an HSD pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner is to be worked out under Division 2 of Part 5.
Note: An approved hospital authority for a private hospital or an approved pharmacist may make claims for payment in accordance with rules made by the Minister under subsection 99AAA(8) of the Act—see section 99AAA(2) of the Act.
Part 5—Dispensed price
Division 1—Dispensed price for supply of an HSD pharmaceutical benefit by a hospital authority for a public hospital
37 The dispensed price—supply by public hospital
Subject to section 43, the dispensed price for the supply of an HSD pharmaceutical benefit, by a hospital authority for a public hospital, is as follows:
(a) if the quantity of the HSD pharmaceutical benefit that is ordered and 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 for each pack quantity;
(b) if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 38;
(c) if the quantity of the HSD pharmaceutical benefit that is ordered and 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 for each pack quantity; and
(ii) the amount calculated in accordance with section 38 for the remainder of the quantity supplied that is less than a pack quantity.
38 Where quantity is less than a pack quantity
If the quantity of an HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 37(b) and subparagraph 37(c)(ii) is to be calculated 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 for the pack quantity.
Division 2—Dispensed price for supply of HSD pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or approved medical practitioner
39 The dispensed price—supply by an approved hospital authority for a private hospital or by an approved pharmacist or approved medical practitioner
(1) The dispensed price for the supply of an HSD pharmaceutical benefit by an approved hospital authority for a private hospital, or by an approved pharmacist, or by an approved medical practitioner, is as follows:
(a) if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of:
(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity, plus the mark‑up mentioned in section 40, taken to the nearest cent, with one half cent being rounded up to 1 cent; and
(ii) either:
(A) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or
(B) if the HSD pharmaceutical benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or
(b) if a quantity of the HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of:
(i) the amount calculated in accordance with section 41; and
(ii) either:
(A) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or
(B) if the HSD pharmaceutical benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or
(c) if a quantity of the HSD pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:
(i) for each pack quantity, the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, plus the mark‑up mentioned in section 40, taken to the nearest cent, with one half cent being counted as 1 cent; and
(ii) the amount calculated in accordance with section 41 for the remainder of the quantity supplied that is less than a pack quantity; and
(iii) either:
(A) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or
(B) if the HSD pharmaceutical benefit has the drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee set out in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit.
(2) For sub‑subparagraphs (1)(a)(ii)(B), (1)(b)(ii)(B) and (1)(c)(iii)(B), 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;
(c) valganciclovir as a powder for oral solution 50mg (as hydrocholoride) per mL, 100 mL.
40 Mark‑up
For subparagraphs 39(1)(a)(i) and 39(1)(c)(i) and paragraph 41(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:
(a) if the pack quantity for which a mark‑up is to be calculated under this section is equal to a maximum quantity of the HSD pharmaceutical benefit, the mark‑up is the amount mentioned in the table below for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer price (PEMP) for that quantity.
| Item | AEMP or PEMP for Maximum Quantity | Mark‑up for Maximum Quantity |
| 1 | < $40 | 10% of AEMP or PEMP |
| 2 | ≥ $40, ≤ $100 | $4.00 |
| 3 | > $100, ≤ $1,000 | 4% of AEMP or PEMP |
| 4 | > $1,000 | $40.00 |
(b) if the pack quantity for which a mark‑up is to be calculated under this section is not equal to a maximum quantity of the HSD pharmaceutical benefit, the mark‑up is worked out as follows:
(i) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark‑up for the pack quantity is that monetary amount reduced proportionately for the relative quantities; and
(ii) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark‑up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.
41 Where quantity is less than a pack quantity
If the quantity of an HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraph 39(b)(i) and 39(c)(ii) is to be calculated by:
(a) adding the mark‑up mentioned in section 40 to the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being counted as 1 cent; and
(b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(c) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).
42 Dispensing fee if quantity of repeated supply directed to be supplied on one occasion
If an authorised prescriber for an HSD pharmaceutical benefit, instead of directing a repeated supply of the HSD pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the HSD pharmaceutical benefit, not exceeding the total quantity or number of units that could be prescribed if the authorised prescriber directed a repeated supply, the dispensed price for the supply of the HSD pharmaceutical benefit will include only one dispensing fee.
Note: See section 49 of the Regulations for the circumstances in which such a supply may be directed.
Division 3—Dispensed price—other matters
44 Rounding up of dispensed price
The dispensed price for the supply of an HSD pharmaceutical benefit will in each case be taken to the nearest cent, one half cent being counted as one cent.
Part 6—Patient contributions
46 Patient contributions in relation to approved hospital authorities
(1) This section applies to an approved hospital authority for a public hospital or a private hospital that supplies an HSD pharmaceutical benefit.
(2) The approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.
(3) For section 87 of the Act, the amount that is equal to the special patient contribution for the supply of an HSD pharmaceutical benefit that is a brand of a pharmaceutical item is the amount mentioned in section 48 if the HSD pharmaceutical benefit is mentioned in Schedule 4.
47 Patient contributions for claims by approved pharmacists or approved medical practitioners
(1) This section applies if an approved pharmacists or an approved medical practitioner supplies an HSD pharmaceutical benefit to an eligible patient and makes a claim for payment.
(2) The approved pharmacist or the approved medical practitioner may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.
(3) For section 87 of the Act, the amount that is equal to the special patient contribution for the supply of an HSD pharmaceutical benefit that is a brand of a pharmaceutical item is the amount mentioned in section 48 if the HSD pharmaceutical benefit is mentioned in Schedule 4.
48 Additional patient contributions
For subsections 46(3) and 47(3), the amount is the amount that is the difference between:
(a) the price that would have been the dispensed price for the quantity of the HSD pharmaceutical benefit supplied if that dispensed price had been based on the claimed price mentioned for the benefit in the column in Schedule 4 headed ‘Claimed Price’; and
(b) the dispensed price for that quantity of the HSD pharmaceutical benefit.
Part 7—Miscellaneous
49 Compliance and audit arrangements
(1) If an approved supplier supplies HSD pharmaceutical benefits under this Special Arrangement, the approved supplier that supplies the HSD pharmaceutical benefits 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.
50 PBS Safety Net
(2) An amount paid by a person because of a charge made by an approved hospital authority under subsection 46(2) counts towards the person’s PBS safety net if it is equivalent to the amount chargeable under subsection 87(5) of the Act for the supply of the HSD pharmaceutical benefit less the amount chargeable under that subsection because of subsection 87(2A) of the Act.
(3) An amount paid by a person because of a charge made by an approved pharmacist or approved medical practitioner under subsection 47(2) counts towards the person’s PBS safety net, other than an amount equivalent to the amount chargeable under subsection 87(2A) of the Act for the supply of the HSD pharmaceutical benefit to the person.
Note: Division 1A of Part VII of the Act contains provisions about safety net concession cards.
51 Application of Act and Part VII instruments to approved suppliers and prescriptions etc
For the application of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act:
(a) a reference in the Act or other instrument to an approved supplier or an approved hospital authority includes a reference to a hospital authority approved under:
(i) subsection 52(2) of this Special Arrangement; or
(ii) subsection 52(2) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010); and
(b) a reference in the Act or other instrument to a number allotted to an approval under section 16 includes a reference to a number allotted to an approval under:
(i) subsection 52(3) of this Special Arrangement; and
(ii) subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010); and
(c) a medication chart prescription may be written for an eligible patient receiving treatment from a hospital; and
(f) the rules made under subsection 98AC(4) of the Act apply to a supply of a HSD pharmaceutical benefit by an approved pharmacist, approved medical practitioner or approved hospital authority for a hospital under this Special Arrangement as if the definition of under co‑payment data appearing in those rules was replaced with the definition of under co‑payment data in section 4 of this Special Arrangement.
Note: Section 84 of the Act defines approved hospital authority and approved supplier for Part VII of the Act.
Note: The rules made by the Minister under subsection 99AAA(8) of the Act are instruments made under Part VII of the Act.
Part 8—Approval of certain hospital authorities
52 Approval of certain public hospital authorities
(1) A hospital authority for a public hospital, that must not be approved under section 94 of the Act because of subsection 94(5) of the Act, may apply, in writing, to the Secretary for approval under this Part for the purpose of its supplying HSD pharmaceutical benefits under this Special Arrangement to eligible patients receiving treatment at or from the hospital of which it is the governing body.
(2) The Secretary may, in writing, approve the hospital authority for this Special Arrangement.
(3) If the Secretary approves the hospital authority, he or she may allot a number to the approval.
(4) A number allotted to a hospital authority under either of the following provisions is to be treated as having been allotted by the Secretary under subsection 16(4) of the Regulations:
(a) subsection (3) of this section;
(b) subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010.
(5) The approval may be subject to any conditions the Secretary determines.
(6) The Secretary must, in writing, notify the hospital authority of his or her decision on the hospital authority’s application.
(7) The Secretary may, at any time, by notice in writing to the hospital authority, vary, suspend or revoke the approval.
Note: An approval under this Part may only be made for a hospital authority for a public hospital and does not constitute an approval under section 94 of the Act.
Part 9—Transitional arrangements
53 Approvals of certain hospital authorities of public hospitals
Despite the revocation of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010), an approval that was in force under subsection 52(2) of that Instrument immediately before the commencement of this section continues in force under this Special Arrangement as if it were an approval under subsection 52(2) of this Special Arrangement.
54 Transitional arrangements for existing public hospital medication chart prescribing and paperless claiming
(1) An eligible medical practitioner at a public hospital may prescribe a HSD pharmaceutical benefit that has a non‑CAR drug under this Special Arrangement, before 1 April 2017, by following the requirements for prescribing from a medication chart in the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015.
(2) An approved hospital authority for a public hospital can supply a HSD pharmaceutical benefit prescribed under subsection (1).
(3) The requirements for prescribing, supplying and claiming from a medication chart set out in the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015, continue to apply in relation to a medication chart prepared under subsection (1).
(4) However, this section does not apply if the public hospital referred to in subsections (1) and (2) is a listed approved hospital under regulation 59 of the National Health (Pharmaceutical Benefits) Regulations 1960 as in force immediately before the commencement of the Regulations.
(5) However, if this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules.
55 Transitional arrangements for existing non‑medication chart public hospital paperless claiming
(1) An approved hospital authority for a public hospital may supply a HSD pharmaceutical benefit that has a non‑CAR drug before 1 April 2017, from a prescription other than a medication chart, in accordance with Part 4, Division 2, Subdivision 2 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015.
(2) However, if this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules.
56 Transitional arrangements for repeat prescriptions
(1) Where an authorised prescriber has issued a repeat prescription prior to 1 July 2015, the new arrangements apply to the supply of the repeat pharmaceutical benefits.
(2) In this section new arrangements mean the National Health (Highly specialised drugs program) Special Arrangement 2010 as in force on 1 July 2015.