Source: https://www.legislation.gov.au/Details/F2019C00866
Timestamp: 2020-07-12 03:24:18
Document Index: 585422292

Matched Legal Cases: ['art 2', 'art 4', 'art 5', 'art 6', 'art 8', 'art 9', 'art 1', 'art 2', 'art 4', 'art 5', 'art 6', 'art 7', 'art 8', 'art 9', 'art 1', 'art 1', 'art 6', 'art 5', 'art 5', 'art 4']

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Details: F2019C00866
- F2019C00866
PB 116 of 2010 Arrangements as amended, taking into account amendments up to National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10) (PB 87 of 2019)
This Arrangement provides for the supply of certain highly specialised drugs to patients receiving treatment at or from public or private hospitals having access to appropriate specialised facilities.
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10) (PB 87 of 2019) - F2019L01395
sch 1 (items 1-71)
Registered 26 Nov 2019
End Date 30 Nov 2019
F2019C00866
Division 2—HSD pharmaceutical benefits
Division 3—HSD Authority Required procedures
Division 4—Maximum quantity and maximum number of repeats
Division 5—Section 100 only
Part 2—Supply of HSD pharmaceutical benefits
Part 4—Claiming procedures and payment amounts
Part 5—Dispensed price
Part 6—Patient contributions
Part 8—Approval of certain hospital authorities
Part 9—Transitional arrangements
Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information
Schedule 2—Responsible Person Codes
Schedule 3—Circumstances and Purposes Codes
Schedule 3 Part 1—General statement for drugs for the treatment of hepatitis C
Schedule 4—Patient contributions
made under subsections 100(1) and (2) of the
Compilation No. 100
Includes amendments up to: PB 87 of 2019
Registered: 26 November 2019
This is a compilation of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) that shows the text of the law as amended and in force on 1 November 2019 (the compilation date).
Division 1—General 1
1............ Name of Special Arrangement....................................................................................... 1
Division 2—HSD pharmaceutical benefits 8
5............ Pharmaceutical benefits covered by this Special Arrangement...................................... 8
6............ Application of Part VII of the Act................................................................................. 8
7............ Responsible person....................................................................................................... 8
8............ Authorised Prescriber.................................................................................................... 9
9............ Prescription circumstances............................................................................................ 9
9A......... HSD pharmaceutical benefits which may be supplied to public hospital admitted patients 9
Division 3—HSD Authority Required procedures 11
10.......... HSD Authority Required procedures.......................................................................... 11
Division 4—Maximum quantity and maximum number of repeats 12
14.......... Maximum quantity...................................................................................................... 12
15.......... Maximum number of repeats....................................................................................... 13
Division 5—Section 100 only 14
16.......... Section 100 only supply.............................................................................................. 14
Part 2—Supply of HSD pharmaceutical benefits 15
Division 1—General requirements for supply 15
17.......... Entitlement to HSD pharmaceutical benefits................................................................ 15
17A....... Modified application of paragraph 92A(1)(f) conditions of approval.......................... 15
18.......... Supply of HSD pharmaceutical benefits under this Special Arrangement................... 15
Division 2—Repeat prescriptions 17
19.......... Application of section 51 of the Regulations............................................................... 17
20.......... No repeats for visitors................................................................................................. 17
Division 3—Prescribing HSD pharmaceutical benefits that have non‑CAR drugs 18
21.......... Methods of prescribing HSD pharmaceutical benefits that have non‑CAR drugs....... 18
22A....... Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have non‑CAR drugs........................................................................................................................... 18
Division 4—Prescribing HSD pharmaceutical benefits that have CAR drugs 19
23.......... Prescriptions for HSD pharmaceutical benefits that have CAR drugs......................... 19
23A....... Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have CAR drugs.................................................................................................................................... 19
24.......... HSD pharmaceutical benefits that have CAR drugs—quantity exceptions.................. 19
25.......... HSD pharmaceutical benefits that have CAR drugs—repeat exceptions..................... 25
26.......... Application of section 30 of the Regulations in relation to CAR drugs....................... 30
Part 4—Claiming procedures and payment amounts 31
Division 2—Modified section 99AAA claims by approved public hospitals 31
Subdivision 1—General requirements 31
30.......... How claims to be made—modified section 99AAA claiming..................................... 31
31.......... Limit on number of prescriptions in one claim............................................................ 31
Subdivision 3—Payment of claims 31
35.......... Payments to suppliers that are approved hospital authorities for public hospitals........ 31
Division 3—Payments to suppliers of HSD pharmaceutical benefits that are approved hospital authorities for private hospitals or approved pharmacists or approved medical practitioners 32
36.......... Payments to certain suppliers of HSD pharmaceutical benefits................................... 32
Part 5—Dispensed price 33
Division 1—Dispensed price for supply of an HSD pharmaceutical benefit by a hospital authority for a public hospital 33
37.......... The dispensed price—supply by public hospital......................................................... 33
38.......... Where quantity is less than a pack quantity................................................................. 33
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 34
39.......... The dispensed price—supply by an approved hospital authority for a private hospital or by an approved pharmacist or approved medical practitioner...................................................................................... 34
40.......... Mark‑up...................................................................................................................... 35
41.......... Where quantity is less than a pack quantity................................................................. 36
42.......... Dispensing fee............................................................................................................. 36
Division 3—Dispensed price—other matters 37
44.......... Rounding up of dispensed price.................................................................................. 37
Part 6—Patient contributions 38
46.......... Patient contributions in relation to approved hospital authorities................................. 38
47.......... Patient contributions for claims by approved pharmacists or approved medical practitioners 38
48.......... Additional patient contributions................................................................................... 38
Part 7—Miscellaneous 39
49.......... Compliance and audit arrangements............................................................................ 39
50.......... PBS Safety Net........................................................................................................... 39
51.......... Application of Act and Part VII instruments to approved suppliers and prescriptions etc 39
Part 8—Approval of certain hospital authorities 41
52.......... Approval of certain public hospital authorities............................................................ 41
Part 9—Transitional arrangements 42
53.......... Approvals of certain hospital authorities of public hospitals....................................... 42
54.......... Transitional arrangements for existing public hospital medication chart prescribing and paperless claiming 42
55.......... Transitional arrangements for existing non‑medication chart public hospital paperless claiming 42
56.......... Transitional arrangements for repeat prescriptions...................................................... 43
Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information 44
Schedule 2—Responsible Person Codes 109
Schedule 3—Circumstances and Purposes Codes 111
Schedule 3 Part 1—General statement for drugs for the treatment of hepatitis C 489
Schedule 4—Patient contributions 497
Endnotes 498
Endnote 1—About the endnotes 498
Endnote 2—Abbreviation key 499
Endnote 3—Legislation history 500
Endnote 4—Amendment history 506
(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.
In this Special Arrangement:
accredited prescriber of medication for the treatment of hepatitis B means a medical 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 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 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.
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
(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 prescriber, for an HSD pharmaceutical benefit, means a person who is a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised Prescriber’ for the benefit.
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) ambristentan
(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) tocilizumab
(ee) ustekinumab
(ff) 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
(b) who is, for the prescription of medication for the treatment of HIV or AIDS—an accredited prescriber of medication for the treatment of HIV or AIDS; or
(ba) who is, for the prescription of medication for the treatment of hepatitis B—an accredited prescriber of medication for the treatment of hepatitis B; 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
(c) who is, for the prescription of medication for the treatment of hepatitis C:
(i) an accredited prescriber of medication for the treatment of hepatitis C; or
(ii) a medical practitioner, for Daclatasvir, Ledipasvir with sofosbuvir, Ribavirin, Sofosbuvir, and Grazoprevir with elbasvir; 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 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 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
(fa) bictegravir with emtricitabine with tenofovir alafenamide
(g) darunavir
(h) darunavir with cobicistat
(i) dolutegravir
(j) dolutegravir with abacavir and lamivudine
(k) dolutegravir with rilpivirine
(l) doxorubicin ‑ pegylated liposomal
(m) efavirenz
(n) emtricitabine with rilpivirine with tenofovir alafenamide
(o) emtricitabine with tenofovir alafenamide
(p) enfuvirtide
(q) etravirine
(r) fosamprenavir
(s) ganciclovir
(t) lamivudine
(u) lamivudine with zidovudine
(v) lopinavir with ritonavir
(w) maraviroc
(x) nevirapine
(y) raltegravir
(z) rifabutin
(aa) rilpivirine
(bb) ritonavir
(cc) saquinavir
(dd) tenofovir
(ee) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat
(ff) tenofovir with emtricitabine
(gg) tenofovir with emtricitabine and efavirenz
(hh) tenofovir with emtricitabine and rilpivirine
(ii) tenofovir with emtricitabine, elvitegravir and cobicistat
(jj) tenofovir with emtricitabine and rilpivirine
(kk) tipranavir
(ll) valganciclovir
(mm) tipranavir
(nn) 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.
prescriber code has the meaning given by paragraph 8(2)(b).
purposes code means the letter ‘P’ followed by a number.
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
· pack quantity
· pharmaceutical item
· private hospital
· proportional ex‑manufacturer price
· public hospital.
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.
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.
(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 Authorised Prescriber
(1) Only an authorised prescriber may write a prescription for the supply of an HSD pharmaceutical benefit to an eligible patient.
(2) For this Special Arrangement:
(a) only an eligible medical practitioner is an authorised prescriber; and
(b) the prescriber code for the authorised prescriber is the letters ‘EMP’.
(3) A reference in this Special Arrangement to an eligible medical practitioner is a reference to an authorised prescriber.
(4) For subsection (1), the HSD pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(5) Subsection 88(1) of the Act does not apply to the supply of an HSD pharmaceutical benefit under this Special Arrangement.
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:
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.
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).
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’.
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 eligible medical practitioner 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:
(5) For this section, the HSD pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(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 eligible medical practitioner 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:
(5) Subsection (1) applies, in relation to an HSD pharmaceutical benefit that has a CAR drug, subject to section 25.
(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 eligible medical practitioner 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.
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.
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 eligible medical practitioner must not write a repeat prescription for an 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 eligible medical practitioner may prescribe an HSD pharmaceutical benefit that has a non‑CAR drug 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 eligible medical practitioner may only prescribe more than the maximum quantity or more than the maximum number of repeats of an HSD pharmaceutical benefit that has a non‑CAR drug in accordance with section 30.
22A Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have non‑CAR drugs
(1) If an eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit has a non‑CAR drug, then either the:
(a) eligible medical practitioner; 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 eligible medical practitioner may prescribe an HSD pharmaceutical benefit that has a CAR drug 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 eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit has a CAR drug, then either the:
24 HSD pharmaceutical benefits that have CAR drugs—quantity exceptions
(1) An eligible medical practitioner may write a prescription for an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) to be supplied to an eligible patient on any 1 occasion only in accordance with the limitation mentioned in subsection (2) for each HSD pharmaceutical benefit mentioned in subsection (2).
(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:
(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):
(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:
(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:
(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 eligible medical practitioner may authorise the repeat supply of an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) only in accordance with the limitations mentioned in subsection (2) for the drug.
(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:
(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:
(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;
(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;
(o) for adalimumab for the treatment of a patient with juvenile idiopathic arthritis:
(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:
(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:
(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;
(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:
(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:
(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:
(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;
(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.
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.
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
(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 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
(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
(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 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.
AEMP or PEMP for Maximum Quantity
10% of AEMP or PEMP
≥ $40, ≤ $100
> $100, ≤ $1,000
4% of AEMP or PEMP
(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 an eligible medical practitioner, instead of directing a repeated supply of an HSD pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the HSD pharmaceutical benefit will include only one dispensing fee.
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.
46 Patient contributions in relation to approved hospital authorities
(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.
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.
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
(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.
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.
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.
(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.
(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.
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.
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.
(sections 5, 7, 8, 9, 10, 14, 15, 16 and 25)
Section 100 only
Tablet 300 mg (as sulfate)
C4454 C4512
Oral solution 20 mg (as sulfate) per mL, 240 mL
Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg
Abacavir/Lamivudine GH 600/300
C4527 C4528
Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg
Abacavir/Lamivudine 600/300 APOTEX
ABACAVIR/LAMIVUDINE 600/300 SUN
Abacavir with Lamivudine and Zidovudine
Tablet containing abacavir 300 mg (as sulfate) with lamivudine 150 mg and zidovudine 300 mg
C4480 C4495
Powder for I.V. infusion 250 mg
C8627 C8638 C8655 C8688 C8748 C8759
Injection 20 mg in 0.4 mL pre‑filled syringe
C9384 C9417 C9423 C9424 C9425 C9426
Injection 40 mg in 0.8 mL pre‑filled syringe
Injection 40 mg in 0.8 mL pre‑filled pen
Tablet containing adefovir dipivoxil 10 mg
APO‑Adefovir
C4490 C4510
C6847 C7714 C9589 C9636
P6847 P9589
P7714 P9636
C6089 C6711 C6722 C6734 C6748 C6765
Injection 100 mg in 0.67 mL single use pre‑filled syringe
Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL
C4833 C9561
Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL
Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL
Apomine Solution for Infusion
C6813 C9561
Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen
Apomine Intermittent
Movapo Pen
Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre‑filled syringe
Movapo PFS
Capsule 150 mg (as sulfate)
Capsule 200 mg (as sulfate)
Capsule 300 mg (as sulfate)
C6132 C6143 C6144 C6177 C6186 C6199
AZACITIDINE DR.REDDY’S
Azacitidine Juno
Celazadine
Tablet 600 mg (as dihydrate)
C6356 C9604
Intrathecal injection 10 mg in 5 mL
Bacthecal
C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637
Sintetica Baclofen Intrathecal
Intrathecal injection 40 mg in 20 mL
C7134 C7148 C7152 C7153 C9525 C9562 C9606 C9638
Injection 30 mg in 1 mL single dose pre‑filled syringe
C8157 C8175 C8176 C8190 C8499
P8157 P8175 P8499
P8176 P8190
C4470 C4522
Tablet 62.5 mg (as monohydrate)
Bosentan APO
C4628 C6089 C6710 C6734 C6748 C6764 C6776
BOSENTAN DR. REDDY'S
BOSENTAN‑DRLA
BOSLEER
Tablet 125 mg (as monohydrate)
C6089 C6710 C6734 C6748 C6764 C6776
Bosentan GH
Neoral 10
C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764
Cyclosporin Sandoz
Neoral 50
Oral liquid 100 mg per mL, 50 mL
Solution concentrate for I.V. infusion 50 mg in 1 mL
C6628 C9831
Clopine 25
C4998 C5015 C9490
Clopine 50
Clopine 100
Clozaril 100
Clopine 200
Clopine Suspension
C5969 C5972
P5969
Injection 10 micrograms in 0.4 mL pre‑filled syringe
C6294 C9688
Injection 20 micrograms in 0.5 mL pre‑filled syringe
Injection 20 micrograms in 0.5 mL pre‑filled injection pen
Aranesp SureClick
Injection 30 micrograms in 0.3 mL pre‑filled syringe
Injection 40 micrograms in 0.4 mL pre‑filled syringe
Injection 40 micrograms in 0.4 mL pre‑filled injection pen
Injection 50 micrograms in 0.5 mL pre‑filled syringe
Injection 60 micrograms in 0.3 mL pre‑filled syringe
Injection 60 micrograms in 0.3 mL pre‑filled injection pen
Injection 80 micrograms in 0.4 mL pre‑filled syringe
Injection 80 micrograms in 0.4 mL pre‑filled injection pen
Injection 100 micrograms in 0.5 mL pre‑filled syringe
Injection 100 micrograms in 0.5 mL pre‑filled injection pen
Injection 150 micrograms in 0.3 mL pre‑filled syringe
Injection 150 micrograms in 0.3 mL pre‑filled injection pen
Tablet 150 mg (as ethanolate)
Tablet 600 mg (as ethanolate)
Tablet 800mg (as ethanolate)
Darunavir with cobicistat
Tablet containing darunavir 800mg with cobicistat 150 mg
C6377 C6413 C6428
Tablet 90 mg
C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302
P7385 P8326 P8328 P8329 P9222 P9258 P9302
P7374 P7375
Tablet 360 mg
C6403 C6448 C9228 C9286
C6403 C6448 C9590 C9623
Oral solution 100 mg per mL, 250 mL
Powder for injection containing desferrioxamine mesilate 500 mg
C6394 C9696
Powder for injection containing desferrioxamine mesilate 2 g
Tablet 50mg (as sodium)
C8214 C8226
Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL
C5634 C5635 C5740 C9591 C9592 C9624
Doxorubicin ‑
Pegylated Liposomal
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
C6234 C6274 C9223 C9287
Liposomal Doxorubicin SUN
Solution concentrate for I.V. infusion 300 mg in 30 mL
C6626 C6637 C6642 C6668 C6686 C6687 C6688
P6668 P6686
P6687 P6688
Oral solution 30 mg per mL, 180 mL
C6724 C6725 C6738 C6739 C6790
Emtricitabine with rilpivirine with tenofovir alafenamide
Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg
Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg
Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg
Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)
Tablet 0.5 mg (as monohydrate)
C4993 C5036
Entecavir Amneal
ENTECAVIR APO
Entecavir APOTEX
Entecavir GH
ENTECAVIR RBX
Entecavir Sandoz
ENTECLUDE
Tablet 1 mg (as monohydrate)
C5037 C5044
Injection 1,000 units in 0.5 mL pre‑filled syringe
Eprex 1000
Injection 2,000 units in 0.5 mL pre‑filled syringe
Injection 3,000 units in 0.3 mL pre‑filled syringe
Eprex 3000
Injection 4,000 units in 0.4 mL pre‑filled syringe
Injection 5,000 units in 0.5 mL pre‑filled syringe
Eprex 5000
Injection 6,000 units in 0.6 mL pre‑filled syringe
Eprex 6000
Injection 8,000 units in 0.8 mL pre‑filled syringe
Eprex 8000
Injection 10,000 units in 1 mL pre‑filled syringe
Injection 20,000 units in 0.5 mL pre‑filled syringe
Eprex 20,000
Injection 40,000 units in 1 mL pre‑filled syringe
Eprex 40,000
Injection 2,000 units in 0.3 mL pre‑filled syringe
Injection 4,000 units in 0.3 mL pre‑filled syringe
Injection 5,000 units in 0.3 mL pre‑filled syringe
Injection 6,000 units in 0.3 mL pre‑filled syringe
Injection 10,000 units in 0.6 mL pre‑filled syringe
Novicrit
Injection 2,000 units in 1 mL pre‑filled syringe
Powder for I.V. infusion 500 micrograms (as sodium)
C6123 C6734 C6748 C6945 C6955
Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL
Powder for I.V. infusion 1.5 mg (as sodium)
Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL
Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL
C9384 C9416 C9417 C9418 C9532 C9565
Injections 50 mg in 1 mL single use pre‑filled syringes, 4
Injection 50 mg in 1 mL single use auto‑injector, 4
Tablet 0.25 mg
C5554 C5795 C9691 C9693
Tablet 0.75 mg
Injection 120 micrograms in 0.2 mL single-use pre-filled syringe
C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696
Injection 300 micrograms in 0.5 mL single-use pre-filled syringe
Injection 300 micrograms in 1 mL
Injection 480 micrograms in 0.5 mL single-use pre-filled syringe
Injection 480 micrograms in 1.6 mL
Tablet 700 mg (as calcium)
Powder for I.V. infusion 500 mg (as sodium)
C4972 C4999 C5000 C9404 C9526
GANCICLOVIR SXP
Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir
C7593 C7594 C7615
Tablet containing grazoprevir 100 mg with elbasvir 50 mg
C5969 C6625
Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL
C5291 C9333
Solution for inhalation 20 micrograms (as trometamol) in 2 mL
C6089 C6692 C6734 C6747 C6748 C6775
Powder for I.V. infusion 100 mg
C4524 C7777 C8296 C8644 C8645 C8646 C8715 C8743 C8744 C8745 C8755 C8800 C8801 C8844 C8847 C8881 C8883 C8885 C8886 C8911 C8940 C8941 C8962 C8983 C9065 C9067 C9068 C9110 C9111 C9169 C9188 C9191 C9400 C9401 C9402 C9472 C9481 C9487 C9558 C9559 C9584 C9587 C9602 C9615 C9621 C9632 C9668 C9669 C9675 C9676 C9677 C9719 C9721 C9731 C9732 C9733 C9751 C9752 C9754 C9756 C9759 C9775 C9776 C9778 C9779 C9781 C9782 C9783 C9785 C9787 C9788 C9799 C9800 C9803 C9806
C4524 C7777 C8296 C8644 C8645 C8646 C8715 C8743 C8744 C8745 C8800 C8801 C8847 C8881 C8883 C8885 C8886 C8911 C8941 C8962 C8983 C9065 C9067 C9068 C9110 C9111 C9169 C9191 C9400 C9401 C9402 C9487 C9558 C9559 C9587 C9632 C9669 C9675 C9676 C9677 C9719 C9721 C9751 C9752 C9754 C9756 C9759 C9776 C9778 C9779 C9781 C9782 C9783 C9788 C9799 C9800 C9803
Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe
Roferon‑A
C4993 C5036 C5042 C9259
Injection 9,000,000 I.U. in 0.5 mL single dose pre‑filled syringe
Injection 2,000,000 I.U. in 0.5 mL
C6222 C9639
Sachet containing granules 50 mg
C9045 C9145
Sachet containing granules 75 mg
Oral solution 10 mg per mL, 240 mL
Tablet 150 mg‑300 mg
Lamivudine 150 mg + Zidovudine 300 mg Alphapharm
Powder for suspension for injection 30 mg (as acetate) with diluent
C7042 C9225
Injection 60 mg (as acetate) in single dose pre‑filled syringe
C4575 C7025 C7509 C7532 C9260 C9261
Injection 90 mg (as acetate) in single dose pre‑filled syringe
Injection 120 mg (as acetate) in single dose pre‑filled syringe
C4575 C7025 C7509 C7532 C8260 C9161 C9260 C9261 C9323
Tablet, chewable, 500 mg (as carbonate hydrate)
C5530 C9762
Tablet, chewable, 750 mg (as carbonate hydrate)
Tablet, chewable, 1000 mg (as carbonate hydrate)
Ledipasvir with sofosbuvir
Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir
C5944 C5969 C5972
C4282 C4287 C7381 C7383 C7807 C7808
C7381 C7383 C7807 C7808
Powder for injection 13,400,000 I.U. (105 micrograms)
C6502 C6507 C6516 C6522 C6523 C6532 C6535 C6634 C6644 C6653 C6654 C6657 C6673 C6682 C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327
Powder for injection 33,600,000 I.U. (263 micrograms)
Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL
Intra‑
C6863 C9405
Injection 6 mg in 0.6 mL single use pre‑filled syringe
C7822 C7843 C9224 C9322
Lopinavir with Ritonavir
Tablet 100 mg‑25 mg
Tablet 200 mg‑50 mg
Oral liquid 400 mg‑100 mg per 5 mL, 60 mL
Lumacaftor with ivacaftor
Tablet containing lumacaftor 100 mg with ivacaftor 125 mg
C8003 C8006
Tablet containing lumacaftor 200 mg with ivacaftor 125 mg
C8004 C8010
C6089 C6693 C6722 C6734 C6735 C6748
Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers