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PB 79 of 2011 Arrangements as amended, taking into account amendments up to National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 1) (PB 7 of 2018)
Administered by: Health
Registered 01 Feb 2018
Start Date 01 Feb 2018

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

made under subsection 100(1) of the

National Health Act 1953

Compilation No. 71

Compilation date:                              1 February 2018

Includes amendments up to:            PB 7 of 2018

Registered:                                         1 February 2018

 

About this compilation

This compilation

This is a compilation of the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) that shows the text of the law as amended and in force on 1 February 2018 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Part 1—General                                                                                                                                                1

Division 1—Preliminary                                                                                                                        1

1............ Name of Special Arrangement....................................................................................... 1

3............ Definitions..................................................................................................................... 1

Division 2—Pharmaceutical benefits                                                                                              5

4............ Pharmaceutical benefits covered by this Special Arrangement...................................... 5

5............ Application of Part VII of the Act................................................................................. 5

6............ Responsible person....................................................................................................... 5

7............ Authorised prescriber.................................................................................................... 6

8............ Prescription circumstances............................................................................................ 6

9............ Maximum amount—chemotherapy drug....................................................................... 6

10.......... Maximum quantity—related pharmaceutical benefit...................................................... 7

11.......... Maximum number of repeats—chemotherapy drug...................................................... 7

12.......... Maximum number of repeats—related pharmaceutical benefit...................................... 8

13.......... Section 100 only supply................................................................................................ 8

Part 2—Prescription                                                                                                                                     10

Division 1—Chemotherapy pharmaceutical benefits                                                           10

14.......... Methods of prescribing chemotherapy pharmaceutical benefit.................................... 10

15.......... Information to be included in infusion prescription, other than infusion medication chart prescriptions  10

16.......... Information to be included in infusion medication chart prescription.......................... 11

17.......... Dose or number of repeats greater than maximum...................................................... 11

18.......... Direction to vary dose of chemotherapy drug in infusion............................................ 12

Division 2—Related pharmaceutical benefits                                                                          13

19.......... Methods of prescribing related pharmaceutical benefit................................................ 13

Division 3—Authority required procedures                                                                             14

22.......... Authority required procedures to be followed............................................................. 14

Part 3—Supply                                                                                                                                                 16

30.......... Entitlement to infusion or related pharmaceutical benefit............................................. 16

31.......... Supply of infusion under this Special Arrangement.................................................... 16

32.......... Supply of related pharmaceutical benefits under this Special Arrangement................. 16

33.......... Selection of chemotherapy pharmaceutical benefits to make infusion.......................... 16

34.......... Modified application of Act and Regulations.............................................................. 17

34A....... Modified application of paragraph 92A(1)(f) conditions of approval.......................... 18

Part 4Claims, payment and provision of under co‑payment data                              19

Division 1Claims for payment and provision of under co‑payment data             19

36.......... How claims to be made............................................................................................... 19

37.......... Modified references for claim and provision of under co‑payment data...................... 19

39.......... Modified requirements for supply of infusion............................................................. 19

Division 2—Payment of claim                                                                                                          21

41.......... Payment of approved pharmacist or approved medical practitioner for supply of infusion      21

42.......... Payment of approved hospital authority or HSD hospital authority for supply of infusion      21

43.......... Payment of participating hospital authority for supply of related pharmaceutical benefit 21

45.......... Method of working out dispensed price...................................................................... 21

46.......... No separate entitlement to payment for supply of diluent............................................ 22

Division 2A—Payments to TGA licensed compounders                                                     23

46A....... Payments in relation to infusions prepared between 1 July 2015 and 30 November 2017       23

46B....... Payments in relation to infusions prepared on or after 1 December 2017.................... 23

Division 3—Dispensed price of chemotherapy drug                                                            24

47.......... Dispensed price if drug is in infusion supplied by approved pharmacist or approved medical practitioner              24

48.......... Mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab.. 25

49.......... Mark‑up for chemotherapy pharmaceutical benefit that has trastuzumab..................... 25

50.......... Dispensed price if drug is in infusion supplied by approved private hospital authority 26

51.......... Dispensed price if drug is in infusion supplied by public hospital authority............... 27

Division 4—Dispensed price of related pharmaceutical benefit                                     28

52.......... Dispensed price for supply of related pharmaceutical benefit...................................... 28

53.......... Quantity less than manufacturer’s pack....................................................................... 28

Part 5—Patient contributions                                                                                                                 29

54.......... Supply of infusion by approved pharmacist or approved medical practitioner............ 29

55.......... Supply of infusion by approved hospital authority or HSD hospital authority............ 29

57.......... Supply of related pharmaceutical benefit by participating hospital authority................ 30

58.......... Special patient contribution for Schedule 5 pharmaceutical benefit.............................. 30

59.......... Amounts taken into account for eligibility for concession and entitlement cards......... 31

Part 6—Transitional                                                                                                                                     32

60.......... Transitional provisions for existing medication chart prescribing................................ 32

Schedule 1—Chemotherapy pharmaceutical benefits and chemotherapy drugs          33

Part 1—Chemotherapy pharmaceutical benefits and related information                33

Part 2—Chemotherapy drugs and related information                                                         45

Schedule 2—Related pharmaceutical benefits                                                         48

Schedule 3—Responsible Person Codes                                                                          53

Schedule 4—Circumstances and Purposes Codes                                                55

Schedule 5—Patient contributions                                                                                     100

Endnotes                                                                                                                                                             101

Endnote 1—About the endnotes                                                                                                    101

Endnote 2—Abbreviation key                                                                                                        102

Endnote 3—Legislation history                                                                                                     103

Endnote 4—Amendment history                                                                                                   107

 


Part 1General

Division 1Preliminary

1  Name of Special Arrangement

             (1)  This Special Arrangement is the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

             (2)  This Special Arrangement may also be cited as PB 79 of 2011.

3  Definitions

                   In this Special Arrangement:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.

Act means the National Health Act 1953.

additional TGA licensed compounding fee, for the compounding of a dose of a chemotherapy drug for an infusion by a TGA licensed compounder – an amount of $20.

authorised prescriber means:

                     (a)  for a chemotherapy pharmaceutical benefit—a kind of person identified by a prescriber code mentioned in the column in Part 1 of Schedule 1 headed ‘Authorised Prescriber’ for the benefit; or

                     (b)  for a related pharmaceutical benefit—a kind of person identified by a prescriber code mentioned in the column in Schedule 2 headed ‘Authorised Prescriber’ for the benefit.

authority prescription means a prescription that has been authorised:

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

                     (b)  in accordance with Division 3 of Part 2 of this Special Arrangement.

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 cleft palate identification 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.

chemotherapy drug, means a drug that is mentioned in the column in Part 1 of Schedule 1 headed ‘Listed Drug’ for one or more chemotherapy pharmaceutical benefits.

Note:          Each chemotherapy drug is also mentioned in Part 2 of Schedule 1.

chemotherapy pharmaceutical benefit means a pharmaceutical benefit that is mentioned in Part 1 of Schedule 1.

circumstances code means the letter ‘C’ followed by a number.

compounder means an entity (including a person, pharmacy, hospital or a body corporate) who undertakes and is responsible for the compounding of an infusion, so the infusion may be supplied by an approved supplier under this Special Arrangement.

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

Note:          Australian Healthcare Associates Pty Ltd is currently the Chemotherapy Compounding Payment Scheme Administration Agency.

diluent fee means an amount of $5.21.

dispensing fee means an amount of $7.15.

distribution fee means an amount of $26.28.

dose, for a chemotherapy drug, means the quantity of the drug contained in an infusion, including unit of use, such as international units, grams, micrograms, or milligrams.

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)  is receiving treatment from an authorised prescriber.

eligible private hospital patient means an eligible patient who is receiving treatment at or from a private hospital.

eligible public hospital patient means an eligible patient who is receiving treatment at, or from, a public hospital as a non‑admitted patient, day admitted patient or patient on discharge.

entitlement number, for an eligible patient, means the number listed on the patient’s benefit card.

HSD hospital authority means a public hospital authority approved by the Chief Executive Medicare under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010.

Human Services Department means the Department administered by the Human Services Minister.

infusion means a single treatment for a patient that is made from one or more chemotherapy pharmaceutical benefits.

infusion medication chart prescription means a medication chart directing the supply of an infusion.

infusion prescription means a prescription directing the supply of an infusion.

medication chart prescription has the meaning given by the Regulations, but does not include a medication chart prescription for a person receiving treatment in a residential care service.

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

other Special Arrangement means another Special Arrangement under section 100 of the Act.

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

preparation fee means an amount of $83.83.

Note:          The preparation fee includes $40 for compounding the dose of chemotherapy drug in the infusion.  Where a TGA licensed compounder has compounded the dose of a chemotherapy drug, an additional TGA licensed compounding fee of $20 is payable to that TGA licensed compounder - see section 46B.

prescriber code means any of the following codes identifying the kind of person mentioned for the code:

                     (a)  MP—medical practitioner;

                     (b)  PDP—participating dental practitioner;

                     (c)  AO—authorised optometrist;

                     (d)  MW—authorised midwife;

                     (e)  NP—authorised nurse practitioner.

purposes code means the letter ‘P’ followed by a number.

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

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

residential care service has the meaning given by the Regulations.

supplier means a person who may supply an infusion or related pharmaceutical benefit under Part 3 of this Special Arrangement.

TGA licensed compounder means a compounder who holds a license issued under the Therapeutic Goods Act 1989 for aseptic compounding of sterile cytotoxic preparations.

under co‑payment data means information in relation to the supply under this Special Arrangement of:

                     (a)  an infusion by an approved pharmacist, approved medical practitioner, approved hospital authority, or HSD hospital authority; or

                     (b)  a related pharmaceutical benefit by a participating hospital authority;

where a claim is not payable as the dispensed price for the supply under this Special Arrangement does not exceed the amount that the supplier was entitled to charge under subsection 54(2) or 55(2) for supply of an infusion, or under subsection 57(2) for supply of a related pharmaceutical benefit.

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 hospital authority

·      approved medical practitioner

·      approved pharmacist

·      approved supplier

·      pharmaceutical benefit

·      pharmaceutical item

·      public hospital authority.

Division 2Pharmaceutical benefits

4  Pharmaceutical benefits covered by this Special Arrangement

             (1)  This Special Arrangement applies to each pharmaceutical benefit mentioned in Part 1 of Schedule 1 or in Schedule 2.

             (2)  Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:

                     (a)  in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and

                     (b)  with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.

Note:          Each listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Part 1 of Schedule 1 or in Schedule 2 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

5  Application of Part VII of the Act

             (1)  Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.

Note:          Under this Special Arrangement, pharmaceutical benefits listed in Part 1 of Schedule 1 are supplied as an infusion made from one or more pharmaceutical benefits.

             (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.

6  Responsible person

             (1)  If a code is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 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 3 for the code, with the ABN, if any, mentioned in Schedule 3 for the person; and

                     (b)  the pharmaceutical item is the listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:

                              (i)  in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and

                             (ii)  with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.

Note:          A person identified by a code in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Responsible Person’ has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.

7  Authorised prescriber

             (1)  Only an authorised prescriber for a chemotherapy pharmaceutical benefit may prescribe the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit to an eligible patient.

             (2)  Only an authorised prescriber for a related pharmaceutical benefit may prescribe the supply of the related pharmaceutical benefit to an eligible patient.

Note:          Each person mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Authorised Prescriber’ is authorised by subsection 88(1) of the Act, or has been authorised by the Minister under section 88 of the Act, to prescribe the pharmaceutical benefit.

8  Prescription circumstances

             (1)  If at least one circumstances code is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’ for a chemotherapy pharmaceutical benefit, the circumstances in Schedule 4 for a code are circumstances in which the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit may be prescribed.

             (2)  If each chemotherapy pharmaceutical benefit that has the same chemotherapy drug has at least one circumstances code, then the supply of an infusion that includes the chemotherapy drug may only be prescribed in circumstances mentioned for a circumstances code.

             (3)  If at least one circumstances code is mentioned in the column in Schedule 2 headed ‘Circumstances’ for a related pharmaceutical benefit:

                     (a)  the circumstances mentioned in Schedule 4 for a code are circumstances in which the related pharmaceutical benefit may be prescribed; and

                     (b)  the related pharmaceutical benefit may only be prescribed in circumstances mentioned for a circumstances code.

Note:          Circumstances for a code mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Circumstances’ have been determined by the Minister under paragraph 85(7)(b) of the Act, except for circumstances in relation to chemotherapy pharmaceutical benefits containing trastuzumab or fluorouracil.

9  Maximum amount—chemotherapy drug

             (1)  This section applies subject to section 17.

             (2)  The maximum amount of a chemotherapy drug that an authorised prescriber may direct to be included in an infusion in one infusion prescription or infusion medication chart prescription is the amount mentioned in the column in Part 2 of Schedule 1 headed ‘Maximum Amount’ for the chemotherapy drug.

             (3)  If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for a chemotherapy drug, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for the particular purposes mentioned in Schedule 4 for each code.

             (4)  If no purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy drug.

10  Maximum quantity—related pharmaceutical benefit

             (2)  The maximum quantity or number of units of the pharmaceutical item in a related pharmaceutical benefit that an authorised prescriber may direct to be supplied in one prescription is the quantity or number of units mentioned in the column in Schedule 2 headed ‘Maximum Quantity’ for the pharmaceutical benefit.

             (3)  If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for a related 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 4 for each code.

             (4)  If no purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same related pharmaceutical benefit.

             (5)  For subsection (2), the pharmaceutical item is the listed drug mentioned in Schedule 2:

                     (a)  in the form mentioned in Schedule 2 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 2 for the form of the listed drug.

Note:          The maximum quantities and numbers of units mentioned in the column in Schedule 2 headed ‘Maximum quantity’ have been determined by the Minister under paragraph 85A(2)(a) of the Act.

11  Maximum number of repeats—chemotherapy drug

             (1)  This section applies subject to section 17.

             (2)  The maximum number of occasions an authorised prescriber may, in one infusion prescription or infusion medication chart prescription, direct that the supply of an infusion containing a chemotherapy drug be repeated is the number in the column in Part 2 of Schedule 1 headed ‘Number of Repeats’ for the chemotherapy drug.

             (3)  If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for the chemotherapy drug, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.

             (4)  If no purposes code is mentioned in the column in Part 2 of Schedule 1 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 chemotherapy drug.

             (5)  If an infusion contains more than one chemotherapy drug, the maximum number of repeats for the infusion is the smallest maximum number that applies in relation to one of the chemotherapy drugs.

12  Maximum number of repeats—related pharmaceutical benefit

             (2)  The maximum number of occasions an authorised prescriber may, in one prescription, direct that the supply of a related pharmaceutical benefit be repeated is the number in the column in Schedule 2 headed ‘Number of Repeats’ for the related pharmaceutical benefit.

             (3)  If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for the related pharmaceutical benefit, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.

             (4)  If no purposes code is mentioned in the column in Schedule 2 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 related pharmaceutical benefit.

Note:          The numbers of repeats mentioned in the column in Schedule 2 headed ‘Number of Repeats’ have been determined by the Minister under paragraph 85A(2)(b) of the Act.

13  Section 100 only supply

             (1)  If the letter ‘D’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 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)  A 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 Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit, the pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.

             (4)  A 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 pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.

             (5)  If the letter ‘C’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit and a code is mentioned in the column headed ‘Circumstances’, the pharmaceutical benefit may be supplied in the circumstances signified by the code only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.

             (6)  A 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 one or more of the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.

Part 2Prescription

Division 1Chemotherapy pharmaceutical benefits

14  Methods of prescribing chemotherapy pharmaceutical benefit

             (1)  An authorised prescriber may prescribe a chemotherapy pharmaceutical benefit under this Special Arrangement by:

                     (a)  writing an infusion prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with section 40 of the Regulations as modified by section 15 of this Special Arrangement; or

                     (b)  preparing an infusion medication chart prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with section 41 of the Regulations as modified by section 16 of this Special Arrangement.

             (2)  However, an infusion medication chart prescription may only be prepared for an eligible public hospital patient or eligible private hospital patient.

             (3)  However, chemotherapy pharmaceutical benefits containing the following chemotherapy drugs may only be prescribed by writing an infusion prescription:

                     (a)  bortezomib;

                     (b)  trastuzumab.

             (4)  An infusion prescription written in accordance with section 15 or an infusion medication chart prescription written in accordance with section 16 is taken to be a duly written prescription for section 40 or 41 of the Regulations.

             (5)  Paragraph 40(3)(a) of the Regulations does not apply to an infusion prescription.

Note:          Section 41 of the Regulations does not prohibit same day prescribing for infusion medication chart prescriptions.

15  Information to be included in infusion prescription, other than infusion medication chart prescriptions

             (1)  For paragraph 14(1)(a), this section modifies the requirements of section 40 of the Regulations.

             (2)  An infusion prescription must include the following information:

                     (a)  the name of each chemotherapy drug included in the infusion;

                     (b)  the dose of each chemotherapy drug;

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

             (3)  An infusion prescription does not need to include the following information:

                     (a)  the form of a chemotherapy drug to be supplied;

                     (b)  the quantity or number of units of a pharmaceutical benefit to be supplied;

                     (c)  the number of times supply of a pharmaceutical benefit is to be repeated.

Note:          If the prescription does include this information, a supplier is not required to follow the prescriber’s directions—see section 33.

16  Information to be included in infusion medication chart prescription

             (1)  For paragraph 14(1)(b) this section modifies the requirements of section 41 of the Regulations.

             (2)  An infusion medication chart prescription must include the following information:

                     (a)  the name of each chemotherapy drug included in the infusion; and

                     (b)  for each chemotherapy drug – the dose, the frequency of administration and the route of administration.

             (3)  An infusion medication chart prescription does not need to include the form of the chemotherapy drug supplied.

Note:          If the medication chart includes information about the form or brand of a chemotherapy drug to be supplied, or the quantity, number of units or number of repeats of a particular pharmaceutical benefit to be supplied, a supplier is not required to follow the prescriber’s directions except if they relate to the method of administering the chemotherapy drug—see section 33.

17  Dose or number of repeats greater than maximum

             (1)  If an authorised prescriber prescribes a dose of a chemotherapy drug that is greater than the maximum amount permitted under section 9, then:

(a)  for an infusion prescription written in accordance with paragraph 14(1)(a); or

(b)  for an infusion medication chart prescription written in accordance with paragraph 14(1)(b),

                   the prescription must be authorised in accordance with the procedures set out in section 30 of the Regulations as modified by subsection (2).

             (2)  A reference in section 30 of the Regulations to a determination in force under paragraph 85A(2)(a) of the Act is to be read as a reference to the maximum amount of the chemotherapy drug as described in section 9.

             (3)  If an authorised prescriber directs that the supply of an infusion be repeated more times than the maximum number of repeats permitted under section 11 for one or more of the chemotherapy drugs included in the infusion, then:

(a)  for an infusion prescription written in accordance with paragraph 14(1)(a); or

(b)  for an infusion medication chart prescription written in accordance with paragraph 14(1)(b),

                   the prescription must be authorised in accordance with the procedures set out in section 30 of the Regulations as modified by subsection (4).

             (4)  A reference in section 30 of the Regulations to a determination in force under paragraph 85A(2)(b) of the Act is to be read as a reference to the maximum number of repeats for a chemotherapy drug as described in section 11.

18  Direction to vary dose of chemotherapy drug in infusion

             (1)  An authorised prescriber may direct a supplier to increase or decrease the dose of a chemotherapy drug in a prescribed infusion, without writing a new infusion prescription or infusion medication chart prescription, if the new dose of the drug is between 90% and 110% of the dose that was originally prescribed.

             (2)  A new dose directed under subsection (1) that is greater than the maximum amount for the chemotherapy drug does not require approval under section 17.

             (3)  If a supplier receives a direction in accordance with subsection (1), the supplier must record on the infusion prescription or infusion medication chart prescription:

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

                     (b)  the means by which the supplier was notified of the direction (for example, by phone or by fax); and

                     (c)  the date and time the supplier was notified.

Division 2Related pharmaceutical benefits

19  Methods of prescribing related pharmaceutical benefit

             (1)  An authorised prescriber may prescribe a related pharmaceutical benefit under this Special Arrangement by:

                     (a)  writing a prescription for the related pharmaceutical benefit in accordance with section 40 of the Regulations; or

                     (b)  writing a medication chart prescription for the related pharmaceutical benefit in accordance with section 41 of the Regulations.

Note:          Related pharmaceutical benefits can only be supplied under this Special Arrangement by a participating hospital authority to eligible public hospital patients—see section 32.

Division 3Authority required procedures

22  Authority required procedures to be followed

             (1)  This section applies to an infusion prescription or infusion medication chart prescription if:

                     (a)  a circumstances code is mentioned in Part 1 of Schedule 1 for a chemotherapy pharmaceutical benefit that has a chemotherapy drug included in the infusion; and

                     (b)  the supply of the infusion is prescribed in the circumstances mentioned in Schedule 4 for the code; and

                     (c)  the circumstances include one of the following statements:

                              (i)  Compliance with Authority Required procedures;

                             (ii)  Compliance with Written Authority Required procedures;

                            (iii)  Compliance with Telephone Authority Required procedures;

                            (iv)  Compliance with Written or Telephone Authority Required procedures;

                             (v)  Compliance with modified Written Authority Required procedures.

Note:          If at least one circumstances code is mentioned in Part 1 of Schedule 1 for each chemotherapy pharmaceutical benefit that has the same chemotherapy drug, supply of an infusion containing the chemotherapy drug may only be prescribed in one of the circumstances to which a code relates—see subsections 8(1) and (2).

(1A)     If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with Authority Required Procedures’.

             (2)  This section applies to a prescription (including a medication chart prescription) for a related pharmaceutical benefit if:

                     (a)  a circumstances code is mentioned in Schedule 2 for the related pharmaceutical benefit; and

                     (b)  the related pharmaceutical benefit is prescribed in the circumstances mentioned in Schedule 4 for the code; and

                     (c)  the circumstances include one of the following statements:

                              (i)  Compliance with Authority Required procedures;

                             (ii)  Compliance with Written Authority Required procedures;

                            (iii)  Compliance with Telephone Authority Required procedures;

                            (iv)  Compliance with Written or Telephone Authority Required procedures;

                             (v)  Compliance with modified Written Authority Required procedures.

Note:          If at least one circumstances code is mentioned in Schedule 2, the related pharmaceutical benefit may only be prescribed in one of the circumstances to which the code relates—see subsection 8(3).

(2A)     If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words  used are ‘Compliance with Authority Required Procedures’.

             (3)  The authority required procedures set out in sections 11 to 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 are to be followed.

Note:          See section 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 for Streamlined Authority Code.

             (4)  In addition to the requirements of subsection (3) where ‘Compliance with modified Written Authority Required procedures’  appears in the circumstances mentioned in Schedule 4 for the code, any other requirement included in the circumstances is to be followed as part of the authority required procedures. 

Example:    The circumstances in Schedule 4 may require additional documents to be submitted along with the prescription.

Part 3Supply

  

30  Entitlement to infusion or related pharmaceutical benefit

                   An eligible patient is entitled to receive an infusion or a related pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made under Part 5.

31  Supply of infusion under this Special Arrangement

             (1)  An infusion may be supplied under this Special Arrangement by any of the following:

                     (a)  an approved pharmacist;

                     (b)  an approved medical practitioner;

                     (c)  an approved hospital authority for a private hospital; or

                     (d)  a public hospital authority to an eligible public hospital patient.

             (2)  However, a public hospital authority that is not a participating hospital authority may only supply an infusion that contains trastuzumab and that does not contain any other chemotherapy drug.

             (3)  However, an infusion medication chart prescription cannot be supplied by:

                     (a)  an approved medical practitioner;  or

                     (b)  a public hospital authority that is not a participating hospital authority. 

32  Supply of related pharmaceutical benefits under this Special Arrangement

                   A related pharmaceutical benefit may be supplied under this Special Arrangement by a participating hospital authority to an eligible public hospital patient.

33  Selection of chemotherapy pharmaceutical benefits to make infusion

Form, brand and method of administering

             (1)  If an authorised prescriber directs the supply of a form of a chemotherapy drug in an infusion prescription or infusion medication chart prescription, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different form to make the infusion.

             (2)  If an authorised prescriber directs the supply of a listed brand of a chemotherapy drug in an infusion prescription or infusion medication chart prescription, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different listed brand to make the infusion.

             (3)  If an authorised prescriber identifies a method of administering a chemotherapy drug in an infusion prescription or infusion medication chart prescription, the supply of the infusion must be consistent with the method.

             (4)  Subsection (3) applies regardless of whether the method identified by the authorised prescriber is also a manner of administration for one or more chemotherapy pharmaceutical benefits containing the chemotherapy drug.

Note:          Authorised prescribers are required to identify each chemotherapy drug in an infusion and the dose of each drug. They are not required to identify a particular chemotherapy pharmaceutical benefit by including the form, manner of administration or brand.

Quantity and number of repeats

             (5)  If an authorised prescriber directs the supply of a quantity or number of units of a particular chemotherapy pharmaceutical benefit, the supplier of the infusion may disregard the direction.

             (6)  If an authorised prescriber directs how many times the supply of a particular chemotherapy pharmaceutical benefit is to be repeated, the supplier of the infusion may disregard the direction.

Note:          Authorised prescribers are required to identify the dose of each chemotherapy drug and for an infusion prescription the number of times that supply of the infusion is to be repeated. They are not required to identify the quantity or number of units of a pharmaceutical benefit to be supplied, or the number of times supply of a pharmaceutical benefit is to be repeated.

Circumstances

             (7)  If an infusion prescription or infusion medication chart prescription has been authorised in circumstances mentioned in Schedule 4, the supplier must only use chemotherapy pharmaceutical benefits for which the circumstances code for those circumstances is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’.

34  Modified application of Act and Regulations

Infusions

             (1)  A supply of an infusion under this Special Arrangement is not an early supply of a specified pharmaceutical benefit within the meaning of subsection 84AAA(1) of the Act.

             (2)  Subsections 51(2) to (4) of the Regulations do not apply to the supply of an infusion under this Special Arrangement.

Note:          The effect of those subregulations is to restrict how soon a repeat supply may be made. There is no restriction on how soon a repeat supply of an infusion may be made under this Special Arrangement.

             (3)  Sections 49 and 53 of the Regulations do not apply to the supply of an infusion for an infusion prescription under this Special Arrangement.

Note:          Sections 49 and 53 already do not apply to infusion medication chart prescriptions.

             (4)  A reference elsewhere in the Regulations to the supply of a pharmaceutical benefit is taken to include the supply of an infusion under this Special Arrangement.

34A  Modified application of paragraph 92A(1)(f) conditions of approval

              a)  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 an infusion, once prepared as a final product ready for infusion to a person, when the infusion has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.

              b)  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.

Part 4Claims, payment and provision of under co‑payment data

Division 1Claims for payment and provision of under co‑payment data

36  How claims to be made

             (1)  The following may make a claim for payment for the supply of an infusion or related pharmaceutical benefit to an eligible patient under this Special Arrangement in accordance with section 99AAA of the Act, and the rules made under subsection 99AAA(8) of the Act, as modified by this Division:

                     (a)  an approved supplier;

                     (b)  an HSD hospital authority.

37  Modified references for claim and provision of under co‑payment data

             (1)  The rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act apply to a claim or provision of under co‑payment data as follows:

                     (a)  a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority;

                     (b)  a reference to a number allotted to an approval under section 16 of the Regulations includes a reference to a number allotted to an approval under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 for a HSD hospital authority; and

                     (c)  the definition of under co‑payment data in section 4 of this Special Arrangement replaces the definition of under co‑payment data appearing in the rules made under subsection 98AC(4) of the Act.

39  Modified requirements for supply of infusion

                   For a claim or provision of under co‑payment data for supply of an infusion, the requirements in the rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act are modified as follows:

                     (a)  a reference to a pharmaceutical benefit includes a reference to an infusion;

                     (b)  a reference to an authority prescription in the rules includes a reference to an authority prescription within the meaning given by section 3 of this Special Arrangement;

                     (c)  the claim or provision of under co‑payment data must include:

                              (i)  a drug code for each chemotherapy drug in the infusion, being the code for the drug published in the Schedule of Pharmaceutical Benefits published by the Department; and

                             (ii)  the dose of each chemotherapy drug in the infusion; and

                            (iii)  the compounder ID of the site at which the compounder compounded the dose of a chemotherapy drug for the infusion; and

                     (d)  the supplier is not required to include in the claim or provision of under co‑payment data:

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

                             (ii)  the brand of the supplied pharmaceutical item;

                            (iii)  whether or not section 49 applies; or

                            (iv)  whether or not immediate supply was necessary.

Division 2Payment of claim

41  Payment of approved pharmacist or approved medical practitioner for supply of infusion

                   An approved pharmacist or approved medical practitioner who makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved pharmacist or approved medical practitioner was required to charge under subsection 54(2).

42  Payment of approved hospital authority or HSD hospital authority for supply of infusion

                   An approved hospital authority or HSD hospital authority that makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved hospital authority or HSD hospital authority was entitled to charge under subsection 55(2).

43  Payment of participating hospital authority for supply of related pharmaceutical benefit

                   A participating hospital authority that makes a claim under Division 1 for the supply of a related pharmaceutical benefit is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the related pharmaceutical benefit is greater than the amount that the supplier was entitled to charge under subsection 57(2).

45  Method of working out dispensed price

Infusion

             (1)  The dispensed price for the supply of an infusion is the sum of:

                     (a)  the dispensed prices of the doses of chemotherapy drugs in the infusion; and

                     (b)  if the supply is a repeated supply—an amount equivalent to the amount that may be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the eligible patient.

             (2)  The dispensed price for a dose of a chemotherapy drug is to be worked out under Division 3.

Related pharmaceutical benefit

             (3)  The dispensed price for the supply of a related pharmaceutical benefit is to be worked out under Division 4.

Rounding

             (4)  A dispensed price worked out under Division 3 or 4 is rounded to the nearest cent, with a half cent being rounded up.

46  No separate entitlement to payment for supply of diluent

             (1)  If a supplier adds a pharmaceutical benefit to an infusion supplied under this Special Arrangement as a diluent, no amount is payable under Part VII of the Act for supply of the pharmaceutical benefit.

             (2)  Subsection (1) applies regardless of whether the pharmaceutical benefit added as a diluent is one to which this Special Arrangement applies.

Note:          For the application of this Special Arrangement to pharmaceutical benefits, see section 5.

Division 2APayments to TGA licensed compounders

46A  Payments in relation to infusions prepared between 1 July 2015 and 30 November 2017

             (1)  A TGA licensed compounder may make a claim for payment for the compounding of a dose of a chemotherapy drug for an infusion prepared between 1 July 2015 and 30 November 2017.

             (2)  A claim under subsection (1) must:

                     (a)  be in writing; and

                     (b)  include a certification by the TGA licensed compounder that:

                              (i)  each dose of a chemotherapy drug for the infusion to which the claim relates was prepared in accordance with a compounding order; and

                             (ii)  the information provided in the claim is correct.

             (3)  If a claim is made under subsection (1), the Secretary may, at his or her discretion, if the Secretary is satisfied on reasonable grounds that it is appropriate to do so, pay an amount of $20 to the TGA licensed compounder for the compounding.

46B  Payments in relation to infusions prepared on or after 1 December 2017

             (1)  If a TGA licensed compounder compounds a dose of a chemotherapy drug for an infusion prepared on or after 1 December 2017, the compounder is entitled to be paid an additional TGA licensed compounding fee by the Commonwealth.

             (2)  A TGA licensed compounder must not be paid more than one additional TGA licensed compounding fee for the compounding of a dose of a chemotherapy drug for a single infusion that is prepared in accordance with an infusion prescription for an individual patient.

Division 3Dispensed price of chemotherapy drug

47  Dispensed price if drug is in infusion supplied by approved pharmacist or approved medical practitioner

             (1)  For a dose of a chemotherapy drug in an infusion supplied by an approved pharmacist or an approved medical practitioner to an eligible patient, the dispensed price is the sum of the following amounts:

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

                     (b)  the distribution fee;

                     (c)  the dispensing fee;

                     (d)  the preparation fee;

                     (e)  the diluent fee.

             (2)  The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.

Note:          If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.

             (3)  A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.

Example:    Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.

Note:          A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.

             (4)  In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:

                     (a)  the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and

                     (b)  the mark‑up for the chemotherapy pharmaceutical benefit worked out under:

                              (i)  if the chemotherapy pharmaceutical benefit does not have trastuzumab—section 48; or

                             (ii)  if the chemotherapy pharmaceutical benefit has trastuzumab—section 49.

Note:          The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.

                   For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

48  Mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab

                   For subparagraph 47(4)(b)(i), the mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab is:

(mark‑up for maximum multiple) divided by (maximum multiple of pharmaceutical benefit).

where:

mark‑up for maximum multiple means the administration, handling and infrastructure fee worked out under the determination made under paragraph 98B(1)(a) of the Act.

maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of the chemotherapy drug in the benefit that is permitted under section 9.

Note:          The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.

49  Mark‑up for chemotherapy pharmaceutical benefit that has trastuzumab

             (1)  For subparagraph 47(4)(b)(ii), the mark‑up for a chemotherapy pharmaceutical benefit that has trastuzumab is:

where:

mark‑up for maximum multiple means the amount worked out under subsection (2).

maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of trastuzumab that is permitted under section 9.

Note:          The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.

             (2)  The mark‑up for the maximum multiple of a chemotherapy pharmaceutical benefit with an ex‑manufacturer price mentioned in the table is the amount mentioned in the table.

 

Item

Ex‑manufacturer price for maximum multiple of pharmaceutical benefit

Mark‑up for maximum multiple

1

≤ $40

10% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit

2

> $40, ≤ $100

$4

3

> $100, ≤ $1 000

4% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit

4

> $1 000

$40

50  Dispensed price if drug is in infusion supplied by approved private hospital authority

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

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

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

                     (c)  the dispensing fee;

                     (d)  the preparation fee;

                     (e)  the diluent fee.

             (2)  The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.

Note:          If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.

             (3)  A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.

Example:    Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.

Note:          A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.

             (4)  In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:

                     (a)  the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and

                     (b)  1.4% of the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

Note:          The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.

                   For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

51  Dispensed price if drug is in infusion supplied by public hospital authority

             (1)  For a dose of a chemotherapy drug in an infusion supplied by a public hospital authority to an eligible patient, the dispensed price is the sum of the following amounts:

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

                     (b)  the preparation fee.

             (2)  The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.

Note:          If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.

             (3)  A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.

Example:    Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.

Note:          A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.

             (4)  In this section, the reference price of a chemotherapy pharmaceutical benefit is the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up).

Note:          The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.

                   For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.

Division 4Dispensed price of related pharmaceutical benefit

52  Dispensed price for supply of related pharmaceutical benefit

             (1)  For a related pharmaceutical benefit supplied by a participating hospital authority to an eligible public hospital patient, the dispensed price is as follows:

                     (a)  if the quantity of the related pharmaceutical benefit that is ordered and supplied is equal to the quantity contained in the manufacturer’s pack—the ex‑manufacturer price for the pack;

                     (b)  if the quantity of the related pharmaceutical benefit that is ordered and supplied is less than the quantity contained in the manufacturer’s pack—the amount worked out under section 53;

                     (c)  if the quantity of the related pharmaceutical benefit that is ordered and supplied is more than the quantity contained in the manufacturer’s pack—the sum of:

                              (i)  the ex‑manufacturer price for each complete pack in the quantity; and

                             (ii)  the amount worked out under section 53 for any remainder.

             (2)  However, if there are 2 or more related pharmaceutical benefits that are different brands of the same pharmaceutical item, the dispensed price of those pharmaceutical benefits is to be based on the pharmaceutical benefit with the lowest ex‑manufacturer price.

53  Quantity less than manufacturer’s pack

                   For paragraph 52(1)(b) and subparagraph 52(1)(c)(ii), the amount for a quantity of a related pharmaceutical benefit that is less than the quantity contained in the manufacturer’s pack (a broken quantity) is worked out by:

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

                     (b)  applying that percentage to the ex‑manufacturer price for the complete pack.

Part 5Patient contributions

  

54  Supply of infusion by approved pharmacist or approved medical practitioner

             (1)  The amount that an approved pharmacist or approved medical practitioner may or must charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.

Patient co‑payment for original supply

             (2)  For an original supply of an infusion, the approved pharmacist or approved medical practitioner must charge the eligible patient an amount that is equivalent to the amount that is required to be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the patient.

Note:          This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.

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

Special patient contribution for Schedule 5 pharmaceutical benefit

             (4)  If a chemotherapy pharmaceutical benefit the approved pharmacist or approved medical practitioner uses to make the infusion is mentioned in Schedule 5, the approved pharmacist or approved medical practitioner may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.

Note:          If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.

55  Supply of infusion by approved hospital authority or HSD hospital authority

             (1)  The amount that an approved hospital authority or HSD hospital authority may charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.

Patient co‑payment for original supply

             (2)  For an original supply of an infusion, the hospital authority may charge the eligible patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained a pharmaceutical benefit from an approved pharmacist.

Note:          This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.

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

Special patient contribution for Schedule 5 pharmaceutical benefit

             (4)  If a chemotherapy pharmaceutical benefit the hospital authority uses to make the infusion is mentioned in Schedule 5, the hospital authority may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.

Note:          If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.

57  Supply of related pharmaceutical benefit by participating hospital authority

             (1)  The amount that a participating hospital authority may charge an eligible public hospital patient for the supply of a related pharmaceutical benefit is the total of the amounts set out in this section.

Patient co‑payment

             (2)  The participating hospital authority may charge the eligible public hospital patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained the related pharmaceutical benefit from an approved pharmacist.

Special patient contribution for Schedule 5 pharmaceutical benefit

             (3)  If the related pharmaceutical benefit is mentioned in Schedule 5, the participating hospital authority may also charge the eligible public hospital patient an amount not exceeding the amount for the related pharmaceutical benefit worked out under section 58.

58  Special patient contribution for Schedule 5 pharmaceutical benefit

             (1)  The amount an eligible patient may be charged for a pharmaceutical benefit mentioned in Schedule 5 is worked out by subtracting the amount mentioned for the pharmaceutical benefit in the ‘Approved Ex‑manufacturer Price’ column in Schedule 5 from the amount mentioned for the pharmaceutical benefit in the ‘Claimed Ex‑manufacturer Price’ column in Schedule 5.

             (2)  However, the amounts mentioned in the ‘Approved Ex‑manufacturer price’ and ‘Claimed Ex‑manufacturer price’ columns must be adjusted proportionally if:

                     (a)  for a chemotherapy pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit used to make the infusion is more or less than the number mentioned in the ‘Quantity or Number of Units’ column; and

                     (b)  for a related pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit supplied is more or less than the number mentioned in the ‘Quantity or Number of Units’ column.

59  Amounts taken into account for eligibility for concession and entitlement cards

                   An amount charged under any of the following provisions is to be taken into account when determining a person’s eligibility for a concession card or entitlement card under section 84C of the Act:

                     (a)  subsection 54(2);

                     (b)  subsection 55(2);

                     (d)  subsection 57(2).

Part 6Transitional

  

60  Transitional provisions for existing medication chart prescribing

             (1)  An authorised prescriber may prescribe a pharmaceutical benefit for an eligible public hospital patient by writing:

(a)  an infusion medication chart, or

(b)  a medication chart,

                   by following the requirements for prescribing from an infusion medication chart or medication chart in the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before 1 April 2015.

             (2)  A participating hospital authority can supply a pharmaceutical benefit prescribed under subsection (1).

             (3)  The provisions for prescribing, supplying and claiming from an infusion medication chart or medication chart set out in the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before 1 April 2015, continue to apply in relation to an infusion medication chart or a medication chart written under subsection (1).

             (5)  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.


Schedule 1Chemotherapy pharmaceutical benefits and chemotherapy drugs

(sections 3, 4, 6, 8, 9, 11, 13, 22 and 33)

Part 1Chemotherapy pharmaceutical benefits and related information

 

Listed Drug

Form

Manner of Administration

Brand

Responsible Person

Authorised Prescriber

Circumstances

Section 100 only

Arsenic

Injection concentrate containing arsenic trioxide 10 mg in 10 mL

Injection

Phenasen

PL

MP

C4793 C5997 C6018

D

Bendamustine

Powder for injection containing bendamustine hydrochloride 25 mg

Injection

Ribomustin

JC

MP

C6075 C6124

D

Powder for injection containing bendamustine hydrochloride 100 mg

Injection

Ribomustin

JC

MP

C6075 C6124

D

Bevacizumab

Solution for I.V. infusion 100 mg in 4 mL

Injection

Avastin

RO

MP

C4584 C4587 C4594 C4814 C4939 C4968 C6337 C6338 C6353

D

Solution for I.V. infusion 400 mg in 16 mL

Injection

Avastin

RO

MP

C4584 C4587 C4594 C4814 C4939 C4968 C6337 C6338 C6353

D

Bleomycin

Powder for injection containing bleomycin sulfate 15,000 I.U.

Injection

Bleo 15K

EA

MP

C6224 C6275

D

CIPLA BLEOMYCIN

LR

MP

C6224 C6275

D

Hospira Pty Limited

PF

MP

C6224 C6275

D

Blinatumomab

Powder for I.V. infusion 38.5 micrograms

Injection

Blincyto

AN

MP

C6892 C6893 C6894 C6895

D

Bortezomib

Powder for injection 1 mg

Injection

Velcade

JC

MP

C7376 C7377 C7389 C7390 C7402

D

Powder for injection 3 mg

Injection

Velcade

JC

MP

C4080 C4081 C4161 C4162 C7376 C7377 C7389 C7390 C7402 C7414 C7416

D

Powder for injection 3.5 mg

Injection

Velcade

JC

MP

C4080 C4081 C4161 C4162 C7414 C7416

D

Brentuximab vedotin

Powder for I.V. infusion 50 mg

Injection

Adcetris

TK

MP

C4675 C6903 C6904 C6936 C6941 C7244

D

Cabazitaxel

Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent

Injection

Jevtana

SW

MP

C4662

D

Carboplatin

Solution for I.V. injection 50 mg in 5 mL

Injection

Hospira Pty Limited

PF

MP

D

Solution for I.V. injection 150 mg in 15 mL

Injection

Hospira Pty Limited

PF

MP

D

Solution for I.V. injection 450 mg in 45 mL

Injection

Carboplatin Accord

OC

MP

D

Hospira Pty Limited

PF

MP

D

Carfilzomib

Powder for I.V. infusion 30 mg

Injection

Kyprolis

AN

MP

C7344 C7348 C7355

D

 

Powder for I.V. infusion 60 mg

Injection

Kyprolis

AN

MP

C7344 C7348 C7355

D

Cetuximab

Solution for I.V. infusion 100 mg in 20 mL

Injection

Erbitux

SG

MP

C4785 C4788 C4794 C4908 C4912 C4945 C4965

D

Solution for I.V. infusion 500 mg in 100 mL

Injection

Erbitux

SG

MP

C4785 C4788 C4794 C4908 C4912 C4945 C4965

D

Cisplatin

I.V. injection 50 mg in 50 mL

Injection

Hospira Pty Limited

PF

MP

D

I.V. injection 100 mg in 100 mL

Injection

Hospira Pty Limited

PF

MP

D

Cladribine

Injection 10 mg in 5 mL

Injection

Litak

OA

MP

C6265

D

Solution for I.V. infusion 10 mg in 10 mL single use vial

Injection

Leustatin

JC

MP

C6265

D

Cyclophosphamide

Powder for injection 500 mg (anhydrous)

Injection

Endoxan

BX

MP

PB

Powder for injection 1 g (anhydrous)

Injection

Endoxan

BX

MP

PB

Powder for injection 2 g (anhydrous)

Injection

Endoxan

BX

MP

PB

Cytarabine

Injection 100 mg in 5 mL vial

Injection

Pfizer Australia Pty Ltd

PF

MP

D

Docetaxel

Solution concentrate for I.V. infusion 20 mg in 2 mL

Injection

DBL Docetaxel Concentrated Injection

PF

MP

D

Solution concentrate for I.V. infusion 80 mg in 4 mL

Injection

Docetaxel Accord

OC

MP

D

Solution concentrate for I.V. infusion 80 mg in 8 mL

Injection

DBL Docetaxel Concentrated Injection

PF

MP

D

Docetaxel Sandoz

SZ

MP

D

Solution concentrate for I.V. infusion 160 mg in 8 mL

Injection

Docetaxel Accord

OC

MP

D

Solution concentrate for I.V. infusion 160 mg in 16 mL

Injection

DBL Docetaxel Concentrated Injection

PF

MP

D

Doxorubicin

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial

Injection/
intravesical

Adriamycin

PF

MP

D

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

Injection/
intravesical

Adriamycin

PF

MP

D

Doxorubicin ACC

OC

MP

D

Doxorubicin - pegylated liposomal

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

Injection

Caelyx

JC

MP

C4786 C4787 C4791

D

Liposomal Doxorubicin SUN

RA

MP

C4786 C4787 C4791

D

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL

Injection

Caelyx

JC

MP

C4786 C4787 C4791

D

Liposomal Doxorubicin SUN

RA

MP

C4786 C4787 C4791

D

Epirubicin

Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

Injection/
intravesical

Epirube

TB

MP

D

Epirubicin ACT

EA

MP

D

Epirubicin SZ

HX

MP

D

Pharmorubicin

PF

MP

D

Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL

Injection/
intravesical

Epirubicin ACT

EA

MP

D

Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

Injection/
intravesical

Epirube

TB

MP

D

Epirubicin Accord

OC

MP

D

Epirubicin ACT

EA

MP

D

Pharmorubicin

PF

MP

D

Eribulin

Solution for I.V. injection containing eribulin mesilate 1 mg in 2 mL

Injection

Halaven

EI

MP

C4649 C7258 C7280

D

Etoposide

Powder for I.V. infusion 1 g (as phosphate)

Injection

Etopophos

BQ

MP

PB

Solution for I.V. infusion 100 mg in 5 mL

Injection

Etoposide Ebewe

SZ

MP

PB

Pfizer Australia Pty Ltd

PF

MP

PB

Fludarabine

Powder for I.V. injection containing fludarabine phosphate 50 mg

Injection

Fludarabine ACT

EA

MP

PB

Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL

Injection

Fludarabine Ebewe

SZ

MP

PB

Fluorouracil

Injection 500 mg in 10 mL

Injection

Hospira Pty Limited

PF

MP

C6266 C6297

D

Injection 1000 mg in 20 mL

Injection

DBL Fluorouracil Injection BP

PF

MP

C6266 C6297

D

Fluorouracil Ebewe

SZ

MP

C6266 C6297

D

Injection 2500 mg in 50 mL

Injection

DBL Fluorouracil Injection BP

PF

MP

C6266 C6297

D

Fluorouracil Ebewe

SZ

MP

C6266 C6297

D

Injection 5000 mg in 100 mL

Injection

Fluorouracil Ebewe

SZ

MP

C6266 C6297

D

Fotemustine

Powder for injection 208 mg with solvent

Injection

Muphoran

SE

MP

C6288

D

Gemcitabine

Solution for injection 200 mg (as hydrochloride) in 5.3 mL

Injection

DBL Gemcitabine Injection

PF

MP

D

Solution for injection 1 g (as hydrochloride) in 26.3 mL

Injection

DBL Gemcitabine Injection

PF

MP

D

Solution for injection 2 g (as hydrochloride) in 52.6 mL

Injection

DBL Gemcitabine Injection

PF

MP

D

Idarubicin

Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL

Injection

Idarubicin Ebewe

SZ

MP

C6247

PB

Zavedos Solution

PF

MP

C6247

PB

Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL

Injection

Idarubicin Ebewe

SZ

MP

C6247

PB

Zavedos Solution

PF

MP

C6247

PB

Ifosfamide

Powder for I.V. injection 1 g

Injection

Holoxan

BX

MP

D

Powder for I.V. injection 2 g

Injection

Holoxan

BX

MP

D

Ipilimumab

Injection concentrate for I.V. infusion 50 mg in 10 mL

Injection

Yervoy

BQ

MP

C6562 C6585

D

Injection concentrate for I.V. infusion 200 mg in 40 mL

Injection

Yervoy

BQ

MP

C6562 C6585

D

Irinotecan

I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

Injection

MEDITAB IRINOTECAN

LR

MP

D

Omegapharm Irinotecan

OE

MP

D

I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

Injection

Hospira Pty Limited

PF

MP

D

Irinotecan Accord

OC

MP

D

Irinotecan Alphapharm

AF

MP

D

Irinotecan Kabi

PK

MP

D

MEDITAB IRINOTECAN

LR

MP

D

Omegapharm Irinotecan

OE

MP

D

I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

Injection

Hospira Pty Limited

PF

MP

D

IRINOTECAN ACT

ED

MP

D

Irinotecan Alphapharm

AF

MP

D

Methotrexate

Injection 5 mg in 2 mL vial

Injection

Hospira Pty Limited

PF

MP

C

Injection 50 mg in 2 mL vial

Injection

Hospira Pty Limited

PF

MP

C

Methotrexate Accord

OD

MP

C

Solution concentrate for I.V. infusion 500 mg in 20 mL vial

Injection

Hospira Pty Limited

PF

MP

C

Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

Injection

Hospira Pty Limited

PF

MP

PB

Methaccord

EA

MP

PB

Methotrexate Accord

OD

MP

PB

Pfizer Australia Pty Ltd

PF

MP

PB

Solution concentrate for I.V. infusion 5000 mg in 50 mL vial

Injection

Methotrexate Ebewe

SZ

MP

PB

Mitozantrone

Injection 20 mg (as hydrochloride) in 10 mL

Injection

Mitozantrone Ebewe

SZ

MP

D

Onkotrone

BX

MP

D

Injection 25 mg (as hydrochloride) in 12.5 mL

Injection

Onkotrone

BX

MP

D

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

BQ

MP

C6070 C6095 C6111 C6988 C6993 C6996 C6997 C6999

D

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

BQ

MP

C6070 C6095 C6111 C6988 C6993 C6996 C6997 C6999

D

Obinutuzumab

Solution for I.V. infusion 1000 mg in 40 mL

Injection

Gazyva

RO

MP

C5126

D

Ofatumumab

Solution concentrate for I.V. infusion 100 mg in 5 mL

Injection

Arzerra

NV

MP

C4828

D

Solution concentrate for I.V. infusion 1000 mg in 50 mL

Injection

Arzerra

NV

MP

C4828 C4858

D

Oxaliplatin

Solution concentrate for I.V. infusion 50 mg in 10 mL

Injection

DBL Oxaliplatin Concentrate

PF

MP

D

Oxaliplatin SUN

RA

MP

D

Solution concentrate for I.V. infusion 100 mg in 20 mL

Injection

DBL Oxaliplatin Concentrate

PF

MP

D

Oxaliplatin Accord

OC

MP

D

Oxaliplatin SUN

RA

MP

D

Oxaliplatin SZ

HX

MP

D

Solution concentrate for I.V. infusion 200 mg in 40 mL

Injection

Oxaliplatin SUN

RA

MP

D

Paclitaxel

Solution concentrate for I.V. infusion 30 mg in 5 mL

Injection

Paclitaxel ACT

EF

MP

D

Paclitaxel Kabi

PK

MP

D

Paclitaxin

TB

MP

D

Paclitaxel Ebewe

SZ

MP

D

Solution concentrate for I.V. infusion 100 mg in 16.7 mL

Injection

Anzatax

PF

MP

D

Paclitaxel ACT

EF

MP

D

Paclitaxin

TB

MP

D

Solution concentrate for I.V. infusion 150 mg in 25 mL

Injection

Anzatax

PF

MP

D

Paclitaxel ACT

EF

MP

D

Paclitaxel Ebewe

SZ

MP

D

Paclitaxin

TB

MP

D

Solution concentrate for I.V. infusion 300 mg in 50 mL

Injection

Anzatax

PF

MP

D

Paclitaxel Accord

OC

MP

D

Paclitaxel ACT

EF

MP

D

Paclitaxel Ebewe

SZ

MP

D

Paclitaxel Kabi

PK

MP

D

Paclitaxin

TB

MP

D

Paclitaxel, nanoparticle albumin-bound

Powder for I.V. injection containing 100 mg paclitaxel

Injection

Abraxane

TS

MP

C4657 C6106 C6119

D

Panitumumab

Solution concentrate for I.V. infusion 100 mg in 5 mL

Injection

Vectibix

AN

MP

C5439 C5447 C5452 C5526

D

Solution concentrate for I.V. infusion 400 mg in 20 mL

Injection

Vectibix

AN

MP

C5439 C5447 C5452 C5526

D

Pembrolizumab

Powder for injection 50 mg

Injection

Keytruda

MK

MP

C6801 C6806 C6817

D

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

MK

MP

C6801 C6806 C6817

D

Pemetrexed

Powder for I.V. infusion 100 mg (as disodium)

Injection

Alimta

LY

MP

C4792 C7195

D

DBL Pemetrexed

PF

MP

C4792 C7195

D

Pemetrexed Accord

OD

MP

C4792 C7195

D

Pemetrexed APOTEX

TX

MP

C4792 C7195

D

Pemetrexed Juno

JU

MP

C4792 C7195

D

Pemetrexed MYX

OC

MP

C4792 C7195

D

PEMETREXED-DRLA

RZ

MP

C4792 C7195

D

Reladdin

AF

MP

C4792 C7195

D

Tevatrexed

TB

MP

 C4792 C7195

D

Powder for I.V. infusion 500 mg (as disodium)

Injection

Alimta

LY

MP

C4792 C7195

D

DBL Pemetrexed

PF

MP

C4792 C7195

D

Pemetrexed Accord

OD

MP

C4792 C7195

D

Pemetrexed APOTEX

TX

MP

C4792 C7195

D

Pemetrexed DRLA

RZ

MP

C4792 C7195

D

Pemetrexed Juno

JU

MP

C4792 C7195

D

Pemetrexed MYX

OC

MP

C4792 C7195

D

Pemetrexed Sandoz

SZ

MP

C4792 C7195

D

Reladdin

AF

MP

C4792 C7195

D

Tevatrexed

TB

MP

C4792 C7195

D

Powder for I.V. infusion 1 g (as disodium)

Injection

DBL Pemetrexed

PF

MP

C4792 C7195

D

Pemetrexed Accord

OD

MP

C4792 C7195

D

Pemetrexed MYX

OC

MP

C4792 C7195

D

Pertuzumab

Solution for I.V. infusion 420 mg in 14 mL

Injection

Perjeta

RO

MP

C4971 C5013 C5023

D

Raltitrexed

Powder for I.V. infusion 2 mg in single use vial

Injection

Tomudex

PF

MP

C6228

D

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Mabthera

RO

MP

C6011 C6161 C7399 C7400

PB

Solution for I.V. infusion 500 mg in 50 mL

Injection

Mabthera

RO

MP

C6011 C6161 C7399 C7400

PB

Topotecan

Powder for I.V. infusion 4 mg (as hydrochloride)

Injection

Hycamtin

SZ

MP

C6238

D

Trastuzumab

Powder for I.V. infusion 60 mg

Injection

Herceptin

RO

MP

C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041 C5825 C5834 C5844

PB

Powder for I.V. infusion 150 mg

Injection

Herceptin

RO

MP

C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041 C5825 C5834 C5844

PB

Trastuzumab emtansine

Powder for I.V. infusion 100 mg

Injection

Kadcyla

RO

MP

C4978 C4986 C6096 C6129

D

Powder for I.V. infusion 160 mg

Injection

Kadcyla

RO

MP

C4978 C4986 C6096 C6129

D

Vinblastine

Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL

Injection

Hospira Pty Limited

PF

MP

D

Vinblastine Teva

DZ

MP

D

Vincristine

I.V. injection containing vincristine sulfate 1 mg in 1 mL

Injection

Hospira Pty Limited

PF

MP

D

Vinorelbine

Solution for I.V. infusion 10 mg (as tartrate) in 1 mL

Injection

Hospira Pty Limited

PF

MP

PB

Navelbine

FB

MP

PB

Vinorelbine Ebewe

SZ

MP

PB

Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

Injection

Hospira Pty Limited

PF

MP

PB

Navelbine

FB

MP

PB

Vinorelbine Ebewe

SZ

MP

PB

 


Part 2Chemotherapy drugs and related information

 

Listed Drug

Purposes

Maximum Amount

Number of Repeats

Arsenic

P4793 P5997

18

89

P6018

18

140

Bendamustine

200

11

Bevacizumab

P4814

900

5

P4584 P4587 P4594 P4939 P4968

900

11

P6337 P6338 P6353

1800

7

Bleomycin

30000

11

Blinatumomab

P6895

651

0

P6893 P6894

784

0

P6892

784

2

Bortezomib

P4080 P4081

3000

11

P4161 P4162 P7390 P7414 P7416

3000

15

P7376 P7402

3000

19

P7377 P7389

3000

31

Brentuximab vedotin

P6903 P6936 P7244

200

3

P4675 P6904 P6941

200

11

Cabazitaxel

55

5

Carboplatin

900

5

Carfilzomib

 

120

17

Cetuximab

P4788

550

5

P4945

550

11

P4912

550

18

P4785 P4794 P4908 P4965

880

0

Cisplatin

220

14

Cladribine

17

6

Cyclophosphamide

2800

17

Cytarabine

7000

15

Docetaxel

250

5

Doxorubicin

135

11

Doxorubicin - pegylated liposomal

100

5

Epirubicin

220

5

Eribulin

P7258 P7280

3

7

 

P4649

3

13

Etoposide

440

14

Fludarabine

55

29

Fluorouracil

P6297

1000

23

P6266

5500

11

Fotemustine

220

8

Gemcitabine

3000

17

Idarubicin

30

5

Ifosfamide

4000

19

Ipilimumab

360

3

Irinotecan

800

11

Methotrexate

250

5

P6276

20000

0

Mitozantrone

30

5

Nivolumab

P6070 P6095 P6988 P6996

360

8

P6111 P6993 P6997 P6999

360

11

Obinutuzumab

1000

7

Ofatumumab

300

0

1000

5

Oxaliplatin

300

11

Paclitaxel

450

3

Paclitaxel, nanoparticle albumin-bound

P4657

275

11

P6106 P6119

580

5

Panitumumab

P5439 P5447

720

5

P5452 P5526

720

9

Pembrolizumab

P6806 P6817

240

5

P6801

240

7

Pemetrexed

1100

5

Pertuzumab

P4971

420

3

P5013

840

0

P5023

840

1

Raltitrexed

7

8

Rituximab

P7399

800

5

 

P6011 P7400

800

7

 

P6161

800

11

Topotecan

3500

17

Trastuzumab

P4104 P4156

250

9

P4142 P4164

500

0

P4083 P4093 P5024 P5825 P5834

750

3

P4143 P4144 P5032 P5844

1000

0

P5041

1000

3

Trastuzumab emtansine

450

8

Vinblastine

20

17

Vincristine

2

7

Vinorelbine

70

7

 


Schedule 2Related pharmaceutical benefits

(sections 3, 4, 6, 8, 10, 12, 13 and 22)

  

 

Listed Drug

Form

Manner of Administration

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Section 100 only

Aprepitant

Capsule 165 mg

Oral

Emend

MK

MP

C4216 C4223 C6383 C6464

1

5

C

Bacillus Calmette and Guerin, Tice strain

Vial containing powder for intravesical administration approximately 5 x 108 CFU

Intravesical

OncoTICE

MK

MP

C5597

3

1

C

Folinic acid

Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

Injection

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

10

2

Leucovorin Calcium (Pfizer Australia Pty Ltd)

PF

MP

10

2

Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL

Injection

Calcium Folinate Ebewe

SZ

MP

10

1

Leucovorin Calcium (Pfizer Australia Pty Ltd)

PF

MP

10

1

Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL

Injection

Calcium Folinate Ebewe

SZ

MP

4

1

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

4

1

Injection containing calcium folinate equivalent to 1000 mg folinic acid in 100 mL

Injection

Calcium Folinate Ebewe

SZ

MP

1

1

Tablet containing calcium folinate equivalent to 15 mg folinic acid

Oral

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

C5973

10

0

C

Fosaprepitant

Powder for I.V. infusion 150 mg

Injection

Emend IV

MK

MP

C6852 C6886 C6887 C6891

1

5

Granisetron

Concentrated injection 3 mg (as hydrochloride) in 3 mL

Injection

Granisetron Kabi

PK

MP

C4139

1

0

C

Granisetron-AFT

AE

MP

C4139

1

0

C

Kytril

IX

MP

C4139

1

0

C

Tablet 2 mg (as hydrochloride)

Oral

Kytril

IX

MP

C4139

2

0

C

Interferon alfa-2a

Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe

Injection

Roferon-A

RO

MP

C6661 C6662 C6678

P6662 P6678

15

4

C

MP

C6661 C6662 C6678

P6661

15

5

C

Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe

Injection

Roferon-A

RO

MP

C6661 C6678

P6678

5

4

C

MP

C6661 C6678

P6661

5

5

C

Interferon alfa-2b

Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen

Injection

Intron A Redipen

MK

MP

C6639 C6661 C6662

P6662

3

4

C

MP

C6639 C6661 C6662

P6639 P6661

3

5

C

Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen

Injection

Intron A Redipen

MK

MP

C6639 C6661

3

5

C

Mesna

Solution for I.V. injection 400 mg in 4 mL ampoule

Injection

Uromitexan

BX

MP

C5130

15

5

C

Solution for I.V. injection 1 g in 10 mL ampoule

Injection

Uromitexan

BX

MP

C5130

15

5

C

Netupitant with Palonosetron

Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride)

Oral

Akynzeo

MF

MP

C5991 C5994 C6879 C6937

1

5

Ondansetron

I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

Injection

Ondansetron Alphapharm

AF

MP

C5749

1

0

C

Onsetron

ZP

MP

C5749

1

0

C

I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

Injection

Ondansetron Alphapharm

AF

MP

C5749

1

0

C

Onsetron

ZP

MP

C5749

1

0

C

Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

Oral

Zofran syrup 50 mL

AS

MP

C5778

1

0

C

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron AN ODT

EA

MP

C5743

4

0

C

Ondansetron ODT GH

GQ

MP

C5743

4

0

C

Ondansetron ODT-DRLA

RZ

MP

C5743

4

0

C

Ondansetron SZ ODT

HX

MP

C5743

4

0

C

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

TX

MP

C5778

4

0

C

Ondansetron AN

EA

MP

C5778

4

0

C

Ondansetron SZ

HX

MP

C5778

4

0

C

Ondansetron-DRLA

RZ

MP

C5778

4

0

C

Onsetron 4

ZP

MP

C5778

4

0

C

Zofran

AS

MP

C5778

4

0

C

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron AN ODT

EA

MP

C5743

4

0

C

Ondansetron ODT GH

GQ

MP

C5743

4

0

C

Ondansetron ODT-DRLA

RZ

MP

C5743

4

0

C

Ondansetron SZ ODT

HX

MP

C5743

4

0

C

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

TX

MP

C5778

4

0

C

Ondansetron AN

EA

MP

C5778

4

0

C

Ondansetron SZ

HX

MP

C5778

4

0

C

Ondansetron-DRLA

RZ

MP

C5778

4

0

C

Onsetron 8

ZP

MP

C5778

4

0

C

Zofran

AS

MP

C5778

4

0

C

Wafer 4 mg

Oral

Zofran Zydis

AS

MP

C5743

4

0

C

Wafer 8 mg

Oral

Zofran Zydis

AS

MP

C5743

4

0

C

Palonosetron

Injection 250 micrograms (as hydrochloride) in 5 mL

Injection

Aloxi

MF

MP

C5805

1

0

C

Rituximab

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL

Injection

Mabthera SC

RO

MP

C6011 C6161 C7399 C7400

P7399

1

5

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P7400

1

6

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P6011

1

7

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P6161

1

11

 

Trastuzumab

Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL

Injection

Herceptin SC

RO

MP

C5024 C5032 C5041 C6059 C6060 C6061 C6062

P5032 P6059 P6060

1

0

MP

C5024 C5032 C5041 C6059 C6060 C6061 C6062

P5024 P5041 P6061 P6062

1

3

Tropisetron

I.V. injection 5 mg (as hydrochloride) in 5 mL

Injection

Tropisetron-AFT

AE

MP

C5749

1

0

C

 


Schedule 3Responsible Person Codes

(section 6)

  

 

Code

Responsible Person

ABN

AE

AFT Pharmaceuticals Pty Ltd

 29 105 636 413

AF

Alphapharm Pty Ltd

 93 002 359 739

AN

Amgen Australia Pty Ltd

 31 051 057 428 

AS

Aspen Pharmacare Australia Pty Limited

 51 096 236 985

BQ

Bristol‑Myers Squibb Australia Pty Ltd

 33 004 333 322

BX

Baxter Healthcare Pty Ltd

 43 000 392 781

DZ

Medsurge Healthcare Pty Ltd

92 124 728 892

EA

Amneal Pharmaceuticals Pty Ltd

 11 163 167 851

ED

Amneal Pharmaceuticals Pty Ltd

 11 163 167 851

EF

Amneal Pharmaceuticals Pty Ltd

 11 163 167 851

EI

Eisai Australia Pty Ltd

 73 117 970 993

FB

Pierre Fabre Medicament Australia Pty Ltd

 30 098 999 850

GQ

Generic Health Pty Ltd

93 110 617 859

HX

Sandoz Pty Ltd

 60 075 449 553

IX

Clinect Pty Ltd

76 150 558 473

JC

Janssen‑Cilag Pty Ltd

 47 000 129 975

JU

Juno Pharmaceuticals Pty Ltd

55 156 303 650

LR

Cipla Australia Pty Ltd

46 132 155 063

LY

Eli Lilly Australia Pty Ltd

 39 000 233 992

MF

Mundipharma Pty Limited

87 081 322 509

MK

Merck Sharp & Dohme (Australia) Pty Ltd

 14 000 173 508

NV

Novartis Pharmaceuticals Australia Pty Limited

 18 004 244 160

OA

Orphan Australia Pty Ltd

 11 067 189 342

OC

Accord Healthcare Pty Ltd

 49 110 502 513

OD

Accord Healthcare Pty Ltd

 49 110 502 513

OE

Omegapharm Pty Ltd

 86 128 078 151

PF

Pfizer Australia Pty Ltd

 50 008 422 348

PK

Fresenius Kabi Australia Pty Limited

 39 109 383 593

PL

The Trustee for Virgo Unit Trust (trading as Phebra)

 77 695 661 635

RA

Ranbaxy Australia Pty Limited

17 110 871 826

RO

Roche Products Pty Ltd

 70 000 132 865

RZ

Dr Reddy’s Laboratories (Australia) Pty Ltd

 16 120 092 408

SE

Servier Laboratories (Aust.) Pty Ltd

 54 004 838 500

SG

Merck Serono Australia Pty Ltd

 72 006 900 830

SW

sanofi‑aventis Australia Pty Ltd

 31 008 558 807

SZ

Sandoz Pty Ltd

 60 075 449 553

TB

Teva Pharma Australia Pty Limited

41 169 715 664

TK

Takeda Pharmaceuticals Australia Pty Ltd

 71 095 610 870

TS

Specialised Therapeutics Australia Pty Ltd

 73 124 031 241

TX

Apotex Pty Ltd

 52 096 916 148

ZP

Spirit Pharmaceuticals Pty Ltd

 67 109 225 747

 


Schedule 4Circumstances and Purposes Codes

(sections 8 to 12, 22 and 24)

  

 

Listed Drug

Circumstances Code

Purposes Code

Circumstances and Purposes

Authority Requirements
(part of Circumstances)

Aprepitant

C4216

 

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 4216

C4223

 

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 4223

C6383

 

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 6383

C6464

 

Acute promyelocytic leukaemia

Induction and consolidation treatment

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction.

Compliance with Authority Required procedures - Streamlined Authority Code 6464

Arsenic

C4793

P4793

Acute promyelocytic leukaemia

Induction and consolidation treatment

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction.

Compliance with Authority Required procedures - Streamlined Authority Code 4793

C5997

P5997

Acute promyelocytic leukaemia

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.

Compliance with Authority Required procedures - Streamlined Authority Code 5997

C6018

P6018

Acute promyelocytic leukaemia

Induction and consolidation treatment

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.

Compliance with Authority Required procedures - Streamlined Authority Code 6018

Bacillus Calmette and Guerin, Tice strain

C5597

 

Primary and relapsing superficial urothelial carcinoma of the bladder

 

Bendamustine

C6075

 

Previously untreated stage III or IV indolent CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with rituximab; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6075

C6124

 

Previously untreated stage III or IV CD20 positive mantle cell lymphoma

Induction treatment

The treatment must be in combination with rituximab; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND
Patient must not be eligible for stem cell transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 6124

Bevacizumab

C4584

P4584

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 4584

C4587

P4587