PB 117 of 2010
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 20101
National Health Act 1953
I, DAVID LEARMONTH, Deputy Secretary, Department of Health and Ageing, make this Special Arrangement under subsections 100 (1) and (2) of the National Health Act 1953.
Dated  29 November  2010
 
Signed. D Learmonth
Deputy Secretary,
Department of Health and Ageing
Contents
Part 1                    Preliminary                                                                                    4
Division 1                General                                                                                             4
                        1     Name of Special Arrangement                                                              4
                        2     Commencement                                                                                  4
                        3     Revocation                                                                                          4
                        4     Definitions                                                                                           4
Division 2                Chemotherapy pharmaceutical benefits                                           6
                        5     Pharmaceutical benefits covered by this Special Arrangement                 6
                        6     Application of Part VII of the Act                                                           6
                        7     Responsible person                                                                             6
                        8     Authorised prescriber                                                                           6
                        9     Prescription circumstances                                                                  7
                       10     Methods of prescribing a chemotherapy pharmaceutical benefit               7
                       11     Information to be included in medication chart                                        8
Division 3                Authority required procedures                                                          8
                       12     Authority required procedures                                                               8
                       13     Authority required procedures — submission of paragraph 10 (1) (a) prescription           9
                       14     Authority required procedures — authorisation of paragraph 10 (1) (a) prescription         10
                       15     Authority required procedures — submission of paragraph 10 (1) (b) medication chart   11
                       16     Authority required procedures — authorisation of paragraph 10 (1) (b) medication chart 12
                       17     Streamlined Authority Code                                                                12
Division 4                Maximum quantity and maximum number of repeats                    12
                       18     Maximum quantity                                                                             12
                       19     Variation to maximum quantity or number of units                                 13
                       20     Maximum number of repeats — paragraph 10 (1) (a) prescription           13
                       21     Maximum number of repeats — paragraph 10 (1) (b) medication chart    14
Division 5                Section 100 only                                                                              14
                       22     Section 100 only supply                                                                     14
Part 2                    Supply of chemotherapy pharmaceutical benefits          16
                       23     Entitlement to chemotherapy pharmaceutical benefits                           16
                       24     Supply of chemotherapy pharmaceutical benefits under this Special Arrangement         16
                       25     Certain regulations not to apply to paragraph 10 (1) (b) medication charts 16
                       26     Acknowledging receipt of supplied chemotherapy pharmaceutical benefits 16
Part 3                    Claims and payment                                                                17
Division 1                Claims for payment                                                                         17
                       27     How claims to be made                                                                      17
                       28     Claims for payment for supply of a chemotherapy pharmaceutical benefit — paragraph 10 (1) (b) medication chart                                                                                17
Division 2                Payments to approved hospital authorities                                     18
                       29     Payments to approved hospital authorities                                           18
                       30     Method of working out dispensed price                                                18
Division 3                Dispensed price                                                                               18
                       31     Dispensed price for supply of a chemotherapy pharmaceutical benefit    18
                       32     Where quantity is less than in manufacturers’ pack                              19
                       33     Lowest price to be applied                                                                  19
                       34     Rounding of dispensed price                                                               19
Part 4                    Patient contributions                                                               20
                       35     Patient contribution for chemotherapy pharmaceutical benefits mentioned in Schedule 4           20
                       36     Patient contribution for chemotherapy pharmaceutical benefits not mentioned in Schedule 4      20
                       37     Additional patient contributions                                                           20
Schedule 1             Pharmaceutical benefits covered by this Special Arrangement and related information 21
Schedule 2             Responsible Person Codes                                                              46
Schedule 3             Circumstances and Purposes Codes                                                46
Schedule 4             Patient contributions                                                                       47
 
 
Part 1                 Preliminary
Division 1              General
1              Name of Special Arrangement
         (1)   This Special Arrangement is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010.
         (2)   This Special Arrangement may also be cited as PB 117 of 2010.
2              Commencement
                This Special Arrangement commences on 1 December 2010.
3              Revocation
                Instrument PB 55 of 2009 is revoked.
4              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.
approved hospital means a public hospital that:
                (a)    has an approved hospital authority; and
               (b)    is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Health Care Agreement.
approved hospital authority, for an approved hospital, means the hospital authority for the hospital that is approved by the Minister under section 94 of the Act.
authorised prescriber, for a chemotherapy pharmaceutical benefit, means a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised Prescriber’ for the benefit.
benefit card means any of the following:
                (a)    a PBS Entitlement Card;
               (b)    a PBS Safety Net Concession Card;
                (c)    a Pensioner Concession Card;
               (d)    a Health Care Card (including Low Income Health Care Card and Foster Child Health Care Card);
                (e)    a Commonwealth Seniors Health Card;
                (f)    a Cleft Lip and Palate Card;
                (g)    a DVA Gold Card;
                (h)    a DVA White Card;
                 (i)    a DVA Orange Card;
                (j)    War Widow/Widower Transport Card;
               (k)    a card or voucher approved by the Medicare Australia CEO for this paragraph.
chemotherapy pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
circumstances code means the letter ‘C’ followed by a number.
dispensed price, for the supply of a chemotherapy pharmaceutical benefit by an approved hospital authority, has the meaning given by section 31.
eligible medical practitioner, for the prescription of a chemotherapy pharmaceutical benefit under this Special Arrangement to an eligible patient, means a medical practitioner who is affiliated with the approved hospital at or from which the eligible patient is receiving treatment.
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 medical treatment by an eligible medical practitioner at, or from, an approved hospital as:
                          (i)    a non-admitted patient; or
                         (ii)    a day admitted patient; or
                         (iii)    a patient on discharge.
entitlement number, for an eligible patient, means the number listed on the patient’s benefit card.
hospital authority means the governing body of a public hospital.
manufacturers’ pack has the same meaning as in subsection 6 (2) of the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010, as in force from time to time.
prescriber code has the meaning given by paragraph 8 (2) (b).
purposes code means the letter ‘P’ followed by a number.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
Streamlined Authority Code means the code mentioned in section 17.
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:
·      Medicare Australia CEO
·      pharmaceutical benefit
·      pharmaceutical item
·      public hospital
·      Secretary.
Division 2              Chemotherapy pharmaceutical benefits
5              Pharmaceutical benefits covered by this Special Arrangement
         (1)   This Special Arrangement applies to each chemotherapy pharmaceutical benefit mentioned in Schedule 1.
         (2)   Each chemotherapy pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note   Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85 (2) of the Act.  The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsection 85 (3), (5) and (6) of the Act respectively.
6              Application of Part VII of the Act
         (1)   Each chemotherapy pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
         (2)   A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.
Note   See subsection 100 (3) of the Act.
7              Responsible person
         (1)   If a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2) (a) is the responsible person for the brand of the pharmaceutical item.
         (2)   For subsection (1):
                (a)    the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and
               (b)    the pharmaceutical item is the listed drug mentioned in Schedule 1:
                          (i)    in the form mentioned in Schedule 1 for the listed drug; and
                         (ii)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note   A person identified by a code in the column headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be a responsible person for the brand of the pharmaceutical item.
8              Authorised prescriber
         (1)   Only an authorised prescriber may write a prescription for the supply of a chemotherapy pharmaceutical benefit to an eligible patient.
         (2)   For this Special Arrangement:
                (a)    only an eligible medical practitioner is an authorised prescriber; and
               (b)    the prescriber code for the authorised prescriber is the letters ‘EMP’.
         (3)   A reference in this Special Arrangement to an eligible medical practitioner is a reference to an authorised prescriber.
         (4)   For subsection (1), the chemotherapy pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
         (5)   Subsections 88(1), 88(1A), 88(1C), 88(1D) and 88(1E) of the Act do not apply to the supply of a chemotherapy pharmaceutical benefit under this Special Arrangement.
9              Prescription circumstances
         (1)   If at least 1 circumstance code is mentioned in the column in Schedule 1 headed ‘Circumstances’ for the chemotherapy pharmaceutical benefit, the circumstances mentioned in Schedule 3 for the code are the circumstances in which a prescription for the supply of the chemotherapy pharmaceutical benefit may be made.
         (2)   For subsection (1), the chemotherapy pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note   Circumstances for a code mentioned in the column headed ‘Circumstances’ in Schedule 1 have been determined by the Minister under paragraph 85 (7) (b) of the Act.
10            Methods of prescribing a chemotherapy pharmaceutical benefit
         (1)   An eligible medical practitioner may prescribe a chemotherapy pharmaceutical benefit under this Special Arrangement by:
                (a)    writing a prescription for the chemotherapy pharmaceutical benefit in accordance with regulation 19 of the Regulations; or
               (b)    preparing a medication chart for the chemotherapy pharmaceutical benefit in accordance with section 11.
         (2)   A medication chart prepared in accordance with section 11 is taken to be a duly written prescription for regulation 19 of the Regulations.
11            Information to be included in medication chart
                For paragraph 10 (1) (b), a medication chart for an eligible patient must include the following information:
                (a)    the name and provider number of the hospital where the chart is prepared;
               (b)    the name, signature and prescriber number of the eligible medical practitioner;
                (c)    the Streamlined Authority Code for the chemotherapy pharmaceutical benefit, if applicable;
               (d)    the patient’s name and address;
                (e)    a patient’s entitlement number, if applicable;
                (f)    the name of the chemotherapy pharmaceutical benefit;
                (g)    the strength of the chemotherapy pharmaceutical benefit;
                (h)    the quantity or dosage of the chemotherapy pharmaceutical benefit or both the quantity and dosage of the chemotherapy pharmaceutical benefit;
                 (i)    if the dosage of the chemotherapy pharmaceutical benefit is provided under paragraph (h) — how often the chemotherapy pharmaceutical benefit is to be taken by the patient and the period that the  chemotherapy pharmaceutical benefit is prescribed;
                (j)    the date the medication chart is prepared.
Division 3              Authority required procedures
12            Authority required procedures
         (1)   This section applies to a chemotherapy pharmaceutical benefit if the circumstances mentioned in Schedule 3 for a circumstances code mentioned in Schedule 1 for the chemotherapy pharmaceutical benefit include any of the following:
                (a)    Compliance with Authority Required procedures;
               (b)    Compliance with Written Authority Required procedures;
                (c)    Compliance with Telephone Authority Required procedures;
               (d)    Compliance with Written or Telephone Authority Required procedures.
         (2)   A prescription written in accordance with paragraph 10 (1) (a) for the supply of the chemotherapy pharmaceutical benefit must be:
                (a)    submitted by the eligible medical practitioner to the Medicare Australia CEO in accordance with section 13; and
               (b)    authorised by the Medicare Australia CEO in accordance with section 14.
         (3)   A medication chart prepared in accordance with paragraph 10 (1) (b) for the supply of the chemotherapy pharmaceutical benefit must be:
                (a)    submitted by a pharmacist employed by the approved hospital authority to the Medicare Australia CEO in accordance with section 15; and
               (b)    authorised by the Medicare Australia CEO in accordance with section 16.
13            Authority required procedures — submission of paragraph 10 (1) (a) prescription
         (1)   If subsection 12 (2) applies to a prescription for the supply of a chemotherapy pharmaceutical benefit, the eligible medical practitioner must:
                (a)    deliver or post to the Medicare Australia CEO a prescription for the supply of the chemotherapy pharmaceutical benefit, prepared and signed by the eligible medical practitioner:
                          (i)    in a form approved by the Secretary and completed by the eligible medical practitioner in ink in his or her own handwriting; or
                         (ii)    in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subparagraph (i); or
                         (iii)    in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
                        (iv)    by a method approved in writing by the Secretary; or      
               (b)    submit to the Medicare Australia CEO, by telephone, details of a prescription for the supply of the pharmaceutical benefit prepared and signed by the eligible medical practitioner in accordance with subparagraph (a) (i), (ii), (iii) or (iv); or 
                (c)    if the eligible medical practitioner has attempted to give details of the prescription to the Medicare Australia CEO in accordance with paragraph (b) but has been unable to do so because the telephone system established by the Medicare Australia CEO for the provision of such authorisations was unavailable — submit the prescription in accordance with the instructions in an emergency telephone message provided to the eligible medical practitioner by the Medicare Australia CEO; or
               (d)    submit to the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of a prescription for the supply of the chemotherapy pharmaceutical benefit prepared and signed by the eligible medical practitioner in accordance with subparagraph (a) (i), (ii), (iii) or (iv).
         (2)   If a circumstance mentioned in Schedule 3 for a circumstances code applying to the chemotherapy pharmaceutical benefit includes Compliance with Written Authority Required procedures, the eligible medical practitioner must submit a prescription for the supply of the chemotherapy pharmaceutical benefit to the Medicare Australia CEO in accordance with paragraph (1) (a).
         (3)   If a circumstance mentioned in Schedule 3 for a circumstances code applying to the chemotherapy pharmaceutical benefit includes Compliance with Telephone Authority Required procedures, the eligible medical practitioner must submit a prescription for the supply of the chemotherapy pharmaceutical benefit to the Medicare Australia CEO in accordance with paragraph (1) (b) or (c).
         (4)   If a circumstance mentioned in Schedule 3 for a circumstances code applying to the chemotherapy pharmaceutical benefit includes Compliance with Written or Telephone Authority Required procedures, the eligible medical practitioner must submit a prescription for the supply of the chemotherapy pharmaceutical benefit to the Medicare Australia CEO in accordance with paragraph (1) (a), (b) or (c).
         (5)   For paragraph (1) (a), a prescription prepared and signed by the eligible medical practitioner in accordance with subsection (1) is taken to have been submitted by the eligible medical practitioner if it is submitted by his or her employee.
14            Authority required procedures — authorisation of paragraph 10 (1) (a) prescription
         (1)   A prescription submitted in accordance with paragraph 13 (1) (a) may be authorised by the Medicare Australia CEO:
                (a)    signing his or her authorisation on the prescription; and
               (b)    either:
                          (i)    if the Medicare Australia CEO requires the eligible medical practitioner to alter the prescription — returning it to the eligible medical practitioner for alteration before the eligible medical practitioner gives it to the person in respect of whom it was prepared; or
                         (ii)    in any other case:
                                   (A)     returning the authorised prescription to the eligible medical practitioner; or
                                   (B)     sending it to the person in respect of whom it was prepared.
         (2)   A prescription submitted in accordance with paragraph 13 (1) (b) may be authorised by the Medicare Australia CEO telling the eligible medical practitioner by telephone, at the time the Medicare Australia CEO is given details of the prescription, that the prescription is authorised.
         (3)   A prescription submitted in accordance with paragraph 13 (1) (d) may be authorised by the Medicare Australia CEO sending his or her authorisation by electronic communication, to the eligible medical practitioner.
         (4)   If the Medicare Australia CEO authorises a prescription under subsection (2) or (3):
                (a)    the Medicare Australia CEO must tell the eligible medical practitioner by telephone or by electronic communication the number given by the CEO to the prescription; and
               (b)    the eligible medical practitioner must:
                          (i)    mark that number on the prescription; and
                         (ii)    retain a copy of the prescription for 1 year from the date the prescription was authorised. 
         (5)   A prescription submitted in accordance with paragraph 13 (1) (c) is taken to have been authorised by the Medicare Australia CEO if the eligible medical practitioner completes the prescription in accordance with the instructions given in the emergency telephone message.         
15            Authority required procedures — submission of paragraph 10 (1) (b) medication chart
         (1)   If subsection 12 (3) applies to a medication chart prepared in accordance with paragraph 10 (1) (b) for the supply of a chemotherapy pharmaceutical benefit, a pharmacist employed by the approved hospital authority must, on behalf of the eligible medical practitioner, submit the information mentioned in section 11 to the Medicare Australia CEO by means of an electronic communication of a kind approved by the Medicare Australia CEO.
         (2)   If a circumstance mentioned in paragraph (3) (a) or (b) applies, an authorisation for the supply of the chemotherapy pharmaceutical benefit may be obtained if the eligible medical practitioner prepares a prescription in accordance with paragraph 10 (1) (a) and submits that prescription in accordance with section 13 for authorisation under section 14.
         (3)   For subsection (2), the circumstances are:
                (a)    the pharmacist attempted to submit the information in accordance with subsection (1) but was unable to do so because the system established by the Medicare Australia CEO for the provision of such authorisation was unavailable; or
               (b)    the pharmacist submitted the information in accordance with subsection (1) but the authorisation was not granted by the system established by the Medicare Australia CEO.       
16            Authority required procedures — authorisation of paragraph 10 (1) (b) medication chart
                If the information in the medication chart is submitted in accordance with subsection 15 (1), the supply of the chemotherapy pharmaceutical benefit is taken to have been authorised when:
                (a)    the pharmacist receives a message by electronic communication from the system established by the Medicare Australia CEO indicating that the authorisation has been granted; and
               (b)    the pharmacist completes the medication chart in accordance with the instructions given by the message mentioned in paragraph (a).
17            Streamlined Authority Code
         (1)   This section applies to a chemotherapy pharmaceutical benefit if the circumstances mentioned in Schedule 3 for a circumstances code applying to the chemotherapy pharmaceutical benefit include the words ‘Streamlined Authority Code’ followed by a number.
         (2)   The requirements of section 13 are taken to have been complied with, and the Medicare Australia CEO is taken to have authorised the prescription of the chemotherapy pharmaceutical benefit under section 14, if the eligible medical practitioner has:
                (a)    prepared and signed a prescription for the supply of the chemotherapy pharmaceutical benefit in accordance with subparagraph 13 (a) (i), (ii), (iii) or (iv); and
               (b)    has written the Streamlined Authority Code on the prescription.
         (3)   The requirements of section 15 are taken to have been complied with, and the supply of the chemotherapy pharmaceutical benefit is taken to be authorised under section 16, if the eligible medical practitioner has prepared a medication chart in accordance with paragraph 10 (1) (b).
Division 4              Maximum quantity and maximum number of repeats
18            Maximum quantity
         (1)   This section applies subject to section 19.
         (2)   The maximum quantity or number of units of the pharmaceutical item in a chemotherapy pharmaceutical benefit that may, in 1 prescription for the supply of the chemotherapy pharmaceutical benefit, be directed to be supplied by an eligible medical practitioner is the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for the chemotherapy pharmaceutical benefit.
         (3)   If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for a chemotherapy pharmaceutical benefit, the quantity or number of the units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 3.
         (4)   If no purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’, the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy pharmaceutical benefit.
         (5)   For subsection (2), the pharmaceutical item is the listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
         (6)   For this section, the chemotherapy pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.          
Note   The maximum quantities and numbers of units mentioned in the column headed ‘Maximum quantity’ in Schedule 1 have been determined by the Minister under paragraph 85A (2) (a) of the Act.
19            Variation to maximum quantity or number of units
                If an eligible medical practitioner prescribes a supply of a chemotherapy pharmaceutical benefit that is greater than the maximum quantity or number of units permitted under section 18, the supply of a chemotherapy pharmaceutical benefit must be:
                (a)    if the prescription was written in accordance with paragraph 10 (1) (a) — authorised in accordance with the procedures mentioned in regulation 13 of the Regulations; and
               (b)    if a medication chart was prepared in accordance with paragraph 10 (1) (b) — authorised in accordance with the procedures mentioned in section 15.
20            Maximum number of repeats — paragraph 10 (1) (a) prescription
         (1)   If a prescription for the supply of a chemotherapy pharmaceutical benefit is written in accordance with paragraph 10 (1) (a), the maximum number of occasions an eligible medical practitioner may, in 1 prescription, direct that the supply of the chemotherapy pharmaceutical benefit be repeated is the number in the column in Schedule 1 headed ‘Number of Repeats’ for the chemotherapy pharmaceutical benefit.
         (2)   If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for the pharmaceutical benefit, the number of repeats mentioned in the column in Schedule 1 headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 3 for each code.
         (3)   If no purposes code is mentioned in the column headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.
         (4)   If a prescription is written in accordance with paragraph 10 (1) (a) for the repeat supply of a chemotherapy pharmaceutical benefit that is greater than the maximum number of occasions an eligible medical practitioner may, in 1 prescription, direct the repeat supply of a chemotherapy pharmaceutical benefit under this section, the prescription must be authorised in accordance with the procedures mentioned in regulation 13 of the Regulations.
         (5)   Nothing in this Special Arrangement is intended to modify the operation of regulation 24 in relation to a prescription written in accordance with paragraph 10 (1) (a).
         (6)   For this section, the chemotherapy pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
                (a)    in the form mentioned in Schedule 1 for the listed drug; and
               (b)    with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note   The numbers of repeats mentioned in the column headed ‘Number of Repeats’ have been determined by the Minister under paragraph 85A (2) (b) of the Act.    
21            Maximum number of repeats — paragraph 10 (1) (b) medication chart
         (1)   If an eligible medical practitioner prescribes a chemotherapy pharmaceutical benefit in a medication chart in accordance with paragraph 10 (1) (b), the eligible medical practitioner may not direct the repeat supply of the chemotherapy pharmaceutical benefit in 1 prescription.
         (2)   If the medication chart contains a direction that the supply of a chemotherapy pharmaceutical benefit be repeated, the direction is invalid.
Division 5              Section 100 only
22            Section 100 only supply
         (1)   If the letter ‘D’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.
         (2)   A chemotherapy pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note   The Minister has declared, under subsection 85 (2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
         (3)   If the letters ‘PB’ are mentioned in the column in Schedule 1 headed ‘Section 100 only’ for a chemotherapy pharmaceutical benefit, the chemotherapy pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the chemotherapy pharmaceutical benefit.
         (4)   A chemotherapy 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 chemotherapy pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.
         (5)   If the letter ‘C’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for a chemotherapy pharmaceutical benefit, the chemotherapy pharmaceutical benefit may be supplied in the circumstances mentioned in Schedule 3 for the circumstances code in the column headed ‘Circumstances’ only in accordance with this Special Arrangement and any other Special Arrangement relating to the chemotherapy pharmaceutical benefit.
         (6)   A chemotherapy pharmaceutical benefit mentioned in subsection (5) is not available in the circumstances mentioned in subsection (5) for general supply on the Pharmaceutical Benefits Scheme.
Part 2                 Supply of chemotherapy pharmaceutical benefits
23            Entitlement to chemotherapy pharmaceutical benefits
                Subject to this Special Arrangement, a person who is an eligible patient is entitled to receive a chemotherapy pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made under Part 4.
24            Supply of chemotherapy pharmaceutical benefits under this Special Arrangement
                This Special Arrangement only applies to the supply of a chemotherapy pharmaceutical benefit to an eligible patient by an approved hospital authority of an approved hospital.
25            Certain regulations not to apply to paragraph 10 (1) (b) medication charts
                If the supply of a chemotherapy pharmaceutical benefit is prescribed in accordance with paragraph 10 (1) (b), regulations 22, 26A and 31 and subregulations 25 (2), (3) and (4) of the Regulations do not apply to the supply of the chemotherapy pharmaceutical benefit.
26            Acknowledging receipt of supplied chemotherapy pharmaceutical benefits
                If the supply of a chemotherapy pharmaceutical benefit is prescribed in accordance with paragraph 10 (1) (b), the eligible medical practitioner or an employee of the approved hospital authority must on the eligible patient’s medication chart:
                (a)    record the date that the chemotherapy pharmaceutical benefit was supplied to the eligible patient; and
               (b)    sign his or her name.
Part 3                 Claims and payment
Division 1              Claims for payment
27            How claims to be made
                An approved hospital authority of an approved hospital may make a claim for payment for the supply of the chemotherapy pharmaceutical benefit to an eligible patient under this Special Arrangement in accordance with section 99AAA of the Act, as modified by this Division.
28            Claims for payment for supply of a chemotherapy pharmaceutical benefit — paragraph 10 (1) (b) medication chart
         (1)   Subject to subsection (2), if an eligible medical practitioner prescribes a chemotherapy pharmaceutical benefit in a medication chart prepared in accordance with paragraph 10 (1) (b), the approved hospital authority must make a claim for the payment of the supply of the chemotherapy pharmaceutical benefit in accordance with section 99AAA and the rules determined by the Minister under subsection 99AAA (8) of the Act.
         (2)   For a claim mentioned in subsection (1), the requirements in section 99AAA and the rules determined by the Minister under subsection 99AAA (8) of the Act are modified by the following requirements:
                (a)    the approved hospital authority is not required to supply the medication chart prepared in accordance with paragraph 10 (1) (b) with the claim;
               (b)    the approved hospital authority must keep an electronic version of the information supplied with the claim under Schedules 1, 2 or 3 of the National Health Act 1953 Pharmaceutical Benefits Rules under Subsection 99AAA (8) for 1 years from the date the chemotherapy pharmaceutical benefit is supplied;
                (c)    if requested by the Medicare Australia CEO — the approved hospital authority must give the Medicare Australia CEO a copy of:
                          (i)    the medication chart mentioned in paragraph (a); and
                         (ii)    the information mentioned in paragraph (b).
Division 2              Payments to approved hospital authorities
29            Payments to approved hospital authorities
An approved hospital authority is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the chemotherapy pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under Part 4.
30            Method of working out dispensed price
                The dispensed price for the supply of a chemotherapy pharmaceutical benefit by an approved hospital authority is to be worked out under Division 3.
Division 3              Dispensed price
31            Dispensed price for supply of a chemotherapy pharmaceutical benefit
                Subject to section 33, the dispensed price for the supply of the chemotherapy pharmaceutical benefit by an approved hospital authority is as follows:
                (a)    if the quantity of the chemotherapy pharmaceutical benefit that is ordered and supplied is equal to the quantity contained in the manufacturers’ pack — the price ex-manufacturer for the pack;
               (b)    if the quantity of the chemotherapy pharmaceutical benefit that is ordered and supplied is less than the quantity contained in the manufacturers’ pack — the amount calculated in accordance with section 32.
                (c)    if the quantity of the chemotherapy pharmaceutical benefit that is ordered and supplied is more than the quantity contained in the manufacturers’ pack — the sum of:
                          (i)    the price ex-manufacturer for each complete pack contained in the quantity supplied; and
                         (ii)    the amount calculated in accordance with section 32 for the quantity supplied that is less than the quantity contained in the manufacturers’ pack.
32            Where quantity is less than in manufacturers’ pack
                If the quantity of a chemotherapy pharmaceutical benefit that is ordered and supplied is less than the quantity contained in the manufacturers’ pack (a broken quantity), the amount mentioned in paragraph 31 (b) and subparagraph 31 (c) (ii) is to be calculated by:
                (a)    dividing the quantity or number of units in the broken quantity by the quantity or number of units in the manufacturers’ pack, expressed as a percentage of 2 decimal places; and
               (b)    applying that percentage to the price ex-manufacturer for each complete pack.
33            Lowest price to be applied
                If there are 2 or more chemotherapy pharmaceutical benefits mentioned in Schedule 1 that are different brands but have the same drug in the same form with the same manner of administration, the dispensed price of those chemotherapy pharmaceutical benefits is to be based on the price ex-manufacturer of the chemotherapy pharmaceutical benefit with the lowest dispensed price.
34            Rounding of dispensed price
                The dispensed price for the supply of a chemotherapy pharmaceutical benefit will in each case be taken to the nearest cent, one half cent being counted as one cent.
Part 4                 Patient contributions
35            Patient contribution for chemotherapy pharmaceutical benefits mentioned in Schedule 4       
         (1)   This section applies if the chemotherapy pharmaceutical benefit supplied by an approved hospital authority to an eligible patient is:
                (a)    a listed drug mentioned in the column in Schedule 4 headed ‘Listed Drug’; and
               (b)    in the form mentioned in the column in Schedule 4 headed ‘Form’ for the listed drug mentioned in paragraph (a); and
                (c)    administered in a manner mentioned in the column in Schedule 4 headed ‘Manner of ‘Manner of Administration’ for the listed drug mentioned in paragraph (a); and
               (d)    marketed under the brand mentioned in the column in Schedule 4 headed ‘Brand’ for the listed drug mentioned in paragraph (a).
         (2)   The approved hospital authority may charge the eligible patient:
                (a)    an amount not exceeding the amount that the patient could have been required to pay in accordance with subsection 87(2) of the Act if the patient had obtained the chemotherapy pharmaceutical benefit from an approved pharmacist; and
               (b)    an amount not exceeding the amount mentioned in subsection 37 (1).
36            Patient contribution for chemotherapy pharmaceutical benefits not mentioned in Schedule 4
         (1)   This section applies if the chemotherapy pharmaceutical benefit supplied by an approved hospital authority to an eligible patient is not mentioned in Schedule 4.
         (2)   The approved hospital authority may charge the eligible patient an amount not exceeding the amount that the patient could have been required to pay in accordance with subsection 87(2) of the Act if the patient had obtained the chemotherapy pharmaceutical benefit from an approved pharmacist.
37            Additional patient contributions
         (1)   For paragraph 35 (2) (b), the amount is the amount calculated by subtracting the amount for the chemotherapy pharmaceutical benefit mentioned in the column in Schedule 4 headed ‘Approved Ex-manufacturer Price’ from the amount mentioned for the chemotherapy pharmaceutical benefit in the column in Schedule 4 headed ‘Claimed Ex-manufacturer Price’.
         (2)   However, if the quantity of the chemotherapy pharmaceutical benefit being supplied is for more or less than the quantity mentioned in the column in Schedule 4 headed ‘Quantity or Number of Units’, the amounts mentioned in the columns in Schedule 4 headed ‘Approved Ex-manufacturer Price’ and ‘Claimed Ex-manufacturer Price’ must be adjusted proportionally.
Schedule 1        Pharmaceutical benefits covered by this Special Arrangement and related information
(sections 5, 7, 8, 9, 12, 17, 18, 20 and 22)
  
Listed Drug
Form
Manner of Administration
Brand
Responsible Person
Authorised Prescriber
Circumstances
Purposes
Maximum Quantity
Number of Repeats
Section 100 only

Aprepitant
Pack containing 1 capsule 125 mg and 2 capsules 80 mg
Oral
Emend
MK
EMP
C2071 C2330 C3446
 
1
0
 

Arsenic
Injection concentrate containing arsenic trioxide 10 mg in 10 mL
Injection
Phenasen
PL
EMP
C3150
 
60
2
 

"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)
Single dose set comprising 1 vial powder for intravesical administration containing 6.6 to 19.2 x 10 8  CFU and 1 vial diluent 3 mL
Intravesical
ImmuCyst
SW
EMP
C1419
 
3
1
 

"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)
Vial containing powder for intravesical administration approximately 5 x 10 8  CFU
Intravesical
OncoTICE
SH
EMP
C1290
 
3
1
 

Bevacizumab
Solution for I.V. infusion 100 mg in 4 mL
Injection
Avastin
RO
EMP
C3430 C3431
 
1
0
 

 
Solution for I.V. infusion 400 mg in 16 mL
Injection
Avastin
RO
EMP
C3430 C3431
 
1
0
 

Bleomycin
Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent)
Injection
Blenamax
SI
EMP
C1139 C1198
 
10
0
 

 
 
 
Blenoxane
BQ
EMP
C1139 C1198
 
10
0
 

 
 
 
Hospira Pty Limited
HH
EMP
C1139 C1198
 
10
0
 

Carboplatin
Solution for I.V. injection 50 mg in 5 mL
Injection
Carboplatin Ebewe
IT
EMP
 
 
2
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
2
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
2
0
 

 
Solution for I.V. injection 150 mg in 15 mL
Injection
Carboplatin Ebewe
IT
EMP
 
 
6
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
6
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
6
0
 

 
Solution for I.V. injection 450 mg in 45 mL
Injection
Carboplatin Ebewe
IT
EMP
 
 
2
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
2
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
2
0
 

Cetuximab
Solution for I.V. infusion 100 mg in 20 mL
Injection
Erbitux
SG
EMP
C2713 C2714 C2715
P2713 P2714
1
0
 

 
 
 
Erbitux
SG
EMP
C2713 C2714 C2715
P2715
1
6
 

 
Solution for I.V. infusion 500 mg in 100 mL
Injection
Erbitux
SG
EMP
C2713 C2714 C2715
P2713 P2714
1
0
 

 
 
 
Erbitux
SG
EMP
C2713 C2714 C2715
P2715
1
6
 

Cisplatin
I.V. injection 10 mg in 10 mL
Injection
Pfizer Australia Pty Ltd
PF
EMP
 
 
1
0
 

 
I.V. injection 50 mg in 50 mL
Injection
Hospira Pty Limited
HH
EMP
 
 
1
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
1
0
 

 
I.V. injection 100 mg in 100 mL
Injection
Cisplatin Ebewe
IT
EMP
 
 
1
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
1
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
1
0
 

Cladribine
Injection 10 mg in 5 mL
Injection
Litak
OA
EMP
C3180
 
7
0
 

 
Solution for I.V. infusion 10 mg in 10 mL single use vial
Injection
Leustatin
JC
EMP
C3180
 
7
0
 

Cyclophosphamide
Powder for injection 500 mg (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)
Injection
Endoxan
BX
EMP
 
 
2
0
 

 
Powder for injection 1 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)
Injection
Endoxan
BX
EMP
 
 
1
0
 

 
Powder for injection 2 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)
Injection
Endoxan
BX
EMP
 
 
1
0
 

Cytarabine
Injection 100 mg in 5 mL vial
Injection
Pfizer Australia Pty Ltd
PF
EMP
 
 
10
1
 

Docetaxel
Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent
Injection
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P3051
1
0
 

 
 
 
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P1194 P1742 P2416 P2439 P2732 P3292 P3428
2
0
 

 
Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
Injection
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
 
1
0
 

Dolasetron
Tablet containing dolasetron mesylate 200 mg
Oral
Anzemet
SW
EMP
C3050
 
2
0
 

 
I.V. injection containing dolasetron mesylate 100 mg in 5 mL
Injection
Anzemet
SW
EMP
C3050
 
1
0
 

Doxorubicin
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial
Injection/
intravesical
Adriamycin Solution
PF
EMP
 
 
4
0
 

 
 
 
Doxorubicin Ebewe
IT
EMP
 
 
4
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
4
0
 

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial
Injection/
intravesical
Adriamycin Solution
PF
EMP
 
 
4
0
 

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
Injection/
intravesical
Adriamycin Solution
PF
EMP
 
 
3
0
 

 
 
 
Doxorubicin Ebewe
IT
EMP
 
 
3
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
3
0
 

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial
Injection/
intravesical
Doxorubicin Ebewe
IT
EMP
 
 
1
0
 

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
Injection/
intravesical
Adriamycin
PF
EMP
 
 
1
0
 

 
 
 
Doxorubicin Ebewe
IT
EMP
 
 
1
0
 

Doxorubicin - Pegylated Liposomal
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
Injection
Caelyx
SH
EMP
C1568 C1795 C1796
 
1
0
 

 
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
Injection
Caelyx
SH
EMP
C1568 C1795 C1796
 
1
0
 

Epirubicin
Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
Injection/
intravesical
Epirubicin Ebewe
IT
EMP
 
 
4
0
 

 
 
 
Pharmorubicin Solution
PF
EMP
 
 
4
0
 

 
Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL
Injection/
intravesical
Pharmorubicin Solution
PF
EMP
 
 
4
0
 

 
Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
Injection/
intravesical
Epirubicin Ebewe
IT
EMP
 
 
4
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
4
0
 

 
 
 
Pharmorubicin Solution
PF
EMP
 
 
4
0
 

 
Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
Injection/
intravesical
Epirubicin Ebewe
IT
EMP
 
 
2
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
2
0
 

 
Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
Injection/
intravesical
Epirubicin Ebewe
IT
EMP
 
 
1
0
 

Etoposide
Solution for I.V. infusion 100 mg in 5 mL vial
Injection
Etoposide Ebewe
IT
EMP
 
 
5
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
5
0
 

 
Powder for I.V. infusion 100 mg (as phosphate)
Injection
Etopophos
BQ
EMP
 
 
5
0
 

 
Powder for I.V. infusion 1 g (as phosphate)
Injection
Etopophos
BQ
EMP
 
 
1
0
 

Fludarabine
Powder for I.V. injection containing fludarabine phosphate 50 mg
Injection
Farine
WQ
EMP
C3015
 
5
3
 

 
 
 
Fludara
GZ
EMP
C3015
 
5
3
 

 
 
 
Fludarabine Actavis
GQ
EMP
C3015
 
5
3
 

 
Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL
Injection
Fludarabine Ebewe
IT
EMP
C3015
 
5
3
 

Fluorouracil
Injection 500 mg in 10 mL
Injection
Fluorouracil Ebewe
IT
EMP
 
 
10
0
 

 
 
 
Hospira Pty Limited
HH
EMP
 
 
10
0
 

 
Injection 1000 mg in 20 mL
Injection
Fluorouracil Ebewe
IT
EMP
 
 
5
0
 

Folinic acid
Tablet containing calcium folinate equivalent to 15 mg folinic acid
Oral
Leucovorin Calcium (Hospira Pty Limited)
HH
EMP
C1028
 
10
0
 

 
Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL
Injection
Calcium Folinate Ebewe
IT
EMP
 
 
5
5
 

 
 
 
Leucovorin Calcium (Hospira Pty Limited)
HH
EMP
 
 
5
5
 

 
 
 
Leucovorin Calcium (Pfizer Australia Pty Ltd)
PF
EMP
 
 
5
5
 

 
Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL
Injection
Calcium Folinate Ebewe
IT
EMP
 
 
10
1
 

 
 
 
Leucovorin Calcium (Pfizer Australia Pty Ltd)
PF
EMP
 
 
10
1
 

 
Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
Injection
Leucovorin Calcium (Hospira Pty Limited)
HH
EMP
 
 
4
1
 

Fotemustine
Powder for injection 208 mg with solvent
Injection
Muphoran
SE
EMP
C3181
 
1
4
 

Gemcitabine
Powder for I.V. infusion 200 mg (as hydrochloride)
Injection
DBL Gemcitabine for Injection
HH
EMP
C1193 C1194 C1740 C2069 C2141
 
4
2
 

 
 
 
Gemcitabine Actavis
GQ
EMP
C1193 C1194 C1740 C2069 C2141
 
4
2
 

 
 
 
Gemcitabine Ebewe
IT
EMP
C1193 C1194 C1740 C2069 C2141
 
4
2
 

 
 
 
Gemcite
ZP
EMP
C1193 C1194 C1740 C2069 C2141
 
4
2
 

 
 
 
Gemzar
LY
EMP
C1193 C1194 C1740 C2069 C2141
 
4
2
 

 
Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
Injection
Gemcitabine Ebewe
IT
EMP
C1193 C1194 C1740 C2069 C2141
 
4
2
 

 
Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL
Injection
Gemcitabine Ebewe
IT
EMP
C1193 C1194 C1740 C2069 C2141
 
4
2
 

 
Powder for I.V. infusion 1 g (as hydrochloride)
Injection
DBL Gemcitabine for Injection
HH
EMP
C1193 C1194 C1740 C2069 C2141
 
2
2
 

 
 
 
Gemcitabine Actavis
GQ
EMP
C1193 C1194 C1740 C2069 C2141
 
2
2
 

 
 
 
Gemcitabine Ebewe
IT
EMP
C1193 C1194 C1740 C2069 C2141
 
2
2
 

 
 
 
Gemcite
ZP
EMP
C1193 C1194 C1740 C2069 C2141
 
2
2
 

 
 
 
Gemzar
LY
EMP
C1193 C1194 C1740 C2069 C2141
 
2
2
 

 
Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
Injection
Gemcitabine Ebewe
IT
EMP
C1193 C1194 C1740 C2069 C2141
 
2
2
 

 
Powder for I.V. infusion 2 g (as hydrochloride)
Injection
DBL Gemcitabine for Injection
HH
EMP
C1193 C1194 C1740 C2069 C2141
 
1
2
 

Granisetron
Tablet 2 mg (as hydrochloride)
Oral
Kytril
HH
EMP
C3050
 
2
0
 

 
Concentrated injection 3 mg (as hydrochloride) in 3 mL
Injection
Granisetron Kabi
PK
EMP
C3050

 
1

0

 

Idarubicin
Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL single use vial
Injection
Zavedos Solution
PF
EMP
C1006
 
3
0
 

 
Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL single use vial
Injection
Zavedos Solution
PF
EMP
C1006
 
6
0
 

Ifosfamide
Powder for I.V. injection 1 g in single dose vial
Injection
Holoxan
BX
EMP
C1325 C1327
 
5
5
 

 
Powder for I.V. injection 2 g in single dose vial
Injection
Holoxan
BX
EMP
C1325 C1327
 
5
5
 

Interferon Alfa-2a
Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
EMP
C1149 C1196 C1234
P1149 P1234
15
4
 

 
 
 
 
 
EMP
C1149 C1196 C1234
P1196
15
5
 

 
Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
EMP
C1196 C1234
P1234
5
4
 

 
 
 
 
 
EMP
C1196 C1234
P1196
5
5
 

 
Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
EMP
C1196 C1234
P1234
5
4
 

 
 
 
 
 
EMP
C1196 C1234
P1196
5
5
 

 
Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
Roferon-A
RO
EMP
C1196 C1234
P1234
5
4
 

 
 
 
 
 
EMP
C1196 C1234
P1196
5
5
 

Interferon Alfa-2b
Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen
Injection
Intron A Redipen
SH
EMP
C1149 C1196 C1206
P1149
3
4
 

 
 
 
 
 
EMP
C1149 C1196 C1206
P1196 P1206
3
5
 

 
Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen
Injection
Intron A Redipen
SH
EMP
C1196 C1206
 
3
5
 

Irinotecan
I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
Injection
Camptosar
PF
EMP
C3184
 
1
3
 

 
 
 
Hospira Pty Limited
HH
EMP
C3184
 
1
3
 

 
 
 
Irinotecan Actavis
GQ
EMP
C3184
 
1
3
 

 
 
 
Irinotecan Alphapharm
AF
EMP
C3184
 
1
3
 

 
 
 
Irinotecan Ebewe
IT
EMP
C3184
 
1
3
 

 
 
 
Irinotecan Sandoz
SZ
EMP
C3184
 
1
3
 

 
 
 
Omegapharm Irinotecan
OE
EMP
C3184
 
1
3
 

 
 
 
Tecan
WQ
EMP
C3184
 
1
3
 

 
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
Injection
Camptosar
PF
EMP
C3184
 
2
3
 

 
 
 
Hospira Pty Limited
HH
EMP
C3184
 
2
3
 

 
 
 
Irinotecan Actavis
GQ
EMP
C3184
 
2
3
 

 
 
 
Irinotecan Alphapharm
AF
EMP
C3184
 
2
3
 

 
 
 
Irinotecan Ebewe
IT
EMP
C3184
 
2
3
 

 
 
 
Irinotecan Sandoz
SZ
EMP
C3184
 
2
3
 

 
 
 
Omegapharm Irinotecan
OE
EMP
C3184
 
2
3
 

 
 
 
Tecan
WQ
EMP
C3184
 
2
3
 

 
I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL
Injection
Camptosar
PF
EMP
C3184
 
1
3
 

 
 
 
Irinotecan Ebewe
IT
EMP
C3184
 
1
3
 

 
I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
Injection
Hospira Pty Limited
HH
EMP
C3184
 
1
3
 

 
 
 
Irinotecan Ebewe
IT
EMP
C3184
 
1
3
 

Mesna
Solution for I.V. injection 400 mg in 4 mL ampoule
Injection
Uromitexan
BX
EMP
C1618
 
15
5
 

 
Solution for I.V. injection 1 g in 10 mL ampoule
Injection
Uromitexan
BX
EMP
C1618
 
15
5
 

Methotrexate
Injection 5 mg in 2 mL vial
Injection
Hospira Pty Limited
HH
EMP
 
 
5
0
 

 
Injection 50 mg in 2 mL vial
Injection
Hospira Pty Limited
HH
EMP
 
 
5
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
5
0
 

 
Solution concentrate for I.V. infusion 500 mg in 20 mL vial
Injection
Hospira Pty Limited
HH
EMP
 
 
1
0
 

 
Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
Injection
Hospira Pty Limited
HH
EMP
 
 
1
0
 

 
 
 
Methotrexate Ebewe
IT
EMP
 
 
1
0
 

 
Solution concentrate for I.V. infusion 5000 mg in 50 mL vial
Injection
Methotrexate Ebewe
IT
EMP
 
 
1
0
 

Mitozantrone
Injection 10 mg (as hydrochloride) in 5 mL
Injection
Pfizer Australia Pty Ltd
PF
EMP
 
 
1
0
 

 
Injection 20 mg (as hydrochloride) in 10 mL
Injection
Hospira Pty Limited
HH
EMP
 
 
1
0
 

 
 
 
Mitozantrone Ebewe
IT
EMP
 
 
1
0
 

 
 
 
Onkotrone
BX
EMP
 
 
1
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
1
0
 

 
Injection 25 mg (as hydrochloride) in 12.5 mL
Injection
Onkotrone
BX
EMP
 
 
1
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
1
0
 

Ondansetron
Tablet 4 mg (as hydrochloride dihydrate)
Oral
APO-Ondansetron
TX
EMP
C3050
 
4
0
 

 
 
 
Ondaz
SZ
EMP
C3050

 
4

0

 

 
 
 
Onsetron 4
ZP
EMP
C3050

 
4

0

 

 
 
 
Zofran
GK
EMP
C3050

 
4

0

 

 
Tablet 8 mg (as hydrochloride dihydrate)
Oral
APO-Ondansetron
TX
EMP
C3050
 
 
4

0

 

 
 
 
Ondaz
SZ
EMP
C3050
 
 
4

0

 

 
 
 
Onsetron 8
ZP
EMP
C3050
 
 
4

0

 

 
 
 
Zofran
GK
EMP
C3050
 
 
4

0

 

 
Wafer 4 mg
Oral
Ondaz Zydis
SZ
EMP
C3050
 
 
4

0

 

 
 
 
Zofran Zydis
GK
EMP
C3050
 
 
4

0

 

 
Wafer 8 mg
Oral
Ondaz Zydis
SZ
EMP
C3050
 
 
4

0

 

 
 
 
Zofran Zydis
GK
EMP
C3050
 
 
4

0

 

 
Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL
Oral
Zofran syrup 50 mL
GK
EMP
C3050
 
 
1

0

 

 
I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
Injection
Ondansetron-Claris
AE
EMP
C3050
 
 
1

0

 

 
 
 
Ondaz
SZ
EMP
C3050
 
 
1

0

 

 
 
 
Onsetron
ZP
EMP
C3050
 
 
1

0

 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
C3050
 
 
1

0

 

 
 
 
Zofran
GK
EMP
C3050
 
 
1

0

 

 
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
Injection
Ondansetron-Claris
AE
EMP
C3050
 
 
1

0

 

 
 
 
Ondaz
SZ
EMP
C3050
 
 
1

0

 

 
 
 
Onsetron
ZP
EMP
C3050
 
 
1

0

 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
C3050
 
 
1

0

 

 
 
 
Zofran
GK
EMP
C3050
 
 
1

0

 

Oxaliplatin
Solution concentrate for I.V. infusion 50 mg in 10 mL
Injection
DBL Oxaliplatin Concentrate
HH
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Eloxatin
SW
EMP
C2717 C3449 C3450
 
1
2
 

 
Powder for I.V. infusion 50 mg
Injection
Hospira Pty Limited
HH
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxalatin
ZP
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Actavis
GQ
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Alphapharm
AF
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Ebewe
IT
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Link
PK
EMP
C2717 C3449 C3450
 
1
2
 

 
Solution concentrate for I.V. infusion 100 mg in 20 mL
Injection
DBL Oxaliplatin Concentrate
HH
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Eloxatin
SW
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Kabi
PK
EMP
C2717 C3449 C3450
 
1
2
 

 
Powder for I.V. infusion 100 mg
Injection
Hospira Pty Limited
HH
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxalatin
ZP
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Actavis
GQ
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Alphapharm
AF
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Ebewe
IT
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Oxaliplatin Link
PK
EMP
C2717 C3449 C3450
 
1
2
 

 
 
 
Winthrop Oxaliplatin
WA
EMP
C2717 C3449 C3450
 
1
2
 

 
Solution concentrate for I.V. infusion 200 mg in 40 mL
Injection
Eloxatin
SW
EMP
C2717 C3449 C3450
 
1
2
 

Paclitaxel
Solution concentrate for I.V. infusion 30 mg in 5 mL
Injection
Anzatax
HH
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
5
0
 

 
 
 
Paclitaxel Actavis
GQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
5
0
 

 
 
 
Paclitaxel Ebewe
IT
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
5
0
 

 
 
 
Plaxel
WQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
5
0
 

 
 
 
Taxol
BQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
5
0
 

 
Solution concentrate for I.V. infusion 100 mg in 16.7 mL
Injection
Anzatax
HH
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
 
 
Paclitaxel Actavis
GQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
 
 
Paclitaxel Ebewe
IT
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
 
 
Plaxel
WQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
 
 
Taxol
BQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
Solution concentrate for I.V. infusion 150 mg in 25 mL
Injection
Anzatax
HH
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
 
 
Paclitaxel Actavis
GQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
 
 
Paclitaxel Ebewe
IT
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
 
 
Plaxel
WQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
2
0
 

 
Solution concentrate for I.V. infusion 300 mg in 50 mL
Injection
Anzatax
HH
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
1
0
 

 
 
 
Paclitaxel Actavis
GQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
1
0
 

 
 
 
Paclitaxel Ebewe
IT
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
1
0
 

 
 
 
Plaxel
WQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
1
0
 

 
 
 
Taxol
BQ
EMP
C1194 C1293 C1742 C2417 C2439 C3428
 
1
0
 

Paclitaxel, nanoparticle albumin-bound
Powder for I.V. injection containing 100 mg paclitaxel
Injection
Abraxane
TS
EMP
C3432
 
1
0
 

Palonosetron
Injection 250 micrograms (as hydrochloride) in 5 mL
Injection
Aloxi
TS
EMP
C3545
 
1
0
 

Pemetrexed
Powder for I.V. infusion 100 mg (as disodium heptahydrate)
Injection
Alimta
LY
EMP
C2957 C2958
 
1
3
 

 
Powder for I.V. infusion 500 mg (as disodium heptahydrate)
Injection
Alimta
LY
EMP
C2957 C2958
 
1
3
 

Raltitrexed
Powder for I.V. infusion 2 mg in single use vial
Injection
Tomudex
HH
EMP
C3185
 
3
2
 

Rituximab
Solution for I.V. infusion 100 mg in 10 mL
Injection
Mabthera
RO
EMP
C1744 C1745 C2068 C2386
P1744 P1745
2
3
 

 
 
 
Mabthera
RO
EMP
C1744 C1745 C2068 C2386
P2068 P2386
2
7
 

 
Solution for I.V. infusion 500 mg in 50 mL
Injection
Mabthera
RO
EMP
C1744 C1745 C2068 C2386
P1744 P1745
1
3
 

 
 
 
Mabthera
RO
EMP
C1744 C1745 C2068 C2386
P2068 P2386
1
7
 

Thiotepa
Powder for injection 15 mg
Injection/
intravesical
Sigma Pharmaceuticals (Australia) Pty Ltd
SI
EMP
 
 
2
1
 

Topotecan
Powder for I.V. infusion 4 mg (as hydrochloride)
Injection
Hycamtin
GK
EMP
C3186
 
5
1
 

Tropisetron
Capsule 5 mg (as hydrochloride)
Oral
Navoban
NV
EMP
C3050
 
2
0
 

 
I.V. injection 5 mg (as hydrochloride) in 5 mL
Injection
Navoban
NV
EMP
C3050
 
1
0
 

Vinblastine
Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL
Injection
Hospira Pty Limited
HH
EMP
 
 
5
0
 

Vincristine
I.V. injection containing vincristine sulfate 1 mg in 1 mL
Injection
Hospira Pty Limited
HH
EMP
 
 
10
0
 

 
 
 
Pfizer Australia Pty Ltd
PF
EMP
 
 
10
0
 

Vinorelbine
Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
Injection
Hospira Pty Limited
HH
EMP
C1194 C1741
 
16
2
 

 
 
 
Navelbine
FB
EMP
C1194 C1741
 
16
2
 

 
 
 
Vinorelbine Ebewe
IT
EMP
C1194 C1741
 
16
2
 

 
 
 
Vinorelbine Link
PK
EMP
C1194 C1741
 
16
2
 

 
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
Injection
Hospira Pty Limited
HH
EMP
C1194 C1741
 
4
2
 

 
 
 
Navelbine
FB
EMP
C1194 C1741
 
4
2
 

 
 
 
Vinorelbine Ebewe
IT
EMP
C1194 C1741
 
4
2
 

 
 
 
Vinorelbine Link
PK
EMP
C1194 C1741
 
4
2
 

Schedule 2        Responsible Person Codes
(section 7)
  
Code
Responsible Person
Australian Business Number

AE
AFT Pharmaceuticals Pty Ltd
 29 105 636 413

AF
Alphapharm Pty Ltd
 93 002 359 739

BQ
Bristol-Myers Squibb Australia Pty Ltd
 33 004 333 322

BX
Baxter Healthcare Pty Ltd
 43 000 392 781

FB
Pierre Fabre Medicament Australia Pty Ltd
 30 098 999 850

GK
GlaxoSmithKline Australia Pty Ltd
 47 100 162 481

GQ
Generic Health Pty Ltd
 93 110 617 859

GZ
Genzyme Australasia Pty Ltd
 24 083 420 526

HH
Hospira Pty Limited
 13 107 058 328

IT
InterPharma Pty Ltd
 19 099 877 899

JC
Janssen-Cilag Pty Ltd
 47 000 129 975

LY
Eli Lilly Australia Pty Ltd
 39 000 233 992

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

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
Virgo Unit Trust
 77 695 661 635

RO
Roche Products Pty Ltd
 70 000 132 865

SE
Servier Laboratories (Aust.) Pty Ltd
 54 004 838 500

SG
Merck Serono Australia Pty Ltd
 72 006 900 830

SH
Schering-Plough Pty Limited
 57 000 235 245

SI
Sigma Pharmaceuticals (Australia) Pty Ltd
 88 004 118 594

SW
sanofi-aventis Australia Pty Ltd
 31 008 558 807

SZ
Sandoz Pty Ltd
 60 075 449 553

TS
Specialised Therapeutics Australia Pty Ltd
 73 124 031 241

TX
Apotex Pty Ltd
 52 096 916 148

WA
sanofi-aventis Australia Pty Ltd
 31 008 558 807

WQ
Willow Pharmaceuticals Pty Ltd
 80 118 534 704

ZP
Spirit Pharmaceuticals Pty Ltd
 67 109 225 747

Schedule 3    Circumstances and Purposes Codes
(sections 9, 18 and 20)
  
Listed Drug
Circumstances Code
Purposes Code

Circumstances and Purposes

Authority Requirements
- Part of Circumstances

Aprepitant
C2071
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered:
(a) altretamine;
(b) carmustine;
(c) cisplatin, when a single dose constitutes a cycle of chemotherapy;
(d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
(e) dacarbazine;
(f) procarbazine, when a single dose constitutes a cycle of chemotherapy;
(g) streptozocin; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy
Compliance with Authority Required procedures

 
C2330
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co-administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy
Compliance with Authority Required procedures

 
C3446
 
Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered:
(a) arsenic trioxide;
(b) azacitidine;
(c) carboplatin;
(d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day;
(e) cytarabine, at a dose of greater than 1 g per square metre per day;
(f) dactinomycin;
(g) daunorubicin;
(h) doxorubicin;
(i) epirubicin;
(j) fotemustine;
(k) idarubicin;
(l) ifosfamide;
(m) irinotecan;
(n) melphalan;
(o) methotrexate, at a dose of 250 mg to 1 g per square metre;
(p) oxaliplatin;
(q) raltitrexed; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where 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

Arsenic
C3150
 
Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction
Compliance with Authority Required procedures

"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)
C1419
 
Treatment of carcinoma in situ of the urinary bladder
 

"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)
C1290
 
Primary and relapsing superficial urothelial carcinoma of the bladder
 

Bevacizumab
C3430
 
Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
Compliance with Authority Required procedures

 
C3431
 
Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
Compliance with Authority Required procedures

Bleomycin
C1139
 
Germ cell neoplasms
 

 
C1198
 
Lymphoma
 

Cetuximab
C2713
P2713
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information
Compliance with Authority Required procedures

 
C2714
P2714
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Compliance with Authority Required procedures

 
C2715
P2715
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Compliance with Authority Required procedures

Cladribine
C3180
 
Hairy cell leukaemia
Compliance with Authority Required procedures - Streamlined Authority Code 3180


Docetaxel
C1194
P1194
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures

 
C1742
P1742
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Compliance with Authority Required procedures

 
C2416
P2416
Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide
Compliance with Authority Required procedures

 
C2439
P2439
Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures

 
C2732
P2732
Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles
Compliance with Authority Required procedures

 
C3051
P3051
Neoadjuvant treatment of a patient with a World Health Organisation performance status of 1 or less, with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx, in combination with cisplatin and fluorouracil
Compliance with Authority Required procedures

 
C3292
P3292
Adjuvant treatment of operable breast cancer in combination with cyclophosphamide
Compliance with Authority Required procedures

 
C3428
P3428
Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures

Dolasetron
C3050
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
 

Doxorubicin - Pegylated Liposomal
C1568
 
Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen
Compliance with Authority Required procedures

 
C1795
 
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
Compliance with Authority Required procedures

 
C1796
 
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Compliance with Authority Required procedures

Fludarabine
C3015
 
B-cell chronic lymphocytic leukaemia in combination with cyclophosphamide where the patient has advanced disease (Binet Stage B or C) or evidence of progressive Stage A disease, and where:
(1) Stage A progressive disease is defined by at least 1 of the following:
— persistent rise in lymphocyte count with doubling time less than 12 months;
— a downward trend in haemoglobin or platelets, or both;
— more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present;
— constitutional symptoms attributable to disease; and
(2) the diagnosis of chronic lymphocytic leukaemia has been established based on:
(a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and
(b) a clonal population of B-cells (CD5/CD19) documented by flow cytometry
Compliance with Authority Required procedures

Folinic acid
C1028
 
Antidote to folic acid antagonists
 

Fotemustine
C3181
 
Metastatic malignant melanoma
Compliance with Authority Required procedures - Streamlined Authority Code 3181


Gemcitabine
C1193
 
Locally advanced or metastatic adenocarcinoma of the pancreas
Compliance with Authority Required procedures

 
C1194
 
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures

 
C1740
 
Locally advanced or metastatic bladder cancer, when used in combination with cisplatin
Compliance with Authority Required procedures

 
C2069
 
Advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline
Compliance with Authority Required procedures

 
C2141
 
Advanced epithelial ovarian cancer, in combination with carboplatin, in patients who relapse more than 6 months after platinum-based therapy
Compliance with Authority Required procedures

Granisetron
C3050
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
 

Idarubicin
C1006
 
Acute myelogenous leukaemia
 

Ifosfamide
C1325
 
Relapsed or refractory germ cell tumours following first-line chemotherapy
 

 
C1327
 
Relapsed or refractory sarcomas following first-line chemotherapy
 

Interferon Alfa-2a
C1149
P1149
Hairy cell leukaemia
Compliance with Authority Required procedures

 
C1196
P1196
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Compliance with Authority Required procedures

 
C1234
P1234
Myeloproliferative disease with excessive thrombocytosis
Compliance with Authority Required procedures

Interferon Alfa-2b
C1149
P1149
Hairy cell leukaemia
Compliance with Authority Required procedures

 
C1196
P1196
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Compliance with Authority Required procedures

 
C1206
P1206
Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy
Compliance with Authority Required procedures

Irinotecan
C3184
 
Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less
Compliance with Authority Required procedures - Streamlined Authority Code 3184


Mesna
C1618
 
Adjunctive therapy for use with ifosfamide or high dose cyclophosphamide
 

Ondansetron
C3050
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
 

Oxaliplatin
C2717
 
Adjuvant treatment of stage III (Dukes C) colon cancer, in combination with fluorouracil and folinic acid, following complete resection of the primary tumour
Compliance with Authority Required procedures

 
C3449
 
Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with capecitabine
Compliance with Authority Required procedures

 
C3450
 
Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and folinic acid
Compliance with Authority Required procedures

Paclitaxel
C1194
 
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures

 
C1293
 
Primary treatment of ovarian cancer in combination with a platinum compound
Compliance with Authority Required procedures

 
C1742
 
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Compliance with Authority Required procedures

 
C2417
 
Adjuvant treatment of node-positive breast cancer administered sequentially to an anthracycline and cyclophosphamide
Compliance with Authority Required procedures

 
C2439
 
Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures

 
C3428
 
Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures

Paclitaxel, nanoparticle albumin-bound
C3432
 
Metastatic breast cancer after failure of prior therapy
Compliance with Authority Required procedures

Palonosetron
C3545
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
 

Pemetrexed
C2957
 
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application
Compliance with Authority Required procedures

 
C2958
 
Mesothelioma, in combination with cisplatin, where the dose per treatment cycle does not exceed 500 mg per metre squared body surface area (BSA) and where the patient's BSA is included in the authority application
Compliance with Authority Required procedures

Raltitrexed
C3185
 
For use as a single agent in the treatment of advanced colorectal cancer
Compliance with Authority Required procedures - Streamlined Authority Code 3185


Rituximab
C1744
P1744
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Compliance with Authority Required procedures

 
C1745
P1745
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Compliance with Authority Required procedures

 
C2068
P2068
Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Compliance with Authority Required procedures

 
C2386
P2386
Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Compliance with Authority Required procedures

Topotecan
C3186
 
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Compliance with Authority Required procedures - Streamlined Authority Code 3186


Tropisetron
C3050
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
 

Vinorelbine
C1194
 
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures

 
C1741
 
Advanced breast cancer after failure of prior therapy which includes an anthracycline
Compliance with Authority Required procedures

Schedule 4           Patient contributions
(sections 35 to 37)
  
 
Listed Drug
Form
Manner of Administration
Brand
Quantity or Number of Units
Approved Ex-manufacturer Price
Claimed Ex-manufacturer Price

Bleomycin
 
 
Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent.
Injection
Hospira Pty Ltd
 
1
 
 
$41.72
 
 
$79.26
 
 

 
 
 
Blenamax
 
10
$417.22
$792.56

 
 
 
Blenoxane
10
$417.22
$857.24

 
 
 
 
 
 
 

Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.