PB 87 of 2011
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011
as amended
made under subsections 100 (1) and (2) of the
National Health Act 1953
This compilation was prepared on 1 March 2012
taking into account amendments up to PB 3 of 2012
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra
Contents
Part 1 Preliminary
Division 1 General
1 Name of Special Arrangement [see Note 1]
2 Commencement
3 Revocation
4 Definitions
Division 2 Chemotherapy pharmaceutical benefits
5 Pharmaceutical benefits covered by this Special Arrangement
6 Application of Part VII of the Act
7 Responsible person
8 Authorised prescriber
9 Prescription circumstances
10 Methods of prescribing a chemotherapy pharmaceutical benefit
11 Information to be included in medication chart
Division 3 Authority required procedures
12 Authority required procedures
13 Authority required procedures — submission of paragraph 10 (1) (a) prescription
14 Authority required procedures — authorisation of paragraph 10 (1) (a) prescription
15 Authority required procedures — submission of paragraph 10 (1) (b) medication chart
16 Authority required procedures — authorisation of paragraph 10 (1) (b) medication chart
17 Streamlined Authority Code
Division 4 Maximum quantity and maximum number of repeats
18 Maximum quantity
19 Variation to maximum quantity or number of units
20 Maximum number of repeats — paragraph 10 (1) (a) prescription
21 Maximum number of repeats — paragraph 10 (1) (b) medication chart
Division 5 Section 100 only
22 Section 100 only supply
Part 2 Supply of chemotherapy pharmaceutical benefits
23 Entitlement to chemotherapy pharmaceutical benefits
24 Supply of chemotherapy pharmaceutical benefits under this Special Arrangement
25 Modification to regulations
26 Acknowledging receipt of supplied chemotherapy pharmaceutical benefits
Part 3 Claims and payment
Division 1 Claims for payment
27 How claims to be made
28 Modifications to claim rules
Division 2 Payments to approved hospital authorities
29 Payments to approved hospital authorities
30 Method of working out dispensed price
Division 3 Dispensed price
31 Dispensed price for supply of a chemotherapy pharmaceutical benefit
32 Where quantity is less than in manufacturers’ pack
33 Lowest price to be applied
34 Rounding of dispensed price
Part 4 Patient contributions
35 Patient contribution for chemotherapy pharmaceutical benefits mentioned in Schedule 4
36 Patient contribution for chemotherapy pharmaceutical benefits not mentioned in Schedule 4
37 Additional patient contributions
Part 5 Transitional arrangements
38 Prescriptions written prior to 1 December 2011
39 Old Arrangements
Schedule 1 Pharmaceutical benefits covered by this Special Arrangement and related information
Schedule 2 Responsible Person Codes
Schedule 3 Circumstances and Purposes Codes
Schedule 4 Patient contributions
Notes
Part 1 Preliminary
Division 1 General
1 Name of Special Arrangement [see Note 1]
(1) This Special Arrangement is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011.
(2) This Special Arrangement may also be cited as PB 87 of 2011.
2 Commencement
This Special Arrangement commences on 1 December 2011.
3 Revocation
Instrument PB 117 of 2010 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 Healthcare 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 Chief Executive Medicare 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 the determination made under paragraph 98B(1)(a) of the Act, 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:
Chief Executive Medicare
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 letters ‘PBS’ or ‘RPBS’, as appropriate;
(g) the name of the chemotherapy pharmaceutical benefit;
(h) the strength of the chemotherapy pharmaceutical benefit;
(i) the quantity or dosage of the chemotherapy pharmaceutical benefit or both the quantity and dosage of the chemotherapy pharmaceutical benefit;
(j) if the dosage of the chemotherapy pharmaceutical benefit is provided under paragraph (i) — how often the chemotherapy pharmaceutical benefit is to be taken by the patient and the period that the chemotherapy pharmaceutical benefit is prescribed;
(k) 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 Chief Executive Medicare in accordance with section 13; and
(b) authorised by the Chief Executive Medicare 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 Chief Executive Medicare in accordance with section 15; and
(b) authorised by the Chief Executive Medicare 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 Chief Executive Medicare 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 Chief Executive Medicare, 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 Chief Executive Medicare in accordance with paragraph (b) but has been unable to do so because the telephone system established by the Chief Executive Medicare 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 Chief Executive Medicare; or
(d) submit to the Chief Executive Medicare, by means of an electronic communication of a kind approved in writing by the Chief Executive Medicare, 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 Chief Executive Medicare 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 Chief Executive Medicare 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 Chief Executive Medicare 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 Chief Executive Medicare:
(a) signing his or her authorisation on the prescription; and
(b) either:
(i) if the Chief Executive Medicare 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 Chief Executive Medicare telling the eligible medical practitioner by telephone, at the time the Chief Executive Medicare 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 Chief Executive Medicare sending his or her authorisation by electronic communication, to the eligible medical practitioner.
(4) If the Chief Executive Medicare authorises a prescription under subsection (2) or (3):
(a) the Chief Executive Medicare 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 Chief Executive Medicare 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 Chief Executive Medicare by means of an electronic communication of a kind approved by the Chief Executive Medicare.
(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 Chief Executive Medicare 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 Chief Executive Medicare.
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 Chief Executive Medicare 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 Chief Executive Medicare 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.
19 Variation to maximum quantity or number of units
(1) 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 as modified by subsection (2); 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.
(2) A reference in regulation 13 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 quantity or number of units of the chemotherapy pharmaceutical benefit as described in section 18.
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 as modified by subsection (5).
(5) A reference in regulation 13 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 occasions an eligible medical practitioner may, in one prescription, direct that the supply of the chemotherapy pharmaceutical be repeated as described in this section.
(6) A reference in regulation 24 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 occasions an eligible medical practitioner may, in one prescription, direct that the supply of the chemotherapy pharmaceutical be repeated as described in this section.
(7) 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.
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 Modification to regulations
(1) 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.
(2) A reference to authority prescription in the Regulations includes a prescription authorised in accordance with Regulation 13 as modified by subsection 19(2) of this Special Arrangement.
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 Modifications to claim rules
(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 in accordance with the rules determined by the Minister under subsection 99AAA(8) for 1 years from the date the chemotherapy pharmaceutical benefit is supplied;
(c) if requested by the Chief Executive Medicare — the approved hospital authority must give the Chief Executive Medicare a copy of:
(i) the medication chart mentioned in paragraph (a); and
(ii) the information mentioned in paragraph (b).
(3) A reference in the rules determined by the Minister under subsection 99AAA(8) of the Act to an authority prescription is to be read as including a prescription that has been authorised under Regulation 13 as modified by this Special Arrangement.
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.
Part 5 Transitional arrangements
38 Prescriptions written prior to 1 December 2011
If the supply of a chemotherapy pharmaceutical benefit was prescribed for an eligible patient under the old Arrangements, and the supply was not made prior to the commencement of this Special Arrangement, the supply of the chemotherapy pharmaceutical benefit is taken to have been validly prescribed under this Special Arrangement, and may be supplied to the eligible patient under this Special Arrangement.
39 Old Arrangements
In this Part, old Arrangements means the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010).
Schedule 1 Pharmaceutical benefits covered by this Special Arrangement and related information
(sections 5, 7, 8, 9, 12, 17, 18, 20 and 22)
"BCG Immunotherapeutic" (Bacillus Calmette‑Guérin/ Connaught strain) | Powder for intravesical administration containing 6.6 to 19.2 x 10 8 CFU | 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 | MK | EMP | C1290 |
| 3 | 1 |
|
Aprepitant | Pack containing 1 capsule 125 mg and 2 capsules 80 mg | Oral | Emend | MK | EMP | C3619 C3620 C3621 |
| 1 | 5 |
|
Arsenic | Injection concentrate containing arsenic trioxide 10 mg in 10 mL | Injection | Phenasen | PL | EMP | C3891 |
| 60 | 2 | D |
Bevacizumab | Solution for I.V. infusion 100 mg in 4 mL | Injection | Avastin | RO | EMP | C3894 C3896 |
| 1 | 0 | D |
| Solution for I.V. infusion 400 mg in 16 mL | Injection | Avastin | RO | EMP | C3894 C3896 |
| 1 | 0 | D |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. | Injection | Hospira Pty Limited | HH | EMP | C1139 C1198 |
| 10 | 0 | D |
Carboplatin | Solution for I.V. injection 50 mg in 5 mL | Injection | Carboplatin Ebewe | SZ | EMP |
|
| 2 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 2 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 2 | 0 | D |
| Solution for I.V. injection 150 mg in 15 mL | Injection | Carboplatin Ebewe | SZ | EMP |
|
| 6 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 6 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 6 | 0 | D |
| Solution for I.V. injection 450 mg in 45 mL | Injection | Carboplatin Ebewe | SZ | EMP |
|
| 2 | 0 | D |
|
|
| Carboplatin Kabi | PK | EMP |
|
| 2 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 2 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 2 | 0 | D |
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | SG | EMP | C3903 C3904 C3919 C3920 C3921 | P3903 P3904 P3919 P3920 | 1 | 0 | D |
|
|
| Erbitux | SG | EMP | C3903 C3904 C3919 C3920 C3921 | P3921 | 1 | 6 | D |
| Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | SG | EMP | C3903 C3904 C3919 C3920 C3921 | P3903 P3904 P3919 P3920 | 1 | 0 | D |
|
|
| Erbitux | SG | EMP | C3903 C3904 C3919 C3920 C3921 | P3921 | 1 | 6 | D |
Cisplatin | I.V. injection 10 mg in 10 mL | Injection | Pfizer Australia Pty Ltd | PF | EMP |
|
| 1 | 0 | D |
| I.V. injection 50 mg in 50 mL | Injection | Hospira Pty Limited | HH | EMP |
|
| 1 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 1 | 0 | D |
| I.V. injection 100 mg in 100 mL | Injection | Cisplatin Ebewe | SZ | EMP |
|
| 1 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 1 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 1 | 0 | D |
Cladribine | Injection 10 mg in 5 mL | Injection | Litak | OA | EMP | C3180 |
| 7 | 0 | D |
| Solution for I.V. infusion 10 mg in 10 mL single use vial | Injection | Leustatin | JC | EMP | C3180 |
| 7 | 0 | D |
Cyclophosphamide | Powder for injection 500 mg (anhydrous) | Injection | Endoxan | BX | EMP |
|
| 2 | 0 | PB |
| Powder for injection 1 g (anhydrous) | Injection | Endoxan | BX | EMP |
|
| 1 | 0 | PB |
| Powder for injection 2 g (anhydrous) | Injection | Endoxan | BX | EMP |
|
| 1 | 0 | PB |
Cytarabine | Injection 100 mg in 5 mL vial | Injection | Pfizer Australia Pty Ltd | PF | EMP |
|
| 10 | 1 | D |
Docetaxel | Solution concentrate for I.V. infusion 140 mg in 7 mL | Injection | Oncotaxel 140 | TA | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 |
| 1 | 0 | D |
| Solution concentrate for I.V. infusion 160 mg in 16 mL | Injection | DBL Docetaxel Concentrated Injection | HH | EMP | C3186 C3884 C3888 C3890 C3916 C3955 C3956 |
| 1 | 0 | D |
| Powder for I.V. infusion 20 mg with solvent | Injection | Docetaxel SUN | ZF | EMP | C3186 C3884 C3890 C3955 |
| 2 | 0 | D |
| Powder for I.V. infusion 80 mg with solvent | Injection | Docetaxel SUN | ZF | EMP | C3186 C3884 C3890 C3955 |
| 1 | 0 | D |
| Solution concentrate for I.V. infusion 20 mg in 1 mL | Injection | Oncotaxel 20 | TA | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 | P3888 | 1 | 0 | D |
|
|
| Taxotere | SW | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 | P3888 | 1 | 0 | D |
|
|
| Oncotaxel 20 | TA | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 | P3186 P3884 P3890 P3892 P3916 P3955 P3956 | 2 | 0 | D |
|
|
| Taxotere | SW | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 | P3186 P3884 P3890 P3892 P3916 P3955 P3956 | 2 | 0 | D |
| Solution concentrate for I.V. infusion 20 mg in 2 mL | Injection | DBL Docetaxel Concentrated Injection | HH | EMP | C3186 C3884 C3888 C3890 C3916 C3955 C3956 | P3888 | 1 | 0 | D |
|
|
| Docetaxel Ebewe | HX | EMP | C3186 C3884 C3888 C3890 C3916 C3955 | P3888 | 1 | 0 | D |
|
|
| Docetaxel Sandoz | SZ | EMP | C3186 C3884 C3888 C3890 C3916 C3955 C3956 | P3888 | 1 | 0 | D |
|
|
| DBL Docetaxel Concentrated Injection | HH | EMP | C3186 C3884 C3888 C3890 C3916 C3955 C3956 | P3186 P3884 P3890 P3916 P3955 P3956 | 2 | 0 | D |
|
|
| Docetaxel Ebewe | HX | EMP | C3186 C3884 C3888 C3890 C3916 C3955 | P3186 P3884 P3890 P3916 P3955 | 2 | 0 | D |
|
|
| Docetaxel Sandoz | SZ | EMP | C3186 C3884 C3888 C3890 C3916 C3955 C3956 | P3186 P3884 P3890 P3916 P3955 P3956 | 2 | 0 | D |
| 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 | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 | P3888 | 1 | 0 | D |
|
|
| Taxotere | SW | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 | P3186 P3884 P3890 P3892 P3916 P3955 P3956 | 2 | 0 | D |
| Solution concentrate for I.V. infusion 80 mg in 4 mL | Injection | Oncotaxel 80 | TA | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 |
| 1 | 0 | D |
|
|
| Taxotere | SW | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 |
| 1 | 0 | D |
| Solution concentrate for I.V. infusion 80 mg in 8 mL | Injection | DBL Docetaxel Concentrated Injection | HH | EMP | C3186 C3884 C3888 C3890 C3916 C3955 C3956 |
| 1 | 0 | D |
|
|
| Docetaxel Ebewe | HX | EMP | C3186 C3884 C3888 C3890 C3916 C3955 |
| 1 | 0 | D |
|
|
| Docetaxel Sandoz | SZ | EMP | C3186 C3884 C3888 C3890 C3916 C3955 C3956 |
| 1 | 0 | D |
| Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent | Injection | Taxotere | SW | EMP | C3186 C3884 C3888 C3890 C3892 C3916 C3955 C3956 |
| 1 | 0 | D |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial | Injection/ | Adriamycin Solution | PF | EMP |
|
| 4 | 0 | D |
|
|
| Doxorubicin Ebewe | SZ | EMP |
|
| 4 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 4 | 0 | D |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial | Injection/ | Adriamycin Solution | PF | EMP |
|
| 4 | 0 | D |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial | Injection/ | Adriamycin Solution | PF | EMP |
|
| 3 | 0 | D |
|
|
| Doxorubicin Ebewe | SZ | EMP |
|
| 3 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 3 | 0 | D |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial | Injection/ | Doxorubicin Ebewe | SZ | EMP |
|
| 1 | 0 | D |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial | Injection/ | Adriamycin | PF | EMP |
|
| 1 | 0 | D |
|
|
| Doxorubicin Ebewe | SZ | EMP |
|
| 1 | 0 | D |
Doxorubicin ‑ Pegylated Liposomal | Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL | Injection | Caelyx | JC | EMP | C3905 C3910 C3911 |
| 1 | 0 | D |
| Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL | Injection | Caelyx | JC | EMP | C3905 C3910 C3911 |
| 1 | 0 | D |
Epirubicin | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL | Injection/intravesical | Epirubicin Actavis 10 | TA | EMP |
|
| 4 | 0 | D |
|
|
| Epirubicin Ebewe | SZ | EMP |
|
| 4 | 0 | D |
|
|
| Pharmorubicin Solution | PF | EMP |
|
| 4 | 0 | D |
| Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL | Injection/ | Epirubicin Actavis 20 | TA | EMP |
|
| 4 | 0 | D |
|
|
| Pharmorubicin Solution | PF | EMP |
|
| 4 | 0 | D |
| Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL | Injection/ | Epirubicin Actavis 50 | TA | EMP |
|
| 4 | 0 | D |
|
|
| Epirubicin Ebewe | SZ | EMP |
|
| 4 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 4 | 0 | D |
|
|
| Pharmorubicin Solution | PF | EMP |
|
| 4 | 0 | D |
| Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL | Injection/ | Epirubicin Actavis 100 | TA | EMP |
|
| 2 | 0 | D |
|
|
| Epirubicin Ebewe | SZ | EMP |
|
| 2 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 2 | 0 | D |
| Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL | Injection/ intravesical | DBL Epirubicin Hydrochloride Injection | HH | EMP |
|
| 1 | 0 | D |
|
|
| Epirubicin Actavis 200 | TA | EMP |
|
| 1 | 0 | D |
|
|
| Epirubicin Ebewe | SZ | EMP |
|
| 1 | 0 | D |
Etoposide | Solution for I.V. infusion 100 mg in 5 mL vial | Injection | Etoposide Ebewe | SZ | EMP |
|
| 5 | 0 | PB |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 5 | 0 | PB |
| Powder for I.V. infusion 100 mg (as phosphate) | Injection | Etopophos | BQ | EMP |
|
| 5 | 0 | PB |
| Powder for I.V. infusion 1 g (as phosphate) | Injection | Etopophos | BQ | EMP |
|
| 1 | 0 | PB |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg | Injection | Farine | WQ | EMP | C3887 |
| 5 | 3 | PB |
|
|
| Fludara | GZ | EMP | C3887 |
| 5 | 3 | PB |
|
|
| Fludarabine Actavis | TA | EMP | C3887 |
| 5 | 3 | PB |
| Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL | Injection | Fludarabine Ebewe | SZ | EMP | C3887 |
| 5 | 3 | PB |
Fluorouracil | Injection 500 mg in 10 mL | Injection | Fluorouracil Ebewe | SZ | EMP |
|
| 10 | 0 | D |
|
|
| Hospira Pty Limited | HH | EMP |
|
| 10 | 0 | D |
| Injection 1000 mg in 20mL | Injection | DBL Fluorouracil Injection BP | HH | EMP |
|
| 5 | 0 | D |
|
|
| Fluorouracil Ebewe | SZ | EMP |
|
| 5 | 0 | D |
| Injection 2500 mg in 50 mL | Injection | DBL Fluorouracil Injection BP | HH | EMP |
|
| 2 | 0 | D |
|
|
| Fluorouracil Ebewe | SZ | EMP |
|
| 2 | 0 | D |
| Injection 5000 mg in 100 mL | Injection | Fluorouracil Ebewe | SZ | EMP |
|
| 1 | 0 | D |
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 | SZ | 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 | SZ | 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 | Calcium Folinate Ebewe | SZ | EMP |
|
| 4 | 1 |
|
|
|
| Leucovorin Calcium (Hospira Pty Limited) | HH | EMP |
|
| 4 | 1 |
|
| Injection containing calcium folinate equivalent to 1000 mg folinic acid in 100 mL | Injection | Calcium Folinate Ebewe | SZ | EMP |
|
| 1 | 1 |
|
Fotemustine | Powder for injection 208 mg with solvent | Injection | Muphoran | SE | EMP | C3181 |
| 1 | 4 | D |
Gemcitabine | Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL | Injection | Gemcitabine Ebewe | SZ | EMP |
|
| 4 | 2 | D |
| Solution for injection 200 mg (as hydrochloride) in 5.3 mL | Injection | DBL Gemcitabine Injection | HH | EMP |
|
| 4 | 2 | D |
| Powder for I.V. infusion 200 mg (as hydrochloride) | Injection | DBL Gemcitabine for Injection | HH | EMP |
|
| 4 | 2 | D |
|
|
| Gemcitabine Actavis | TA | EMP |
|
| 4 | 2 | D |
|
|
| Gemcitabine Ebewe | SZ | EMP |
|
| 4 | 2 | D |
|
|
| Gemcitabine Kabi | PK | EMP |
|
| 4 | 2 | D |
|
|
| Gemcitabine Sun | ZF | EMP |
|
| 4 | 2 | D |
|
|
| Gemcite | ZP | EMP |
|
| 4 | 2 | D |
|
|
| Gemplan | WQ | EMP |
|
| 4 | 2 | D |
|
|
| Gemzar | LY | EMP |
|
| 4 | 2 | D |
| Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL | Injection | Gemcitabine Ebewe | SZ | EMP |
|
| 4 | 2 | D |
| Solution for injection 1 g (as hydrochloride) in 26.3 mL | Injection | DBL Gemcitabine Injection | HH | EMP |
|
| 2 | 2 | D |
| Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL | Injection | Gemcitabine Ebewe | SZ | EMP |
|
| 2 | 2 | D |
| Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL | Injection | Gemcitabine Ebewe | SZ | EMP |
|
| 4 | 2 | D |
| Powder for I.V. infusion 1 g (as hydrochloride) | Injection | DBL Gemcitabine for Injection | HH | EMP |
|
| 2 | 2 | D |
|
|
| Gemcitabine Actavis | TA | EMP |
|
| 2 | 2 | D |
|
|
| Gemcitabine Ebewe | SZ | EMP |
|
| 2 | 2 | D |
|
|
| Gemcitabine Kabi | PK | EMP |
|
| 2 | 2 | D |
|
|
| Gemcitabine Sun | ZF | EMP |
|
| 2 | 2 | D |
|
|
| Gemcite | ZP | EMP |
|
| 2 | 2 | D |
|
|
| Gemplan | WQ | EMP |
|
| 2 | 2 | D |
|
|
| Gemzar | LY | EMP |
|
| 2 | 2 | D |
| Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL | Injection | Gemcitabine Ebewe | SZ | EMP |
|
| 2 | 2 | D |
| Solution for injection 2 g (as hydrochloride) in 52.6 mL | Injection | DBL Gemcitabine Injection | HH | EMP |
|
| 1 | 2 | D |
| Powder for I.V. infusion 2 g (as hydrochloride) | Injection | DBL Gemcitabine for Injection | HH | EMP |
|
| 1 | 2 | D |
|
|
| Gemcitabine Kabi | PK | EMP |
|
| 1 | 2 | D |
| Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL | Injection | Gemcitabine Ebewe | SZ | EMP |
|
| 1 | 2 | D |
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 |
|
|
|
| Kytril | HH | EMP | C3050 |
| 1 | 0 |
|
Idarubicin | Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL | Injection | Idarubicin Ebewe | SZ | EMP | C1006 |
| 3 | 0 | PB |
|
|
| Zavedos Solution | PF | EMP | C1006 |
| 3 | 0 | PB |
| Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL | Injection | Idarubicin Ebewe | SZ | EMP | C1006 |
| 6 | 0 | PB |
|
|
| Zavedos Solution | PF | EMP | C1006 |
| 6 | 0 | PB |
Ifosfamide | Powder for I.V. injection 1 g in single dose vial | Injection | Holoxan | BX | EMP | C1325 C1327 |
| 5 | 5 | D |
| Powder for I.V. injection 2 g in single dose vial | Injection | Holoxan | BX | EMP | C1325 C1327 |
| 5 | 5 | D |
Interferon Alfa‑2a | Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | Roferon‑A | RO | EMP | C3180 C3895 C3899 | P3180 P3899 | 15 | 4 |
|
|
|
| Roferon‑A | RO | EMP | C3180 C3895 C3899 | P3895 | 15 | 5 |
|
| Injection 4,500,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | Roferon‑A | RO | EMP | C3895 C3899 | P3899 | 5 | 4 |
|
|
|
| Roferon‑A | RO | EMP | C3895 C3899 | P3895 | 5 | 5 |
|
| Injection 6,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | Roferon‑A | RO | EMP | C3895 C3899 | P3899 | 5 | 4 |
|
|
|
| Roferon‑A | RO | EMP | C3895 C3899 | P3895 | 5 | 5 |
|
| Injection 9,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | Roferon‑A | RO | EMP | C3895 C3899 | P3899 | 5 | 4 |
|
|
|
| Roferon‑A | RO | EMP | C3895 C3899 | P3895 | 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 | MK | EMP | C3180 C3895 C3898 | P3180 | 3 | 4 |
|
|
|
| Intron A Redipen | MK | EMP | C3180 C3895 C3898 | P3895 P3898 | 3 | 5 |
|
| Solution for injection 30,000,000 I.U. in 1.2 mL multi‑dose injection pen | Injection | Intron A Redipen | MK | EMP | C3895 C3898 |
| 3 | 5 |
|
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Injection | Camptosar | PF | EMP | C3184 |
| 1 | 3 | D |
|
|
| Hospira Pty Limited | HH | EMP | C3184 |
| 1 | 3 | D |
|
|
| Irinotecan Actavis | TA | EMP | C3184 |
| 1 | 3 | D |
|
|
| Irinotecan Alphapharm | AF | EMP | C3184 |
| 1 | 3 | D |
|
|
| Irinotecan Ebewe | SZ | EMP | C3184 |
| 1 | 3 | D |
|
|
| Irinotecan Kabi | PK | EMP | C3184 |
| 1 | 3 | D |
|
|
| Omegapharm Irinotecan | OE | EMP | C3184 |
| 1 | 3 | D |
|
|
| Tecan | WQ | EMP | C3184 |
| 1 | 3 | D |
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Injection | Camptosar | PF | EMP | C3184 |
| 2 | 3 | D |
|
|
| Hospira Pty Limited | HH | EMP | C3184 |
| 2 | 3 | D |
|
|
| Irinotecan Actavis | TA | EMP | C3184 |
| 2 | 3 | D |
|
|
| Irinotecan Alphapharm | AF | EMP | C3184 |
| 2 | 3 | D |
|
|
| Irinotecan Ebewe | SZ | EMP | C3184 |
| 2 | 3 | D |
|
|
| Irinotecan Kabi | PK | EMP | C3184 |
| 2 | 3 | D |
|
|
| Omegapharm Irinotecan | OE | EMP | C3184 |
| 2 | 3 | D |
|
|
| Tecan | WQ | EMP | C3184 |
| 2 | 3 | D |
| I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL | Injection | Camptosar | PF | EMP | C3184 |
| 1 | 3 | D |
|
|
| Irinotecan Ebewe | SZ | EMP | C3184 |
| 1 | 3 | D |
| I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL | Injection | Hospira Pty Limited | HH | EMP | C3184 |
| 1 | 3 | D |
|
|
| Irinotecan Actavis 500 | TA | EMP | C3184 |
| 1 | 3 | D |
|
|
| Irinotecan Ebewe | SZ | EMP | C3184 |
| 1 | 3 | D |
|
|
| Tecan | WQ | EMP | C3184 |
| 1 | 3 | D |
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 | 5 |
|
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 5 | 5 |
|
| Solution concentrate for I.V. infusion 500 mg in 20 mL vial | Injection | Hospira Pty Limited | HH | EMP |
|
| 1 | 0 | PB |
| Solution concentrate for I.V. infusion 1000 mg in 10 mL vial | Injection | Hospira Pty Limited | HH | EMP |
|
| 1 | 0 | PB |
|
|
| Methotrexate Ebewe | SZ | EMP |
|
| 1 | 0 | PB |
| Solution concentrate for I.V. infusion 5000 mg in 50 mL vial | Injection | Methotrexate Ebewe | SZ | EMP |
|
| 1 | 0 | PB |
Mitozantrone | Injection 10 mg (as hydrochloride) in 5 mL | Injection | Pfizer Australia Pty Ltd | PF | EMP |
|
| 1 | 0 | D |
| Injection 20 mg (as hydrochloride) in 10 mL | Injection | Hospira Pty Limited | HH | EMP |
|
| 1 | 0 | D |
|
|
| Mitozantrone Ebewe | SZ | EMP |
|
| 1 | 0 | D |
|
|
| Onkotrone | BX | EMP |
|
| 1 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 1 | 0 | D |
| Injection 25 mg (as hydrochloride) in 12.5 mL | Injection | Onkotrone | BX | EMP |
|
| 1 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 1 | 0 | D |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) | Oral | APO‑Ondansetron | TX | EMP | C3050 |
| 4 | 0 |
|
|
|
| Ondansetron‑DRLA | RZ | 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 |
|
|
|
| Ondansetron‑DRLA | RZ | EMP | C3050 |
| 4 | 0 |
|
|
|
| Ondaz | SZ | EMP | C3050 |
| 4 | 0 |
|
|
|
| Onsetron 8 | ZP | EMP | C3050 |
| 4 | 0 |
|
|
|
| Zofran | GK | EMP | C3050 |
| 4 | 0 |
|
| Tablet (orally disintegrating) 4 mg | Oral | Ondansetron ODT‑DRLA | RZ | EMP | C3050 |
| 4 | 0 |
|
| Tablet (orally disintegrating) 8 mg | Oral | Ondansetron ODT‑DRLA | RZ | 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 Alphapharm | AF | EMP | C3050 |
| 1 | 0 |
|
|
|
| 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 Alphapharm | AF | EMP | C3050 |
| 1 | 0 |
|
|
|
| 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 | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Eloxatin | SW | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Kabi | PK | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin SUN | ZF | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
| Powder for I.V. infusion 50 mg | Injection | Hospira Pty Limited | HH | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxalatin | ZP | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Actavis | TA | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Alphapharm | AF | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Ebewe | SZ | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Link | PK | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Xalox | WQ | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
| Solution concentrate for I.V. infusion 100 mg in 20 mL | Injection | DBL Oxaliplatin Concentrate | HH | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Eloxatin | SW | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Kabi | PK | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin SUN | ZF | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
| Powder for I.V. infusion 100 mg | Injection | Hospira Pty Limited | HH | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxalatin | ZP | EMP | C3900 C3901 C3030 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Actavis | TA | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Alphapharm | AF | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Ebewe | SZ | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin Link | PK | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Winthrop Oxaliplatin | WA | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Xalox | WQ | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
| Solution concentrate for I.V. infusion 200 mg in 40 mL | Injection | Eloxatin | SW | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
|
|
| Oxaliplatin SUN | ZF | EMP | C3900 C3901 C3930 C3939 |
| 1 | 2 | D |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | Anzatax | HH | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 5 | 0 | D |
|
|
| Paclitaxel Actavis | TA | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 5 | 0 | D |
|
|
| Paclitaxel Ebewe | SZ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 5 | 0 | D |
|
|
| Paclitaxel Kabi | PK | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 5 | 0 | D |
|
|
| Paclitaxel Pfizer | PF | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 5 | 0 | D |
|
|
| Plaxel | WQ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 5 | 0 | D |
|
|
| Taxol | BQ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 5 | 0 | D |
| Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | Anzatax | HH | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Paclitaxel Actavis | TA | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Paclitaxel Ebewe | SZ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Paclitaxel Kabi | PK | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Paclitaxel Pfizer | PF | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Plaxel | WQ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Taxol | BQ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
| Solution concentrate for I.V. infusion 150 mg in 25 mL | Injection | Anzatax | HH | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Paclitaxel Actavis | TA | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Paclitaxel Ebewe | SZ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
|
|
| Plaxel | WQ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 2 | 0 | D |
| Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | Anzatax | HH | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 1 | 0 | D |
|
|
| Paclitaxel Actavis | TA | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 1 | 0 | D |
|
|
| Paclitaxel Ebewe | SZ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 1 | 0 | D |
|
|
| Paclitaxel Kabi | PK | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 1 | 0 | D |
|
|
| Paclitaxel Pfizer | PF | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 1 | 0 | D |
|
|
| Plaxel | WQ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 1 | 0 | D |
|
|
| Taxol | BQ | EMP | C3186 C3890 C3902 C3917 C3955 C3956 |
| 1 | 0 | D |
Paclitaxel, nanoparticle albumin‑bound | Powder for I.V. injection containing 100 mg paclitaxel | Injection | Abraxane | TS | EMP | C3955 C3956 |
| 1 | 0 | D |
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 | C3885 C3886 |
| 1 | 3 | D |
| Powder for I.V. infusion 500 mg (as disodium heptahydrate) | Injection | Alimta | LY | EMP | C3885 C3886 |
| 1 | 3 | D |
Raltitrexed | Powder for I.V. infusion 2 mg in single use vial | Injection | Tomudex | HH | EMP | C3185 |
| 3 | 2 | D |
Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | Mabthera | RO | EMP | C3908 C3909 C3912 C3915 C3932 | P3908 P3909 | 2 | 3 | D |
|
|
| Mabthera | RO | EMP | C3908 C3909 C3912 C3915 C3932 | P3932 | 2 | 5 | D |
|
|
| Mabthera | RO | EMP | C3908 C3909 C3912 C3915 C3932 | P3912 P3915 | 2 | 7 | D |
| Solution for I.V. infusion 500 mg in 50 mL | Injection | Mabthera | RO | EMP | C3908 C3909 C3912 C3915 C3932 | P3908 P3909 | 1 | 3 | D |
|
|
| Mabthera | RO | EMP | C3908 C3909 C3912 C3915 C3932 | P3912 P3915 | 1 | 7 | D |
|
|
| Mabthera | RO | EMP | C3908 C3909 C3912 C3915 C3932 | P3932 | 2 | 5 | D |
Topotecan | Powder for I.V. infusion 4 mg (as hydrochloride) | Injection | Hycamtin | GK | EMP | C3186 |
| 5 | 1 | D |
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 | D |
Vincristine | I.V. injection containing vincristine sulfate 1 mg in 1 mL | Injection | Hospira Pty Limited | HH | EMP |
|
| 10 | 0 | D |
|
|
| Pfizer Australia Pty Ltd | PF | EMP |
|
| 10 | 0 | D |
Vinorelbine | Solution for I.V. infusion 10 mg (as tartrate) in 1 mL | Injection | Hospira Pty Limited | HH | EMP | C3890 C3907 |
| 16 | 2 | PB |
|
|
| Navelbine | FB | EMP | C3890 C3907 |
| 16 | 2 | PB |
|
|
| Vinorelbine Ebewe | SZ | EMP | C3890 C3907 |
| 16 | 2 | PB |
| Solution for I.V. infusion 50 mg (as tartrate) in 5 mL | Injection | Hospira Pty Limited | HH | EMP | C3890 C3907 |
| 4 | 2 | PB |
|
|
| Navelbine | FB | EMP | C3890 C3907 |
| 4 | 2 | PB |
|
|
| Vinorelbine Ebewe | SZ | EMP | C3890 C3907 |
| 4 | 2 | PB |
|
|
| Vinorelbine Kabi | PK | EMP | C3890 C3907 |
| 4 | 2 | PB |
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 |
GZ | Genzyme Australasia Pty Ltd | 24 083 420 526 |
HH | Hospira Pty Limited | 13 107 058 328 |
HX | Sandoz Pty Ltd | 60 075 449 553 |
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 | The Trustee for Virgo Unit Trust (trading as Phebra) | 77 695 661 635 |
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 |
TA | Actavis Australia Pty Ltd | 43 122 896 468 |
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 |
ZF | Sun Pharmaceutical Industries Pty Ltd | 64 130 119 603 |
ZP | Spirit Pharmaceuticals Pty Ltd | 67 109 225 747 |
Schedule 3 Circumstances and Purposes Codes
(sections 9, 18 and 20)
Circumstances and Purposes |
Authority Requirements | |||
"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 |
|
Aprepitant | C3619 |
| 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: | Compliance with Authority Required procedures – Streamlined Authority Code 3619 |
| C3620 |
| 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 – Streamlined Authority Code 3620 |
| C3621 |
| 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: | Compliance with Authority Required procedures ‑ Streamlined Authority Code 3621 |
Arsenic | C3891 |
| 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 – Streamlined Authority Code 3891 |
Bevacizumab | C3894 |
| 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, and where the patient’s WHO performance status and body weight is recorded in the patient’s medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures – Streamlined Authority Code 3894 |
| C3896 |
| Continuing PBS‑subsidised treatment, in combination with first‑line chemotherapy, of a patient with metastatic colorectal cancer who has previously received PBS‑subsidised treatment with 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, and where the patient’s body weight is documented in the patient’s medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures – Streamlined Authority Code 3896 |
Bleomycin | C1139 |
| Germ cell neoplasms |
|
| C1198 |
| Lymphoma |
|
Cetuximab | C3903 | P3903 | Initial PBS‑subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K‑RAS wild type metastatic colorectal cancer after failure of first line chemotherapy | Compliance with Authority Required procedures – Streamlined Authority Code 3903 |
| C3904 | P3904 | Continuing PBS‑subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K‑RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease | Compliance with Authority Required procedures – Streamlined Authority Code 3904 |
| C3919 | P3919 | 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 – Streamlined Authority Code 3919 |
| C3920 | P3920 | 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 – Streamlined Authority Code 3920 |
| C3921 | P3921 | 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 – Streamlined Authority Code 3921 |
Cladribine | C3180 |
| Hairy cell leukaemia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 3180 |
Docetaxel | C3186 | P3186 | Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | Compliance with Authority Required procedures – Streamlined Authority Code 3186 |
| C3884 | P3884 | 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 – Streamlined Authority Code 3884 |
| C3888 | P3888 | 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 – Streamlined Authority Code 3888 |
| C3890 | P3890 | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3890 |
| C3892 | P3892 | Adjuvant treatment of operable breast cancer in combination with cyclophosphamide | Compliance with Authority Required procedures – Streamlined Authority Code 3892 |
| C3916 | P3916 | Adjuvant treatment of node‑positive breast cancer in combination with an anthracycline and cyclophosphamide | Compliance with Authority Required procedures – Streamlined Authority Code 3916 |
| C3955 | P3955 | Metastatic breast cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3955 |
| C3956 | P3956 | Treatment of HER2 positive breast cancer in combination with trastuzumab | Compliance with Authority Required procedures – Streamlined Authority Code 3956 |
Doxorubicin ‑ Pegylated Liposomal | C3905 |
| Advanced epithelial ovarian cancer in women who have failed a first‑line platinum‑based chemotherapy regimen | Compliance with Authority Required procedures – Streamlined Authority Code 3905 |
| C3910 |
| Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane | Compliance with Authority Required procedures – Streamlined Authority Code 3910 |
| C3911 |
| Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated | Compliance with Authority Required procedures – Streamlined Authority Code 3911 |
Fludarabine | C3887 |
| 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: | Compliance with Authority Required procedures – Streamlined Authority Code 3887 |
Folinic acid | C1028 |
| Antidote to folic acid antagonists |
|
Fotemustine | C3181 |
| Metastatic malignant melanoma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 3181 |
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 | C3180 | P3180 | Hairy cell leukaemia | Compliance with Authority Required procedures – Streamlined Authority Code 3180 |
| C3895 | P3895 | 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 – Streamlined Authority Code 3895 |
| C3899 | P3899 | Myeloproliferative disease with excessive thrombocytosis | Compliance with Authority Required procedures – Streamlined Authority Code 3899 |
Interferon Alfa‑2b | C3180 | P3180 | Hairy cell leukaemia | Compliance with Authority Required procedures – Streamlined Authority code 3180 |
| C3895 | P3895 | 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 – Streamlined Authority Code 3895 |
| C3898 | P3898 | Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy | Compliance with Authority Required procedures – Streamlined Authority Code 3898 |
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 | C3900 |
| 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 – Streamlined Authority Code 3900 |
| C3901 |
| 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 – Streamlined Authority Code 3901 |
| C3930 |
| Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour used in combination with capecitabine | Compliance with Authority Required procedures – Streamlined Authority Code 3930 |
| C3939 |
| Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour used in combination with 5‑fluorouracil and folinic acid | Compliance with Authority Required procedures – Streamlined Authority Code 3939 |
Paclitaxel | C3186 |
| Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | Compliance with Authority Required procedures – Streamlined Authority Code 3186 |
| C3890 |
| Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3890 |
| C3902 |
| Primary treatment of ovarian cancer in combination with a platinum compound | Compliance with Authority Required procedures – Streamlined Authority Code 3902 |
| C3917 |
| Adjuvant treatment of node‑positive breast cancer administered sequentially to an anthracycline and cyclophosphamide | Compliance with Authority Required procedures – Streamlined Authority Code 3917 |
| C3955 |
| Metastatic breast cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3955 |
| C3956 |
| Treatment of HER2 positive breast cancer in combination with trastuzumab | Compliance with Authority Required procedures – Streamlined Authority Code 3956 |
Paclitaxel, nanoparticle albumin-bound | C3955 |
| Metastatic breast cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3955 |
| C3956 |
| Treatment of HER2 positive breast cancer in combination with trastuzumab | Compliance with Authority Required procedures – Streamlined Authority Code 3956 |
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 | C3885 |
| 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 documented in the patient’s medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures – Streamlined Authority Code 3885 |
| C3886 |
| 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 documented in the patient’s medical records at the time the treatment cycle is initiated | Compliance with Authority Required procedures – Streamlined Authority Code 3886 |
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 | C3908 | P3908 | Relapsed or refractory low‑grade B‑cell non‑Hodgkin's lymphoma | Compliance with Authority Required procedures – Streamlined Authority Code 3908 |
| C3909 | P3909 | Relapsed or refractory follicular B‑cell non‑Hodgkin's lymphoma | Compliance with Authority Required procedures – Streamlined Authority Code 3909 |
| C3912 | P3912 | Treatment of previously untreated, CD20 positive, diffuse large B‑cell non‑Hodgkin's lymphoma, in combination with chemotherapy | Compliance with Authority Required procedures – Streamlined Authority Code 3912 |
| C3915 | P3915 | 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 – Streamlined Authority Code 3915 |
| C3932 | P3932 | CD20 positive, chronic lymphocytic leukaemia, in combination with fludarabine and cyclophosphamide | Compliance with Authority Required procedures – Streamlined Authority Code 3932 |
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 | C3890 |
| Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3890 |
| C3907 |
| Advanced breast cancer after failure of prior therapy which includes an anthracycline | Compliance with Authority Required procedures – Streamlined Authority Code 3907 |
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. | Injection | Hospira Pty Ltd | 1 | $40.89 | $77.67 |
Notes to the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87of 2011)
Note 1
The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87 of 2011) in force under subsections 100 (1) and (2) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.
Table of Instruments
Title | Date of FRLI Registration | Date of | Application, saving or |
PB 87 of 2011 | 30 Nov 2011 (see F2011L02507) | 1 Dec 2011 |
|
PB 101 of 2011 | 20 Dec 2011 (see F2011L02753) | 1 Jan 2012 | — |
PB 3 of 2012 | 23 Feb 2012 (see F2012L00378) | 1 Mar 2012 | — |
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
Provision affected | How affected |
Schedule 1 |
|
Schedule 1................. | am. PB 101 of 2011; PB 3 of 2012 |
Schedule 3 |
|
Schedule 3................. | am. PB 101 of 2011; PB 3 of 2012 |