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Special Arrangements – Chemotherapy Pharmaceuticals Access Program
(PB 121 of 2008)

Commencement [see Note 1]

1. (a) These Arrangements commence on 1 December 2008.

(b) Instrument No. PB 82 of 2008 is repealed.

Definitions

2. In these Arrangements:

(a) unless the contrary intention appears, a word or phrase will be taken to have the same meaning as in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations;

(b) “Act” means the National Health Act 1953;

(c) “brand” means the brand of a pharmaceutical item determined under subsection 85(6) of the Act; or if the chemotherapy pharmaceutical does not have a pharmaceutical item, the trade name under which it is supplied, or if there is no trade name, the name of the manufacturer of the chemotherapy pharmaceutical.

(d) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;

(e) “chemotherapy pharmaceutical” means a special pharmaceutical product in relation to which, by virtue of paragraphs 5, 8 and 12, these Arrangements apply;

(f) “Medicare Australia authority notification computer system” means a computer system operated by the Medicare Australia CEO for the purpose of receiving messages from medical practitioners and sending authorisations for supply of chemotherapy pharmaceuticals or refusals of such authorisations, having an electronic mail address approved by the Medicare Australia CEO;

(g) “hospital” means a public hospital that is participating in the arrangements provided for in Appendix F to Australian Health Care Agreements;

(h) “medical practitioner” means a medical practitioner, within the meaning of the Health Insurance Act 1973, who is affiliated with the hospital in or at which the patient is receiving treatment;

(i) “patient” means a person receiving treatment as a non-admitted patient, a day admitted patient or a patient on discharge of the hospital of which the approved hospital authority is the governing body;

(j) “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.

3. Except where otherwise specified in these Arrangements, the provisions of the Act and the Regulations, and declarations, determinations and other instruments made under the Act shall apply to the prescribing and supply of chemotherapy pharmaceuticals.

Entitlement to receive chemotherapy pharmaceuticals under these Arrangements

4. Subject to these Arrangements, a person who:

(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and

(b) is receiving treatment as a non-admitted patient, a day admitted patient or a patient on discharge, of a hospital as defined in paragraph 2(g); and

(c) is receiving medical treatment by a medical practitioner, within the meaning of the Health Insurance Act 1973, who is affiliated with the hospital in or at which the patient is receiving treatment;

is entitled to receive chemotherapy pharmaceuticals under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraphs 20 and 20A.

5. The special pharmaceutical products to which these Arrangements apply are the chemotherapy pharmaceuticals specified in column 1 of Schedule 1.

6. The prescribing of a chemotherapy pharmaceutical is authorised under these Arrangements only in the circumstances, if any, specified in column 2 of Schedule 1 in relation to the chemotherapy pharmaceutical.

7. The following circumstances are specified in relation to each chemotherapy pharmaceutical:

(a) where a class of persons is specified in column 2 of Schedule 1 — the chemotherapy pharmaceutical is to be supplied for the treatment of a person included in that class of persons; or

(b) where a disease or condition is specified in column 2 of Schedule 1 —

(i) if subsubparagraph (ii) does not apply — the chemotherapy pharmaceutical is to be supplied for the treatment of that disease or condition in relation to any person; or

(ii) if the disease or condition is specified in relation to a specified class of persons — that the chemotherapy pharmaceutical is to be supplied for the treatment of that disease or condition in a person included in that class of persons; or

(c) where a purpose is specified in column 2 of Schedule 1 — the chemotherapy pharmaceutical is to be supplied for that purpose.

8. Where strength, type of unit, size of unit or other particulars of form are specified in column 2 of Schedule 2 or column 2 of Schedule 3 in relation to a special pharmaceutical product, each specified form of the product is a chemotherapy pharmaceutical, and these Arrangements do not apply in relation to the special pharmaceutical product in any other form.

9. The manner of administration specified in column 3 of Schedule 2 or column 4 of Schedule 3 in relation to a chemotherapy pharmaceutical is the only manner of administration that may be directed to be used in relation to that product.

10. The maximum quantity or number of units of a chemotherapy pharmaceutical that may, in one prescription, be directed to be supplied on any one occasion is:

(a) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 2 — the quantity or number, if any, specified in column 4 of that Schedule in relation to the chemotherapy pharmaceutical; or

(b) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 3 and the chemotherapy pharmaceutical is prescribed in accordance with the provisions of column 3 of that Schedule — the quantity or number, if any, specified in column 5 of that Schedule in relation to the chemotherapy pharmaceutical.

11. The maximum number of occasions, if any, on which the supply of a chemotherapy pharmaceutical may, in one prescription, be directed to be repeated is:

(a) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 2 — the number, if any, specified in column 5 of that Schedule in relation to the chemotherapy pharmaceutical; or

(b) where the name of the chemotherapy pharmaceutical is specified in column 1 of Schedule 3 and the chemotherapy pharmaceutical is prescribed in accordance with the provisions of column 3 of that Schedule — the number, if any, specified in column 6 of that Schedule in relation to the chemotherapy pharmaceutical.

12. These Arrangements only apply to the supply of a chemotherapy pharmaceutical having a brand mentioned in column 6 of Schedule 2 or column 7 of Schedule 3 for the form and manner of administration mentioned of the chemotherapy pharmaceutical.

Prescribing of chemotherapy pharmaceuticals

13. A medication chart prepared by a medical practitioner, on which is prescribed a chemotherapy pharmaceutical for the medical treatment of a patient of the hospital who is named on the medication chart, will be taken to be a duly written prescription within the meaning of regulation 19 of the Regulations, notwithstanding that it does not comply with the requirements of paragraphs 19(1)(a) and (aa) of the Regulations, provided that:

(a) the medication chart bears the number issued by the Medicare Australia CEO, in pursuance of the function granted to him or her by subsection 18(a) of the Medicare Australia (Functions of Chief Executive Officer) Direction 2005 made under paragraph 5(1)(d) of the Medicare Australia Act 1973, to the medical practitioner who prescribed the chemotherapy pharmaceutical; and

(b) if the medication chart contains a direction, pursuant to paragraph 85A(2)(b) of the Act and subparagraph 19(1)(f)(ii) of the Regulations, that the supply of the chemotherapy pharmaceutical is to be repeated, that direction will be invalid; and

(c) if the medication chart contains a direction for the supply of an increased quantity or number of units of the chemotherapy pharmaceutical pursuant to subsection 88(6) of the Act and regulation 24 of the Regulations, that direction will be taken to be a direction to supply the maximum quantity or number of units for that chemotherapy pharmaceutical as specified in Schedule 2 or Schedule 3, as the case may be; and

(d) if the medication chart contains a direction for the supply of a quantity or number of units of a chemotherapy pharmaceutical greater than the maximum quantity for that chemotherapy pharmaceutical as specified in column 4 of Schedule 2, or column 5 of Schedule 3, as the case may be, an authorisation has been obtained, in accordance with paragraph 15, for the supply of that greater quantity or number of units; and

(e) if the medication chart contains a direction for the supply of a chemotherapy pharmaceutical for which it is necessary to obtain the authorisation of the Medicare Australia CEO pursuant to column 2 of Schedule 1, or column 3 of Schedule 3, an authorisation has been obtained, in accordance with paragraph 14, for the supply of the chemotherapy pharmaceutical.

14. A medical practitioner who wishes to prescribe a chemotherapy pharmaceutical for which an authorisation has to be obtained pursuant to subparagraph 13(e) may:

(a) seek that authorisation from the Medicare Australia CEO in accordance with the determination in force under subsection 85(2A) of the Act; or

(b) arrange for the authorisation to be sought, on behalf of the medical practitioner, by the approved hospital authority in accordance with paragraph 16.

15. A medical practitioner who wishes to prescribe a quantity of a chemotherapy pharmaceutical for which an authorisation has to be obtained pursuant to subparagraph 13(d) may:

(a) seek that authorisation in accordance with the provisions of regulation 13 of the Regulations; or

(b) arrange for the authorisation to be sought, on behalf of the medical practitioner, by the approved hospital authority in accordance with paragraph 16.

16. Where, pursuant to subparagraph 14(b) or 15(b), a medical practitioner arranges for an approved hospital authority to seek an authorisation for the supply of a chemotherapy pharmaceutical, a pharmacist employed by the approved hospital authority must, on behalf of the medical practitioner, submit details of the medication chart by giving to the Medicare Australia authority notification computer system, by computer message in a manner and form approved by the Medicare Australia CEO, details of the medication chart that has been prepared and signed by the medical practitioner in accordance with regulation 19 of the Regulations, as modified by paragraph 13.

17. Where, on behalf of a medical practitioner, a pharmacist employed by an approved hospital authority submits details of a medication chart to the Medicare Australia authority notification computer system in accordance with paragraph 16, and it is received by that computer system, the computer system may send a message, in a manner and form approved by the Medicare Australia CEO, to the approved hospital authority, and:

(a) if the message indicates that authorisation has been granted, the pharmacist employed by the approved hospital authority must complete the medication chart in accordance with the instructions contained in the message; or

(b) if the message indicates that authorisation has not been granted, or the Medicare Australia authority notification computer system fails to send a message indicating whether or not authorisation has been granted, the medical practitioner may, if the medical practitioner so wishes, resubmit the details of the medication chart to the Medicare Australia CEO in accordance with the determination in force under subsection 85(2A) of the Act or regulation 13 of the Regulations, as the case may be.

18. When the Medicare Australia authority notification computer system has sent to the approved hospital authority a message indicating that authorisation has been granted, the supply of the chemotherapy pharmaceutical shall be taken to have been approved under these Arrangements.

Supply of chemotherapy pharmaceuticals under these Arrangements

19. The approved hospital authority will supply chemotherapy pharmaceuticals to the patients of the hospital as if medication charts were original prescriptions, provided that:

(a) where a medication chart contains a direction to supply more than one chemotherapy pharmaceutical, the approved hospital authority must not, pursuant to regulation 26A of the Regulations, defer the supply of one or more of the chemotherapy pharmaceuticals; and

(b) in lieu of the requirements of regulation 31 of the Regulations, a person authorised for the purpose by the approved hospital authority certifies on the medication chart that the chemotherapy pharmaceutical has been supplied and the date on which it was supplied, and signs his or her name.

Cost to patient of chemotherapy pharmaceuticals supplied under these Arrangements

20. An approved hospital authority that supplies a chemotherapy pharmaceutical may charge the person to whom the chemotherapy pharmaceutical is supplied an amount equivalent to the amount that may be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the person.

20A. In addition to the amount that may be charged by an approved hospital authority under paragraph 20, an approved hospital authority which supplies a chemotherapy pharmaceutical which is:

(i) named in column 1 of Schedule 4;

(ii) in the form specified in column 2 of Schedule 4 in relation to that chemotherapy pharmaceutical;

(iii) marketed under the brand specified in column 3 of Schedule 4 in relation to that chemotherapy pharmaceutical; and

(iv) in the quantity or number of units specified in column 4 of Schedule 4 in relation to that chemotherapy pharmaceutical;

may charge the person to whom the chemotherapy pharmaceutical is supplied the amount calculated by subtracting the amount specified in column 5 of Schedule 4 in relation to that chemotherapy pharmaceutical from the amount specified in column 6 of Schedule 4 in relation to that chemotherapy pharmaceutical.

Payment to supplier of chemotherapy pharmaceuticals under these Arrangements

21. An approved hospital authority that has supplied a chemotherapy pharmaceutical is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the chemotherapy pharmaceutical exceeds the amount that the approved hospital authority was entitled to charge under paragraph 20.

22. The dispensed price for the supply of a chemotherapy pharmaceutical will be ascertained in accordance with the determination in force under subsection 99(4) of the Act in respect of the supply of pharmaceutical benefits by public hospitals.

23. Regulation 22 and subregulations 25(2), (3) and (4) of the Regulations do not apply to the supply of chemotherapy pharmaceuticals under these Arrangements.

Claims for payment for the supply of chemotherapy pharmaceuticals under these Arrangements

24. The approved hospital authority must prepare an electronic pharmacy record in respect of each medication chart in respect of which a chemotherapy pharmaceutical has been supplied to a patient of the hospital, and must retain that electronic pharmacy record for not less than one year after the day on which the chemotherapy pharmaceutical was supplied.

25. The electronic pharmacy record referred to in paragraph 24 must contain all information required to be included in a prescription record by Part 4 of Schedule 1 to the rules in force under subsection 99AAA(8) of the Act, as modified by paragraph 29 of these Arrangements.

26. Subject to paragraph 27, a claim by the approved hospital authority in respect of chemotherapy pharmaceuticals supplied to the patients of the hospital may be furnished unaccompanied by the medication charts in respect of which chemotherapy pharmaceuticals have been supplied to the patients of the hospital.

27. If the Medicare Australia CEO notifies the approved hospital authority that a copy of all or any of the medication charts in respect of chemotherapy pharmaceuticals supplied to the patients of the hospital is required to be submitted, the approved hospital authority must submit a copy of each such medication chart to the Medicare Australia CEO.

28. If the Medicare Australia CEO notifies the approved hospital authority that a copy of all or any of the electronic pharmacy records in respect of chemotherapy pharmaceuticals supplied to the patients of the hospital is required to be submitted, the approved hospital authority must submit a copy of each such electronic pharmacy record to the Medicare Australia CEO.

29. Information provided by electronic means to the Secretary by the approved hospital authority in respect of a claim in respect of chemotherapy pharmaceuticals supplied to the patients of the hospital will conform to the requirements of paragraph 5 of, and Schedule 1 to, the rules in force under subsection 99AAA(8) of the Act, provided that Part 4 of Schedule 1 to those rules is amended:

(a) by omitting the specifications for the field “Prescriber Number” and substituting “Seven bytes numeric, right justified, zero filled, being the prescriber number of the prescribing medical practitioner, issued by the Medicare Australia CEO, in pursuance of the function granted to him or her by subsection 18(a) of the Medicare Australia (Functions of Chief Executive Officer) Direction 2005 made under paragraph 5(1)(d) of the Medicare Australia Act 1973”; and

(b) by omitting the field “Filler” and substituting the following field:

“Field:	Hospital patient indicator
Start:	32
End:	32
Specifications for field:	One byte alphanumeric, value 'H' to indicate that the person for whose treatment the medication chart was written was a patient of the hospital; otherwise '0' “

SCHEDULE 1
Column 1	Column 2
Name of chemotherapy pharmaceutical	Circumstances
Aprepitant	In compliance with authority procedures set out in paragraph 14: Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, 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 the cytotoxic chemotherapy to be administered to the patient includes any of the following agents:
	altretamine;
	carmustine;
	cisplatin, when a single dose constitutes a cycle of chemotherapy;
	cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
	dacarbazine;
	procarbazine, when a single dose constitutes a cycle of chemotherapy;
	streptozocin
	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer where cyclophosphamide and an anthracycline are to be co-administered, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, and where treatment with aprepitant is limited to an intial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy
“BCG Immunotherapeutic” (Bacillus Calmette-Guérin/Connaught strain)	Treatment of carcinoma in situ of the urinary bladder
“BCG-Tice” (Bacillus Calmette-Guérin/Tice strain)	Primary and relapsing superficial urothelial carcinoma of the bladder
Bleomycin	Germ cell neoplasms
	Lymphoma
Carboplatin	—
Cetuximab	In compliance with authority procedures set out in paragraph 14: 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
	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
	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
Cisplatin	—
Cladribine	In compliance with authority procedures set out in paragraph 14: Hairy cell leukaemia
Cyclophosphamide	—
Cytarabine	—
Docetaxel	In compliance with authority procedures set out in paragraph 14: 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
	Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide
	Advanced breast cancer after failure of prior therapy which includes an anthracycline
	Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
	Locally advanced or metastatic non-small cell lung cancer
	Treatment of HER2 positive early breast cancer in combination with trastuzumab
	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

SCHEDULE 1 — continued
Column 1	Column 2
Name of chemotherapy pharmaceutical	Circumstances
Dolasetron	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
Doxorubicin	—
Doxorubicin - Pegylated Liposomal	In compliance with authority procedures set out in paragraph 14: Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen
	Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
	Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Epirubicin	—
Etoposide	—
Fludarabine	In compliance with authority procedures set out in paragraph 14: 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
Fluorouracil	—
Folinic acid	In respect of the tablet containing calcium folinate equivalent to 15 mg folinic acid:
	Antidote to folic acid antagonists
	In respect of the injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL, injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL and injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL:
	—
Fotemustine	In compliance with authority procedures set out in paragraph 14: Metastatic malignant melanoma
Gemcitabine	In compliance with authority procedures set out in paragraph 14: Advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline
	Advanced epithelial ovarian cancer, in combination with carboplatin, in patients who relapse more than 6 months after platinum-based therapy
	Locally advanced or metastatic non-small cell lung cancer
	Locally advanced or metastatic adenocarcinoma of the pancreas
	Locally advanced or metastatic bladder cancer, when used in combination with cisplatin
Granisetron	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
Idarubicin	Acute myelogenous leukaemia
Ifosfamide	Relapsed or refractory germ cell tumours following first-line chemotherapy Relapsed or refractory sarcomas following first-line chemotherapy
Interferon Alfa-2a	In respect of the injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe:
	In compliance with authority procedures set out in paragraph 14: Hairy cell leukaemia
	Myeloproliferative disease with excessive thrombocytosis
	Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
	In respect of the injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe, injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe and injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe:
	In compliance with authority procedures set out in paragraph 14: Myeloproliferative disease with excessive thrombocytosis
	Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Interferon Alfa-2b	In respect of the solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen:
	In compliance with authority procedures set out in paragraph 14: Hairy cell leukaemia
	Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy
	Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
	In respect of the solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen:
	In compliance with authority procedures set out in paragraph 14: Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy
	Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Irinotecan	In compliance with authority procedures set out in paragraph 14: Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less
Mesna	Adjunctive therapy for use with ifosfamide or high dose cyclophosphamide
Methotrexate	—
Mitozantrone	—
Ondansetron	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
Oxaliplatin	In compliance with authority procedures set out in paragraph 14: Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and calcium folinate Adjuvant treatment of stage III (Dukes C) colon cancer, in combination with fluorouracil and calcium folinate, following complete resection of the primary tumour
Paclitaxel	In compliance with authority procedures set out in paragraph 14: Adjuvant treatment of node-positive breast cancer administered sequentially to an anthracycline and cyclophosphamide
	Advanced breast cancer after failure of prior therapy which includes an anthracycline
	Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
	Primary treatment of ovarian cancer in combination with a platinum compound
	Locally advanced or metastatic non-small cell lung cancer
	Treatment of HER2 positive early breast cancer in combination with trastuzumab
Paclitaxel, nanoparticle albumin-bound	In compliance with authority procedures set out in paragraph 14: Metastatic breast cancer after failure of prior therapy which includes an anthracycline
Pemetrexed	In compliance with authority procedures set out in paragraph 14: 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 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
Raltitrexed	In compliance with authority procedures set out in paragraph 14: For use as a single agent in the treatment of advanced colorectal cancer
Rituximab	In compliance with authority procedures set out in paragraph 14: Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
	Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
	Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
	Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Thiotepa	—
Topotecan	In compliance with authority procedures set out in paragraph 14: Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Tropisetron	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
Vinblastine	—
Vincristine	—
Vinorelbine	In compliance with authority procedures set out in paragraph 14: Advanced breast cancer after failure of prior therapy which includes an anthracycline Locally advanced or metastatic non-small cell lung cancer

SCHEDULE 2
Column 1	Column 2	Column 3	Column 4	Column 5	Column 6
Name of chemotherapy pharmaceutical	Form (strength, type, size, etc.)	Manner of administration	Maximum quantity	Maximum number of repeats	Brand
Aprepitant	Pack containing 1 capsule 125 mg and 2 capsules 80 mg	Oral	1	..	Emend
“BCG Immunotherapeutic” (Bacillus Calmette-Guérin/ Connaught strain)	Single dose set comprising 1 vial powder for intravesical administration containing 6.6 to 19.2 x 108 CFU and 1 vial diluent 3 mL	Intravesical	3	1	ImmuCyst
“BCG-Tice” (Bacillus Calmette-Guérin/Tice strain)	Vial containing powder for intravesical administration approximately 5 x 108 CFU	Intravesical	3	1	OncoTICE
Bleomycin	Powder for injection containing bleomycin sulfate 15,000 I.U.	Injection	10	..	Blenamax Blenoxane Hospira Pty Limited
Carboplatin	Solution for I.V. injection 50 mg in 5 mL	Injection	2	..	Carboplatin Ebewe
					Hospira Pty Limited
					Pfizer Australia Pty Ltd
	Solution for I.V. injection 150 mg in 15 mL	Injection	6	..	Carboplatin Ebewe
					Hospira Pty Limited
					Pfizer Australia Pty Ltd
	Solution for I.V. injection 450 mg in 45 mL	Injection	2	..	Baxter Carboplatin
					Carboplatin Ebewe
					Hospira Pty Limited
					Pfizer Australia Pty Ltd
Cetuximab	Solution for I.V. infusion 100 mg in 20 mL	Injection	1	..	Erbitux
	Solution for I.V. infusion 100 mg in 50 mL	Injection	1	..	Erbitux
	Solution for I.V. infusion 500 mg in 100 mL	Injection	1	..	Erbitux
Cisplatin	I.V. injection 10 mg in 10 mL	Injection	1	..	Pfizer Australia Pty Ltd
	I.V. injection 50 mg in 50 mL	Injection	1	..	Hospira Pty Limited Pfizer Australia Pty Ltd
	I.V. injection 100 mg in 100 mL	Injection	1	..	Cisplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd
Cladribine	Injection 10 mg in 5 mL vial	Injection	7	..	Litak
	Solution for I.V. infusion 10 mg in 10 mL single use vial	Injection	7	..	Leustatin
Cyclophosphamide	Powder for injection 500 mg (anhydrous)	Injection	2	..	Endoxan
	Powder for injection 1 g (anhydrous)	Injection	1	..	Endoxan
	Powder for injection 2 g (anhydrous)	Injection	1	..	Endoxan

SCHEDULE 2 — continued
Column 1		Column 2		Column 3		Column 4		Column 5		Column 6
Name of chemotherapy pharmaceutical		Form (strength, type, size, etc.)		Manner of administration		Maximum quantity		Maximum number of repeats		Brand
Cytarabine	Injection 100 mg in 5 mL vial		Injection		10		1		Pfizer Australia Pty Ltd
Docetaxel	Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL and 1 single use vial solvent 1.5 mL		Injection		1		..		Taxotere
	Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL and 1 single use vial solvent 6 mL		Injection		1		..		Taxotere
Dolasetron	Tablet containing dolasetron mesylate 200 mg		Oral		2		..		Anzemet
	I.V. injection containing dolasetron mesylate 100 mg in 5 mL		Injection		1		..		Anzemet
Doxorubicin	Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial		Injection/intravesical		4		..		Adriamycin Solution Doxorubicin Ebewe Hospira Pty Limited
	Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial		Injection/intravesical		4		..		Adriamycin Solution
	Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial		Injection/intravesical		3		..		Adriamycin Solution Doxorubicin Ebewe Hospira Pty Limited
	Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial		Injection/intravesical		1		..		Doxorubicin Ebewe
	Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial		Injection/intravesical		1		..		Adriamycin Doxorubicin Ebewe
Doxorubicin - Pegylated Liposomal	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL		Injection		1		..		Caelyx
	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL		Injection		1		..		Caelyx
Epirubicin	Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL		Injection/intravesical		4		..		Epirubicin Ebewe Pharmorubicin Solution
	Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL		Injection/intravesical		4		..		Pharmorubicin Solution
	Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL		Injection/intravesical		4		..		Epirubicin Ebewe Pharmorubicin Solution Hospira Pty Limited
	Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL		Injection/intravesical		2		..		Epirubicin Ebewe Hospira Pty Limited
	Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL		Injection/intravesical		1		..		Epirubicin Ebewe
Etoposide	Solution for I.V. infusion 100 mg in 5 mL vial		Injection		5		..		Etoposide Ebewe Hospira Pty Limited
	Powder for I.V. infusion 100 mg (as phosphate)		Injection		5		..		Etopophos
	Powder for I.V. infusion 1 g (as phosphate)		Injection		1		..		Etopophos
Fludarabine	Powder for I.V. injection containing fludarabine phosphate 50 mg		Injection		5		3		Fludara
	Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL		Injection		5		3		Fludarabine Ebewe
Fluorouracil	Injection 500 mg in 10 mL		Injection		10		..		Fluorouracil Ebewe Hospira Pty Limited
	Injection 1000 mg in 20 mL		Injection		5		..		Fluorouracil Ebewe
Folinic acid	Tablet containing calcium folinate equivalent to 15 mg folinic acid		Oral		10		..		Leucovorin Calcium (Hospira Pty Limited)
	Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL		Injection		5		5		Calcium Folinate Ebewe
									Leucovorin Calcium (Hospira Pty Limited)
									Leucovorin Calcium (Pfizer Australia Pty Ltd)
	Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL		Injection		10		1		Calcium Folinate Ebewe Leucovorin Calcium (Pfizer Australia Pty Ltd)
	Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL		Injection		4		1		Leucovorin Calcium (Hospira Pty Limited)
Fotemustine	Powder for injection 208 mg with solvent		Injection		1		4		Muphoran
Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)		Injection		4		2		DBL Gemcitabine for Injection Gemzar
	Powder for I.V. infusion 1 g (as hydrochloride)		Injection		2		2		DBL Gemcitabine for Injection Gemzar
	Powder for I.V. infusion 2 g (as hydrochloride)		Injection		1		2		DBL Gemcitabine for Injection
	Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL		Injection		4		2		Gemcitabine Ebewe
	Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL		Injection		2		2		Gemcitabine Ebewe
Granisetron	Tablet 2 mg (as hydrochloride)		Oral		2		..		Kytril
	Concentrated injection 3 mg (as hydrochloride) in 3 mL		Injection		1		..		Kytril
Idarubicin	Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL single use vial		Injection		3		..		Zavedos Solution
	Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL single use vial		Injection		6		..		Zavedos Solution
Ifosfamide	Powder for I.V. injection 1 g in single dose vial		Injection		5		5		Holoxan
	Powder for I.V. injection 2 g in single dose vial		Injection		5		5		Holoxan
Interferon Alfa-2a	Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe		Injection		15		4		Roferon-A
	Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe		Injection		5		4		Roferon-A
	Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe		Injection		5		4		Roferon-A
	Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe		Injection		5		4		Roferon-A
Interferon Alfa-2b	Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen		Injection		3		4		Intron A Redipen
	Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen		Injection		3		5		Intron A Redipen
Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL		Injection		1		3		Camptosar Hospira Pty Limited Irinotecan Sandoz Omegapharm Irinotecan
	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL		Injection		2		3		Camptosar Hospira Pty Limited Irinotecan Sandoz Omegapharm Irinotecan
	I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL		Injection		1		3		Camptosar
	I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL		Injection		1		3		Hospira Pty Limited
Mesna	Solution for I.V. injection 400 mg in 4 mL ampoule		Injection		15		5		Uromitexan
	Solution for I.V. injection 1 g in 10 mL ampoule		Injection		15		5		Uromitexan
Methotrexate	Injection 5 mg in 2 mL vial		Injection		5		..		Hospira Pty Limited
	Injection 50 mg in 2 mL vial		Injection		5		..		Hospira Pty Limited Pfizer Australia Pty Ltd
	Solution concentrate for I.V. infusion 500 mg in 20 mL vial		Injection		1		..		Hospira Pty Limited
	Solution concentrate for I.V. infusion 1000 mg in 10 mL vial		Injection		1		..		Methotrexate Ebewe Hospira Pty Limited
	Solution concentrate for I.V. infusion 5000 mg in 50 mL vial		Injection		1		..		Methotrexate Ebewe
Mitozantrone	Injection 10 mg (as hydrochloride) in 5 mL		Injection		1		..		Mitozantrone Ebewe Pfizer Australia Pty Ltd
	Injection 20 mg (as hydrochloride) in 10 mL		Injection		1		..		Mitozantrone Ebewe
									Onkotrone
									Hospira Pty Limited
									Pfizer Australia Pty Ltd
	Injection 25 mg (as hydrochloride) in 12.5 mL		Injection		1		..		Onkotrone Pfizer Australia Pty Ltd
Ondansetron	Wafer 4 mg		Oral		4		..		Ondanstron-RL Zydis Ondaz Zydis Zofran Zydis
	Wafer 8 mg		Oral		4		..		Ondansetron-RL Zydis Ondaz Zydis Zofran Zydis
	Tablet 4 mg (as hydrochloride dihydrate)		Oral		4		..		APO-Ondansetron
									Ondansetron-RL
									Ondaz
									Onsetron 4
									Zofran
	Tablet 8 mg (as hydrochloride dihydrate)		Oral		4		..		APO-Ondansetron
									Ondansetron-RL
									Ondaz
									Onsetron 8
									Zofran
	I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL		Injection		1		..		Ondansetron-RL
									Ondaz
									Onsetron
									Zofran
									Pfizer Australia Pty Ltd
	I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL		Injection		1		..		Ondansetron-RL
									Ondaz
									Onsetron
									Zofran
									Pfizer Australia Pty Ltd
Oxaliplatin	Solution concentrate for I.V. infusion 50 mg in 10 mL vial		Injection		1		2		Eloxatin
	Powder for I.V. infusion 50 mg		Injection		1		2		Oxalatin
									Oxaliplatin Ebewe
									Winthrop Oxaliplatin
									Hospira Pty Limited
	Solution concentrate for I.V. infusion 100 mg in 20 mL vial		Injection		1		2		Eloxatin
	Powder for I.V. infusion 100 mg		Injection		1		2		Oxalatin
									Oxaliplatin Ebewe
									Winthrop Oxaliplatin
									Hospira Pty Limited
	Solution concentrate for I.V. infusion 200 mg in 40 mL		Injection		1		2		Eloxatin
Paclitaxel	Solution concentrate for I.V. infusion 30 mg in 5 mL		Injection		5		..		Anzatax Baxter Paclitaxel Paclitaxel Ebewe Taxol
	Solution concentrate for I.V. infusion 100 mg in 16.7 mL		Injection		2		..		Anzatax Baxter Paclitaxel Paclitaxel Ebewe Taxol
	Solution concentrate for I.V. infusion 150 mg in 25 mL		Injection		2		..		Anzatax Paclitaxel Ebewe Taxol
	Solution concentrate for I.V. infusion 300 mg in 50 mL		Injection		1		..		Anzatax Baxter Paclitaxel Paclitaxel Ebewe Taxol
Paclitaxel, nanoparticle albumin-bound	Powder for I.V. injection containing 100 mg paclitaxel		Injection		1		..		Abraxane
Pemetrexed	Powder for I.V. infusion 100 mg (as disodium heptahydrate)		Injection		1		3		Alimta
	Powder for I.V. infusion 500 mg (as disodium heptahydrate)		Injection		1		3		Alimta
Raltitrexed	Powder for I.V. infusion 2 mg in single use vial		Injection		3		2		Tomudex
Rituximab	Solution for I.V. infusion 100 mg in 10 mL		Injection		2		3		Mabthera
	Solution for I.V. infusion 500 mg in 50 mL		Injection		1		3		Mabthera
Thiotepa	Powder for injection 15 mg		Injection/ intravesical		2		1		Sigma Pharma-ceuticals (Australia) Pty Ltd
Topotecan	Powder for I.V. infusion 4 mg (as hydrochloride)		Injection		5		1		Hycamtin
Tropisetron	Capsule 5 mg (as hydrochloride)		Oral		2		..		Navoban
	I.V. injection 5 mg (as hydrochloride) in 5 mL		Injection		1		..		Navoban
Vinblastine	Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL		Injection		5		..		Hospira Pty Limited
Vincristine	I.V. injection containing vincristine sulfate 1 mg in 1 mL		Injection		10		..		Hospira Pty Limited Pfizer Australia Pty Ltd
Vinorelbine	Solution for I.V. infusion 10 mg (as tartrate) in 1 mL		Injection		16		2		Navelbine Vinorelbine Link Vinorelbine Ebewe Hospira Pty Limited
	Solution for I.V. infusion 50 mg (as tartrate) in 5 mL		Injection		4		2		Navelbine Vinorelbine Link Vinorelbine Ebewe Hospira Pty Limited

Title	Date of FRLI Registration	Date of commencement	Application, saving or transitional provisions
PB 121 of 2008	28 Nov 2008 (see F2008L04422)	1 Dec 2008
PB 130 of 2008	11 Dec 2008 (see F2008L04643)	1 Jan 2009	—
PB 13 of 2009	12 Feb 2009 (see F2009L00432)	1 Mar 2009	—
PB 25 of 2009	18 Mar 2009 (see F2009L01116)	1 Apr 2009	—
PB 36 of 2009	8 Apr 2009 (see F2009L01255)	1 May 2009	—
PB 44 of 2009	12 May 2009 (see F2009L01715)	1 June 2009	—

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected		How affected
	Schedule 1
	Schedule 1.................		am. PB 36 of 2009
	Schedule 2
Schedule 2.................		am. PB 130 of 2008; PB 13, 25, 36 and 44 of 2009