National Health Act 1953 Special Arrangements under subsection 100(1) Chemotherapy Pharmaceuticals Access Program (No. PB 93 of 2007) (Cth)

Special Arrangements — Chemotherapy Pharmaceuticals Access Program
(PB 93 of 2007)

as amended

made under subsection 100(1) of the

National Health Act 1953

This compilation was prepared on 1 July 2008
taking into account amendments up to PB 67 of 2008

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Special Arrangements – Chemotherapy Pharmaceuticals Access Program
(PB 93 of 2007)

Commencement [see Note 1]

1.        

(a)     These Arrangements commence on 1 December 2007.

(b)     Instrument No. PB 54 of 2007 is repealed.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(f); 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 7 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' "

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:

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

Dolasetron

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy

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

—

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

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

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

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

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

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	..	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
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
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	2	..	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
Powder for injection containing epirubicin hydrochloride 50 mg	Injection/intravesical	4	..	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 containing etoposide phosphate 113.6 mg	Injection	5	..	Etopophos
Powder for I.V. infusion containing etoposide phosphate 1.136 g	Injection	1	..	Etopophos
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	Gemzar
Powder for I.V. infusion 1 g (as hydrochloride)	Injection	2	2	Gemzar
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
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	2	3	Camptosar Hospira Pty Limited Irinotecan Sandoz
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 5 mL vial	Injection	1	..	Methotrexate Ebewe
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	..	Ondansetron-RL Ondaz Onsetron 4 Zofran
Tablet 8 mg (as hydrochloride dihydrate)	Oral	4	..		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 vial	Injection	5	..	Anzatax Paclitaxel Ebewe Taxol
Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial	Injection	2	..	Anzatax Paclitaxel Ebewe Taxol
Solution concentrate for I.V. infusion 150 mg in 25 mL vial	Injection	2	..	Anzatax Paclitaxel Ebewe Taxol
Solution concentrate for I.V. infusion 300 mg in 50 mL vial	Injection	1	..	Anzatax Paclitaxel Ebewe Taxol
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 Pharmaceuticals (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 Ebewe Hospira Pty Limited
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL	Injection	4	2	Navelbine Vinorelbine Ebewe Hospira Pty Limited

Cetuximab	Solution for I.V. infusion 100 mg in 20 mL	In compliance with authority procedures set out in paragraph 14: 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	Injection	1	6	Erbitux
Solution for I.V. infusion 100 mg in 50 mL	In compliance with authority procedures set out in paragraph 14: 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	Injection	1	6	Erbitux
Solution for I.V. infusion 500 mg in 100 mL	In compliance with authority procedures set out in paragraph 14: 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	Injection	1	6	Erbitux
Interferon Alfa-2a	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: Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	15	5	Roferon-A
Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe	In compliance with authority procedures set out in paragraph 14: Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	5	5	Roferon-A
Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe	In compliance with authority procedures set out in paragraph 14: Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	5	5	Roferon-A
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: Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	5	5	Roferon-A
Interferon Alfa-2b	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: 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	Injection	3	5	Intron A Redipen
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	In compliance with authority procedures set out in paragraph 14: Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy	Injection	2	7	Mabthera
Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Solution for I.V. infusion 500 mg in 50 mL	In compliance with authority procedures set out in paragraph 14: 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	Injection	1	7	Mabthera

Bleomycin	Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent)	Hospira Pty Limited	1	44.33	84.20
Blenamax	10	443.25	842.02
Blenoxane	10	443.25	910.80
Folinic acid	Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL	Leucovorin Calcium (Hospira Pty Limited)	1	25.59	25.60
Leucovorin Calcium (Pfizer Australia Pty Ltd)	10	205.31	205.51
Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL	Calcium Folinate Ebewe	1	23.62	23.63
Ondansetron	Wafer 4 mg	Zofran Zydis	4	28.38	28.95
Wafer 8 mg	Zofran Zydis	4	44.45	45.03
Tablet 4 mg (as hydrochloride dihydrate)	Zofran	4	28.38	28.95
Tablet 8 mg (as hydrochloride dihydrate)	Zofran	4	44.45	45.03
I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL	Zofran	1	16.00	16.58
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL	Zofran	1	25.42	25.99

Notes to the Special Arrangements — Chemotherapy Pharmaceuticals Access Program (PB 93 of 2007)

Note 1

The Special Arrangements — Chemotherapy Pharmaceuticals Access Program
(PB 93 of 2007) (in force under subsections 100(1) 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 commencement	Application, saving or transitional provisions
PB 93 of 2007	16 Nov 2007 (see F2007L04365)	1 Dec 2007
PB 5 of 2008	23 Nov 2007 (see F2007L04467)	1 Jan 2008	—
PB 19 of 2008	9 Jan 2008 (see F2008L00041)	1 Feb 2008	—
PB 28 of 2008	8 Feb 2008 (see F2008L00286)	1 Mar 2008	—
PB 37 of 2008	11 Mar 2008 (see F2008L00702)	1 Apr 2008	—
PB 56 of 2008	12 May 2008 (see F2008L01391)	1 June 2008	—
PB 67 of 2008	10 June 2008 (see F2008L02058)	1 July 2008	—

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 5, 19, 28 and 37 of 2008
Schedule 2
Schedule 2........................................	am. PB 19, 28, 37, 56 and 67 of 2008
Schedule 3
Schedule 3........................................	am. PB 5, 19 and 37 of 2008
Schedule 4
Schedule 4........................................	am. PB 37 and 67 of 2008