National Health Act 1953 Special Arrangements under subsection 100(1) Chemotherapy Pharmaceuticals Access Program (No. PB 54 of 2007) (Cth)
Special Arrangements — Chemotherapy Pharmaceuticals Access Program
(PB 54 of 2007)as amended
made under subsection 100(1) of the
National Health Act 1953
This compilation was prepared on 1 November 2007
taking into account amendments up to PB 84 of 2007Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General’s Department, Canberra
Special Arrangements — Chemotherapy Pharmaceuticals Access Program
(PB 54 of 2007)Commencement [see Note 1]
1. (a) These Arrangements commence on 1 August 2007.
(b) The Arrangements made on 30 March 2007 with effect from 1 May 2007 (No. PB 35 of 2007) are repealed with effect from the commencement of these Arrangements.
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
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 the patient was receiving prior treatment with other chemotherapy for androgen independent (hormone refractory) metastatic carcinoma of the prostate at 1 November 2007, and where docetaxel is 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
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with paclitaxel or docetaxel is contraindicated Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where intolerance to treatment with either docetaxel or paclitaxel has developed Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with either docetaxel or paclitaxel has been unsuccessful Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where transfer to docetaxel or paclitaxel is likely to result in adverse clinical consequences 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
Mayne Pharma Pty Ltd
Carboplatin Solution for I.V. injection 50 mg in 5 mL Injection 2 .. Carboplatin Ebewe
Mayne Pharma Pty Ltd
Pfizer Pty Limited
Solution for I.V. injection 150 mg in 15 mL Injection 6 .. Carboplatin Ebewe
Mayne Pharma Pty Ltd
Pfizer Pty Limited
Solution for I.V. injection 450 mg in 45 mL Injection 2 .. Carboplatin Ebewe
Mayne Pharma Pty Ltd
Pfizer Pty Limited
Cetuximab Solution for I.V. infusion 100 mg in 50 mL Injection 6 .. Erbitux Cisplatin I.V. injection 10 mg in 10 mL Injection 1 .. Pfizer Pty Limited I.V. injection 50 mg in 50 mL Injection 1 .. Mayne Pharma Pty Ltd
Pfizer Pty Limited
I.V. injection 100 mg in 100 mL Injection 1 .. Cisplatin Ebewe
Mayne Pharma 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 Cytarabine Injection 100 mg in 5 mL vial Injection 10 1 Pfizer Pty Limited 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
Mayne Pharma Pty Ltd
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
Mayne Pharma Pty Ltd
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
Mayne Pharma Pty Ltd
Powder for injection containing epirubicin hydrochloride 50 mg Injection/ intravesical 4 .. Mayne Pharma Pty Ltd Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL Injection/ intravesical 2 .. Epirubicin Ebewe
Mayne Pharma Pty Ltd
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
Mayne Pharma Pty Ltd
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
Mayne Pharma Pty Ltd
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 (Mayne Pharma Pty Ltd) Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL Injection 5 5 Calcium Folinate Ebewe
Leucovorin Calcium (Mayne Pharma Pty Ltd)
Leucovorin Calcium (Pfizer Pty Limited)
Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL Injection 10 1 Calcium Folinate Ebewe
Leucovorin Calcium (Pfizer Pty Limited)
Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL Injection 4 1 Leucovorin Calcium (Mayne Pharma Pty Ltd) 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
Mayne Pharma Pty Ltd
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL Injection 2 3 Camptosar
Mayne Pharma Pty Ltd
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 .. Mayne Pharma Pty Ltd Injection 50 mg in 2 mL vial Injection 5 .. Mayne Pharma Pty Ltd
Pfizer Pty Limited
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 .. Mayne Pharma Pty Ltd Solution concentrate for I.V. infusion 1000 mg in 10 mL vial Injection 1 .. Methotrexate Ebewe
Mayne Pharma Pty Ltd
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 Pty Limited
Injection 20 mg (as hydrochloride) in 10 mL Injection 1 .. Mitozantrone Ebewe Onkotrone Mayne Pharma Pty Ltd Pfizer Pty Limited Injection 25 mg (as hydrochloride) in 12.5 mL Injection 1 .. Onkotrone
Pfizer Pty Limited
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 Pty Limited I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL Injection 1 .. Ondansetron-RL
Ondaz
Onsetron
Zofran Pfizer Pty Limited 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 Mayne Pharma Pty Ltd 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 Mayne Pharma Pty Ltd 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 500 mg (as disodium heptahydrate) Injection 2 2 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 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 .. Mayne Pharma Pty Ltd Vincristine I.V. injection containing vincristine sulfate 1 mg in 1 mL Injection 10 .. Mayne Pharma Pty Ltd
Pfizer Pty Limited
Vinorelbine Solution for I.V. infusion 10 mg (as tartrate) in 1 mL Injection 16 2 Navelbine
Vinorelbine Ebewe
Mayne Pharma Pty Ltd
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL Injection 4 2 Navelbine
Vinorelbine Ebewe
Mayne Pharma Pty Ltd
| Cetuximab | 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 | 4 | 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 |
| Pemetrexed | Powder for I.V. infusion 500 mg (as disodium heptahydrate) | 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 treatment with paclitaxel or docetaxel is contraindicated | Injection | 2 | 2 | Alimta |
| Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where intolerance to treatment with either docetaxel or paclitaxel has developed | ||||||
| Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with either docetaxel or paclitaxel has been unsuccessful | ||||||
| Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where transfer to docetaxel or paclitaxel is likely to result in adverse clinical consequences | ||||||
| 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 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 | 2 | 7 | Mabthera |
| 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. Mayne Pharma Pty Ltd 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 (Mayne Pharma Pty Ltd) 1
25.59 25.60 Leucovorin Calcium (Pfizer Pty Limited) 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 Pemetrexed Powder for I.V. infusion 500 mg (as disodium heptahydrate) (unless authorisation is obtained in accordance with paragraph 14 for a purpose specified in column 3 of Schedule 3) Alimta 1 1395.59 1594.95
Notes to the Special Arrangements — Chemotherapy Pharmaceuticals Access Program (PB 54 of 2007)
Note 1
The Special Arrangements — Chemotherapy Pharmaceuticals Access Program
(PB 54 of 2007) (in force under subsection 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 | Application, saving or |
| PB 54 of 2007 | 31 July 2007 (see F2007L02398) | 1 Aug 2007 | |
| PB 65 of 2007 | 23 Aug 2007 (see F2007L02635) | 1 Sept 2007 | — |
| PB 74 of 2007 | 12 Aug 2007 (see F2007L03625) | 1 Oct 2007 | — |
| PB 84 of 2007 | 8 Oct 2007 (see F2007L03948) | 1 Nov 2007 | — |
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 65, 74 and 84 of 2007 |
| Schedule 2 | |
| Schedule 2............................................ | am. PB 65 and 74 of 2007 |
| Schedule 3 | |
| Schedule 3............................................ | am. PB 65 of 2007 |
| Schedule 4 | |
| Schedule 4............................................ | am. PB 74 of 2007 |
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