National Health Act 1953 Special Arrangements under subsection 100(1) Chemotherapy Pharmaceuticals Access Program (No. PB 55 of 2009) (Cth)
Special Arrangements — Chemotherapy Pharmaceuticals Access Program
(PB 55 of 2009)as amended
made under subsection 100(1) of the
National Health Act 1953
This compilation was prepared on 1 November 2010
taking into account amendments up to PB 105 of 2010Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, CanberraSpecial Arrangements – Chemotherapy Pharmaceuticals Access Program
(PB 55 of 2009)Commencement [see Note 1]
1.(a) These Arrangements commence on 1 July 2009.
(b) Instrument No. PB 121 of 2008 is repealed.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, in respect of which an approved hospital authority is approved under section 94 of the Act, which is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Healthcare Agreement;
(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 subparagraph (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.
14A. If a medical practitioner or an approved hospital authority on behalf of a medical practitioner, has written on a medication chart that has been prepared in accordance with paragraph 13, the four digit code mentioned in Schedule 1 or Schedule 3 for a chemotherapy pharmaceutical and circumstances:
(a) subparagraph 13(e) is taken to have been complied with; and
(b) the Medicare Australia CEO is taken to have authorised the medication chart.
14B. Paragraph 14A applies to a medication chart only if there is a four digit code for the chemotherapy pharmaceutical and circumstances in Schedule 1 or Schedule 3 whichever applies.
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 subparagraph 14 (d): Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered:
(a) altretamine;
(b) carmustine;
(c) cisplatin, when a single dose constitutes a cycle of chemotherapy;
(d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
(e) dacarbazine;
(f) procarbazine, when a single dose constitutes a cycle of chemotherapy;
(g) streptozocin; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co-administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered:
(a) arsenic trioxide;
(b) azacitidine;
(c) carboplatin;
(d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day;
(e) cytarabine, at a dose of greater than 1 g per square metre per day;
(f) dactinomycin;
(g) daunorubicin;
(h) doxorubicin;
(i) epirubicin;
(j) fotemustine;
(k) idarubicin;
(l) ifosfamide;
(m) irinotecan;
(n) melphalan;
(o) methotrexate, at a dose of 250 mg to 1 g per square metre;
(p) oxaliplatin;
(q) raltitrexed; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle
Arsenic In compliance with authority procedures set out in paragraph 14:
Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction
“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 Bevacizumab In compliance with authority procedures set out in paragraph 14:
Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
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:
3180
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 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 Adjuvant treatment of operable breast cancer in combination with cyclophosphamide 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:
3181
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:
3184
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 subparagraph 14 (d): Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with capecitabine Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and folinic acid 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 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
Palonosetron Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration 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:
3185
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:
3186
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 |
| Arsenic | Injection concentrate containing arsenic trioxide 10 mg in 10 mL | Injection | 60 | 2 | Phenasen |
| “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 |
| Bevacizumab | Solution for I.V. infusion 100 mg in 4 mL | Injection | 1 | .. | Avastin |
| Solution for I.V. infusion 400 mg in 16 mL | Injection | 1 | .. | Avastin | |
| 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 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 | 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 with solvent | Injection | 1 | .. | Taxotere |
| Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent | 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 | Farine Fludara |
| Fludarabine Actavis | |||||
| 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 Gemcitabine Actavis Gemcitabine Ebewe Gemcite Gemzar |
| Powder for I.V. infusion 1 g (as hydrochloride) | Injection | 2 | 2 | DBL Gemcitabine for Injection Gemcitabine Actavis Gemcitabine Ebewe Gemcite 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 500 mg (as hydrochloride) in 50 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 Actavis Irinotecan Alphapharm Irinotecan Ebewe |
| Irinotecan Sandoz | |||||
| Omegapharm Irinotecan Tecan | |||||
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Injection | 2 | 3 | Camptosar Hospira Pty Limited Irinotecan Actavis Irinotecan Alphapharm Irinotecan Ebewe | |
| Irinotecan Sandoz Omegapharm Irinotecan Tecan | |||||
| I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL | Injection | 1 | 3 | Camptosar Irinotecan Ebewe | |
| I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL | Injection | 1 | 3 | Hospira Pty Limited Irinotecan Ebewe | |
| 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 | .. | 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 | 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 | |||||
| Wafer 4 mg | Oral | 4 | .. | Ondansetron-RL Zydis Ondaz Zydis Zofran Zydis | |
| Wafer 8 mg | Oral | 4 | .. | Ondansetron-RL Zydis Ondaz Zydis Zofran Zydis | |
| Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL | Oral | 1 | .. | Zofran syrup 50 mL | |
| 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 | DBL Oxaliplatin Concentrate |
| Eloxatin | |||||
| Powder for I.V. infusion 50 mg | Injection | 1 | 2 | Oxalatin | |
| Oxaliplatin Actavis | |||||
| Oxaliplatin Alphapharm | |||||
| Oxaliplatin Ebewe | |||||
| Oxaliplatin Link | |||||
| Hospira Pty Limited | |||||
| Solution concentrate for I.V. infusion 100 mg in 20 mL vial | Injection | 1 | 2 | DBL Oxaliplatin Concentrate | |
| Eloxatin | |||||
| Powder for I.V. infusion 100 mg | Injection | 1 | 2 | Oxalatin | |
| Oxaliplatin Actavis | |||||
| Oxaliplatin Alphapharm | |||||
| Oxaliplatin Ebewe | |||||
| Oxaliplatin Link | |||||
| Hospira Pty Limited | |||||
| Winthrop Oxaliplatin | |||||
| 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 |
| Paclitaxel Actavis | |||||
| Paclitaxel Ebewe | |||||
| Plaxel | |||||
| Taxol | |||||
| Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | 2 | .. | Anzatax | |
| Paclitaxel Actavis | |||||
| Paclitaxel Ebewe | |||||
| Plaxel | |||||
| Taxol | |||||
| Solution concentrate for I.V. infusion 150 mg in 25 mL | Injection | 2 | .. | Anzatax Paclitaxel Actavis Paclitaxel Ebewe Plaxel | |
| Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | 1 | .. | Anzatax | |
| Paclitaxel Actavis | |||||
| Paclitaxel Ebewe | |||||
| Plaxel | |||||
| Taxol | |||||
| Paclitaxel, nanoparticle albumin-bound | Powder for I.V. injection containing 100 mg paclitaxel | Injection | 1 | .. | Abraxane |
| Palonosetron | Injection 250 micrograms (as hydrochloride) in 5mL | Injection | 1 | .. | Aloxi |
| 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 |
| Vinorelbine Link | |||||
| Hospira Pty Limited | |||||
| Solution for I.V. infusion 50 mg (as tartrate) in 5 mL | Injection | 4 | 2 | Navelbine Vinorelbine Ebewe Vinorelbine Link Hospira Pty Limited | |
SCHEDULE 3 Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Name of chemo-therapy pharma-ceutical Form (strength, type, size, etc.) Purposes Manner of admini-stration Maximum quantity Maximum number of repeats Brand 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 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 Docetaxel Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent 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
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
Adjuvant treatment of operable breast cancer in combination with cyclophosphamide
Injection 2 .. Taxotere 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
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
SCHEDULE 4 Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Name of
chemotherapy pharmaceuticalForm (strength, type, size, etc.) Brand Relevant quantity or number of units Approved price
$Price claimed by manu-facturer
$Bleomycin Powder for injection containing bleomycin sulfate 15,000 I.U. Hospira Pty Limited
Blenamax
1
10
41.72
417.22
79.26
792.56
Blenoxane 10 417.22 857.24 Folinic acid Injection containing calcium folinate equivalent to 50 mg folinic acid in
5 mLLeucovorin Calcium (Pfizer Australia Pty Ltd) 10 193.30 193.31
Notes to the Special Arrangements — Chemotherapy Pharmaceuticals Access Program (PB 55 of 2009)
The Special Arrangements — Chemotherapy Pharmaceuticals Access Program
(PB 55 of 2009) (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
commencementApplication, saving or
transitional provisionsPB 55 of 2009 17 June 2009 (see F2009L02364) 1 July 2009 PB 70 of 2009 17 July 2009 (see F2009L02871) 1 Aug 2009 — PB 83 of 2009 17 Aug 2009 (see F2009L03155) 1 Sept 2009 — PB 93 of 2009 17 Sept 2009 (see F2009L03546) 1 Oct 2009 — PB 102 of 2009 14 Oct 2009 (see F2009L03892) 1 Nov 2009 — PB 114 of 2009 20 Nov 2009 (see F2009L04291) 1 Dec 2009 — PB 124 of 2009 14 Dec 2009 (see F2009L04612) 1 Jan 2010 — PB 132 of 2009 13 Jan 2010 (see F2010L00106) 1 Feb 2010 — PB 9 of 2010 17 Feb 2010 (see F2010L00476) 1 Mar 2010 — PB 22 of 2010 17 Mar 2010 (see F2010L00682) 1 Apr 2010 — PB 40 of 2010 15 Apr 2010 (see F2010L00943) 1 May 2010 — PB 50 of 2010 31 May 2010 (see F2010L01489) 1 June 2010 — PB 60 of 2010 21 June 2010 (see F2010L01644) 1 July 2010 — PB 76 of 2010 19 July 2010 (see F2010L02076) 1 Aug 2010 — PB 92 of 2010 24 Sept 2010 (see F2010L02530) 1 Oct 2010 — PB 105 of 2010 29 Oct 2010 (see F2010L02862) 1 Nov 2010 —
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 70 and 83 of 2009; PB 22, 60, 76 and 105 of 2010
Schedule 2
Schedule 2........................................
am. PB 70, 83, 93, 102, 114, 124 and 132 of 2009; PB 9, 40, 50, 60, 76 and 105 of 2010
Schedule 3
Schedule 3........................................
am. PB 22, 50 and 60 of 2010
Schedule 4
Schedule 4........................................
am. PB 70 and 114 of 2009; PB 22, 76 and 92 of 2010
0
0
0