National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10) (PB 89 of 2017) (Cth)

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PB 89 of 2017

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10)

National Health Act 1953

I, JULIANNE QUAINE, Assistant Secretary, Pharmacy and Insurance Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated                        26 October      2017

JULIANNE QUAINE

Assistant Secretary

Pharmacy and Insurance Branch

Technology Assessment and Access Division

Department of Health


1          Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10).

(2)This Instrument may also be cited as PB 89 of 2017.

2          Commencement

This Instrument commences on 1 November 2017.

3Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

This Instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1     Amendments

[1]Schedule 1, Part 1

substitute table under existing headings in the columns in the order indicated:

Listed Drug Form Manner of Administration Brand Responsible Person Authorised Prescriber Circumstances Section 100 only
Arsenic Injection concentrate containing arsenic trioxide 10 mg in 10 mL Injection Phenasen PL MP C4793 C5997 C6018 D
Bendamustine Powder for injection containing bendamustine hydrochloride 25 mg Injection Ribomustin JC MP C6075 C6124 D
Powder for injection containing bendamustine hydrochloride 100 mg Injection Ribomustin JC MP C6075 C6124 D
Bevacizumab Solution for I.V. infusion 100 mg in 4 mL Injection Avastin RO MP C4584 C4587 C4594 C4814 C4939 C4968 C6337 C6338 C6353 D
Solution for I.V. infusion 400 mg in 16 mL Injection Avastin RO MP C4584 C4587 C4594 C4814 C4939 C4968 C6337 C6338 C6353 D
Bleomycin Powder for injection containing bleomycin sulfate 15,000 I.U. Injection Bleo 15K EA MP C6224 C6275 D
CIPLA BLEOMYCIN LR MP C6224 C6275 D
Hospira Pty Limited PF MP C6224 C6275 D
Blinatumomab Powder for I.V. infusion 38.5 micrograms Injection Blincyto AN MP C6892 C6893 C6894 C6895 D
Bortezomib Powder for injection 1 mg Injection Velcade JC MP C6372 C6384 C6466 C6472 C6478 D
Powder for injection 3 mg Injection Velcade JC MP C4080 C4081 C4161 C4162 C6372 C6373 C6384 C6452 C6466 C6472 C6478 D
Powder for injection 3.5 mg Injection Velcade JC MP C4080 C4081 C4161 C4162 C6373 C6452 D
Brentuximab vedotin Powder for I.V. infusion 50 mg Injection Adcetris TK MP C4675 C4719 C6903 C6904 C6936 C6941 D
Cabazitaxel Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent Injection Jevtana SW MP C4662 D
Carboplatin Solution for I.V. injection 50 mg in 5 mL Injection Hospira Pty Limited PF MP D
Solution for I.V. injection 150 mg in 15 mL Injection Hospira Pty Limited PF MP D
Solution for I.V. injection 450 mg in 45 mL Injection Carboplatin Accord OC MP D
Hospira Pty Limited PF MP D
Cetuximab Solution for I.V. infusion 100 mg in 20 mL Injection Erbitux SG MP C4785 C4788 C4794 C4908 C4912 C4945 C4965 D
Solution for I.V. infusion 500 mg in 100 mL Injection Erbitux SG MP C4785 C4788 C4794 C4908 C4912 C4945 C4965 D
Cisplatin I.V. injection 50 mg in 50 mL Injection Hospira Pty Limited PF MP D
I.V. injection 100 mg in 100 mL Injection Hospira Pty Limited PF MP D
Cladribine Injection 10 mg in 5 mL Injection Litak OA MP C6265 D
Solution for I.V. infusion 10 mg in 10 mL single use vial Injection Leustatin JC MP C6265 D
Cyclophosphamide Powder for injection 500 mg (anhydrous) Injection Endoxan BX MP PB
Powder for injection 1 g (anhydrous) Injection Endoxan BX MP PB
Powder for injection 2 g (anhydrous) Injection Endoxan BX MP PB
Cytarabine Injection 100 mg in 5 mL vial Injection Pfizer Australia Pty Ltd PF MP D
Docetaxel Solution concentrate for I.V. infusion 20 mg in 2 mL Injection DBL Docetaxel Concentrated Injection PF MP D
Solution concentrate for I.V. infusion 80 mg in 4 mL Injection Docetaxel Accord OC MP D
Solution concentrate for I.V. infusion 80 mg in 8 mL Injection DBL Docetaxel Concentrated Injection PF MP D
Docetaxel Sandoz SZ MP D
Solution concentrate for I.V. infusion 140 mg in 7 mL Injection Oncotaxel 140 EA MP D
Solution concentrate for I.V. infusion 160 mg in 8 mL Injection Docetaxel Accord OC MP D
Solution concentrate for I.V. infusion 160 mg in 16 mL Injection DBL Docetaxel Concentrated Injection PF MP D
Doxorubicin Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial Injection/
intravesical 		Adriamycin PF MP D
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial Injection/
intravesical 		Accord Doxorubicin EA MP D
Adriamycin PF MP D
Doxorubicin ACC OC MP D
Doxorubicin - pegylated liposomal Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL Injection Caelyx JC MP C4786 C4787 C4791 D
Liposomal Doxorubicin SUN RA MP C4786 C4787 C4791 D
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL Injection Caelyx JC MP C4786 C4787 C4791 D
Liposomal Doxorubicin SUN RA MP C4786 C4787 C4791 D
Epirubicin Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL Injection/
intravesical 		Epirube TB MP D
Epirubicin ACT EA MP D
Epirubicin SZ HX MP D
Pharmorubicin PF MP D
Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL Injection/
intravesical 		Epirubicin ACT EA MP D
Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL Injection/
intravesical 		Epirube TB MP D
Epirubicin Accord OC MP D
Epirubicin ACT EA MP D
Pharmorubicin PF MP D
Eribulin Solution for I.V. injection containing eribulin mesilate 1 mg in 2 mL Injection Halaven EI MP C4649 D
Etoposide Powder for I.V. infusion 100 mg (as phosphate) Injection Etopophos BQ MP PB
Powder for I.V. infusion 1 g (as phosphate) Injection Etopophos BQ MP PB
Solution for I.V. infusion 100 mg in 5 mL Injection Etoposide Ebewe SZ MP PB
Pfizer Australia Pty Ltd PF MP PB
Fludarabine Powder for I.V. injection containing fludarabine phosphate 50 mg Injection Fludarabine ACT EA MP PB
Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL Injection Fludarabine Ebewe SZ MP PB
Fluorouracil Injection 500 mg in 10 mL Injection Hospira Pty Limited PF MP C6266 C6297 D
Injection 1000 mg in 20 mL Injection DBL Fluorouracil Injection BP PF MP C6266 C6297 D
Fluorouracil Ebewe SZ MP C6266 C6297 D
Injection 2500 mg in 50 mL Injection DBL Fluorouracil Injection BP PF MP C6266 C6297 D
Fluorouracil Ebewe SZ MP C6266 C6297 D
Injection 5000 mg in 100 mL Injection Fluorouracil Ebewe SZ MP C6266 C6297 D
Fotemustine Powder for injection 208 mg with solvent Injection Muphoran SE MP C6288 D
Gemcitabine Powder for I.V. infusion 200 mg (as hydrochloride) Injection Gemcitabine Ebewe SZ MP D
Powder for I.V. infusion 1 g (as hydrochloride) Injection Gemcitabine Ebewe SZ MP D
Powder for I.V. infusion 2 g (as hydrochloride) Injection Gemcitabine Actavis 2000 EA MP D
Solution for injection 200 mg (as hydrochloride) in 5.3 mL Injection DBL Gemcitabine Injection PF MP D
Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL Injection Gemcitabine Ebewe SZ MP D
Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL Injection Gemcitabine Ebewe SZ MP D
Solution for injection 1 g (as hydrochloride) in 26.3 mL Injection DBL Gemcitabine Injection PF MP D
Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL Injection Gemcitabine Ebewe SZ MP D
Solution for injection 2 g (as hydrochloride) in 52.6 mL Injection DBL Gemcitabine Injection PF MP D
Idarubicin Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL Injection Idarubicin Ebewe SZ MP C6247 PB
Zavedos Solution PF MP C6247 PB
Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL Injection Idarubicin Ebewe SZ MP C6247 PB
Zavedos Solution PF MP C6247 PB
Ifosfamide Powder for I.V. injection 1 g Injection Holoxan BX MP D
Powder for I.V. injection 2 g Injection Holoxan BX MP D
Ipilimumab Injection concentrate for I.V. infusion 50 mg in 10 mL Injection Yervoy BQ MP C6562 C6585 D
Injection concentrate for I.V. infusion 200 mg in 40 mL Injection Yervoy BQ MP C6562 C6585 D
Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL Injection MEDITAB IRINOTECAN LR MP D
Omegapharm Irinotecan OE MP D
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL Injection Hospira Pty Limited PF MP D
Irinotecan Accord OC MP D
Irinotecan Alphapharm AF MP D
Irinotecan Kabi PK MP D
MEDITAB IRINOTECAN LR MP D
Omegapharm Irinotecan OE MP D
I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL Injection Irinotecan Ebewe SZ MP D
I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL Injection Hospira Pty Limited PF MP D
IRINOTECAN ACT ED MP D
Irinotecan Alphapharm AF MP D
Methotrexate Injection 5 mg in 2 mL vial Injection Hospira Pty Limited PF MP C
Injection 50 mg in 2 mL vial Injection Hospira Pty Limited PF MP C
Methotrexate Accord OD MP C
Solution concentrate for I.V. infusion 500 mg in 20 mL vial Injection Hospira Pty Limited PF MP C
Solution concentrate for I.V. infusion 1000 mg in 10 mL vial Injection Hospira Pty Limited PF MP PB
Methaccord EA MP PB
Methotrexate Accord OD MP PB
Pfizer Australia Pty Ltd PF MP PB
Solution concentrate for I.V. infusion 5000 mg in 50 mL vial Injection Methotrexate Ebewe SZ MP PB
Mitozantrone Injection 20 mg (as hydrochloride) in 10 mL Injection Mitozantrone Ebewe SZ MP D
Onkotrone BX MP D
Injection 25 mg (as hydrochloride) in 12.5 mL Injection Onkotrone BX MP D
Nivolumab Injection concentrate for I.V. infusion 40 mg in 4 mL Injection Opdivo BQ MP C6070 C6095 C6111 C6988 C6993 C6996 C6997 C6999 D
Injection concentrate for I.V. infusion 100 mg in 10 mL Injection Opdivo BQ MP C6070 C6095 C6111 C6988 C6993 C6996 C6997 C6999 D
Obinutuzumab Solution for I.V. infusion 1000 mg in 40 mL Injection Gazyva RO MP C5126 D
Ofatumumab Solution concentrate for I.V. infusion 100 mg in 5 mL Injection Arzerra NV MP C4828 D
Solution concentrate for I.V. infusion 1000 mg in 50 mL Injection Arzerra NV MP C4828 C4858 D
Oxaliplatin Solution concentrate for I.V. infusion 50 mg in 10 mL Injection DBL Oxaliplatin Concentrate PF MP D
Oxaliplatin SUN RA MP D
Solution concentrate for I.V. infusion 100 mg in 20 mL Injection DBL Oxaliplatin Concentrate PF MP D
Oxaliccord EA MP D
Oxaliplatin Accord OC MP D
Oxaliplatin SUN RA MP D
Oxaliplatin SZ HX MP D
Solution concentrate for I.V. infusion 200 mg in 40 mL Injection Oxaliplatin SUN RA MP D
Paclitaxel Solution concentrate for I.V. infusion 30 mg in 5 mL Injection Paclitaxel ACT EF MP D
Paclitaxel Kabi PK MP D
Paclitaxin TB MP D
Paclitaxel Ebewe SZ MP D
Solution concentrate for I.V. infusion 100 mg in 16.7 mL Injection Anzatax PF MP D
Paclitaxel ACT EF MP D
Paclitaxin TB MP D
Solution concentrate for I.V. infusion 150 mg in 25 mL Injection Anzatax PF MP D
Paclitaxel ACT EF MP D
Paclitaxel Ebewe SZ MP D
Paclitaxin TB MP D
Solution concentrate for I.V. infusion 300 mg in 50 mL Injection Anzatax PF MP D
Paclitaxel Accord OC MP D
Paclitaxel ACT EF MP D
Paclitaxel Ebewe SZ MP D
Paclitaxel Kabi PK MP D
Paclitaxin TB MP D
Paclitaxel, nanoparticle albumin-bound Powder for I.V. injection containing 100 mg paclitaxel Injection Abraxane TS MP C4657 C6106 C6119 D
Panitumumab Solution concentrate for I.V. infusion 100 mg in 5 mL Injection Vectibix AN MP C5439 C5447 C5452 C5526 D
Solution concentrate for I.V. infusion 400 mg in 20 mL Injection Vectibix AN MP C5439 C5447 C5452 C5526 D
Pembrolizumab Powder for injection 50 mg Injection Keytruda MK MP C6801 C6806 C6817 D
Solution concentrate for I.V. infusion 100 mg in 4 mL Injection Keytruda MK MP C6801 C6806 C6817 D
Pemetrexed Powder for I.V. infusion 100 mg (as disodium) Injection Alimta LY MP C4789 C4792 D
DBL Pemetrexed PF MP C4789 C4792 D
Pemetrexed Accord OD MP C4789 C4792 D
Pemetrexed APOTEX TX MP C4789 C4792 D
Pemetrexed Juno JU MP C4789 C4792 D
Pemetrexed MYX OC MP C4789 C4792 D
PEMETREXED-DRLA RZ MP C4789 C4792 D
Reladdin AF MP C4789 C4792 D
Tevatrexed TB MP C4789 C4792 D
Powder for I.V. infusion 500 mg (as disodium) Injection Alimta LY MP C4789 C4792 D
DBL Pemetrexed PF MP C4789 C4792 D
Pemetrexed Accord OD MP C4789 C4792 D
Pemetrexed APOTEX TX MP C4789 C4792 D
Pemetrexed DRLA RZ MP C4789 C4792 D
Pemetrexed Juno JU MP C4789 C4792 D
Pemetrexed MYX OC MP C4789 C4792 D
Pemetrexed Sandoz SZ MP C4789 C4792 D
Reladdin AF MP C4789 C4792 D
Tevatrexed TB MP C4789 C4792 D
Powder for I.V. infusion 1 g (as disodium) Injection DBL Pemetrexed PF MP C4789 C4792 D
Pemetrexed Accord OD MP C4789 C4792 D
Pemetrexed MYX OC MP C4789 C4792 D
Pertuzumab Solution for I.V. infusion 420 mg in 14 mL Injection Perjeta RO MP C4971 C5013 C5023 D
Raltitrexed Powder for I.V. infusion 2 mg in single use vial Injection Tomudex PF MP C6228 D
Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Mabthera RO MP C5998 C6009 C6034 C6039 C6161 C6162 C6309 C7040 PB
Solution for I.V. infusion 500 mg in 50 mL Injection Mabthera RO MP C5998 C6009 C6034 C6039 C6161 C6162 C6309 C7040 PB
Topotecan Powder for I.V. infusion 4 mg (as hydrochloride) Injection Hycamtin SZ MP C6238 D
Trastuzumab Powder for I.V. infusion 60 mg Injection Herceptin RO MP C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041 C5825 C5834 C5844 PB
Powder for I.V. infusion 150 mg Injection Herceptin RO MP C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041 C5825 C5834 C5844 PB
Trastuzumab emtansine Powder for I.V. infusion 100 mg Injection Kadcyla RO MP C4978 C4986 C6096 C6129 D
Powder for I.V. infusion 160 mg Injection Kadcyla RO MP C4978 C4986 C6096 C6129 D
Vinblastine Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL Injection Hospira Pty Limited PF MP D
Vinblastine Teva DZ MP D
Vincristine I.V. injection containing vincristine sulfate 1 mg in 1 mL Injection Hospira Pty Limited PF MP D
Vinorelbine Solution for I.V. infusion 10 mg (as tartrate) in 1 mL Injection Hospira Pty Limited PF MP PB
Navelbine FB MP PB
Vinorelbine Ebewe SZ MP PB
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL Injection Hospira Pty Limited PF MP PB
Navelbine FB MP PB
Vinorelbine Ebewe SZ MP PB

[2]Schedule 1, Part 2

substitute table under existing headings in the columns in the order indicated:

Listed Drug Purposes Maximum Amount Number of Repeats
Arsenic P4793 P5997 18 89
P6018 18 140
Bendamustine 200 11
Bevacizumab P4814 900 5
P4584 P4587 P4594 P4939 P4968 900 11
P6337 P6338 P6353 1800 7
Bleomycin 30000 11
Blinatumomab P6895 651 0
P6893 P6894 784 0
P6892 784 2
Bortezomib P4080 P4081 3000 11
P4161 P4162 P6373 P6452 P6466 3000 15
P6372 P6472 3000 19
P6384 P6478 3000 31
Brentuximab vedotin P4719 P6903 P6936 200 3
P4675 P6904 P6941 200 11
Cabazitaxel 55 5
Carboplatin 900 5
Cetuximab P4788 550 5
P4945 550 11
P4912 550 18
P4785 P4794 P4908 P4965 880 0
Cisplatin 220 14
Cladribine 17 6
Cyclophosphamide 2800 17
Cytarabine 7000 15
Docetaxel 250 5
Doxorubicin 135 11
Doxorubicin - pegylated liposomal 100 5
Epirubicin 220 5
Eribulin 3 13
Etoposide 440 14
Fludarabine 55 29
Fluorouracil P6297 1000 23
P6266 5500 11
Fotemustine 220 8
Gemcitabine 3000 17
Idarubicin 30 5
Ifosfamide 4000 19
Ipilimumab 360 3
Irinotecan 800 11
Methotrexate 250 5
P6276 20000 0
Mitozantrone 30 5
Nivolumab P6070 P6095 P6988 P6996 360 8
P6111 P6993 P6997 P6999 360 11
Obinutuzumab 1000 7
Ofatumumab 300 0
1000 5
Oxaliplatin 300 11
Paclitaxel 450 3
Paclitaxel, nanoparticle albumin-bound P4657 275 11
P6106 P6119 580 5
Panitumumab P5439 P5447 720 5
P5452 P5526 720 9
Pembrolizumab P6806 P6817 240 5
P6801 240 7
Pemetrexed 1100 5
Pertuzumab P4971 420 3
P5013 840 0
P5023 840 1
Raltitrexed 7 8
Rituximab P5998 P6039 800 3
P6009 P6034 P6162 P6309 800 7
P6161 800 11
P7040 1100 5
Topotecan 3500 17
Trastuzumab P4104 P4156 250 9
P4142 P4164 500 0
P4083 P4093 P5024 P5825 P5834 750 3
P4143 P4144 P5032 P5844 1000 0
P5041 1000 3
Trastuzumab emtansine 450 8
Vinblastine 20 17
Vincristine 2 7
Vinorelbine 70 7

[3]Schedule 2

substitute table under existing headings in the columns in the order indicated:

Listed Drug Form Manner of Administration Brand Responsible Person Authorised Prescriber Circumstances Purposes Maximum Quantity Number of Repeats Section 100 only
Aprepitant Capsule 165 mg Oral Emend MK MP C4216 C4223 C6383 C6464 1 5 C
Bacillus Calmette and Guerin, Tice strain Vial containing powder for intravesical administration approximately 5 x 108 CFU Intravesical OncoTICE MK MP C5597 3 1 C
Folinic acid Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL Injection Leucovorin Calcium (Hospira Pty Limited) PF MP 10 2
Leucovorin Calcium (Pfizer Australia Pty Ltd) PF MP 10 2
Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL Injection Calcium Folinate Ebewe SZ MP 10 1
Leucovorin Calcium (Pfizer Australia Pty Ltd) PF MP 10 1
Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL Injection Calcium Folinate Ebewe SZ MP 4 1
Leucovorin Calcium (Hospira Pty Limited) PF MP 4 1
Injection containing calcium folinate equivalent to 1000 mg folinic acid in 100 mL Injection Calcium Folinate Ebewe SZ MP 1 1
Tablet containing calcium folinate equivalent to 15 mg folinic acid Oral Leucovorin Calcium (Hospira Pty Limited) PF MP C5973 10 0 C
Fosaprepitant Powder for I.V. infusion 150 mg Injection Emend IV MK MP C6852 C6886 C6887 C6891 1 5
Granisetron Concentrated injection 3 mg (as hydrochloride) in 3 mL Injection Granisetron Kabi PK MP C4139 1 0 C
Granisetron-AFT AE MP C4139 1 0 C
Kytril IX MP C4139 1 0 C
Tablet 2 mg (as hydrochloride) Oral Kytril IX MP C4139 2 0 C
Interferon alfa-2a Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO MP C6661 C6662 C6678 P6662 P6678 15 4 C
MP C6661 C6662 C6678 P6661 15 5 C
Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO MP C6661 C6678 P6678 5 4 C
MP C6661 C6678 P6661 5 5 C
Interferon alfa-2b Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK MP C6639 C6661 C6662 P6662 3 4 C
MP C6639 C6661 C6662 P6639 P6661 3 5 C
Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK MP C6639 C6661 3 5 C
Mesna Solution for I.V. injection 400 mg in 4 mL ampoule Injection Uromitexan BX MP C5130 15 5 C
Solution for I.V. injection 1 g in 10 mL ampoule Injection Uromitexan BX MP C5130 15 5 C
Netupitant with Palonosetron Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride) Oral Akynzeo MF MP C5991 C5994 C6879 C6937 1 5
Ondansetron I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL Injection Ondansetron Alphapharm AF MP C5749 1 0 C
Onsetron ZP MP C5749 1 0 C
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL Injection Ondansetron Alphapharm AF MP C5749 1 0 C
Onsetron ZP MP C5749 1 0 C
Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL Oral Zofran syrup 50 mL AS MP C5778 1 0 C
Tablet (orally disintegrating) 4 mg Oral Ondansetron AN ODT EA MP C5743 4 0 C
Ondansetron ODT GH GQ MP C5743 4 0 C
Ondansetron ODT-DRLA RZ MP C5743 4 0 C
Ondansetron SZ ODT HX MP C5743 4 0 C
Tablet 4 mg (as hydrochloride dihydrate) Oral APO-Ondansetron TX MP C5778 4 0 C
Ondansetron AN EA MP C5778 4 0 C
Ondansetron SZ HX MP C5778 4 0 C
Ondansetron-DRLA RZ MP C5778 4 0 C
Onsetron 4 ZP MP C5778 4 0 C
Zofran AS MP C5778 4 0 C
Tablet (orally disintegrating) 8 mg Oral Ondansetron AN ODT EA MP C5743 4 0 C
Ondansetron ODT GH GQ MP C5743 4 0 C
Ondansetron ODT-DRLA RZ MP C5743 4 0 C
Ondansetron SZ ODT HX MP C5743 4 0 C
Tablet 8 mg (as hydrochloride dihydrate) Oral APO-Ondansetron TX MP C5778 4 0 C
Ondansetron AN EA MP C5778 4 0 C
Ondansetron SZ HX MP C5778 4 0 C
Ondansetron-DRLA RZ MP C5778 4 0 C
Onsetron 8 ZP MP C5778 4 0 C
Zofran AS MP C5778 4 0 C
Wafer 4 mg Oral Zofran Zydis AS MP C5743 4 0 C
Wafer 8 mg Oral Zofran Zydis AS MP C5743 4 0 C
Palonosetron Injection 250 micrograms (as hydrochloride) in 5 mL Injection Aloxi MF MP C5805 1 0 C
Rituximab Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL Injection Mabthera SC RO MP C5998 C6008 C6039 C6161 C6162 C6317 P5998 P6039 1 2 C
MP C5998 C6008 C6039 C6161 C6162 C6317 P6162 P6317 1 6 C
MP C5998 C6008 C6039 C6161 C6162 C6317 P6008 1 7 C
MP C5998 C6008 C6039 C6161 C6162 C6317 P6161 1 11 C
Trastuzumab Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL Injection Herceptin SC RO MP C5024 C5032 C5041 C6059 C6060 C6061 C6062 P5032 P6059 P6060 1 0
MP C5024 C5032 C5041 C6059 C6060 C6061 C6062 P5024 P5041 P6061 P6062 1 3
Tropisetron I.V. injection 5 mg (as hydrochloride) in 5 mL Injection Tropisetron-AFT AE MP C5749 1 0 C

[4]Schedule 3, after details relevant to Responsible Person code FB

insert:

GQ Generic Health Pty Ltd 93 110 617 859

[5]Schedule 3

omit:

GN Actavis Pty Ltd 17 003 854 626

[6]Schedule 3, after details relevant to Responsible Person code HX

insert:

IX Clinect Pty Ltd 76 150 558 473

[7]Schedule 3

omit:

UA Actavis Pty Ltd 17 003 854 626
YA Agila Australasia Pty Ltd 12 154 055 339
ZD Specialized Therapeutics Pty Ltd 89 601 114 087
ZF Sun Pharmaceutical Industries (Australia) Pty Ltd 64 130 119 603

[8]Schedule 4

substitute table under existing headings in the columns in the order indicated:

Listed Drug Circumstances Code Purposes Code Circumstances and Purposes Authority Requirements
(part of Circumstances)
Aprepitant C4216

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 4216
C4223

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 4223
C6383

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 6383
C6464

Acute promyelocytic leukaemia

Induction and consolidation treatment

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6464
Arsenic C4793 P4793

Acute promyelocytic leukaemia

Induction and consolidation treatment

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction.

 Compliance with Authority Required procedures - Streamlined Authority Code 4793
C5997 P5997

Acute promyelocytic leukaemia

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.

 Compliance with Authority Required procedures - Streamlined Authority Code 5997
C6018 P6018

Acute promyelocytic leukaemia

Induction and consolidation treatment

The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.

 Compliance with Authority Required procedures - Streamlined Authority Code 6018
Bacillus Calmette and Guerin, Tice strain C5597 Primary and relapsing superficial urothelial carcinoma of the bladder
Bendamustine C6075

Previously untreated stage III or IV indolent CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with rituximab; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6075
C6124

Previously untreated stage III or IV CD20 positive mantle cell lymphoma

Induction treatment

The treatment must be in combination with rituximab; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND
Patient must not be eligible for stem cell transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6124
Bevacizumab C4584 P4584

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer.

 Compliance with Authority Required procedures - Streamlined Authority Code 4584
C4587 P4587

Metastatic colorectal cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 4587
C4594 P4594

Metastatic colorectal cancer

Initial treatment

The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks.
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 4594
C4814 P4814

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Initial treatment

The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm) only if the patient presents with Stage IIIB or Stage IIIC disease; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer.
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 4814
C4939 P4939

Metastatic colorectal cancer

Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must be previously treated with PBS-subsidised first-line anti-EGFR antibodies; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with second-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 4939
C4968 P4968

Metastatic colorectal cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with second-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 4968
C6337 P6337

Advanced carcinoma of cervix

Initial treatment

Patient must have a Gynaecologic Oncology Group (GOG) performance status of 0 or 1; AND
The condition must not be amenable to curative treatment with surgery; OR
The condition must not be amenable to curative radiation therapy; AND
The condition must be previously untreated with this drug; AND
Patient must not have received prior chemotherapy; OR
Patient must have received prior chemotherapy with radiation therapy; AND
The treatment must be in combination with platinum-based chemotherapy plus paclitaxel.
Advanced carcinoma of the cervix is defined as persistent carcinoma, recurrent carcinoma or metastatic carcinoma of the cervix.
The patient's Gynaecologic Oncology Group (GOG) performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6337
C6338 P6338

Advanced carcinoma of cervix

Grandfathering treatment

Patient must have received non-PBS treatment with this drug for this condition prior to 1 September 2016; AND
Patient must not have progressive disease; AND
The treatment must be in combination with platinum-based chemotherapy plus paclitaxel.
Advanced carcinoma of the cervix is defined as persistent carcinoma, recurrent carcinoma or metastatic carcinoma of the cervix.
The patient's Gynaecologic Oncology Group (GOG) performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6338
C6353 P6353

Advanced carcinoma of cervix

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with platinum-based chemotherapy plus paclitaxel.
Advanced carcinoma of the cervix is defined as persistent carcinoma, recurrent carcinoma or metastatic carcinoma of the cervix.

 Compliance with Authority Required procedures - Streamlined Authority Code 6353
Bleomycin C6224 Lymphoma
C6275 Germ cell neoplasms
Blinatumomab C6892 P6892

Acute lymphoblastic leukaemia (ALL)

Consolidation treatment

Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND
Patient must have achieved a complete remission; OR
Patient must have achieved a complete remission with partial haematological recovery; AND
The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.

 Compliance with Authority Required procedures
C6893 P6893

Acute lymphoblastic leukaemia (ALL)

Induction treatment – balance of supply

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2; AND
The condition must not be present in the central nervous system or testis; AND
The condition must be Philadelphia chromosome negative; AND
Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 784 mcg will be sufficient for a continuous infusion of bllinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

 Compliance with Authority Required procedures
C6894 P6894

Acute lymphoblastic leukaemia (ALL)

Grandfathering treatment

Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2; AND
The condition must not be present in the central nervous system or testis; AND
The condition must be Philadelphia chromosome negative; AND
Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must have a documented history of more than 5% blasts in bone marrow; AND
Patient must have received treatment with this drug for this condition prior to 1 May 2017.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
Treatment with blinatumomab for ALL must not exceed 2 treatment cycles for induction therapy, and 3 treatment cycles for consolidation therapy in a lifetime.
Patients who have received two treatment cycles as induction therapy with this drug for this condition prior to 1 May 2017 must have achieved a complete remission, or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
Patients who have received at least one treatment cycle as consolidation therapy with this drug for this condition prior to 1 May 2017 must have achieved a complete remission, or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.
A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
(4) date of most recent blinatumomab dose, and if this was for induction or consolidation therapy. If for consolidation therapy, how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of consolidation therapy; and
(5) date of latest chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if it was the initial chemotherapy regimen or for salvage therapy; and
(6) a copy of bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab.

 Compliance with Authority Required procedures
C6895 P6895

Acute lymphoblastic leukaemia (ALL)

Induction treatment

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2; AND
The condition must not be present in the central nervous system or testis; AND
The condition must be Philadelphia chromosome negative; AND
Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
The condition must have more than 5% blasts in bone marrow; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.

 Compliance with Authority Required procedures
Bortezomib C4080 P4080

Multiple myeloma

Retreatment of Progressive disease - Continuing PBS-subsidised treatment

The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of application.
Where a response assessment is not submitted prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

 Compliance with Written Authority Required procedures
C4081 P4081

Multiple myeloma

Treatment of Progressive disease - Continuing PBS-subsidised treatment

The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of application.
Where a response assessment is not submitted prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

 Compliance with Written Authority Required procedures
C4161 P4161

Multiple myeloma

Retreatment of Progressive disease - Continuing PBS-subsidised treatment

The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial application and subsequent applications; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of application.
Where a response assessment is not submitted prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

 Compliance with Written Authority Required procedures
C4162 P4162

Multiple myeloma

Treatment of Progressive disease - Continuing PBS-subsidised treatment

The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial application and subsequent applications; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of application.
Where a response assessment is not submitted prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

 Compliance with Written Authority Required procedures
C6372 P6372

Symptomatic multiple myeloma

Continuing PBS-subsidised treatment

Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and be ineligible for high dose chemotherapy; AND
Patient must not have demonstrated progressive disease at the time of application; AND
Patient must not have achieved a best confirmed response to bortezomib at the time of application; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application.

 Compliance with Authority Required procedures
C6373 P6373

Multiple myeloma

Retreatment of Progressive disease - Initial PBS-subsidised treatment

The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease; AND
Patient must have previously been treated with PBS-subsidised bortezomib; AND
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND
Patient must not be receiving concomitant PBS-subsidised lenalidomide or pomalidomide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form which includes details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously provided; and
(4) a signed patient acknowledgment.
To enable confirmation of eligibility for treatment current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.
C6384 P6384

Symptomatic multiple myeloma

Initial PBS-subsidised treatment

Patient must be newly diagnosed; AND
Patient must have severe acute renal failure; AND
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response; and
(3) a signed patient acknowledgement.
Disease activity parameters include current diagnostic reports of at least one of the following:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients.
Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

 Compliance with Written Authority Required procedures
C6452 P6452

Multiple myeloma

Treatment of Progressive disease - Initial PBS-subsidised treatment

The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must have experienced treatment failure after a trial of at least four (4) weeks of thalidomide at a dose of at least 100 mg daily or have failed to achieve at least a minimal response after eight (8) or more weeks of thalidomide-based therapy for progressive disease; AND
Patient must not be receiving concomitant PBS-subsidised lenalidomide or pomalidomide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Thalidomide treatment failure is defined as:
(1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or
(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment.
Severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living.
Toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity.
Failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as:
(1) less than a 25% reduction in serum or urine M protein; or
(2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels.
If the dosing requirement for thalidomide cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(3) duration of thalidomide and daily dose prescribed; and
(4) a signed patient acknowledgment.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

 Compliance with Written Authority Required procedures
C6466 P6466

Symptomatic multiple myeloma

Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
The treatment must be in combination with chemotherapy; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma; and
(3) a signed patient acknowledgement.

 Compliance with Written Authority Required procedures
C6472 P6472

Symptomatic multiple myeloma

Continuing PBS-subsidised treatment

Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and have severe acute renal failure; AND
Patient must have demonstrated at least a partial response at the completion of cycle 4 at the time of application; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form, which includes a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are not being used to monitor disease activity, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application.

 Compliance with Authority Required procedures
C6478 P6478

Symptomatic multiple myeloma

Initial PBS-subsidised treatment

Patient must be newly diagnosed; AND
Patient must be ineligible for high dose chemotherapy; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma and ineligibility for high dose chemotherapy; and
(3) a signed patient acknowledgement.

 Compliance with Written Authority Required procedures
Brentuximab vedotin C4675 P4675

CD30 positive systemic anaplastic large cell lymphoma

Continuing treatment

Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug.
The treatment must not exceed a lifetime total of 16 cycles.

 Compliance with Authority Required procedures
C4719 P4719

CD30 positive systemic anaplastic large cell lymphoma

Initial treatment

The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy;
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory;
(v) a declaration of whether the patient has had, or is planned to have, a transplant
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.

 Compliance with Written Authority Required procedures
C6903 P6903

Relapsed or Refractory Hodgkin lymphoma

Initial treatment

Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement.

 Compliance with Authority Required procedures
C6904 P6904

Relapsed or Refractory Hodgkin lymphoma

Continuing treatment

Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)
The treatment must not exceed a total of 16 cycles in a lifetime

 Compliance with Authority Required procedures
C6936 P6936

Relapsed or Refractory Hodgkin lymphoma

Initial treatment

Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement.

 Compliance with Authority Required procedures
C6941 P6941

Relapsed or Refractory Hodgkin lymphoma

Continuing treatment

Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)
The treatment must not exceed a total of 16 cycles in a lifetime

 Compliance with Authority Required procedures
Cabazitaxel C4662

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with abiraterone; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.

 Compliance with Authority Required procedures - Streamlined Authority Code 4662
Cetuximab C4785 P4785

Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx

Initial treatment

The treatment must be in combination with radiotherapy; AND
Patient must be unable to tolerate cisplatin.

 Compliance with Authority Required procedures - Streamlined Authority Code 4785
C4788 P4788

Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx

Continuing treatment

The treatment must be in combination with radiotherapy; AND
Patient must be unable to tolerate cisplatin; OR
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.

 Compliance with Authority Required procedures - Streamlined Authority Code 4788
C4794 P4794

Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx

Initial treatment

The treatment must be for the week prior to radiotherapy; AND
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.

 Compliance with Authority Required procedures - Streamlined Authority Code 4794
C4908 P4908

Metastatic colorectal cancer

Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must be previously untreated; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 4908
C4912 P4912

Metastatic colorectal cancer

Continuing treatment

Patient must have received an initial authority prescription for this drug for first-line treatment of RAS wild-type metastatic colorectal cancer; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 4912
C4945 P4945

Metastatic colorectal cancer

Continuing treatment

Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

 Compliance with Authority Required procedures - Streamlined Authority Code 4945
C4965 P4965

Metastatic colorectal cancer

Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

 Compliance with Authority Required procedures - Streamlined Authority Code 4965
Cladribine C6265 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6265
Doxorubicin - pegylated liposomal C4786

Advanced epithelial ovarian cancer

Patient must have failed a first-line platinum-based chemotherapy regimen.

 Compliance with Authority Required procedures - Streamlined Authority Code 4786
C4787

Metastatic breast cancer

The treatment must be as monotherapy; AND
Patient must have a contraindication to therapy with capecitabine and/or a taxane.

 Compliance with Authority Required procedures - Streamlined Authority Code 4787
C4791

Metastatic breast cancer

The treatment must be as monotherapy; AND
Patient must have failed prior therapy which included capecitabine and a taxane.

 Compliance with Authority Required procedures - Streamlined Authority Code 4791
Eribulin C4649

Locally advanced or metastatic breast cancer

Patient must have progressive disease; AND
Patient must have failed at least two prior chemotherapeutic regimens for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 4649
Fluorouracil C6266 P6266 Patients requiring administration of fluorouracil by intravenous infusion
C6297 P6297 Patients requiring administration of fluorouracil by intravenous injection
Folinic acid C5973

Megaloblastic anaemias

The condition must be a result of folic acid deficiency from the use of folic acid antagonists.
Fosaprepitant C6852

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 6852
C6886

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 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.
No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6886
C6887

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 6887
C6891

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6891
Fotemustine C6288 Metastatic malignant melanoma Compliance with Authority Required procedures - Streamlined Authority Code 6288
Granisetron C4139

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
Idarubicin C6247 Acute myelogenous leukaemia (AML)
Interferon alfa-2a C6661 P6661

Low grade non-Hodgkin's lymphoma

The condition must have clinical features suggestive of a poor prognosis; AND
The treatment must be in combination with anthracycline-based chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6661
C6662 P6662 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6662
C6678 P6678

Myeloproliferative disease

Patient must have excessive thrombocytosis.

 Compliance with Authority Required procedures - Streamlined Authority Code 6678
Interferon alfa-2b C6639 P6639

Multiple myeloma

Maintenance treatment

The condition must be in remission following chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6639
C6661 P6661

Low grade non-Hodgkin's lymphoma

The condition must have clinical features suggestive of a poor prognosis; AND
The treatment must be in combination with anthracycline-based chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6661
C6662 P6662 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6662
Ipilimumab C6562

Unresectable Stage III or Stage IV malignant melanoma

Induction treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior treatment with ipilimumab; AND
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6562
C6585

Unresectable Stage III or Stage IV malignant melanoma

Re-induction treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction); AND
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response.
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6585
Mesna C5130

Urothelial toxicity

Prophylaxis or reduction of toxicity
The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide.
Methotrexate P6276 Patients receiving treatment with a high dose regimen
Netupitant with Palonosetron C5991

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 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.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 5991
C5994

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 5994
C6879

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6879
C6937

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6937
Nivolumab C6070 P6070

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment 2

The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6070
C6095 P6095

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment 1

The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6095
C6111 P6111

Unresectable Stage III or Stage IV malignant melanoma

Continuing treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose of 3 mg per kg every 2 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6111
C6988 P6988

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial Treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6988
C6993 P6993

Stage IV clear cell variant renal cell carcinoma (RCC)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 6993
C6996 P6996

Locally advanced or metastatic non-small cell lung cancer

Initial treatment

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6996
C6997 P6997

Locally advanced or metastatic non-small cell lung cancer

Grandfathering treatment

Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

 Compliance with Authority Required procedures - Streamlined Authority Code 6997
C6999 P6999

Locally advanced or metastatic non-small cell lung cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 6999
Obinutuzumab C5126

Chronic lymphocytic leukaemia (CLL)

Patient must require treatment for CD20 positive chronic lymphocytic leukaemia (CLL); AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression while on treatment.
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; AND
(b) a completed CD20 positive Chronic Lymphocytic Leukaemia PBS Authority Application - Supporting Information Form which includes:
i) documentation that the patient has CD20 positive CLL (flow cytometry pathology report from blood or bone marrow, noting that this may be from some time earlier); AND
ii) a statement that the patient is previously untreated, is inappropriate for fludarabine based chemo immunotherapy, that treatment will be in combination with chlorambucil; AND
iii) documentation that the patient has a creatinine clearance 30 mL/min or greater; AND
iv) One of the following, either:
- A completed cumulative illness rating scale (CIRS) score form demonstrating that the patient has a score of greater than 6 (excluding CLL-induced illness or organ damage)
OR
-Documentation that the patient has a creatinine clearance less than 70 mL/min;

 Compliance with Written Authority Required procedures
Ofatumumab C4828

Chronic lymphocytic leukaemia (CLL)

Initial treatment

The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The condition must be previously untreated; AND
The treatment must be in combination with chlorambucil; AND
Patient must be inappropriate for fludarabine based therapy.
C4858

Chronic lymphocytic leukaemia (CLL)

Continuing treatment

The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease; AND
Patient must be inappropriate for fludarabine based therapy; AND
The treatment must be in combination with chlorambucil.

 Compliance with Authority Required procedures - Streamlined Authority Code 4858
Ondansetron C5743

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
C5749

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
C5778

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
Paclitaxel, nanoparticle albumin-bound C4657 P4657

Stage IV (metastatic) adenocarcinoma of the pancreas

The treatment must be in combination with gemcitabine; AND
The condition must not have been treated previously with PBS-subsidised therapy; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 4657
C6106 P6106 Metastatic breast cancer Compliance with Authority Required procedures - Streamlined Authority Code 6106
C6119 P6119 HER2 positive breast cancer Compliance with Authority Required procedures - Streamlined Authority Code 6119
Palonosetron C5805

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Panitumumab C5439 P5439

Metastatic colorectal cancer

Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

 Compliance with Authority Required procedures - Streamlined Authority Code 5439
C5447 P5447

Metastatic colorectal cancer

Continuing treatment

Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

 Compliance with Authority Required procedures - Streamlined Authority Code 5447
C5452 P5452

Metastatic colorectal cancer

Continuing treatment

Patient must have received an initial authority prescription for panitumumab for first-line treatment of RAS wild-type metastatic colorectal cancer; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

 Compliance with Authority Required procedures - Streamlined Authority Code 5452
C5526 P5526

Metastatic colorectal cancer

Initial Treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must be previously untreated; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

 Compliance with Authority Required procedures - Streamlined Authority Code 5526
Pembrolizumab C6801 P6801

Unresectable Stage III or Stage IV malignant melanoma

Continuing treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6801
C6806 P6806

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment 1

The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6806
C6817 P6817

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment 2

The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6817
Pemetrexed C4789

Mesothelioma

The treatment must be in combination with cisplatin.
The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated
Doses greater than 500 mg per metre squared BSA are not PBS-subsidised

 Compliance with Authority Required procedures - Streamlined Authority Code 4789
C4792

Locally advanced or metastatic non-small cell lung cancer

Patient must have received prior treatment with platinum-based chemotherapy.
The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated
Doses greater than 500 mg per metre squared BSA are not PBS-subsidised

 Compliance with Authority Required procedures - Streamlined Authority Code 4792
Pertuzumab C4971 P4971

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be in combination with trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
The treatment must not exceed a lifetime total of one continuous course. However, short treatment breaks are permitted. A patient who has a treatment break of less than 6 weeks in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug. A patient who has a treatment break of more than 6 weeks in PBS-subsidised treatment with this drug is not eligible to receive PBS-subsidised treatment with this drug.
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.

 Compliance with Authority Required procedures
C5013 P5013

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have received prior anti-HER2 therapy for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
The treatment must be in combination with trastuzumab and a taxane; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease; and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C5023 P5023

HER2 positive breast cancer

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; AND
Patient must not have received non-PBS-subsidised treatment with trastuzumab for this condition before 1 July 2014; AND
Patient must not have received prior therapy with trastuzumab emtansine or lapatinib for this condition; AND
The treatment must be in combination with trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
Raltitrexed C6228

Advanced colorectal cancer

The treatment must only be used as a single agent in the treatment of this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 6228
Rituximab C5998 P5998

Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma

Re-induction treatment

The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 5998
C6008 P6008

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6008
C6009 P6009

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6009
C6034 P6034

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6034
C6039 P6039

Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma

Re-induction treatment

The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6039
C6161 P6161

Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

Patient must have demonstrated a partial or complete response to induction treatment with either R-CHOP or R-CVP regimens for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
Patient must not have received bendamustine induction therapy; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6161
C6162 P6162

Previously untreated symptomatic indolent CD20 positive non-Hodgkin's lymphoma in combination with chemotherapy
Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6162
C6309 P6309

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6309
C6317 P6317

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6317
C7040 P7040

Chronic lymphocytic leukaemia (CLL)

The condition must be CD20 positive; AND
The treatment must be in combination with chemotherapy or idelalisib.

 Compliance with Authority Required procedures - Streamlined Authority Code 7040
Topotecan C6238

Advanced metastatic ovarian cancer

Patient must have failed prior therapy which included a platinum compound.

 Compliance with Authority Required procedures - Streamlined Authority Code 6238
Trastuzumab C4083 P4083

Locally advanced HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Authority Required procedures
C4093 P4093

Early HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Authority Required procedures
C4104 P4104

Locally advanced HER2 positive breast cancer

Continuing treatment (weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Authority Required procedures
C4142 P4142

Locally advanced HER2 positive breast cancer

Initial treatment (weekly regimen)

Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg.

 Compliance with Written Authority Required procedures
C4143 P4143

Locally advanced HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg.

 Compliance with Written Authority Required procedures
C4144 P4144

Early HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg.

 Compliance with Written Authority Required procedures
C4156 P4156

Early HER2 positive breast cancer

Continuing treatment (weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Authority Required procedures
C4164 P4164

Early HER2 positive breast cancer

Initial treatment (weekly regimen)

Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg.

 Compliance with Written Authority Required procedures
C5024 P5024

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, authority approval will be granted for a new loading dose.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Authority Required procedures
C5032 P5032

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the patient has Stage IV disease.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C5041 P5041

HER2 positive breast cancer

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Authority Required procedures
C5825 P5825

Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction

Initial PBS-subsidised treatment (Grandfather patient)

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity; AND
Patient must have been treated with this drug for this condition prior to 1 January 2016; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) positivity.

 Compliance with Written Authority Required procedures
C5834 P5834

Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not have progressive disease; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Authority Required procedures
C5844 P5844

Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND
Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND
Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND
Patient must commence treatment in combination with cisplatin and capecitabine; OR
Patient must commence treatment in combination with cisplatin and 5 fluorouracil; AND
Patient must not have previously received this drug for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated in tumour material by both (i) immunohistochemistry (IHC) 2+ or IHC 3+ AND (ii) in situ hybridisation (ISH) results based on both more than 6 copies of HER2 AND the ratio of HER2: chromosome 17 being more than 2 in the same tumour tissue sample
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

 Compliance with Written Authority Required procedures
C6059 P6059

Early HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C6060 P6060

Locally advanced HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C6061 P6061

Early HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Authority Required procedures
C6062 P6062

Locally advanced HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Authority Required procedures
Trastuzumab emtansine C4978

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
The treatment must not exceed a lifetime total of one continuous course.
C4986

Metastatic (Stage IV) HER2 positive breast cancer

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR
Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C6096

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) a copy of the signed patient acknowledgement form;
(iii) dates of treatment with trastuzumab and pertuzumab; and
(iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.

 Compliance with Written Authority Required procedures
C6129

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) a copy of the signed patient acknowledgement form;
(iii) dates of treatment with trastuzumab and pertuzumab; and
(iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.

 Compliance with Written Authority Required procedures
Tropisetron C5749

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
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