1.  The whole of this instrument

1 November 2023

1 November 2023

Bortezomib Juno

JU

MP

C11099 C13745

D

IRINOTECAN BAXTER

BX

MP

D

Trastuzumab deruxtecan

Powder for I.V. infusion 100 mg

Injection

Enhertu

AP

MP

C14470

D

Listed Drug

Purposes

Maximum Amount

Number of Repeats

Arsenic

P4793 P5997

18 mg

89

P6018

18 mg

140

Atezolizumab

P10206 P10939

1200 mg

3

P10521

1200 mg

4

P10125 P13443 P13448

1200 mg

5

P10216 P10297 P13442

1200 mg

7

P10917

1200 mg

8

P10509 P13446

1680 mg

3

P10215 P10257 P10972 P13451

1680 mg

5

Avelumab

P13303 P13313

800 mg

7

P13290

800 mg

11

P8947

1200 mg

8

P10023

1200 mg

11

Bendamustine

200 mg

11

Bevacizumab

1800 mg

7

Bleomycin

30000 iu

11

Blinatumomab

P14588

651 mcg

0

P9519

784 mcg

0

P14587 P14631

784 mcg

1

P9369

784 mcg

2

Bortezomib

3000 mcg

15

Brentuximab vedotin

P13179

180 mg

3

P13181

180 mg

11

P13212

200 mg

1

P13182 P13209 P13259

200 mg

3

P13134

200 mg

5

P13208 P13231 P13261

200 mg

11

Cabazitaxel

55 mg

5

Carboplatin

900 mg

5

Carfilzomib

P14363 P14364 P14389

60 mg

17

P12930 P12934

120 mg

17

P12694 P12849

160 mg

8

Cemiplimab

P13419

350 mg

2

P13373 P13766

350 mg

6

P13322 P13411

350 mg

7

Cetuximab

P4788

550 mg

5

P12016 P12470

550 mg

11

P4912

550 mg

18

P4785 P4794 P4908 P12045 P12483

880 mg

0

Cisplatin

220 mg

14

Cladribine

17 mg

6

Cyclophosphamide

2800 mg

17

Cytarabine

7000 mg

15

Daratumumab

P12845

1920 mg

4

P12691

1920 mg

5

P12844

1920 mg

7

P13752

1920 mg

8

Docetaxel

250 mg

5

Doxorubicin

135 mg

11

Doxorubicin ‑ pegylated liposomal

100 mg

5

Durvalumab

1500 mg

4

Elotuzumab

P12847

1200 mg

5

P12891

1200 mg

9

Enfortumab vedotin

125 mg

8

Epirubicin

220 mg

5

Eribulin

P7258 P7280

3 mg

7

P4649

3 mg

13

Etoposide

440 mg

14

Fludarabine

55 mg

29

Fluorouracil

P6297

1000 mg

23

P6266

5500 mg

11

Gemcitabine

3000 mg

17

Gemtuzumab ozogamicin

P12566

5 mg

1

P12559

5 mg

2

Idarubicin

30 mg

5

Ifosfamide

4000 mg

19

Inotuzumab ozogamicin

P9601

2820 mcg

4

P9470

3384 mcg

2

Ipilimumab

P8555 P11930

120 mg

3

P11391 P11478

120 mg

4

P6562 P6585 P13841

360 mg

3

Irinotecan

800 mg

11

Methotrexate

250 mg

5

P6276

20000 mg

0

Mitozantrone

30 mg

5

Nivolumab

P13852 P13853

120 mg

3

P14001

360 mg

3

P11985

360 mg

8

P11468 P13433

360 mg 

13

P10119 P10120 P13900

480 mg

5

P9216 P9312 P10155 P13445

480 mg

8

P9252 P9298 P9299 P9321 P11477 P13839 P13863

480 mg

11

P13888

480 mg

13

Obinutuzumab

P11785 P11787

1000 mg

5

P11755 P14326

1000 mg

7

P11015

1000 mg

8

P11815

1000 mg

9

Oxaliplatin

300 mg

11

Paclitaxel

450 mg

3

Paclitaxel, nanoparticle albumin‑bound

P4657

275 mg

11

P6106 P6119

580 mg

5

Panitumumab

P12035 P12066

720 mg

5

P5452 P5526

720 mg

9

Pembrolizumab

P10696

200 mg

5

P13431 P13432

200 mg

6

P10687 P10695 P10705

200 mg

7

P10689

400 mg

2

P10676 P10688 P10701 P13436 P13437

400 mg

3

P13726 P13727 P13728 P13730 P13731 P13732 P13735 P13736 P13738 P13739 P13741 P13948 P13949 P13986 P14027 P14028 P14044 P14324 P14403 P14404 P14405

400 mg

6

Pemetrexed

1100 mg

5

Pertuzumab

P10414

420 mg

3

P13018

840 mg

0

Pralatrexate

P7558

80 mg

5

P7526

80 mg

11

Raltitrexed

7 mg

8

Rituximab

800 mg

11

Sacituzumab govitecan

P12656

1200 mg

7

P12669

1200 mg

13

Topotecan

3500 mcg

17

Trabectedin

P14196

3250 mcg

3

P14188 P14197

3250 mcg

7

Trastuzumab

P10213

250 mg

9

P10296

500 mg

0

P9349 P9571 P10294

750 mg

3

P9353 P9573 P10293

1000 mg

0

Trastuzumab deruxtecan

675 mg

8

Trastuzumab emtansine

P10295 P13004

450 mg

6

P12989 P13017

450 mg

8

Vinblastine

20 mg

17

Vincristine

2 mg

7

Vinorelbine

70 mg

7

FOSAPREPITANT MSN

RQ

MP

C6852 C6886 C6887 C6891

1

5

C9911

P9911

Acute lymphoblastic leukaemia
Induction treatment
The condition must be relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
The condition must not be present in the central nervous system or testis; AND
Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must not have received more than 1 line of salvage therapy; AND
Patient must not have received blinatumomab previously for the treatment of minimal residual disease; OR
Patient must have had a relapse‑free period of at least six months following completion of treatment with blinatumomab for minimal residual disease; 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; and
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application ‑ Supporting Information Form; and
(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(4) if applicable, the date of completion of blinatumomab treatment for minimal residual disease and the date of the patient's subsequent relapse; and
(5) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.

Compliance with Written Authority Required procedures

C9936

P9936

Minimal residual disease of precursor B‑cell acute lymphoblastic leukaemia (Pre‑B‑cell ALL)
Continuing treatment of previously detectable minimal residual disease of Pre‑B‑cell ALL
Must be treated by a physician experienced in the treatment of haematological malignancies.
Patient must have previously received PBS‑subsidised initial treatment with this drug for this condition; AND
Patient must have achieved a complete remission; AND
Patient must be minimal residual disease negative, defined as either undetectable using the same method used to determine original eligibility or less than 10‑4(0.01%) blasts based on measurement in bone marrow; AND
Patient must not develop disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
For all subsequent cycle starts and re‑initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
Blinatumomab is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
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.

Compliance with Authority Required procedures

C9937

P9937

Minimal residual disease of precursor B‑cell acute lymphoblastic leukaemia (Pre‑B‑cell ALL)
Initial treatment of minimal residual disease of Pre‑B‑cell ALL
Must be treated by a physician experienced in the treatment of haematological malignancies.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be present in the central nervous system or testis; AND
Patient must have achieved complete remission following intensive combination chemotherapy for initial treatment of acute lymphoblastic leukaemia (ALL) or for subsequent salvage therapy; AND
Patient must have minimal residual disease defined as at least 10‑4(0.01%) blasts based on measurement in bone marrow, documented after an interval of at least 2 weeks from the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL or as subsequent salvage therapy, whichever was the later, and measured using polymerase chain reaction or flow cytometry; 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 3 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 four 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 blinatumomab over 28 days in each cycle.
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; and
(2) a completed Minimal residual disease positive Acute Lymphoblastic Leukaemia PBS Authority Application ‑ Supporting Information Form; and
(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
(4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application
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.

Compliance with Written Authority Required procedures

C14587

P14587

Measurable residual disease of precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)
Continuing treatment of previously measurable residual disease of Pre-B-cell ALL
Must be treated by a physician experienced in the treatment of haematological malignancies.
Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND
Patient must have achieved a complete remission; AND
The condition must be negative for measurable residual disease using the same method used to determine initial PBS eligibility; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
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.

Compliance with Authority Required procedures

C14588

P14588

Acute lymphoblastic leukaemia
Induction treatment
The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
The condition must not be present in the central nervous system or testis; AND
Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must not have received more than 1 line of salvage therapy; AND
The condition must be one of the following: (i) untreated with this drug for measurable residual disease, (ii) treated with this drug for measurable residual disease, but the condition has not relapsed within 6 months of completing that course of treatment; 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; and
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(4) if applicable, the date of completion of blinatumomab treatment for measurable residual disease and the date of the patient's subsequent relapse; and
(5) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.

Compliance with Written Authority Required procedures

C14631

P14631

Measurable residual disease of precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)
Initial treatment of measurable residual disease of Pre-B-cell ALL
Must be treated by a physician experienced in the treatment of haematological malignancies.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be present in the central nervous system or testis; AND
Patient must have achieved complete remission following intensive combination chemotherapy for initial treatment of acute lymphoblastic leukaemia (ALL) or for subsequent salvage therapy; AND
Patient must have measurable residual disease based on measurement in bone marrow, documented after an interval of at least 2 weeks from the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL/as subsequent salvage therapy, whichever was the later, measured using flow cytometry/molecular methods; 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 3 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 four 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 blinatumomab over 28 days in each cycle.
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; and
(2) a completed Measurable residual disease positive Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
(4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.
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.

Compliance with Written Authority Required procedures

Trastuzumab deruxtecan

C14470

Metastatic (Stage IV) HER2 positive breast cancer
Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND
The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; OR
The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND
Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only.
Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR
Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.
Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:
1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable).
2) Details of prior HER2 directed drug regimens prescribed for the patient.
3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable).

Compliance with Authority Required procedures