National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 10) (Cth)

PB 108 of 2023

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 10)

National Health Act 1953

I, EDEN SIMON, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Date                 30 October 2023

EDEN SIMON

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011
(PB 79 of 2011)   2

1. Name

(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 10)

(2)This instrument may also be cited as PB 108 of 2023.

1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 November 2023	1 November 2023

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)     Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

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

1. Schedule 1, Part 1, entry for Blinatumomab

(a)omit from the column headed “Circumstances”: C9911 C9936 C9937

(b)insert in numerical order in the column headed “Circumstances”: C14587 C14588 C14631

1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg

omit:

Bortezomib Juno JU MP C11099 C13745 D

1. Schedule 1, Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

IRINOTECAN BAXTER BX MP D

1. Schedule 1, Part 1, after entry for Trastuzumab in the form Powder for I.V. infusion 440 mg with diluent

insert:

Trastuzumab deruxtecan Powder for I.V. infusion 100 mg Injection Enhertu AP MP C14470 D

1. Schedule 1, Part 2

omit table and substitute:

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

1. Schedule 2, entry for Fosaprepitant

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

FOSAPREPITANT MSN RQ MP C6852 C6886 C6887 C6891 1 5

1. Schedule 4, entry for Blinatumomab

(a)omit:

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

(b)insert in numerical order after existing text:

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

1. Schedule 4, after entry for Trastuzumab

insert:

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