National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 4) (PB 32 of 2019) (Cth)

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PB 32 of 2019

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 4)

National Health Act 1953

___________________________________________________________________________

I, NATASHA PLOENGES, Assistant Secretary (Acting), Pharmacy 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         29 April 2019

NATASHA PLOENGES

Assistant Secretary (Acting)

Pharmacy 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 2019 (No. 4).

(2)This Instrument may also be cited as PB 32 of 2019.

  1. Commencement

This Instrument commences on 1 May 2019.

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

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1       Amendments

  1. Schedule 1, Part 1, after entry for Atezolizumab

insert:

Avelumab Solution concentrate for I.V. infusion 200 mg in 10 mL Injection Bavencio SG MP C8856 C8947 D

  1. Schedule 1, Part 1, entry for Blinatumomab

omit from the column headed “Circumstances”: C6892 C6893 C6894 C6895           substitute: C8812 C8924 C8949 C8966

  1. Schedule 1, Part 1, after entry for Ifosfamide in the form Powder for I.V. injection 2 g

insert:

Inotuzumab ozogamicin Powder for I.V. infusion 1 mg Injection Besponsa PF MP C8768 C8857 C8858 D

  1. Schedule 1, Part 2, after entry for Atezolizumab [Maximum Amount: 1200; Number of Repeats: 7]

insert:

Avelumab P8947 1200 8
P8856 1200 11

  1. Schedule 1, Part 2, entry for Blinatumomab [Maximum Amount: 651; Number of Repeats: 0]

omit from the column headed “Purposes”: P6895            substitute: P8812

  1. Schedule 1, Part 2, entry for Blinatumomab [Maximum Amount: 784; Number of Repeats: 0]

omit from the column headed “Purposes”: P6893 P6894           substitute: P8949 P8966

  1. Schedule 1, Part 2, entry for Blinatumomab [Maximum Amount: 784; Number of Repeats: 2]

omit from the column headed “Purposes”: P6892            substitute: P8924

  1. Schedule 1, Part 2, after entry for Ifosfamide

insert:

Inotuzumab ozogamicin P8858 2820 4
P8768 3384 1
P8857 3384 2

  1. Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

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

Ondansetron APOTEX GX MP C5778 4 0 C

  1. Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

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

Ondansetron APOTEX GX MP C5778 4 0 C

  1. Schedule 3, after details relevant to Responsible Person code GQ

insert:

GX Apotex Pty Ltd 52 096 916 148

  1. Schedule 4, after entry for Atezolizumab

insert:

Avelumab C8856 P8856 Stage IV (metastatic) Merkel Cell Carcinoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 12 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 8856
C8947 P8947 Stage IV (metastatic) Merkel Cell Carcinoma
Initial treatment
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 10 mg per kg every 2 weeks under this restriction.
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 8947

  1. Schedule 4, entry for Blinatumomab

substitute:

Blinatumomab C8812 P8812 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 2 or less; 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
Patient must not have received more than 1 line of 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) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(4) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application. 		Compliance with Written Authority Required procedures
C8924 P8924 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; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug. 		Compliance with Written Authority Required procedures
C8949 P8949 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 2 or less; 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 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. 		Compliance with Written Authority Required procedures
C8966 P8966 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 2 or less; 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 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. 		Compliance with Written Authority Required procedures

  1. Schedule 4, entry for Brentuximab vedotin

omit from the column headed "Circumstances and Purposes" for circumstances code C8722: T cell          substitute: T-cell

  1. Schedule 4, after entry for Idarubicin

insert:

Inotuzumab ozogamicin C8768 P8768 Acute lymphoblastic leukaemia (ALL)
Grandfather 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 2 or less; 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 not have received more than 2 lines of salvage therapy; AND
The condition must be Philadelphia chromosome negative; AND
The condition must be CD22-positive; 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 2019; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
This drug 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 this drug for this condition must not exceed 6 treatment cycles in a lifetime.
Patients who have received up to three treatment cycles as induction therapy with this drug for this condition prior to 1 May 2019 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 2019 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 fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 3 cycles of PBS-subsidised treatment with this agent must cease PBS-subsidised treatment 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) evidence that the condition is CD22-positive; and
(4) date of most recent inotuzumab ozogamicin dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS-subsidised inotuzumab ozogamicin will be required for completion of induction or consolidation therapy; and
(5) date of latest chemotherapy prior to receiving non-PBS subsidised inotuzumab ozogamicin, and if it was the initial chemotherapy regimen or for salvage therapy and what line of salvage; and
(6) a copy of bone marrow biopsy report prior to receiving non-PBS subsidised inotuzumab ozogamicin. 		Compliance with Written Authority Required procedures
C8857 P8857 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 2 or less; 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 Philadelphia chromosome negative; AND
The condition must be CD22-positive; AND
The condition must have more than 5% blasts in bone marrow; AND
The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.
This drug 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) two completed authority prescription forms;
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) evidence that the condition is CD22-positive; and
(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.
The treatment must not exceed 0.8mg per m2 for the first dose of a treatment cycle (Day 1), and 0.5mg per m2 for subsequent doses (Days 8 and 15) within a treatment cycle.
Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime. 		Compliance with Written Authority Required procedures
C8858 P8858 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 5 treatment cycles under this restriction in a lifetime; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
The treatment must not exceed 0.5mg per m2 for all doses within a treatment cycle
Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime. 		Compliance with Written Authority Required procedures
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