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PB 88 of 2019 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to add, delete and make changes to drugs, forms, brands, responsible person codes, maximum quantities/amounts and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 31 Oct 2019
Tabling HistoryDate
Tabled Senate11-Nov-2019

PB 88 of 2019

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 10)

 

National Health Act 1953

___________________________________________________________________________

 

I, BEN SLADIC, Assistant Secretary, 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 30 October 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BEN SLADIC

Assistant Secretary

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. 10).

(2)          This Instrument may also be cited as PB 88 of 2019.

2          Commencement

This Instrument commences on 1 November 2019.

3          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, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL

                           omit:

 

 

 

Docetaxel Sandoz

SZ

MP

 

D

[2]             Schedule 1, Part 1, entry for Etoposide in the form Powder for I.V. infusion 1 g (as phosphate)

                           omit from the column headed “Responsible Person”: BQ        substitute: LM

[3]             Schedule 1, Part 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

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

 

 

 

Fludarabine Juno

JO

MP

 

PB

[4]             Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

                   (a)        omit from the column headed “Circumstances”: C8142

                   (b)        insert in numerical order in the column headed “Circumstances”: C9840

[5]             Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 200 mg in 40 mL

                   (a)        omit from the column headed “Circumstances”: C8142

                   (b)        insert in numerical order in the column headed “Circumstances”: C9840

[6]             Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

                   (a)        omit from the column headed “Circumstances”: C8141

                   (b)        omit from the column headed “Circumstances”: C9219

                   (c)        insert in numerical order in the column headed “Circumstances”: C9832 C9844

[7]             Schedule 1, Part 1, entry for Pembrolizumab

                   (a)        omit from the column headed “Circumstances”: C9178

                   (b)        insert in numerical order in the column headed “Circumstances“: C9843

[8]             Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg

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

 

 

 

Herzuma

EW

MP

C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628

PB

[9]             Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 360; Number of Repeats: 3]

                   (a)        omit from the column headed “Purposes”: P8142

                   (b)        insert in numerical order in the column headed “Purposes”: P9840

[10]           Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 120; Number of Repeats: 3]

                   (a)        omit from the column headed “Purposes”: P8141

                   (b)        insert in numerical order in the column headed “Purposes”: P9844

[11]           Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480; Number of Repeats: 8]

                   (a)        omit from the column headed “Purposes”: P9219

                   (b)        insert in numerical order in the column headed “Purposes”: P9832

[12]           Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P9178

                   (b)        insert in numerical order in the column headed “Purposes”: P9843

[13]           Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg

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

 

 

 

APO-Ondansetron ODT

TX

MP

C5743

 

4

0

C

[14]           Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg

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

 

 

 

APO-Ondansetron ODT

TX

MP

C5743

 

4

0

C

[15]           Schedule 3, after details relevant to Responsible Person code EI

                           insert:

EW

Celltrion Healthcare Australia Pty Ltd

66 625 407 105

[16]           Schedule 3, after details relevant to Responsible Person code JC

                           insert:

JO

Juno Pharmaceuticals Pty Ltd

55 156 303 650

[17]           Schedule 3, after details relevant to Responsible Person code JU

                           insert:

LM

Link Medical Products Pty Ltd

73 010 971 516

[18]           Schedule 4, entry for Ipilimumab

                   (a)        omit:



C8142

P8142

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
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); OR
Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR
Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with ipilimumab or a PD‑1 (programmed cell death‑1) inhibitor for this condition; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS‑subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab 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 8142

                   (b)        insert in numerical order after existing text:

 

C9840

P9840

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab 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 9840

[19]           Schedule 4, entry for Nivolumab

                   (a)        omit:

 

C8141

P8141

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
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); OR
Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR
Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with ipilimumab or a PD‑1 (programmed cell death‑1) inhibitor for this condition; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS‑subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab 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
8141

                   (b)        omit:

 

C9219

P9219

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 dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9219

                   (c)        insert in numerical order after existing text:

 

C9832

C9832

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9832

 

C9844

P9844

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab 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 9844

[20]           Schedule 4, entry for Pembrolizumab

                   (a)        omit:

 

C9178

P9178

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 administered every 3 weeks, with each maximum dose fixed at 200 mg.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 

                   (b)        insert in numerical order after existing text:

 

C9843

P9843

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses administered every 3 weeks, with each maximum dose fixed at 200 mg.
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 9843