National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 8) (PB 71 of 2019) (Cth)

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PB 71 of 2019

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 8)

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 August 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. 8).

(2)This Instrument may also be cited as PB 71 of 2019.

  1. Commencement

This Instrument commences on 1 September 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, 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”: C6070 C6095 C6111 C6997 C6999 C7567 C7787 C7802 C7864

(b)omit from the column headed “Circumstances”: C8143

(c)omit from the column headed “Circumstances”: C8552 C8568

(d)omit from the column headed “Circumstances”: C8581

(e)insert in numerical order in the column headed “Circumstances”: C9214 C9216 C9217 C9219 C9252 C9253 C9298 C9299 C9311 C9312 C9320 C9321 C9331

  1. Schedule 1, Part 1, omit entry for Ofatumumab

  1. Schedule 1, Part 1, entry for Pembrolizumab

omit:

Powder for injection 50 mg Injection Keytruda MK MP C7606 C7610 C7773 C9044 C9127 C9178 D

  1. Schedule 1, Part 2, entry for Nivolumab

substitute:

Nivolumab P8141 P8146 P8182 P8220 120 3
P8571 360 2
P8573 360 3
P9216 P9219 P9312 P9320 P9331 480 8
P9214 P9217 P9252 P9253 P9298 P9299 P9311 P9321 480 11

  1. Schedule 1, Part 2, omit entry for Ofatumumab

  1. Schedule 3

omit:

NV Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

  1. Schedule 4, entry for Nivolumab

(a)omit:

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
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
C7567 P7567 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 or a programmed cell death ligand‑1 (PD‑L1) 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 7567
C7787 P7787 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
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 7787
C7802 P7802 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Grandfather treatment
Patient must have received non‑PBS subsidised treatment with this drug for this condition prior to 1 August 2018; AND
Patient must have had a WHO performance status of 0 or 1; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy, prior to commencing non‑PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving non‑PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
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 7802
C7864 P7864 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor for this condition.
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 7864

(b)omit:

C8143 P8143 Unresectable Stage III or Stage IV malignant melanoma
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS‑subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition.
Maintenance treatment with nivolumab must not exceed 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 8143

(c)omit:

C8552 P8552 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 not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 8552
C8568 P8568 Stage IV clear cell variant renal cell carcinoma (RCC)
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS‑subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition.
Maintenance treatment with nivolumab must not exceed 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 8568

(d)omit:

C8581 P8581 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 prior treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition.
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 8581

(e)insert in numerical order after existing text:

C9214 P9214 Unresectable Stage III or Stage IV malignant melanoma
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
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.
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 9214
C9216 P9216 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition.
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 9216
C9217 P9217 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.
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 9217
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
C9252 P9252 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
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.
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 9252
C9253 P9253 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Grandfather treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 August 2018; AND
Patient must have had a WHO performance status of 0 or 1; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy, prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
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.
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 9253
C9298 P9298 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.
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 9298
C9299 P9299 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 not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
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 9299
C9311 P9311 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.
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 9311
C9312 P9312 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 prior treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.
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 9312
C9320 P9320 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 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 9320
C9321 P9321 Stage IV clear cell variant renal cell carcinoma (RCC)
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
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.
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 9321
C9331 P9331 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 or a programmed cell death ligand-1 (PD-L1) 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.
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 9331

  1. Schedule 4, omit entry for Ofatumumab

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