National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 2) (PB 14 of 2019) (Cth)

Case

PB 14 of 2019

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 2)

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  26 February 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. 2).

(2)This Instrument may also be cited as PB 14 of 2019.

  1. Commencement

This Instrument commences on 1 March 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 Carboplatin

omit:

Solution for I.V. injection 50 mg in 5 mL Injection Hospira Pty Limited PF MP D

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

insert in numerical order in the column headed “Circumstances”: C8555 C8569

  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”: C6988 C6993

(b)insert in numerical order in the column headed “Circumstances”: C8552 C8568 C8571 C8573 C8581

  1. Schedule 1, Part 1, entry for Pembrolizumab in the form Solution concentrate for I.V. infusion 100 mg in 4 mL

insert in numerical order in the column headed “Circumstances”: C8542 C8543 C8563

  1. Schedule 1, Part 2, entry for Ipilimumab

substitute:

Ipilimumab P8569 120 2
P8555 120 3
P6562 P6585 P8142 P8178 P8180 P8206 360 3

  1. Schedule 1, Part 2, entry for Nivolumab

substitute:

Nivolumab P8141 P8146 P8182 P8220 120 3
P8571 360 2
P8573 360 3
P6070 P6095 P7567 P7864 P8581 360 8
P6111 P6997 P6999 P7787 P7802 P8143 P8552 P8568 360 11

  1. Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]

insert in numerical order in the column headed “Purposes”: P8542 P8543 P8563

  1. Schedule 4, entry for Ipilimumab

(a)insert in the column headed “Purposes Code” for circumstances code C6562: P6562

(b)insert in the column headed “Purposes Code” for circumstances code C6585: P6585

(c)insert in the column headed “Purposes Code” for circumstances code C8142: P8142

(d)insert in the column headed “Purposes Code” for circumstances code C8178: P8178

(e)insert in the column headed “Purposes Code” for circumstances code C8180: P8180

(f)insert in the column headed “Purposes Code” for circumstances code C8206: P8206

(g)insert in numerical order after existing text:

C8555 P8555 Stage IV clear cell variant renal cell carcinoma (RCC)
Induction treatment
The condition must not have previously been treated; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 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 8555
C8569 P8569 Stage IV clear cell variant renal cell carcinoma (RCC)
Induction treatment - Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The condition must not have previously been treated prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The treatment must be in combination with PBS-subsidised-treatment with nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction 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.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 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 8569

  1. Schedule 4, entry for Nivolumab

(a)omit:

C6988 P6988

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 first‑line treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal.
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 6988
C6993 P6993

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 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 6993

(b)       insert in numerical order after existing text:

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
C8571 P8571 Stage IV clear cell variant renal cell carcinoma (RCC)
Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 March 2019; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The condition must not have previously been treated prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; OR
Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition; OR
The treatment must be as monotherapy as maintenance for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
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.
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 8571
C8573 P8573 Stage IV clear cell variant renal cell carcinoma (RCC)
Induction treatment
The condition must not have previously been treated; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; 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 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 8573
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

  1. Schedule 4, entry for Pembrolizumab

insert in numerical order after existing text:

C8542 P8542 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Grandfathering treatment
Patient must have received non-PBS treatment with this drug for this condition prior to 1 March 2019; 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 prior to initiating treatment with this drug for this condition; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer prior to initiating treatment with this drug for this condition; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer prior to initiating treatment with this drug for this condition; AND
Patient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed 35 cycles in total or up to 24 months of treatment, at a dose of 200 mg every 3 weeks with this drug for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 8542
C8543 P8543 Locally advanced (Stage III) or metastatic (Stage IV) urothelial 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; AND
The treatment must not exceed 35 cycles in total or up to 24 months of treatment, at a dose of 200 mg every 3 weeks with this drug for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 8543
C8563 P8563 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Initial treatment
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; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses at a maximum dose of 200 mg every 3 weeks for this condition under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 8563
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