National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 7) (PB 83 of 2020) (Cth)

Case

PB 83 of 2020

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 7)

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         27 August 2020

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 2020 (No. 7).

(2)This Instrument may also be cited as PB 83 of 2020.

  1. Commencement

This Instrument commences on 1 September 2020.

  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 Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U.

omit from the column headed “Brand”: Hospira Pty Limited      substitute: DBL Bleomycin Sulfate

  1. Schedule 1, Part 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 150 mg in 15 mL; and Solution for I.V. injection
    450 mg in 45 mL

omit from the column headed “Brand”: Hospira Pty Limited      substitute: DBL Carboplatin

  1. Schedule 1, Part 1, entry for Methotrexate in each of the forms: Injection 5 mg in 2 mL vial; and Injection 50 mg in 2 mL vial

omit from the column headed “Brand”: Hospira Pty Limited      substitute: DBL Methotrexate

  1. Schedule 1, Part 1, entry for Methotrexate in each of the forms: Solution concentrate for I.V. infusion 500 mg in 20 mL vial; and Solution concentrate for I.V. infusion 1000 mg in 10 mL vial         

omit from the column headed “Brand”: Hospira Pty Limited      substitute: DBL Methotrexate

  1. Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C9868

(b)omit from the column headed “Circumstances”: C9924  

(c)omit from the column headed “Circumstances”: C10088 C10142 C10159 C10181

(d)insert in numerical order in the column headed “Circumstances”: C10675 C10676 C10678 C10679 C10681 C10682 C10683 C10685 C10687 C10688 C10689 C10693 C10695 C10696 C10697 C10701 C10702 C10704 C10705  

  1. Schedule 1, Part 1, entry for Vinblastine

omit from the column headed “Brand”: Hospira Pty Limited      substitute: DBL Vinblastine 

  1. Schedule 1, Part 1, entry for Vincristine

omit from the column headed “Brand”: Hospira Pty Limited      substitute: DBL Vincristine Sulfate 

  1. Schedule 1, Part 2, entry for Pembrolizumab

substitute:

Pembrolizumab

P10696

200

5

P9863 P9864 P9894 P9897 P9921 P9966 P10678 P10679 P10681 P10682 P10697 P10702

200

6

P10685 P10687 P10695 P10705

200

7
P10689 400 2
P10675 P10676 P10683 P10688 P10693 P10701 P10704 400 3

  1. Schedule 4, entry for Bevacizumab

omit from the column headed “Authority Requirements (part of Circumstances)” for Circumstances Code “C9102”: Written

  1. Schedule 4, entry for Blinatumomab

(a)omit from the column headed “Authority Requirements (part of Circumstances)” for Circumstances Code “C9369”: Written

(b)omit from the column headed “Authority Requirements (part of Circumstances)” for Circumstances Code “C9519”: Written

(c)omit from the column headed “Authority Requirements (part of Circumstances)” for Circumstances Code “C9936”: Written

  1. Schedule 4, entry for Brentuximab vedotin

omit from the column headed “Authority Requirements (part of Circumstances)” for Circumstances Code “C8736”: Written

  1. Schedule 4, entry for Inotuzumab ozogamicin

omit from the column headed “Authority Requirements (part of Circumstances)” for Circumstances Code “C9601”: Written

  1. Schedule 4, entry for Pembrolizumab

(a)omit:

C9868 P9868 Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
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 not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 9868

(b)omit:

C9924 P9924 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. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 9924

(c)omit:

C10088 P10088 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2 ‑ 3 weekly treatment regimen
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 the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD‑1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD‑1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV 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 under this restriction. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 10088
C10142 P10142

Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have previously received non‑PBS subsidised treatment with this drug for this condition prior to 1 December 2019; 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 non‑small cell lung cancer; AND

Patient must not have had been treated for this condition in the metastatic setting prior to initiating non‑PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non‑PBS‑subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c‑ROS proto‑oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

 Compliance with Authority Required procedures ‑ Streamlined Authority Code 10142
C10159 P10159 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1 ‑ 3 weekly treatment regimen
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) 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 been treated with an adjuvant programmed cell death‑1 (PD‑1) inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma; OR
Patient must have experienced disease recurrence after at least 6 months from completion of an adjuvant PD‑1 inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma, followed by disease progression after treatment with a BRAF inhibitor (with or without MEK inhibitor) in the unresectable or metastatic setting 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 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 under this restriction. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 10159
C10181 P10181 Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Initial treatment
Patient must not have previously been treated for this condition in the metastatic setting; 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 non‑small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c‑ROS proto‑oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 10181

(d)insert in numerical order after existing text:

C10675 P10675 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 6 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
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
C10676 P10676 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment - 6 weekly treatment regimen
Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. 		Compliance with Authority Required procedures
C10678 P10678 Relapsed or refractory primary mediastinal B-cell lymphoma
Grandfather treatment (initial treatment of a patient commenced on non-PBS-subsidised treatment)
Patient must have received treatment with this drug for this condition prior to 1 September 2020; AND
The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND
Patient must have been treated with rituximab-based chemotherapy prior to initiating treatment with this drug for this condition; AND
Patient must have been experiencing relapsed/refractory disease prior to initiating treatment with this drug for this condition; AND
Patient must have been autologous stem cell transplant (ASCT) ineligible following a single line of treatment prior to initiating treatment with this drug for this condition; OR
Patient must have undergone an autologous stem cell transplant (ASCT) prior to initiating treatment with this drug for this condition; OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must have included rituximab-based chemotherapy, prior to initiating treatment with this drug for this condition; AND
Patient must not have received treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed primary mediastinal B-cell lymphoma pembrolizumab PBS Authority Application for Grandfathered patients, which includes:
(i) confirmation that histology results and PET/CT scans support a diagnosis of primary mediastinal B-cell lymphoma and are retained on the patient's medical records;
(ii) details of prior treatments for this condition 		Compliance with Written Authority Required procedures
C10679 P10679 Relapsed or refractory primary mediastinal B-cell lymphoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime. 		Compliance with Authority Required procedures
C10681 P10681 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment - 3 weekly treatment regimen
Patient must not have previously been treated for this condition in the metastatic setting; 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 non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10681
C10682 P10682 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment - 3 weekly treatment regimen
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 35 cycles or up to 24 months of treatment under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10682
C10683 P10683 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment - 6 weekly treatment regimen
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; 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 non-small cell lung cancer; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10683
C10685 P10685 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 3 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
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
C10687 P10687 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment - 3 weekly treatment regimen
The treatment must be adjuvant to complete surgical resection; AND
Patient must have a WHO performance status of 1 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. 		Compliance with Authority Required procedures
C10688 P10688 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment - 6 weekly treatment regimen
The treatment must be adjuvant to complete surgical resection; AND
Patient must have a WHO performance status of 1 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. 		Compliance with Authority Required procedures
C10689 P10689 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment - 6 weekly treatment regimen
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 not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 3 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10689
C10693 P10693 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment - 6 weekly treatment regimen
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 18 cycles or up to 24 months of treatment under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10693
C10695 P10695 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment - 3 weekly treatment regimen
Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. 		Compliance with Authority Required procedures
C10696 P10696 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment - 3 weekly treatment regimen
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 not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV 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 under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10696
C10697 P10697 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment - 3 weekly treatment regimen
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; 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 non-small cell lung cancer; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10697
C10701 P10701 Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment - 6 weekly treatment regimen
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. 		Compliance with Authority Required procedures - Streamlined Authority Code 10701
C10702 P10702 Relapsed or refractory primary mediastinal B-cell lymphoma
Initial treatment
The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND
Patient must have been treated with rituximab-based chemotherapy for this condition; AND
Patient must be experiencing relapsed/refractory disease; AND
Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR
Patient must have undergone an autologous stem cell transplant (ASCT); OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; 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; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed primary mediastinal B-cell lymphoma pembrolizumab PBS Authority Application, which includes:
(i) confirmation that histology results with PET/CT scans support a diagnosis of primary mediastinal B-cell lymphoma and are retained on the patient's medical records;
(ii) details of prior treatments for this condition. 		Compliance with Written Authority Required procedures
C10704 P10704 Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment - 6 weekly treatment regimen
Patient must not have previously been treated for this condition in the metastatic setting; 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 non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 4 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10704
C10705 P10705 Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment - 3 weekly treatment regimen
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. 		Compliance with Authority Required procedures - Streamlined Authority Code 10705
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0