National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 3) (PB 25 of 2020) (Cth)
Case
PB 25 of 2020
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 3)
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 March 2020
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 3).
(2)This Instrument may also be cited as PB 25 of 2020.
Commencement
This Instrument commences on 1 April 2020.
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
Schedule 1, Part 1, entry for Atezolizumab
insert as first entry:
| Solution concentrate for I.V. infusion 840 mg in 14 mL | Injection | Tecentriq | RO | MP | C10215 C10257 C10312 | D |
Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL
(a)omit from the column headed “Circumstances”: C9567
(b)omit from the column headed “Circumstances”: C10143
(c)omit from the column headed “Circumstances”: C10190
(d)insert in numerical order in the column headed “Circumstances”: C10216 C10276 C10297
Schedule 1, Part 1, entry for Bortezomib in each of the forms: Powder for injection 1 mg; and Powder for injection 3 mg
(a)omit from the column headed “Circumstances”: C7992
(b)insert in numerical order in the column headed “Circumstances”: C10338
Schedule 1, Part 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL
omit:
| Hospira Pty Limited | PF | MP | D |
Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
omit:
| Pharmorubicin | PF | MP | D |
Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit:
| Pharmorubicin | PF | MP | D |
Schedule 1, Part 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
omit:
| Fludarabine ACT | JU | MP | PB |
Schedule 1, Part 1, entry for Pertuzumab
(a)omit from the column headed “Circumstances”: C9516
(b)insert in numerical order in the column headed “Circumstances”: C10275
Schedule 1, Part 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg in
50 mL
insert in numerical order in the column headed “Circumstances” (all instances): C10227
Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 60 mg
(a)omit from the column headed “Circumstances”: C9354 C9356 C9461
(b)omit from the column headed “Circumstances”: C9628
(c)insert in numerical order in the column headed “Circumstances”: C10213 C10293 C10294 C10296
Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
(a)omit from the column headed “Circumstances” (all instances): C9354 C9356 C9461
(b)omit from the column headed “Circumstances” (all instances): C9628
(c)insert in numerical order in the column headed “Circumstances” (all instances): C10213 C10293 C10294 C10296
Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 420 mg
(a)omit from the column headed “Circumstances”: C9354 C9356 C9461
(b)omit from the column headed “Circumstances”: C9628
(c)insert in numerical order in the column headed “Circumstances”: C10213 C10293 C10294 C10296
Schedule 1, Part 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg
(a)omit from the column headed “Circumstances”: C9359
(b)insert in numerical order in the column headed “Circumstances”: C10214 C10255 C10273 C10295
Schedule 1, Part 2, entry for Atezolizumab
substitute:
| Atezolizumab | P10206 | 1200 | 3 |
| P10203 P10204 | 1200 | 4 | |
| P10125 P10182 P10276 | 1200 | 5 | |
| P9345 P10216 P10297 | 1200 | 7 | |
| P10312 | 1680 | 3 | |
| P10215 P10257 | 1680 | 5 |
Schedule 1, Part 2, entry for Bortezomib [Maximum Amount: 3000; Number of Repeats: 15]
(a)omit from the column headed “Purposes”: P7992
(b)insert in numerical order in the column headed “Purposes”: P10338
Schedule 1, Part 2, entry for Pertuzumab [Maximum Amount: 840; Number of Repeats: 0]
omit from the column headed “Purposes”: P9516 substitute: P10275
Schedule 1, Part 2, entry for Rituximab
insert as first entry:
| P10227 | 800 | 3 |
Schedule 1, Part 2, entry for Trastuzumab
substitute:
| Trastuzumab | P10213 | 250 | 9 |
| P10296 | 500 | 0 | |
| P9349 P9571 P10294 | 750 | 3 | |
| P9353 P9573 P10293 | 1000 | 0 |
Schedule 1, Part 2, entry for Trastuzumab emtansine
substitute:
| Trastuzumab emtansine | P10255 P10273 P10295 | 450 | 6 |
| P9577 P9599 P10214 | 450 | 8 |
Schedule 2, entry for Rituximab
substitute:
| Rituximab | Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL | Injection | Mabthera SC | RO | MP | C6011 C6161 C7399 C7400 C10227 | P10227 | 1 | 2 |
| MP | C6011 C6161 C7399 C7400 C10227 | P7399 | 1 | 5 | |||||
| MP | C6011 C6161 C7399 C7400 C10227 | P7400 | 1 | 6 | |||||
| MP | C6011 C6161 C7399 C7400 C10227 | P6011 | 1 | 7 | |||||
| MP | C6011 C6161 C7399 C7400 C10227 | P6161 | 1 | 11 |
Schedule 2, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL [Maximum Amount: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C9351
(b)insert in numerical order in the column headed “Circumstances”: C10212
Schedule 2, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL [Maximum Amount: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C9351
(b)insert in numerical order in the column headed “Circumstances”: C10212
(c)omit from the column headed “Purposes”: P9351
(d)insert in numerical order in the column headed “Purposes”: P10212
Schedule 4, entry for Atezolizumab
(a)omit:
| C9567 | P9567 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Continuing treatment Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated. Patient must have previously received PBS‑subsidised treatment with this drug in this line of treatment; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9567 |
(b)omit:
| C10143 | P10143 | 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 non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10143 |
(c)omit:
| C10190 | P10190 | 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 systemic anti-cancer therapy for this condition; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10190 |
(d)insert in numerical order after existing text:
| C10215 | P10215 | Locally advanced or metastatic non-small cell lung cancer Continuing treatment - 4 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10215 |
| C10216 | P10216 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated. Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10216 |
| C10257 | P10257 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen Patient must have experienced intolerance to combination treatment with bevacizumab; AND Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; 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 10257 |
| C10276 | P10276 | Locally advanced or metastatic non-small cell lung cancer Initial treatment - 3 weekly treatment regimen 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 treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10276 |
| C10297 | P10297 | Locally advanced or metastatic non-small cell lung cancer Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10297 |
| C10312 | P10312 | Locally advanced or metastatic non-small cell lung cancer Initial treatment - 4 weekly treatment regimen 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 therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10312 |
Schedule 4, entry for Bortezomib
(a)omit entry for circumstances code “C7938” and substitute:
| C7938 | P7938 | Multiple myeloma Retreatment of Progressive disease - Initial PBS-subsidised treatment The treatment must be as monotherapy; OR The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND Patient must have progressive disease; AND Patient must have previously been treated with PBS-subsidised bortezomib; AND Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein). If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours. If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels. If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as: (a) at least a 50% reduction in bone marrow plasma cells; or (b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or (c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or (d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L. Details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters that will be used to assess response, and diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously documented must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) must be documented in the patient's medical records. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 7938 |
(b)omit entry for circumstances code “C7961” and substitute:
| C7961 | P7961 | Multiple myeloma Treatment of Progressive disease - Initial PBS-subsidised treatment The condition must be confirmed by a histological diagnosis; AND The treatment must be as monotherapy; OR The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a primary stem cell transplant; AND Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 7961 |
(c)omit:
| C7992 | P7992 | Symptomatic multiple myeloma Patient must be newly diagnosed; AND Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND Patient must not be receiving concomitant PBS‑subsidised thalidomide or its analogues; AND The treatment must be in combination with chemotherapy; AND Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7992 |
(d)insert in numerical order after existing text:
| C10338 | P10338 | Symptomatic multiple myeloma Patient must be newly diagnosed; AND Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND The treatment must be in combination with chemotherapy. Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 10338 |
Schedule 4, entry for Carfilzomib
substitute
| Carfilzomib | C7344 | Multiple myeloma Grandfathering Patient must have received treatment with this drug for this condition prior to 1 January 2018; AND Patient must have a documented histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have had documented progressive disease after at least one prior therapy prior to commencing 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 Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 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 |
| C7348 | Multiple myeloma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not develop disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures | |
| C7355 | Multiple myeloma Initial treatment The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not have previously received this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND Patient must not receive more than three cycles of treatment under this restriction. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
Schedule 4, entry for Pertuzumab
(a)omit:
| C9516 | P9516 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND Patient must have a WHO performance status of 0 or 1; AND Patient must not have received prior anti‑HER2 therapy for this condition; AND Patient must not have received prior chemotherapy for this condition; AND The treatment must be in combination with trastuzumab and a taxane; AND The treatment must not be in combination with nab‑paclitaxel; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C10275 | P10275 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND Patient must have a WHO performance status of 0 or 1; AND Patient must not have received prior anti-HER2 therapy for this condition; AND Patient must not have received prior chemotherapy for this condition; AND The treatment must be in combination with trastuzumab and a taxane; AND The treatment must not be in combination with nab-paclitaxel; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes details of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Written Authority Required procedures |
Schedule 4, entry for Rituximab
insert in numerical order after existing text:
| C10227 | P10227 | Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma Re-induction therapy The treatment must be for re-induction treatment purposes only; AND The condition must have relapsed or be refractory to treatment; AND Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction. An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total. | Compliance with Authority Required procedures - Streamlined Authority Code 10227 |
Schedule 4, entry for Trastuzumab
(a)omit:
| C9351 | P9351 | Early HER2 positive breast cancer 3 weekly treatment regimen Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9351 |
(b)omit:
| C9354 | P9354 | Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9354 |
| C9356 | P9356 | Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9356 |
| C9461 | P9461 | Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9461 |
(c)omit:
| C9628 | P9628 | Early HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9628 |
(d)insert in numerical order after existing text:
| C10212 | P10212 | Early HER2 positive breast cancer 3 weekly treatment regimen Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10212 |
| C10213 | P10213 | Early HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. | Compliance with Authority Required procedures - Streamlined Authority Code 10213 |
| C10293 | P10293 | Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10293 |
| C10294 | P10294 | Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. | Compliance with Authority Required procedures - Streamlined Authority Code 10294 |
| C10296 | P10296 | Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10296 |
Schedule 4, entry for Trastuzumab emtansine
(a)omit:
| C9359 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course. | Compliance with Authority Required procedures |
(b)insert in the column headed “Purposes Code” for the circumstance code “C9577”: P9577
(c)insert in the column headed “Purposes Code” for the circumstance code “C9599”: P9599
(d)insert in numerical order after existing text:
| C10214 | P10214 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course for this PBS indication. | Compliance with Authority Required procedures |
| C10255 | P10255 | Early HER2 positive breast cancer Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery. | Compliance with Written Authority Required procedures |
| C10273 | P10273 | Early HER2 positive breast cancer Grandfather adjuvant treatment Patient must have received non-PBS-subsidised treatment with this drug as adjuvant treatment of early HER2 positive breast cancer prior to 1 April 2020; AND The treatment must have been prescribed within 12 weeks after surgery prior to commencing treatment with this drug; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration using non-PBS-subsidised and PBS-subsidised drug supply obtained under the grandfather restriction and the continuing treatment restrictions combined. Authority applications for grandfather treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Early Breast Cancer - PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery and the number of non-PBS-subsidised cycles of treatment received by the patient. | Compliance with Written Authority Required procedures |
| C10295 | P10295 | Early HER2 positive breast cancer Continuing adjuvant 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 be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. | Compliance with Authority Required procedures |
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