PB 38 of 2022
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 4)
National Health Act 1953
I, MARIANA CRANK, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.
Date 28 April 2022
MARIANA CRANK
Assistant Secretary (Acting)
Pharmacy Branch
Technology Assessment and Access Division
Contents
1......... Name............................................................................................................................... 1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1
Schedule 1—Amendments 2
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011
(PB 79 of 2011) 2
1 Name
(1) This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 4).
(2) This instrument may also be cited as PB 38 of 2022.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information |
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 May 2022 | 1 May 2022 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 100(2) of the National Health Act 1953.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
[1] Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | DBL Bortezomib | PF | MP | C11099 | D |
[2] Schedule 1, Part 1, entry for Carfilzomib in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg
omit from the column headed “Circumstances”: C11196 C11197 C11198 C11291 substitute: C12694 C12849 C12930 C12934
[3] Schedule 1, Part 1, entry for Daratumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL
omit from the column headed “Circumstances”: C11075 C11076 C11131 C12350 substitute: C12691 C12692 C12844 C12845
[4] Schedule 1, Part 1, after entry for Durvalumab in the form Solution concentrate for I.V. infusion 500 mg in 10 mL
insert:
| Elotuzumab | Powder for injection 300 mg | Injection | Empliciti | BQ | MP | C12847 C12891 | D |
| | Powder for injection 400 mg | Injection | Empliciti | BQ | MP | C12847 C12891 | D |
[5] Schedule 1, Part 1, after entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL
insert:
| Sacituzumab govitecan | Powder for injection 180 mg | Injection | Trodelvy | GI | MP | C12656 C12669 C12670 | D |
[6] Schedule 1, Part 2, entry for Carfilzomib
substitute:
[7] Schedule 1, Part 2, entry for Daratumumab
substitute:
| Daratumumab | P12845 | 1920 | 4 |
| | P12691 | 1920 | 5 |
| | P12844 | 1920 | 7 |
| | P12692 | 1920 | 8 |
[8] Schedule 1, Part 2, after entry for Durvalumab
insert:
| Elotuzumab | P12847 | 1200 | 5 |
| | P12891 | 1200 | 9 |
[9] Schedule 1, Part 2, after entry for Rituximab [Maximum Amount: 800; Number of Repeats: 11]
insert:
| Sacituzumab govitecan | P12656 | 1200 | 7 |
| | P12669 P12670 | 1200 | 13 |
[10] Schedule 2, entry for Daratumumab
substitute:
| Daratumumab | Solution for subcutaneous injection containing daratumumab 1800 mg in 15 mL | Injection | Darzalex SC | JC | MP | C12691 C12692 C12842 C12845 | P12845 | 1 | 4 | |
| | | | | | MP | C12691 C12692 C12842 C12845 | P12691 | 1 | 5 | |
| | | | | | MP | C12691 C12692 C12842 C12845 | P12842 | 1 | 7 | |
| | | | | | MP | C12691 C12692 C12842 C12845 | P12692 | 1 | 8 | |
[11] Schedule 2, entry for Netupitant with Palonosetron
omit from the column headed “Responsible Person”: MF substitute: JZ
[12] Schedule 2, entry for Palonosetron
omit from the column headed “Responsible Person”: MF substitute: JZ
[13] Schedule 3, after details relevant for Responsible Person code FF
insert:
| GI | Gilead Sciences Pty Limited | 71 072 611 708 |
[14] Schedule 3, after details relevant for Responsible Person code JU
insert:
| JZ | Juniper Biologics Pty Ltd | 97 655 479 897 |
[15] Schedule 4, entry for Carfilzomib
substitute:
| Carfilzomib | C12694 | P12694 | Multiple myeloma
Initial treatment - once weekly treatment regimen
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 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 - Streamlined Authority Code 12694 |
| | C12849 | P12849 | Multiple myeloma
Continuing treatment - once weekly treatment regimen
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 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 - Streamlined Authority Code 12849 |
| | C12930 | P12930 | Multiple myeloma
Continuing treatment - twice weekly treatment regimen
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 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 - Streamlined Authority Code 12930 |
| | C12934 | P12934 | Multiple myeloma
Initial treatment - twice weekly treatment regimen
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 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 - Streamlined Authority Code 12934 |
[16] Schedule 4, entry for Daratumumab
substitute:
| Daratumumab | C12691 | P12691 | Relapsed and/or refractory multiple myeloma
Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks)
Patient must have previously received 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.
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 |
| | C12692 | P12692 | Relapsed and/or refractory multiple myeloma
Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly)
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with bortezomib and dexamethasone; AND
Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised).
Patient must be undergoing treatment with this drug in one of the following situations: (i) for the first time, (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment.
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; the basis of the diagnosis of progressive disease or failure to respond; and 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 documented 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.
A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.
A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures |
| | C12842 | P12842 | Relapsed and/or refractory multiple myeloma
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have been on treatment with this drug in the subcutaneous form for this condition prior to 1 November 2021; AND
Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with another PBS-subsidised drug indicated for this condition outside of the intended combination where stated, and (v) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
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; the basis of the diagnosis of progressive disease or failure to respond; and 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 documented 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.
A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.
A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures |
| | C12844 | P12844 | Relapsed and/or refractory multiple myeloma
Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2021; AND
Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with another PBS-subsidised drug indicated for this condition outside of the intended combination where stated, and (v) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
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; the basis of the diagnosis of progressive disease or failure to respond; and 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 documented 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.
A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.
A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures |
| | C12845 | P12845 | Relapsed and/or refractory multiple myeloma
Continuing treatment of second-line drug therapy for weeks 10 to 24 (administered every 3 weeks)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with bortezomib and dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
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 |
[17] Schedule 4, after entry for Durvalumab
insert:
| Elotuzumab | C12847 | P12847 | Relapsed and/or refractory 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 lenalidomide and dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
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 |
| | C12891 | P12891 | Relapsed and/or refractory multiple myeloma
Initial treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with lenalidomide and 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.
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 |
[18] Schedule 4, after entry for Rituximab
insert:
| Sacituzumab govitecan | C12656 | P12656 | Unresectable locally advanced or metastatic triple-negative breast cancer
Initial treatment
Patient must have progressive disease following two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
The treatment must be the sole PBS-subsidised therapy for this PBS indication. | Compliance with Authority Required procedures - Streamlined Authority Code 12656 |
| | C12669 | P12669 | Unresectable locally advanced or metastatic triple-negative breast cancer
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 PBS indication. | Compliance with Authority Required procedures - Streamlined Authority Code 12669 |
| | C12670 | P12670 | Unresectable locally advanced or metastatic triple-negative breast cancer
Transitioning from non-PBS to PBS-subsidised supply - Grandfather treatment
Patient must must have received treatment with this drug for this PBS indication prior to 1 May 2022; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 1 prior to treatment initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this PBS indication. | Compliance with Authority Required procedures - Streamlined Authority Code 12670 |