National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 9) (No. PB 97 of 2012) (Cth)
PB 97 of 2012
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 27 November 2012
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
___________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 9).
(2)This Instrument may also be cited as PB 97 of 2012.
2 Commencement
This Instrument commences on 1 December 2012.
3 Amendments to 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 Bortezomib in the form Powder for injection 3.5 mg with the manner of administration Injection, in the column headed ‘Circumstances’
omit:
C3762 C3763 C3764 C3765 C3766 C3767
insert:
C4079 C4080 C4081 C4126 C4161 C4162
Schedule 1 Part 1, entry for Bortezomib in the form Powder for Injection 1mg with the manner of administration Injection, in the column headed ‘Circumstances’
omit:
C7003 C7004 C7005 C7006 C7007
insert:
C4082 C4103 C4127 C4141 C4163
Schedule 1 Part 1, entry for Cabazitaxel in the form Concentrated injection 60mg (as acetone solvate) in 1.5 mL, with diluent, with the manner of administration Injection in the column headed ‘Circumstances’
omit:
C7000 C7001
insert:
C4073 C4138
Schedule 1 Part 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent with the manner of administration Injection, in the column headed ‘Circumstances’
(a) omit:
C3186
(b) omit:
C3890
(c) omit:
C3955
(d) omit:
C7002
(e) insert after C3956:
C4078 C4140 C4155 C4160
Schedule 1 Part 1, entry for Docetaxel in the form Powder for I.V. infusion 20 mg with solvent with the manner of administration Injection, in the column headed ‘Circumstances’
omit:
C3186 C3890 C3955 C7002
insert:
C4078 C4140 C4155 C4160
Schedule 1 Part 1, entry for Docetaxel in the form Powder for I.V. infusion 80 mg with solvent with the manner of administration Injection, in the column headed ‘Circumstances’
omit:
C3186 C3890 C3955 C7002
insert:
C4078 C4140 C4155 C4160
Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL with the manner of administration Injection, in the column headed ‘Circumstances’
(a) omit:
C3186
(b) omit:
C3890
(c) omit:
C3955
(d) omit:
C7002
(e) insert after C3956:
C4078 C4140 C4155 C4160
Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL with the manner of administration Injection, in the column headed ‘Circumstances’
(a) omit:
C3186
(b) omit:
C3890
(c) omit:
C3955
(d) omit:
C7002
(e) insert after C3956:
C4078 C4140 C4155 C4160
Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL with the manner of administration Injection, in the column headed ‘Circumstances’
(a) omit (all instances):
C3186
(b) omit (all instances):
C3890
(c) omit (all instances):
C3955
(d) omit (all instances):
C7002
(e) insert in numerical order:
C4078 C4140 C4155 C4160
[10] Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL with the manner of administration Injection and brands DBL Docetaxel Concentrated Injection and Docetaxel Sandoz, in the column headed ‘Circumstances’
(a) omit (all instances):
C3186
(b) omit (all instances):
C3890
(c) omit (all instances):
C3955
(d) omit (all instances):
C7002
(e) insert after C3956 (all instances):
C4078 C4140 C4155 C4160
[11] Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL with the manner of administration Injection and brand Docetaxel Ebewe, in the column headed ‘Circumstances’
(a) omit:
C3186
(b) omit:
C3890
(c) omit:
C3955 C7002
(d) insert after C3916:
C4078 C4140 C4155 C4160
[12] Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL with the manner of administration Injection, in the column headed ‘Circumstances’
(a) omit (all instances):
C3186
(b) omit (all instances):
C3890
(c) omit (all instances):
C3955
(d) omit (all instances):
C7002
(e) insert after C3956 (all instances):
C4078 C4140 C4155 C4160
[13] Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL with the manner of administration Injection and brands DBL Docetaxel Concentrated Injection and Docetaxel Sandoz, in the column headed ‘Circumstances’
(a) omit (all instances):
C3186
(b) omit (all instances):
C3890
(c) omit (all instances):
C3955
(d) omit (all instances):
C7002
(e) insert in numerical order:
C4078 C4140 C4155 C4160
[14] Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL with the manner of administration Injection and brand Docetaxel Ebewe, in the column headed ‘Circumstances’
(a) omit:
C3186
(b) omit:
C3890
(c) omit:
C3955 C7002
(d) insert after C3916:
C4078 C4140 C4155 C4160
[15] Schedule 1 Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150mg with manner of administration Injection, in the column headed ‘Circumstances’
omit:
C3926 C3927 C3928 C3929
insert:
C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164
[16] Schedule 1 Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 60mg with manner of administration Injection, in the column headed ‘Circumstances’
omit:
C3926 C3927 C3928 C3929
insert:
C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164
[17] Schedule 1 Part 2, entry for Bortezomib
omit:
| Bortezomib | P3762 P3763 P3765 P3766 | 3000 | 15 |
| P3764 P3767 P7003 P7004 P7006 P7005 P7007 | 3000 3000 3000 | 11 15 19 |
insert in the columns in the order indicated:
| Bortezomib | P4079 P4103 P4126 P4161 P4162 | 3000 | 15 | ||
| P4080 P4081 P4082 P4141 P4127 P4163 | 3000 3000 3000 | 11 19 31 | |||
[18] Schedule 1 Part 2, entry for Trastuzumab
omit:
| Trastuzumab | P3929 | 250 | 9 |
| P3927 | 500 | 0 | |
| P3928 | 750 | 3 | |
| P3926 | 1000 | 0 |
insert in the columns in the order indicated:
| Trastuzumab | P4104 P4156 | 250 | 9 |
| P4142 P4164 | 500 | 0 | |
| P4083 P4093 | 750 | 3 | |
| P4143 P4144 | 1000 | 0 |
[19] Schedule 2, entry for Granisetron
omit:
| Granisetron | Tablet 2 mg (as hydrochloride) | Oral | Kytril | HH | EMP | C3050 | 2 | 0 |
| Concentrated injection 3 mg (as hydrochloride) in 3 mL | Injection | Granisetron Kabi | PK | EMP | C3050 | 1 | 0 | |
| Kytril | HH | EMP | C3050 | 1 | 0 |
insert:
| Granisetron | Tablet 2 mg (as hydrochloride) | Oral | Kytril | RO | EMP | C4139 | 2 | 0 |
| Concentrated injection 3 mg (as hydrochloride) in 3 mL | Injection | Granisetron Kabi | PK | EMP | C4139 | 1 | 0 | |
| Kytril | RO | EMP | C4139 | 1 | 0 |
[20] Schedule 4, entry for Bortezomib
omit:
| Bortezomib | C3762 | P3762 | Retreatment of a patient who has been previously treated with PBS-subsidised bortezomib Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of a patient with multiple myeloma who has progressive disease and who has been previously treated with PBS-subsidised bortezomib. The patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy. 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 of 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 and less than 200 mg per 24 hour Bence-Jones proteinuria. If serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to re-treatment with bortezomib) is defined as: (a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or (b) 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 and Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as: (c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value If serum M protein and urine Bence-Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as: (d) at least a 50% reduction in bone marrow plasma cells; or (e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or (f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or (g) normalization of corrected serum calcium to less than or equal to 2.65 mmol per L. The same parameters provided for the diagnosis of progressive disease are to be used to demonstrate at least a partial response to treatment. Bortezomib will only be subsidised for patients with multiple myeloma who are not receiving concomitant PBS-subsidised lenalidomide The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma Authority Application - Supporting Information Form which includes details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously provided to the Chief Executive Medicare To enable confirmation by the Chief Executive Medicare, current diagnostic reports of at least one of the following are required: (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. magnetic resonance imaging or computed tomography scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will 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) should be provided. 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 (either previous or current serum M protein less than 10 g per L and urinary Bence-Jones protein undetectable or less than 200 mg per 24 hours) must be provided; and (4) a signed patient acknowledgment | Compliance with modified Written Authority Required procedures |
| C3763 | P3763 | Continuing retreatment of a patient who has been previously treated with PBS-subsidised bortezomib | Compliance with modified Written Authority Required procedures |
| C3764 | P3764 | Continuing retreatment of a patient who has been previously treated with PBS-subsidised bortezomib | Compliance with modified Written Authority Required procedures |
| C3765 | P3765 | Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and | Compliance with modified Written Authority Required procedures |
| C3766 | P3766 | Initial treatment with PBS-subsidised bortezomib Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of a patient with a histological diagnosis of multiple myeloma who has progressive disease after at least 1 prior therapy, who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily or who has failed to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease; and where 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 of 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); where oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein and less than 200 mg per 24 hour Bence-Jones proteinuria; where thalidomide treatment failure is defined as: (1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or (2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment; where severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living; where toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or Grade 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity; where failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as: (1) less than a 25% reduction in serum or urine M protein; or (2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels; and where the following conditions apply: the patient is not receiving concomitant PBS-subsidised lenalidomide; the authority application is made in writing and includes: (1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form, which includes 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 thalidomide treatment failure; 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; and (2) duration of thalidomide and daily dose prescribed; and (3) a signed patient acknowledgment; if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied; to enable confirmation of eligibility by the Chief Executive Medicare, current diagnostic reports of at least 1 of the following are required: (a) the level of serum M protein (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. magnetic resonance imaging or computed tomography scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration; as these parameters will be used to determine response, results of the above diagnostic reports must be provided with the authority application as follows: (i) for all patients, results for (a) or (b) or (c) must be provided; (ii) where the patient has oligo-secretory or non-secretory multiple myeloma, (c) or (d) or if relevant (e), (f) or (g) must be provided; 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 (either previous or current serum M protein less than 10 g per L and urinary Bence-Jones protein undetectable or less than 200 mg per 24 hours) must be provided | Compliance with modified Written Authority Required procedures |
| C3767 | P3767 | Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 8 treatment cycles with bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response; and where the following conditions apply: if serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as: (a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or (b) 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 and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as: (c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value; if serum M protein and urine Bence-Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as: (d) at least a 50% reduction in bone marrow plasma cells; or (e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or (f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or (g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment; a patient is eligible for continuing PBS-subsidised bortezomib treatment beyond 8 cycles if they have achieved at least a partial response at the completion of cycle 8, and the results of the response assessment are included in the application for authorisation of further treatment; where a response assessment is not submitted to the Chief Executive Medicare prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib; the authority application is made in writing not later than 10 months after the application for initial treatment and includes: (1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and (2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response; a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved; PBS-subsidised treatment with bortezomib is limited to a maximum of 11 cycles per treatment course | Compliance with modified Written Authority Required procedures |
| C7003 | P7003 | Treatment, in combination with chemotherapy, of a patient with newly diagnosed symptomatic multiple myeloma who is eligible for high dose chemotherapy and autologous stem cell transplantation | Compliance with written authority required procedures |
| C7004 | P7004 | Initial PBS-subsidised treatment in combination with a corticosteroid and melphalan or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who is ineligible for high dose chemotherapy | Compliance with written authority required procedures |
| C7005 | P7005 | Continuing PBS-subsidised treatment in combination with a corticosteroid and melphalan or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who is ineligible for high dose chemotherapy and who has received an initial authority prescription for bortezomib and who, at the time of application has demonstrated: | Compliance with written or telephone authority required procedures |
| C7006 | P7006 | Initial PBS-subsidised treatment, in combination with a corticosteroid and/or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who has severe acute renal failure. Patients must require dialysis or be at high risk of requiring dialysis in the opinion of a nephrologist | Compliance with written authority required procedures |
| C7007 | P7007 | Continuing PBS-subsidised treatment in combination with a corticosteroid and/or cyclophosphamide, of a patient with newly diagnosed symptomatic multiple myeloma who has severe acute renal failure and who has received an initial authority prescription for bortezomib and who, at the time of application has demonstrated at least a partial response at the completion of cycle 4 | Compliance with written or telephone authority required procedures |
insert:
| Bortezomib | C4079 | P4079 | 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, Patient must have progressive disease, Patient must have previously been treated with PBS-subsidised bortezomib, Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy, Patient must not be receiving concomitant PBS-subsidised lenalidomide, 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 of 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. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form which includes details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously provided; and (4) a signed patient acknowledgment. To enable confirmation of eligibility for treatment current diagnostic reports of at least one of the following must be provided: (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 will 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) should be provided. 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 provided. | Compliance with Written Authority Required procedures |
| C4080 | P4080 | Multiple myeloma Retreatment of Progressive disease - Continuing PBS-subsidised treatment The treatment must be as monotherapy; or The treatment must be in combination with a corticosteroid and/or cyclophosphamide, Patient must have previously received 8 treatment cycles of bortezomib in the current treatment course, Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib, Patient must not have received 2 treatment cycles after first achieving a confirmed complete response, Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles, Patient must not receive more than 3 cycles of bortezomib under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response. 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. Diagnostic reports must be no more than one month old at the time of application. Where a response assessment is not submitted prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib. Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. | Compliance with Written Authority Required procedures |
| C4081 | P4081 | Multiple myeloma Treatment of Progressive disease - Continuing PBS-subsidised treatment The treatment must be as monotherapy; or The treatment must be in combination with a corticosteroid and/or cyclophosphamide, Patient must have previously received 8 treatment cycles of bortezomib for progressive disease, Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib, Patient must not have received 2 treatment cycles after first achieving a confirmed complete response, Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles, Patient must not receive more than 3 cycles of bortezomib under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response. 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. Diagnostic reports must be no more than one month old at the time of application. Where a response assessment is not submitted prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib. Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart | Compliance with Written Authority Required procedures |
| C4082 | P4082 | Symptomatic multiple myeloma Continuing PBS-subsidised treatment Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and be ineligible for high dose chemotherapy, Patient must not have demonstrated progressive disease at the time of application, Patient must not have achieved a best confirmed response to bortezomib at the time of application, Patient must not be receiving PBS-subsidised thalidomide or lenalidomide, The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide, Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction. Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application. | Compliance with Written or Telephone Authority Required procedures |
| C4103 | P4103 | Symptomatic multiple myeloma Patient must be newly diagnosed, Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation, Patient must not be receiving PBS-subsidised thalidomide or lenalidomide, The treatment must be in combination with chemotherapy, Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma; and (3) a signed patient acknowledgement. | Compliance with Written Authority Required procedures |
| C4126 | P4126 | Multiple myeloma Treatment of Progressive disease - Initial PBS-subsidised treatment The condition must be confirmed by a histological diagnosis, The treatment must be as monotherapy; or The treatment must be in combination with a corticosteroid and/or cyclophosphamide, Patient must have progressive disease after at least one prior therapy, Patient must have undergone or be ineligible for a primary stem cell transplant, Patient must have experienced treatment failure after a trial of at least four (4) weeks of thalidomide at a dose of at least 100 mg daily or have failed to achieve at least a minimal response after eight (8) or more weeks of thalidomide-based therapy for progressive disease, Patient must not be receiving concomitant PBS-subsidised lenalidomide, 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 of 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. Thalidomide treatment failure is defined as: (1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or (2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment. Severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living. Toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity. Failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as: (1) less than a 25% reduction in serum or urine M protein; or (2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels. If the dosing requirement for thalidomide cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form, which includes 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 thalidomide treatment failure; 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; and (3) duration of thalidomide and daily dose prescribed; and (4) a signed patient acknowledgment. To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided: (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 will 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) should be provided. 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 provided. | Compliance with Written Authority Required procedures |
| C4127 | P4127 | Symptomatic multiple myeloma Initial PBS-subsidised treatment Patient must be newly diagnosed, Patient must have severe acute renal failure, Patient must require dialysis; or Patient must be at high risk of requiring dialysis in the opinion of a nephrologist, The treatment must be in combination with a corticosteroid and/or cyclophosphamide, Patient must not be receiving PBS-subsidised thalidomide or lenalidomide, Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response; and (3) a signed patient acknowledgement. Disease activity parameters include current diagnostic reports of at least one of the following: (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) in oligo-secretory and non-secretory myeloma patients only, 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. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will 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) should be provided. 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 provided. | Compliance with Written Authority Required procedures |
| C4141 | P4141 | Symptomatic multiple myeloma Continuing PBS-subsidised treatment Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and have severe acute renal failure, Patient must have demonstrated at least a partial response at the completion of cycle 4 at the time of application, The treatment must be in combination with a corticosteroid and/or cyclophosphamide, Patient must not be receiving PBS-subsidised thalidomide or lenalidomide, Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form, which includes a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response. 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 not being used to monitor disease activity, 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. Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application. | Compliance with Written or Telephone Authority Required procedures |
| C4161 | P4161 | Multiple myeloma Retreatment of Progressive disease - Continuing PBS-subsidised treatment The treatment must be as monotherapy; or The treatment must be in combination with a corticosteroid and/or cyclophosphamide, Patient must have previously received 4 treatment cycles of bortezomib in the current treatment course, Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib, Patient must not have received 2 treatment cycles after first achieving a confirmed complete response, Patient must not have a gap of more than 6 months between the initial application and subsequent applications, Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response. 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. Diagnostic reports must be no more than one month old at the time of application. Where a response assessment is not submitted prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib. Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. | Compliance with Written Authority Required procedures |
| C4162 | P4162 | Multiple myeloma Treatment of Progressive disease - Continuing PBS-subsidised treatment The treatment must be as monotherapy; or The treatment must be in combination with a corticosteroid and/or cyclophosphamide, Patient must have previously received 4 treatment cycles of bortezomib for progressive disease, Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib, Patient must not have received 2 treatment cycles after first achieving a confirmed complete response, Patient must not have a gap of more than 6 months between the initial application and subsequent applications, Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and (3) diagnostic reports demonstrating the patient has achieved at least a partial response. 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. Diagnostic reports must be no more than one month old at the time of application. Where a response assessment is not submitted prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib. Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. | Compliance with Written Authority Required procedures |
| C4163 | P4163 | Symptomatic multiple myeloma | Compliance with Written Authority Required procedures |
[21] Schedule 4, entry for Cabazitaxel
omit:
| Cabazitaxel | C7000 | Where the patient is receiving treatment in the community setting or at/from a Private Hospital, treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a WHO performance status of 2 or less. | Compliance with Authority Required procedures |
| C7001 | Where the patient is receiving treatment at/from a Public Hospital, treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a WHO performance status of 2 or less. | Compliance with Authority Required procedures - Streamlined Authority Code 7001 |
insert:
| Cabazitaxel | C4073 | Castration resistant metastatic carcinoma of the prostate | Compliance with Written or Telephone Authority Required procedures Compliance with Electronic Authority Required procedures |
| C4138 | Castration resistant metastatic carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 4138 |
[22] Schedule 4, entry for Docetaxel
(a) omit:
C3186 (b) omit: | P3186 | Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | Compliance with Authority Required procedures – Streamlined Authority Code 3186 |
C3890 (c) omit: | P3890 | Locally advanced or metastatic non-small cell lung cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3890 |
C3955 (d) omit: | P3955 | Metastatic breast cancer | Compliance with Authority Required procedures – Streamlined Authority Code 3955 |
| C7002 | P7002 | Treatment of androgen independent (castration resistant) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles | Compliance with Authority Required procedures – Streamlined Authority Code 7002 |
(e) insert after C3956:
| C4078 | Locally advanced or metastatic non-small cell lung cancer | Compliance with Authority Required procedures - Streamlined Authority Code 4078 |
| C4140 | Advanced metastatic ovarian cancer Patient must have failed prior therapy which included a platinum compound. | Compliance with Authority Required procedures - Streamlined Authority Code 4140 |
| C4155 | Androgen independent (castration resistant) metastatic carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 4155 |
| C4160 | Metastatic breast cancer | Compliance with Authority Required procedures - Streamlined Authority Code 4160 |
[23] Schedule 4, entry for Granisetron
omit:
| Granisetron | C3050 | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration |
insert in the columns:
| Granisetron | C4139 | Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle. |
[24] Schedule 4, entry for Trastuzumab
omit:
| Trastuzumab | C3926 | P3926 | Initial treatment (3-weekly regimen) Initial treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery. | Compliance with modified Written Authority Required procedures |
C3927 P3927 Initial treatment (weekly regimen)
Initial treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery.
The total duration of PBS-subsidised treatment (initial plus continuing) that will be authorised is 52 weeks.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
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:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kgCompliance with modified Written Authority Required procedures C3928 P3928 Continuing treatment (3-weekly regimen)
Continuing treatment for HER2 positive early breast cancer where the patient has previously received treatment with PBS-subsidised trastuzumab.
The patient is eligible to receive sufficient trastuzumab to complete 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
Authority applications for continuing treatment may be made by telephone.
For a patient on the 3-weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg.
Breaks in therapy.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. Authority applications for new loading doses may be made by telephone
Compliance with Written or Telephone Authority Required procedures C3929 P3929 Continuing treatment (weekly regimen)
Continuing treatment for HER2 positive early breast cancer where the patient has previously received treatment with PBS-subsidised trastuzumab.
The patient is eligible to receive sufficient trastuzumab to complete 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
Authority applications for continuing treatment may be made by telephone.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg.
Breaks in therapy.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. Authority applications for new loading doses may be made by telephoneCompliance with Written or Telephone Authority Required procedures
insert:
| Trastuzumab | C4083 | P4083 | Locally advanced HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab, 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, Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. | Compliance with Written or Telephone Authority Required procedures |
| C4093 | P4093 | Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab, 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, Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. | Compliance with Written or Telephone Authority Required procedures | |
| C4104 | P4104 | Locally advanced HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab, 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, Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. | Compliance with Written or Telephone Authority Required procedures | |
| C4142 | P4142 | Locally advanced HER2 positive breast cancer Initial treatment (weekly regimen) Patient must commence treatment concurrently with neoadjuvant chemotherapy, 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, 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). 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: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg. | Compliance with Written Authority Required procedures | |
| C4143 | P4143 | Locally advanced HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with neoadjuvant chemotherapy, 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, 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). 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: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg. | Compliance with Written Authority Required procedures | |
| C4144 | P4144 | Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must commence treatment concurrently with adjuvant chemotherapy, Patient must have undergone surgery, 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, 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). 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: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg. | Compliance with Written Authority Required procedures | |
| C4156 | P4156 | Early HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received treatment with PBS-subsidised trastuzumab, 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, Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg. Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. | Compliance with Written or Telephone Authority Required procedures | |
| C4164 | P4164 | Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must commence treatment concurrently with adjuvant chemotherapy, Patient must have undergone surgery, 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, 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). 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: (i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and (ii) a copy of the signed patient acknowledgement form. Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg. | Compliance with Written Authority Required procedures |
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
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