National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 10) (PB 85 of 2016) (Cth)
PB 85 of 2016
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 10)
National Health Act 1953
I, KAREN HALL, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits 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.
Dated 28 SEPTEMBER 2016
KAREN HALL
Acting Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 10).
(2) This Instrument may also be cited as PB 85 of 2016.
2 Commencement
This Instrument commences on 1 October 2016.
3Amendment of PB 79 of 2011
Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Schedule 1 Amendments
1 Schedule 1, Part 1 (table item dealing with Bortezomib)
substitute:
Bortezomib Powder for injection 1 mg Injection Velcade JC MP C6372 D
C6384
C6466
C6472
C6478Powder for injection 3 mg Injection Velcade JC MP C4080 D
C4081
C4161
C4162
C6372
C6373
C6384
C6452
C6466
C6472
C6478
Powder for injection 3.5 mg Injection Velcade JC MP C4080 D
C4081
C4161
C4162
C6373
C6452
2 Schedule 1, Part 1 (table item dealing with Carboplatin)
substitute:
Carboplatin Solution for I.V. injection 50 mg in 5 mL Injection Hospira Pty Ltd HH MP D
Solution for I.V. injection 150 mg in 15 mL Injection Hospira Pty Ltd HH MP D
Solution for I.V. injection 450 mg in 45 mL Injection Hospira Pty Ltd HH MP D
3 Schedule 1, Part 1 (table item dealing with Etoposide, after the form Solution for I.V. infusion 100 mg in 5 mL vial, manner of administration Injection and brand Etoposide Ebewe)
insert:
Pfizer Australia Pty Ltd PF MP PB4 Schedule 1, Part 1 (table item dealing with Gemcitabine, in the form Powder for I.V. infusion 1 g (as hydrochloride))
omit:
Gemcitabine Sun RA MP D
5 Schedule 1, Part 1 (table item dealing with Gemcitabine, in the form Powder for I.V. infusion 200 mg (as hydrochloride))
omit:
Gemcitabine Sun RA MP D
6 Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL)
omit:
Paclitaxel Actavis EA MP D
7 Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form Solution concentrate for I.V. infusion 150 mg in 25 mL)
omit:
Paclitaxel Actavis EA MP D
8 Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form Solution concentrate for I.V. infusion 30 mg in 5 mL)
omit:
Anzatax HH MP D
9 Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form Solution concentrate for I.V. infusion 300 mg in 50 mL)
omit:
Paclitaxel Actavis EA MP D
10 Schedule 1, Part 2 (table item dealing with Bortezomib)
substitute:
Bortezomib
P4080
3000
11
P4081
P4161
3000
15
P4162
P6373
P6452
P6466
P6372
3000
19
P6472
P6384
3000
31
P6478
11 Schedule 2 (table item dealing with Aprepitant)
substitute:
| Capsule 165 mg | Oral | Emend | MK | EMP | C4216 | 1 | 5 |
| C4223 | |||||||
| C6383 | |||||||
| C6464 |
12 Schedule 2 (table item dealing with Interferon Alfa-2a)
omit:
| Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe | Injection | Roferon-A | RO | EMP | C3895 C3899 | P3899 | 5 | 4 |
| Roferon-A | RO | EMP | C3895 | P3895 | 5 | 5 |
13 Schedule 4 (table item dealing with Aprepitant)
substitute:
C4216 Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Compliance with Authority Required procedures - Streamlined Authority Code 4216 C4223 Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Compliance with Authority Required procedures - Streamlined Authority Code 4223 C6383 Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.
Compliance with Authority Required procedures - Streamlined Authority Code 6383 C6464 Nausea and vomiting
The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.
Compliance with Authority Required procedures - Streamlined Authority Code 6464
14 Schedule 4 (table item dealing with Bortezomib)
substitute:
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; AND
Patient must have previously received 8 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles; AND
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; AND
Patient must have previously received 8 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles; AND
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 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; AND
Patient must have previously received 4 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial application and subsequent applications; AND
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; AND
Patient must have previously received 4 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial application and subsequent applications; AND
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 C6372 P6372 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; AND
Patient must not have demonstrated progressive disease at the time of application; AND
Patient must not have achieved a best confirmed response to bortezomib at the time of application; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
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 Authority Required procedures C6373 P6373 Multiple myeloma
Retreatment of Progressive disease - Initial PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease; AND
Patient must have previously been treated with PBS-subsidised bortezomib; AND
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND
Patient must not be receiving concomitant PBS-subsidised lenalidomide or pomalidomide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase 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 C6384 P6384 Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed; AND
Patient must have severe acute renal failure; AND
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
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 C6452 P6452 Multiple myeloma
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must 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; AND
Patient must not be receiving concomitant PBS-subsidised lenalidomide or pomalidomide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase 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 C6466 P6466 Symptomatic multiple myeloma
Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
The treatment must be in combination with chemotherapy; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
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 C6472 P6472 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; AND
Patient must have demonstrated at least a partial response at the completion of cycle 4 at the time of application; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
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 Authority Required procedures C6478 P6478 Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed; AND
Patient must be ineligible for high dose chemotherapy; AND
Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
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 ineligibility for high dose chemotherapy; and
(3) a signed patient acknowledgement.
Compliance with Written Authority Required procedures
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