National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 9) (PB 86 of 2018) (Cth)

Case

PB 86 of 2018

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 9)

National Health Act 1953

___________________________________________________________________________

I, NATASHA PLOENGES, Acting Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated    25 September 2018

NATASHA PLOENGES

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

  1. Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 9).

(2)This Instrument may also be cited as PB 86 of 2018.

  1. Commencement

This Instrument commences on 1 October 2018.

  1. Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1       Amendments

  1. Schedule 1, Part 1, entry for Bendamustine in each of the forms: Powder for injection containing bendamustine hydrochloride 25 mg; and Powder for injection containing bendamustine hydrochloride 100 mg

(a)omit from the column headed “Circumstances”: C6075 C6124

(b)insert in numerical order in the column headed “Circumstances”: C7943 C7944 C7972

  1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg

(a)omit from the column headed “Circumstances”: C7376 C7377 C7389 C7390 C7402

(b)insert in numerical order in the column headed “Circumstances”: C7940 C7941 C7963 C7984 C7992

  1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3 mg

(a)omit from the column headed “Circumstances”: C4080 C4081 C4161 C4162 C7376 C7377 C7389 C7390 C7402 C7414 C7416

(b)insert in numerical order in the column headed “Circumstances”: C7938 C7939 C7940 C7941 C7960 C7961 C7962 C7963 C7974 C7984 C7992

  1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg

(a)omit from the column headed “Circumstances”: C4080 C4081 C4161 C4162 C7414 C7416

(b)insert in numerical order in the column headed “Circumstances”: C7938 C7939 C7960 C7961 C7962 C7974

  1. Schedule 1, Part 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cisplatin Accord OC MP D

  1. Schedule 1, Part 1, entry for Fluorouracil

substitute:

Fluorouracil Injection 500 mg in 10 mL Injection Fluorouracil Accord OC MP C6266 C6297 D
Hospira Pty Limited PF MP C6266 C6297 D
Injection 1000 mg in 20 mL Injection DBL Fluorouracil Injection BP PF MP C6266 C6297 D
Fluorouracil Accord OC MP C6266 C6297 D
Fluorouracil Ebewe SZ MP C6266 C6297 D
Injection 2500 mg in 50 mL Injection DBL Fluorouracil Injection BP PF MP C6266 C6297 D
Fluorouracil Accord OC MP C6266 C6297 D
Fluorouracil Ebewe SZ MP C6266 C6297 D
Injection 5000 mg in 100 mL Injection Fluorouracil Accord OC MP C6266 C6297 D
Fluorouracil Ebewe SZ MP C6266 C6297 D

  1. Schedule 1, Part 1, entry for Obinutuzumab

insert in numerical order in the column headed “Circumstances”: C7935 C7936 C7950 C7959 C7968 C7981

  1. Schedule 1, Part 2, entry for Bortezomib [Maximum Amount: 3000; Number of Repeats: 11]

(a)omit from the column headed “Purposes”: P4080 P4081

(b)insert in numerical order in the column headed “Purposes”: P7960 P7962

  1. Schedule 1, Part 2, entry for Bortezomib [Maximum Amount: 3000; Number of Repeats: 15]

(a)omit from the column headed “Purposes”: P4161 P4162 P7390 P7414 P7416

(b)insert in numerical order in the column headed “Purposes”: P7938 P7939 P7961 P7974 P7992

  1. Schedule 1, Part 2, entry for Bortezomib [Maximum Amount: 3000; Number of Repeats: 19]

(a)omit from the column headed “Purposes”: P7376 P7402

(b)insert in numerical order in the column headed “Purposes”: P7940 P7941

  1. Schedule 1, Part 2, entry for Bortezomib [Maximum Amount: 3000; Number of Repeats: 31]

(a)omit from the column headed “Purposes”: P7377 P7389

(b)insert in numerical order in the column headed “Purposes”: P7963 P7984

  1. Schedule 1, Part 2, entry for Obinutuzumab

substitute:

Obinutuzumab P7935 P7950 1000 5
P5126 P7959 P7968 1000 7
P7936 P7981 1000 9

  1. Schedule 3, after details relevant to Responsible Person code PL

omit:

RA Ranbaxy Australia Pty Limited 17 110 871 826

substitute:

RA Sun Pharma Pty Ltd 17 110 871 826

  1. Schedule 3, after details relevant to Responsible Person code TX

omit:

ZP Spirit Pharmaceuticals Pty Ltd 67 109 225 747

substitute:

ZP Medis Pharma Pty Ltd 67 109 225 747

  1. Schedule 4, entry for Bendamustine

substitute:

Bendamustine C7943 Previously untreated stage II bulky or stage III or IV indolent non-Hodgkin's lymphoma
Induction treatment
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
The treatment must be in combination with rituximab or obinutuzumab; AND
The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 7943
C7944 Follicular lymphoma
Re-induction treatment
The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for re-induction treatment purposes only; AND
The treatment must be in combination with obinutuzumab; AND
The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen. 		Compliance with Authority Required procedures - Streamlined Authority Code 7944
C7972 Previously untreated stage III or IV mantle cell lymphoma
Induction treatment
The condition must be CD20 positive; AND
The treatment must be in combination with rituximab; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND
Patient must not be eligible for stem cell transplantation. 		Compliance with Authority Required procedures - Streamlined Authority Code 7972

  1. Schedule 4, entry for Bortezomib

substitute:

Bortezomib C7938 P7938 Multiple myeloma
Retreatment of Progressive disease - Initial PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease; AND
Patient must have previously been treated with PBS-subsidised bortezomib; AND
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase 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.
Details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters that will be used to assess response, and diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously documented must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) must be documented in the patient's medical records. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7938
C7939 P7939 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 PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
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 prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7939
C7940 P7940 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 developed disease progression while receiving PBS subsidised treatment with this drug for this condition; AND
Patient must not have achieved a best confirmed response to bortezomib at the time of prescribing; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; 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 requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months. 		Compliance with Authority Required procedures - Streamlined Authority Code 7940
C7941 P7941 Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have previously received PBS-subsidised treatment with this drug for newly diagnosed symptomatic multiple myeloma; AND
Patient must have severe acute renal failure; AND
Patient must have demonstrated at least a partial response at the completion of cycle 4; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
A copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority and diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
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 requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months. 		Compliance with Authority Required procedures - Streamlined Authority Code 7941
C7960 P7960 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 PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
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 prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7960
C7961 P7961 Multiple myeloma
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase 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.
Details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7961
C7962 P7962 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 PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
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 prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7962
C7963 P7963 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 concomitant PBS-subsidised thalidomide or its analogues; 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 7963
C7974 P7974 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 PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
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 prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7974
C7984 P7984 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 concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
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 must be documented in the patient's medical records. 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 documented in the patient's medical records 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 documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7984
C7992 P7992 Symptomatic multiple myeloma
Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with chemotherapy; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7992

  1. Schedule 4, entry for Obinutuzumab

substitute:

Obinutuzumab C5126 P5126 Chronic lymphocytic leukaemia (CLL)
Patient must require treatment for CD20 positive chronic lymphocytic leukaemia (CLL); AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression while on treatment.
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; AND
(b) a completed CD20 positive Chronic Lymphocytic Leukaemia PBS Authority Application - Supporting Information Form which includes:
i) documentation that the patient has CD20 positive CLL (flow cytometry pathology report from blood or bone marrow, noting that this may be from some time earlier); AND
ii) a statement that the patient is previously untreated, is inappropriate for fludarabine based chemo immunotherapy, that treatment will be in combination with chlorambucil; AND
iii) documentation that the patient has a creatinine clearance 30 mL/min or greater; AND
iv) One of the following, either:
- A completed cumulative illness rating scale (CIRS) score form demonstrating that the patient has a score of greater than 6 (excluding CLL-induced illness or organ damage)
OR
-Documentation that the patient has a creatinine clearance less than 70 mL/min; 		Compliance with Written Authority Required procedures
C7935 P7935 Stage II bulky or Stage III/IV follicular lymphoma
Maintenance therapy
Patient must have previously received PBS subsidised treatment with this drug under the previously untreated initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the previously untreated grandfather restriction; AND
The condition must be CD20 positive; AND
Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C7936 P7936 Stage II bulky or Stage III/IV follicular lymphoma
Grandfather treatment - previously untreated setting
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; AND
The condition must have been untreated prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be in combination with chemotherapy for induction treatment; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to induction treatment with this drug for this condition for maintenance treatment; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures
C7950 P7950 Follicular lymphoma
Maintenance therapy
Patient must have previously received PBS subsidised treatment with this drug under the rituximab refractory initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the rituximab refractory grandfather restriction; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab; AND
Patient must have demonstrated a partial or complete response to PBS subsidised re-induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C7959 P7959 Follicular lymphoma
Re-induction treatment
Patient must not have previously received PBS subsidised obinutuzumab; AND
The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for re-induction treatment purposes only; AND
The treatment must be in combination with bendamustine; AND
The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures
C7968 P7968 Follicular lymphoma
Grandfather treatment - rituximab refractory
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab prior to initiating non-PBS treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be in combination with bendamustine for re-induction treatment; AND
The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to re-induction treatment with this drug for this condition; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures
C7981 P7981 Stage II bulky or Stage III/IV follicular lymphoma
Induction treatment
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
The treatment must be in combination with chemotherapy; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures
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