Federal Register of Legislation - Australian Government

Primary content

PB 7 of 2018 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to add, delete and make changes to forms, brands, responsible person codes, maximum quantities and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Made 25 Jan 2018
Registered 30 Jan 2018
Tabled HR 05 Feb 2018
Tabled Senate 05 Feb 2018
Date of repeal 02 Feb 2018
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

PB 7 of 2018

 

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

 

 

National Health Act 1953

I, NATASHA PLOENGES, Acting Assistant Secretary, Private Health Insurance and 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 January 2018

 

 

 

 

 

 

 

 

 

 

 

 

NATASHA PLOENGES

Acting Assistant Secretary

Private Health Insurance and 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. 1).

 

(2)               This Instrument may also be cited as PB 7 of 2018.

2          Commencement

This Instrument commences on 1 February 2018.

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

This Instrument 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 Bortezomib in the form Powder for injection 1 mg

omit from the column headed “Circumstances”:            C6372 C6384 C6466 C6472 C6478         substitute:      C7376 C7377 C7389 C7390 C7402

[2]           Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3 mg

omit from the column headed “Circumstances”:            C6372 C6373 C6384 C6452 C6466 C6472 C6478

insert in numerical order in the column headed “Circumstances”:     C7376 C7377 C7389 C7390 C7402 C7414 C7416

[3]           Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg

omit from the column headed “Circumstances”:            C6373 C6452

insert in numerical order in the column headed “Circumstances”:     C7414 C7416

[4]           Schedule 1, Part 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

omit:

Accord Doxorubicin

EA

MP

D

[5]           Schedule 1, Part 1, entry for Gemcitabine

(a)      omit:

 

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

Gemcitabine Ebewe

SZ

MP

 

D

(b)      omit:

 

Powder for I.V. infusion 1 g (as hydrochloride)

Injection

Gemcitabine Ebewe

SZ

MP

 

D

(c)      omit:

 

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

Injection

Gemcitabine Ebewe

SZ

MP

 

D

(d)      omit:

 

Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL

Injection

Gemcitabine Ebewe

SZ

MP

 

D

(e)      omit:

 

Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL

Injection

Gemcitabine Ebewe

SZ

MP

 

D

 

[6]           Schedule 1, Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

omit:                                                                                                                                                                                                                               

Oxaliccord

EA

MP

D

[7]           Schedule 1, Part 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg in 50 mL

(a)      omit from the column headed “Circumstances”: C5998 C6009 C6034 C6039

(b)      omit from the column headed “Circumstances”: C6162 C6309 C7040

(c)      insert in numerical order in the column headed “Circumstances”:       C6011

(d)      insert in numerical order in the column headed “Circumstances”:       C7399 C7400

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

omit from the column headed “Purposes”:         P6373 P6452 P6466

insert in numerical order in the column headed “Purposes”: P7390 P7414 P7416

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

omit from the column headed “Purposes”:         P6372 P6472

substitute:   P7376 P7402

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

omit from the column headed “Purposes”:         P6384 P6478

substitute:   P7377 P7389

[11]         Schedule 1, Part 2, entry for Rituximab

substitute:

Rituximab

P7399

800

5

 

P6011 P7400

800

7

 

P6161

800

11


 

[12]         Schedule 2, entry for Rituximab

substitute:

Rituximab

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL

Injection

Mabthera SC

RO

MP

C6011 C6161 C7399 C7400

P7399

1

5

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P7400

1

6

 

MP

C6011 C6161 C7399 C7400

P6011

1

7

MP

C6011 C6161 C7399 C7400

P6161

1

11

[13]         Schedule 4, entry for Bortezomib

(a)      omit:

 

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

(b)      insert in numerical order after existing text:

 

C7376

P7376

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 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 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

 

C7377

P7377

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.
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

 

C7389

P7389

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.
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

 

C7390

P7390

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.
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

 

C7402

P7402

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 concomitant PBS-subsidised thalidomide or its analogues; 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

 

C7414

P7414

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 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.
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

 

C7416

P7416

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 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.
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 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) 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

[14]         Schedule 4, entry for Rituximab

(a)      omit:

 

C5998

P5998

Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma

Re-induction treatment

The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 5998

 

C6008

P6008

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6008

 

C6009

P6009

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6009

 

C6034

P6034

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6034

 

C6039

P6039

Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma

Re-induction treatment

The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6039

substitute:

 

C6011

P6011

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6011

(b)      omit:

 

C6162

P6162

Previously untreated symptomatic indolent CD20 positive non-Hodgkin's lymphoma in combination with chemotherapy

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; 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 the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6162

 

C6309

P6309

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6309

 

C6317

P6317

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6317

 

C7040

P7040

Chronic lymphocytic leukaemia (CLL)

The condition must be CD20 positive; AND
The treatment must be in combination with chemotherapy or idelalisib.

Compliance with Authority Required procedures - Streamlined Authority Code 7040

substitute:

 

C7399

P7399

Previously untreated or Relapsed/refractory CD20 positive acute lymphoblastic leukaemia

Maintenance therapy

The treatment must be maintenance therapy; AND
The treatment must be in combination with chemotherapy; AND
Patient must be in complete remission; AND
Patient must not receive more than 6 doses in total under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 7399

 

C7400

P7400

Previously untreated or relapsed/refractory CD20 positive lymphoid cancer

Induction or re-induction therapy

The treatment must be for induction or re-induction for CD20 positive lymphoma; OR
The treatment must be for induction or re-induction for CD20 positive chronic lymphocytic leukaemia; OR
The treatment must be for induction or consolidation for CD20 positive acute lymphoblastic leukaemia; AND
The treatment must be in combination with chemotherapy; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab.
No more than 8 doses in total as per course of treatment will be allowed for lymphoma or chronic lymphocytic leukaemia.
No more than 12 doses in total as per course of treatment will be allowed for acute lymphoblastic leukaemia for induction course (including consolidation course).

Compliance with Authority Required procedures - Streamlined Authority Code 7400