National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 11) (PB 130 of 2020) (Cth)

PB 130 of 2020

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 11)

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         21 December 2020

NATASHA PLOENGES

Acting Assistant Secretary

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 2020 (No. 11).

(2)This Instrument may also be cited as PB 130 of 2020.

1. Commencement

This Instrument commences on 1 January 2021.

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 Arsenic

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

Arsenic Trioxide Accord OC MP C4793 C5997 C6018 D

1. Schedule 1, Part 1, entry for Bortezomib in each of the forms: Powder for injection 1 mg; Powder for injection 3 mg; and Powder for injection
   3.5 mg

insert in numerical order in the column headed “Circumstances”: C11099

1. Schedule 1, Part 1, after entry for Cytarabine

insert:

Daratumumab	Solution concentrate for I.V. infusion 100 mg in 5 mL	Injection	Darzalex	JC	MP	C11075 C11076 C11131 C11142	D
Solution concentrate for I.V. infusion 400 mg in 20 mL	Injection	Darzalex	JC	MP	C11075 C11076 C11131 C11142	D

1. Schedule 1, Part 1, entry for Fluorouracil in the form Injection 500 mg in 10 mL

omit:

DBL Fluorouracil Injection BP PF MP C6266 C6297 D

1. Schedule 1, Part 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL

omit:

Anzatax PF MP D

1. Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion
   500 mg (as disodium)

omit:

Alimta LY MP D

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

insert in numerical order in the column headed “Purposes”: P11099

1. Schedule 1, Part 2, after entry for Cytarabine

insert:

Daratumumab	P11076	1920	4
P11075	1920	5
P11131	1920	7
P11142	1920	8

1. Schedule 3

omit:

LY Eli Lilly Australia Pty Ltd 39 000 233 992

1. Schedule 4, entry for Bortezomib

insert in numerical order after existing text:

C11099 P11099 Multiple myeloma

1. Schedule 4, after entry for Cladribine

insert:

Daratumumab	C11075	P11075	Relapsed and/or refractory multiple myeloma Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, carfilzomib or thalidomide or its analogues. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
C11076	P11076	Relapsed and/or refractory multiple myeloma Continuing treatment of second-line drug therapy for weeks 10 to 24 (administered every 3 weeks) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with bortezomib and dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
C11131	P11131	Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2021; AND Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with PBS-subsidised carfilzomib, thalidomide or its analogues, and (v) the patient had never been treated with this drug; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.	Compliance with Authority Required procedures
C11142	P11142	Relapsed and/or refractory multiple myeloma Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly) The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with bortezomib and dexamethasone; AND Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised); AND Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.	Compliance with Authority Required procedures