National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 5) (PB 47 of 2020) (Cth)
PB 47 of 2020
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 5)
National Health Act 1953
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I, BEN SLADIC, 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 29 May 2020
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 5).
(2)This Instrument may also be cited as PB 47 of 2020.
Commencement
This Instrument commences on 1 June 2020.
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
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg
(a)omit from the column headed “Circumstances”: C7963 C7984
(b)insert in numerical order in the column headed “Circumstances”: C10426 C10454 C10455
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3 mg
(a)omit from the column headed “Circumstances”: C7963
(b)omit from the column headed “Circumstances”: C7984
(c)insert in numerical order in the column headed “Circumstances”: C10426 C10454 C10455
Schedule 1, Part 2, entry for Bortezomib [Maximum Amount: 3000; Number of Repeats: 31]
omit from the column headed “Purposes”: P7963 P7984 substitute: P10426 P10454 P10455
Schedule 4, entry for Bortezomib
(a)omit:
| 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 |
(b)omit:
| 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 |
(c)insert in numerical order after existing text:
| C10426 | P10426 | Symptomatic multiple myeloma Initial PBS-subsidised treatment The condition 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 10426 |
| C10454 | P10454 | Multiple myeloma Triple combination therapy (bortezomib, lenalidomide and dexamethasone) The condition must be newly diagnosed; AND The treatment must be in combination with lenalidomide and dexamethasone; AND The treatment must not be in combination with PBS-subsidised thalidomide, pomalidomide or carfilzomib; AND The treatment must not be changing from dual combination therapy with lenalidomide and dexamethasone for symptomatic multiple myeloma to triple therapy with lenalidomide, bortezomib and dexamethasone; AND Patient must not receive more than 8 cycles of treatment with bortezomib under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10454 |
| C10455 | P10455 | Symptomatic multiple myeloma Initial PBS-subsidised treatment The condition 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 10455 |
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