Source: https://www.legislation.gov.au/Details/F2018L00066
Timestamp: 2018-10-21 23:03:01
Document Index: 796603957

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2']

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 1) (PB 7 of 2018)
Details: F2018L00066
- F2018L00066
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).
Made 25 Jan 2018
Registered 30 Jan 2018
Tabled HR 05 Feb 2018
Tabled Senate 05 Feb 2018
Date of repeal 02 Feb 2018
PB 7 of 2018
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 1)
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.
Private Health Insurance and Pharmacy Branch
(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.
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).
[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
[5] Schedule 1, Part 1, entry for Gemcitabine
Powder for I.V. infusion 200 mg (as hydrochloride)
Powder for I.V. infusion 1 g (as hydrochloride)
Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL
[6] Schedule 1, Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
[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
[12] Schedule 2, entry for Rituximab
[13] Schedule 4, entry for Bortezomib
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.
Retreatment of Progressive disease - Initial PBS-subsidised treatment
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.
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.
(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
To enable confirmation of eligibility for treatment current diagnostic reports of at least one of the following must be provided:
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.
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
(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
Disease activity parameters include current diagnostic reports of at least one of the following:
(c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; 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
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.
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; 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
(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
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma; and
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
(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 and urine Bence-Jones protein and serum FLC are not being used to monitor disease activity, partial response compared with baseline is defined as:
Patient must be ineligible for high dose chemotherapy; 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
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; 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.
[14] Schedule 4, entry for Rituximab
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
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
Compliance with Authority Required procedures - Streamlined Authority Code 6009
Compliance with Authority Required procedures - Streamlined Authority Code 6034
Compliance with Authority Required procedures - Streamlined Authority Code 6039
Compliance with Authority Required procedures - Streamlined Authority Code 6011
Previously untreated symptomatic indolent CD20 positive non-Hodgkin's lymphoma in combination with chemotherapy
The treatment must be in combination with PBS-subsidised 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 with no more than 8 doses in total.
Compliance with Authority Required procedures - Streamlined Authority Code 6162
Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma
Compliance with Authority Required procedures - Streamlined Authority Code 6309
Compliance with Authority Required procedures - Streamlined Authority Code 6317
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
Previously untreated or Relapsed/refractory CD20 positive acute lymphoblastic leukaemia
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
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
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