National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 5) (PB 46 of 2016) (Cth)
PB 46 of 2016
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 5)
National Health Act 1953
___________________________________________________________________________
I, Julianne Quaine, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 31 May 2016
JULIANNE QUAINE
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 5).
(2)This Instrument may also be cited as PB 46 of 2016.
2 Commencement
This Instrument commences on 1 June 2016.
3 Amendments to PB 79 of 2011
Amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Amendments
Schedule 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’ and brand ‘Doxorubicin MYX’
omit from the column headed ‘Responsible Person’: YN substitute: OC
Schedule 1 entry for Eribulin
omit from the column headed ‘Circumstances’: C4646
Schedule 1 entry for Irinotecan in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ and brand ‘Irinotecan MYX’
omit from the column headed ‘Responsible Person’: YN substitute: OC
Schedule 1 entry for Methotrexate in each of the forms ‘Injection 50 mg in 2 mL vial’ and ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’; and brand ‘Methotrexate MYX’
omit from the column headed ‘Responsible Person’: YN substitute: OC
Schedule 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); and brand ‘Pemetrexed MYX’
omit from the column headed ‘Responsible Person’: YN substitute: OC
Schedule 1 entry for Rituximab
substitute:
Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Mabthera RO MP C4706 C5998 C6009 C6034 C6039 C6161 C6162 C6187 D Solution for I.V. infusion 500 mg in 50 mL Injection Mabthera RO MP C4706 C5998 C6009 C6034 C6039 C6161 C6162 C6187 D
Schedule 1 Part 2 entry for Rituximab
substitute:
Rituximab P6009 P6034 P6162 P6187 800 7 P5998
P6039
800 3 P4706 1100 5 P6161 800 11
Schedule 2 after entry for Ondansetron in the form ‘Tablet (as hydrochloride dihydrate) 4 mg’ and ‘Tablet 8 mg (as hydrochloride dihydrate)’; and brand ‘Ondansetron-DRLA’
insert:
| Ondansetron GH | GQ | EMP | C5778 | 4 | 0 |
Schedule 2 after entry for Ondansetron in the form ‘Tablet 4 mg (orally disintegrating)’ and ‘Tablet 8 mg (orally disintegrating’; and brand ‘Ondansetron-DRLA’
insert:
| Ondansetron ODT GH | GQ | EMP | C5743 | 4 | 0 |
[10] Schedule 2 entry for Ondansetron in the forms Wafer 4 mg and Wafer 8 mg
omit:
| Ondaz Zydis | SZ | EMP | C5743 | 4 | 0 |
[11] Schedule 2 entry for Rituximab
substitute:
Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL Injection Mabthera SC RO EMP C5998 C6008 C6039 C6161 C6162 C6187 P5998 P6039 1 2 D EMP C5998 C6008 C6039 C6161 C6162 C6187 P6162 P6187 1 6 D EMP C5998 C6008 C6039 C6161 C6162 C6187 P6008 1 7 D EMP C5998 C6008 C6039 C6161 C6162 C6187 P6161 1 11 D
[12] Schedule 3 after entry for OA:
insert:
OC Accord Healthcare Pty Ltd 49 110 502 513
[13] Schedule 3 after entry for YA:
omit:
YN Mayne Pharma International Pty Ltd 88 007 870 984
[14] Schedule 4 entry for Eribulin
omit:
C4646 Locally advanced or metastatic breast cancer
Patient must have progressive disease,
Patient must have failed at least two prior chemotherapeutic regimens for this condition,
The treatment must be the sole PBS‑subsidised therapy for this condition.Compliance with Authority Required procedures
[15] Schedule 4 entry for Rituximab
substitute:
Rituximab C4706 P4706 Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The treatment must be in combination with chemotherapy.Compliance with Authority Required procedures - Streamlined Authority Code 4706 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 C6161 P6161 Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to induction treatment with either R-CHOP or R-CVP regimens for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
Patient must not have received bendamustine induction therapy; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.Compliance with Authority Required procedures - Streamlined Authority Code 6161 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 C6187 P6187 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 be eligible for stem cell transplantation if they have mantle cell lymphoma.
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 6187
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