National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 4) (PB 34 of 2016) (Cth)

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PB 34 of 2016

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 4)

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   29 April 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. 4).

(2)This Instrument may also be cited as PB 34 of 2016.

2             Commencement

This Instrument commences on 1 May 2016.

3              Amendments to PB 79 of 2011

Amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Amendments

  1. Section 22 (1)

    insert after “Note:        If at least one circumstances code is mentioned in Part 1 of Schedule 1 for each chemotherapy pharmaceutical benefit that has the same chemotherapy drug, supply of an infusion containing the chemotherapy drug may only be prescribed in one of the circumstances to which a code relates—see subsections 8(1) and (2).”:

    (1A)     If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with Authority Required Procedures’.

  2. Section 22 (2)

    insert after “Note:       If at least one circumstances code is mentioned in Schedule 2, the related pharmaceutical benefit may only be prescribed in one of the circumstances to which the code relates—see subsection 8(3)”:

    (2A)     If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words  used are ‘Compliance with Authority Required Procedures’.

  1. Schedule 1 Part 1 after the entry for Arsenic

    insert:

Bendamustine Powder for injection containing bendamustine hydrochloride 25 mg Injection Ribomustin JC MP C6075 C6124 D
Powder for injection containing bendamustine hydrochloride 100 mg Injection Ribomustin JC MP C6075 C6124 D

  1. Schedule 1 Part 1 entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

    omit in the column listed ‘Brand’:

Fludara GZ MP C3887 PB

insert in the column headed ‘Brand’ in alphabetical order :

Fludarabine ACT EA MP C3887 PB

  1. Schedule 1 Part 1 for the entry Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

    insert in the column listed ‘Brand’ after the entry ‘Hospira Pty Limited’:

IRINOTECAN ACT ED MP D

  1. Schedule 1 Part 1 after the entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

    insert in the column listed ‘Brand’ after the entry ‘Irinoccord’:

IRINOTECAN ACT ED MP D

  1. Schedule 1 Part 1 after the entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

    a)    insert in the column listed ‘Brand’ after the entry ‘Hospira Pty Limited’:

IRINOTECAN ACT ED MP D

b)    omit in the column listed ‘Brand’ after the entry ‘Irinotecan Ebewe’;

Tecan ED MP D

  1. Schedule 1 Part 1 after the entry for Mitozantrone

    insert:

Nivolumab Injection concentrate for I.V. infusion 40 mg in 4 mL Injection Opdivo BQ MP C6070 C6083 C6095 C6111 C6116 D
Injection concentrate for I.V. infusion 100 mg in 10 mL Injection Opdivo BQ MP C6070 C6083 C6095 C6111 C6116 D

  1. Schedule 1 Part 1 entry for Paclitaxel, nanoparticle albumin‑bound

    omit from the column headed ‘Circumstances’: C3955 C3956

    insert: C4657 C6106 C6119

[10]Schedule 1 Part 1 entry for Pembrolizumab

omit from the column headed ‘Circumstances’: C5293 C5334 C5361 C5362

substitute: C5362 C6093 C6094 C6103 C6104

[11]Schedule 1 Part 1 entry for Trastuzumab emtansine

omit from the column headed ‘Circumstances’: C4987

insert in numerical order: C6096 C6129

[12]  Schedule 1 Part 2 after the entry for Arsenic

insert:

Bendamustine 200 11

[13]  Schedule 1 Part 2 after the entry for Mitozantrone

insert:

Nivolumab P6070 P6083 P6095 P6116 360 8
P6111 360 11

[14]  Schedule 1 Part 2 entry for Paclitaxel, nanoparticle albumin‑bound

substitute:

Paclitaxel, nanoparticle albumin‑bound P4657 275 11
P6106 P6119 580 5

[15]  Schedule 1 Part 2 entry for Pembrolizumab

omit from the column headed ‘Purposes’: P5293 P5334 P5361

substitute: P6093 P6094 P6103 P6104

[16]  Schedule 2 entry for Ondansetron in the forms Tablet 4 mg (as hydrochloride dihydrate) and Tablet 8 mg (as hydrochloride dihydrate)

omit :

Ondaz SZ EMP C5778 4 0

[17]  Schedule 2 entry for Ondansetron in the forms Wafer 4 mg and Wafer 8 mg

omit:

Ondaz Zydis SZ EMP C5778 4 0

[18]  Schedule 3 after entry for GN:

omit:

GZ sanofi‑aventis Australia Pty Ltd  31 008 558 807

[19]  Schedule 4 after the entry for Bacillus Calmette and Guerin, Tice strain

insert:

Bendamustine C6075 Previously untreated stage III or IV indolent CD20 positive non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with rituximab; 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 6 cycles (12 doses) of treatment under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6075
C6124 Previously untreated stage III or IV CD20 positive mantle cell lymphoma
Induction treatment
The treatment must be in combination with rituximab; 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 6 cycles (12 doses) of treatment under this restriction; AND
Patient must not be eligible for stem cell transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6124

[20]  Schedule 4 after the entry for Netupitant with Palonosetron

insert:

Nivolumab C6070 P6070 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6070
C6083 P6083 Unresectable Stage III or Stage IV malignant melanoma
Grandfathering treatment 1
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 May 2016; AND
Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a maximum dose of 3 mg per kg every 2 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6083
C6095 P6095 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6095
C6111 P6111 Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose of 3 mg per kg every 2 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6111
C6116 P6116 Unresectable Stage III or Stage IV malignant melanoma
Grandfathering treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 May 2016; AND
Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a maximum dose of 3 mg per kg every 2 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6116

[21]  Schedule 4 entry for Paclitaxel, nanoparticle albumin-bound

omit:

Paclitaxel, nanoparticle albumin‑bound C3955 Metastatic breast cancer Compliance with Authority Required procedures – Streamlined Authority Code 3955
C3956 Treatment of HER2 positive breast cancer in combination with trastuzumab Compliance with Authority Required procedures – Streamlined Authority Code 3956

insert:

Paclitaxel, nanoparticle albumin-bound C4657 P4657 Stage IV (metastatic) adenocarcinoma of the pancreas
The treatment must be in combination with gemcitabine; AND
The condition must not have been treated previously with PBS-subsidised therapy; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 4657
C6106 P6106 Metastatic breast cancer

 Compliance with Authority Required procedures - Streamlined Authority Code 6106
C6119 P6119 HER2 positive breast cancer

 Compliance with Authority Required procedures - Streamlined Authority Code 6119

[22]  Schedule 4 entry for Pembrolizumab

substitute:

Pembrolizumab C5362 P5362 Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 5362
C6093 P6093 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6093
C6094 P6094 Unresectable Stage III or Stage IV malignant melanoma
Grandfathering treatment 1
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND
Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6094
C6103 P6103 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6103
C6104 P6104 Unresectable Stage III or Stage IV malignant melanoma
Grandfathering treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND
Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6104

[23]  Schedule 4 entry for Trastuzumab emtansine

substitute:

Trastuzumab emtansine C4978 P4978 Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
The treatment must not exceed a lifetime total of one continuous course.

 Compliance with Written or Telephone Authority Required procedures
C4986 P4986 Metastatic (Stage IV) HER2 positive breast cancer
Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR
Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C6096 P6096 Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) a copy of the signed patient acknowledgement form;
(iii) dates of treatment with trastuzumab and pertuzumab; and
(iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.

 Compliance with Written Authority Required procedures
C6129 P6129 Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) a copy of the signed patient acknowledgement form;
(iii) dates of treatment with trastuzumab and pertuzumab; and
(iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.

 Compliance with Written Authority Required procedures
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