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PB 60 of 2020 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 drugs, forms, manners of administration, brands, responsible person codes, authorised prescribers, maximum quantities/amounts and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 30 Jun 2020

PB 60 of 2020

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 6)

 

National Health Act 1953

___________________________________________________________________________

 

I, NATASHA PLOENGES, Assistant Secretary (Acting), 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 June 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NATASHA PLOENGES

Assistant Secretary (Acting)

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. 6).

(2)          This Instrument may also be cited as PB 60 of 2020.

2          Commencement

This Instrument commences on 1 July 2020.

3          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]        Part 1, Division 1, Section 3, Definition for “diluent fee”

omit: $5.35                       substitute: $5.44

[2]        Part 1, Division 1, Section 3, Definition for “dispensing fee”

omit: $7.39                              substitute: $7.74

[3]        Part 1, Division 1, Section 3, Definition for “distribution fee”

omit: $27.02                            substitute: $27.45

[4]        Part 1, Division 1, Section 3, Definition for “preparation fee”

omit: $85.06                            substitute: $85.78

[5]        Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 840 mg in 14 mL

insert in numerical order in the column headed “Circumstances”: C10509

[6]        Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL

(a)        omit from the column headed “Circumstances”: C10203

(b)        insert in numerical order in the column headed “Circumstances”: C10521

[7]        Schedule 1, Part 1, entry for Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U.

omit:

 

 

 

Bleo 15K

JU

MP

C6224 C6275

D

[8]        Schedule 1, Part 1, entry for Brentuximab vedotin

(a)        omit from the column headed “Circumstances”: C6904

(b)        omit from the column headed “Circumstances”: C6941

(c)        insert in numerical order in the column headed “Circumstances”: C10519 C10524

[9]        Schedule 1, Part 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

omit:

 

 

 

IRINOTECAN ACT

JU

MP

 

D

[10]      Schedule 1, Part 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; 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:

 

 

 

Paclitaxel ACT

JU

MP

 

D

[11]      Schedule 1, Part 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

(a)        omit from the column headed “Circumstances”: C9599

(b)        insert in numerical order in the column headed “Circumstances”: C10510

[12]      Schedule 1, Part 2, entry for Atezolizumab [Maximum Amount: 1200; Number of Repeats: 4]

(a)        omit from the column headed “Purposes”: P10203

(b)        insert in numerical order in the column headed “Purposes”: P10521

[13]      Schedule 1, Part 2, entry for Atezolizumab [Maximum Amount: 1680; Number of Repeats: 3]

insert in numerical order in the column headed “Purposes”: P10509

[14]      Schedule 1, Part 2, entry for Brentuximab vedotin [Maximum Amount: 200; Number of Repeats: 11]

(a)        omit from the column headed “Purposes”: P6904 P6941

(b)        insert in numerical order in the column headed “Purposes”: P10519 P10524

[15]      Schedule 1, Part 2, entry for Trastuzumab emtansine [Maximum Amount: 450; Number of Repeats: 8]

(a)        omit from the column headed “Purposes”: P9599

(b)        insert in numerical order in the column headed “Purposes”: P10510

[16]      Schedule 2, entry for Ondansetron

omit:

 

I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

Injection

Ondansetron Alphapharm

AF

MP

C5749

 

1

0

C

 

I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

Injection

Ondansetron Alphapharm

AF

MP

C5749

 

1

0

C

[17]      Schedule 4, entry for Atezolizumab

(a)        omit:

 

C10203

P10203

Extensive‑stage small cell lung cancer
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 10203

(b)        insert in numerical order after existing text:

 

C10509

P10509

Extensive-stage small cell lung cancer
Continuing treatment - 4 weekly treatment regimen
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10509

 

C10521

P10521

Extensive-stage small cell lung cancer
Continuing treatment - 3 weekly treatment regimen
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10521

[18]      Schedule 4, entry for Brentuximab vedotin

(a)        omit:

 

C6904

P6904

Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS‑subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)
The treatment must not exceed a total of 16 cycles in a lifetime

Compliance with Authority Required procedures

(b)        omit:

 

C6941

P6941

Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi‑agent chemotherapy for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS‑subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)
The treatment must not exceed a total of 16 cycles in a lifetime

Compliance with Authority Required procedures

(c)        insert in numerical order after existing text:

 

C10519

P10519

Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
The treatment must not exceed a total of 16 cycles in a lifetime

Compliance with Authority Required procedures

 

C10524

P10524

Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
The treatment must not exceed a total of 16 cycles in a lifetime

Compliance with Authority Required procedures

[19]      Schedule 4, entry for Ondansetron

omit:

 

C5749

 

Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.

 

[20]      Schedule 4, entry for Trastuzumab emtansine

(a)        omit:

 

C9599

P9599

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) dates of treatment with trastuzumab and pertuzumab; and
(iii) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(iv) date of demonstration of progression and date of completion of adjuvant trastuzumab 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.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.

Compliance with Written Authority Required procedures

(b)        insert in numerical order after existing text:

 

C10510

P10510

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) details 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) dates of treatment with trastuzumab and pertuzumab; and
(iii) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or
(iv) date of demonstration of progression and date of completion of adjuvant trastuzumab 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.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.

Compliance with Written Authority Required procedures