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:
[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:
[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:
[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 |
