Source: https://www.global-regulation.com/law/australia/216732/national-health-%2528efficient-funding-of-chemotherapy%2529-special-arrangement-amendment-instrument-2015-%2528no.-1%2529-%2528pb-4-of-2015%2529.html
Timestamp: 2018-06-22 13:21:15
Document Index: 211528169

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

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 1) (PB 4 of 2015) (Australia)
Link to law: https://www.comlaw.gov.au/Details/F2015L00083
PB 4 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 1)
(1) This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No.1).
(2) This Instrument may also be cited as PB 4 of 2015.
[1] Schedule 1 Part 1 entry for ‘Arsenic’ in the form ‘Injection concentrate containing arsenic trioxide 10 mg in 10 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’: C3150 C3891
insert in the column headed ‘Circumstances’: C4793
[2] Schedule 1 Part 1 entry for ‘Bevacizumab’ in each of the forms ‘Solution for I.V. infusion 100 mg in 4 mL’ and ‘Solution for I.V. infusion 400 mg in 16 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4585 C4588 C4589 C4597
[3] Schedule 1 Part 1 entry for ‘Cabazitaxel’ in the form ‘Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent’ with manner of administration Injection:
omit from the column headed ‘Circumstances’: C4661
[4] Schedule 1 Part 1 entry for ‘Cetuximab’ in each of the forms ‘Solution for I.V. infusion 100 mg in 20 mL’ and ‘Solution for I.V. infusion 500 mg in 100 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C2713 C2714 C2715 C3919 C3920 C3921 C4775 C4780
insert in the column headed ‘Circumstances’ (all instances): C4785 C4788 C4794
[5] Schedule 1 Part 1 entry for ‘Doxorubicin – Pegylated Liposomal’ in each of the forms ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL’ and ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C1568 C1795 C1796 C3905 C3910 C3911
insert in the column headed ‘Circumstances’ (all instances): C4786 C4787 C4791
[6] Schedule 1 Part 1 entry for ‘Ipilimumab’ in each of the forms ‘Injection concentrate for I.V. infusion 50 mg in 10 mL’ and ‘Injection concentrate for I.V. infusion 200 mg in 40 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4235 C4236 C4256 C4265
[7] Schedule 1 Part 1 after the entry for ‘Irinotecan’ in the form ‘I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ with manner of administration Injection and brand ‘Irinotecan Kabi’:
[8] Schedule 1 Part 1 after the entry for ‘Methotrexate’ in the form ‘Injection 50 mg in 2 mL vial’ with manner of administration Injection and brand ‘Methaccord’:
[9] Schedule 1 Part 1 after the entry for ‘Methotrexate’ in the form ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’ with manner of administration Injection and brand ‘Methotrexate Ebewe’:
[10] Schedule 1 Part 1 after the entry for ‘Oxaliplatin’ in the form ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’ with manner of administration Injection and brand ‘Oxaliplatin Kabi’:
[11] Schedule 1 Part 1 entry for ‘Panitumumab’ in each of the forms ‘Solution concentrate for I.V. infusion 100 mg in 5 mL’ and ‘Solution concentrate for I.V. infusion 400 mg in 20 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4774 C4776
[12] Schedule 1 Part 1 entry for ‘Pemetrexed’ in each of the forms ‘Powder for I.V. infusion 100 mg (as disodium heptahydrate)’ and ‘Powder for I.V. infusion 500 mg (as disodium heptahydrate)’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C2957 C2958 C3885 C3886
insert in the column headed ‘Circumstances’ (all instances): C4789 C4792
[13] 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’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4671 C4679 C4687 C4727 C4728 C4752 C4765
[14] Schedule 1, Part 2 entry for Bevacizumab:
[15] Schedule 1, Part 2 entry for Cetuximab:
[16] Schedule 1, Part 2 entry for Rituximab:
[17] Schedule 4, entry for Arsenic:
Acute promyelocytic leukaemia. Treatment Phase: Induction and consolidation treatment. The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript, the condition must be relapsed, and the patient must be arsenic naive at induction.
[18] Schedule 4, entry for Bevacizumab:
Patient must have previously received PBS‑subsidised treatment with bevacizumab for this condition, patient must not have progressive disease, the treatment must not exceed a dose of 7.5 mg per kg every 3 weeks, the treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer.
Patient must have previously received PBS‑subsidised treatment with bevacizumab for this condition, patient must not have progressive disease, and the treatment must be in combination with first‑line chemotherapy. The treatment must not exceed a dose of 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks.
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm), patient must have a WHO performance status of 2 or less, and the condition must be previously untreated; treatment must be commenced in combination with platinum‑based chemotherapy. The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks and a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer. The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.
The condition must be previously untreated, patient must have a WHO performance status of 0 or 1, and treatment must be in combination with first‑line chemotherapy,
[19] Schedule 4, entry for Cabazitaxel:
Patient must not receive PBS‑subsidised cabazitaxel if progressive disease develops while on cabazitaxel.
[20] Schedule 4, entry for Cetuximab:
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy. Patient must not have progressive disease, treatment must be as monotherapy; or treatment must be in combination with an irinotecan based therapy. Treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition. Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab. Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.
Patient must have RAS wild-type metastatic colorectal cancer, and must have a WHO performance status of 2 or less. The condition must have failed to respond to first-line chemotherapy, treatment must be as monotherapy; or in combination with an irinotecan based therapy, and must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition. Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab. Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx. Treatment Phase: Initial treatment. Treatment must be in combination with radiotherapy, and patient must be unable to tolerate cisplatin.
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx. Treatment Phase: Continuing treatment. Treatment must be in combination with radiotherapy. Patient must be unable to tolerate cisplatin; or patient must have a contraindication to cisplatin according to the TGA-approved Product Information.
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx. Treatment Phase: Initial treatment. Treatment must be for the week prior to radiotherapy.
[21] Schedule 4, entry for Doxorubicin – Pegylated Liposomal:
Advanced epithelial ovarian cancer. Patient must have failed a first-line platinum-based chemotherapy regimen.
Metastatic breast cancer. Treatment must be as monotherapy. Patient must have a contraindication to therapy with capecitabine and/or a taxane.
Metastatic breast cancer. Treatment must be as monotherapy. Patient must have failed prior therapy which included capecitabine and a taxane.
[22] Schedule 4, entry for Ipilimumab:
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Completion of induction treatment. Treatment must be as monotherapy, and must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013. Treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 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. For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS subsidised).
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Completion of re-induction treatment. Treatment must be as monotherapy. Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013. Treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013, and must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.
(ii) a partial or complete response.
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated. For patients who commenced re-induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS-subsidised).
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Induction treatment
Treatment must be as monotherapy, and must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. Patient must not have received prior treatment with ipilimumab,
and the patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Re-induction treatment
Treatment must be as monotherapy, and must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction).
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.
[23] Schedule 4, entry for Panitumumab:
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy, and must not have progressive disease. Treatment must be as monotherapy; or in combination with an irinotecan based therapy. Treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition. Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab. Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.
Metastatic colorectal cancer. Treatment Phase: Initial treatment. Patient must have RAS wild-type metastatic colorectal cancer, and have a WHO performance status of 2 or less. The condition must have failed to respond to first-line chemotherapy. Treatment must be as monotherapy; or in combination with an irinotecan based therapy. Treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition. Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab. Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.
[24] Schedule 4, entry for Pemetrexed:
Mesothelioma. Treatment must be in combination with cisplatin. The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated. Doses greater than 500 mg per metre squared BSA are not PBS-subsidised.
Locally advanced or metastatic non-small cell lung cancer. Patient must have received prior treatment with platinum-based chemotherapy. The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated. Doses greater than 500 mg per metre squared BSA are not PBS-subsidised
[25] Schedule 4, entry for Rituximab:
Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy. Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application, and must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction. Treatment must be maintenance therapy.
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment. Treatment must be for re-induction treatment purposes only, and the condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction.
Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy. Treatment must be maintenance therapy. Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application, andmust not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.
Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. Treatment must be in combination with chemotherapy.The condition must be previously untreated, must be symptomatic, and must be for induction treatment purposes only. Patient must not receive more than 8 doses under this restriction.
Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. Treatment must be in combination with chemotherapy. The condition must be previously untreated, must be symptomatic, and must be for induction treatment purposes only. Patient must not receive more than 8 doses under this restriction.