National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 10) (PB 88 of 2019) (Cth)
PB 88 of 2019
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 10)
National Health Act 1953
___________________________________________________________________________
I, BEN SLADIC, Assistant Secretary, 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 30 October 2019
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 10).
(2)This Instrument may also be cited as PB 88 of 2019.
Commencement
This Instrument commences on 1 November 2019.
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
Schedule 1, Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL
omit:
| Docetaxel Sandoz | SZ | MP | D |
Schedule 1, Part 1, entry for Etoposide in the form Powder for I.V. infusion 1 g (as phosphate)
omit from the column headed “Responsible Person”: BQ substitute: LM
Schedule 1, Part 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Fludarabine Juno | JO | MP | PB |
Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL
(a)omit from the column headed “Circumstances”: C8142
(b)insert in numerical order in the column headed “Circumstances”: C9840
Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 200 mg in 40 mL
(a)omit from the column headed “Circumstances”: C8142
(b)insert in numerical order in the column headed “Circumstances”: C9840
Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL
(a)omit from the column headed “Circumstances”: C8141
(b)omit from the column headed “Circumstances”: C9219
(c)insert in numerical order in the column headed “Circumstances”: C9832 C9844
Schedule 1, Part 1, entry for Pembrolizumab
(a)omit from the column headed “Circumstances”: C9178
(b)insert in numerical order in the column headed “Circumstances“: C9843
Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Herzuma | EW | MP | C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628 | PB |
Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 360; Number of Repeats: 3]
(a)omit from the column headed “Purposes”: P8142
(b)insert in numerical order in the column headed “Purposes”: P9840
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 120; Number of Repeats: 3]
(a)omit from the column headed “Purposes”: P8141
(b)insert in numerical order in the column headed “Purposes”: P9844
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480; Number of Repeats: 8]
(a)omit from the column headed “Purposes”: P9219
(b)insert in numerical order in the column headed “Purposes”: P9832
Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 5]
(a)omit from the column headed “Purposes”: P9178
(b)insert in numerical order in the column headed “Purposes”: P9843
Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Ondansetron ODT | TX | MP | C5743 | 4 | 0 | C |
Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Ondansetron ODT | TX | MP | C5743 | 4 | 0 | C |
Schedule 3, after details relevant to Responsible Person code EI
insert:
| EW | Celltrion Healthcare Australia Pty Ltd | 66 625 407 105 |
Schedule 3, after details relevant to Responsible Person code JC
insert:
| JO | Juno Pharmaceuticals Pty Ltd | 55 156 303 650 |
Schedule 3, after details relevant to Responsible Person code JU
insert:
| LM | Link Medical Products Pty Ltd | 73 010 971 516 |
Schedule 4, entry for Ipilimumab
(a)omit:
| C8142 | P8142 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment 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); OR Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must not have received prior treatment with ipilimumab or a PD‑1 (programmed cell death‑1) inhibitor for this condition; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS‑subsidised treatment with nivolumab as induction therapy for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses 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. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8142 |
(b)insert in numerical order after existing text:
| C9840 | P9840 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment The condition must be positive for a BRAF V600 mutation; AND Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses 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. | Compliance with Authority Required procedures - Streamlined Authority Code 9840 |
Schedule 4, entry for Nivolumab
(a)omit:
| C8141 | P8141 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment 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); OR Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must not have received prior treatment with ipilimumab or a PD‑1 (programmed cell death‑1) inhibitor for this condition; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS‑subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses 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. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8141 |
(b)omit:
| C9219 | P9219 | 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 dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9219 |
(c)insert in numerical order after existing text:
| C9832 | C9832 | Unresectable Stage III or Stage IV malignant melanoma Initial treatment 1 The condition must be positive for a BRAF V600 mutation; AND Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 9832 |
| C9844 | P9844 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment The condition must be positive for a BRAF V600 mutation; AND Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses 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. | Compliance with Authority Required procedures - Streamlined Authority Code 9844 |
Schedule 4, entry for Pembrolizumab
(a)omit:
| C9178 | P9178 | 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 administered every 3 weeks, with each maximum dose fixed at 200 mg. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. |
(b)insert in numerical order after existing text:
| C9843 | P9843 | Unresectable Stage III or Stage IV malignant melanoma Initial treatment 1 The condition must be positive for a BRAF V600 mutation; AND Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses administered every 3 weeks, with each maximum dose fixed at 200 mg. 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 9843 |
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