National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 2) (Cth)
PB 15 of 2023
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 2)
National Health Act 1953
I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.
Date 27 February 2023
NIKOLAI TSYGANOV
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Contents
1......... Name............................................................................................................................... 1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1
Schedule 1—Amendments 2
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011
(PB 79 of 2011) 2
Name
(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 2).
(2)This instrument may also be cited as PB 15 of 2023.
Commencement
(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 March 2023 | 1 March 2023 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
Authority
This instrument is made under subsection 100(2) of the National Health Act 1953.
Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit:
| Epirube | TB | MP | D |
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
(a)omit from the column headed “Circumstances”: C10122
(b)insert in numerical order in the column headed “Circumstances”: C13841
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”: C9214
(b)omit from the column headed “Circumstances”: C10195
(c)insert in numerical order in the column headed “Circumstances”: C13839 C13852 C13853 C13863
Schedule 1, Part 1, entry for Paclitaxel
omit:
| Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | Paclitaxin | TB | MP | D |
Schedule 1, Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
omit:
| Paclitaxin | TB | MP | D |
Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)
omit:
| Tevatrexed | TB | MP | D |
Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 360; Number of Repeats: 3]
(a)omit from the column headed “Purposes”: P10122
(b)insert in numerical order in the column headed “Purposes”: P13841
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 120; Number of Repeats: 3]
omit from the column headed “Purposes”: P10195 substitute: P13852 P13853
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480; Number of Repeats: 11]
(a)omit from the column headed “Purposes”: P9214
(b)insert in numerical order in the column headed “Purposes”: P13839 P13863
Schedule 4, entry for Ipilimumab
(a)omit:
| C10122 | P10122 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment 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 not have experienced disease progression whilst on adjuvant PD‑1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD‑1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV 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 10122 |
(b)insert in numerical order after existing text:
| C13841 | P13841 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment 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 13841 |
Schedule 4, entry for Nivolumab
(a)omit:
| C9214 | P9214 | Unresectable Stage III or Stage IV malignant melanoma Maintenance treatment Patient must have previously received of up to maximum 4 doses of PBS‑subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND The treatment must be as monotherapy for this condition; AND Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition. 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. 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 9214 |
(b)omit:
| C10195 | P10195 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment 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 not have experienced disease progression whilst on adjuvant PD‑1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD‑1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV 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. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10195 |
(c)insert in numerical order after existing text:
| C13839 | P13839 | Unresectable Stage III or Stage IV malignant melanoma Maintenance treatment Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND The treatment must be as monotherapy for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this PBS indication. 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. 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 13839 |
| C13852 | P13852 | Unresectable Stage III or Stage IV malignant melanoma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for combination induction therapy Patient must have received non-PBS-subsidised treatment with nivolumab in combination with ipilimumab for this PBS indication prior to 1 March 2023; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to commencing non-PBS-subsidised treatment; 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. | Compliance with Authority Required procedures - Streamlined Authority Code 13852 |
| C13853 | P13853 | Unresectable Stage III or Stage IV malignant melanoma Induction treatment 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. | Compliance with Authority Required procedures - Streamlined Authority Code 13853 |
| C13863 | P13863 | Unresectable Stage III or Stage IV malignant melanoma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for maintenance treatment Patient must have previously received of up to maximum 4 doses of PBS-subsidised ipilimumab combined therapy with non-PBS-subsidised nivolumab as induction for this condition prior to 1 March 2023; AND The treatment must be as monotherapy for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this PBS indication. 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. 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 13863 |
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