National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 9) (Cth)
PB 102 of 2021
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 9)
National Health Act 1953
I, DAVID LAFFAN, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.
Date 28 September 2021
DAVID LAFFAN
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
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 2021 (No. 9).
(2)This instrument may also be cited as PB 102 of 2021.
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 October 2021 | 1 October 2021 |
Note: This table relates only to the provisions of this instrument as originally made.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 Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL
omit from the column headed “Circumstances”: C10204
Schedule 1, Part 1, entry for Bleomycin
omit:
| Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial | Injection | Bleomycin for Injection, USP | QY | MP | C6224 C6275 | D |
Schedule 1, Part 1, entry for Durvalumab in each of the forms: Solution concentrate for I.V. infusion 120 mg in 2.4 mL; and Solution concentrate for I.V. infusion 500 mg in 10 mL
(a)omit from the column headed “Circumstances”: C10145 C10174
(b)insert in numerical order in the column headed “Circumstances”: C12271
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”: C10118
(b)omit from the column headed “Circumstances”: C10156
Schedule 1, Part 1, entry for Pembrolizumab
(a)omit from the column headed “Circumstances”: C10683
(b)omit from the column headed “Circumstances”: C10697
Schedule 1, Part 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg; and Powder for I.V. infusion 150 mg
omit:
| Herceptin | RO | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
Schedule 1, Part 2, entry for Atezolizumab [Maximum Amount: 1200; Number of Repeats: 4]
omit from the column headed “Purposes”: P10204
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 120; Number of Repeats: 3]
omit from the column headed “Purposes”: P10156
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480; Number of Repeats: 5]
omit from the column headed “Purposes”: P10118
Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]
omit from the column headed “Purposes”: P10697
Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400; Number of Repeats: 3]
omit from the column headed “Purposes”: P10683
Schedule 2, entry for Folinic acid
omit:
| Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL | Injection | Leucovorin Calcium (Hospira Pty Limited) | PF | MP | 4 | 1 |
Schedule 2, omit entry for Rituximab
Schedule 3, details relevant to the Responsible Person code TB
omit from the column headed “Responsible Person”: Teva Pharma Australia Pty Limited substitute: Teva Pharma Australia Pty Ltd
Schedule 4, entry for Atezolizumab
omit:
| C10204 | P10204 | Extensive‑stage small cell lung cancer Grandfather treatment Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 March 2020; AND The condition must have been untreated prior to initiating non‑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; AND Patient must have had a WHO performance status of 0 or 1 at the time non‑PBS‑subsidised treatment with this drug for this condition was initiated; AND The treatment must be in combination with etoposide and a platinum‑based antineoplastic if the patient is yet to complete their first 4 cycles of treatment; OR The treatment must be as monotherapy if being administered as maintenance therapy. A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10204 |
Schedule 4, entry for Durvalumab
(a)omit:
| C10145 | Unresectable Stage III non‑small cell lung cancer Continuing treatment 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; AND The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND The treatment must not exceed 12 months in total for this condition under the initial, grandfathering or this continuing restriction combined; AND The treatment must be once in a lifetime with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10145 |
| C10174 | Unresectable Stage III non‑small cell lung cancer Grandfather treatment Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 March 2020; AND Patient must have received platinum based chemoradiation therapy prior to initiation of non‑PBS‑subsidised treatment with this drug for this condition; AND The condition must not have progressed following platinum based chemoradiation therapy; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non‑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; AND The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition. A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10174 |
(b)insert in numerical order after existing text:
| C12271 | Unresectable Stage III non-small cell lung cancer Continuing treatment 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; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed 12 months in total for this condition under the initial and continuing restriction combined; AND The treatment must be once in a lifetime with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 12271 |
Schedule 4, entry for Nivolumab
(a)omit:
| C10118 | P10118 | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma Grandfather treatment Patient must have previously received non‑PBS‑subsidised drug for adjuvant treatment following complete surgical resection prior to 1 March 2020; AND Patient must have a WHO performance status of 1 or less prior to starting non‑PBS treatment with this drug; AND Patient must not have evidence of recurrence; AND The treatment must be the sole PBS‑subsidised therapy for this condition; AND Patient must not have received prior PBS‑subsidised treatment for this condition; AND Patient must have commenced non‑PBS‑subsidised treatment within 12 weeks of complete surgical resection; AND Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy. 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. A Grandfathered patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures |
(b)omit:
| C10156 | P10156 | Unresectable Stage III or Stage IV malignant melanoma Grandfathered patients treated with nivolumab as first‑line therapy in unresectable Stage III or Stage IV malignant melanoma prior to 1 March 2020 Patient must have received non‑PBS‑subsidised supply of this drug as first‑line therapy for unresectable Stage III or Stage IV malignant melanoma prior to 1 March 2020; AND The treatment must be the sole PBS‑subsidised therapy for this condition. A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. 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 10156 |
Schedule 4, entry for Pembrolizumab
(a)omit:
| C10683 | P10683 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Grandfather treatment ‑ 6 weekly treatment regimen Patient must have previously received non‑PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for non‑small cell lung cancer; AND Patient must not have been treated for this condition in the metastatic setting prior to initiating non‑PBS-subsidised treatment with this drug for this condition; AND Patient must have stable or responding disease; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non‑PBS‑subsidised treatment with this drug for this condition; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c‑ROS proto‑oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10683 |
(b)omit:
| C10697 | P10697 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Grandfather treatment ‑ 3 weekly treatment regimen Patient must have previously received non‑PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for non‑small cell lung cancer; AND Patient must not have been treated for this condition in the metastatic setting prior to initiating non‑PBS-subsidised treatment with this drug for this condition; AND Patient must have stable or responding disease; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non‑PBS‑subsidised treatment with this drug for this condition; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c‑ROS proto‑oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10697 |
Schedule 4, entry for Rituximab
omit:
| C6011 | P6011 | Relapsed or refractory Stage III or IV CD20 positive follicular B‑cell non‑Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re‑induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6011 |
| C6161 | P6161 | Stage III or IV CD20 positive follicular B‑cell non‑Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to induction treatment with either R‑CHOP or R‑CVP regimens for previously untreated follicular B‑cell Non‑Hodgkin's lymphoma, received immediately prior to this current Authority application; AND Patient must not have received bendamustine induction therapy; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6161 |
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