Schedule 1 Amendments
[1] Schedule 1, Part 1, entry for Atezolizumab
(a) omit from the column headed “Circumstances”: C6999 C7539 C7572
(b) omit from the column headed “Circumstances”: C9348 C9514
(c) insert in numerical order in the column headed “Circumstances”: C10125 C10143 C10182 C10190 C10203 C10204 C10206
[2] Schedule 1, Part 1, entry for Cladribine in the form Injection 10 mg in 5 mL
omit from the column headed “Responsible Person”: AS substitute: AF
[3] Schedule 1, Part 1, after entry for Doxorubicin - pegylated liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
insert:
Durvalumab | Solution concentrate for I.V. infusion 120 mg in 2.4 mL | Injection | Imfinzi | AP | MP | C10126 C10145 C10174 | D |
| Solution concentrate for I.V. infusion 500 mg in 10 mL | Injection | Imfinzi | AP | MP | C10126 C10145 C10174 | D |
[4] Schedule 1, Part 1, entry for Fluorouracil in the form Injection 2500 mg in 50 mL
omit:
| | | Fluorouracil Ebewe | SZ | MP | C6266 C6297 | D |
[5] Schedule 1, Part 1, entry for Idarubicin in the form Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL
omit:
| | | Idarubicin Ebewe | SZ | MP | C6247 | PB |
[6] 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”: C8178 C8180 C8206
(b) omit from the column headed “Circumstances”: C9840
(c) insert in numerical order in the column headed “Circumstances”: C10122
[7] 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”: C8178 C8180 C8206 C9840
(b) insert in numerical order in the column headed “Circumstances”: C10122
[8] 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:
| | | Hospira Pty Limited | PF | MP | | D |
[9] 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”: C8146 C8182 C8220
(b) omit from the column headed “Circumstances”: C9217
(c) omit from the column headed “Circumstances”: C9311
(d) omit from the column headed “Circumstances”: C9320
(e) omit from the column headed “Circumstances”: C9331 C9832 C9844
(f) insert in numerical order in the column headed “Circumstances”: C10117 C10118 C10119 C10120 C10155 C10156 C10165 C10195
[10] Schedule 1, Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
omit:
[11] Schedule 1, Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
omit:
[12] Schedule 1, Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL
omit:
[13] Schedule 1, Part 1, entry for Pembrolizumab
(a) omit from the column headed “Circumstances”: C9869
(b) omit from the column headed “Circumstances”: C9895
(c) omit from the column headed “Circumstances”: C9926
(d) omit from the column headed “Circumstances”: C9974
(e) insert in numerical order in the column headed “Circumstances”: C10088 C10142 C10159 C10181
[14] Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); Powder for I.V. infusion 500 mg
(as disodium); and Powder for I.V. infusion 1 g (as disodium)
omit:
[15] Schedule 1, Part 2, entry for Atezolizumab
substitute:
Atezolizumab | P10206 | 1200 | 3 |
| P10203 P10204 | 1200 | 4 |
| P10125 P10143 P10182 | 1200 | 5 |
| P9345 P9567 P10190 | 1200 | 7 |
[16] Schedule 1, Part 2, after entry for Doxorubicin ‑ pegylated liposomal
insert:
[17] Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 360; Number of Repeats: 3]
(a) omit from the column headed “Purposes”: P8178 P8180 P8206 P9840
(b) insert in numerical order in the column headed “Purposes”: P10122
[18] Schedule 1, Part 2, entry for Nivolumab
substitute:
Nivolumab | P10156 P10195 | 120 | 3 |
| P8571 | 360 | 2 |
| P8573 | 360 | 3 |
| P10118 P10119 P10120 | 480 | 5 |
| P9216 P9312 P10155 P10165 | 480 | 8 |
| P9214 P9252 P9253 P9298 P9299 P9321 P10117 | 480 | 11 |
[19] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 5]
omit from the column headed “Purposes”: P9895 P9974 substitute: P10088 P10159
[20] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]
(a) omit from the column headed “Purposes”: P9869
(b) omit from the column headed “Purposes”: P9926
(c) insert in numerical order in the column headed “Purposes”: P10142 P10181
[21] Schedule 2, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL
omit:
| | | Calcium Folinate Ebewe | SZ | MP | | | 10 | 1 | |
[22] Schedule 2, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
omit:
| | | Calcium Folinate Ebewe | SZ | MP | | | 4 | 1 | |
[23] Schedule 3, after details relevant to Responsible Person code AN
insert:
AP | AstraZeneca Pty Ltd | 54 009 682 311 |
[24] Schedule 4, entry for Atezolizumab
(a) omit:
| C6999 | P6999 | Locally advanced or metastatic non‑small cell lung cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised treatment for this condition; AND
Patient must have stable or responding disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6999 |
| C7539 | P7539 | Locally advanced or metastatic non‑small cell lung cancer
Initial treatment
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 this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS‑subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7539 |
| C7572 | P7572 | Locally advanced or metastatic non‑small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 April 2018; AND
The treatment must be the sole PBS‑subsidised treatment for this condition; AND
Patient must have stable or responding disease; 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.
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 7572 |
(b) omit:
| C9348 | P9348 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Initial treatment 2
Patient must be undergoing combination treatment with bevacizumab and platinum‑doublet chemotherapy.
The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); 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 this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9348 |
| C9514 | P9514 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with bevacizumab and platinum‑doublet chemotherapy.
The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9514 |
(c) insert in numerical order after existing text:
| C10125 | P10125 | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 2
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); 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. | Compliance with Authority Required procedures - Streamlined Authority Code 10125 |
| C10143 | P10143 | Locally advanced or metastatic non-small cell lung cancer
Initial treatment
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 have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10143 |
| C10182 | P10182 | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; 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 have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures - Streamlined Authority Code 10182 |
| C10190 | P10190 | Locally advanced or metastatic non-small cell lung cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10190 |
| 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 |
| 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 |
| C10206 | P10206 | Extensive-stage small cell lung cancer
Initial treatment
The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with etoposide and a platinum-based antineoplastic drug. | Compliance with Authority Required procedures - Streamlined Authority Code 10206 |
[25] Schedule 4, after entry for Doxorubicin - pegylated liposomal
insert:
Durvalumab | C10126 | | Unresectable Stage III non-small cell lung cancer
Initial treatment
Patient must have received platinum based chemoradiation therapy; AND
The condition must not have progressed following platinum based chemoradiation therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10126 |
| 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 |
[26] Schedule 4, entry for Ipilimumab
(a) omit:
| C8178 | P8178 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment ‑ Grandfather patients
The condition must be negative for a BRAF V600 mutation; AND
Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; AND
Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD‑1) inhibitor prior to initiating combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; 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.
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.
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 8178 |
| C8180 | P8180 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment ‑ Grandfather patients
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 have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; 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.
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.
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 8180 |
| C8206 | P8206 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be negative for a BRAF V600 mutation; 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 8206 |
(b) omit:
| 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 |
(c) insert in numerical order after existing text:
| 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 |
[27] Schedule 4, entry for Nivolumab
(a) omit:
| C8146 | P8146 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment ‑ Grandfather patients
The condition must be negative for a BRAF V600 mutation; AND
Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 December 2018; AND
Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD‑1) inhibitor prior to initiating combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; OR
Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; 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; OR
The treatment must be as monotherapy as maintenance 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.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
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.
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 8146 |
| C8182 | P8182 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be negative for a BRAF V600 mutation; 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 8182 |
| C8220 | P8220 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment ‑ Grandfather patients
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 have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 December 2018; AND
Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD‑1) inhibitor prior to initiating combined therapy with ipilimumab and nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; OR
Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; 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; OR
The treatment must be as monotherapy as maintenance 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.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
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.
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 8220 |
(b) omit:
| C9217 | P9217 | Locally advanced or metastatic non‑small cell lung cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised treatment for this condition; AND
Patient must have stable or responding disease.
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 9217 |
(c) omit:
| C9311 | P9311 | Locally advanced or metastatic non‑small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.
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 9311 |
(d) omit:
| C9320 | P9320 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; 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 9320 |
(e) omit:
| C9331 | P9331 | Locally advanced or metastatic non‑small cell lung cancer
Initial treatment
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 this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
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 9331 |
| 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 |
(f) insert in numerical order after existing text:
| C10117 | P10117 | Locally advanced or metastatic non-small cell lung cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
Patient must have stable or responding disease.
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 10117 |
| 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 |
| C10119 | P10119 | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
Patient must have a WHO performance status of 1 or less; 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
The treatment must commence within 12 weeks of complete 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. | Compliance with Authority Required procedures |
| C10120 | P10120 | Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; 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. | Compliance with Authority Required procedures |
| C10155 | P10155 | Unresectable Stage III or Stage IV malignant melanoma
Initial 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
The treatment must be the sole PBS-subsidised therapy 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. | Compliance with Authority Required procedures - Streamlined Authority Code 10155 |
| 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 |
| C10165 | P10165 | Locally advanced or metastatic non-small cell lung cancer
Initial treatment
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 have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
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 10165 |
| 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 |
[28] Schedule 4, entry for Obinutuzumab
omit entry for circumstances code “C7936” and substitute:
| C7936 | P7936 | Stage II bulky or Stage III/IV follicular lymphoma
Grandfather treatment - previously untreated setting
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; 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 receiving treatment with this drug for this condition; AND
The treatment must be in combination with chemotherapy for induction treatment; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to induction treatment with this drug for this condition for maintenance treatment; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. | Compliance with Authority Required procedures |
[29] Schedule 4, entry for Pembrolizumab
(a) omit:
| C9869 | P9869 | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
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 had 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 9869 |
(b) omit:
| C9895 | P9895 | 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 under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9895 |
(c) omit:
| C9926 | P9926 | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must have a WHO performance status of 0 or 1; 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 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9926 |
(d) omit:
| C9974 | P9974 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; 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 under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9974 |
(e) insert in numerical order after existing text:
| C10088 | P10088 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2 - 3 weekly treatment regimen
The condition must be negative for a BRAF V600 mutation; 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 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
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10088 |
| C10142 | P10142 | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
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 had 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 10142 |
| C10159 | P10159 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1 - 3 weekly treatment regimen
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) 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 been treated with an adjuvant programmed cell death-1 (PD-1) inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma; OR
Patient must have experienced disease recurrence after at least 6 months from completion of an adjuvant PD-1 inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma, followed by disease progression after treatment with a BRAF inhibitor (with or without MEK inhibitor) in the unresectable or metastatic setting 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 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 under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10159 |
| C10181 | P10181 | Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
Patient must not have previously been treated for this condition in the metastatic setting; 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 have a WHO performance status of 0 or 1; 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 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10181 |
