Schedule 1—Amendments
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
[1] Schedule 1, Part 1, entry for Bleomycin
omit:
| | | CIPLA BLEOMYCIN | LR | MP | C6224 C6275 | D |
[2] 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”: C13841
(b) insert in numerical order in the column headed “Circumstances”: C14808
[3] Schedule 1, Part 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
omit:
[4] Schedule 1, Part 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
omit:
| | | Pfizer Australia Pty Ltd | PF | MP | | PB |
[5] 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”: C10155
(b) omit from the column headed “Circumstances”: C13853
(c) insert in numerical order in the column headed “Circumstances”: C14816 C14830
[6] Schedule 1, Part 1, entry for Pembrolizumab
(a) omit from the column headed “Circumstances”: C10689 C10696
(b) insert in numerical order in the column headed “Circumstances”: C14817 C14818
[7] Schedule 1, Part 1, after entry for Sacituzumab govitecan
insert:
Tebentafusp | Solution concentrate for I.V. infusion 100 micrograms in 0.5 mL | Injection | Kimmtrak | WM | MP | C14813 C14821 C14822 C14825 | D |
[8] Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 360 mg; Number of Repeats: 3]
(a) omit from the column headed “Purposes”: P13841
(b) insert in numerical order in the column headed “Purposes”: P14808
[9] Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 120 mg; Number of Repeats: 3]
(a) omit from the column headed “Purposes”: P13853
(b) insert in numerical order in the column headed “Purposes”: P14830
[10] Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480 mg; Number of Repeats: 8]
(a) omit from the column headed “Purposes”: P10155
(b) insert in numerical order in the column headed “Purposes”: P14816
[11] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200 mg; Number of Repeats: 5]
omit from the column headed “Purposes”: P10696 substitute: P14818
[12] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400 mg; Number of Repeats: 2]
omit from the column headed “Purposes”: P10689 substitute: P14817
[13] Schedule 1, Part 2, after entry for Sacituzumab govitecan [Maximum Amount: 1200 mg; Number of Repeats: 13]
insert:
Tebentafusp | P14813 | 20 mcg | 0 |
| P14821 | 30 mcg | 0 |
| P14825 | 68 mcg | 0 |
| P14822 | 136 mcg | 7 |
[14] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg
omit:
| | | Ondansetron AN ODT | EA | MP | C5743 | | 4 | 0 | C |
[15] Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
omit:
| | | Ondansetron AN | EA | MP | C5778 | | 4 | 0 | C |
[16] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg
omit:
| | | Ondansetron AN ODT | EA | MP | C5743 | | 4 | 0 | C |
[17] Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
omit:
| | | Ondansetron AN | EA | MP | C5778 | | 4 | 0 | C |
[18] Schedule 2, entry for Palonosetron
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | PALONOSETRON Medsurge | DZ | MP | C5805 | | 1 | 0 | C |
[19] Schedule 3, after details relevant to Responsible Person code CR
insert:
DZ | Medsurge Healthcare Pty Ltd | 92 124 728 892 |
[20] Schedule 3
omit:
EA | Amneal Pharmaceuticals Pty Ltd | 11 163 167 851 |
[21] Schedule 3, after details relevant to Responsible Person code TY
insert:
WM | MEDISON PHARMA AUSTRALIA PTY LIMITED | 19 659 723 403 |
[22] Schedule 4, entry for Ipilimumab
(a) omit:
| 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 |
(b) insert in numerical order after existing text:
| C14808 | P14808 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with nivolumab plus relatlimab, 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 14808 |
[23] Schedule 4, entry for Nivolumab
(a) omit:
| 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 |
(b) omit:
| 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 |
(c) insert in numerical order after existing text:
| C14816 | P14816 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must not have received prior treatment with nivolumab plus relatlimab, 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 14816 |
| C14830 | P14830 | Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with nivolumab plus relatlimab, 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 14830 |
[24] Schedule 4, entry for Pembrolizumab
(a) omit:
| C10689 | P10689 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment ‑ 6 weekly treatment regimen
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 3 doses under this restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10689 |
| C10696 | P10696 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment ‑ 3 weekly treatment regimen
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 10696 |
(b) insert in numerical order after existing text:
| C14817 | P14817 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment - 6 weekly treatment regimen
Patient must not have received prior treatment with nivolumab plus relatlimab, 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 3 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 14817 |
| C14818 | P14818 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment - 3 weekly treatment regimen
Patient must not have received prior treatment with nivolumab plus relatlimab, 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 14818 |
[25] Schedule 4, after entry for Sacituzumab govitecan
insert:
Tebentafusp | C14813 | P14813 | Advanced (unresectable or metastatic) uveal melanoma
Initial treatment - day 1
Patient must have HLA-A*02:01-positive disease; AND
Patient must have uveal melanoma that has been confirmed either (i) histologically, (ii) cytologically; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior systemic therapy for metastatic disease.
Patient must be at least 18 years of age.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.
This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
Positive HLA-A*02:01 assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C14821 | P14821 | Advanced (unresectable or metastatic) uveal melanoma
Initial treatment - day 8
Patient must have HLA-A*02:01-positive disease; AND
Patient must have previously received PBS-subsidised initial day 1 treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.
This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
Positive HLA-A*02:01 assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14821 |
| C14822 | P14822 | Advanced (unresectable or metastatic) uveal melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug for this condition if it is no longer determined to be clinically beneficial by the treating clinician.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. | Compliance with Authority Required procedures - Streamlined Authority Code 14822 |
| C14825 | P14825 | Advanced (unresectable or metastatic) uveal melanoma
Initial treatment - day 15
Patient must have HLA-A*02:01-positive disease; AND
Patient must have previously received PBS-subsidised initial day 8 treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.
This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
Positive HLA-A*02:01 assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14825 |
