Source: https://www.legislation.gov.au/Details/F2019L00218
Timestamp: 2019-03-19 03:45:13
Document Index: 523241827

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'art 2', 'art 2']

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 2) (PB 14 of 2019)
Details: F2019L00218
- F2019L00218
PB 14 of 2019 Arrangements as made
PB 14 of 2019
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 2)
(1) This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 2).
(2) This Instrument may also be cited as PB 14 of 2019.
[1] Schedule 1, Part 1, entry for Carboplatin
[2] Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL
insert in numerical order in the column headed “Circumstances”: C8555 C8569
[3] 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”: C6988 C6993
(b) insert in numerical order in the column headed “Circumstances”: C8552 C8568 C8571 C8573 C8581
[4] Schedule 1, Part 1, entry for Pembrolizumab in the form Solution concentrate for I.V. infusion 100 mg in 4 mL
insert in numerical order in the column headed “Circumstances”: C8542 C8543 C8563
[5] Schedule 1, Part 2, entry for Ipilimumab
[6] Schedule 1, Part 2, entry for Nivolumab
[7] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]
insert in numerical order in the column headed “Purposes”: P8542 P8543 P8563
[8] Schedule 4, entry for Ipilimumab
(a) insert in the column headed “Purposes Code” for circumstances code C6562: P6562
(b) insert in the column headed “Purposes Code” for circumstances code C6585: P6585
(c) insert in the column headed “Purposes Code” for circumstances code C8142: P8142
(d) insert in the column headed “Purposes Code” for circumstances code C8178: P8178
(e) insert in the column headed “Purposes Code” for circumstances code C8180: P8180
(f) insert in the column headed “Purposes Code” for circumstances code C8206: P8206
(g) insert in numerical order after existing text:
The condition must not have previously been treated; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Compliance with Authority Required procedures - Streamlined Authority Code 8555
Induction treatment - Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The condition must not have previously been treated prior to initiating non-PBS-subsidised induction therapy with nivolumab and ipilimumab; AND
The treatment must be in combination with PBS-subsidised-treatment with 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.
Compliance with Authority Required procedures - Streamlined Authority Code 8569
[9] Schedule 4, entry for Nivolumab
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following first‑line treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal.
Compliance with Authority Required procedures ‑ Streamlined Authority Code 6988
Compliance with Authority Required procedures ‑ Streamlined Authority Code 6993
Compliance with Authority Required procedures - Streamlined Authority Code 8552
Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition.
Compliance with Authority Required procedures - Streamlined Authority Code 8568
Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 March 2019; 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
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 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures - Streamlined Authority Code 8571
Compliance with Authority Required procedures - Streamlined Authority Code 8573
Compliance with Authority Required procedures - Streamlined Authority Code 8581
[10] Schedule 4, entry for Pembrolizumab
The treatment must not exceed 35 cycles in total or up to 24 months of treatment, at a dose of 200 mg every 3 weeks with this drug for this condition.
Compliance with Authority Required procedures - Streamlined Authority Code 8542
Compliance with Authority Required procedures - Streamlined Authority Code 8543
The treatment must not exceed a total of 7 doses at a maximum dose of 200 mg every 3 weeks for this condition under this restriction.
Compliance with Authority Required procedures - Streamlined Authority Code 8563