Source: https://www.global-regulation.com/law/australia/218554/national-health-%2528efficient-funding-of-chemotherapy%2529-special-arrangement-amendment-instrument-2015-%2528no.-5%2529-%2528pb-51-of-2015%2529.html
Timestamp: 2018-10-22 01:08:48
Document Index: 211832415

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

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 5) (PB 51 of 2015) (Australia)
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 5) (PB 51 of 2015)
Link to law: https://www.comlaw.gov.au/Details/F2015L00769
PB 51 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 5)
(1) This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No.5).
(2) This Instrument may also be cited as PB 51 of 2015.
[1] Schedule 1 Part 1 entry for ‘Bevacizumab’ in each of the forms ‘Solution for I.V. infusion 100 mg in 4 mL’ and ‘Solution for I.V. infusion 400 mg in 16 mL’ with manner of administration Injection:
insert in the column headed ‘Circumstances’ (all instances): C4939 C4968
[2] Schedule 1 Part 1 entry for ‘Cetuximab’ in each of the forms ‘Solution for I.V. infusion 100 mg in 20 mL’ and ‘Solution for I.V. infusion 500 mg in 100 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4771 C4779
insert in the column headed ‘Circumstances’ (all instances): C4908 C4912 C4945 C4965
[3] Schedule 1 Part 1 entry for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’ and manner of administration ‘Injection’:
[4] Schedule 1 Part 1 entry for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’ and manner of administration ‘Injection’:
[5] Schedule 1 Part 1 entry for ‘Oxaliplatin’:
[6] Schedule 1, Part 2 entry for Bevacizumab:
[7] Schedule 1, Part 2 entry for Cetuximab:
[8] Schedule 2, after the entry for ‘Ondansetron’ in each of the forms ‘Tablet 4 mg (as hydrochloride dihydrate)’ and ‘Tablet 8 mg (as hydrochloride dihydrate)’ and brand ‘Ondansteron-DRLA’ with manner of administration ‘Oral’:
[9] Schedule 2, after the entry for ‘Ondansetron’ in each of the forms ‘Tablet (orally disintegrating) 4 mg’ and ‘Tablet (orally disintegrating) 8 mg’ and brand ‘Ondansteron AN ODT’ with manner of administration ‘Oral’:
[10] Schedule 2, entry for ‘Ondansetron’ in each of the forms ‘I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL’ and ‘I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL’ with manner of administration ‘Injection’:
[11] Schedule 4, entry for Bevacizumab:
Insert (in numerical order):
Metastatic colorectal cancer;Treatment Phase: Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer,
Patient must be previously treated with PBS-subsidised first-line anti-EGFR antibodies,
Patient must not have previously received PBS-subsidised treatment with this drug for this condition,
Patient must have a WHO performance status of 0 or 1,
The treatment must be in combination with second-line chemotherapy,
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks.
[12] Schedule 4, entry for Cetuximab:
The treatment must be in combination with radiotherapy,
Patient must be unable to tolerate cisplatin.
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.
The treatment must be for the week prior to radiotherapy,
The condition must be previously untreated,
The treatment must be in combination with first-line chemotherapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patient must have received an initial authority prescription for this drug for first-line treatment of RAS wild-type metastatic colorectal cancer,
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy,
The treatment must be in combination with chemotherapy,
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.
The condition must have failed to respond to first-line chemotherapy,