Source: https://www.global-regulation.com/law/australia/220217/national-health-%2528efficient-funding-of-chemotherapy%2529-special-arrangement-amendment-instrument-2014-%2528no.-3%2529-%2528no.-pb-21-of-2014%2529.html
Timestamp: 2018-10-22 14:25:13
Document Index: 528531286

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

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3) (No. PB 21 of 2014) (Australia)
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3) (No. PB 21 of 2014)
Link to law: https://www.comlaw.gov.au/Details/F2014L00360
PB 21 of 2014
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3)
(1) This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3).
(2) This Instrument may also be cited as PB 21 of 2014.
[1] Schedule 1 Part 1, entry for Cetuximab in the forms ‘Solution for I.V. infusion 100 mg in 20 mL’ and ‘Solution for I.V. infusion 500 mg in 100 mL’ with the manner of administration Injection:
C3843 C3844 C3903 C3904
add after C3921:
[2] Schedule 1 Part 1, entry for Doxorubicin - Pegylated Liposomal in the form ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL’ with manner of administration Injection:
[3] Schedule 1 Part 1, entry for Doxorubicin-Pegylated Liposomal in the form ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection:
[4] Schedule 1 Part 1, entry for Irinotecan in the forms ‘I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’; ‘I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL’; ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ and; ‘I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL’ with manner of administration Injection:
[5] Schedule 1 Part 1, entry for Oxaliplatin in the forms ‘Powder for I.V. infusion 100 mg’; ‘Powder for I.V. infusion 50 mg’; ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’; ‘Solution concentrate for I.V. infusion 200 mg in 40 mL’ and; ‘Solution concentrate for I.V. infusion 50 mg in 10 mL’ with the manner of administration Injection:
[6] Schedule 1, Part 1 after the entry for Paclitaxel, nanoparticle albumin‑bound;
insert in the columns in order indicated:
C4530 C4543
[8] Schedule 1, Part 2 after the entry for Paclitaxel, nanoparticle albumin‑bound;
[9] Schedule 2 entry for Tropisetron:
[10] Schedule 3, Responsible Person codes, after entry for AF:
[11] Schedule 3, Responsible Person codes, after entry for MK:
[12] Schedule 4 entry for Cetuximab:
Initial PBS‑subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K‑RAS wild type metastatic colorectal cancer after failure of first‑line chemotherapy
Continuing PBS‑subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K‑RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3903
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3904
insert after entry for C3921:
Patient must have K-RAS wild-type metastatic colorectal cancer,
Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy,
[13] Schedule 4 following the entry for Interferon Alfa‑2b:
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3184
[14] Schedule 4 following the entry for Ondansetron:
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3900
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3901
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3930
Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of the primary tumour used in combination with 5‑fluorouracil and folinic acid
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3939
[15] Schedule 4, after the entry for Paclitaxel, nanoparticle albumin‑bound;
The treatment must be in combination with an irinotecan-based therapy,
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.
Patient must have received an initial authority prescription for panitumumab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy,