National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 9) (PB 95 of 2015) (Cth)
PB 95 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, Steve Dunlop, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Medical Research, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 25 September 2015
STEVE DUNLOP
Acting Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 9).
(2)This Instrument may also be cited as PB 95 of 2015.
2 Commencement
This Instrument commences on 1 October 2015.
3 Amendments to PB 79 of 2011
Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Amendments
Schedule 1 Part 1 entry for Bleomycin in the form Powder for injection containing bleomycin sulphate 15,000 I.U. and brand Bleo 15K:
Omit from the column headed “Responsible Person”: GN substitute: EA
Schedule 1 Part 1 entry for Carboplatin in each of the forms: Solution for I.V. injection 150 mg in 15 mL and Solution for I.V. injection 50 mg in 5 mL, and brand Carbaccord:
Omit from the column headed “Responsible Person”: GN substitute: EA
Schedule 1 Part 1 entry for Docetaxel in the form Solution for I.V. injection 140 mg in 7 ml, and brand Oncotaxel 140:
Omit from the column headed “Responsible Person”: GN substitute: EA
Schedule 1 Part 1 entry for Docetaxel in the form Solution for I.V. injection 80 mg in 4 ml, and brand Oncotaxel 80:
Omit from the column headed “Responsible Person”: GN substitute: EA
Schedule 1 Part 1 entry for Doxorubicin in the form Solution for injection or intravesical containing hydrochloride 200 mg in 100 mL and brand Accord Doxorubicin:
Omit from the column headed “Responsible Person”: GN substitute: EA
Schedule 1 Part 1 entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL; Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL; and Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL and brand Epirubicin ACT:
Omit from the column headed “Responsible Person”: VN substitute: EA
Schedule 1 Part 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride) and brand Gemaccord:
Omit from the column headed “Responsible Person”: GN substitute: EA
Schedule 1 Part 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride) and brand Gemcitabine Actavis 2000:
Omit from the column headed “Responsible Person”: GN substitute: EA
Schedule 1 Part 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride) and brand Gemaccord:
Omit from the column headed “Responsible Person”: GN substitute: EA
[10] Schedule 1 Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL and brand Irinoccord:
Omit from the column headed “Responsible Person”: GN substitute: EA
[11] Schedule 1 Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL and brand Irinoccord:
Omit from the column headed “Responsible Person”: GN substitute: EA
[12] Schedule 1 Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL and brand Irinotecan Actavis 2000:
Omit from the column headed “Responsible Person”: UA substitute: EA
[13] Schedule 1 Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL and brand Tecan:
Omit from the column headed “Responsible Person”: GN substitute: ED
[14] Schedule 1 Part 1 entry for Methotrexate in each of the forms: Injection 50 mg in 2 mL vial and Solution concentrate for I.V. infusion 1000 mg in 10 mL vial and brand Methaccord:
Omit from the column headed “Responsible Person”: GN substitute: EA
[15] Schedule 1 Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL and brand Oxaliccord:
Omit from the column headed “Responsible Person”: GN substitute: EA
[16] Schedule 1 Part 1, entry for Paclitaxel in each of the forms: Solution for I.V infusion 100 mg in 16.7 mL; Solution for I.V infusion 150 mg in 25 mL; Solution for I.V infusion 30 mg in 5 mL and Solution for I.V infusion 300 mg in 50 mL and brand Paclitaxel Actavis:
Omit from the column headed “Responsible Person”: UA substitute: EA
[17] Schedule 1 Part 1, entry for Paclitaxel in each of the forms: Solution for I.V infusion 100 mg in 16.7 mL; Solution for I.V infusion 150 mg in 25 mL; Solution for I.V infusion 30 mg in 5 mL; and Solution for I.V infusion 300 mg in 50 mL and brand Plaxel:
Omit from the column headed “Responsible Person”: GN substitute: ED
[18] Schedule 1 Part 1, entry for Panitumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5ml and Solution concentrate for I.V. infusion 400 mg in 20ml and brand Vectibix:
Omit from the column headed ‘Circumstances’: C4783 C4784
Insert in the column headed ‘Circumstances’: C5439 C5447 C5452 C5526
[19] Schedule 1 Part 2, entry for Panitumumab:
Substitute:
| Panitumumab | P5452 P5526 P5439 P5447 | 720 720 | 9 5 |
[20] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg and brand Onsetron ODT 4:
Omit from the column headed “Responsible Person”: GN substitute: ED
[21]Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg and brand Onsetron ODT 8:
Omit from the column headed “Responsible Person”: GN substitute: ED
[22]Schedule 3, after the entry for Amneal Pharmaceuticals Pty Ltd, Responsible Person code, EA:
Insert:
ED Amneal Pharmaceuticals Pty Ltd 11 163 167 851 [23]Schedule 3, after the entry for Actavis Pty Ltd, Responsible Person code, UA:
Remove:
VN Actavis Australia Pty Ltd 43 122 896 468
[24]Schedule 4, entry for Panitumumab:
Substitute:
Panitumumab C5439 P5439 Metastatic colorectal cancer
Treatment Phase: Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer, AND
Patient must have a WHO performance status of 2 or less, AND
The condition must have failed to respond to first-line chemotherapy, AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy, AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
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.Compliance with Authority Required procedures - Streamlined Authority Code 5439
C5447 P5447 Metastatic colorectal cancer
Treatment Phase: Continuing treatment
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, AND
Patient must not have progressive disease, AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy, AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
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.Compliance with Authority Required procedures - Streamlined Authority Code 5447
C5452 P5452 Metastatic colorectal cancer
Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for panitumumab for first-line treatment of RAS wild-type metastatic colorectal cancer, AND
Patient must not have progressive disease, AND
The treatment must be in combination with first-line chemotherapy, AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
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.Compliance with Authority Required procedures - Streamlined Authority Code 5452
C5526 P5526 Metastatic colorectal cancer
Treatment Phase: Initial Treatment
Patient must have RAS wild-type metastatic colorectal cancer, AND
Patient must have a WHO performance status of 0 or 1, AND
The condition must be previously untreated, AND
The treatment must be in combination with first-line chemotherapy, AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
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.Compliance with Authority Required procedures - Streamlined Authority Code 5526
[25]Entry for Schedule 5 – Patient contributions:
Substitute the table as:
Listed Drug Form Manner of Administration Brand Quantity or Number of Units Approved Ex‑manufacturer Price Claimed Ex‑manufacturer Price Nil entry
0
0
0