National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 1) (PB 1 of 2015)

Link to law: https://www.comlaw.gov.au/Details/F2015L00040

PB 1 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 1)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 12th January 2015
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2015 (No. 1).
            (2)        This Instrument may also be cited as PB 1 of 2015.
2          Commencement
This Instrument commences on 1 February 2015.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
 
Schedule 1     Amendments
[1]           Schedule 1, entry for Anastrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Anastrozole FBM
FO
MP NP
C2213
 
30
5
30
 
 
[2]           Schedule 1, entry for Arsenic
omit from the column headed “Circumstances”:        C3150  C3891     substitute:             C4793 
[3]           Schedule 1, entry for Baclofen in the form Tablet 10 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Baclofen
CH
MP NP
 
 
100
5
100
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
GenRx Baclofen
GX
MP NP
 
 
100
5
100
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Baclofen
TW
MP NP
 
 
100
5
100
 
 
[4]           Schedule 1, entry for Baclofen in the form Tablet 25 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Baclofen
CH
MP NP
 
 
100
5
100
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
GenRx Baclofen
GX
MP NP
 
 
100
5
100
 
 
[5]           Schedule 1, entry for Bevacizumab in the form Solution for I.V. infusion 100 mg in 4 mL
(a)      omit from the column headed “Circumstances”:            C4585
(b)      omit from the column headed “Circumstances”:            C4588  C4589
(c)      omit from the column headed “Circumstances”:            C4597
[6]           Schedule 1, entry for Bevacizumab in the form Solution for I.V. infusion 400 mg in 16 mL
(a)      omit from the column headed “Circumstances”:            C4585
(b)      omit from the column headed “Circumstances”:            C4588  C4589
(c)      omit from the column headed “Circumstances”:            C4597
[7]           Schedule 1, entry for Cabazitaxel
omit from the column headed “Circumstances”:          C4661
[8]           Schedule 1, entry for Carmellose
omit:
 
Mouth spray containing carmellose sodium 10 mg per mL, 25 mL
Oral application
Aquae
IA
MP NP
C3636 C3637
P3637
1
0
1
 
 

 
 
 
 
 
MP NP
C3636 C3637
P3636
1
3
1
 
 

 
Mouth spray containing carmellose sodium 10 mg per mL, 100 mL
Oral application
Aquae
IA
MP NP
C3636 C3637
P3637
1
0
1
 
 

 
 
 
 
 
MP NP
C3636 C3637
P3636
1
3
1
 
 

[9]           Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 100 mg in 20 mL
(a)      omit from the column headed “Circumstances”:            C2713  C2714  C2715  C3919  C3920  C3921
(b)      omit from the column headed “Circumstances”:            C4775
(c)      omit from the column headed “Circumstances”:            C4780
(d)      insert in numerical order:     C4785  C4788  C4794
(e)      omit from the column headed “Purposes”:       See Note 3
[10]         Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 500 mg in 100 mL
(a)      omit from the column headed “Circumstances”:            C2713  C2714  C2715  C3919  C3920  C3921
(b)      omit from the column headed “Circumstances”:            C4775
(c)      omit from the column headed “Circumstances”:            C4780
(d)      insert in numerical order:     C4785  C4788  C4794
(e)      omit from the column headed “Purposes”:       See Note 3
[11]         Schedule 1, entry for Chloramphenicol in the form Eye drops 5 mg per mL, 10 mL
(a)      omit:
 
 
 
Chloromycetin
PF
PDP
 
 
1
0
1
 
 
(b)      omit:
 
 
 
Chloromycetin
PF
AO MP NP MW
 
 
1
2
1
 
 
[12]         Schedule 1, omit entry for Cidofovir
[13]         Schedule 1, entry for Clopidogrel with aspirin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Clopidogrel/ Aspirin Actavis 75/100
GN
MP NP
C1722 C3219 C3880
 
30
5
30
 
 
[14]         Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
omit from the column headed “Circumstances” (twice occurring):          C1568  C1795  C1796  C3905  C3910  C3911        
substitute:             C4786  C4787  C4791
[15]         Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
omit from the column headed “Circumstances” (twice occurring):           C1568  C1795  C1796  C3905  C3910  C3911        
substitute:              C4786  C4787  C4791
[16]         Schedule 1, entry for Hypromellose
omit:
 
Oral gel 20 mg per g, 100 g
Oral application
Aquae Gel
IA
MP NP
C3636 C3637
P3637
1
0
1
 
 

 
 
 
 
 
MP NP
C3636 C3637
P3636
1
3
1
 
 

[17]         Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Odaplix SR
AF
MP NP
 
 
90
1
90
 
 
[18]         Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL
(a)      omit from the column headed “Circumstances”:            C4235  C4236
(b)      omit from the column headed “Circumstances”:            C4256
(c)      omit from the column headed “Circumstances”:            C4265
(d)      omit from the column headed “Purposes”:       See Note 3
[19]         Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 200 mg in 40 mL
(a)      omit from the column headed “Circumstances”:            C4235  C4236
(b)      omit from the column headed “Circumstances”:            C4256
(c)      omit from the column headed “Circumstances”:            C4265
(d)      omit from the column headed “Purposes”:       See Note 3
[20]         Schedule 1, entry for Irbesartan in the form Tablet 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan Actavis 150
UA
MP NP
 
 
30
5
30
 
 
 
[21]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCT Actavis 300/12.5
UA
MP NP
C4374
 
30
5
30
 
 
[22]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irinotecan MYX
YN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[23]         Schedule 1, entry for Isotretinoin in the form Capsule 20 mg
omit:
 
 
 
GenRx Isotretinoin
GX
MP
C1354
 
60
3
60
 
 
[24]         Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL [Maximum Quantity: 3; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dulose
FM
MP NP
C1150 C1613 C3642 C3643
P3643
3
0
1
 
 
[25]         Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL [Maximum Quantity: 3; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dulose
FM
MP NP
C1150 C1613 C3642 C3643
P3642
3
3
1
 
 
[26]         Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL [Maximum Quantity: 1; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dulose
FM
MP NP
C1150 C1613 C3642 C3643
P1150 P1613
1
5
1
 
 
[27]         Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lansoprazole ODT GH
GQ
MP NP
C1177
 
28
1
28
 
 
[28]         Schedule 1, entry for Lansoprazole in the form Tablet 15 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lansoprazole ODT GH
GQ
MP NP
C1337 C1533
 
28
5
28
 
 
[29]         Schedule 1, entry for Letrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Letrozole FBM
FO
MP NP
C1608 C2691 C2692
 
30
5
30
 
 
[30]         Schedule 1, entry for Lignocaine
insert as first item in the columns in the order indicated:
 
Injection containing lignocaine hydrochloride 50 mg in 5 mL
Injection
Pfizer Australia Pty Ltd
PF
MP NP
See Note 4
 
 
See Note 4
See Note 4
1
1
D(MP)
D(NP)
[31]         Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg
omit:
 
 
 
Medroxyprogest-erone Sandoz
SZ
MP NP
 
 
30
2
30
 
 
[32]         Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg
omit:
 
 
 
Meloxicam Sandoz
SZ
MP NP
C1547 C1848
 
30
3
30
 
 
[33]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:
 
 
 
GenRx Metformin
GX
MP NP
 
 
100
5
100
 
 
[34]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
 
 
 
GenRx Metformin
GX
MP NP
 
 
60
5
60
 
 
[35]         Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Methotrexate MYX
YN
MP
 
See Note 2
5
See Note 2
5
See
Note 2
1
 
 
[36]         Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Methotrexate MYX
YN
MP
 
See Note 3
See Note 3
See
Note 3
1
 
PB(100)
[37]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Metoprolol
TX
MP NP
 
 
100
5
100
 
 
[38]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Metoprolol
TX
MP NP
 
 
60
5
60
 
 
[39]         Schedule 1, after entry for Mifepristone
insert:
Mifepristone and misoprostol
Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms
Oral
MS-2 Step
XH
MP
C4790
 
1
0
1
 
 
[40]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Oxaliplatin MYX
YN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[41]         Schedule 1, entry for Panitumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL
omit from the column headed “Circumstances”:        C4774  C4776
[42]         Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium heptahydrate); and Powder for
I.V. infusion 500 mg (as disodium heptahydrate)
omit from the column headed “Circumstances”:        C2957  C2958  C3885  C3886       substitute:             C4789  C4792
[43]         Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit:
 
 
 
Sequase
PM
MP NP
C4385 C4391 C4396
 
60
0
60
 
 
[44]         Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit:
 
 
 
Sequase
PM
MP NP
C1589 C2044 C2765
 
90
5
90
 
 
 
[45]         Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
omit:
 
 
 
Sequase
PM
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[46]         Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL
(a)      omit from the column headed “Circumstances”:            C4671
(b)      omit from the column headed “Circumstances”:            C4679
(c)      omit from the column headed “Circumstances”:            C4687
(d)      omit from the column headed “Circumstances”:            C4727  C4728  C4752  C4765
[47]         Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL
(a)      omit from the column headed “Circumstances”:            C4671
(b)      omit from the column headed “Circumstances”:            C4679
(c)      omit from the column headed “Circumstances”:            C4687
(d)      omit from the column headed “Circumstances”:            C4727  C4728  C4752  C4765
[48]         Schedule 1, omit entry for Ticlopidine
[49]         Schedule 3, after details relevant to Responsible Person code FM
insert:
FO
For Benefit Medicines Pty Ltd
 56 155 126 346
[50]         Schedule 4, Part 1, entry for Arsenic
substitute:
Arsenic
C4793
 
 
Acute promyelocytic leukaemia
Induction and consolidation treatment
The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction
Compliance with Authority Required procedures – Streamlined Authority Code 4793
[51]         Schedule 4, Part 1, entry for Bevacizumab
(a)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4584:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(b)      omit:
 
C4585
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
Compliance with Authority Required procedures

(c)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4587:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(d)      omit:

 
C4588
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks
Compliance with Authority Required procedures


 
C4589
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures


(e)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4594:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(f)       omit:
 
C4597
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Initial treatment
The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks
Compliance with Authority Required procedures

(g)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4598:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
[52]         Schedule 4, Part 1, entry for Cabazitaxel
(a)      omit:
 
C4661
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with abiraterone; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel
Compliance with Authority Required procedures
(b)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4662:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
[53]         Schedule 4, Part 1, entry for Carmellose
omit:

 
C3636
P3636
 
Initial supply, for up to 4 months, for a palliative care patient where dry mouth is a symptom
Compliance with Authority Required procedures – Streamlined Authority Code 3636

 
C3637
P3637
 
Continuing supply for a palliative care patient where dry mouth is a symptom
Compliance with Authority Required procedures – Streamlined Authority Code 3637

[54]         Schedule 4, Part 1, entry for Cetuximab
(a)      omit:

 
C2713
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration‑approved Product Information
Compliance with Authority Required procedures

 
C2714
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Compliance with Authority Required procedures

 
C2715
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Compliance with Authority Required procedures

 
C3919
 
 
Where the patient is receiving treatment at/from a Public Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration‑approved Product Information
Compliance with Authority Required procedures – Streamlined Authority Code 3919

 
C3920
 
 
Where the patient is receiving treatment at/from a Public Hospital
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Compliance with Authority Required procedures – Streamlined Authority Code 3920

 
C3921
 
 
Where the patient is receiving treatment at/from a Public Hospital
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Compliance with Authority Required procedures – Streamlined Authority Code 3921

(b)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4771:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(c)      omit:
 
C4775
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
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 an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
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
Compliance with Authority Required procedures

(d)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4779:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(e)      omit:
 
C4780
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
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 an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
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
Compliance with Authority Required procedures

(f)       insert in numerical order following existing text:

 
C4785
 
 
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
Initial treatment
The treatment must be in combination with radiotherapy; AND
Patient must be unable to tolerate cisplatin
Compliance with Authority Required procedures - Streamlined Authority Code 4785

 
C4788
 
 
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
Continuing treatment
The treatment must be in combination with radiotherapy; AND
Patient must be unable to tolerate cisplatin; OR
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information
Compliance with Authority Required procedures - Streamlined Authority Code 4788

 
C4794
 
 
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
Initial treatment
The treatment must be for the week prior to radiotherapy; AND
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information
Compliance with Authority Required procedures - Streamlined Authority Code 4794

[55]         Schedule 4, Part 1, omit entry for Cidofovir
 
[56]         Schedule 4, Part 1, entry for Doxorubicin – Pegylated Liposomal
(a)      omit:

 
C1568
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Advanced epithelial ovarian cancer in women who have failed a first‑line platinum‑based chemotherapy regimen
Compliance with Authority Required procedures

 
C1795
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
Compliance with Authority Required procedures

 
C1796
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Compliance with Authority Required procedures

(b)      omit:

 
C3905
 
 
Where the patient is receiving treatment at/from a Public Hospital
Advanced epithelial ovarian cancer in women who have failed a first‑line platinum‑based chemotherapy regimen
Compliance with Authority Required procedures – Streamlined Authority Code 3905

 
C3910
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
Compliance with Authority Required procedures – Streamlined Authority Code 3910

 
C3911
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Compliance with Authority Required procedures – Streamlined Authority Code 3911

(c)      insert in numerical order following existing text:

 
C4786
 
 
Advanced epithelial ovarian cancer
Patient must have failed a first-line platinum-based chemotherapy regimen
Compliance with Authority Required procedures - Streamlined Authority Code 4786

 
C4787
 
 
Metastatic breast cancer
The treatment must be as monotherapy; AND
Patient must have a contraindication to therapy with capecitabine and/or a taxane
Compliance with Authority Required procedures - Streamlined Authority Code 4787

 
C4791
 
 
Metastatic breast cancer
The treatment must be as monotherapy; AND
Patient must have failed prior therapy which included capecitabine and a taxane
Compliance with Authority Required procedures - Streamlined Authority Code 4791

[57]         Schedule 4, Part 1, entry for Hypromellose
omit:

 
C3636
P3636
 
Initial supply, for up to 4 months, for a palliative care patient where dry mouth is a symptom
Compliance with Authority Required procedures – Streamlined Authority Code 3636

 
C3637
P3637
 
Continuing supply for a palliative care patient where dry mouth is a symptom
Compliance with Authority Required procedures – Streamlined Authority Code 3637

[58]         Schedule 4, Part 1, entry for Ipilimumab
(a)      omit:

 
C4235
 
 
Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The treatment must be as monotherapy;
Patient must not have received prior treatment with ipilimumab;
The treatment 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

 
C4236
 
 
Unresectable Stage III or Stage IV malignant melanoma
Re‑induction treatment
The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction);
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response
The patient’s body weight must be documented in the patient’s medical records at the time treatment with ipilimumab is initiated
Compliance with Authority Required procedures

(b)      omit:
 
C4256
 
 
Unresectable Stage III or Stage IV malignant melanoma
Completion of re‑induction treatment
The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction) received prior to 1 August 2013;
The treatment must be for completion of re‑induction treatment in a patient who commenced re‑induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS‑subsidised and non‑PBS‑subsidised) at a maximum dose of 3 mg per kg every 3 weeks
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response
The patient’s body weight must be documented in the patient’s medical records at the time treatment with ipilimumab is initiated
For patients who commenced re‑induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS‑subsidised and non‑PBS‑subsidised)
Compliance with Authority Required procedures
(c)      omit:
 
C4265
 
 
Unresectable Stage III or Stage IV malignant melanoma
Completion of induction treatment
The treatment must be as monotherapy;
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS‑subsidised and non‑PBS‑subsidised) 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
For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS‑subsidised and non‑PBS subsidised)
Compliance with Authority Required procedures
[59]         Schedule 4, Part 1, after entry for Mifepristone
insert:
Mifepristone and misoprostol
C4790
 
 
Termination of an intra-uterine pregnancy
The condition must be an intra-uterine pregnancy of up to 63 days of gestation
Must be treated by a prescriber who is registered with the MS 2 Step Prescribing Program
Compliance with Authority Required procedures
[60]         Schedule 4, Part 1, entry for Panitumumab
(a)      omit:

 
C4774
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
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 an irinotecan based therapy; 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


 
C4776
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
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 an irinotecan based therapy; 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


(b)      omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4783 and C4784:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
[61]         Schedule 4, Part 1, entry for Pemetrexed
substitute:

Pemetrexed
C4789
 
 
Mesothelioma
The treatment must be in combination with cisplatin
The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated
Doses greater than 500 mg per metre squared BSA are not PBS-subsidised
Compliance with Authority Required procedures - Streamlined Authority Code 4789

 
C4792
 
 
Locally advanced or metastatic non-small cell lung cancer
Patient must have received prior treatment with platinum-based chemotherapy
The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated
Doses greater than 500 mg per metre squared BSA are not PBS-subsidised
Compliance with Authority Required procedures - Streamlined Authority Code 4792

[62]         Schedule 4, Part 1, entry for Rituximab
(a)      omit:
 
C4671
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The treatment must be in combination with chemotherapy
Compliance with Authority Required procedures

(b)      omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4674, C4677 and C4678:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(c)      omit:
 
C4679
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction
Compliance with Authority Required procedures

(d)      omit from the column headed “Circumstances and Purposes” for Circumstances Code C4686:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(e)      omit:
 
C4687
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses under this restriction
Compliance with Authority Required procedures

(f)       omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4706 and C4726:
 
 
 
 
Where the patient is receiving treatment at/from a Public Hospital
 
(g)      omit:

 
C4727
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses under this restriction
Compliance with Authority Required procedures


 
C4728
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction
Compliance with Authority Required procedures


 
C4752
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses under this restriction
Compliance with Authority Required procedures


 
C4765
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses under this restriction
Compliance with Authority Required procedures


[63]         Schedule 4, Part 1, omit entry for Ticlopidine
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