National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 1)

Link to law: https://www.comlaw.gov.au/Details/F2014L00051

PB 1 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(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 8 January 2014
 
 
 
 
 
 
 
 
 
 
 
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 2014 (No. 1).
            (2)        This Instrument may also be cited as PB 1 of 2014.
2          Commencement
This Instrument commences on 1 February 2014.
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, after entry for Alogliptin in the form Tablet 25 mg (as benzoate)
insert:
Alogliptin with metformin
Tablet containing 12.5 mg alogliptin (as benzoate) and 500 mg metformin hydrochloride
Oral
Nesina Met 12.5/500
TK
MP NP
C4423 C4427
 
56
5
56
 

 
Tablet containing 12.5 mg alogliptin (as benzoate) and 850 mg metformin hydrochloride
Oral
Nesina Met 12.5/850
TK
MP NP
C4423 C4427
 
56
5
56
 
 

 
Tablet containing 12.5 mg alogliptin (as benzoate) and 1 g metformin hydrochloride
Oral
Nesina Met 12.5/1000
TK
MP NP
C4423 C4427
 
56
5
56
 
 

[2]           Schedule 1, entry for Alprazolam in each of the forms: Tablet 250 micrograms; and Tablet 500 micrograms
omit:
 
 
 
Xanax
PF
MP NP
C1975
 
50
0
50
 
[3]           Schedule 1, entry for Alprazolam in the form Tablet 1 mg
omit:
 
 
 
Xanax
PF
MP NP
C1975
 
50
2
50
 
[4]           Schedule 1, entry for Alprazolam in the form Tablet 2 mg
omit:
 
 
 
Xanax Tri‑Score
PF
MP NP
C1975
 
50
2
50
 
[5]           Schedule 1, after entry for Budesonide in the form Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses
insert in the columns in the order indicated:
 
Rectal foam 2 mg per application, 14 applications, aerosol 16.8 g, 2
Rectal
Budenofalk
OA
MP NP
 
1
3
1
 
[6]           Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
[Maximum Quantity: 1; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Cefaclor
TX
PDP
 
 
1
0
1
 
 
 
[7]           Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
[Maximum Quantity: 1; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Cefaclor
TX
MP
 
 
1
1
1
 
 
[8]           Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
[Maximum Quantity: 1; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Cefaclor
TX
PDP
 
 
1
0
1
 
 
[9]           Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
[Maximum Quantity: 1; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Cefaclor
TX
MP
 
 
1
1
1
 
 
[10]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in numerical order after existing codes in the column headed “Circumstances” for the brand “Piax”:              C4165  C4166  
[11]         Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
omit:
 
 
 
Paclitaxel Pfizer
PF
MP
C3186 C3890 C3902 C3917 C3955 C3956
 
See Note 3
See
Note 3
1
D(100)
[12]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 15 mg in 5 mL
[Maximum Quantity: 4; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C3256   substitute:          C4422
[13]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 15 mg in 5 mL
[Maximum Quantity: 4; Number of Repeats: 2]
omit from the column headed “Circumstances”:          C1500  C3341    substitute:          C4430  C4433
[14]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
[Maximum Quantity: 2; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C3256   substitute:          C4420
[15]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
[Maximum Quantity: 2; Number of Repeats: 2]
omit from the column headed “Circumstances”:          C1500  C3341    substitute:          C4424  C4425
[16]         Schedule 1, entry for Pamidronic Acid in the form Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL [Maximum Quantity: 1; Number of Repeats: 0]
(a)      omit from the column headed “Authorised Prescriber”:  MP MP NP        substitute:          MP NP
(b)      omit from the column headed “Circumstances”:               C3256   substitute:          C4420
[17]         Schedule 1, entry for Pamidronic Acid in the form Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL [Maximum Quantity: 1; Number of Repeats: 2]
omit from the column headed “Circumstances”:          C1500  C3341    substitute:          C4424  C4425
[18]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 60 mg in 10 mL
[Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C3256   substitute:          C4422
[19]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 60 mg in 10 mL
[Maximum Quantity: 1; Number of Repeats: 2]
omit from the column headed “Circumstances”:          C1500  C3341    substitute:          C4430  C4433
[20]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL
omit from the column headed “Circumstances”:          C1035  C1233  C1500  C3341  C3342  C3343      
substitute:          C4421  C4426  C4428  C4429  C4431  C4432
[21]         Schedule 1, entry for Pamidronic Acid in the form Injection set containing 1 vial powder for I.V. infusion containing disodium pamidronate 90 mg and 1 ampoule solvent 10 mL
omit from the column headed “Circumstances”:          C1035  C1233  C1500  C3341  C3342  C3343      
substitute:          C4421  C4426  C4428  C4429  C4431  C4432
[22]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]
omit from the column headed “Brand”:         Paracetamol Sandoz    substitute:          Paracetamol (Sandoz)
[23]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]
omit from the column headed “Brand”:         Paracetamol Sandoz    substitute:          Paracetamol (Sandoz)
[24]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]
omit from the column headed “Brand”:         Paracetamol Sandoz    substitute:          Paracetamol (Sandoz)
[25]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]
omit from the column headed “Brand”:         Paracetamol Sandoz    substitute:          Paracetamol (Sandoz)
[26]         Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)
omit:
 
 
 
Quinapril generichealth
GQ
MP NP
 
30
5
30
 
 
[27]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
(a)      omit:
 
 
 
Chem mart Risedronate
CH
MP NP
C4122 C4123 C4133
 
4
5
4
 
(b)      omit:
 
 
 
Terry White Chemists Risedronate
TW
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[28]         Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 5
ZP
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
 
 

 
 
 
 
 
NP
C4228 C4248
 
30
5
30
 
 

[29]         Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 5
ZP
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
 
 
[30]         Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 10
ZP
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
 
 

 
 
 
 
 
NP
C4228 C4248
 
30
5
30
 
 

[31]         Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 10
ZP
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
 
 
[32]         Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 20
ZP
MP
C4225 C4227 C4238 C4259
P4227 P4259
30
5
30
 
 

 
 
 
 
 
NP
C4227 C4259
 
30
5
30
 
 

[33]         Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 20
ZP
MP
C4225 C4227 C4238 C4259
P4225 P4238
30
11
30
 
 
[34]         Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 40
ZP
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
 
 

 
 
 
 
 
NP
C4226 C4263
 
30
5
30
 
 

[35]         Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Crosuva 40
ZP
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
 
 
[36]         Schedule 1, entry for Sitagliptin with simvastatin in each of the forms: Tablet 100 mg (as phosphate monohydrate)-10 mg; Tablet 100 mg (as phosphate monohydrate)-20 mg; and Tablet 100 mg (as phosphate monohydrate)-40 mg
omit from the column headed “Circumstances”:          C4183   substitute:             C4419
[37]         Schedule 1, entry for Sotalol in each of the forms: Tablet containing sotalol hydrochloride 80 mg; and Tablet containing sotalol hydrochloride 160 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Sotalol
TX
MP NP
C1350
 
60
5
60
 
[38]         Schedule 1, entry for Temozolomide in the form Capsule 180 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Orion Temozolomide
ON
MP
C1736 C1737 C2101
 
5
5
5
 
[39]         Schedule 3, details relevant to Responsible Person Code ZP
omit:       Spirit Pharmaceuticals Pty Ltd substitute:            Medis Pharma Pty Ltd
 
[40]         Schedule 4, Part 1, after entry for Alogliptin
insert:

Alogliptin with metformin
C4423
 
 
Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination
Compliance with Authority Required procedures – Streamlined Authority Code 4423


 
C4427
 
 
Diabetes mellitus type 2
Continuing treatment
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and alogliptin
Compliance with Authority Required procedures – Streamlined Authority Code 4427


[41]         Schedule 4, Part 1, entry for Pamidronic Acid
substitute:

Pamidronic Acid
C4420
 
 
Symptomatic Paget disease of bone
Compliance with Authority Required procedures – Streamlined Authority Code 4420

 
C4421
 
 
Where the patient is receiving treatment at/from a public hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy
Compliance with Written and Telephone Authority Required procedures –  Streamlined Authority Code 4421

 
C4422
 
 
Symptomatic Paget disease of bone
Compliance with Authority Required procedures –  Streamlined Authority Code 4422

 
C4424
 
 
Where the patient is receiving treatment at/from a private hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy
Compliance with Written and Telephone Authority Required procedures

 
C4425
 
 
Where the patient is receiving treatment at/from a public hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy
Compliance with Written and Telephone Authority Required procedures –  Streamlined Authority Code 4425

 
C4426
 
 
Where the patient is receiving treatment at/from a public hospital
Bone metastases
The condition must be due to breast cancer
Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4426

 
C4428
 
 
Where the patient is receiving treatment at/from a private hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy
Compliance with Written and Telephone Authority Required procedures

 
C4429
 
 
Where the patient is receiving treatment at/from a private hospital
Bone metastases
The condition must be due to breast cancer
Compliance with Written and Telephone Authority Required procedures

 
C4430
 
 
Where the patient is receiving treatment at/from a private hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy
Compliance with Written and Telephone Authority Required procedures

 
C4431
 
 
Where the patient is receiving treatment at/from a private hospital
Multiple myeloma
Compliance with Written and Telephone Authority Required procedures

 
C4432
 
 
Where the patient is receiving treatment at/from a public hospital
Multiple myeloma
Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4432

 
C4433
 
 
Where the patient is receiving treatment at/from a public hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy
Compliance with Written and Telephone Authority Required procedures –  Streamlined Authority Code 4433

[42]         Schedule 4, Part 1, entry for Rivaroxaban [Circumstances Code C4098]
insert in the column headed “Purposes Code”:           P4098
[43]         Schedule 4, Part 1, entry for Sitagliptin with simvastatin
substitute:
Sitagliptin with simvastatin
C4419
 
 
Diabetes mellitus type 2 and hypercholesterolaemia
Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs,
AND
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea,
AND
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea,
AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4419

 
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