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PB 1 of 2014 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (No. PB 71 of 2012) to provide for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status.
Administered by: Health
Registered 10 Jan 2014
Tabling HistoryDate
Tabled HR11-Feb-2014
Tabled Senate11-Feb-2014
Date of repeal 02 Feb 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

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