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 February 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. 2).

 (2) This Instrument may also be cited as PB 9 of 2014.

2 Commencement

This Instrument commences on 1 March 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, entry for Amino acid formula with vitamins and minerals without phenylalanine

omit:

[2]                Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)

omit:

[3]                Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[4]                Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[5]                Schedule 1, entry for Anastrozole in the form Tablet 1 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[6]                Schedule 1, after entry for Aprepitant

insert:

[7]                Schedule 1, entry for Bicalutamide in the form Tablet 50 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[8]                Schedule 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL

insert in the columns in the order indicated:

[9]                Schedule 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements

omit from the column headed “Circumstances”: C1276 substitute: C4438

[10]            Schedule 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements

insert:

[11]            Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 150 mg in 15 mL

omit:

[12]            Schedule 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL

omit:

[13]            Schedule 1, entry for Dicloxacillin in the form Capsule 500 mg (as sodium)

omit:

[14]            Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent

omit from the column headed “Responsible Person”:  YA substitute: AF

[15]            Schedule 1, after entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent

insert:

[16]            Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

omit:

[17]            Schedule 1, entry for Felodipine in each of the forms: Tablet 2.5 mg (extended release); Tablet 5 mg (extended release); and
Tablet 10 mg (extended release)

omit from the column headed “Responsible Person” for the brand “Plendil ER”: AP substitute: GX

[18]            Schedule 1, entry for Fludarabine in the form Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL

omit:

[19]            Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg

omit:

[20]            Schedule 1, entry for Gabapentin in the form Tablet 800 mg

omit:

[21]            Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)

omit:

[22]            Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

omit:

[23]            Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL

omit:

[24]            Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)

omit:

[25]            Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[26]            Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

omit:

[27]            Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL

(a)        omit:

(b)        omit:

(c)        omit:

[28]            Schedule 1, after entry for Linagliptin

insert:

[29]            Schedule 1, entry for Lisinopril in the form Tablet 5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[30]            Schedule 1, entry for Lisinopril in the form Tablet 10 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[31]            Schedule 1, entry for Lisinopril in the form Tablet 20 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[32]            Schedule 1, entry for Mitozantrone in the form Injection 20 mg (as hydrochloride) in 10 mL

omit:

[33]            Schedule 1, entry for Nevirapine in the form Tablet 200 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[34]            Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg

omit:

[35]            Schedule 1, entry for Olanzapine in the form Tablet 5 mg

omit:

[36]            Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg

omit:

[37]            Schedule 1, entry for Olanzapine in the form Tablet 10 mg

omit:

[38]            Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

omit:

[39]            Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)

omit:

[40]            Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL

omit:

[41]            Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL

omit:

[42]            Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL

(a)        omit:

(b)        omit:

[43]            Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL

omit:

[44]            Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[45]            Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[46]            Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)        insert in numerical order in the column headed “Circumstances”: C4435  C4439  C4444

(b)        insert in numerical order in the column headed “Purposes”: P4439

[47]            Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]

(a)        insert in numerical order in the column headed “Circumstances”: C4435  C4439  C4444

(b)        insert in numerical order in the column headed “Purposes”: P4444

[48]            Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]

(a)        insert in numerical order in the column headed “Circumstances”: C4435  C4439  C4444

(b)        insert in numerical order in the column headed “Purposes”: P4435

[49]            Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)        insert in numerical order in the column headed “Circumstances”: C4435  C4439  C4444

(b)        insert in numerical order in the column headed “Purposes”: P4439

[50]            Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)        insert in numerical order in the column headed “Circumstances”: C4435  C4439  C4444

(b)        insert in numerical order in the column headed “Purposes”: P4444

[51]            Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

(a)        insert in numerical order in the column headed “Circumstances”: C4435  C4439  C4444

(b)        insert in numerical order in the column headed “Purposes”: P4435

[52]            Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg
(as hydrochloride)

omit:

[53]            Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[54]            Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[55]            Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[56]            Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[57]            Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[58]            Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[59]            Schedule 1, entry for Risperidone in the form Tablet 3 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[60]            Schedule 1, entry for Risperidone in the form Tablet 4 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[61]            Schedule 1, after entry for Saxagliptin

insert:

[62]            Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

(a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

(b)        omit:

(c)        omit:

[63]            Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)

(a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

(b)        omit:

(c)        omit:

[64]            Schedule 1, entry for Somatropin

omit:

[65]            Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[66]            Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[67]            Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[68]            Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[69]            Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[70]            Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[71]            Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[72]            Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[73]            Schedule 1, entry for Temozolomide in the form Capsule 250 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

[74]            Schedule 1, entry for Terbutaline

omit:

[75]            Schedule 1, entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Topotecan Agila”: YA substitute: AF

[76]            Schedule 1, after entry for Trifluoperazine in the form Tablet 5 mg (as hydrochloride)

insert:

[77]            Schedule 1, after entry for Triglycerides, medium chain in the form Oral emulsion 250 mL (Liquigen)

insert in the columns in the order indicated:

[78]            Schedule 3, after details relevant to Responsible Person code NI

insert:

[79]            Schedule 3

omit:

[80]            Schedule 4, Part 1, after entry for Aprepitant

insert:

[81]            Schedule 4, Part 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements

substitute:

[82]            Schedule 4, Part 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements

insert:

[83]            Schedule 4, Part 1, after entry for Docetaxel

insert:

[84]            Schedule 4, Part 1, after entry for Linagliptin

insert:

[85]            Schedule 4, Part 1, entry for Pazopanib

insert in numerical order following existing text:

[86]            Schedule 4, Part 1, after entry for Saxagliptin

insert:

[87]            Schedule 4, Part 1, after entry for Triamcinolone

insert:

[88]            Schedule 4, Part 1, entry for Triglycerides, medium chain

insert in numerical order following existing text: