National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 6) (No. PB 44 of 2012) (Cth)

Case

PB 44 of 2012

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.6)1

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated   19 July 2012

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 6).

(2)        This Instrument may also be cited as PB 44 of 2012.

2          Commencement

This Instrument commences on 1 August 2012.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).

Schedule 1     Amendments

  1. Schedule 1, entry for Adalimumab in each of the forms: Injection 20 mg in 0.4 mL pre-filled syringe; Injection 40 mg in 0.8 mL pre-filled syringe; Injection 40 mg in 0.8 mL pre-filled pen; Injection 40 mg in 0.8 mL pre-filled syringe, 6; and Injection 40 mg in 0.8 mL pre-filled pen, 6

omit from the column headed “Responsible Person”: AB          substitute: VE

  1. Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)

omit from the column headed “Responsible Person” for the brand “Alendrobell 70mg”: BF          substitute: GQ

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan

(a) omit from the column headed “Form”: (GA express)         substitute: (GA express 15)

(b) omit from the column headed “Brand”: GA express          substitute: GA express 15

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine

(a) omit from the column headed “Form”: (HCU express)       substitute: (HCU express 15)

(b) omit from the column headed “Brand”: HCU express       substitute: HCU express 15

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

(a) omit from the column headed “Form”: (MMA/PA express)              substitute: (MMA/PA express 15)

(b) omit from the column headed “Brand”:   MMA/PA express             substitute: MMA/PA express 15

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine in the form Oral powder 500 g (XMTVI Maxamum)

insert in the columns in the order indicated:

Oral liquid 130 mL, 30 (MMA/PA cooler) Oral MMA/PA cooler VF MP NP C1225 C1307 4 5

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine

(a) omit from the column headed “Form”: (PKU Express)      substitute: (PKU express 15)

(b) omit from the column headed “Brand”:   PKU Express     substitute: PKU express 15

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder 29 g, 30 (PKU Anamix Junior)

insert in the columns in the order indicated:

Sachets containing oral powder 34 g, 30
(PKU express 20) 		Oral PKU express 20 VF MP NP C1286 4 5

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

(a) omit from the column headed “Form”: (TYR Express)      substitute: (TYR express 15)

(b) omit from the column headed “Brand”:   TYR Express     substitute: TYR express 15

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

(a) omit from the column headed “Form”: (MSUD Express)  substitute: (MSUD express 15)

(b) omit from the column headed “Brand”:   MSUD Express substitute: MSUD express 15

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Sachets containing oral powder 29 g, 30 (MSUD Anamix Junior)

insert in the columns in the order indicated:

Sachets containing oral powder 34 g, 30 (MSUD express 20) Oral MSUD express 20 VF MP NP C1220 4 5

  1. Schedule 1, entry for Aspirin in the form Tablet 100 mg

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

Spren 100 QA MP NP 112 1

  1. Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

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

Atorvastatin SCP 10 RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

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

STADA Atorvastatin TD MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

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

Atorvastatin SCP 10 RZ MP C1540 C3047 P3047 30 11

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

STADA Atorvastatin TD MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

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

Atorvastatin SCP 20 RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

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

STADA Atorvastatin TD MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

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

Atorvastatin SCP 20 RZ MP C1540 C3047 P3047 30 11

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

STADA Atorvastatin TD MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

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

Atorvastatin SCP 40 RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

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

STADA Atorvastatin TD MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

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

Atorvastatin SCP 40 RZ MP C1540 C3047 P3047 30 11

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

STADA Atorvastatin TD MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

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

Atorvastatin SCP 80 RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

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

STADA Atorvastatin TD MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

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

Atorvastatin SCP 80 RZ MP C1540 C3047 P3047 30 11

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

STADA Atorvastatin TD MP C1540 C3047 P3047 30 11

  1. Schedule 1, after entry for Auranofin in the form Tablet 3 mg

insert in the columns in the order indicated:

Capsule 3 mg Oral Ridaura BZ MP NP 60 5

  1. Schedule 1, after entry for Busulfan

insert in the columns in the order indicated:

Cabazitaxel Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent Injection Jevtana SW MP C7000 C7001

See Note 3

 See Note 3 D

  1. Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent); and Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

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

Cefepime Sandoz SZ MP NP C1427 10 0

  1. Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium) [Max Pharma Pty Ltd]

(a)        omit from the column headed “Brand”: Max Pharma Pty Ltd              substitute: Max Pharma Ceftriaxone

(b)          omit from the column headed “Responsible Person”: XF  substitute: GQ

  1. Schedule 1, after entry for Cefuroxime in the form Tablet 250 mg (as axetil)

insert in the columns in the order indicated:

Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL Oral Zinnat GK PDP 1 0
MP 1 1

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)

(a) omit:

Cephabell BF PDP 20 0

(b) omit:

Cephabell BF MP NP MW 20 1

  1. Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Ciprofloxacin-BW”: BF          substitute: GQ

  1. Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)

omit:

Citalobell BF MP NP C1211 28 5

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

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

Plavicor 75 MI MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

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

STADA Clopidogrel TD MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

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

Cyprocur 100 QA MP C1014 C1404 50 5

  1. Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe

omit from the column headed “Circumstances”:

C2758

insert in numerical order:

C4054

  1. Schedule 1, entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

(a) omit from the column headed “Responsible Person” for the brand “Diltahexal CD”: SZ          substitute: HX

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

Diltiazem Sandoz CD SZ MP NP 30 5

  1. Schedule 1, entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

(a) omit from the column headed “Responsible Person” for the brand “Diltahexal CD”: SZ          substitute: HX

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

Diltiazem Sandoz CD SZ MP NP 30 5

  1. Schedule 1, entry for Docetaxel

omit from the column headed “Circumstances” (all instances):

C3884

insert in numerical order:

C7002

  1. Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg;  Tablet containing enalapril maleate 10 mg;  and Tablet containing enalapril maleate 20 mg

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

Enalapril-PS FZ MP NP 30 5

  1. Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes
    solvent 1 mL

(a) insert in numerical order in the column headed “Circumstances” (twice occurring):

C4057 C4058 C4059 C4060

(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 2; Number of repeats 3:

P4057 P4058 P4059 P4060

  1. Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4

(a) insert in numerical order in the column headed “Circumstances” (twice occurring):

C4057 C4058 C4059 C4060

(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 1; Number of repeats 3:

P4057 P4058 P4059 P4060

  1. Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4

(a) insert in numerical order in the column headed “Circumstances” (twice occurring):

C4057 C4058 C4059 C4060

(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 1; Number of repeats 3:

P4057 P4058 P4059 P4060

  1. Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)

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

APO-Galantamine MR TX MP NP C2934 C2938 C3875 C3876 28 5

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

Gamine XR QA MP NP C2934 C2938 C3875 C3876 28 5

  1. Schedule 1, entry for Gliclazide in the form Tablet 80 mg

omit:

Mellihexal SZ MP NP 100 5

  1. Schedule 1, entry for Hydroxychloroquine

substitute:

Hydroxychloroquine Tablet containing hydroxychloroquine sulfate 200 mg Oral APO-Hydroxychloroquine TX MP NP 100 1
Chem mart Hydroxychloroquine CH MP NP 100 1
Plaquenil SW MP NP 100 1
Terry White Chemist Hydroxychloroquine TW MP NP 100 1

  1. Schedule 1, after entry for Ibuprofen

insert in the columns in the order indicated:

Icatibant Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe Injection Firazyr ZI MP C4055 C4056 1 1

  1. Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

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

Indapamide-PS FZ MP NP 90 1

  1. Schedule 1, entry for Lamivudine in the form Tablet 150 mg

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

Lamivudine RBX RA

MP

See Note 1

C3586 C3587

C3588 C3589

 120 5 D

  1. Schedule 1, entry for Lamivudine in the form Tablet 300 mg

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

Lamivudine RBX RA

MP

See Note 1

C3586 C3587

C3588 C3589

 60 5 D

  1. Schedule 1, entry for Latanoprost in the form Eye drops 50 micrograms per mL, 2.5 mL

substitute:

Latanoprost Eye drops 50 micrograms per mL, 2.5 mL Application to the eye APO-Latanoprost TX MP AO 1 5
Chem mart Latanoprost CH MP AO 1 5
Latanoprost Pfizer FZ MP AO 1 5
Latanoprost Sandoz SZ MP AO 1 5
Terry White Chemists Latanoprost TW MP AO 1 5
Xalatan PF MP AO 1 5

  1. Schedule 1, entry for Latanoprost with Timolol in the form Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

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

Latanocom FZ MP AO C3426 C3427 1 5

  1. Schedule 1, entry for Letrozole in the form Tablet 2.5 mg

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

Lezole WQ MP NP C1608 C2691 C2692 30 5

  1. Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre-filled dual-chamber syringe

omit from the column headed “Responsible Person”: AB          substitute: VE

  1. Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre-filled dual-chamber syringe

omit from the column headed “Responsible Person”: AB          substitute: VE

  1. Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe

omit from the column headed “Responsible Person”: AB          substitute: VE

  1. Schedule 1, entry for Levodopa with Carbidopa in the form Intestinal gel 20 mg-5 mg per mL, 100 mL

omit from the column headed “Responsible Person”: AB          substitute: VE

  1. Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and Oral liquid 400 mg-100 mg per 5 mL, 60 mL

omit from the column headed “Responsible Person” for the brand “Kaletra” : AB            substitute: VE

  1. Schedule 1, after entry for Magnesium

insert in the columns in the order indicated:

Mannitol Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers Inhalation by mouth bronchitol XA MP
See Note 1 		C4061 C4062 C4063 C4064 4 5 D

  1. Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg

(a)       omit from the column headed “Responsible Person” for the brand “Meloxibell”: BF        substitute: GQ

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

Meloxicam-PS FZ MP NP C1547 C1848 30 3

  1. Schedule 1, entry for Meloxicam in the form Tablet 15 mg

(a)       omit from the column headed “Responsible Person” for the brand “Meloxibell”: BF        substitute: GQ

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

Meloxicam-PS FZ MP NP C1547 C1848 30 3

  1. Schedule 1, entry for Meloxicam in the form Capsule 7.5 mg

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

Melox 7.5 GM MP NP C1547 C1848 30 3

  1. Schedule 1, entry for Meloxicam in the form Capsule 15 mg

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

Melox 15 GM MP NP C1547 C1848 30 3

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

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

Formet Aspen 500 AS MP NP 100 5

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

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

Formet Aspen 850 AS MP NP 60 5

  1. Schedule 1, entry for Mirtazapine in each of the forms: Tablet 15 mg (orally disintegrating); Tablet 30 mg (orally disintegrating); and Tablet 45 mg (orally disintegrating);

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

Remeron SolTab FR MP NP C1211 30 5

  1. Schedule 1, entry for Morphine in each of the forms: Capsule containing morphine sulfate 10 mg (containing sustained release pellets); Capsule containing morphine sulfate 20 mg (containing sustained release pellets); Capsule containing morphine sulfate 50 mg (containing sustained release pellets); and Capsule containing morphine sulfate 100 mg (containing sustained release pellets)

omit from the column headed “Max Quantity”:           20           substitute:             28

  1. Schedule 1, entry for Norfloxacin in the form Tablet 400 mg

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

Norfloxacin-PS FZ MP NP C1002 C1070 14 1

  1. Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL

omit from the column headed “Responsible Person” for the brand “Octreotide MaxRx”: XF          substitute:             GQ

  1. Schedule 1, entry for Oestradiol

omit:

Transdermal patches 2 mg, 8 Transdermal Estraderm 25 NV MP NP 1 5

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg (as benzoate); and Tablet 10 mg (as benzoate)

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

STADA Olanzapine TD MP NP C1589 C2044 28 5

  1. Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]

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

Omeprazole-PS FZ MP NP C1177 C1337 C1476 C1533 P1337 P1476 P1533 30 5

  1. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms

omit:

Sifrol BY MP NP C3088 C3216 P3216 30 0
MP NP C3088 C3216 P3088 30 2

substitute:

Sifrol BY MP NP C3088 C3216 P3216 30 0
Simipex 0.125 QA MP NP C3088 C3216 P3216 30 0
Sifrol BY MP NP C3088 C3216 P3088 30 2

  1. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Max Quantity 100; Number of Repeats 5]

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

Simipex 0.25 QA MP NP C3088 C3216 P3216 100 5

  1. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg

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

Simipex 1 QA MP NP C3216 100 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]

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

Pravastatin-PS FZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]

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

Pravastatin-PS FZ MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]

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

Pravastatin-PS FZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]

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

Pravastatin-PS FZ MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]

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

Pravastatin-PS FZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]

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

Pravastatin-PS FZ MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Max Quantity 30; Number of Repeats 5]

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

Pravastatin-PS FZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Max Quantity 30; Number of Repeats 11]

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

Pravastatin-PS FZ MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

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

Quetiapine-Synthon ZT MP NP C1589 C2044 C2765 60 5

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

STADA Quetiapine TD MP NP C1589 C2044 C2765 60 5

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

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

Quetiapine-Synthon ZT MP NP C1589 C2044 C2765 90 5

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

STADA Quetiapine TD MP NP C1589 C2044 C2765 90 5

  1. Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

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

Quetiapine-Synthon ZT MP NP C1589 C2044 C2765 60 5

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

STADA Quetiapine TD MP NP C1589 C2044 C2765 60 5

  1. Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

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

Quetiapine-Synthon ZT MP NP C1589 C2044 C2765 60 5

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

STADA Quetiapine TD MP NP C1589 C2044 C2765 60 5

  1. Schedule 1, entry for Ramipril in the form Capsule 1.25 mg

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

APO-Ramipril TX MP NP 30 5

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

Chem mart Ramipril CH MP NP 30 5

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

Terry White Chemists Ramipril TW MP NP 30 5

  1. Schedule 1, entry for Ramipril in the form Capsule 2.5 mg

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

APO-Ramipril TX MP NP 30 5

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

Chem mart Ramipril CH MP NP 30 5

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

Terry White Chemists Ramipril TW MP NP 30 5

  1. Schedule 1, entry for Ramipril in the form Capsule 5 mg

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

APO-Ramipril TX MP NP 30 5

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

Chem mart Ramipril CH MP NP 30 5

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

Terry White Chemists Ramipril TW MP NP 30 5

  1. Schedule 1, after entry for Ranitidine in the form Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL

insert:

Rasagiline Tablet 1 mg (as mesilate) Oral Azilect LU MP NP C4053 30 5

  1. Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg

omit:

Actonel Once-a-Week SW MP NP C2645 C2646 C3070 4 5

  1. Schedule 1, entry for Risedronic Acid and Calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)

omit:

Actonel Combi SW MP NP C2645 C2646 C3070 1 5

  1. Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL

omit from the column headed “Responsible Person” for the brand “Norvir”: AB               substitute: VE

  1. Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 0]

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

Roxithromycin-PS FZ PDP 10 0

  1. Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 1]

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

Roxithromycin-PS FZ MP NP 10 1

  1. Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 0]

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

Roxithromycin-PS FZ PDP 5 0

  1. Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 1]

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

Roxithromycin-PS FZ MP NP 5 1

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]

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

Simvastatin-DRLA RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]

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

Simvastatin-DRLA RZ MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]

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

Simvastatin-DRLA RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]

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

Simvastatin-DRLA RZ MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]

(a) omit:

Simvahexal HX MP C1540 C3047 P1540 30 5
NP C1540 30 5

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

Simvastatin-DRLA RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]

(a) omit:

Simvahexal HX MP C1540 C3047 P3047 30 11

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

Simvastatin-DRLA RZ MP C1540 C3047 P3407 30 11

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]

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

Simvastatin-DRLA RZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]

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

Simvastatin-DRLA RZ MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

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

Sumagran Aspen 50 AS MP NP C3233 4 5

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

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5

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

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2

  1. Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Max Quantity 5; Number of Repeats 5]

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5

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

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2

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

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5

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

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2

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

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5

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

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

Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2

  1. 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”:

Orion Temozolomide ON MP C1736 C1737 C2101 5 5

  1. Schedule 1, after entry for Tiaprofenic Acid

insert:

Ticagrelor Tablet 90 mg Oral Brilinta AP MP NP C3879 56 5

  1. Schedule 1, entry for Tipranavir

omit:

Oral liquid 100 mg per mL, 95 mL Oral Aptivus BY MP
See Note 1 		C3602 C3603 7 5 D

  1. Schedule 1, entry for Topotecan

insert in the columns in the order indicated:

Topotecan PK MP C3186 See Note 3 See Note 3 D

  1. Schedule 1, after entry for Triglycerides – medium chain, formula in the form Sachets containing oral powder 16 g, 30 (MCT Pro-Cal)

insert in the columns in the order indicated:

Oral powder 400 g (Lipistart) Oral Lipistart VF MP NP C1068 C1511 C1513 C1670 C1671 8 5

  1. Schedule 3

omit:

BF Bellwether Pharma Ltd 15 109 403 287

  1. Schedule 3, after details relevant to Responsible person code TA

insert:

TD STADA Pharmaceuticals Australia Pty Limited 73 154 966 944

  1. Schedule 3, after details relevant to Responsible person code UC

insert:

VE AbbVie Pty Ltd 48 156 384 262

  1. Schedule 3, after details relevant to Responsible person code WQ

insert:

XA Pharmaxis Ltd 75 082 811 630

  1. Schedule 3

omit:

XF Max Pharma Pty Ltd 93 121 857 878

  1. Schedule 4, Part 1, after entry for Bupropion

insert:

Cabazitaxel C7000

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less

 Compliance with Authority Required procedures
C7001

Where the patient is receiving treatment at/from a Public Hospital

Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less

 Compliance with Authority Required procedures – Streamlined Authority Code 7001

  1. Schedule 4, Part 1, entry for Denosumab

(a)           omit:

C2758 Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated Compliance with Authority Required procedures – Streamlined Authority Code 2758

(b)          insert in numerical order after existing text:

C4054 Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated Compliance with Authority Required procedures – Streamlined Authority Code 4054

  1. Schedule 4, Part 1, entry for Docetaxel

(a)           omit:

C3884 Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles Compliance with Authority Required procedures – Streamlined Authority Code 3884

(b)          insert in numerical order after existing text:

C7002 Treatment of androgen independent (castration resistant) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles Compliance with Authority Required procedures – Streamlined Authority Code 7002

  1. Schedule 4, Part 1, entry for Etanercept

insert in numerical order after existing text:

C4057 P4057 Chronic plaque psoriasis (Whole body) [Initial treatment — No prior biological agent]
Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:
(a) has severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and
(c) whose parent or authorised guardian has signed a patient acknowledgement; and
(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or
(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application
If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment.  Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
An adequate response to treatment is defined as:
Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value 		Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course Compliance with Written or Telephone Authority Required procedures
C4058 P4058 Chronic plaque psoriasis (Whole body) [Re-Treatment — Received prior etanercept under PBS]
Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:
(a) a documented history of severe chronic plaque psoriasis; and
(b) received prior PBS-subsidised treatment with etanercept for this condition; and
(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date
A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept 		Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course Compliance with Written or Telephone Authority Required procedures
C4059 P4059 Chronic plaque psoriasis (Face, hand, foot) [Initial treatment — No prior biological agent]
Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:
(a) has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and
(c) whose parent or authorised guardian has signed a patient acknowledgement; and
(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or
(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application
If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated.  This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment.  Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value 		Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course Compliance with Written or Telephone Authority Required procedures
C4060 P4060 Chronic plaque psoriasis (Face, hand, foot) [Re-Treatment — Received prior etanercept under PBS]
Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:
(a) a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) received prior PBS-subsidised treatment with etanercept for this condition; and
(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date
A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept 		Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, after entry for Ibuprofen

insert:

Icatibant C4055 Initial supply for anticipated emergency treatment of an acute attack of hereditary angioedema in a patient with confirmed diagnosis of C1-esterase inhibitor deficiency who has been assessed to be at significant risk of an acute attack of hereditary angioedema by or in consultation with a clinical immunologist, respiratory physician, specialist allergist or general physician experienced in the management of patients with hereditary angioedema
The name of the specialist consulted must be provided at the time of application for initial supply
The name of the Approved Pathology Authority and date of the diagnosing pathology test must be included in the authority application 		Compliance with Authority Required procedures
C4056 Continuing supply for anticipated emergency treatment of an acute attack of hereditary angioedema, where the patient has previously been issued with an authority prescription for this drug Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Magnesium

insert:

Mannitol C4061 Where the patient is receiving treatment at/from a private hospital
Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:
(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
(2) Is 6 years of age or older;
(3) Has a FEV1 greater than 30% predicted for age, gender and height;
(4) Is intolerant or inadequately responsive to dornase alfa;
(5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial
In order for patients to be eligible for participation in the HSD program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;
(3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;
(4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily;
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;
(8) Other aspects of treatment, such as physiotherapy, must be continued;
(9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period) 		Compliance with Written or Telephone Authority Required procedures
C4062 Where the patient is receiving treatment at/from a private hospital
Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012
Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use 		Compliance with Written or Telephone Authority Required procedures
C4063 Where the patient is receiving treatment at/from a public hospital
Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:
(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
(2) Is 6 years of age or older;
(3) Has a FEV1 greater than 30% predicted for age, gender and height;
(4) Is intolerant or inadequately responsive to dornase alfa;
(5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial
In order for patients to be eligible for participation in the HSD program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;
(3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;
(4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily;
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;
(8) Other aspects of treatment, such as physiotherapy, must be continued;
(9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period) 		Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4063
C4064 Where the patient is receiving treatment at/from a public hospital
Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012
Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use 		Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4064

  1. Schedule 4, Part 1, after entry for Ranitidine

insert:

Rasagiline C4053 Parkinson disease Compliance with Authority Required procedures – Streamlined Authority Code 4053

  1. Schedule 4, Part 1, after entry for Tiaprofenic acid

insert:

Ticagrelor C3879 Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin Compliance with Authority Required procedures – Streamlined Authority Code 3879

  1. Schedule 4, Part 1, entry for Tipranavir

omit:

C3602

Where the patient is receiving treatment at/from a private hospital

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

 Compliance with Written or Telephone Authority Authority Required procedures
C3603 Where the patient is receiving treatment at/from a public hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity 		Compliance with Written or Telephone Authority Authority Required procedures - Streamlined Authority Code 3603

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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