National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 5) (PB 47 of 2015) (Cth)

PB 47 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 5)

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 22 May 2015

FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health

1 Name of Instrument

(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 5).
(2) This Instrument may also be cited as PB 47 of 2015.

2 Commencement

This Instrument commences on 1 June 2015.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1 Amendments

Schedule 1, entry for Abciximab
omit from the column headed “Circumstances”: C1716 C1717 C1718 substitute: C4915 C4942 C4943
Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Aciclovir Sandoz

MP NP

C3632 C3633

P3632

Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 90; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Aciclovir Sandoz

MP NP

C3632 C3633

P3633

Schedule 1, entry for Adapalene with benzoyl peroxide in the form Gel 1 mg-25 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C3689 C3690 substitute: C4898 C4961
(b)omit from the column headed “Purposes”: P3689 substitute: P4961
Schedule 1, entry for Adapalene with benzoyl peroxide in the form Gel 1 mg-25 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances” [Authorised Prescriber “MP”]:C3689 C3690    substitute:    C4898 C4961
(b)omit from the column headed “Purposes”:      P3690   substitute:         P4898
(c)omit from the column headed “Circumstances” [Authorised Prescriber “NP”]:C3690   substitute:         C4898
Schedule 1, entry for Adrenaline in each of the forms: I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector
(EpiPen Jr.); I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior); I.M. injection 300 micrograms
in 0.3 mL single dose syringe auto-injector (EpiPen); and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen)
omit from the column headed “Circumstances”: C3434 C3435 C3436 substitute: C4909 C4946 C4947
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
omit from the column headed “Brand”: FonatPlus substitute: FonatPLUS
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
omit from the column headed “Brand”: Fonat Plus substitute: FonatPLUS

Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder 34 g, 30 (PKU express 20)
insert in the columns in the order indicated:

Sachets containing oral powder 36 g, 30 (PKU Anamix Junior)

Oral

PKU Anamix Junior

MP NP

C4964

Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Sachets containing oral powder 29 g, 30 (TYR Anamix Junior)
insert in the columns in the order indicated:

Sachets containing oral powder 36 g, 30 (TYR Anamix Junior)

Oral

TYR Anamix Junior

MP NP

C4923

Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Sachets containing oral powder 34 g, 30 (MSUD express 20)
insert in the columns in the order indicated:

Sachets containing oral powder 36 g, 30 (MSUD Anamix Junior)

Oral

MSUD Anamix Junior

MP NP

C4954

Schedule 1, after entry for Amylopectin, modified long chain
insert:

Anakinra

Injection 100 mg in 0.67 mL single use pre-filled syringe

Injection

Kineret

C4920

D(100)

Schedule 1, entry for Apraclonidine
omit from the column headed “Circumstances”: C1374 substitute: C4901
Schedule 1, entry for Atenolol in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Atenolol RBX

MP NP

Schedule 1, entry for Azathioprine in the form Tablet 50 mg
omit from the column headed “Brand”: Thioprine substitute: Thioprine 50
Schedule 1, entry for Betamethasone in the form Cream 500 micrograms (as dipropionate) per g, 15 g
omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4957
Schedule 1, entry for Betamethasone in the form Cream 200 micrograms (as valerate) per g, 100 g
omit from the column headed “Circumstances” (all instances): C1422 substitute: C4924

Schedule 1, entry for Betamethasone in each of the forms: Ointment 500 micrograms (as dipropionate) per g, 15 g; and
Cream 500 micrograms (as valerate) per g, 15 g
omit from the column headed “Circumstances” (all instances): C1422 substitute: C4957
Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg
in 16 mL
insert in numerical order in the column headed “Circumstances”: C4939 C4968
Schedule 1, entry for Bivalirudin
omit from the column headed “Circumstances”: C3075 substitute: C4919
Schedule 1, entry for Buprenorphine in each of the forms: Transdermal patch 5 mg; Transdermal patch 10 mg; and Transdermal patch
20 mg
omit from the column headed “Circumstances”: C1062 substitute: C4951
Schedule 1, omit entry for Calcipotriol
Schedule 1, entry for Captopril in the form Oral solution 5 mg per mL, 95 mL
omit from the column headed “Circumstances”: C1998 substitute: C4966
Schedule 1, entry for Celecoxib in each of the forms: Capsule 100 mg; and Capsule 200 mg
omit from the column headed “Circumstances” (all instances): C1547 C1848 substitute: C4907 C4962
Schedule 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg
in 100 mL
(a)omit from the column headed “Circumstances”: C4771 C4779
(b)insert in numerical order: C4908 C4912 C4945 C4965
Schedule 1, entry for Chloramphenicol
omit:

Ear drops (aqueous) 5 mg per mL, 5 mL

Application to the ear

Chloromycetin

MP NP

Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)
omit:

Ciproxin 750

MP NP

C1431 C1432 C1572 C1573 C3680

Schedule 1, entry for Clodronic Acid in each of the forms: Capsule containing 400 mg sodium clodronate (as tetrahydrate); and
Tablet containing 800 mg sodium clodronate (as tetrahydrate)
omit from the column headed “Circumstances”: C1035 C1205 C1233 substitute: C4933 C4955 C4956

Schedule 1, entry for Codeine with Paracetamol in the form Tablet containing codeine phosphate 30 mg with paracetamol 500 mg [Maximum Quantity: 60; Number of Repeats: 0]
(a)omit from the column headed “Purposes” (all instances):               P2064   substitute:         P4903
(b)omit from the column headed “Maximum Quantity” (all instances):         60 CN2064        substitute:         60 CN4903
(c)omit from the column headed “Number of Repeats” (all instances):         0          substitute:         0 CN4903
Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Purposes”: P3688 substitute: P4967
Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre‑filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Purposes”: P3688 substitute: P4967
Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe
omit:

MP NP	P1148	20	3	10
MP NP	P3688	20	3	10

substitute:

MP NP	P4910	20	3	10
MP NP	P4967	30	5	10

Schedule 1, entry for Dalteparin in each of the forms: Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe; and Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe
omit from the column headed “Circumstances”: C3688 substitute: C4967
Schedule 1, entry for Diphtheria and tetanus vaccine, adsorbed, diluted for adult use in the form Injection 0.5 mL
omit from the column headed “Section 100/Prescriber Bag only”: PB(MP) PB(NP)
Schedule 1, entry for Dipyridamole with Aspirin
(a)omit from the column headed “Manner of Administration” for the brand “Asasantin SR”: Oral
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Diasp SR

MP NP

C1728

Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL
omit:

Dotax

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL
omit:

Dotax

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Depreta 30

MP NP

C1211

Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Depreta 60

MP NP

C1211

Schedule 1, entry for Enoxaparin in the form Solution for injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
Schedule 1, entry for Eplerenone in each of the forms: Tablet 25 mg; and Tablet 50 mg
omit from the column headed “Circumstances”: C2637 substitute: C4937
Schedule 1, entry for Essential amino acids formula
omit from the column headed “Circumstances”: C1147 C1458 substitute: C4925 C4958
Schedule 1, entry for Essential amino acids formula with minerals and vitamin C
omit from the column headed “Circumstances”: C1147 C1458 substitute: C4925 C4958
Schedule 1, entry for Essential amino acids formula with vitamins and minerals
omit from the column headed “Circumstances”: C1147 C1458 substitute: C4925 C4958
Schedule 1, entry for Ethacrynic Acid
omit from the column headed “Circumstances”: C1261 substitute:C4936
Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”: C4267 substitute: C4914
Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)omit from the column headed “Circumstances”: C4267 substitute: C4914
(b)omit from the column headed “Purposes”: P4267 substitute: P4914
Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”: C4267 substitute: C4914
Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)omit from the column headed “Circumstances”: C4267 substitute: C4914
(b)omit from the column headed “Purposes”: P4267 substitute: P4914
Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”: C4267 substitute: C4914
Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)omit from the column headed “Circumstances”: C4267 substitute: C4914
(b)omit from the column headed “Purposes”: P4267 substitute: P4914
Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”: C4267 substitute: C4914
Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)omit from the column headed “Circumstances”: C4267 substitute: C4914
(b)omit from the column headed “Purposes”: P4267 substitute: P4914
Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”: C4267 substitute: C4914
Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)omit from the column headed “Circumstances”: C4267 substitute: C4914
(b)omit from the column headed “Purposes”: P4267 substitute: P4914
Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”: C4267 substitute: C4914
Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)omit from the column headed “Circumstances”: C4267 substitute: C4914
(b)omit from the column headed “Purposes”: P4267 substitute: P4914
Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 1.28 mg; Transdermal patch 2.063 mg; Transdermal patch 2.1 mg; Transdermal patch 2.55 mg; Transdermal patch 4.125 mg; Transdermal patch 4.2 mg; Transdermal patch 5.10 mg; Transdermal patch 7.65 mg; Transdermal patch 8.25 mg; Transdermal patch 8.4 mg; Transdermal patch 10.20 mg; Transdermal patch 12.375 mg; Transdermal patch 12.6 mg; Transdermal patch 16.5 mg; and Transdermal patch 16.8 mg
omit from the column headed “Circumstances” (all instances): C1062 substitute: C4952
Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses; and Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
omit from the column headed “Circumstances”: C4408 substitute: C4930
Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); and Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
(a)omit from the column headed “Circumstances”: C4408
(b)insert in numerical order: C4930
Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Frusemide RBX

MP NP

100

Schedule 1, entry for Fusidic Acid
omit from the column headed “Circumstances”: C1130 substitute: C4963
Schedule 1, entry for Gabapentin in the form Capsule 100 mg
omit:

Gabatine 100

MP NP

C2664

100

Schedule 1, entry for Gabapentin in the form Capsule 300 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Gabapentin GH

MP NP

C2664

100

(b)omit:

Gabatine 300

MP NP

C2664

100

Schedule 1, entry for Gabapentin in the form Capsule 400 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Gabapentin GH

MP NP

C2664

100

(b)omit:

Gabatine 400

MP NP

C2664

100

Schedule 1, entry for Gabapentin in the form Tablet 600 mg
omit:

Gabatine 600

MP NP

C2664

100

Schedule 1, entry for Gabapentin in the form Tablet 800 mg
omit:

Gabatine 800

MP NP

C2664

100

Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4934

Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4899
Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4934
Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4899
Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4934

Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4899
Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4934
Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (twice occurring): C1422 substitute: C4899 C4934
(b)insert in the column headed “Purposes” (twice occurring): P4899
Schedule 1, entry for Hydromorphone in each of the forms: Tablet containing hydromorphone hydrochloride 2 mg; Tablet containing hydromorphone hydrochloride 4 mg; and Tablet containing hydromorphone hydrochloride 8 mg
omit from the column headed “Circumstances” (all instances): C1358 substitute: C4926 C4959
Schedule 1, entry for Hydromorphone in each of the forms: Tablet (modified release) containing hydromorphone hydrochloride 4 mg; Tablet (modified release) containing hydromorphone hydrochloride 8 mg; Tablet (modified release) containing hydromorphone hydrochloride 16 mg; Tablet (modified release) containing hydromorphone hydrochloride 32 mg; and Tablet (modified release) containing hydromorphone hydrochloride 64 mg
omit from the column headed “Circumstances”: C1062 substitute: C4556
Schedule 1, entry for Hydromorphone in the form Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL
omit from the column headed “Circumstances”: C1358 substitute: C4926 C4959
Schedule 1, entry for Hydroxychloroquine
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Hydroxychloroquine RBX

MP NP

100

Schedule 1, entry for Ibandronic acid in the form Tablet 50 mg (as ibandronate sodium monohydrate)
omit from the column headed “Circumstances”: C1035 substitute: C4922
Schedule 1, entry for Icatibant
omit from the column headed “Circumstances”: C4055 C4056 substitute: C4917 C4949
Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Logem

MP NP

C1426

Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APO-Lansoprazole ODT

MP NP

C1177 C1337 C1533

P1177

Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APO-Lansoprazole ODT

MP NP

C1177 C1337 C1533

P1337 P1533

Schedule 1, entry for Lansoprazole in the form Tablet 15 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APO-Lansoprazole ODT

MP NP

C1337 C1533

Schedule 1, entry for Methadone in the form Tablet containing methadone hydrochloride 10 mg
omit from the column headed “Circumstances”: C1358 substitute: C4953
Schedule 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL
[Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C3659 C3660 substitute: C4902 C4941
(b)omit from the column headed “Purposes”: P3660 substitute: P4941
Schedule 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL
[Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C3659 C3660 substitute: C4902 C4941
(b)omit from the column headed “Purposes”: P3659 substitute: P4902
Schedule 1, entry for Methadone in the form Injection containing methadone hydrochloride 10 mg in 1 mL
omit from the column headed “Circumstances”: C1358 substitute: C4953
Schedule 1, entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Solu-Medrol

MP NP

Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Metoclopramide RBX

MP NP MW PDP

Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Metoprolol RBX

MP NP

100

Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Metoprolol RBX

MP NP

Schedule 1, entry for Metronidazole in the form Tablet 400 mg [Maximum Quantity: 21; Number of Repeats: 0]
insert in the column headed “Circumstances” (all instances): C1416C4932
Schedule 1, entry for Metronidazole in the form Tablet 400 mg [Maximum Quantity: 21; Number of Repeats: 1]
(a)insert in the column headed “Circumstances” (all instances): C1416C4932
(b)omit from the column headed “Purposes”: P1416 substitute: P4932
Schedule 1, entry for Minoxidil
omit from the column headed “Circumstances”: C2759 substitute: C4906
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg [Maximum Quantity: 20; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C1789 C3661 C3662 substitute: C4935 C4948 C4960
(b)omit from the column headed “Purposes”: P1789 P3662 substitute: P4935 P4960
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg [Maximum Quantity: 20; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C1789 C3661 C3662 substitute: C4935 C4948 C4960
(b)omit from the column headed “Purposes”: P3661 substitute: P4948
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 20 mg [Maximum Quantity: 20; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C1789 C3661 C3662 substitute: C4935 C4948 C4960
(b)omit from the column headed “Purposes”: P1789 P3662 substitute: P4935 P4960
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 20 mg [Maximum Quantity: 20; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C1789 C3661 C3662 substitute: C4935 C4948 C4960
(b)omit from the column headed “Purposes”: P3661 substitute: P4948
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 30 mg
omit from the column headed “Circumstances”: C1358 substitute: C4926 C4959
Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 5 mg (controlled release); Tablet containing morphine sulfate 10 mg (controlled release); Tablet containing morphine sulfate 15 mg (controlled release); Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)
omit from the column headed “Circumstances” (all instances): C1062 substitute: C4556
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 200 mg (controlled release) [Maximum Quantity: 28; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C1499 C3659 C3660 substitute: C4900 C4911 C4927
(b)omit from the column headed “Purposes”: P1499 P3660 substitute: P4900 P4927
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 200 mg (controlled release) [Maximum Quantity: 28; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C1499 C3659 C3660 substitute: C4900 C4911 C4927
(b)omit from the column headed “Purposes”: P3659 substitute: P4911
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 30 mg (controlled release); Capsule containing morphine sulfate 50 mg (containing sustained release pellets); Capsule containing morphine sulfate 60 mg (controlled release); Capsule containing morphine sulfate 90 mg (controlled release); Capsule containing morphine sulfate 100 mg (containing sustained release pellets); Capsule containing morphine sulfate 120 mg (controlled release); Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet; Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet; Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet; and Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet
omit from the column headed “Circumstances”: C1062 substitute: C4556
Schedule 1, entry for Morphine in the form Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet
omit from the column headed “Circumstances”: C1499 substitute: C4900
Schedule 1, entry for Morphine in each of the forms: Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL; Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL; and Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL
omit from the column headed “Circumstances”: C1358 substitute: C4926 C4959
Schedule 1, entry for Moxonidine in each of the forms: Tablet 200 micrograms; and Tablet 400 micrograms
omit from the column headed “Circumstances”: C2385 substitute: C4944
Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ ODT

MP NP

C3050 C3611 See Note 2

P3050
See Note 2

4
See Note 2

0
See
Note 2

Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ ODT

MP NP

C3050 C3611

P3611

Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ ODT

MP NP

C3050 C3611 See Note 2

P3050
See Note 2

4
See Note 2

0
See
Note 2

Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ ODT

MP NP

C3050 C3611

P3611

Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ

MP NP

C3050 C3611 See Note 2

P3050
See Note 2

4
See Note 2

0
See
Note 2

Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ

MP NP

C3050 C3611

P3611

Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ

MP NP

C3050 C3611 See Note 2

P3050
See Note 2

4
See Note 2

0
See
Note 2

Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron SZ

MP NP

C3050 C3611

P3611

Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
omit:

Ondaz

MP NP

C3050 C3611
See Note 2

See Note 2

1
See Note 2

0
See
Note 2

Schedule 1, entry for Oxaliplatin
(a)omit:

Powder for I.V. infusion 50 mg

Injection

Hospira Pty Limited

See Note 3

See
Note 3

D(100)

(b)omit:

Powder for I.V. infusion 100 mg

Injection

Hospira Pty Limited

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Oxycodone in each of the forms: Tablet containing oxycodone hydrochloride 5 mg; Capsule containing oxycodone hydrochloride 5 mg; Capsule containing oxycodone hydrochloride 10 mg
omit from the column headed “Circumstances”: C1358 substitute: C4926 C4959
Schedule 1, entry for Oxycodone in the form Capsule containing oxycodone hydrochloride 20 mg
omit from the column headed “Circumstances”: C1358 substitute: C4959
Schedule 1, entry for Oxycodone in the form Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL
omit from the column headed “Circumstances”: C1358 substitute: C4926 C4959
Schedule 1, entry for Oxycodone in the form Suppository 30 mg (as pectinate)
omit from the column headed “Circumstances”: C1358 substitute: C4926 C4959
Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg; Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg; Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg; and Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg
omit from the column headed “Circumstances”: C1062 substitute: C4951
Schedule 1, entry for Paracetamol in the form Tablet 500 mg
omit from the column headed “Purposes” (all instances): P2046 substitute: P4913
Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 0]
(a)omit from the column headed “Circumstances” for the brands “Osteomol 665 Paracetamol” and “Panadol Osteo”:
C2094 C3649 C3650 substitute: C4940 C4950 C4969
(b)omit from the column headed “Purposes”: P3650 substitute: P4950

Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 3]
(a)omit from the column headed “Circumstances” for the brands “Osteomol 665 Paracetamol” and “Panadol Osteo”:
C2094 C3649 C3650 substitute: C4940 C4950 C4969
(b)omit from the column headed “Purposes”: P3649 substitute: P4940
Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” for the brands “Osteomol 665 Paracetamol” and “Panadol Osteo”:
C2094 C3649 C3650 substitute: C4940 C4950 C4969
(b)omit from the column headed “Purposes”: P2094 substitute: P4969
Schedule 1, entry for Paracetamol in the form Suppositories 500 mg, 24 [Maximum Quantity: 4; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C3649 C3650 substitute: C4940 C4950
(b)omit from the column headed “Purposes”: P3650 substitute: P4950
Schedule 1, entry for Paracetamol in the form Suppositories 500 mg, 24 [Maximum Quantity: 4; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C3649 C3650 substitute: C4940 C4950
(b)omit from the column headed “Purposes”: P3649 substitute: P4940
Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Paroxetine GH

MP NP

C1211 C1241 C1862

Schedule 1, entry for Peginterferon beta-1a in the form Pack containing single use injection pens containing 63 micrograms in 0.5 mL and 94 micrograms in 0.5 mL
omit from the column headed “Circumstances”: C4798 substitute: C4881

Schedule 1, entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL
[Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4798 C4811 substitute: C4881 C4887
(b)omit from the column headed “Purposes”: P4798 substitute: P4881
Schedule 1, entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL
[Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4798 C4811 substitute: C4881 C4887
(b)omit from the column headed “Purposes”: P4811 substitute: P4887
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Zabep

MP NP

C1177 C1337 C1533

P1177

Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Zabep

MP NP

C1177 C1337 C1533

P1337 P1533

Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ranitidine GH

MP NP MW

Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:
P4227 P4259 substitute: P4226 P4263
Schedule 1, entry for Salcatonin
omit from the column headed “Circumstances”: C1412 C3256 substitute: C4918 C4938
Schedule 1, entry for Sapropterin in the form Tablet (soluble) containing sapropterin dihydrochloride 100 mg [Maximum Quantity: 180; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”:           C4547
(b)insert in numerical order:     C4921
(c)omit from the column headed “Purposes”:      P4547   substitute:         P4921
Schedule 1, entry for Sapropterin in the form Tablet (soluble) containing sapropterin dihydrochloride 100 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4547
(b)insert in numerical order: C4921
Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
omit from the column headed “Form” for the brand “Temozolomide AN” : f
Schedule 1, entry for Tiagabine in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 15 mg (as hydrochloride)
omit from the column headed “Circumstances”: C2664 substitute: C4928
Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg
omit:

Dilart HCT 80/12.5

MP NP

C4374

Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dilart HCT 320/12.5

MP NP

C4361

Schedule 1, entry for Vigabatrin in each of the forms: Tablet 500 mg; and Oral powder, sachet 500 mg
omit from the column headed “Circumstances”: C1426 substitute: C4929
Schedule 1, entry for Vitamins, minerals and trace elements with carbohydrate in the form Oral powder 200 g (Paediatric Seravit)
omit from the column headed “Circumstances”: C3301 substitute: C4916
Schedule 1, entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
omit from the column headed “Circumstances”: C1596 substitute: C4322
Schedule 3, details relevant to Responsible Persons Code BD
omit:
Biogen Idec Australia Pty Ltd substitute: Biogen Australia Pty Ltd
Schedule 4, Part 1, entry for Abciximab
substitute:

Abciximab

C4915

Coronary artery disease

Patient must be undergoing percutaneous coronary stent placement

Compliance with Authority Required procedures - Streamlined Authority Code 4915

C4942

Coronary artery disease

Patient must be undergoing percutaneous coronary balloon angioplasty

Compliance with Authority Required procedures - Streamlined Authority Code 4942

C4943

Coronary artery disease

Patient must be undergoing percutaneous coronary atherectomy

Compliance with Authority Required procedures - Streamlined Authority Code 4943

Schedule 4, Part 1, entry for Adapalene with benzoyl peroxide
substitute:

Adapalene with benzoyl peroxide

C4898

P4898

Severe acne vulgaris

The treatment must be maintenance therapy

C4961

P4961

Severe acne vulgaris

Acute treatment

The treatment must in combination with an oral antibiotic

Schedule 4, Part 1, entry for Adrenaline
substitute:

Adrenaline

C4909

Acute allergic reaction with anaphylaxis

Initial sole PBS-subsidised supply for anticipated emergency treatment

Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician

The name of the specialist consulted must be provided at the time of application for initial supply

Compliance with Authority Required procedures

C4946

Acute allergic reaction with anaphylaxis

Initial sole PBS-subsidised supply for anticipated emergency treatment

Patient must have been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis

Compliance with Authority Required procedures

C4947

Acute allergic reaction with anaphylaxis

Continuing sole PBS-subsidised supply for anticipated emergency treatment

Patient must have previously been issued with an authority prescription for this drug

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
insert in numerical order:

C4964

Phenylketonuria

Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
insert in numerical order:

C4923

Tyrosinaemia

Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
insert in numerical order:

C4954

Maple syrup urine disease

Schedule 4, Part 1, after entry for Amylopectin, modified long chain
insert:

Anakinra

C4920

Moderate to severe cryopyrin associated periodic syndromes (CAPS)

Must be treated by a rheumatologist or in consultation with a rheumatologist

A diagnosis of CAPS must be documented in the patient's medical records

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4920

Schedule 4, Part 1, entry for Apraclonidine
substitute:

Apraclonidine

C4901

Intra-ocular pressure

The treatment must be for short-term reduction of intra-ocular pressure; AND
Patient must already be on maximally tolerated anti-glaucoma therapy

Schedule 4, Part 1, entry for Betamethasone
(a)omit:

C1422

Treatment of corticosteroid‑responsive dermatoses

(b)insert in numerical order after existing text:

C4924	Corticosteroid-responsive dermatoses
C4957	Corticosteroid-responsive dermatoses

Schedule 4, Part 1, entry for Bevacizumab
insert in numerical order:

C4939

Metastatic colorectal cancer

Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must be previously treated with PBS-subsidised first-line anti-EGFR antibodies; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with second-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks

Compliance with Authority Required procedures - Streamlined Authority Code 4939

C4968

Metastatic colorectal cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with second-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks

Compliance with Authority Required procedures - Streamlined Authority Code 4968

Schedule 4, Part 1, entry for Bivalirudin
substitute:

Bivalirudin

C4919

Coronary artery disease

Patient must be undergoing percutaneous coronary intervention

Compliance with Authority Required procedures - Streamlined Authority Code 4919

Schedule 4, Part 1, entry for Buprenorphine
substitute:

C4951

Chronic severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

Schedule 4, Part 1, omit entry for Calcipotriol
Schedule 4, Part 1, entry for Captopril
substitute:

Captopril

C4966

Patients unable to take a solid dose form of an ACE inhibitor

Patient must not be pregnant. Use of ACE inhibitors is contraindicated during pregnancy since these drugs have been associated with foetal death in utero

Schedule 4, Part 1, entry for Celecoxib
substitute:

Celecoxib

C4907

Rheumatoid arthritis

The treatment must be for symptomatic treatment

C4962

Osteoarthritis

The treatment must be for symptomatic treatment

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

C4771

Metastatic colorectal cancer
Continuing treatment

Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition

Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab

Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab

Compliance with Authority Required procedures - Streamlined Authority Code 4771

C4779

Metastatic colorectal cancer
Initial treatment

Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition

Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab

Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab

Compliance with Authority Required procedures - Streamlined Authority Code 4779

(b)insert in numerical order after existing text:

C4908	Metastatic colorectal cancer Initial treatment Patient must have RAS wild-type metastatic colorectal cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must be previously untreated; AND The treatment must be in combination with first-line chemotherapy; AND The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition	Compliance with Authority Required procedures - Streamlined Authority Code 4908
C4912	Metastatic colorectal cancer Continuing treatment Patient must have received an initial authority prescription for this drug for first-line treatment of RAS wild-type metastatic colorectal cancer; AND Patient must not have progressive disease; AND The treatment must be in combination with first-line chemotherapy; AND The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition	Compliance with Authority Required procedures - Streamlined Authority Code 4912
C4945	Metastatic colorectal cancer Continuing treatment Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND Patient must not have progressive disease; AND The treatment must be as monotherapy; OR The treatment must be in combination with chemotherapy; AND The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab	Compliance with Authority Required procedures - Streamlined Authority Code 4945
C4965	Metastatic colorectal cancer Initial treatment Patient must have RAS wild-type metastatic colorectal cancer; AND Patient must have a WHO performance status of 2 or less; AND The condition must have failed to respond to first-line chemotherapy; AND The treatment must be as monotherapy; OR The treatment must be in combination with chemotherapy; AND The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab	Compliance with Authority Required procedures - Streamlined Authority Code 4965

Schedule 4, Part 1, entry for Clodronic Acid
substitute:

Clodronic acid

C4933

Bone metastases

The condition must be due to breast cancer

C4955

Hypercalcaemia of malignancy

Patient must have a malignancy refractory to anti-neoplastic therapy

C4956

Multiple myeloma

Schedule 4, Part 1, entry for Codeine with Paracetamol
substitute:

Codeine with paracetamol

P4903

CN4903

Severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Dalteparin
substitute:

Dalteparin

P4910

Haemodialysis

C4967

P4967

Symptomatic venous thromboembolism

Management

Patient must have a solid tumour(s)

Schedule 4, Part 1, entry for Enoxaparin
insert in numerical order:

P4910

Haemodialysis

Schedule 4, Part 1, entry for Eplerenone
substitute:

Eplerenone

C4937

Heart failure with a left ventricular ejection fraction of 40% or less

The condition must occur within 3 to 14 days following an acute myocardial infarction; AND
The treatment must be commenced within 14 days of an acute myocardial infarction

The date of the acute myocardial infarction and the date of initiation of treatment with this drug must be documented in the patient's medical records when PBS-subsidised treatment is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 4937

Schedule 4, Part 1, entry for Essential amino acids formula
(a)omit from the column headed “Circumstances Code”: C1147 substitute: C4925
(b)omit from the column headed “Circumstances Code”: C1458 substitute: C4958
Schedule 4, Part 1, entry for Essential amino acids formula with minerals and vitamin C
(a)omit from the column headed “Circumstances Code”: C1147 substitute: C4925
(b)omit from the column headed “Circumstances Code”: C1458 substitute: C4958
Schedule 4, Part 1, entry for Essential amino acids formula with vitamins and minerals
(a)omit from the column headed “Circumstances Code”: C1147 substitute: C4925
(b)omit from the column headed “Circumstances Code”: C1458 substitute: C4958
Schedule 4, Part 1, entry for Ethacrynic Acid
omit from the column headed “Circumstances Code”: C1261 substitute: C4936
Schedule 4, Part 1, entry for Fentanyl
(a)omit:

C1062

Chronic severe disabling pain not responding to non‑narcotic analgesics

(b)omit:

C4267

P4267

Breakthrough pain

Continuing treatment

Patient must be undergoing palliative care;
Patient must have cancer;
Patient must be receiving opioids for their persistent pain;
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects

Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C4914

Breakthrough pain

Continuing treatment

Patient must have cancer; AND
Patient must be receiving opioids for their persistent pain; AND
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects

Patient must be undergoing palliative care

Compliance with Authority Required procedures

C4952

Chronic severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

Schedule 4, Part 1, entry for Fluticasone with Salmeterol
(a)omit:

C4408

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids;
Patient must have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate if aged less than 12 years

(b)insert in numerical order after existing text:

C4930

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids

Patient must be aged 4 years or older

Schedule 4, Part 1, entry for Fusidic Acid
substitute:

Fusidic acid

C4963

Serious staphylococcal infections

The treatment must be used in combination with another antibiotic; AND
The condition must be proven to be due to a staphylococcus

Schedule 4, Part 1, entry for Hydrocortisone
(a)omit:

C1422

Treatment of corticosteroid‑responsive dermatoses

(b)insert in numerical order after existing text:

C4899	P4899	Corticosteroid-responsive dermatoses
C4934	P4934	Corticosteroid-responsive dermatoses

Schedule 4, Part 1, entry for Hydromorphone
substitute:

Hydromorphone

C4556

Chronic severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

C4926

Severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

C4959

Severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

Schedule 4, Part 1, entry for Ibandronic acid
insert in numerical order:

C4922

Bone metastases

The condition must be due to breast cancer

Schedule 4, Part 1, entry for Icatibant
substitute:

Icatibant

C4917

Anticipated emergency treatment of an acute attack of hereditary angioedema

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug

Compliance with Authority Required procedures

C4949

Anticipated emergency treatment of an acute attack of hereditary angioedema

Initial treatment

Patient must have confirmed diagnosis of C1-esterase inhibitor deficiency; AND
Patient must have been assessed to be at significant risk of an acute attack of hereditary angioedema; AND
The condition must be assessed by a clinical immunologist; OR
The condition must be assessed by a respiratory physician; OR
The condition must be assessed by a specialist allergist; OR
The condition must be assessed by a 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 date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Methadone
substitute:

Methadone

C4902

Chronic severe disabling pain

Initial treatment, for up to 3 months

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics

Compliance with Authority Required procedures

C4941

Chronic severe disabling pain

Continuing treatment

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics

Compliance with Authority Required procedures

C4953

Severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

Schedule 4, Part 1, entry for Metronidazole [Purposes Code P1416]
insert in the column headed: “Circumstances Code”: C1416
Schedule 4, Part 1, entry for Metronidazole
insert in numerical order:

C4932

P4932

Infection

The condition must be due to anaerobic bacteria

Schedule 4, Part 1, entry for Minoxidil
substitute:

Minoxidil

C4906

Severe refractory hypertension

The treatment must be initiated by a consultant physician

Compliance with Authority Required procedures - Streamlined Authority Code 4906

Schedule 4, Part 1, entry for Morphine
substitute:

Morphine	C4556	Chronic severe disabling pain The condition must be unresponsive to non-narcotic analgesics
C4900	P4900	Chronic severe disabling pain The condition must be due to cancer; AND The condition must be unresponsive to non-narcotic analgesics	Compliance with Authority Required procedures
C4911	P4911	Chronic severe disabling pain Initial treatment, for up to 3 months Patient must be receiving palliative care; AND The condition must be unresponsive to non-narcotic analgesics	Compliance with Authority Required procedures
C4926	Severe disabling pain The condition must be unresponsive to non-narcotic analgesics
C4927	P4927	Chronic severe disabling pain Continuing treatment Patient must be receiving palliative care; AND The condition must be unresponsive to non-narcotic analgesics	Compliance with Authority Required procedures
C4935	P4935	Severe disabling pain Continuing treatment Patient must be receiving palliative care; AND The condition must be unresponsive to non-narcotic analgesics	Compliance with Authority Required procedures
C4948	P4948	Severe disabling pain Initial treatment, for up to 3 months Patient must be receiving palliative care; AND The condition must be unresponsive to non-narcotic analgesics	Compliance with Authority Required procedures
C4959	Severe disabling pain The condition must be unresponsive to non-narcotic analgesics
C4960	P4960	Severe disabling pain The condition must be due to cancer; AND The condition must be unresponsive to non-narcotic analgesics

Schedule 4, Part 1, entry for Moxonidine
substitute:

Moxonidine

C4944

Hypertension

Patient must be receiving concurrent antihypertensive therapy

Schedule 4, Part 1, entry for Oxycodone
(a)omit:

C1358

Severe disabling pain not responding to non‑narcotic analgesics

(b)insert in numerical order after existing text:

C4926

Severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

C4959

Severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

Schedule 4, Part 1, entry for Oxycodone with naloxone
substitute:

Oxycodone with naloxone

C4951

Chronic severe disabling pain

The condition must be unresponsive to non-narcotic analgesics

Schedule 4, Part 1, entry for Paracetamol
substitute:

Paracetamol	P4913	Chronic arthropathies
C4940	P4940	Analgesia or fever Initial treatment, for up to 4 months Patient must be receiving palliative care; AND Patient must be intolerant to alternative therapy	Compliance with Authority Required procedures - Streamlined Authority Code 4940
C4950	P4950	Analgesia or fever Continuing treatment Patient must be receiving palliative care; AND Patient must be intolerant to alternative therapy	Compliance with Authority Required procedures - Streamlined Authority Code 4950
C4969	P4969	Persistent pain The condition must be associated with osteoarthritis

Schedule 4, Part 1, entry for Peginterferon beta-1a
substitute:

Peginterferon beta-1a

C4881

P4881

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records

Compliance with Authority Required procedures - Streamlined Authority Code 4881

C4887

P4887

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy

Compliance with Authority Required procedures - Streamlined Authority Code 4887

Schedule 4, Part 1, entry for Salcatonin
substitute:

Salcatonin

C4918

Hypercalcaemia

The treatment must be initiated in a hospital

Compliance with Authority Required procedures - Streamlined Authority Code 4918

C4938

Symptomatic Paget disease of bone

Compliance with Authority Required procedures - Streamlined Authority Code 4938

Schedule 4, Part 1, entry for Sapropterin
(a)omit:

C4547

P4547

Hyperphenylalaninaemia

Initial treatment

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency

Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured

The authority application must be made in writing

Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C4921

P4921

Hyperphenylalaninaemia

Initial treatment

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency

The authority application must be made in writing

Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Tiagabine
substitute:

Tiagabine

C4928

Partial epileptic seizures

The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs

Compliance with Authority Required procedures - Streamlined Authority Code 4928

Schedule 4, Part 1, entry for Vigabatrin
substitute:

Vigabatrin

C4929

Epileptic seizures

The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs

Compliance with Authority Required procedures - Streamlined Authority Code 4929

Schedule 4, Part 1, entry for Vitamins, minerals and trace elements with carbohydrate
(a)omit:

C3301

Infants and children whose vitamin and mineral intake is insufficient due to a specific diagnosis requiring a highly restrictive therapeutic diet, and whose vitamin, mineral and trace element needs cannot be adequately met with other proprietary vitamin and mineral preparations

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C4916

Dietary management of conditions requiring a highly restrictive therapeutic diet

Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations

Patient must be an infant or a child

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
substitute:

Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose

C4322

Chronic renal failure

Patient must require treatment with a low protein and a low phosphorus diet; OR
Patient must require treatment with a low protein, low phosphorus and low potassium diet

Patient must be an infant or a young child

Compliance with Authority Required procedures