Federal Register of Legislation - Australian Government

Primary content

PB 89 of 2020 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 30 Sep 2020
Tabling HistoryDate
Tabled HR06-Oct-2020
Tabled Senate06-Oct-2020

 

 

 

 

PB 89 of 2020

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 9)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA CONNOLLY, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access 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                  28 September 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA CONNOLLY

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

1          Name of Instrument

(1)          This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 9).

(2)          This Instrument may also be cited as PB 89 of 2020.

2          Commencement

This Instrument commences on 1 October 2020.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).


 


Schedule 1           Amendments

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

                             omit:

 

 

 

a

Glucobay 50

BN

MP NP

 

 

90

5

90

 

 

[2]              Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 4 [Maximum Quantity: 1; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C6971 C6972

(b)        insert in numerical order in the column headed “Circumstances”: C10838

[3]              Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 4 [Maximum Quantity: 1; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C6971 C6972

(b)        insert in numerical order in the column headed “Circumstances”: C10838

(c)        omit from the column headed “Purposes”: P6971 P6972                 substitute: P10838

[4]              Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6

(a)        omit from the column headed “Circumstances”: C6951

(b)        insert in numerical order in the column headed “Circumstances”: C10892

[5]              Schedule 1, entry for Aflibercept

                             insert as first entry:

 

Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe

Injection

 

Eylea

BN

MP

C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911

P10708 P10715 P10783 P10789 P10818 P10827 P10862 P10911

1

2

1

 

 

MP

C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911

P10716 P10826

1

5

1

 

 

[6]              Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum Quantity: 1; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C7517 C7536 C7553 C7564 C7570 C7571 C7587 C7592 substitute: C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911

(b)        omit from the column headed “Purposes”: P7536 P7564 P7570 P7571 P7587 P7592                   substitute: P10708 P10715 P10783 P10789 P10818 P10827 P10862 P10911

[7]              Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum Quantity: 1; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C7517 C7536 C7553 C7564 C7570 C7571 C7587 C7592 substitute: C10708 C10715 C10716 C10783 C10789 C10818 C10826 C10827 C10862 C10911

(b)        omit from the column headed “Purposes”: P7517 P7553                 substitute: P10716 P10826

[8]              Schedule 1, entry for Alectinib

                             omit from the column headed “Circumstances”: C7353

[9]              Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

                             omit:

 

 

 

a

Dronalen Plus

AL

MP NP

C6306 C6319 C6325

 

4

5

4

 

 

[10]            Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder 27.8 g, 30 (PKU Lophlex)

                             insert:

 

Sachets containing oral powder 28 g, 30 (PKU Lophlex)

Oral

 

PKU Lophlex

SB

MP NP

C4295

 

4

5

1

 

 

[11]            Schedule 1, entry for Apomorphine

                             substitute:

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL

Injection

 

Movapo

TD

MP

C4833 C9561

 

360

5

5

 

PB(100)

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

Injection

 

Movapo

TD

MP

C4833 C9561

 

180

5

5

 

PB(100)

Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

Injection

 

Apomine Solution for Infusion

PF

MP NP

C10844

 

90

5

5

 

 

MP

C10830 C10863

 

90

5

5

 

C(100)

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe

Injection

 

Movapo PFS

TD

MP

C4833 C9561

 

180

5

5

 

PB(100)

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen

Injection

a

Apomine Intermittent

PF

MP NP

C10844

 

100

5

5

 

 

MP

C10830 C10863

 

100

5

5

 

C(100)

a

Movapo Pen

TD

MP NP

C10844

 

100

5

5

 

 

MP

C10830 C10863

 

100

5

5

 

C(100)

[12]            Schedule 1, entry for Brentuximab vedotin

(a)        omit from the column headed “Circumstances”: C6903 C6936

(b)        insert in numerical order in the column headed “Circumstances”: C10811 C10902

[13]            Schedule 1, entry for Buprenorphine

                             substitute:

Buprenorphine

Injection (modified release) 8 mg in 0.16 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 16 mg in 0.32 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 24 mg in 0.48 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 32 mg in 0.64 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 64 mg in 0.18 mL pre-filled syringe

Injection

 

Buvidal Monthly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 96 mg in 0.27 mL pre-filled syringe

Injection

 

Buvidal Monthly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 100 mg in 0.5 mL pre-filled syringe

Injection

 

Sublocade

IR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 128 mg in 0.36 mL pre-filled syringe

Injection

 

Buvidal Monthly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Injection (modified release) 300 mg in 1.5 mL pre-filled syringe

Injection

 

Sublocade

IR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

Transdermal patch 5 mg

Transdermal

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

Transdermal patch 10 mg

Transdermal

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

Transdermal patch 15 mg

Transdermal

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

Transdermal patch 20 mg

Transdermal

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Buprenorphine Sandoz

SZ

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

Transdermal patch 25 mg

Transdermal

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

Transdermal patch 30 mg

Transdermal

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

Transdermal patch 40 mg

Transdermal

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

2

0

2

 

 

a

Bupredermal

TX

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

a

Norspan

MF

MP NP

C6151 C10748 C10752 C10755

P6151

4

2

2

 

 

Tablet (sublingual) 400 micrograms (as hydrochloride)

Sublingual

 

Subutex

IR

MP NP

C6451

 

See Note 3

See Note 3

7

 

PB(100)

Tablet (sublingual) 2 mg (as hydrochloride)

Sublingual

 

Subutex

IR

MP NP

C6451

 

See Note 3

See Note 3

7

 

PB(100)

Tablet (sublingual) 8 mg (as hydrochloride)

Sublingual

 

Subutex

IR

MP NP

C6451

 

See Note 3

See Note 3

7

 

PB(100)

[14]            Schedule 1, entry for Carfilzomib in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg

(a)        omit from the column headed “Circumstances”: C7344

(b)        omit from the column headed “Circumstances”: C7355

(c)        insert in numerical order in the column headed “Circumstances”: C10855

[15]            Schedule 1, entry for Cladribine in the form Tablet 10 mg

                           omit from the column headed “Circumstances” (all instances): C10123

[16]            Schedule 1, entry for Codeine in the form Tablet containing codeine phosphate hemihydrate 30 mg [Authorised Prescriber: MP NP; Maximum Quantity: 10; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C10442 C10444

(b)        insert in numerical order in the column headed “Circumstances”: C10764 C10766 C10771 C10772

(c)        omit from the column headed “Purposes”: P10442                     substitute: P10766


 

[17]            Schedule 1, entry for Codeine in the form Tablet containing codeine phosphate hemihydrate 30 mg [Authorised Prescriber: PDP; Maximum Quantity: 10; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C10442 C10446                     substitute: C10766 C10768

(b)        omit from the column headed “Purposes”: P10442                     substitute: P10766

[18]            Schedule 1, entry for Codeine in the form Tablet containing codeine phosphate hemihydrate 30 mg [Authorised Prescriber: MP NP; Maximum Quantity: 20; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C10442 C10444

(b)        insert in numerical order in the column headed “Circumstances”: C10764 C10766 C10771 C10772

(c)        omit from the column headed “Purposes”: P10444

(d)        insert in numerical order in the column headed “Purposes”: P10764 P10771 P10772

[19]            Schedule 1, entry for Codeine in the form Tablet containing codeine phosphate hemihydrate 30 mg [Authorised Prescriber: PDP; Maximum Quantity: 20; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C10442 C10446                     substitute: C10766 C10768

(b)        omit from the column headed “Purposes”: P10446                     substitute: P10768

[20]            Schedule 1, entry for Codeine with paracetamol

                           substitute:

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

a

APO- Paracetamol/Codeine 500/30

TX

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Codalgin Forte

AF

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Codapane Forte 500/30

AL

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Comfarol Forte

SZ

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Panadeine Forte

SW

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Paracetamol/Codeine GH 500/30

GQ

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Prodeine Forte

AV

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

APO- Paracetamol/Codeine 500/30

TX

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Codalgin Forte

AF

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Codapane Forte 500/30

AL

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Comfarol Forte

SZ

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Panadeine Forte

SW

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Paracetamol/Codeine GH 500/30

GQ

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Prodeine Forte

AV

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

[21]            Schedule 1, omit entry for Daclatasvir

[22]            Schedule 1, omit entry for Danazol

[23]            Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C8020 C8023 C8032 C8033

(b)        insert in numerical order in the column headed “Circumstances”: C10713 C10822 C10861 C10904

[24]            Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 1]

(a)        omit from the column headed “Circumstances”: C8020 C8023 C8032 C8033

(b)        insert in numerical order in the column headed “Circumstances”: C10713 C10822 C10861 C10904

(c)        omit from the column headed “Purposes”: P8020 P8023 P8032 P8033

(d)        insert in numerical order in the column headed “Purposes”: P10713 P10822 P10861 P10904

[25]            Schedule 1, entry for Dexamethasone

                             omit:

 

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL

Injection

 

Dexamethasone Mylan

AF

MP NP

 

 

5

0

5

 

 

Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

Injection

 

Dexamethasone Mylan

AF

MP NP

 

 

5

1

5

 

 

[26]            Schedule 1, omit entry for Dipyridamole

[27]            Schedule 1, entry for Dipyridamole with aspirin

(a)        omit:

 

 

 

a

Asasantin SR

BY

MP NP

C6424

 

60

5

60

 

 

(b)      omit from the column headed “Schedule Equivalent” for the brand “Diasp SR”: a

[28]            Schedule 1, entry for Disopyramide

                             omit from the column headed “Responsible Person”: SW           substitute: PB

[29]            Schedule 1, entry for Fentanyl in the form Transdermal patch 1.28 mg

                             omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

[30]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 2.063 mg; and Transdermal patch 2.1 mg

                             omit from the column headed “Circumstances” (all instances): C10441                      substitute: C10745 C10747 C10751

[31]            Schedule 1, entry for Fentanyl in the form Transdermal patch 2.55 mg

                             omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

[32]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 4.125 mg; and Transdermal patch 4.2 mg

                   omit from the column headed “Circumstances” (all instances): C10441                       substitute: C10745 C10747 C10751

[33]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 5.10 mg; and Transdermal patch 7.65 mg

                             omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

[34]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 8.25 mg; and Transdermal patch 8.4 mg

                             omit from the column headed “Circumstances” (all instances): C10441                       substitute: C10745 C10747 C10751

[35]            Schedule 1, entry for Fentanyl in the form Transdermal patch 10.20 mg

                             omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

[36]            Schedule 1, entry for Fentanyl in each of the forms: 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): C10441                       substitute: C10745 C10747 C10751

[37]            Schedule 1, entry for Gefitinib

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

 

 

 

a

Cipla Gefitinib

LR

MP

C4473 C7447

 

30

3

30

 

 

(b)       insert in the column headed “Schedule Equivalent” for the brand “Iressa”: a

[38]            Schedule 1, entry for Guselkumab

(a)        omit from the column headed “Circumstances”: C8496

(b)        omit from the column headed “Circumstances”: C8909 C8938 C8957 C8958 C8976 C8977 C9903 C9996 C10322 C10327

(c)        insert in numerical order in the column headed “Circumstances: C10742 C10743 C10806 C10807 C10810 C10875 C10889 C10900 C10901

[39]            Schedule 1, entry for Hydromorphone

                             substitute:

Hydromorphone

Injection containing hydromorphone hydrochloride 2 mg in 1 mL

Injection

a

Dilaudid

MF

MP NP

C10764 C10770 C10777

 

5

0

5

 

 

a

HYDROMORPHONE JUNO

JU

MP NP

C10764 C10770 C10777

 

5

0

5

 

 

a

MEDSURGE HYDROMORPHONE 2 mg/1 mL

DZ

MP NP

C10764 C10770 C10777

 

5

0

5

 

 

Injection containing hydromorphone hydrochloride 10 mg in 1 mL

Injection

a

Dilaudid-HP

MF

MP NP

C10764 C10770 C10777

 

5

0

5

 

 

a

HYDROMORPHONE JUNO-HP

JU

MP NP

C10764 C10770 C10777

 

5

0

5

 

 

a

MEDSURGE HYDROMORPHONE HP 10 mg/1 mL

DZ

MP NP

C10764 C10770 C10777

 

5

0

5

 

 

Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 200 mL

Oral

 

Dilaudid

MF

MP NP

C10764 C10770 C10777

 

1

0

1

 

 

PDP

C10859

 

1

0

1

 

 

Tablet containing hydromorphone hydrochloride 2 mg

Oral

 

Dilaudid

MF

MP NP

C10758 C10764 C10770 C10777

P10758

10

0

20

 

 

PDP

C10758 C10859

P10758

10

0

20

 

 

MP NP

C10758 C10764 C10770 C10777

P10764 P10770 P10777

20

0

20

 

 

PDP

C10758 C10859

P10859

20

0

20

 

 

Tablet containing hydromorphone hydrochloride 4 mg

Oral

 

Dilaudid

MF

MP NP

C10758 C10764 C10770 C10777

P10758

10

0

20

 

 

PDP

C10758 C10859

P10758

10

0

20

 

 

MP NP

C10758 C10764 C10770 C10777

P10764 P10770 P10777

20

0

20

 

 

PDP

C10758 C10859

P10859

20

0

20

 

 

Tablet containing hydromorphone hydrochloride 8 mg

Oral

 

Dilaudid

MF

MP NP

C10758 C10764 C10770 C10777

P10758

10

0

20

 

 

PDP

C10758 C10859

P10758

10

0

20

 

 

MP NP

C10758 C10764 C10770 C10777

P10764 P10770 P10777

20

0

20

 

 

PDP

C10758 C10859

P10859

20

0

20

 

 

Tablet (modified release) containing hydromorphone hydrochloride 4 mg

Oral

 

Jurnista

JC

MP NP

C10752 C10753 C10754

 

14

0

14

 

 

Tablet (modified release) containing hydromorphone hydrochloride 8 mg

Oral

 

Jurnista

JC

MP NP

C10752 C10753 C10754

 

14

0

14

 

 

Tablet (modified release) containing hydromorphone hydrochloride 16 mg

Oral

 

Jurnista

JC

MP NP

C10752 C10753 C10754

 

14

0

14

 

 

Tablet (modified release) containing hydromorphone hydrochloride 32 mg

Oral

 

Jurnista

JC

MP NP

C10752 C10753 C10754

 

14

0

14

 

 

Tablet (modified release) containing hydromorphone hydrochloride 64 mg

Oral

 

Jurnista

JC

MP NP

C10752 C10753 C10754

 

14

0

14

 

 

[40]            Schedule 1, entry for Hydroxycarbamide

(a)        insert in the column headed “Schedule Equivalent” for the brand “Hydrea”: a

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

 

 

 

a

HYDROXYCARBAMIDE MEDSURGE

DZ

MP

 

 

100

3

100

 

 

[41]            Schedule 1, entry for Ibrutinib in the form Capsule 140 mg [Maximum Quantity: 90; Number of Repeats: 5]

                             omit from the column headed “Circumstances”: C7806

[42]            Schedule 1, entry for Ibrutinib in the form Capsule 140 mg [Maximum Quantity: 120; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C7806

(b)        omit from the column headed “Purposes”: P7806

[43]            Schedule 1, entry for Icatibant

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

 

 

 

 

Cipla Icatibant

LR

MP

C7273 C7274

 

1

1

1

 

 


 

(b)       omit:

 

 

 

 

Firazyr

TK

MP

C7273 C7274

 

1

1

1

 

 

[44]            Schedule 1, entry for Inotuzumab ozogamicin

                             omit from the column headed “Circumstances”: C9600

[45]            Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

                             omit from the column headed “Circumstances”: C8569

[46]            Schedule 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

                             omit from the column headed “Circumstances”: C8618

[47]            Schedule 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 90; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C8618

(b)        omit from the column headed “Purposes”: P8618

[48]            Schedule 1, entry for Levodopa with carbidopa and entacapone in each of the forms: Tablet 50 mg-12.5 mg (as monohydrate)-200 mg; Tablet 75 mg-18.75 mg (as monohydrate)-200 mg; and Tablet 100 mg-25 mg (as monohydrate)-200 mg

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

 

 

 

a

Carlevent

TX

MP NP

C5212 C5288

 

200

4

100

 

 

[49]            Schedule 1, entry for Levodopa with carbidopa and entacapone in each of the forms: Tablet 125 mg-31.25 mg (as monohydrate)-200 mg; Tablet 150 mg-37.5 mg (as monohydrate)-200 mg; and Tablet 200 mg-50 mg (as monohydrate)-200 mg

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

 

 

 

a

Carlevent

TX

MP NP

C5212 C5288

 

200

4

100

 

 

[50]            Schedule 1, entry for Methadone in the form Injection containing methadone hydrochloride 10 mg in 1 mL

                             omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

[51]            Schedule 1, entry for Methadone in the form Tablet containing methadone hydrochloride 10 mg

                             omit from the column headed “Circumstances”: C10441            substitute: C10745 C10747 C10751

[52]            Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

                             omit:

 

 

 

a

Remeron SolTab

AF

MP NP

C5650

 

30

5

30

 

 


 

[53]            Schedule 1, entry for Morphine

                             substitute:

Morphine

Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C9248 C10748 C10752 C10755

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C9248 C10748 C10752 C10755

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 30 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10748 C10752 C10755

 

14

0

14

 

 

Capsule containing morphine sulfate pentahydrate 50 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 60 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10748 C10752 C10755

 

14

0

14

 

 

Capsule containing morphine sulfate pentahydrate 90 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10748 C10752 C10755

 

14

0

14

 

 

Capsule containing morphine sulfate pentahydrate 100 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 120 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10748 C10752 C10755

 

14

0

14

 

 

Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL

Injection

 

Morphine Juno

JU

MP NP MW

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

Injection containing morphine hydrochloride trihydrate 20 mg in 1 mL

Injection

 

Morphine Juno

JU

MP NP

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

Injection containing morphine hydrochloride trihydrate 50 mg in 5 mL

Injection

 

Morphine Juno

JU

MP NP

C10762 C10764 C10765

 

5

0

5

 

 

Injection containing morphine hydrochloride trihydrate 100 mg in 5 mL

Injection

 

Morphine Juno

JU

MP NP

C10762 C10764 C10765

 

5

0

5

 

 

Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

Injection

 

DBL Morphine Sulfate Pentahydrate

PF

MP NP MW

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

 

MORPHINE SULFATE 10 mg/1 mL MEDSURGE

DZ

MP NP MW

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

Injection containing morphine sulfate pentahydrate 15 mg in 1 mL

Injection

a

DBL Morphine Sulfate Pentahydrate

PF

MP NP MW

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

a

MORPHINE SULFATE 15 mg/1 mL MEDSURGE

DZ

MP NP MW

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

Injection containing morphine sulfate pentahydrate 30 mg in 1 mL

Injection

a

DBL Morphine Sulfate Pentahydrate

PF

MP NP

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

a

MORPHINE SULFATE 30 mg/1 mL MEDSURGE

DZ

MP NP

C10762 C10764 C10765

 

5

0

5

 

 

PDP

C10839

 

5

0

5

 

 

Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 200 mL

Oral

 

Ordine 2

MF

MP NP

C10764 C10770 C10777

 

1

0

1

 

 

PDP

C10859

 

1

0

1

 

 

Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 200 mL

Oral

 

Ordine 5

MF

MP NP

C10764 C10770 C10777

 

1

0

1

 

 

PDP

C10859

 

1

0

1

 

 

Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 200 mL

Oral

 

Ordine 10

MF

MP NP

C10764 C10770 C10777

 

1

0

1

 

 

PDP

C10859

 

1

0

1

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 20 mg per sachet

Oral

 

MS Contin Suspension 20 mg

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 30 mg per sachet

Oral

 

MS Contin Suspension 30 mg

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 60 mg per sachet

Oral

 

MS Contin Suspension 60 mg

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 100 mg per sachet

Oral

 

MS Contin Suspension 100 mg

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 200 mg per sachet

Oral

 

MS Contin Suspension 200 mg

MF

MP NP

C10756 C10814 C10836 C10858

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 5 mg (controlled release)

Oral

 

MS Contin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 10 mg

Oral

 

Sevredol

MF

MP NP

C6168 C10775 C10837 C10891

P10775 P10837 P10891

20

0

20

 

 

MP NP

C6168 C10775 C10837 C10891

P6168

20

2

20

 

 

Tablet containing morphine sulfate pentahydrate 10 mg (controlled release)

Oral

a

Momex SR 10

RW

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 15 mg (controlled release)

Oral

 

MS Contin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 20 mg

Oral

 

Sevredol

MF

MP NP

C6168 C10775 C10837 C10891

P10775 P10837 P10891

20

0

20

 

 

MP NP

C6168 C10775 C10837 C10891

P6168

20

2

20

 

 

Tablet containing morphine sulfate pentahydrate 30 mg

Oral

 

Anamorph

RW

MP NP

C10758 C10764 C10770 C10777

P10758

10

0

20

 

 

PDP

C10758 C10859

P10758

10

0

20

 

 

MP NP

C10758 C10764 C10770 C10777

P10764 P10770 P10777

20

0

20

 

 

PDP

C10758 C10859

P10859

20

0

20

 

 

Tablet containing morphine sulfate pentahydrate 30 mg (controlled release)

Oral

a

Momex SR 30

RW

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 60 mg (controlled release)

Oral

a

Momex SR 60

RW

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 100 mg (controlled release)

Oral

a

Momex SR 100

RW

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 200 mg (controlled release)

Oral

 

MS Contin

MF

MP NP

C6151 C10756 C10814 C10836 C10858

P10756 P10814 P10836 P10858

28

0

28

 

 

 

MP NP

C6151 C10756 C10814 C10836 C10858

P6151

28

2

28

 

 

[54]            Schedule 1, entry for Naloxone in the form Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

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

 

 

 

a

NALOXONE SXP

XC

MP NP PDP

 

 

5

0

5

 

 

[55]            Schedule 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)        omit from the column headed “Circumstances”: C8571

(b)        omit from the column headed “Circumstances”: C9253

[56]            Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

 

 

 

a

Olmekar HCT 20/5/12.5

RF

MP NP

C4311

 

30

5

30

 

 

[57]            Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

 

 

 

a

Olmekar HCT 40/5/12.5

RF

MP NP

C4311

 

30

5

30

 

 

[58]            Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

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

 

 

 

a

Olmekar HCT 40/5/25

RF

MP NP

C4311

 

30

5

30

 

 

[59]            Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

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

 

 

 

a

Olmekar HCT 40/10/12.5

RF

MP NP

C4311

 

30

5

30

 

 

[60]            Schedule 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

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

 

 

 

a

Olmekar HCT 40/10/25

RF

MP NP

C4311

 

30

5

30

 

 


 

[61]            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”:

 

 

 

 

Zotren ODT

RF

MP NP

C5618 C10498

P5618

4

0

4

 

 

MP

C5743

 

4

0

4

 

C(100)

[62]            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”:

 

 

 

 

Zotren ODT

RF

MP NP

C5618 C10498

P10498

10

1

10

 

 

[63]            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”:

 

 

 

 

Zotren ODT

RF

MP NP

C5618 C10498

P5618

4

0

4

 

 

MP

C5743

 

4

0

4

 

C(100)

[64]            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”:

 

 

 

 

Zotren ODT

RF

MP NP

C5618 C10498

P10498

10

1

10

 

 

[65]            Schedule 1, entry for Oxycodone

                             substitute:

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

a

Oxycodone BNM

LI

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

OxyNorm

MF

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Oxycodone BNM

LI

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

OxyNorm

MF

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

Capsule containing oxycodone hydrochloride 10 mg

Oral

a

Oxycodone BNM

LI

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

OxyNorm

MF

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Oxycodone BNM

LI

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

OxyNorm

MF

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

Capsule containing oxycodone hydrochloride 20 mg

Oral

a

Oxycodone BNM

LI

MP NP

C10764 C10771 C10772

 

20

0

20

 

 

a

OxyNorm

MF

MP NP

C10764 C10771 C10772

 

20

0

20

 

 

Oral solution containing oxycodone hydrochloride 1 mg per mL, 250 mL

Oral

 

OxyNorm Liquid 1mg/mL

MF

MP NP

C10764 C10771 C10772

 

1

0

1

 

 

PDP

C10768

 

1

0

1

 

 

Suppository 30 mg (as pectinate)

Rectal

 

Proladone

FF

MP NP

C10764 C10890 C10910

 

12

0

12

 

 

PDP

C10860

 

12

0

12

 

 

Tablet containing oxycodone hydrochloride 5 mg

Oral

a

Endone

AF

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Mayne Pharma Oxycodone IR

YN

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Oxycodone Aspen

AL

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Endone

AF

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Mayne Pharma Oxycodone IR

YN

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Oxycodone Aspen

AL

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

Tablet containing oxycodone hydrochloride 10 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 15 mg (controlled release)

Oral

 

OxyContin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 20 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 30 mg (controlled release)

Oral

 

OxyContin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 40 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 80 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10748 C10752 C10755

 

28

0

28

 

 

[66]            Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg; and Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg

                             omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

[67]            Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg; and Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg

                             omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

[68]            Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg; and Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg

omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

[69]            Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg; and Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg

                             omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755


 

[70]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg

                             omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

[71]            Schedule 1, entry for Palbociclib in each of the forms: Capsule 75 mg; Capsule 100 mg; and Capsule 125 mg

(a)        omit from the column headed “Circumstances”: C10013

(b)        omit from the column headed “Circumstances”: C10043

(c)        insert in numerical order in the column headed “Circumstances”: C10735

[72]            Schedule 1, entry for Pembrolizumab

(a)        omit from the column headed “Circumstances”: C9897

(b)        omit from the column headed “Circumstances”: C9966

(c)        omit from the column headed “Circumstances”: C10675

(d)        omit from the column headed “Circumstances”: C10685

(e)        insert in numerical order in the column headed “Circumstances”: C10809 C10888

[73]            Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)        omit from the column headed “Responsible Person”: TS                  substitute: TK

(b)        omit from the column headed “Circumstances”: C9466

(c)        omit from the column headed “Purposes”: P9466

[74]            Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

                             omit from the column headed “Circumstances”: C9466

[75]            Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 2]

(a)        omit from the column headed “Responsible Person”: TS                  substitute: TK

(b)        omit from the column headed “Circumstances”: C9466

(c)        omit from the column headed “Purposes”: P9466

[76]            Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

                             omit from the column headed “Circumstances”: C9466

[77]            Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg

(a)        omit:

 

 

 

a

Pravastatin generichealth

GQ

MP NP

 

 

30

5

30

 

 


 

(b)       omit:

 

 

 

a

Pravastatin generichealth

GQ

MP

 

P7598

30

11

30

 

 

[78]            Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)        omit from the column headed “Purposes”: P7515 P7551 P7552 P7560 P7561 P7562 P8012 P8017 P8026 P8027 P8029                                                                                                                                                                                                                         substitute: P10708 P10710 P10714 P10780 P10786 P10787 P10818 P10819 P10881 P10893

[79]            Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)        omit from the column headed “Purposes”: P7511 P7514                 substitute: P10785 P10882

[80]            Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)        omit from the column headed “Purposes”: P7515 P7551 P7552 P7560 P7561 P7562 P8012 P8017 P8026 P8027 P8029                                                                                                                                                                                                                         substitute: P10708 P10710 P10714 P10780 P10786 P10787 P10818 P10819 P10881 P10893

[81]            Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562 C8012 C8017 C8026 C8027 C8029 substitute: C10708 C10710 C10714 C10780 C10785 C10786 C10787 C10818 C10819 C10881 C10882 C10893

(b)        omit from the column headed “Purposes”: P7511 P7514                 substitute: P10785 P10882

[82]            Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

                             omit:

 

 

 

a

Ranitidine GH

GQ

MP NP MW

 

 

60

5

60

 

 

[83]            Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

                             omit:

 

 

 

a

Ranitidine GH

GQ

MP NP

 

 

30

5

30

 

 


 

[84]            Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances” (all instances): C10052

(b)        omit from the column headed “Purposes” (all instances): P10052

[85]            Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 5]

                             omit from the column headed “Circumstances” (all instances): C10052

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

(a)        omit from the column headed “Circumstances” (all instances): C10052

(b)        omit from the column headed “Purposes” (all instances): P10052

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

                             omit from the column headed “Circumstances” (all instances): C10052

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

(a)        omit from the column headed “Circumstances” (all instances): C10052

(b)        omit from the column headed “Purposes” (all instances): P10052

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

                             omit from the column headed “Circumstances” (all instances): C10052

[90]            Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)

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

 

 

 

 

Rizatriptan-AU

DZ

MP NP

C5708

 

4

5

2

 

 

[91]            Schedule 1, entry for Tadalafil

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

 

 

 

 

Tadalca

CR

MP

See Note 3

See Note 3

See Note 3

See Note 3

56

 

D(100)

[92]            Schedule 1, entry for Tapentadol in each of the forms: Tablet (modified release) 50 mg (as hydrochloride); and Tablet (modified release) 100 mg (as hydrochloride)

                           omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

[93]            Schedule 1, entry for Tapentadol in each of the forms: Tablet (modified release) 150 mg (as hydrochloride); and Tablet (modified release) 200 mg (as hydrochloride)

                             omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755


 

[94]            Schedule 1, entry for Tapentadol in the form Tablet (modified release) 250 mg (as hydrochloride)

                             omit from the column headed “Circumstances”: C10445            substitute: C10748 C10752 C10755

[95]            Schedule 1, entry for Tenofovir with emtricitabine and efavirenz

                             omit:

 

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg

Oral

 

Atripla

GI

MP NP

C4470 C4522

 

60

5

30

 

D(100)

[96]            Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]

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

 

 

 

a

NOUMED TERBINAFINE

VO

MP NP

C6395 C6404 C6453

P6404 P6453

42

0

42

 

 

[97]            Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 1]

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

 

 

 

a

NOUMED TERBINAFINE

VO

MP NP

C6395 C6404 C6453

P6395

42

1

42

 

 

[98]            Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]

(a)        omit from the column headed “Circumstances”: C8475 C8872 C8908 C8933 C8953 C8970 C8972 C8994 C8995 C8996 C9947 C9997 substitute: C10802 C10806 C10807 C10832 C10833 C10852 C10853 C10854 C10873 C10889

(b)        omit from the column headed “Purposes”: P8475 P8933 P8953 P8970 P8994              substitute: P10806 P10807 P10889

[99]            Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C8475 C8872 C8908 C8933 C8953 C8970 C8972 C8994 C8995 C8996 C9947 C9997 substitute: C10802 C10806 C10807 C10832 C10833 C10852 C10853 C10854 C10873 C10889

(b)        omit from the column headed “Purposes”: P8872 P8908 P8972 P8995 P8996 P9947 P9997                       substitute: P10802 P10832 P10833 P10852 P10853 P10854 P10873

[100]          Schedule 1, entry for Tramadol

                             substitute:

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

a

APO-Tramadol

TX

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Tramadol AMNEAL

EF

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Tramadol AN

EA

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Tramadol Sandoz

SZ

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Tramadol SCP

CR

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Tramal

CS

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Tramedo

AF

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

Zydol

RW

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

a

APO-Tramadol

TX

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Tramadol AMNEAL

EF

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Tramadol AN

EA

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Tramadol Sandoz

SZ

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Tramadol SCP

CR

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Tramal

CS

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Tramedo

AF

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

a

Zydol

RW

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

Injection containing tramadol hydrochloride 100 mg in 2 mL

Injection

a

Tramadol ACT

JO

MP NP

C10764 C10771 C10772

 

5

0

5

 

 

PDP

C10768

 

5

0

5

 

 

a

Tramadol AN

JU

MP NP

C10764 C10771 C10772

 

5

0

5

 

 

PDP

C10768

 

5

0

5

 

 

a

Tramadol Sandoz

SZ

MP NP

C10764 C10771 C10772

 

5

0

5

 

 

PDP

C10768

 

5

0

5

 

 

a

Tramal 100

CS

MP NP

C10764 C10771 C10772

 

5

0

5

 

 

PDP

C10768

 

5

0

5

 

 

Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL

Oral

 

Tramal

CS

MP NP

C10764 C10771 C10772

 

1

0

1

 

 

PDP

C10768

 

1

0

1

 

 

Tablet (sustained release) containing tramadol hydrochloride 50 mg

Oral

 

Tramal SR 50

CS

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

Tablet (sustained release) containing tramadol hydrochloride 100 mg

Oral

a

APO-Tramadol SR

TX

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol AN SR

EA

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol Sandoz SR

SZ

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol SR generichealth

GQ

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramal SR 100

CS

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramedo SR

AL

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Zydol SR 100

RW

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

Tablet (sustained release) containing tramadol hydrochloride 150 mg

Oral

a

APO-Tramadol SR

TX

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol AN SR

EA

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol Sandoz SR

SZ

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol SR generichealth

GQ

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramal SR 150

CS

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramedo SR

AL

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Zydol SR 150

RW

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

Tablet (sustained release) containing tramadol hydrochloride 200 mg

Oral

a

APO-Tramadol SR

TX

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol AN SR

EA

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol Sandoz SR

SZ

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramadol SR generichealth

GQ

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramal SR 200

CS

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Tramedo SR

AL

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

a

Zydol SR 200

RW

MP NP

C10748 C10752 C10755

 

20

0

20

 

 

[101]          Schedule 1, entry for Venetoclax in the form Tablet 100 mg

                             omit from the column headed “Circumstances”: C8579

[102]          Schedule 4, Part 1, entry for Adalimumab

(a)        omit:

 

C6951

 

 

Moderate to severe hidradenitis suppurativa
Initial treatment 1 - New patient
Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND
The treatment must be limited to a maximum duration of 16 weeks.
Must be treated by a dermatologist.
Assessment of disease severity must be no more than 1 month old at the time of application.
An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment.
At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics
(v) a signed patient acknowledgement.

Compliance with Authority Required procedures

(b)       omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C6963”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

(c)        omit:

 

C6971

P6971

 

Moderate to severe hidradenitis suppurativa
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

Compliance with Authority Required procedures

 

C6972

P6972

 

Moderate to severe hidradenitis suppurativa
Initial treatment 3 - Grandfathered patient
Patient must have been receiving treatment with this drug for this condition prior to 1 July 2017; AND
Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug; AND
Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
Assessment of disease severity must be no more than 1 month old at the time treatment with this drug was initiated.
A maximum of 24 weeks treatment will be authorised under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria or recommencement of treatment criteria where there is a break in treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics
(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment
(vi) a signed patient acknowledgement.

Compliance with Authority Required procedures

(d)       insert in numerical order after existing text:

 

C10838

P10838

 

Moderate to severe hidradenitis suppurativa
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and must be provided no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

Compliance with Written Authority Required procedures

 

C10892

 

 

Moderate to severe hidradenitis suppurativa
Initial treatment 1 - New patient
Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND
The treatment must be limited to a maximum duration of 16 weeks.
Must be treated by a dermatologist.
Assessment of disease severity must be no more than 1 month old at the time of application.
An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment.
At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.

Compliance with Written Authority Required procedures


 

[103]          Schedule 4, Part 1, entry for Aflibercept

                             substitute:

Aflibercept

C10708

P10708

 

Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to pathologic myopia (PM); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

 

C10715

P10715

 

Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

 

C10716

P10716

 

Diabetic macular oedema (DMO)
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

 

C10783

P10783

 

Central retinal vein occlusion with macular oedema
Initial treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

 

C10789

P10789

 

Branch retinal vein occlusion with macular oedema
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures

 

C10818

P10818

 

Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to pathologic myopia (PM); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.

Compliance with Authority Required procedures

 

C10826

P10826

 

Diabetic macular oedema (DMO)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures

 

C10827

P10827

 

Central retinal vein occlusion with macular oedema
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures

 

C10862

P10862

 

Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye.

Compliance with Authority Required procedures