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PB 78 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 27 Aug 2020
Tabling HistoryDate
Tabled HR31-Aug-2020
Tabled Senate31-Aug-2020
Date of repeal 08 Dec 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 78 of 2020

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 8)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA DANIEL, 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  26 August 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA DANIEL

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. 8).

(2)          This Instrument may also be cited as PB 78 of 2020.

2          Commencement

This Instrument commences on 1 September 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, after entry for Abiraterone in the form Tablet containing abiraterone acetate 500 mg

                           insert:

Acalabrutinib

Capsule 100 mg

Oral

 

Calquence

AP

MP

C10652 C10668 C10669

 

56

5

56

 

 

[2]             Schedule 1, entry for Adefovir 

                  (a)        omit from the column headed “Schedule Equivalent” for the brand “APO-Adefovir”: a

                  (b)        omit:

 

 

 

a

Hepsera

GI

MP NP

C4490 C4510

 

60

5

30

 

D(100)

[3]             Schedule 1, entry for Amitriptyline in each of the forms: Tablet containing amitriptyline hydrochloride 10 mg; Tablet containing amitriptyline hydrochloride 25 mg; and Tablet containing amitriptyline hydrochloride 50 mg         

                  (a)        omit:

 

 

 

a

Chem mart Amitriptyline

CH

MP NP

 

 

50

2

50

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Amitriptyline

TW

MP NP

 

 

50

2

50

 

 

[4]             Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

                  (a)        omit:

 

 

 

a

Moxiclav Duo 500/125

LN

MP NP

C5832 C5893 C10405

P5832 P5893

10

0

10

 

 

 

 

 

 

 

 

MW

C5832 C5893

 

10

0

10

 

 

 

 

 

 

 

 

PDP

C5833 C5894

 

10

0

10

 

 


 

                  (b)        omit:

 

 

 

a

Moxiclav Duo 500/125

LN

MP NP

C5832 C5893 C10405

P10405

20

0

10

 

 

[5]             Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) 

                  (a)        omit:

 

 

 

a

Moxiclav Duo Forte 875/125

LN

MP NP

C5832 C5893 C10413

P5832 P5893

10

0

10

 

 

 

 

 

 

 

 

PDP

C5833 C5894

 

10

0

10

 

 

                  (b)        omit:

 

 

 

a

Moxiclav Duo Forte 875/125

LN

MP NP

C5832 C5893 C10413

P10413

20

0

10

 

 

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

                  (a)        omit:

 

 

 

a

Chem mart Atenolol

CH

MP NP

 

 

30

5

30

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Atenolol

TW

MP NP

 

 

30

5

30

 

 

[7]             Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium) 

                  (a)        omit:

 

 

 

a

Terry White Chemists Atorvastatin

TW

MP NP

 

 

30

5

30

 

 


 

                  (b)        omit:

 

 

 

a

Terry White Chemists Atorvastatin

TW

MP

 

P7598

30

11

30

 

 

[8]             Schedule 1, entry for Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U.

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Bleomycin Sulfate

[9]             Schedule 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide
200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses 

                           omit from the column headed “Responsible Person” for the brand “DuoResp Spiromax” (all instances): TB                substitute: AF

[10]           Schedule 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide
400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

                           omit from the column headed “Responsible Person” for the brand “DuoResp Spiromax”: TB     substitute: AF

[11]           Schedule 1, entry for Calcitriol

                           omit from the column headed “Responsible Person” for the brand “Rocaltrol”: RO   substitute: IX

[12]           Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 150 mg in 15 mL; and Solution for I.V. injection 450 mg in
45 mL

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Carboplatin

[13]           Schedule 1, entry for Cefalotin

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Cephalothin 

[14]           Schedule 1, entry for Cefazolin

                           substitute:

Cefazolin

Powder for injection 500 mg (as sodium)

Injection

 

Cefazolin-AFT

AE

MP NP

C5826 C5867 C5881 C5890

 

10

0

5

 

 

 

Powder for injection 1 g (as sodium)

Injection

 

Cefazolin-AFT

AE

MP NP

C5861 C5882 C5883 C5891

 

10

0

5

 

 

 

Powder for injection 2 g (as sodium)

Injection

 

Cephazolin Alphapharm

AF

MP NP

C5826 C5867 C5881 C5890

 

10

0

1

 

 

 

 

 

 

 

 

MP NP

C5826 C5867 C5881 C5890

 

10

0

10

 

 


 

[15]           Schedule 1, entry for Cefotaxime in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)

omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Cefotaxime

[16]           Schedule 1, entry for Ceftriaxone

                           substitute:

Ceftriaxone

Powder for injection 500 mg
(as sodium)

Injection

 

Ceftriaxone-AFT

AE

MP NP

C5826 C5855 C5881 C5890

P5855

1

0

1

 

 

 

 

 

 

 

 

MP NP

C5826 C5855 C5881 C5890

P5826 P5881 P5890

5

0

1

 

 

 

Powder for injection 1 g
(as sodium)

Injection

a

Ceftriaxone-AFT

AE

MP NP

C5830 C5862 C5868

 

5

0

1

 

 

 

 

 

a

Ceftriaxone Alphapharm

AF

MP NP

C5830 C5862 C5868

 

5

0

5

 

 

 

 

 

 

 

 

MP NP

C5830 C5862 C5868

 

5

0

10

 

 

 

Powder for injection 2 g
(as sodium)

Injection

a

Ceftriaxone-AFT

AE

MP NP

C5826 C5881 C5890

 

5

0

1

 

 

 

 

 

a

Ceftriaxone Alphapharm

AF

MP NP

C5826 C5881 C5890

 

5

0

5

 

 

 

 

 

 

 

 

MP NP

C5826 C5881 C5890

 

5

0

10

 

 

[17]           Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

                           omit:

 

 

 

a

Ciproxin 500

BN

MP NP

C5614 C5615 C5687 C5688 C5689 C5722 C5780

 

14

0

14

 

 

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

                  (a)        omit:

 

 

 

a

Chem mart Citalopram

CH

MP NP

C4755

 

28

5

28

 

 


 

                  (b)        omit:

 

 

 

a

Terry White Chemists Citalopram

TW

MP NP

C4755

 

28

5

28

 

 

[19]           Schedule 1, entry for Clindamycin

                  (a)        omit:

 

 

 

a

Chem mart Clindamycin

CH

PDP

C5487

 

24

0

24

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Clindamycin

TW

PDP

C5487

 

24

0

24

 

 

                  (c)        omit:

 

 

 

a

Chem mart Clindamycin

CH

MP NP MW

C5470

 

48

1

24

 

 

                  (d)        omit:

 

 

 

a

Terry White Chemists Clindamycin

TW

MP NP MW

C5470

 

48

1

24

 

 

[20]           Schedule 1, entry for Crizotinib in each of the forms: Capsule 200 mg; and Capsule 250 mg

                  (a)        omit from the column headed “Circumstances”: C6994  

                  (b)        omit from the column headed “Circumstances”: C10595

                  (c)        insert in numerical order in the column headed “Circumstances”: C10650 C10665

[21]           Schedule 1, entry for Deferiprone in each of the forms: Oral solution 100 mg per mL, 250 mL; Tablet 500 mg; and Tablet 1000 mg   

                           omit from the column headed “Responsible Person”: TX             substitute: EU 

[22]           Schedule 1, entry for Desferrioxamine in each of the forms: Powder for injection containing desferrioxamine mesilate 500 mg; and Powder for injection containing desferrioxamine mesilate 2 g

                           omit from the column headed “Brand”: Hospira Pty Limited                     substitute: DBL Desferrioxamine Mesilate


 

[23]           Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg

                  (a)        omit:

 

 

 

a

Chem mart Donepezil

CH

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Donepezil

TW

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

                  (c)        omit:

 

 

 

a

Chem mart Donepezil

CH

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5

28

 

 

                  (d)        omit:

 

 

 

a

Terry White Chemists Donepezil

TW

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5

28

 

 

[24]           Schedule 1, entry for Entrectinib

                  (a)        omit from the column headed “Circumstances”: C10597 C10614

                  (b)        insert in numerical order in the column headed “Circumstances”: C10658 C10672

[25]           Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

                  (a)        omit:

 

 

 

a

Chem mart Escitalopram

CH

MP NP

C4755

 

28

5

28

 

 


 

                  (b)        omit:

 

 

 

a

Terry White Chemists Escitalopram

TW

MP NP

C4755

 

28

5

28

 

 

[26]           Schedule 1, entry for Heparin in the form Injection 5,000 units (as sodium) in 0.2 mL

                           omit from the column headed “Brand”: Hospira Pty Limited    substitute: DBL Heparin Sodium 

[27]           Schedule 1, entry for Ibrutinib [Maximum Quantity: 90; Number of Repeats: 5]

                  (a)        omit from the column headed “Circumstances”: C7871  

                  (b)        insert in numerical order in the column headed “Circumstances”: C10647

                  (c)        omit from the column headed “Purposes”: P7871            

                  (d)        insert in numerical order in the column headed “Purposes”: P10647

[28]           Schedule 1, entry for Ibrutinib [Maximum Quantity: 120; Number of Repeats: 5]

                  (a)        omit from the column headed “Circumstances”: C7871  

                  (b)        insert in numerical order in the column headed “Circumstances”: C10647

[29]           Schedule 1, after entry for Imipramine in the form Tablet containing imipramine hydrochloride 25 mg

                           insert:

 

Tablet containing imipramine hydrochloride 25 mg USP

Oral

 

Imipramine (Leading)

QY

MP NP

 

 

50

2

100

 

 

[30]           Schedule 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg               

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

 

 

 

a

Ardix Lurasidone

RX

MP NP

C4246

 

30

5

30

 

 

[31]           Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg 

                  (a)        omit:

 

 

 

 

Chem mart Meloxicam 7.5 mg

CH

MP NP

C4907 C4962

 

30

3

30

 

 


 

                  (b)        omit:

 

 

 

 

Terry White Chemists Meloxicam 7.5 mg

TW

MP NP

C4907 C4962

 

30

3

30

 

 

[32]           Schedule 1, entry for Meloxicam in the form Tablet 15 mg 

                  (a)        omit:

 

 

 

 

Chem mart Meloxicam 15 mg

CH

MP NP

C4907 C4962

 

30

3

30

 

 

                  (b)        omit:

 

 

 

 

Terry White Chemists Meloxicam 15 mg

TW

MP NP

C4907 C4962

 

30

3

30

 

 

[33]           Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

                           omit from the column headed “Brand”: Diabex XR       substitute: Diabex XR 500

[34]           Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

                  (a)        omit:

 

 

 

a

Chem mart Metformin

CH

MP NP

 

 

100

5

100

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Metformin

TW

MP NP

 

 

100

5

100

 

 

[35]           Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g 

                  (a)        omit:

 

 

 

a

Chem mart Metformin 1000

CH

MP NP

 

 

90

5

90

 

 


 

                  (b)        omit:

 

 

 

a

Terry White Chemists Metformin 1000

TW

MP NP

 

 

90

5

90

 

 

[36]           Schedule 1, entry for Methotrexate in the form Injection 5 mg in 2 mL vial

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Methotrexate

[37]           Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial

                           omit from the column headed “Brand” (all instances): Hospira Pty Limited       substitute: DBL Methotrexate

[38]           Schedule 1, entry for Methotrexate in each of the forms: Solution concentrate for I.V. infusion 500 mg in 20 mL vial; and Solution concentrate for I.V. infusion 1000 mg in 10 mL vial         

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Methotrexate

[39]           Schedule 1, after entry for Methylphenidate in the form Capsule containing methylphenidate hydrochloride 40 mg (modified release)

                           insert:

 

Capsule containing methylphenidate hydrochloride 60 mg (modified release)

Oral

 

Ritalin LA

NV

MP NP

C6298

 

30

5

30

 

 

[40]           Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

                  (a)        omit:

 

 

 

b

Chem mart Metoprolol

CH

MP NP

 

 

100

5

100

 

 

                  (b)        omit:

 

 

 

b

Terry White Chemists Metoprolol

TW

MP NP

 

 

100

5

100

 

 

[41]           Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

                  (a)        omit:

 

 

 

b

Chem mart Metoprolol

CH

MP NP

 

 

60

5

60

 

 


 

                  (b)        omit:

 

 

 

b

Terry White Chemists Metoprolol

TW

MP NP

 

 

60

5

60

 

 

[42]           Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

                  (a)        omit:

 

 

 

a

Chem mart Mirtazapine

CH

MP NP

C5650

 

30

5

30

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Mirtazapine

TW

MP NP

C5650

 

30

5

30

 

 

[43]           Schedule 1, entry for Mirtazapine in the form Tablet 45 mg 

                  (a)        omit:

 

 

 

a

Chem mart Mirtazapine

CH

MP NP

C5650

 

30

5

30

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Mirtazapine

TW

MP NP

C5650

 

30

5

30

 

 

[44]           Schedule 1, entry for Morphine in each of the forms: Injection containing morphine sulfate pentahydrate 10 mg in 1 mL; and Injection containing morphine sulfate pentahydrate 15 mg in 1 mL

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Morphine Pentahydrate

[45]           Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 30 mg in 1 mL

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Morphine Pentahydrate

[46]           Schedule 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride)

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

 

 

 

a

Nebivolol Sandoz

SZ

MP NP

C5324

 

56

5

28

 

 


 

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

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

 

 

 

a

Nebivolol Sandoz

SZ

MP NP

C5324

 

28

5

28

 

 

[48]           Schedule 1, entry for Nifedipine in the form Tablet 30 mg (controlled release) 

                           omit:

 

 

 

a

Adalat Oros 30

BN

MP NP

 

 

30

5

30

 

 

[49]           Schedule 1, entry for Nifedipine in the form Tablet 60 mg (controlled release) 

                           omit:

 

 

 

a

Adalat Oros 60

BN

MP NP

 

 

30

5

30

 

 

[50]           Schedule 1, entry for Osimertinib in the form Tablet 40 mg

                           omit from the column headed “Circumstances”: C8537                substitute: C10666

[51]           Schedule 1, entry for Osimertinib in the form Tablet 80 mg

                           omit from the column headed “Circumstances”: C8524 C8537                     substitute: C10663 C10666

[52]           Schedule 1, entry for Paroxetine

                  (a)        omit:

 

 

 

a

Chem mart Paroxetine

CH

MP NP

C4755 C6277 C6636

 

30

5

30

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Paroxetine

TW

MP NP

C4755 C6277 C6636

 

30

5

30

 

 

[53]           Schedule 1, entry for Pembrolizumab

                  (a)        omit from the column headed “Circumstances”: C9868 

                  (b)        omit from the column headed “Circumstances”: C9924

                  (c)        omit from the column headed “Circumstances”: C10088 C10142 C10159 C10181

                  (d)        insert in numerical order in the column headed “Circumstances”: C10675 C10676 C10678 C10679 C10681 C10682 C10683 C10685 C10687 C10688 C10689 C10693 C10695 C10696 C10697 C10701 C10702 C10704 C10705


 

[54]           Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

                  (a)        omit:

 

 

 

 

Chem mart Perindopril

CH

MP NP

 

 

30

5

30

 

 

                  (b)        omit:

 

 

 

 

Terry White Chemists Perindopril

TW

MP NP

 

 

30

5

30

 

 

[55]           Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

                  (a)        omit:

 

 

 

 

Chem mart Perindopril

CH

MP NP

 

 

30

5

30

 

 

                  (b)        omit:

 

 

 

 

Terry White Chemists Perindopril

TW

MP NP

 

 

30

5

30

 

 

[56]           Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

                  (a)        omit:

 

 

 

 

Chem mart Perindopril

CH

MP NP

 

 

30

5

30

 

 

                  (b)        omit:

 

 

 

 

Terry White Chemists Perindopril

TW

MP NP

 

 

30

5

30

 

 

[57]           Schedule 1, entry for Phenoxymethylpenicillin in the form Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

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

[58]           Schedule 1, entry for Promethazine 

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Promethazine Hydrochloride


 

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

                  (a)        omit:

 

 

 

a

Chem mart Quetiapine

CH

MP NP

C7893 C7916 C7927

 

60

0

60

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Quetiapine

TW

MP NP

C7893 C7916 C7927

 

60

0

60

 

 

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

                  (a)        omit:

 

 

 

a

Chem mart Quetiapine

CH

MP NP

C4246 C5611 C5639

 

90

5

90

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Quetiapine

TW

MP NP

C4246 C5611 C5639

 

90

5

90

 

 

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

                  (a)        omit:

 

 

 

a

Chem mart Quetiapine

CH

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Quetiapine

TW

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

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

                  (a)        omit:

 

 

 

a

Chem mart Quetiapine

CH

MP NP

C4246 C5611 C5639

 

60

5

60

 

 


 

                  (b)        omit:

 

 

 

a

Terry White Chemists Quetiapine

TW

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[63]           Schedule 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)   

                  (a)        omit:

 

 

 

a

Chem mart Rosuvastatin

CH

MP NP

 

 

30

5

30

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Rosuvastatin

TW

MP NP

 

 

30

5

30

 

 

                  (c)        omit:

 

 

 

a

Chem mart Rosuvastatin

CH

MP

 

P7598

30

11

30

 

 

                  (d)        omit:

 

 

 

a

Terry White Chemists Rosuvastatin

TW

MP

 

P7598

30

11

30

 

 

[64]           Schedule 1, entry for Roxithromycin in the form Tablet 150 mg

                  (a)        omit:

 

 

 

a

Chem mart Roxithromycin

CH

MP NP PDP

 

 

10

0

10

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Roxithromycin

TW

MP NP PDP

 

 

10

0

10

 

 


 

                  (c)        omit:

 

 

 

a

Chem mart Roxithromycin

CH

MP NP

 

P10404

20
CN10404

0
CN10404

10

 

 

                  (d)        omit:

 

 

 

a

Terry White Chemists Roxithromycin

TW

MP NP

 

P10404

20
CN10404

0
CN10404

10

 

 

[65]           Schedule 1, entry for Roxithromycin in the form Tablet 300 mg

                  (a)        omit:

 

 

 

a

Chem mart Roxithromycin

CH

MP NP PDP

 

 

5

0

5

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Roxithromycin

TW

MP NP PDP

 

 

5

0

5

 

 

                  (c)        omit:

 

 

 

a

Chem mart Roxithromycin

CH

MP NP

 

P10404

10
CN10404

0
CN10404

5

 

 

                  (d)        omit:

 

 

 

a

Terry White Chemists Roxithromycin

TW

MP NP

 

P10404

10
CN10404

0
CN10404

5

 

 

[66]           Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) 

                  (a)        omit from the column headed “Brand”: Ventolin       substitute: Ventolin CFC-Free with dose counter

                  (b)        omit from the column headed “Brand”: Zempreon            substitute: Zempreon CFC-Free with dose counter 


 

[67]           Schedule 1, entry for Simvastatin in each of the forms: Tablet 10 mg; Tablet 20 mg; Tablet 40 mg; and Tablet 80 mg

                  (a)        omit:

 

 

 

a

Chem mart Simvastatin

CH

MP NP

 

 

30

5

30

 

 

                  (b)        omit:

 

 

 

a

Terry White Chemists Simvastatin

TW

MP NP

 

 

30

5

30

 

 

                  (c)        omit:

 

 

 

a

Chem mart Simvastatin

CH

MP

 

P7598

30

11

30

 

 

                  (d)        omit:

 

 

 

a

Terry White Chemists Simvastatin

TW

MP

 

P7598

30

11

30

 

 

[68]           Schedule 1, entry for Tiotropium in the form Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

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

[69]           Schedule 1, entry for Tobramycin in the form Injection 80 mg in 2 mL

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Tobramycin

[70]           Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

                  (a)        omit:

 

 

 

a

Chem mart Tramadol

CH

MP NP

C10442 C10444

P10442

10

0

20

 

 

 

 

 

 

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

 

 

 

a

Terry White Chemists Tramadol

TW

MP NP

C10442 C10444

P10442

10

0

20

 

 

 

 

 

 

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 


 

                  (b)        omit:

 

 

 

a

Chem mart Tramadol

CH

MP NP

C10442 C10444

P10444

20

0

20

 

 

 

 

 

 

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

 

 

 

a

Terry White Chemists Tramadol

TW

MP NP

C10442 C10444

P10444

20

0

20

 

 

 

 

 

 

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

[71]           Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg 

                           omit:

 

 

 

a

Chem mart Tramadol SR

CH

MP NP

C10445

 

20

0

20

 

 

 

 

 

a

Terry White Chemists Tramadol SR

TW

MP NP

C10445

 

20

0

20

 

 

[72]           Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

                           omit from the column headed “Brand” (all instances): Hospira Pty Limited       substitute: DBL Vancomycin Hydrochloride

[73]           Schedule 1, entry for Vinblastine

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Vinblastine 

[74]           Schedule 1, entry for Vincristine

                           omit from the column headed “Brand”: Hospira Pty Limited       substitute: DBL Vincristine Sulfate 

[75]           Schedule 3, details relevant to Responsible Person code EU

                           omit from the column headed “Responsible Person” for the Code “EU”: Emerge Health Pty Ltd              substitute: Chiesi Australia Pty Ltd

[76]           Schedule 4, Part 1, after entry for Abiraterone

                           insert:

Acalabrutinib

C10652

 

 

Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Continuing treatment of relapsed or refractory CLL/SLL
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; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

 

C10668

 

 

Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND
Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR
Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medical Benefits Schedule listed test.

Compliance with Authority Required procedures

 

C10669

 

 

Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Grandfather treatment (initial treatment in a patient commenced on non-PBS-subsidised treatment)
Patient must have previously received non-PBS-subsidised treatment with this drug for relapsed or refractory CLL/SLL prior to 1 September 2020; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must have been considered unsuitable for treatment or retreatment with a purine analogue prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND
Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease) prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following being met prior to commencing non-PBS-subsidised treatment with this drug for this condition:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medical Benefits Schedule listed test.

Compliance with Authority Required procedures

[77]           Schedule 4, Part 1, entry for Crizotinib

                  (a)        omit:

 

C6994

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less.
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ALK-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ALK gene rearrangement in tumour material by FISH testing.

Compliance with Written Authority Required procedures

                  (b)        omit:

 

C10595

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

                  (c)        insert in numerical order after existing text:

 

C10650

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

 

C10665

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less.
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

[78]           Schedule 4, Part 1, entry for Entrectinib

                  (a)        omit:

 

C10597

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

 

C10614

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2020; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
The treatment must be as monotherapy; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing prior to initiating non-PBS subsidised treatment with this drug for this condition.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.
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.

Compliance with Written Authority Required procedures

                  (b)        insert in numerical order after existing text:

 

C10658

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

 

C10672

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2020; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
The treatment must be as monotherapy; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing prior to initiating non-PBS subsidised treatment with this drug for this condition.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form.
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.

Compliance with Written Authority Required procedures


 

[79]           Schedule 4, Part 1, entry for Ibrutinib

                  (a)        omit:

 

C7871

P7871

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH).

Compliance with Authority Required procedures

                  (b)        insert in numerical order after existing text:

 

C10647

P10647

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR
Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL; AND
Patient must be considered unsuitable for treatment or retreatment with a purine analogue.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH).

Compliance with Authority Required procedures


 

[80]           Schedule 4, Part 1, entry for Osimertinib

                           substitute:

Osimertinib

C10663

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND
Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form;
(b) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form;
(c) details of the pathology report from an Approved Pathology Authority confirming evidence of EGFR T790M mutation in tumour material while on or after first line EGFR TKI treatment; and
(d) date of commencement of first line EGFR TKI treatment and date of progression whilst on or after first line EGFR TKI treatment.

Compliance with Written Authority Required procedures

 

C10666

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.

Compliance with Authority Required procedures

[81]           Schedule 4, Part 1, entry for Pembrolizumab

                  (a)        omit:

 

C9868

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 9868

                  (b)        omit:

 

C9924

 

 

Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9924

                  (c)        omit:

 

C10088

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2 - 3 weekly treatment regimen
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10088

 

C10142

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10142

 

C10159

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1 - 3 weekly treatment regimen
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have been treated with an adjuvant programmed cell death-1 (PD-1) inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma; OR
Patient must have experienced disease recurrence after at least 6 months from completion of an adjuvant PD-1 inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma, followed by disease progression after treatment with a BRAF inhibitor (with or without MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10159

 

C10181

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 7 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10181

                  (d)        insert in numerical order after existing text:

 

C10675

 

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 6 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
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.

Compliance with Authority Required procedures

 

C10676

 

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment - 6 weekly treatment regimen
Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

 

C10678

 

 

Relapsed or refractory primary mediastinal B-cell lymphoma
Grandfather treatment (initial treatment of a patient commenced on non-PBS-subsidised treatment)
Patient must have received treatment with this drug for this condition prior to 1 September 2020; AND
The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND
Patient must have been treated with rituximab-based chemotherapy prior to initiating treatment with this drug for this condition; AND
Patient must have been experiencing relapsed/refractory disease prior to initiating treatment with this drug for this condition; AND
Patient must have been autologous stem cell transplant (ASCT) ineligible following a single line of treatment prior to initiating treatment with this drug for this condition; OR
Patient must have undergone an autologous stem cell transplant (ASCT) prior to initiating treatment with this drug for this condition; OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must have included rituximab-based chemotherapy, prior to initiating treatment with this drug for this condition; AND
Patient must not have received treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed primary mediastinal B-cell lymphoma pembrolizumab PBS Authority Application for Grandfathered patients, which includes:
(i) confirmation that histology results and PET/CT scans support a diagnosis of primary mediastinal B-cell lymphoma and are retained on the patient's medical records;
(ii) details of prior treatments for this condition

Compliance with Written Authority Required procedures

 

C10679

 

 

Relapsed or refractory primary mediastinal B-cell lymphoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime.

Compliance with Authority Required procedures

 

C10681

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment - 3 weekly treatment regimen
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 7 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10681

 

C10682

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment - 3 weekly treatment regimen
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10682

 

C10683

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment - 6 weekly treatment regimen
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10683

 

C10685

 

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 3 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
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.

Compliance with Authority Required procedures

 

C10687

 

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment - 3 weekly treatment regimen
The treatment must be adjuvant to complete surgical resection; AND
Patient must have a WHO performance status of 1 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

 

C10688

 

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment - 6 weekly treatment regimen
The treatment must be adjuvant to complete surgical resection; AND
Patient must have a WHO performance status of 1 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

 

C10689

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment - 6 weekly treatment regimen
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 3 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10689

 

C10693

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment - 6 weekly treatment regimen
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10693

 

C10695

 

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment - 3 weekly treatment regimen
Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

 

C10696

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment - 3 weekly treatment regimen
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10696

 

C10697

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment - 3 weekly treatment regimen
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10697

 

C10701

 

 

Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment - 6 weekly treatment regimen
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10701

 

C10702

 

 

Relapsed or refractory primary mediastinal B-cell lymphoma
Initial treatment
The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND
Patient must have been treated with rituximab-based chemotherapy for this condition; AND
Patient must be experiencing relapsed/refractory disease; AND
Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR
Patient must have undergone an autologous stem cell transplant (ASCT); OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed primary mediastinal B-cell lymphoma pembrolizumab PBS Authority Application, which includes:
(i) confirmation that histology results with PET/CT scans support a diagnosis of primary mediastinal B-cell lymphoma and are retained on the patient's medical records;
(ii) details of prior treatments for this condition.

Compliance with Written Authority Required procedures

 

C10704

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment - 6 weekly treatment regimen
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
The treatment must not exceed a total of 4 doses under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10704

 

C10705

 

 

Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment - 3 weekly treatment regimen
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10705

[82]           Schedule 4, Part 1, entry for Venetoclax

                           omit entry for Circumstances Code “C8579” and substitute: 

 

C8579

 

 

Chronic lymphocytic leukaemia (CLL)
Grandfathered treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND
Patient must have been considered unsuitable for treatment or retreatment with a purine analogue prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND
The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment with this drug for this condition, whichever comes first.
A Grandfathered 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.

Compliance with Authority Required procedures

[83]           Schedule 5, after entry for Imatinib in the form Tablet 400 mg (as mesilate) [GRP-21080] 

                           insert:

Imipramine

GRP-24222

Tablet containing imipramine hydrochloride 25 mg

Oral

Tofranil 25

 

 

Tablet containing imipramine hydrochloride 25 mg USP

Oral

Imipramine (Leading)


 

[84]           Schedule 5, entry for Meloxicam in the form Tablet 15 mg [GRP-15468]

                  (a)        omit from the column headed “Brand”: Chem mart Meloxicam 15 mg

                  (b)        omit from the column headed “Brand”: Terry White Chemists Meloxicam 15 mg

[85]           Schedule 5, entry for  Meloxicam in the form Tablet 7.5 mg [GRP-15658] 

                  (a)        omit from the column headed “Brand”: Chem mart Meloxicam 7.5 mg

                  (b)        omit from the column headed “Brand”: Terry White Chemists Meloxicam 7.5 mg

[86]           Schedule 5, entry for  Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg [GRP-24200]

                           omit from the column headed “Brand”: Diabex XR                    substitute: Diabex XR 500

[87]           Schedule 5, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL [GRP-20890]

                           omit from the column headed “Brand”: Hospira Pty Limited                     substitute: DBL Morphine Pentahydrate

[88]           Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442] 

                  (a)        omit from the column headed “Brand”: Chem mart Perindopril

                  (b)        omit from the column headed “Brand”: Terry White Chemists Perindopril

[89]           Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]  

                  (a)        omit from the column headed “Brand”: Chem mart Perindopril

                  (b)        omit from the column headed “Brand”: Terry White Chemists Perindopril

[90]           Schedule 5, entry for Perindoprilin the form Tablet containing perindopril erbumine 2 mg [GRP-15965]

                  (a)        omit from the column headed “Brand”: Chem mart Perindopril

                  (b)        omit from the column headed “Brand”: Terry White Chemists Perindopril

[91]           Schedule 5, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) [GRP-24211]

                  (a)        omit from the column headed “Brand”: Ventolin          substitute: Ventolin CFC-Free with dose counter

                  (b)        omit from the column headed “Brand”: Zempreon       substitute: Zempreon CFC-Free with dose counter