National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 9) (No. PB 57 of 2011) (Cth)

Case

PB 57 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.9)1


National Health Act 1953

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

Dated 29 August 2011

FELICITY McNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 9).

(2)        This Instrument may also be cited as PB 57 of 2011.

2          Commencement

This Instrument commences on 1 September 2011.  

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

Schedule 1 and Schedule 2 amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).

Schedule 1     Amendments relating to Medicare references

[1]Section 4, text of Note

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

[2]Paragraph 11(2)(a)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

[3]Paragraph 11(2)(b)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

[4]Paragraph 12(1)(a)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

[5]Paragraph 12(1)(b)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

[6]Paragraph 12(1)(c)

omit:       Medicare Australia CEO (wherever occurring)   substitute:             Chief Executive Medicare

[7]Paragraph 12(1)(d)

omit:       Medicare Australia CEO (twice occurring)   substitute:             Chief Executive Medicare

[8]Subsection 12(2)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

[9]Subsection 12(3)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Subsection 12(4)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Subsection 13(1)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Subparagraph 13(1)(b)(i)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Subsection 13(2)

omit:       Medicare Australia CEO (twice occurring)   substitute:             Chief Executive Medicare

  1. Subsection 13(3)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Subsection 13(4)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Paragraph 13(4)(a)

(a)  omit:               Medicare Australia CEO   substitute:             Chief Executive Medicare

(b)  omit:               CEO   substitute:             Chief Executive Medicare

  1. Subsection 13(5)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Subsection 13(6)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Subsection 14(2)

omit:       Medicare Australia CEO   substitute:             Chief Executive Medicare

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 2]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C3750
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P2986 P2990
P2993 P3695
P3747 P3753
P3754
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C3750
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P3486 P3502
P3520 P3706
P3743 P3745
P3749 P3751
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 4]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C3750
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P3265 P3267
P3758 P3759
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C3750
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P2988 P2995
P3522 P3697
P3744 P3746
P3748 P3750
P3752 P3755
P3756 P3757
P3760 P3761
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 2]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C3750
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P2986 P2990
P2993 P3695
P3747 P3753
P3754
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C3750
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P3486 P3502
P3520 P3706
P3743 P3745
P3749 P3751
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 4]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C3750
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P3265 P3267
P3758 P3759
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986 C2988
C2990 C2993
C2995 C3265
C3267 C3486
C3502 C3520
C3522 C3695
C3697 C3706
C3743 C3744
C3745 C3746
C3747 C3748
C3749 C370
C3751 C3752
C3753 C3754
C3755 C3756
C3757 C3758
C3759 C3760
C3761

(b)           omit all codes from the column headed “Purposes” and substitute:

P2988 P2995
P3522 P3697
P3744 P3746
P3748 P3750
P3752 P3755
P3756 P3757
P3760 P3761
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe, 6

omit all codes from the column headed “Circumstances” and substitute:

C2986 C2990
C2993 C3695
C3747 C3753
C3754
  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6

omit all codes from the column headed “Circumstances” and substitute:

C2986 C2990
C2993 C3695
C3747 C3753
C3754
  1. Schedule 1, entry for Bortezomib in the form Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) [Max Quantity 4; Number of Repeats 2]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3762 C3763
C3764 C3765
C3766 C3767

(b)           omit both codes from the column headed “Purposes” and substitute:

P3764 P3767
  1. Schedule 1, entry for Bortezomib in the form Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) [Max Quantity 4; Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3762 C3763
C3764 C3765
C3766 C3767

(b)           omit all codes from the column headed “Purposes” and substitute:

P3762 P3763
P3765 P3766
  1. Schedule 1, entry for Certolizumab pegol

omit all codes from the column headed “Circumstances” and substitute:

C3476 C3714
C3768 C3769
  1. Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL [Max Quantity 2; Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273 C3275
C3489 C3510
C3524 C3708
C3770 C3771
C3772 C3773
C3774 C3775
C3776 C3777
C3778 C3779
C3780 C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3273 P3275
P3489 P3510
P3524 P3708
P3770 P3772
P3774 P3776
P3778 P3779
  1. Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL [Max Quantity 2; Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273 C3275
C3489 C3510
C3524 C3708
C3770 C3771
C3772 C3773
C3774 C3775
C3776 C3777
C3778 C3779
C3780 C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3771 P3773
P3775 P3777
P3780 P3781
  1. Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Max Quantity 1; Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273 C3275
C3489 C3510
C3524 C3708
C3770 C3771
C3772 C3773
C3774 C3775
C3776 C3777
C3778 C3779
C3780 C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3273 P3275
P3489 P3510
P3524 P3708
P3770 P3772
P3774 P3776
P3778 P3779
  1. Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Max Quantity 1;
    Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273 C3275
C3489 C3510
C3524 C3708
C3770 C3771
C3772 C3773
C3774 C3775
C3776 C3777
C3778 C3779
C3780 C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3771 P3773
P3775 P3777
P3780 P3781
  1. Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Max Quantity 1; Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273 C3275
C3489 C3510
C3524 C3708
C3770 C3771
C3772 C3773
C3774 C3775
C3776 C3777
C3778 C3779
C3780 C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3273 P3275
P3489 P3510
P3524 P3708
P3770 P3772
P3774 P3776
P3778 P3779
  1. Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Max Quantity 1; Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273 C3275
C3489 C3510
C3524 C3708
C3770 C3771
C3772 C3773
C3774 C3775
C3776 C3777
C3778 C3779
C3780 C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3771 P3773
P3775 P3777
P3780 P3781
  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Max Quantity 1;
    Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484 C3495
C3497 C3516
C3518 C3718
C3782 C3783
C3784 C3785
C3786 C3787

(b)           omit all codes from the column headed “Purposes” and substitute:

P3495 P3516
P3718 P3782
P3784 P3786
  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Max Quantity 1;
    Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484 C3495
C3497 C3516
C3518 C3718
C3782 C3783
C3784 C3785
C3786 C3787

(b)           omit all codes from the column headed “Purposes” and substitute:

P3484 P3497
P3518 P3783
P3785 P3787
  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Max Quantity 1;
    Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484 C3495
C3497 C3516
C3518 C3718
C3782 C3783
C3784 C3785
C3786 C3787

(b)           omit all codes from the column headed “Purposes” and substitute:

P3495 P3516
P3718 P3782
P3784 P3786
  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Max Quantity 1;
    Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484 C3495
C3497 C3516
C3518 C3718
C3782 C3783
C3784 C3785
C3786 C3787

(b)           omit all codes from the column headed “Purposes” and substitute:

P3484 P3497
P3518 P3783
P3785 P3787
  1. Schedule 1, entry for Ranibizumab

omit from the column headed “Circumstances”:          C2822                 substitute:             C3788

  1. Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Max Quantity 1; Number of Repeats 1]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3248 C3250
C3789 C3790
C3791 C3792

(b)           omit both codes from the column headed “Purposes” and substitute:

P3791 P3792
  1. Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Max Quantity 1; Number of Repeats 2]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3248 C3250
C3789 C3790
C3791 C3792

(b)           omit all codes from the column headed “Purposes” and substitute:

P3248 P3250
P3789 P3790
  1. Schedule 1, entry for Verteporfin

omit all codes from the column headed “Circumstances” and substitute:

C3793 C3794
C3795
  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2987]

(a)           omit from the column headed “Circumstances Code”:           C2987                substitute:          C3753

(b)           omit from the column headed “Purposes Code”:       P2987                substitute:          P3753

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2989]

(a)           omit from the column headed “Circumstances Code”:           C2989                substitute:          C3755

(b)           omit from the column headed “Purposes Code”:       P2989                substitute:          P3755

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2991]

(a)           omit from the column headed “Circumstances Code”:           C2991                substitute:          C3754

(b)           omit from the column headed “Purposes Code”:       P2991                substitute:          P3754

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2992]

(a)           omit from the column headed “Circumstances Code”:           C2992                substitute:          C3756

(b)           omit from the column headed “Purposes Code”:       P2992                substitute:          P3756

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2994]

(a)           omit from the column headed “Circumstances Code”:           C2994                substitute:          C3757

(b)           omit from the column headed “Purposes Code”:       P2994                substitute:          P3757

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3266]

(a)           omit from the column headed “Circumstances Code”:           C3266                substitute:          C3758

(b)           omit from the column headed “Purposes Code”:       P3266                substitute:          P3758

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3268]

(a)           omit from the column headed “Circumstances Code”:           C3268                substitute:          C3759

(b)           omit from the column headed “Purposes Code”:       P3268                substitute:          P3759

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3270]

(a)           omit from the column headed “Circumstances Code”:           C3270                substitute:          C3760

(b)           omit from the column headed “Purposes Code”:       P3270                substitute:          P3760

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3272]

(a)           omit from the column headed “Circumstances Code”:           C3272                substitute:          C3761

(b)           omit from the column headed “Purposes Code”:       P3272                substitute:          P3761

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3487]

(a)           omit from the column headed “Circumstances Code”:           C3487                substitute:          C3749

(b)           omit from the column headed “Purposes Code”:       P3487                substitute:          P3749

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3488]

(a)           omit from the column headed “Circumstances Code”:           C3488                substitute:          C3750

(b)           omit from the column headed “Purposes Code”:       P3488                substitute:          P3750

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3503]

(a)           omit from the column headed “Circumstances Code”:           C3503                substitute:          C3751

(b)           omit from the column headed “Purposes Code”:       P3503                substitute:          P3751

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3504]

(a)           omit from the column headed “Circumstances Code”:           C3504                substitute:          C3752

(b)           omit from the column headed “Purposes Code”:       P3504                substitute:          P3752

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3521]

(a)           omit from the column headed “Circumstances Code”:           C3521                substitute:          C3743

(b)           omit from the column headed “Purposes Code”:       P3521                substitute:          P3743

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3523]

(a)           omit from the column headed “Circumstances Code”:           C3523                substitute:          C3744

(b)           omit from the column headed “Purposes Code”:       P3523                substitute:          P3744

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3570]

(a)           omit from the column headed “Circumstances Code”:           C3570                substitute:          C3746

(b)           omit from the column headed “Purposes Code”:       P3570                substitute:          P3746

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3696]

(a)           omit from the column headed “Circumstances Code”:           C3696                substitute:          C3747

(b)           omit from the column headed “Purposes Code”:       P3696                substitute:          P3747

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3698]

(a)           omit from the column headed “Circumstances Code”:           C3698                substitute:          C3748

(b)           omit from the column headed “Purposes Code”:       P3698                substitute:          P3748

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3707]

(a)           omit from the column headed “Circumstances Code”:           C3707                substitute:          C3745

(b)           omit from the column headed “Purposes Code”:       P3707                substitute:          P3745

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Adalimumab

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

  1. Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3196]

(a)           omit from the column headed “Circumstances Code”:           C3196                substitute:          C3765

(b)           omit from the column headed “Purposes Code”:       P3196                substitute:          P3765

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3681]

(a)           omit from the column headed “Circumstances Code”:           C3681                substitute:          C3766

(b)           omit from the column headed “Purposes Code”:       P3681                substitute:          P3766

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3682]

(a)           omit from the column headed “Circumstances Code”:           C3682                substitute:          C3767

(b)           omit from the column headed “Purposes Code”:       P3682                substitute:          P3767

(c)           omit from the column headed “Circumstances and Purposes”, paragraph (g):    authorization                   substitute:                authorisation

(d)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3683]

(a)           omit from the column headed “Circumstances Code”:           C3683                substitute:          C3762

(b)           omit from the column headed “Purposes Code”:       P3683                substitute:          P3762

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3684]

(a)           omit from the column headed “Circumstances Code”:           C3684                substitute:          C3763

(b)           omit from the column headed “Purposes Code”:       P3684                substitute:          P3763

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3685]

(a)           omit from the column headed “Circumstances Code”:           C3685                substitute:          C3764

(b)           omit from the column headed “Purposes Code”:       P3685                substitute:          P3764

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Bortezomib

display re-numbered (amended) Circumstances and Purposes in numerical order

  1. Schedule 4, Part 1, entry for Certolizumab pegol [Circumstances Code C3564]

(a)           omit from the column headed “Circumstances Code”:           C3564                substitute:          C3768

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Certolizumab pegol [Circumstances Code C3715]

(a)           omit from the column headed “Circumstances Code”:           C3715                substitute:          C3769

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Certolizumab pegol

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3274]

(a)           omit from the column headed “Circumstances Code”:           C3274                substitute:          C3778

(b)           omit from the column headed “Purposes Code”:       P3274                substitute:          P3778

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3276]

(a)           omit from the column headed “Circumstances Code”:           C3276                substitute:          C3779

(b)           omit from the column headed “Purposes Code”:       P3276                substitute:          P3779

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3277]

(a)           omit from the column headed “Circumstances Code”:           C3277                substitute:          C3780

(b)           omit from the column headed “Purposes Code”:       P3277                substitute:          P3780

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3278]

(a)           omit from the column headed “Circumstances Code”:           C3278                substitute:          C3781

(b)           omit from the column headed “Purposes Code”:       P3278                substitute:          P3781

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3490]

(a)           omit from the column headed “Circumstances Code”:           C3490                substitute:          C3776

(b)           omit from the column headed “Purposes Code”:       P3490                substitute:          P3776

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3491]

(a)           omit from the column headed “Circumstances Code”:           C3491                substitute:          C3777

(b)           omit from the column headed “Purposes Code”:       P3491                substitute:          P3777

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3511]

(a)           omit from the column headed “Circumstances Code”:           C3511                substitute:          C3774

(b)           omit from the column headed “Purposes Code”:       P3511                substitute:          P3774

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3512]

(a)           omit from the column headed “Circumstances Code”:           C3512                substitute:          C3775

(b)           omit from the column headed “Purposes Code”:       P3512                substitute:          P3775

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3525]

(a)           omit from the column headed “Circumstances Code”:           C3525                substitute:          C3770

(b)           omit from the column headed “Purposes Code”:       P3525                substitute:          P3770

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3526]

(a)           omit from the column headed “Circumstances Code”:           C3526                substitute:          C3771

(b)           omit from the column headed “Purposes Code”:       P3526                substitute:          P3771

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3567]

(a)           omit from the column headed “Circumstances Code”:           C3567                substitute:          C3773

(b)           omit from the column headed “Purposes Code”:       P3567                substitute:          P3773

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3709]

(a)           omit from the column headed “Circumstances Code”:           C3709                substitute:          C3772

(b)           omit from the column headed “Purposes Code”:       P3709                substitute:          P3772

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Etanercept

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

  1. Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3496]

(a)           omit from the column headed “Circumstances Code”:           C3496                substitute:          C3784

(b)           omit from the column headed “Purposes Code”:       P3496                substitute:          P3784

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3498]

(a)           omit from the column headed “Circumstances Code”:           C3498                substitute:          C3785

(b)           omit from the column headed “Purposes Code”:       P3498                substitute:          P3785

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3517]

(a)           omit from the column headed “Circumstances Code”:           C3517                substitute:          C3786

(b)           omit from the column headed “Purposes Code”:       P3517                substitute:          P3786

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3519]

(a)           omit from the column headed “Circumstances Code”:           C3519                substitute:          C3787

(b)           omit from the column headed “Purposes Code”:       P3519                substitute:          P3787

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3578]

(a)           omit from the column headed “Circumstances Code”:           C3578                substitute:          C3783

(b)           omit from the column headed “Purposes Code”:       P3578                substitute:          P3783

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3719]

(a)           omit from the column headed “Circumstances Code”:           C3719                substitute:          C3782

(b)           omit from the column headed “Purposes Code”:       P3719                substitute:          P3782

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Golimumab

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

  1. Schedule 4, Part 1, entry for Ranibizumab [Circumstances Code C2822]

(a)           omit from the column headed “Circumstances Code”:           C2822                substitute:          C3788

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3249]

(a)           omit from the column headed “Circumstances Code”:           C3249                substitute:          C3789

(b)           omit from the column headed “Purposes Code”:       P3249                substitute:          P3789

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3251]

(a)           omit from the column headed “Circumstances Code”:           C3251                substitute:          C3790

(b)           omit from the column headed “Purposes Code”:       P3251                substitute:          P3790

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3253]

(a)           omit from the column headed “Circumstances Code”:           C3253                substitute:          C3791

(b)           omit from the column headed “Purposes Code”:       P3253                substitute:          P3791

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3255]

(a)           omit from the column headed “Circumstances Code”:           C3255                substitute:          C3792

(b)           omit from the column headed “Purposes Code”:       P3255                substitute:          P3792

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Ustekinumab

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

  1. Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2683]

(a)           omit from the column headed “Circumstances Code”:           C2683                substitute:          C3793

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2684]

(a)           omit from the column headed “Circumstances Code”:           C2684                substitute:          C3794

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

substitute:             Chief Executive Medicare

  1. Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2685]

(a)           omit from the column headed “Circumstances Code”:           C2685                substitute:          C3795

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

Schedule 2     Amendments relating to PBS changes

[1]Schedule 1, omit entry for Amiloride

[2]Schedule 1, entry for Bromocriptine in the form Capsule 5 mg (as mesylate)

omit:

Parlodel NV MP C1001 C1255 C1841 C1842 C1843 C1844 60 5

[3]Schedule 1, entry for Bromocriptine in the form Capsule 10 mg (as mesylate)

omit:

Parlodel NV MP C1001 C1255 C1841 C1842 C1843 C1844 100 5

[4]Schedule 1, after entry for Buprenorphine with naloxone in the form Tablet (sublingual) 8 mg (as hydrochloride)-2 mg (as hydrochloride)

insert in the columns in the order indicated:

Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride) Sublingual Suboxone Film 2/0.5 RC

MP NP

See Note 1

See Note 3 See Note 3 See Note 3 See Note 3 D
Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride) Sublingual Suboxone Film 8/2 RC

MP NP

See Note 1

See Note 3 See Note 3 See Note 3 See Note 3 D

[5]Schedule 1, entry for Calcipotriol

omit from the column headed “Responsible Person” (twice occurring):   CS       substitute:        LO

[6]Schedule 1, entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

omit from the column headed “Responsible Person”:                 CS       substitute:        LO

  1. Schedule 1, after entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

insert in the columns in the order indicated:

Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g Application Daivobet 50/500 gel LO MP NP C3827 1 1

[8]Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 100 mg in 20 mL [Max Quantity 1; Number of Repeats 0]

(a)        omit all codes from the column headed “Circumstances” and substitute:

C2713 C2714
C2715 C3843
C3844

(b)        omit all codes from the column headed “Purposes” and substitute:

P2713 P2714
P3843 P3844

[9]Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 100 mg in 20 mL [Max Quantity 1; Number of Repeats 6]

omit all codes from the column headed “Circumstances” and substitute:

C2713 C2714
C2715 C3843
C3844
  1. Schedule 1, entry for Cetuximab Solution for I.V. infusion 500 mg in 100 mL [Max Quantity 1; Number of Repeats 0]

(a)        omit all codes from the column headed “Circumstances” and substitute:

C2713 C2714
C2715 C3843
C3844

(b)        omit all codes from the column headed “Purposes” and substitute:

P2713 P2714
P3843 P3844
  1. Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 500 mg in 100 mL [Max Quantity 1; Number of Repeats 6]

omit all codes from the column headed “Circumstances” and substitute:

C2713 C2714
C2715 C3843
C3844
  1. Schedule 1, entry for Cimetidine

omit:

Tablet 200 mg Oral Magicul 200 AF MP NP 120 5
  1. Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL

substitute:

Eye drops 3 mg (as hydrochloride) per mL, 5 mL Application to the eye CiloQuin IQ MP C1031 2 0
AO C3830 2 0
Ciloxan AQ MP C1031 2 0
AO C3830 2 0
  1. Schedule 1, after entry for Clopidogrel in the form Tablet 75 mg (as besilate) (Clovix 75)

insert in the columns in the order indicated:

Tablet 75 mg Oral Clopidogrel-DRLA RZ MP NP

C1719 C1720

C1721 C1722

C1723 C1724

28 5
  1. Schedule 1, omit entry for Clotrimazole

  1. Schedule 1, entry for Dalteparin in each of the forms: Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe; and Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe

(a)           omit from the column headed “Max Quantity”:   10        substitute:        20

(b)           omit from the column headed “Number of Repeats”:                  1         substitute:        0

  1. Schedule 1, after entry for Dalteparin in the form Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose
    pre-filled syringe

insert in the columns in the order indicated:

Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe Injection Fragmin PF MP NP 10 1
  1. Schedule 1, entry for Deferasirox

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

C3828 C3829
  1. Schedule 1, entry for Dexamethasone

omit:

Eye drops 1 mg per mL, 5 mL Application to the eye Maxidex AQ MP NP 1 2

substitute:

Eye drops 1 mg per mL, 5 mL Application to the eye Maxidex AQ AO 1 0
MP NP 1 2
  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride)

(a)           omit:

Vibramycin PF PDP 7 0

(b)           omit:

Vibramycin PF MP NP 7 1

(c)           omit:

Vibramycin PF MP NP P1459 21 0

(d)           omit:

Vibramycin PF MP NP P1279 28 0
  1. Schedule 1, after entry for Enoxaparin in the form Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe

insert in the columns in the order indicated:

MP NP P1148 20 3
  1. Schedule 1, after entry for Enoxaparin in the form Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe

insert in the columns in the order indicated:

MP NP P1148 20 3
  1. Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

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

Escitalopram-DRLA RZ MP NP C1211 28 5
  1. Schedule 1, entry for Exemestane in the form Tablet 25 mg

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

Exemestane Pfizer FZ MP NP C1541 C2457 30 5
  1. Schedule 1, after entry for Fentanyl in the form Lozenges 1600 micrograms (as citrate), 30

insert in the columns in the order indicated:

Transdermal patch 1.28 mg Transdermal Denpax AF MP NP C1062 5 0
Transdermal patch 2.063 mg Transdermal Fenpatch 12 ZP MP NP C1062 5 0
  1. Schedule 1, after entry for Fentanyl in the form Transdermal patch 2.55 mg

insert in the columns in the order indicated:

Transdermal patch 4.125 mg Transdermal Fenpatch 25 ZP MP NP C1062 5 0
  1. Schedule 1, after entry for Fentanyl in the form Transdermal patch 7.65 mg

insert in the columns in the order indicated:

Transdermal patch 8.25 mg Transdermal Fenpatch 50 ZP MP NP C1062 5 0
  1. Schedule 1, after entry for Fentanyl in the form Transdermal patch 10.20 mg

insert in the columns in the order indicated:

Transdermal patch 12.375 mg Transdermal Fenpatch 75 ZP MP NP C1062 5 0
  1. Schedule 1, after entry for Fentanyl in the form Transdermal patch 12.6 mg

insert in the columns in the order indicated:

Transdermal patch 16.5 mg Transdermal Fenpatch 100 ZP MP NP C1062 5 0
  1. Schedule 1, after entry for Fentanyl in the form Transdermal patch 16.8 mg

insert in the columns in the order indicated:

Ferrous fumarate Tablet 200 mg (equivalent to 67.5 mg iron) Oral Ferro-tab AE MP NP 60 1
  1. Schedule 1, entry for Filgrastim in each of the forms Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim); Injection 300 micrograms in 1 mL; Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen); Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim); Injection 480 micrograms in 1.6 mL; Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen); and Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)

insert in numerical order in the column headed “Circumstances”:

C3833  C3834

  1. Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)

insert:

Fingolimod Capsule 500 micrograms (as hydrochloride) Oral Gilenya NV MP C3845 C3846 28 5
  1. Schedule 1, after entry for Fluconazole in the form Capsule 200 mg (Ozole)

insert in the columns in the order indicated:

Powder for oral suspension 50 mg in 5 mL, 35 mL Oral Diflucan PF MP NP

C3835 C3836

C3837 C3838

C3839 C3840

1 0
  1. Schedule 1, entry for Flupenthixol Decanoate

insert as first item in the columns in the order indicated:

Oily I.M. injection 20 mg in 1 mL Injection Fluanxol Depot LU MP NP 5 0
  1. Schedule 1, entry for Folinic acid

omit from the column headed “Authorised Prescriber” (all instances):                  NP

  1. Schedule 1, entry for Gabapentin in the form Capsule 100 mg

omit:

Gantin AW MP NP C2664 100 5
  1. Schedule 1, entry for Gentamicin

omit:

Eye drops 3 mg (as sulfate) per mL, 5 mL Application to the eye Genoptic AG MP

C1188 C1391

C1714

1 2

substitute:

Eye drops 3 mg (as sulfate) per mL, 5 mL Application to the eye Genoptic AG MP

C1188 C1391

C1714

1 2
AO C1391 C1714 1 2
  1. Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (SensoCard)

insert in the columns in the order indicated:

Test strips, 50 (TRUEbalance) For external use TRUEbalance NX MP NP 2 5
MP P3035 2 11
Test strips, 50 (TRUEresult) For external use TRUEresult NX MP NP 2 5
MP P3035 2 11
  1. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Max Quantity 60; Number of Repeats 2]

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

C3232  C3451

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

C3847  C3848

C3849  C3850

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

P3232 P3451

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

P3849 P3850

  1. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Max Quantity 60; Number of Repeats 5]

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

C3232  C3451

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

C3847  C3848

C3849  C3850

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

P3847 P3848

  1. Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Max Quantity 30; Number of Repeats 2]

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

C3232  C3451

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

C3847  C3848

C3849  C3850

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

P3232 P3451

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

P3849 P3850

  1. Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Max Quantity 30; Number of Repeats 5]

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

C3232  C3451

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

C3847  C3848

C3849  C3850

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

P3847 P3848

  1. Schedule 1, entry for Isosorbide Dinitrate

omit:

Tablet 10 mg Oral Sorbidin AF MP NP 200 2
  1. Schedule 1, entry for Leflunomide in the form Tablet 10 mg [for the brands APO-Leflunomide; Lunava 10]

(a)        omit from the column headed “Purposes”:                    30        (leave column blank)

(b)        omit from the column headed “Max Quantity”:   5         substitute:             30

(c)        insert in the column headed “Number of Repeats”:                    5

  1. Schedule 1, entry for Leflunomide in the form Tablet 20 mg [for the brands APO-Leflunomide; Lunava 20]

(a)        omit from the column headed “Purposes”:                    30        (leave column blank)

(b)        omit from the column headed “Max Quantity”:   5         substitute:             30

(c)        insert in the column headed “Number of Repeats”:                    5

  1. Schedule 1, entry for Mesalazine in the form Suppository 1 g

omit from the column headed “Max Quantity”:   28        substitute:        30

  1. Schedule 1, entry for Minocycline

omit:

Capsule 100 mg (as hydrochloride) Akamin 100 AF MP NP 11 0
  1. Schedule 1, omit entry for Neomycin

  1. Schedule 1, after entry for Ofloxacin in the form Eye drops 3 mg per mL, 5 mL

insert in the columns in the order indicated:

AO C3830 2 0
  1. Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

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

Ondansetron Alphapharm AF

MP NP

See Note 1

C3050 C3611

See Note 2

See Note 2

1

See Note 2

0

See Note 2

  1. Schedule 1, entry for Pegfilgrastim in the form Injection 6 mg in 0.6 mL single use pre-filled syringe

insert in numerical order in the column headed “Circumstances”:

C3833  C3834

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

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

Idaprex 2 SZ MP NP 30 5
  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

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

Idaprex 4 SZ MP NP 30 5
  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

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

Idaprex 8 SZ MP NP 30 5
  1. Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

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

Idaprex Combi 4/1.25 SZ MP NP C3307 30 5
  1. Schedule 1, entry for Pramipexole in the form Tablet (extended release) containing pramipexole hydrochloride 375 micrograms

omit from the column headed “Number of Repeats”:                  0          substitute:          5

  1. Schedule 1, entry for Prednisolone with Phenylephrine

substitute:

Prednisolone with Phenylephrine Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL Application to the eye Prednefrin Forte AG AO C1465 1 0
MP NP C1077 C1465 1 2
  1. Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg (as hydrochloride)

omit from the column headed “Responsible Person”:                 AL       substitute:        FZ

  1. Schedule 1, entry for Risperidone in each of the forms: I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL; I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL; and I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL

insert in numerical order in the column headed “Circumstances”:

C3841

  1. Schedule 1, omit entry for Sulindac

  1. Schedule 1, entry for Tobramycin

(a)           omit:

Eye drops 3 mg per mL, 5 mL Application to the eye Tobrex AQ MP

C1188 C1391

C1714

1 2

substitute:

Eye drops 3 mg per mL, 5 mL Application to the eye Tobrex AQ MP

C1188 C1391

C1714

1 2
AO C1391 C1714 1 2

(b)           omit:

Eye ointment 3 mg per g, 3.5 g Application to the eye Tobrex AQ MP

C1188 C1391

C1714

1 0

substitute:

Eye ointment 3 mg per g, 3.5 g Application to the eye Tobrex AQ MP

C1188 C1391

C1714

1 0
AO C1391 C1714 1 0
  1. Schedule 1, entry for Trimethoprim with Sulfamethoxazole

omit:

Tablet 80 mg-400 mg Oral Resprim AF PDP 10 0
Resprim AF MP NP 10 1
  1. Schedule 1, after entry for Zonisamide in the form Capsule 100 mg

insert:

Zuclopenthixol Decanoate Oily I.M. injection 200 mg in 1 mL Injection Clopixol Depot LU MP NP 5 0
  1. Schedule 3

omit:

AW Aspen Pharma Pty Ltd  88 004 118 594
  1. Schedule 3, after details relevant to Responsible Person code LN

insert:

LO LEO Pharma Pty Ltd  72 147 880 617
  1. Schedule 4, Part 1, entry for Calcipotriol with betamethasone

insert after existing text in the columns in the order indicated:

C3827 Chronic stable plaque type psoriasis vulgaris of the scalp in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy
  1. Schedule 4, Part 1, entry for Cetuximab

insert after existing text in the columns in the order indicated:

C3843 P3843 Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy Compliance with Authority Required procedures
C3844 P3844 Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Ciprofloxacin

insert after existing text in the columns in the order indicated:

C3830 Bacterial keratitis under the supervision and direction of an ophthalmologist Compliance with Authority Required procedures
  1. Schedule 4, omit entry for Clotrimazole

  1. Schedule 4, Part 1, entry for Deferasirox

substitute:

Deferasirox C3828

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

Chronic iron overload in patients with disorders of erythropoiesis

Compliance with Authority Required procedures - Streamlined Authority Code 3828


C3829

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

Chronic iron overload in patients with disorders of erythropoiesis

Compliance with Written or Telephone Authority Required procedures
  1. Schedule 4, Part 1, entry for Filgrastim

insert after existing text in the columns in the order indicated:

C3833

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

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP)

Compliance with Written or Telephone Authority Required procedures
C3834

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

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP)

Compliance with Authority Required procedures - Streamlined Authority Code 3834
  1. Schedule 4, Part 1, after entry for Filgrastim

insert:

Fingolimod C3845 Initial treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years. The diagnosis must be confirmed by magnetic resonance imaging (MRI) of the brain and/or spinal cord and the date of the scan included in the authority application, unless the authority application is accompanied by written certification provided by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. The authority will be limited to the maximum quantity and number of repeats indicated in Schedule 1 Compliance with Authority Required procedures
C3846 Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously issued with an authority prescription for this drug who does not show continuing progression of disability while on treatment with this drug and who has demonstrated compliance with, and an ability to tolerate, this therapy. Authorities will be limited to the maximum quantity and number of repeats indicated in Schedule 1 Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Fluconazole

insert after existing text in the columns in the order indicated:

C3835 Treatment of cryptococcal meningitis in a patient unable to take a solid dose form of fluconazole Compliance with Authority Required procedures
C3836 Maintenance therapy in a patient with cryptococcal meningitis and immunosuppression unable to take a solid dose form of fluconazole Compliance with Authority Required procedures
C3837 Treatment of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole Compliance with Authority Required procedures
C3838 Treatment of oesophageal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole Compliance with Authority Required procedures
C3839 Prophylaxis of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole Compliance with Authority Required procedures
C3840 Treatment of serious and life-threatening candida infections in a patient unable to take a solid dose form of fluconazole Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Imatinib

omit:

C3232 P3232 Gastrointestinal stromal tumour
Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour who have previously been issued with an authority prescription for this drug, and where the patient has not failed to respond, or is not intolerant, to imatinib
Compliance with Written or Telephone Authority Required procedures
C3451 P3451 Gastrointestinal stromal tumour
Initial PBS-subsidised treatment, for up to 3 months, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, where patients commence treatment at a dose that does not exceed 400 mg per day for at least 3 months, and where the application for authorisation includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour or tumours, including whether or not there is evidence of metastatic disease; and
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim
Compliance with Written Authority Required procedures


substitute:

C3847 P3847 Resectable gastrointestinal stromal tumour
Adjuvant treatment of a patient at high risk of recurrence following complete resection of primary gastrointestinal stromal tumour (GIST) which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, at a dose not exceeding 400 mg per day for a period of 12 months.

High risk of recurrence is defined as:
Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
Primary GIST greater than 10 cm with any mitotic rate; or
Primary GIST with a mitotic count of greater than 10/50 HPF.

Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application
Compliance with Written Authority Required procedures


C3848 P3848 Resectable gastrointestinal stromal tumour
Initial treatment of a patient who was receiving adjuvant imatinib mesylate for gastrointestinal stromal tumour (GIST) prior to 1 September 2011 and who meets the PBS eligibility criteria for adjuvant treatment with imatinib mesylate of a patient at high risk of recurrence following complete resection of primary GIST. The patient is eligible to receive sufficient imatinib at a dose of 400 mg per day to complete 12 months of combined PBS-subsidised and non-PBS-subsidised therapy.

Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented
Compliance with Written Authority Required procedures


C3849 P3849 Metastatic or unresectable gastrointestinal stromal tumour
Initial PBS-subsidised treatment, for up to 3 months, of a patient with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, where treatment is commenced at a dose that does not exceed 400 mg per day for at least 3 months, and where the application for authorisation is made in writing and includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Metastatic or Unresectable Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour or tumours, including whether or not there is evidence of metastatic disease; and
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim
Compliance with Written Authority Required procedures


C3850 P3850 Metastatic or unresectable gastrointestinal stromal tumour
Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of a patient with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for this drug, and where the patient has not failed to respond, or is not intolerant, to imatinib
Compliance with Written or Telephone Authority Required procedures


  1. Schedule 4, Part 1, entry for Ofloxacin

insert after existing text in the columns in the order indicated:

C3830 Bacterial keratitis under the supervision and direction of an ophthalmologist. Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C2929]

omit text from column headed “Authority Required ─ Part of Circumstances” and substitute:

Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C2930]

omit text from column headed “Authority Required ─ Part of Circumstances” and substitute:

Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Pegfilgrastim

insert after existing text in the columns in the order indicated:

C3833

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

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP)

Compliance with Written or Telephone Authority Required procedures

C3834

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

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP)

Compliance with Authority Required procedures - Streamlined Authority Code C3834

  1. Schedule 4, Part 1, entry for Risperidone

insert after existing text in the columns in the order indicated:

C3841 Maintenance treatment, in combination with lithium or sodium valproate, of treatment refractory bipolar I disorder Compliance with Authority Required procedures - Streamlined Authority Code C3841


  1. Schedule 4, Part 1, omit entry for Sulindac

1Note

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

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