National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8) (PB 71 of 2017) (Cth)

Case

PB 71 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 8)

National Health Act 1953

I, JULIANNE QUAINE, First Assistant Secretary (Acting), 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 19 September 2017

JULIANNE QUAINE

First Assistant Secretary (Acting)

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 2017 (No. 8).

(2)        This Instrument may also be cited as PB 71 of 2017.

2          Commencement

This Instrument commences on 1 October 2017.

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

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

Schedule 1     Amendments

  1. Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a ZETIN RW MP C5727 C5789 100 2 100

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

(a)omit from the column headed “Circumstances”:               C6518 C6567 C6574 C6594       
insert in numerical order:       C7078 C7100 C7101 C7132

(b)omit from the column headed “Purposes”:         P6567 P6574 P6594
insert in numerical order:       P7100 P7101 P7132

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

(a)omit from the column headed “Circumstances”:               C6518 C6567 C6574 C6594       
insert in numerical order:       C7078 C7100 C7101 C7132

(b)omit from the column headed “Purposes”:         P6518  
insert in numerical order:       P7078

  1. Schedule 1, entry for Alprazolam in the form Tablet 500 micrograms

omit:

a Alprax 0.5 QA MP NP C6773 10 0 50

substitute:

a Alprax 0.5 QA MP NP C6773 10 0 10
MP NP C6773 10 0 50

  1. Schedule 1, entry for Alprazolam in the form Tablet 1 mg

omit:

a Alprax 1 QA MP NP C6773 10 0 50

substitute:

a Alprax 1 QA MP NP C6773 10 0 10
MP NP C6773 10 0 50

  1. Schedule 1, after entry for Amino acid formula without valine, leucine and isoleucine

insert:

Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid Sachets containing oral powder 12.5 g, 30 (PKU Anamix First Spoon) Oral PKU Anamix First Spoon SB MP NP C4295 8 5 1

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 5/10 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 5/10 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 5/20 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 5/20 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 5/40 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 5/40 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 5/80 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 5/80 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 10/10 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 10/10 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 10/20 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 10/20 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 10/40 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 10/40 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)

(a)omit:

Chem mart Amlodipine/ Atorvastatin 10/80 CH MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

(b)omit:

Terry White Chemists Amlodipine/ Atorvastatin 10/80 TW MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Auranofin

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

Capsule 3 mg Oral Ridaura BZ MP NP 60 5 60

  1. Schedule 1, entry for Azacitidine

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

a AZACITIDINE DR.REDDY'S RI MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL

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

a Bimatoprost Sandoz SZ MP AO 1 5 1

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

  1. Schedule 1, after entry for Brentuximab vedotin

insert:

Brexpiprazole Tablet 1 mg Oral Rexulti LU MP NP C4246 30 0 30
Tablet 2 mg Oral Rexulti LU MP NP C4246 30 5 30
Tablet 3 mg Oral Rexulti LU MP NP C4246 30 5 30
Tablet 4 mg Oral Rexulti LU MP NP C4246 30 5 30

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

omit:

a Capecitabine Sandoz SZ MP 60 2 60

  1. Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g
    (as hydrochloride)

omit:

a Cefepime Sandoz SZ MP NP

C5842

 10 0 1

  1. Schedule 1, entry for Cefotaxime in the form Powder for injection 1 g (as sodium)

(a)omit:

Cefotaxime Sandoz SZ MP NP C5827 C5828 C5829 10 0 1
PDP C5892 10 0 1

(b)omit from the column headed “Circumstances” for Authorised Prescriber MP NP:  C5827 C5828 C5829     substitute:      C5826 C5881 C5890

(c)omit from the column headed “Circumstances” for Authorised Prescriber PDP:       C5892   substitute:             C5905

  1. Schedule 1, entry for Chorionic gonadotrophin

omit:

Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL Injection Pregnyl MK MP C6991 1 0 1 C(100)
MP C6979 C6987 C6989 C6990 C6995 1 5 1

  1. Schedule 1, entry for Cisplatin in the form I.V. injection 100 mg in 100 mL

omit:

Cisplatin Ebewe SZ MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms

omit from the column headed “Circumstances”:          C6542 C6560     substitute:             C7083 C7133    

  1. Schedule 1, entry for Doxorubicin

omit:

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial Injection/ intravesical Doxorubicin SZ HX MP See Note 3 See
Note 3 		1 D(100)
Hospira Pty Limited PF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial

(a)insert in the columns in the order indicated:

Adriamycin PF MP See Note 3 See
Note 3 		1 D(100)

(b)omit:

Hospira Pty Limited PF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Doxorubicin

omit:

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial Injection/ intravesical Doxorubicin Ebewe SZ MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

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

Adriamycin PF MP See Note 3 See
Note 3 		1 D(100)

(b)omit:

Doxorubicin SZ HX MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Ibuprofen

substitute:

Ibuprofen Tablet 400 mg Oral a APO-Ibuprofen 400 TX MP NP MW PDP 30 0 30
a Brufen GO MP NP MW PDP 30 0 30
a APO-Ibuprofen 400 TX PDP P6256 P6282 90 0 30
a Brufen GO PDP P6256 P6282 90 0 30
a APO-Ibuprofen 400 TX MP NP P6149 P6214 P6283 90 3 30
a Brufen GO MP NP P6149 P6214 P6283 90 3 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

omit:

a Irbesartan/HCTZ RBX 300/12.5 RA MP NP C4374 30 5 30

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

(a)insert in the column headed “Manner of Administration”:             Injection

(b)omit:

Irinotecan Ebewe SZ MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL; and
    I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

omit:

Irinotecan Ebewe SZ MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Iron Polymaltose Complex

omit:

Ferrum H AS MP NP 5 0 5
MP NP P4302 5
CN4302 		5
CN4302 		5

  1. Schedule 1, entry for Leflunomide in the form Tablet 10 mg

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

a Ataris 10 AF MP C5681 C5766 30 5 30

  1. Schedule 1, entry for Leflunomide in the form Tablet 20 mg

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

a Ataris 20 AF MP C5681 C5766 30 5 30

  1. Schedule 1, entry for Methylphenidate in the form Tablet containing methylphenidate hydrochloride 10 mg

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

a Artige NM MP NP C6226 100 5 100

(b)insert in the column headed “Schedule Equivalent” for the brand “Ritalin 10”:      a

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

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a MIRTANZA RF MP NP C5650 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a MIRTANZA RF MP NP C5650 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a MIRTANZA RF MP NP C5650 30 5 30

  1. Schedule 1, entry for Modafinil

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

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

a Modafinil Mylan AF MP C6537 C6556 120 5 60

  1. Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release)

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

a Morphine MR Mylan AF MP NP C4556 28 0 28

  1. Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)

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

a Morphine MR Mylan AF MP NP C4556 28 0 28

  1. Schedule 1, entry for Norfloxacin

omit:

Norfloxacin Sandoz SZ MP NP C5744 C5806 14 1 14

  1. Schedule 1, entry for Oxycodone in the form Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL

(a)omit from the column headed “Form”:   5 mg per 5 mL  substitute:             1 mg per mL

(b)omit from the column headed “Brand”:               OxyNorm Liquid 5mg/5mL       substitute:             OxyNorm Liquid 1mg/mL

  1. Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release)

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

a Novacodone HX MP NP C4583 28 0 28

(b)insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”:  a

  1. Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release)

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

a Novacodone HX MP NP C4583 28 0 28

(b)insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”:  a

  1. Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 40 mg (controlled release)

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

a Novacodone HX MP NP C4583 28 0 28

(b)insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”:  a

  1. Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release)

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

a Novacodone HX MP NP C4583 28 0 28

(b)insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”:  a

  1. Schedule 1, entry for Paracetamol

omit:

Tablet 665 mg (modified release) Oral Osteomol 665 Paracetamol CR MP NP C6225 C6280 P6225 192 3 96
MP NP C6225 C6280 P6225 192 3 192
MP NP C6225 C6280 P6280 192 5 96
MP NP C6225 C6280 P6280 192 5 192

substitute:

Tablet 665 mg (modified release) Oral a APOHEALTH Osteo Relief Paracetamol 665 mg TX MP NP C6225 C6280 P6225 192 3 96
a Osteomol 665 Paracetamol CR MP NP C6225 C6280 P6225 192 3 96
MP NP C6225 C6280 P6225 192 3 192
a APOHEALTH Osteo Relief Paracetamol 665 mg TX MP NP C6225 C6280 P6280 192 5 96
a Osteomol 665 Paracetamol CR MP NP C6225 C6280 P6280 192 5 96
MP NP C6225 C6280 P6280 192 5 192

  1. Schedule 1, entry for Paroxetine

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

a APO-Paroxetine TX MP NP C4755 C6277 C6636 30 5 30

(b)omit:

Paroxetine Actavis ED MP NP C4755 C6277 C6636 30 5 30

(c)insert in the column headed “Schedule Equivalent” for all brands:             a

  1. Schedule 1, entry for Raloxifene

(a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a Raloxifene AMNEAL ED MP NP C6314 28 5 28

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

(a)omit from the column headed “Circumstances”:               C6500 C6553 C6570 C6581        substitute:             C7081 C7102 C7106 C7115

(b)omit from the column headed “Purposes”:         P6553 P6570 P6581 substitute:             P7081 P7102 P7106

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

(a)omit from the column headed “Circumstances”:               C6500 C6553 C6570 C6581        substitute:             C7081 C7102 C7106 C7115

(b)omit from the column headed “Purposes”:         P6500   substitute:             P7115

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

(a)omit from the column headed “Circumstances”:               C6500 C6553 C6570 C6581        substitute:             C7079 C7115 C7118 C7127

(b)omit from the column headed “Purposes”:         P6553 P6570 P6581 substitute:             P7079 P7118 P7127

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

(a)omit from the column headed “Circumstances”:               C6500 C6553 C6570 C6581        substitute:             C7079 C7115 C7118 C7127

(b)omit from the column headed “Purposes”:         P6500   substitute:P7115

  1. Schedule 1, entry for Riluzole

omit:

Riluzole Winthrop WA MP NP C5341 C5365 56 5 56

  1. Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 150 mg

(a)omit:

a Chem mart Risedronate CH MP NP C6310 C6323 C6327 1 5 1

(b)omit:

a Terry White Chemists Risedronate TW MP NP C6310 C6323 C6327 1 5 1

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

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

MAXATAN RW MP NP C5708 4 5 2

  1. Schedule 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30

omit:

Ventolin Nebules GK MP NP C6815 C6825 2 5 1

  1. Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)

omit:

Omnitrope SZ MP C5150 C5151 C5152 C5153 C5156 C5157 C5158 C5165 C5166 C5167 C5198 C5199 C5201 C5202 C5211 C5235 C5236 C5237 C5242 C5247 C5285 C5286 C5287 C5305 C5306 C5310 C5318 C5319 C5320 C5346 C5348 C5352 C5353 C5354 C5355 C5378 C5379 C5380 C5419 C5420 C5432 C5433 See Note 3 See Note 3 1 D(100)

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

(a)omit:

a Astromide FR MP 5 5 5

(b)omit:

a Astromide FR MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 20 mg

(a)omit:

a Astromide FR MP 5 5 5

(b)omit:

a Astromide FR MP P4897 15 2 5

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

(a)omit:

a Astromide FR MP 5 5 5

(b)omit:

a Astromide FR MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 140 mg

(a)omit:

a Astromide FR MP 5 5 5

(b)omit:

a Astromide FR MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg

(a)omit:

a Astromide FR MP 5 5 5

(b)omit:

a Astromide FR MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 250 mg

omit:

a Astromide FR MP 5 5 5

  1. Schedule 1, entry for Timolol in the form Eye drops 5 mg (as maleate) per mL, 5 mL

omit:

Tenopt QA MP AO 1 5 1

  1. Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum quantity: 2; Number of Repeats: 0]

omit from the column headed “Purposes”:    C7061   substitute:             P7061  

  1. Schedule 1, entry for Verteporfin

omit from the column headed “Circumstances”:          C6099 C6100    
insert in numerical order:  C7109 C7130    

  1. Schedule 1, entry for Vismodegib

omit from the column headed “Circumstances”:          C6802  
omit from the column headed “Circumstances”:          C6820
insert in numerical order:  C7098 C7129    

  1. Schedule 4, Part 1

omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” (multiple occurrences and in all instances), the phrase:
Written or Telephone

  1. Schedule 4, Part 1, entry for Aflibercept

(a)omit:

C6518 P6518

Diabetic macular oedema (DMO)

Initial treatment

Patient must have visual impairment due to diabetic macular oedema; AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be as monotherapy; OR

The treatment must be in combination with laser photocoagulation; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6567 P6567

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6574 P6574

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6594 P6594

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C7078 P7078

Diabetic macular oedema (DMO)

Initial treatment

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

 Compliance with Written Authority Required procedures
C7100 P7100

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7101 P7101

Central retinal vein occlusion with macular oedema

Initial treatment

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

 Compliance with Written Authority Required procedures
C7132 P7132

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

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

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, after entry for Amino acid formula without valine, leucine and isoleucine

insert:

Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid C4295 Phenylketonuria

  1. Schedule 4, Part 1, after entry for Brentuximab vedotin

insert:

Brexpiprazole C4246 Schizophrenia Compliance with Authority Required procedures - Streamlined Authority Code 4246

  1. Schedule 4, Part 1, entry for Cefotaxime

(a)omit:

C5827 Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5828 Septicaemia, suspected
C5829 Septicaemia, proven

(b)omit:

C5892 Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

(c)insert in numerical order after existing text:

C5905 Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

  1. Schedule 4, Part 1, entry for Dexamethasone

(a)omit:

C6542

Diabetic macular oedema (DMO)

Initial treatment

Patient must have visual impairment due to diabetic macular oedema; AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR

Patient must be unsuitable for treatment with VEGF inhibitors; OR

Patient must have failed prior treatment with VEGF inhibitors; AND

The treatment must be as monotherapy; OR

The treatment must be in combination with laser photocoagulation; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Patient must have had a cataract removed in the treated eye; OR

Patient must be scheduled for cataract surgery in the treated eye.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6560

Diabetic macular oedema (DMO)

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2016; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be as monotherapy; OR

The treatment must be in combination with laser photocoagulation; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Patient must have had a cataract removed in the treated eye; OR

Patient must be scheduled for cataract surgery in the treated eye.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C7083

Diabetic macular oedema (DMO)

Initial treatment

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

 Compliance with Written Authority Required procedures
C7133

Diabetic macular oedema (DMO)

Grandfathering treatment

Must be treated by an ophthalmologist.
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2016; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Ranibizumab

(a)omit:

C6500 P6500

Diabetic macular oedema (DMO)

Initial treatment

Patient must have visual impairment due to diabetic macular oedema; AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be as monotherapy; OR

The treatment must be in combination with laser photocoagulation; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6553 P6553

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6570 P6570

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures
C6581 P6581

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; OR

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by an ophthalmologist.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye must be made in writing or by telephone.

A written application must include:

a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and

c) a copy of the optical coherence tomography or fluorescein angiogram report.

A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C7079 P7079

Central retinal vein occlusion with macular oedema

Initial treatment

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

c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7081 P7081

Central retinal vein occlusion with macular oedema

Initial treatment

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

 Compliance with Written Authority Required procedures
C7102 P7102

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7106 P7106

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7115 P7115

Diabetic macular oedema (DMO)

Initial treatment

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

 Compliance with Written Authority Required procedures
C7118 P7118

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

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

 Compliance with Written Authority Required procedures
C7127 P7127

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Verteporfin

(a)omit:

C6099

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be predominantly classic (greater than or equal to 50%); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
Patient must have a baseline visual acuity equal to or better than 6/60 (20/200).
Must be treated by an ophthalmologist.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Written or Telephone Authority Required procedures
C6100

Subfoveal choroidal neovascularisation (CNV)

Initial PBS-subsidised treatment

The condition must be predominantly classic (greater than or equal to 50%); AND
The condition must be due to macular degeneration; AND
Patient must have been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the MBS Visudyne Therapy Program; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a ophthalmologist.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
(a) a completed authority prescription form; and
(b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form, which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and
(c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.

 Compliance with Written or Telephone Authority Required procedures

(b)insert in numerical order after existing text:

C7109

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be predominantly classic (greater than or equal to 50%).
Must be treated by an ophthalmologist.
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
Patient must have a baseline visual acuity equal to or better than 6/60 (20/200).
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram.

 Compliance with Written Authority Required procedures
C7130

Subfoveal choroidal neovascularisation (CNV)

Initial PBS-subsidised treatment

The condition must be predominantly classic (greater than or equal to 50%); AND
The condition must be due to macular degeneration; AND
Patient must have been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the MBS Visudyne Therapy Program; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a ophthalmologist.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
(a) a completed authority prescription form; and
(b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form, which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and
(c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Vismodegib

(a)omit:

C6802

Metastatic or locally advanced basal cell carcinoma

Continuing treatment

Patient must have previously received an authority prescription for this condition with this drug; AND
The condition must not have progressed; AND
The condition must remain inappropriate for surgery; AND
The condition must remain inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) a completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; and
c) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery; and
d) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy; and
e) A confirmation statement from the treating doctor that the disease has not progressed
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/ Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC

 Compliance with Written Authority Required procedures

(b)omit:

C6820

Metastatic or locally advanced basal cell carcinoma

Initial treatment

The condition must be inappropriate for surgery; AND
The condition must be inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) a completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; and
c) A histological confirmation of BCC; and
d) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery; and
e) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy; and
f) A signed patient acknowledgement.
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC.

 Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C7098

Metastatic or locally advanced basal cell carcinoma

Continuing treatment

Patient must have previously received an authority prescription for this condition with this drug; AND
The condition must not have progressed; AND
The condition must remain inappropriate for surgery; AND
The condition must remain inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) A completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; and
c) A confirmation statement from the treating doctor that the disease has not progressed; and
d) In patients with locally advanced BCC, a letter from a surgically qualified clinician demonstrating that the condition remains inappropriate for surgery; or a letter from a radiation oncologist demonstrating that the condition remains inappropriate for curative radiotherapy.
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC.

 Compliance with Written Authority Required procedures
C7129

Metastatic or locally advanced basal cell carcinoma

Initial treatment

The condition must be inappropriate for surgery; AND
The condition must be inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) a completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; and
c) A histological confirmation of BCC and whether the condition is metastatic or locally advanced; and
d) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery for patients with locally advanced BCC; and
e) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy for patients with locally advanced BCC; and
f) A signed patient acknowledgement.
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC.

 Compliance with Written Authority Required procedures

  1. Schedule 5, omit entry for Chorionic gonadotrophin

  1. Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) [GRP-17623]

insert in numerical order in the column headed “Brand”:       MAXATAN

  1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21535]

omit from the column headed “Brand”:       Ventolin Nebules

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