National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 8) (PB 78 of 2015) (Cth)

Case

PB 78 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 8)

National Health Act 1953

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

Dated    25 August  2015

KYLIE JONASSON
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2015 (No. 8).

(2)        This Instrument may also be cited as PB 78 of 2015.

2          Commencement

This Instrument commences on 1 September 2015.

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

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

Schedule 1     Amendments

  1. Schedule 1, entry for Acamprosate

    omit from the column headed “Circumstances”:        C2665   substitute:             C5366

  2. Schedule 1, entry for Aciclovir in the form Tablet 800 mg

    (a)omit:

Acihexal SZ MP NP C3622 C3630 C3631 P3622 P3631 35 0 35

(b)omit:

Acihexal SZ MP NP C3622 C3630 C3631 P3630 120 5 120

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

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

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

  3. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

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

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (d)omit from the column headed “Purposes”:       P3265 P3267 P3758 P3759 substitute: P5144 P5184 P5223 P5294 P5335

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

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (d)omit from the column headed “Purposes”:       P3760 P3761 insert in numerical order: P5265 P5336 P5369

  6. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369

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

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369

  8. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369

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

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369

    (d)omit from the column headed “Purposes”:       P3265 P3267 P3758 P3759 substitute: P5144 P5184 P5223 P5294 P5335

  10. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

    (a)omit from the column headed “Circumstances”:             C3265  C3267

    (b)omit from the column headed “Circumstances”:             C3758  C3759  C3760  C3761 

    (c)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (d)omit from the column headed “Purposes”:       P3760 P3761 insert in numerical order: P5265 P5336 P5369

  11. Schedule 1, entry for Amantadine

    omit from the column headed “Circumstances”:        C1258   substitute:             C5132

  12. Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan in the form Sachets containing oral powder 24 g, 30 (GA gel)

    omit from the column headed “Circumstances”:        C3134   substitute:             C5323

  13. Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan in the form Oral powder 400 g (GA1 Anamix infant)

    omit from the column headed “Circumstances”:        C2612   substitute:             C5323

  14. Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan in the form Oral powder 500 g (XLYS, LOW TRY Maxamaid)

    omit from the column headed “Circumstances”:        C3550   substitute:             C5323

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan in the form Oral powder 500 g (XLYS, LOW TRY Maxamaid)

    insert in the columns in the order indicated:

Oral powder 500 g (XLYS, LOW TRY Maxamum) Oral XLYS, LOW TRY Maxamum SB MP NP C5323 9 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan in the form Sachets containing oral powder 25 g, 30 (GA express 15)

    omit from the column headed “Circumstances”:        C3678   substitute:             C5323

  2. Schedule 1, entry for Apomorphine

    omit:

Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe Injection Apomine PFS HH MP C4833 C4860 180 5 5 D(100)

  1. Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg

    omit from the column headed “Circumstances” (all instances):             C3234   substitute:             C5324

  2. Schedule 1, entry for Botulinum Toxin Type A Purified Neurotoxin Complex

    substitute:

Botulinum toxin type A purified neurotoxin complex Lyophilised powder for injection 100 units Injection Botox AG MP C5178 C5220 C5221 C5261 C5262 C5333 C5359 C5406 C5407 C5408 C5409 4 0 1 D(100)

  1. Schedule 1, entry for Bromocriptine

    substitute:

Bromocriptine Tablet 2.5 mg (as mesylate) Oral Kripton 2.5 AF MP C5134 C5170 C5171 C5172 C5213 C5356 C5397 P5172 30 0 30
NP C5172 30 0 30
Parlodel NV MP C5134 C5170 C5171 C5172 C5213 C5356 C5397 P5172 30 0 30
NP C5172 30 0 30
Kripton 2.5 AF MP C5134 C5170 C5171 C5172 C5213 C5356 C5397 P5134 P5170 P5171 P5213 P5356 P5397 60 5 60
Parlodel NV MP C5134 C5170 C5171 C5172 C5213 C5356 C5397 P5134 P5170 P5171 P5213 P5356 P5397 60 5 30

  1. Schedule 1, entry for Cabergoline

    substitute:

Cabergoline Tablet 500 micrograms Oral Dostan GN MP C5136 C5137 C5357 C5172 C5398 P5172 2 0 2
NP C5172 2 0 2
Dostinex PF MP C5136 C5137 C5357 C5172 C5398 P5172 2 0 2
NP C5172 2 0 2
Dostan GN MP C5136 C5137 C5357 C5172 C5398 P5136 P5137 P5357 P5398 8 5 8
Dostinex PF MP C5136 C5137 C5357 C5172 C5398 P5136 P5137 P5357 P5398 8 5 8
Tablet 1 mg Oral Cabaser PF MP NP C5168 30 5 30
Cobasol GN MP NP C5168 30 5 30
Tablet 2 mg Oral Cabaser PF MP NP C5168 30 5 30
Cobasol GN MP NP C5168 30 5 30

  1. Schedule 1, entry for Calcitriol

    omit from the column headed “Circumstances” (all instances):             C1165  C1166  C1167  C1467  C2636     
    substitute:             C5089  C5114  C5255  C5401  C5402

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

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

Capecitabine MYX YN MP 60 2 60

  1. Schedule 1, entry for Capecitabine in the form Tablet 500 mg

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

Capecitabine MYX YN MP 120 2 120

  1. Schedule 1, entry for Carvedilol in each of the forms: Tablet 3.125 mg; Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg

    omit from the column headed “Circumstances” (all instances):             C1735  C3234    substitute:             C5324  C5394

  2. Schedule 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)

    (a)omit from the column headed “Circumstances” (all instances):    C1211   substitute:           C4755

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

Talam QA MP NP C4755 28 5 28

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

    omit from the column headed “Circumstances” (all instances):             C1211   substitute:             C4755

  2. Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)

    (a)omit from the column headed “Circumstances” (all instances):    C1211   substitute:           C4755

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

Talam QA MP NP C4755 28 5 28

  1. Schedule 1, entry for Clostridium Botulinum Type A Toxin—haemagglutinin Complex

    substitute:

Clostridium botulinum type A toxin—haemagglutinin complex Lyophilised powder for I.M. injection 300 units Injection Dysport IS MP C5220 C5332 C5359 C5405 C5406 4 0 1 D(100)
Lyophilised powder for I.M. injection 500 units Injection Dysport IS MP C5220 C5332 C5359 C5405 C5406 2 0 1 D(100)

  1. Schedule 1, entry for Desmopressin

    substitute:

Desmopressin Tablet containing desmopressin acetate 200 micrograms Oral Minirin FP MP C5266 C5295 C5413 P5295 P5413 30 5 30
NP C5295 C5413 30 5 30
MP C5266 C5295 C5413 P5266 90 5 30
Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle Nasal Minirin FP MP C5266 5 5 1
Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL Nasal Minirin Nasal Spray FP MP C5266 C5267 C5342 P5267 P5342 1 5 1
NP C5267 C5342 1 5 1
MP C5266 C5267 C5342 P5266 2 5 1
Wafer 120 micrograms (as acetate) Sublingual Minirin Melt FP MP NP C5226 C5412 30 5 30
Wafer 240 micrograms (as acetate) Sublingual Minirin Melt FP MP NP C5226 C5412 30 5 30

  1. Schedule 1, entry for Dicloxacillin

    substitute:

Dicloxacillin Capsule 250 mg (as sodium) Oral Distaph 250 AF MP NP MW C5415 24 0 24
PDP C5268 24 0 24
Capsule 500 mg (as sodium) Oral Distaph 500 AF MP NP MW C5415 24 0 24
PDP C5268 24 0 24

  1. Schedule 1, entry for Eletriptan in each of the forms: Tablet 40 mg (as hydrobromide); and Tablet 80 mg (as hydrobromide)

    omit from the column headed “Circumstances”:        C4573   substitute:             C5141

  2. Schedule 1, entry for Entacapone

    omit from the column headed “Circumstances”:        C2067   substitute:             C5133

  3. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 1]

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

Esomeprazole GH GQ MP NP C4988 C5029 C5030 C5039 P4988 30 1 30

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

Esomeprazole GH GQ MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 1]

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

Esomeprazole GH GQ MP NP C5011 C5021 C5028 P5028 30 1 30

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

Esomeprazole GH GQ MP NP C5011 C5021 C5028 P5011 P5021 30 5 30

  1. Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
    Number of Repeats: 3]

    (a)omit from the column headed “Circumstances”:             C3273  C3275  C3778  C3779  C3780  C3781  

    (b)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369  

    (c)omit from the column headed “Purposes”:       P3273 P3275 P3778 P3779

    (d)insert in numerical order:     P5144 P5184 P5223 P5294 P5335

  2. Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
    Number of Repeats: 5]

    (a)omit from the column headed “Circumstances”:             C3273  C3275  C3778  C3779  C3780  C3781  

    (b)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (c)omit from the column headed “Purposes”:       P3780 P3781

    (d)insert in numerical order:     P5265 P5336 P5369

  3. Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
    Number of Repeats: 3]

    (a)omit from the column headed “Circumstances”:             C3273  C3275  C3778  C3779  C3780  C3781  

    (b)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (c)omit from the column headed “Purposes”:       P3273 P3275 P3778 P3779

    (d)insert in numerical order:     P5144 P5184 P5223 P5294 P5335

  4. Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
    Number of Repeats: 5]

    (a)omit from the column headed “Circumstances”:             C3273  C3275  C3778  C3779  C3780  C3781  

    (b)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (c)omit from the column headed “Purposes”:       P3780 P3781

    (d)insert in numerical order:     P5265 P5336 P5369

  5. 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 [Maximum Quantity: 2; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances”:             C3273  C3275  C3778  C3779  C3780  C3781  

    (b)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (c)omit from the column headed “Purposes”:       P3273 P3275 P3778 P3779

    (d)insert in numerical order:     P5144 P5184 P5223 P5294 P5335

  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 [Maximum Quantity: 2; Number of Repeats: 5]

    (a)omit from the column headed “Circumstances”:             C3273  C3275  C3778  C3779  C3780  C3781  

    (b)insert in numerical order:     C5144  C5184  C5223  C5265  C5294  C5335  C5336  C5369 

    (c)omit from the column headed “Purposes”:       P3780 P3781

    (d)insert in numerical order:     P5265 P5336 P5369

  2. Schedule 1, after entry for Famotidine in the form Tablet 40 mg [Brand: Terry White Chemists Famotidine]

    insert:

Febuxostat Tablet 80 mg Oral Adenuric FK MP NP C5322 28 5 28

  1. Schedule 1, entry for Flucloxacillin

    omit:

Capsule 250 mg (as sodium) Oral Flopen AS MP NP MW PDP C1345 24 0 24
Staphylex 250 AF MP NP MW PDP C1345 24 0 24
Capsule 500 mg (as sodium) Oral Flopen AS MP NP MW PDP C1345 24 0 24
Staphylex 500 AF MP NP MW PDP C1345 24 0 24
Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL Oral Flucil LN MP NP PDP C1345 1 0 1
Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL Oral Flucil LN MP NP PDP C1345 1 0 1

substitute:

Capsule 250 mg (as sodium) Oral APO-Flucloxacillin TX MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Flopen AS MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Staphylex 250 AF MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Capsule 500 mg (as sodium) Oral APO-Flucloxacillin TX MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Flopen AS MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Staphylex 250 AF MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL Oral Flucil LN MP NP C5297 1 0 1
PDP C5298 1 0 1
Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL Oral Flucil LN MP NP C5297 1 0 1
PDP C5298 1 0 1

  1. Schedule 1, omit entry for Flurbiprofen

  2. Schedule 1, after entry for Follitropin Alfa in the form Injection 900 I.U. in 1.5 mL multi-dose cartridge [Maximum Quantity: 5; Number of Repeats: 0]

    insert:

Follitropin alfa with lutropin alfa Powder for injection 150 I.U.-75 I.U. with solvent Injection Pergoveris SG MP C5250 7 0 1 D(100)

  1. Schedule 1, entry for Fosamprenavir

    omit:

Oral liquid 50 mg (as calcium) per mL, 225 mL Oral Telzir VI MP C4454 C4512 8 5 1 D(100)

  1. Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; Capsule 400 mg; Tablet 600 mg; and
    Tablet 800 mg

    omit from the column headed “Circumstances” (all instances):             C2664   substitute:             C4928

  2. Schedule 1, entry for Glucose Indicator—Blood

    (a)omit:

Test strips, 50 (Lifeline Attest) For external use Lifeline Attest OI MP NP 2 5 1
MP P4241 2 11 1

(b)omit:

Test strips, 100 (EasyMate II) For external use EasyMate II WI MP NP 1 5 1
MP P4241 1 11 1

  1. Schedule 1, entry for Ibandronic acid in the form Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate)
    in 6 mL

    omit from the column headed “Circumstances”:        C1035  C3343    substitute:             C5257  C5291

  1. Schedule 1, entry for IncobotulinumtoxinA

    substitute:

IncobotulinumtoxinA Lyophilised powder for injection 100 units Injection Xeomin EZ MP C5220 C5222 C5360 3 0 1 D(100)

  1. Schedule 1, entry for Insulin Detemir

    omit from the column headed “Circumstances” (twice occurring):       C2418   substitute:             C5174

  2. Schedule 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; Capsule 20 mg; and Capsule 40 mg

    omit from the column headed “Circumstances” (all instances):             C1354   substitute:             C5224

  3. Schedule 1, omit entry for Lactulose

  4. Schedule 1, entry for Lamotrigine in each of the forms: Tablet 5 mg; Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and
    Tablet 200 mg

    omit from the column headed “Circumstances” (all instances):             C1426   substitute:             C5138

  5. Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

    omit from the column headed “Circumstances” (all instances):             C2664   substitute:             C4928

  6. Schedule 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL

    (a)omit from the column headed “Circumstances” for the brand “Keppra”:  C3291   substitute:           C5215

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

Kerron DO MP NP C5215 1 5 1

(c)omit from the column headed “Circumstances” for the brand “Levetiracetam-AFT”:            C3291   substitute:    C5215

  1. Schedule 1, entry for Levodopa with Carbidopa in the form Tablet 200 mg-50 mg (anhydrous) (modified release)

    omit from the column headed “Circumstances”:        C1257   substitute:             C5253

  2. Schedule 1, entry for Levodopa with Carbidopa and Entacapone in each of the forms: Tablet 50 mg-12.5 mg-200 mg;
    Tablet 75 mg-18.75 mg-200 mg; Tablet 100 mg-25 mg-200 mg; Tablet 125 mg-31.25 mg-200 mg; Tablet 150 mg-37.5 mg-200 mg; and
    Tablet 200 mg-50 mg-200 mg

    omit from the column headed “Circumstances”:        C3305  C3306    substitute:             C5212  C5288

  3. Schedule 1, entry for Levonorgestrel in the form Intrauterine drug delivery system 52 mg

    omit from the column headed “Circumstances”:        C1643  C2689  C2690    substitute:             C5135  C5214  C5289

  4. Schedule 1, after entry for Liothyronine

    insert:

Lisdexamfetamine Capsule containing lisdexamfetamine dimesilate 30 mg Oral Vyvanse ZI MP NP C5252 30 5 30
Capsule containing lisdexamfetamine dimesilate 50 mg Oral Vyvanse ZI MP NP C5252 30 5 30
Capsule containing lisdexamfetamine dimesilate 70 mg Oral Vyvanse ZI MP NP C5252 30 5 30

  1. Schedule 1, after entry for Losartan in the form Tablet containing losartan potassium 50 mg

    insert:

Lutropin alfa Powder for injection 75 I.U. with solvent Injection Luveris SG MP C5251 7 0 1 D(100)

  1. Schedule 1, entry for Magnesium

    omit from the column headed “Circumstances” (twice occurring):       C3937  C3938    substitute:             C5434 C5435

  2. Schedule 1, entry for Methylprednisolone

    omit:

Powder for injection 1 g (as sodium succinate) with diluent Injection Solu-Medrol PF MP NP 1 0 1

  1. Schedule 1, entry for Metoprolol succinate in each of the forms: Tablet 23.75 mg (controlled release); Tablet 47.5 mg (controlled release); Tablet 95 mg (controlled release); and Tablet 190 mg (controlled release)

    omit from the column headed “Circumstances” (all instances):             C3234   substitute:             C5324

  2. Schedule 1, entry for Minoxidil

    omit from the column headed “Circumstances”:        C4906   substitute:             C5177

  3. Schedule 1, entry for Nafarelin

    substitute:

Nafarelin Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses Nasal Synarel PF MP C5046 C5186 C5368 P5186 P5368 1 5 1
MP C5046 C5186 C5368 P5046 2 0 1 C(100)

  1. Schedule 1, entry for Naltrexone

    omit from the column headed “Circumstances” (twice occurring):       C1135   substitute:             C5364

  2. Schedule 1, entry for Nandrolone Decanoate

    omit from the column headed “Circumstances”:        C1262  C1976  C2024 C2025 C2026        substitute:             C5217  C5326  C5327  C5328  C5358

  3. Schedule 1, entry for Nebivolol in each of the forms: Tablet 1.25 mg (as hydrochloride); Tablet 5 mg (as hydrochloride); and
    Tablet 10 mg (as hydrochloride)

    omit from the column headed “Circumstances”:        C3234   substitute:             C5324

  4. Schedule 1, entry for Nicotine in each of the forms: Transdermal patch 17.5 mg; and Transdermal patch 35 mg

    omit from the column headed “Circumstances”:        C4307  C4348    substitute:             C5142  C5219

  5. Schedule 1, entry for Nicotine in each of the forms: Transdermal patch 39.4 mg; Transdermal patch 52.5 mg; and Transdermal patch
    114 mg

    omit from the column headed “Circumstances”:        C4307  C4344  C4348    substitute:             C5140  C5142  C5219

  6. Schedule 1, entry for Oxcarbazepine in each of the forms: Tablet 150 mg; Tablet 300 mg; Tablet 600 mg; and Oral suspension
    60 mg per mL, 250 mL

    omit from the column headed “Circumstances”:        C1587   substitute:             C5183

  7. Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
    [Maximum Quantity: 2; Number of Repeats: 0]

    omit from the column headed “Circumstances”:        C4883   substitute:             C4877

  8. Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
    [Maximum Quantity: 2; Number of Repeats: 2]

    omit from the column headed “Circumstances”:        C4424  C4425    substitute:             C4430  C4433

  9. Schedule 1, entry for Pamidronic Acid

    omit:

Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL Injection Aredia 30 mg NV MP NP C4883 1 0 1
MP C4424 C4425 1 2 1 C(100)

  1. Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL

    omit from the column headed “Circumstances”:        C4421  C4426  C4428  C4429  C4431  C4432      
    substitute:             C4430  C4433  C5218  C5256  C5257  C5291

  2. Schedule 1, entry for Pamidronic Acid

    omit:

Injection set containing 1 vial powder for I.V. infusion containing disodium pamidronate 90 mg and 1 ampoule solvent 10 mL Injection Aredia 90 mg NV MP C4421 C4426 C4428 C4429 C4431 C4432 1 11 1 PB(100)

  1. Schedule 1, after entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL

    insert:

Pembrolizumab Powder for injection 50 mg Injection Keytruda MK MP C5293 C5334 C5361 C5362 See Note 3 See Note 3 1 D(100)
MP C5293 C5334 C5361 C5362 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Posaconazole

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

Tablet (modified release) 100 mg Oral Noxafil MK MP NP C5169 C5395 C5396 24 0 24

  1. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]

    omit from the column headed “Circumstances” for the brands “APO-Pramipexole”, “Pramipexole AN” and “Pramipexole GH”:             C3216  
    substitute:             C5363

  2. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances” for the brand “Sifrol”:      C3088  C3216    substitute:           C5363  C5411

    (b)omit from the column headed “Purposes”:       P3216   substitute:           P5363

  3. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]

    omit from the column headed “Circumstances” for the brands “Simpral” and “Simipex 0.125”:   C3216   substitute:                C5363

  4. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 2]

    (a)omit from the column headed “Circumstances”:               C3088  C3216    substitute:           C5363  C5411

    (b)omit from the column headed “Purposes”:       P3088   substitute:           P5411

  5. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 2]

    (a)omit from the column headed “Circumstances”:               C3088  C3216    substitute:           C5363  C5411

    (b)omit from the column headed “Purposes”:       P3088   substitute:           P5411

  6. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]

    omit from the column headed “Circumstances” for the brands “APO-Pramipexole”, “Pramipexole AN” and “Pramipexole GH”:             C3216  
    substitute:             C5363

  7. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]

    (a)omit from the column headed “Circumstances” for the brand “Sifrol”:      C3088  C3216    substitute:           C5363  C5411

    (b)omit from the column headed “Purposes”:       P3216   substitute:           P5363

  8. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]

    omit from the column headed “Circumstances” for the brands “Simipex 0.25” and “Simpral”:     C3216   substitute:                C5363

  1. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg

    omit from the column headed “Circumstances” (all instances):             C3216   substitute:             C5363

  2. Schedule 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole hydrochloride 375 micrograms; Tablet (extended release) containing pramipexole hydrochloride 750 micrograms; Tablet (extended release) containing pramipexole hydrochloride 1.5 mg; Tablet (extended release) containing pramipexole hydrochloride 2.25 mg; Tablet (extended release) containing pramipexole hydrochloride 3 mg; Tablet (extended release) containing pramipexole hydrochloride 3.75 mg; and Tablet (extended release) containing pramipexole hydrochloride 4.5 mg

    omit from the column headed “Circumstances” (all instances):             C3216   substitute:             C5131

  3. Schedule 1, entry for Quinagolide in each of the forms: Pack containing 3 tablets quinagolide 25 micrograms (as hydrochloride) and 3 tablets quinagolide 50 micrograms (as hydrochloride); and Tablet 75 micrograms (as hydrochloride)

    omit from the column headed “Circumstances”:        C2659  C2660  C2661  C2662     substitute:             C5136  C5137  C5357  C5398

  4. Schedule 1, entry for Rasagiline

    omit from the column headed “Circumstances”:        C4053   substitute:             C5339

  5. Schedule 1, entry for Riluzole

    omit from the column headed “Circumstances” (all instances):             C1762  C2718    substitute:             C5341  C5365

  6. Schedule 1, entry for Rivastigmine

    omit:

Oral solution 2 mg (as hydrogen tartrate) per mL, 120 mL Oral Exelon NV MP NP C4219 C4220 C4224 1 5 1

  1. Schedule 1, entry for Rizatriptan

    omit from the column headed “Circumstances”:        C4573   substitute:             C5141

  2. Schedule 1, entry for Salcatonin

    omit from the column headed “Circumstances”:        C4918  C4938    substitute:             C5260  C5331

  3. Schedule 1, after entry for Saxagliptin with metformin in the form Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

    insert:

Secukinumab Injection 150 mg in 1 mL pre-filled pen Injection Cosentyx NV MP C5144 C5184 C5185 C5223 C5265 C5294 C5335 C5336 C5337 C5410 P5185 P5265 P5336 P5337 P5410 2 5 2
MP C5144 C5184 C5185 C5223 C5265 C5294 C5335 C5336 C5337 C5410 P5144 P5184 P5223 P5294 P5335 2 6 2

  1. Schedule 1, entry for Selegiline

    omit from the column headed “Circumstances” (twice occurring):       C1864   substitute:             C5338

  2. Schedule 1, entry for Somatropin

    substitute:

Somatropin Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100)
Injection 4 mg (12 i.u.) vial with diluent (with preservative) Injection Zomacton FP MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Injection 8 mg (24 i.u.) vial with 1.37 mL diluent cartridge (with preservative) (for use with one.click auto-injector) Injection Saizen 8 mg click.easy SG MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Injection 10 mg (30 i.u.) vial with diluent (with preservative) Injection Zomacton FP MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Injection 12 mg (36 i.u.) in 1 mL cartridge (with preservative) Injection Genotropin PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)
Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative) Injection Humatrope LY MP C5145 C5146 C5147 C5148 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5240 C5269 C5270 C5271 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5370 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative) Injection Humatrope LY MP C5145 C5146 C5147 C5148 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5240 C5269 C5270 C5271 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5370 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative) Injection Humatrope LY MP C5145 C5146 C5147 C5148 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5240 C5269 C5270 C5271 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5370 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative) Injection Genotropin GoQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)
Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative) Injection Genotropin GoQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin SimpleXx NO MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5200 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5272 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)
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)
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5154 C5155 C5160 C5161 C5162 C5207 C5208 C5209 C5210 C5243 C5244 C5245 C5274 C5275 C5277 C5278 C5279 C5308 C5309 C5312 C5313 C5314 C5315 C5316 C5317 C5349 C5350 C5351 C5384 C5385 C5386 C5387 C5388 C5389 C5390 C5391 C5392 C5393 C5423 C5424 C5427 C5428 C5429 C5430 C5431 See Note 3 See Note 3 1 D(100)
Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) Injection Saizen SG MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin SimpleXx NO MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5200 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5272 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)
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)
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5154 C5155 C5160 C5161 C5162 C5207 C5208 C5209 C5210 C5243 C5244 C5245 C5274 C5275 C5277 C5278 C5279 C5308 C5309 C5312 C5313 C5314 C5315 C5316 C5317 C5349 C5350 C5351 C5384 C5385 C5386 C5387 C5388 C5389 C5390 C5391 C5392 C5393 C5423 C5424 C5427 C5428 C5429 C5430 C5431 See Note 3 See Note 3 1 D(100)
Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative) Injection NutropinAq IS MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5200 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5272 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)
Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) Injection Saizen SG MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) Injection Norditropin SimpleXx NO MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5200 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5272 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)
Omnitrope Surepal 15 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)
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5154 C5155 C5160 C5161 C5162 C5207 C5208 C5209 C5210 C5243 C5244 C5245 C5274 C5275 C5277 C5278 C5279 C5308 C5309 C5312 C5313 C5314 C5315 C5316 C5317 C5349 C5350 C5351 C5384 C5385 C5386 C5387 C5388 C5389 C5390 C5391 C5392 C5393 C5423 C5424 C5427 C5428 C5429 C5430 C5431 See Note 3 See Note 3 1 D(100)
Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative) Injection Saizen SG MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Sumatriptan in each of the forms: Tablet 50 mg (as succinate); Tablet (fast disintegrating) 50 mg (as succinate); and Nasal spray 20 mg in 0.1 mL single dose unit

    omit from the column headed “Circumstances” (all instances):             C4558   substitute:             C5259

  2. Schedule 1, entry for Sunitinib

    substitute:

Sunitinib Capsule 12.5 mg (as malate) Oral Sutent PF MP C4106 C4119 C4837 C4862 C5249 C5321 P4119 P5249 P5321 28 1 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4862 28 2 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4106 28 3 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4837 28 5 28
Capsule 25 mg (as malate) Oral Sutent PF MP C4106 C4119 C4837 C4862 C5249 C5321 P4119 P5249 P5321 28 1 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4862 28 2 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4106 28 3 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4837 28 5 28
Capsule 37.5 mg (as malate) Oral Sutent PF MP C4106 C4119 C4837 C4862 C5249 C5321 P4119 P5249 P5321 28 1 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4862 28 2 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4106 28 3 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4837 28 5 28
Capsule 50 mg (as malate) Oral Sutent PF MP C4106 C4119 C4837 C4862 C5249 C5321 P4119 P5249 P5321 28 1 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4862 28 2 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4106 28 3 28
MP C4106 C4119 C4837 C4862 C5249 C5321 P4837 28 5 28

  1. Schedule 1, omit entry for Telaprevir

  2. Schedule 1, entry for Tetrabenazine

    omit from the column headed “Circumstances”:        C1161   substitute:             C5340

  3. Schedule 1, entry for Thiamine

    omit from the column headed “Circumstances”:        C2384   substitute:             C5139

  4. Schedule 1, entry for Thyrotropin Alfa

    omit from the column headed “Circumstances”:        C3193   substitute:             C5296

  5. Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg

    omit from the column headed “Circumstances” (all instances):             C2797 C2799     substitute:             C5290  C5325

  6. Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg

    omit from the column headed “Circumstances” (all instances):             C2797   substitute:             C5290

  7. Schedule 1, entry for Topiramate in each of the forms: Capsule 15 mg; Capsule 25 mg; and Capsule 50 mg

    omit from the column headed “Circumstances”:        C2798   substitute:             C5173

  8. Schedule 1, entry for Toremifene

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

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

    (a)omit from the column headed “Circumstances”:             C3248  C3250  C3789  C3790  C3791  C3792      
    substitute:  C5159  C5203  C5204  C5205  C5206  C5276  C5425  C5426

    (b)omit from the column headed “Purposes”:       P3791 P3792 substitute:           P5206 P5425 P5426

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

    (a)omit from the column headed “Circumstances”:             C3248  C3250  C3789  C3790  C3791  C3792      
    substitute:  C5159  C5203  C5204  C5205  C5206  C5276  C5425  C5426

    (b)omit from the column headed “Purposes”:       P3248 P3250 P3789 P3790 substitute:           P5159 P5203 P5204 P5205 P5276

  11. Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

    omit from the column headed “Circumstances”:        C1035  C1233  C1500  C3341  C3342  C3343  C4051  C4052       

    insert in numerical order:  C5175  C5176  C5258  C5292  C5329  C5330  C5403  C5404

  12. Schedule 1, entry for Zonisamide in each of the forms: Capsule 25 mg; Capsule 50 mg; and Capsule 100 mg

    omit from the column headed “Circumstances”:        C2664   substitute:             C4928

  13. Schedule 3

    omit:

OI Boian Surgical Pty Ltd  25 077 514 464

  1. Schedule 4, Part 1, entry for Acamprosate

    substitute:

Acamprosate C5366

Alcohol dependence

The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence

 Compliance with Authority Required procedures - Streamlined Authority Code 5366

  1. Schedule 4, Part 1, entry for Adalimumab

    (a)omit:

C3265 P3265 Chronic plaque psoriasis (whole body) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS‑subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS‑subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS‑subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient’s condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures
C3267 P3267 Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS‑subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS‑subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS‑subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient’s condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures

(b)omit:

C3758 P3758 Chronic plaque psoriasis (whole body) — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS‑subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS‑subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS‑subsidised adalimumab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient’s condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures
C3759 P3759 Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS‑subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS‑subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS‑subsidised adalimumab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient’s condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures
C3760 P3760 Chronic plaque psoriasis (whole body) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre‑biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16‑week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24‑week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS‑subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient’s condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment 		Compliance with Written Authority Required procedures
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures
C3761 P3761 Chronic plaque psoriasis (face, hand, foot) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre‑biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre‑biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16‑week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24‑week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS‑subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient’s condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment 		Compliance with Written Authority Required procedures
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures

(c)insert in numerical order after existing text:

C5144 P5144

Severe chronic plaque psoriasis

Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment) - balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment) restriction to complete 16 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions

Must be treated by a dermatologist

 Compliance with Written or Telephone Authority Required procedures
C5184 P5184

Severe chronic plaque psoriasis

Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment)

Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction

Patient must be aged 18 years or older

Must be treated by a dermatologist

For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment

Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value

 Compliance with Written Authority Required procedures
C5223 P5223

Severe chronic plaque psoriasis

Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)

Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction

Patient must be aged 18 years or older

Must be treated by a dermatologist

For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab

Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application

Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application

The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment

(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment

(c) The most recent PASI assessment must be no more than 1 month old at the time of application

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements

 Compliance with Written Authority Required procedures
C5265 P5265

Severe chronic plaque psoriasis

Continuing treatment, Face, hand, foot

Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction

Patient must be aged 18 years or older

Must be treated by a dermatologist

For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value

All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course

Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition

The most recent PASI assessment must be no more than 1 month old at the time of application

Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug

The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline

 Compliance with Written Authority Required procedures
C5294 P5294

Severe chronic plaque psoriasis

Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)

Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction

Patient must be aged 18 years or older

Must be treated by a dermatologist

For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application

Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application

The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements

 Compliance with Written Authority Required procedures
C5335 P5335

Severe chronic plaque psoriasis

Initial treatment – Initial 2, Whole body (change or recommencement of treatment)

Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction

Patient must be aged 18 years or older

Must be treated by a dermatologist

For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment

Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment

An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle

 Compliance with Written Authority Required procedures
C5336 P5336

Severe chronic plaque psoriasis

Continuing treatment, Whole body

Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction

Patient must be aged 18 years or older

Must be treated by a dermatologist

For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab

An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle

All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course

Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition

The most recent PASI assessment must be no more than 1 month old at the time of application

Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug

 Compliance with Written Authority Required procedures
C5369 P5369

Severe chronic plaque psoriasis

Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate)

Must be treated by a dermatologist

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Ustekinumab

    substitute:

Ustekinumab C5159 P5159

Severe chronic plaque psoriasis

Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised

 Compliance with Written Authority Required procedures
C5203 P5203

Severe chronic plaque psoriasis

Initial treatment – Initial 2, Whole body (change or recommencement of treatment)
Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle

 Compliance with Written Authority Required procedures
C5204 P5204

Severe chronic plaque psoriasis

Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised

 Compliance with Written Authority Required procedures
C5205 P5205

Severe chronic plaque psoriasis

Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment) restriction to complete 28 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions.
Must be treated by a dermatologist

 Compliance with Written or Telephone Authority Required procedures
C5206 P5206

Severe chronic plaque psoriasis

Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist

 Compliance with Written or Telephone Authority Required procedures
C5276 P5276

Severe chronic plaque psoriasis

Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment)
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value

 Compliance with Written Authority Required procedures
C5425 P5425

Severe chronic plaque psoriasis

Continuing treatment, Whole body
Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised

 Compliance with Written Authority Required procedures
C5426 P5426

Severe chronic plaque psoriasis

Continuing treatment, Face, hand, foot
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Zoledronic acid

    (a)omit:

C1035

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

Bone metastases from breast cancer

 Compliance with Written or Telephone Authority Required procedures
C1233

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

Multiple myeloma

 Compliance with Written or Telephone Authority Required procedures
C1500

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

Treatment of hypercalcaemia of malignancy refractory to anti‑neoplastic therapy

 Compliance with Written or Telephone Authority Required procedures
C3341

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

Treatment of hypercalcaemia of malignancy refractory to anti‑neoplastic therapy

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3341
C3342

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

Multiple myeloma

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3342
C3343

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

Bone metastases from breast cancer

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3343
C4051

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

Bone metastases from castration‑resistant prostate cancer

 Compliance with Written or Telephone Authority Required procedures
C4052

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

Bone metastases from castration‑resistant prostate cancer

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4052

(b)insert in numerical order after existing text:

C5175

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

Bone metastases

The condition must be due to breast cancer

 Compliance with Written or Telephone Authority Required procedures
C5176

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

Hypercalcaemia of malignancy

Patient must have a malignancy refractory to anti-neoplastic therapy

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5176
C5258

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

Bone metastases

The condition must be due to castration-resistant prostate cancer

 Compliance with Written or Telephone Authority Required procedures
C5292

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

Hypercalcaemia of malignancy

Patient must have a malignancy refractory to anti-neoplastic therapy

 Compliance with Written or Telephone Authority Required procedures
C5329

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

Multiple myeloma

 Compliance with Written or Telephone Authority Required procedures
C5330

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

Multiple myeloma

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5330
C5403

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

Bone metastases

The condition must be due to breast cancer

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5403
C5404

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

Bone metastases

The condition must be due to castration-resistant prostate cancer

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5404

  1. Schedule 4, Part 1, entry for Zonisamide

    substitute:

Zonisamide C4928

Partial epileptic seizures

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

 Compliance with Authority Required procedures - Streamlined Authority Code 4928
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