National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 1) (PB 1 of 2019) (Cth)
Case
PB 1 of 2019
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 1)
National Health Act 1953
___________________________________________________________________________
I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 29 January 2019
THEA DANIEL
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 1).
(2)This Instrument may also be cited as PB 1 of 2019.
Commencement
This Instrument commences on 1 February 2019.
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
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | ALENDRONATE PLUS D3 70mg/70ug APOTEX | GX | MP NP | C6307 C6315 C6320 | 4 | 5 | 4 |
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | ALENDRONATE PLUS D3 70mg/140ug APOTEX | GX | MP NP | C6306 C6319 C6325 | 4 | 5 | 4 |
Schedule 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Bosentan APO | GX | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 60 | D(100) |
Schedule 1, entry for Capecitabine in the form Tablet 150 mg
omit:
| a | Capecitabine MYX | OC | MP | 60 | 2 | 60 |
Schedule 1, entry for Capecitabine in the form Tablet 500 mg
omit:
| a | Capecitabine MYX | OC | MP | 120 | 2 | 120 |
Schedule 1, entry for Cefazolin in the form Powder for injection 1 g (as sodium)
omit:
| a | Hospira Cefazolin Sodium | PF | MP NP | C5861 C5882 C5883 C5891 | 10 | 0 | 5 |
Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)
omit:
| a | Hospira Ceftriaxone | PF | MP NP | C5830 C5862 C5868 | 5 | 0 | 1 |
Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
insert in numerical order in the column headed "Circumstances" for the brand “Clopidogrel GH”: C4165 C4166
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 20; Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | APO-Cyproterone | TX | MP | P5532 | 20 CN5532 | 5 CN5532 | 20 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Pharmacor Cyproterone 50 | CR | MP | P5532 | 20 CN5532 | 5 CN5532 | 20 |
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100;
Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | APO-Cyproterone | TX | MP | 100 | 5 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Pharmacor Cyproterone 50 | CR | MP | 100 | 5 | 50 |
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | APO-Cyproterone | TX | MP | 50 | 5 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Pharmacor Cyproterone 100 | CR | MP | 50 | 5 | 50 |
Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed "Purposes": P7372 P7384
(f)omit from the column headed "Purposes": P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed "Purposes": P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed "Purposes": P7372 P7384
(f)omit from the column headed "Purposes": P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed "Purposes": P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed "Purposes": P7372 P7384
(f)omit from the column headed "Purposes": P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed "Purposes": P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 125 mg [Maximum Quantity: 168; Number of Repeats: 2]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed "Purposes": P7372 P7384
(f)omit from the column headed "Purposes": P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed "Purposes": P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 125 mg [Maximum Quantity: 168; Number of Repeats: 5]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 250 mg [Maximum Quantity: 168; Number of Repeats: 2]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed "Purposes": P7372 P7384
(f)omit from the column headed "Purposes": P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed "Purposes": P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 250 mg [Maximum Quantity: 168; Number of Repeats: 5]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 500 mg [Maximum Quantity: 168; Number of Repeats: 2]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
(e)omit from the column headed "Purposes": P7372 P7384
(f)omit from the column headed "Purposes": P7395 P7455 P7469 P7480
(g)insert in numerical order in the column headed "Purposes": P8326 P8328 P8329 P8444 P8445 P8446
Schedule 1, entry for Deferasirox in the form Tablet, dispersible, 500 mg [Maximum Quantity: 168; Number of Repeats: 5]
(a)omit from the column headed "Circumstances": C7372
(b)omit from the column headed "Circumstances": C7384
(c)omit from the column headed "Circumstances": C7395 C7455 C7469 C7480
(d)insert in numerical order in the column headed "Circumstances": C8326 C8328 C8329 C8444 C8445 C8446
Schedule 1, entry for Docetaxel
omit:
| Solution concentrate for I.V. infusion 20 mg in 2 mL | Injection | DBL Docetaxel Concentrated Injection | PF | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Dorzolamide with timolol
omit:
| a | Dorzolamide/Timolol Sandoz 20/5 | SZ | AO | C5038 | 1 | 5 | 1 |
| MP | C4343 | 1 | 5 | 1 |
Schedule 1, after entry for Ferric carboxymaltose in the form Injection 500 mg (iron) in 10 mL
insert:
| Ferric derisomaltose | Injection 500 mg (iron) in 5 mL | Injection | Monofer | PF | MP NP | 2 | 1 | 1 |
Schedule 1, entry for Fluorouracil in the form Injection 1000 mg in 20 mL
omit:
| DBL Fluorouracil Injection BP | PF | MP | C6266 C6297 | See Note 3 | See Note 3 | 5 | D(100) |
Schedule 1, entry for Fluticasone in the form Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | FLUAIR Inhaler | YC | MP NP | 1 | 5 | 1 |
Schedule 1, entry for Fluticasone in the form Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | FLUAIR Inhaler | YC | MP NP | 1 | 1 | 1 |
Schedule 1, entry for Fusidic acid in the form Tablet containing sodium fusidate 250 mg
omit from the column headed "Responsible Person": CS substitute: LO
Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Gabapentin APOTEX | TY | MP NP | C4928 | 100 | 5 | 100 |
Schedule 1, omit entry for Gelatin - succinylated
Schedule 1, entry for Gemcitabine
omit:
| Solution for injection 200 mg (as hydrochloride) in 5.3 mL | Injection | DBL Gemcitabine Injection | PF | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Glyceryl trinitrate
(a)omit:
| Transdermal patch 40 mg | Transdermal | Nitro-Dur 5 | MK | MP NP | 30 | 5 | 30 |
(b)omit:
| Transdermal patch 80 mg | Transdermal | Nitro-Dur 10 | MK | MP NP | 30 | 5 | 30 |
(c)omit:
| Transdermal patch 120 mg | Transdermal | Nitro-Dur 15 | MK | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals
(a)omit:
| Bars 54 g, 7 (Camino Pro Complete) | Oral | Camino Pro Complete | QH | MP NP | C4295 | 14 | 5 | 1 |
(b)omit:
| Oral liquid 250 mL, 30 (PKU Glytactin RTD 10) | Oral | PKU Glytactin RTD 10 | QH | MP NP | C5012 | 4 | 5 | 1 |
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]
omit from the column headed "Purposes": P8224
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
insert in numerical order in the column headed “Purposes”: P8224
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]
omit from the column headed "Purposes": P8224
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]
insert in numerical order in the column headed “Purposes”: P8224
Schedule 1, after entry for Guanfacine in the form Tablet 4 mg (as hydrochloride)
insert:
| Guselkumab | Injection 100 mg in 1 mL single use pre-filled syringe | Injection | Tremfya | JC | MP | C8442 C8443 C8477 C8496 C8497 C8498 C8506 C8507 C8516 C8518 | 1 | 2 | 1 |
Schedule 1, entry for Idarubicin
omit:
| Capsule containing idarubicin hydrochloride 10 mg | Oral | Zavedos | PF | MP | C5812 | 3 | 0 | 1 |
Schedule 1, entry for Idarubicin in the form Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL
omit:
| Idarubicin Ebewe | SZ | MP | C6247 | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, entry for Isotretinoin in the form Capsule 20 mg
substitute:
| Capsule 20 mg | Oral | a | Roaccutane | RO | MP | C5224 | 60 | 3 | 30 |
| MP | C5224 | 60 | 3 | 60 | |||||
| a | APO-Isotretinoin | TX | MP | C5224 | 60 | 3 | 60 | ||
| a | Dermatane | ER | MP | C5224 | 60 | 3 | 60 | ||
| a | Isotretinoin AN | EA | MP | C5224 | 60 | 3 | 60 | ||
| a | Isotretinoin SCP 20 | CR | MP | C5224 | 60 | 3 | 60 | ||
| a | Oratane | RF | MP | C5224 | 60 | 3 | 60 | ||
| a | Rocta 20 | RW | MP | C5224 | 60 | 3 | 60 |
Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| CIPLA MELOXICAM 7.5 | LR | MP NP | C4907 C4962 | 30 | 3 | 30 |
Schedule 1, entry for Meloxicam in the form Tablet 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| CIPLA MELOXICAM 15 | LR | MP NP | C4907 C4962 | 30 | 3 | 30 |
Schedule 1, entry for Nicotine
insert as first entry:
| Gum 2 mg | Buccal | Nicotinell | ON | MP NP | C5140 C6848 | 432 | 1 | 216 |
| Gum 4 mg | Buccal | Nicotinell | ON | MP NP | C5140 C6848 | 216 | 2 | 216 |
| Lozenge 2 mg | Buccal | Nicotinell | ON | MP NP | C5140 C6848 | 216 | 2 | 216 |
| Lozenge 4 mg | Buccal | Nicotinell | ON | MP NP | C5140 C6848 | 216 | 2 | 216 |
Schedule 1, entry for Nifedipine in the form Tablet 10 mg
(a)omit:
| a | Adalat 10 | BN | MP NP | 60 | 5 | 60 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Adefin 10”: a
Schedule 1, entry for Nifedipine in the form Tablet 20 mg
omit from the column headed “Schedule Equivalent” for the brand “Adefin 20”: a
Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Olanzapine APOTEX | GX | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, entry for Olanzapine in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| Olanzapine APOTEX | GX | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand”:
| Olanzapine APOTEX | GX | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, entry for Olanzapine in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand”:
| Olanzapine APOTEX | GX | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 2]
omit from the column headed "Pack Quantity": 112 substitute: 56
Schedule 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 5]
omit from the column headed "Pack Quantity": 112 substitute: 56
Schedule 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 2]
omit from the column headed "Pack Quantity": 112 substitute: 56
Schedule 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 5]
omit from the column headed "Pack Quantity": 115 substitute: 56
Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)
omit:
| a | APO-Olmesartan/Amlodipine 20/5 | TX | MP NP | C4373 | 30 | 5 | 30 |
Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)
omit:
| a | APO-Olmesartan/Amlodipine 40/5 | TX | MP NP | C4373 | 30 | 5 | 30 |
Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)
omit:
| a | APO-Olmesartan/Amlodipine 40/10 | TX | MP NP | C4373 | 30 | 5 | 30 |
Schedule 1, after entry for Ondansetron in the form Wafer 8 mg
insert:
| Osimertinib | Tablet 40 mg | Oral | Tagrisso | AP | MP | C8537 C8538 | 30 | 5 | 30 |
| Tablet 80 mg | Oral | Tagrisso | AP | MP | C8524 C8537 C8538 | 30 | 5 | 30 |
Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
omit:
| DBL Oxaliplatin Concentrate | PF | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir
Schedule 1, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin
Schedule 1, entry for Pemetrexed in all forms
omit:
| Pemetrexed MYX | OC | MP | C4792 C7195 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Rasagiline
(a)insert in the column headed “Schedule Equivalent” for the brand “Azilect”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Pharmacor Rasagiline | CR | MP NP | C5339 | 30 | 5 | 30 |
Schedule 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
omit:
| Salbutamol Sandoz | SZ | MP NP | C6815 C6825 | 2 | 5 | 1 |
Schedule 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
omit:
| Salbutamol Sandoz | SZ | MP NP | C6815 C6825 | 2 | 5 | 1 |
Schedule 1, entry for Somatropin
substitute:
| Somatropin | Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | See Note 3 | See Note 3 | 7 | D(100) |
| Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative) | Injection | Genotropin MiniQuick | PF | MP | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8393 C8394 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8393 C8394 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 | 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 | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8338 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8393 C8394 C8396 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8439 C8472 C8502 | 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 | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8338 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8393 C8394 C8396 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8439 C8472 C8502 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8121 C8242 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8121 C8242 C8334 C8335 C8336 C8337 C8343 C8347 C8348 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8427 C8433 C8452 C8453 C8468 | 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 | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8338 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8393 C8394 C8396 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8439 C8472 C8502 | 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 | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 | See Note 3 | See Note 3 | 1 | D(100) | |
| Omnitrope Surepal 5 | SZ | MP | C5151 C5158 C5165 C5166 C5167 C5236 C5247 C5285 C5286 C5318 C5319 C5352 C8342 C8372 C8373 C8378 C8382 C8386 C8388 C8389 C8411 C8429 C8449 C8456 C8457 C8459 C8463 C8464 C8469 C8471 C8480 C8481 C8482 C8488 C8489 C8490 C8492 C8494 C8495 C8501 C8503 C8525 | See Note 3 | See Note 3 | 1 | D(100) | |||
| Scitropin A | SA | MP | C5151 C5158 C5165 C5166 C5167 C5236 C5247 C5285 C5286 C5318 C5319 C5352 C8342 C8372 C8373 C8378 C8382 C8386 C8388 C8389 C8411 C8429 C8449 C8456 C8457 C8459 C8463 C8464 C8469 C8471 C8480 C8481 C8482 C8488 C8489 C8490 C8492 C8494 C8495 C8501 C8503 C8525 | 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 C5190 C5230 C5239 C5286 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8388 C8393 C8394 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8490 C8503 C8525 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 | See Note 3 | See Note 3 | 1 | D(100) | |
| Omnitrope Surepal 10 | SZ | MP | C5151 C5158 C5165 C5166 C5167 C5236 C5247 C5285 C5286 C5318 C5319 C5352 C8342 C8372 C8373 C8378 C8382 C8386 C8388 C8389 C8411 C8429 C8449 C8456 C8457 C8459 C8463 C8464 C8469 C8471 C8480 C8481 C8482 C8488 C8489 C8490 C8492 C8494 C8495 C8501 C8503 C8525 | See Note 3 | See Note 3 | 1 | D(100) | |||
| SciTropin A | SA | MP | C5151 C5158 C5165 C5166 C5167 C5236 C5247 C5285 C5286 C5318 C5319 C5352 C8342 C8372 C8373 C8378 C8382 C8386 C8388 C8389 C8411 C8429 C8449 C8456 C8457 C8459 C8463 C8464 C8469 C8471 C8480 C8481 C8482 C8488 C8489 C8490 C8492 C8494 C8495 C8501 C8503 C8525 | 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 | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 | 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 C5190 C5230 C5239 C5286 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8388 C8393 C8394 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8490 C8503 C8525 | 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 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 | See Note 3 | See Note 3 | 1 | D(100) | |
| Omnitrope Surepal 15 | SZ | MP | C5151 C5158 C5165 C5166 C5167 C5236 C5247 C5285 C5286 C5318 C5319 C5352 C8342 C8372 C8373 C8378 C8382 C8386 C8388 C8389 C8411 C8429 C8449 C8456 C8457 C8459 C8463 C8464 C8469 C8471 C8480 C8481 C8482 C8488 C8489 C8490 C8492 C8494 C8495 C8501 C8503 C8525 | 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 | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8381 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 | 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 C5190 C5230 C5239 C5286 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8381 C8388 C8393 C8394 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8490 C8503 C8525 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 40 mg-5 mg (as besilate)
omit:
| a | APO-Telmisartan/Amlodipine 40/5 | TX | MP NP | C4373 | 28 | 5 | 28 |
Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 40 mg-10 mg (as besilate)
omit:
| a | APO-Telmisartan/Amlodipine 40/10 | TX | MP NP | C4373 | 28 | 5 | 28 |
Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 80 mg-5 mg (as besilate)
omit:
| a | APO-Telmisartan/Amlodipine 80/5 | TX | MP NP | C4373 | 28 | 5 | 28 |
Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 80 mg-10 mg (as besilate)
omit:
| a | APO-Telmisartan/Amlodipine 80/10 | TX | MP NP | C4373 | 28 | 5 | 28 |
Schedule 1, after entry for Ticagrelor in the form Tablet 90 mg
insert:
| Tildrakizumab | Injection 100 mg in 1 mL single dose pre-filled syringe | Injection | Ilumya | RA | MP | C8318 C8319 C8320 C8441 C8473 C8474 C8475 C8504 C8505 C8522 | P8318 P8441 P8473 P8474 P8475 | 1 | 1 | 1 |
| MP | C8318 C8319 C8320 C8441 C8473 C8474 C8475 C8504 C8505 C8522 | P8319 P8320 P8504 P8505 P8522 | 1 | 2 | 1 |
Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)
substitute:
| Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | Vancomycin Alphapharm | AF | MP | C5716 C5717 C5769 | P5717 | 2 | 0 | 1 |
| PDP | C5801 | 2 | 0 | 1 | |||||
| MP | C5716 C5717 C5769 | P5716 P5769 | 5 | 0 | 1 |
Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
omit:
| Hospira Pty Limited | PF | MP | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
omit:
| Hospira Pty Limited | PF | MP | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4685 | 56 | 0 | 56 |
Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4683 P5692 P5725 P5748 | 56 | 2 | 56 |
Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4685 | 56 | 0 | 56 |
Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Voriconazole APO | GX | MP NP | C4683 C4685 C5692 C5725 C5748 | P4683 P5692 P5725 P5748 | 56 | 2 | 56 |
Schedule 3
omit:
| BR | B. Braun Australia Pty Ltd | 56 002 945 155 |
Schedule 3, details relevant to Responsible Person code DO
omit from the column headed “Responsible Person”: Aurobindo Pharma (Australia) Pty Limited substitute: Fair-Med Healthcare (Australia) Pty Ltd
Schedule 3, details relevant to Responsible Person code FB
omit from the column headed “Responsible Person”: Medicament
Schedule 3, after details relevant to Responsible Person code TX
insert:
| TY | Apotex Pty Ltd | 52 096 916 148 |
Schedule 4, Part 1, entry for Deferasirox
(a)omit:
| C7372 | P7372 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 7372 |
(b)omit:
| C7384 | P7384 | Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 7384 |
(c)omit:
| C7395 | P7395 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 7395 |
| C7455 | P7455 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures |
| C7469 | P7469 | Chronic iron overload Continuing treatment | Compliance with Authority Required procedures |
| C7480 | P7480 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures |
(d)insert in numerical order after existing text:
| C8326 | P8326 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8326 |
| C8328 | P8328 | Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8328 |
| C8329 | P8329 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8329 |
| C8444 | P8444 | Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures |
| C8445 | P8445 | Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures |
| C8446 | P8446 | Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Guanfacine
insert:
| Guselkumab | C8442 | Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to 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 under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. 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 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. An application 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 undertaken the patient will be deemed to have failed to respond to treatment with this drug. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures |
| C8443 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient or recommencement of treatment after more than 5 years break in therapy) 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 prior PBS-subsidised treatment with a biological medicine for this condition; OR Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine 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 The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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]. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures | |
| C8477 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient or recommencement of treatment after more than 5 years break in therapy) 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 prior PBS-subsidised treatment with a biological medicine for this condition; OR Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine 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 The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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]. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. | Compliance with Written Authority Required procedures | |
| C8496 | Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot or Grandfathered patients - 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; OR Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment, Whole body restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment, Face, hand, foot restriction to complete 24 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 24 weeks treatment available under the above restrictions. Must be treated by a dermatologist. | Compliance with Authority Required procedures | |
| C8497 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in therapy of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine 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 medicines 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 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 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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. 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 baseline values for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken the patient will be deemed to have failed to respond to treatment with this drug. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures | |
| C8498 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break in therapy of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in therapy of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient or patient recommencing treatment after a break in therapy of 5 years or more) restriction to complete 20 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in therapy of less than 5 years) restriction to complete 20 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break in therapy of 5 years or more) restriction to complete 20 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in therapy of less than 5 years) restriction to complete 20 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 20 weeks treatment available under the above restrictions. Must be treated by a dermatologist. | Compliance with Authority Required procedures | |
| C8506 | Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to 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 under this restriction. Patient must be aged 18 years or older. 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 baseline values for this treatment cycle. 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 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. An application 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 undertaken the patient will be deemed to have failed to respond to treatment with this drug. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures | |
| C8507 | Severe chronic plaque psoriasis Initial treatment - Initial 3, Face, hand, foot, Grandfathered patients Patient must have documented severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where lesions were present for at least 6 months from the time of initial diagnosis; AND Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND Patient must have had a documented failure 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 demonstrated an adequate response following at least 12 weeks of non-PBS subsidised treatment with this drug for this condition; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 sheets and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. The most recent PASI assessment must be no more than 1 month old at the time of application. 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 were rated as severe or very severe, as assessed, preferably whilst still on prior treatment; or (ii) the skin area affected was 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on prior treatment. (b) A PASI assessment must have been completed for each prior treatment course, preferably whilst still on treatment. The PASI assessment must be performed on the same affected area as assessed at baseline or prior to initiation of treatment with this drug. 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 baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures | |
| C8516 | Severe chronic plaque psoriasis Initial treatment - Initial 3, Whole body, Grandfathered patients Patient must have documented severe chronic plaque psoriasis where lesions were present for at least 6 months from the time of initial diagnosis; AND Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND Patient must have had a documented failure 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 demonstrated an adequate response following at least 12 weeks of non-PBS subsidised treatment with this drug for this condition; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 sheets including the date of the assessment of the patient's condition at baseline (prior to initiation of non-PBS subsidised therapy with this drug) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the completed PASI calculation sheet demonstrating response. The most recent PASI assessment must be no more than 1 month old at the time of application. 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 Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on 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 baseline values for this treatment cycle. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures | |
| C8518 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in therapy of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine 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 medicines 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 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 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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. 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 baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken the patient will be deemed to have failed to respond to treatment with this drug. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, after entry for Ondansetron
insert:
| Osimertinib | C8524 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; (b) a completed EGFR T790M mutation positive non-small cell lung cancer initial PBS authority application - supporting information form; (c) copy of the pathology report from an Approved Pathology Authority confirming evidence of EGFR T790M mutation in tumour material while on or after first line EGFR TKI treatment; and (d) date of commencement of first line EGFR TKI treatment and date of progression whilst on first line EGFR TKI treatment. | Compliance with Written Authority Required procedures |
| C8537 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. | Compliance with Authority Required procedures | |
| C8538 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment; AND The condition must have progressed on or after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have evidence of EGFR T790M mutation following progression on first line EGFR TKI treatment; AND Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; (b) a completed EGFR T790M mutation positive non-small cell lung cancer initial PBS authority application - supporting information form; (c) copy of the pathology report from an Approved Pathology Authority confirming evidence of EGFR T790M mutation in tumour material while on or after first line EGFR TKI treatment; and (d) date of commencement of first line EGFR TKI treatment and date of progression whilst on first line EGFR TKI treatment. For patients commencing non-PBS-subsidised treatment between 1 June 2018 and 1 February 2019, evidence of EGFR T790M mutation must be from tumour material. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir
Schedule 4, Part 1, omit entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin
Schedule 4, Part 1, entry for Somatropin
substitute:
| Somatropin | C5146 | Short stature and slow growth Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months; AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures |
| C5147 | Short stature associated with Turner syndrome Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be female and must not have a height greater than or equal to 155.0cm. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months; AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures | |
| C5151 | Short stature associated with Turner syndrome Continuing treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have a bone age of 13.5 years or greater; AND Patient must not have a height greater than or equal to 155.0 cm. Patient must be aged 3 years or older. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 4. A bone age result performed within the last 12 months; AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures | |
| C5158 | Short stature associated with Turner syndrome Initial treatment Must be treated by a specialist or consultant physician in paediatric endocrinology; OR Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology. Patient must have a current height at or below the 95thpercentile for age on the Turner syndrome growth curve for girls; AND Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND Patient must not have a bone age of 2.5 years or less; AND Patient must not have a height greater than or equal to 155.0 cm; AND Patient must not have a bone age of 13.5 years or greater. Patient must be aged 3 years or older. The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND 3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR (b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND 4. A bone age result performed within the last 12 months; AND 5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures | |
| C5165 | Growth retardation secondary to an intracranial lesion, or cranial irradiation Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. Patient must be aged 3 years or older. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months; AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures | |
| C5166 | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have a chronological age of 5 years or greater. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. Patient must be aged 3 years or older. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months; AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures | |
| C5167 | Short stature associated with Turner syndrome Recommencement of treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature assciated with Turner syndrome; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have had a height at or below the 95th percentile for age on the Turner syndrome growth curve for girls immediately prior to commencing growth hormone treatment; AND Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have a bone age of 2.5 years or less; AND Patient must not have a height greater than or equal to 155.0 cm; AND Patient must not have a bone age of 13.5 years or greater. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. Patient must be aged 3 years or older. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND 3. A height measurement from immediately prior to commencement of growth hormone treatment; AND 4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND 5. Recent growth data (height and weight, not older than three months); AND 6. A bone age result performed within the last 12 months; AND The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures | |
| C5190 | Short stature associated with Turner syndrome Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have had a height at or below the 95th percentile for age on the Turner syndrome growth curve for girls immediately prior to commencing growth hormone treatment; AND Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have a bone age of 2.5 years or less; AND Patient must not have a bone age of 13.5 years or greater; AND Patient must not have a height greater than or equal to 155.0 cm. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. A height measurement from immediately prior to commencement of growth hormone treatment; AND 4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND 5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 6. A bone age result performed within the last 12 months; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. | Compliance with Written Authority Required procedures | |
| C5230 | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have a chronological age of less than 2 years; AND Patient must have a documented clinical risk of hypoglycaemia; AND Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND 4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND 5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. |
Schedule 4, Part 1, after entry for Ticagrelor
insert:
| Tildrakizumab | C8318 | P8318 | Severe chronic plaque psoriasis Initial treatment - Initial 3, Whole body, Grandfathered patients Patient must have documented severe chronic plaque psoriasis where lesions were present for at least 6 months from the time of initial diagnosis; AND Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND Patient must have had a documented failure 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 demonstrated an adequate response following at least 12 weeks of non-PBS subsidised treatment with this drug for this condition; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 sheets including the date of the assessment of the patient's condition at baseline (prior to initiation of non-PBS subsidised therapy with this drug) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the completed PASI calculation sheet demonstrating response. The most recent PASI assessment must be no more than 1 month old at the time of application. 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 Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on 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 baseline values for this treatment cycle. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures |
| C8319 | P8319 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in therapy of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine 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 medicines 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 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. 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. 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 baseline values for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken the patient will be deemed to have failed to respond to treatment with this drug. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures | |
| C8320 | P8320 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break in therapy of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in therapy of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient or patient recommencing treatment after a break in therapy of 5 years or more) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in therapy of less than 5 years) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break in therapy of 5 years or more) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in therapy of less than 5 years) 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 Authority Required procedures | |
| C8441 | P8441 | Severe chronic plaque psoriasis Initial treatment - Initial 3, Face, hand, foot, Grandfathered patients Patient must have documented severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where lesions were present for at least 6 months from the time of initial diagnosis; AND Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND Patient must have had a documented failure 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 demonstrated an adequate response following at least 12 weeks of non-PBS subsidised treatment with this drug for this condition; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 sheets and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. The most recent PASI assessment must be no more than 1 month old at the time of application. 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 were rated as severe or very severe, as assessed, preferably whilst still on prior treatment; or (ii) the skin area affected was 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on prior treatment. (b) A PASI assessment must have been completed for each prior treatment course, preferably whilst still on treatment. The PASI assessment must be performed on the same affected area as assessed at baseline or prior to initiation of treatment with this drug. 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 baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures | |
| C8473 | P8473 | Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to 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 under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. 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 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. An application 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 undertaken the patient will be deemed to have failed to respond to treatment with this drug. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures | |
| C8474 | P8474 | Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to 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 under this restriction. Patient must be aged 18 years or older. 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 baseline values for this treatment cycle. 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 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. An application 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 undertaken the patient will be deemed to have failed to respond to treatment with this drug. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures | |
| C8475 | P8475 | Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot or Grandfathered patients - 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; OR Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment, Whole body restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment, Face, hand, foot restriction to complete 24 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 24 weeks treatment available under the above restrictions. Must be treated by a dermatologist. | Compliance with Authority Required procedures | |
| C8504 | P8504 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient or recommencement of treatment after more than 5 years break in therapy) 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 prior PBS-subsidised treatment with a biological medicine for this condition; OR Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine 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 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. 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]. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures | |
| C8505 | P8505 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in therapy of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine 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 medicines 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 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. 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. 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 baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken the patient will be deemed to have failed to respond to treatment with this drug. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures | |
| C8522 | P8522 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient or recommencement of treatment after more than 5 years break in therapy) 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 prior PBS-subsidised treatment with a biological medicine for this condition; OR Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine 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 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. 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]. A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-15475]
insert in alphabetical order in the column headed “Brand”: Clopidogrel GH
Schedule 5, entry for Meloxicam in the form Tablet 15 mg
insert in alphabetical order in the column headed “Brand”: CIPLA MELOXICAM 15
Schedule 5, entry for Meloxicam in the form Tablet 7.5 mg
insert in alphabetical order in the column headed “Brand”: CIPLA MELOXICAM 7.5
Schedule 5, entry for Olanzapine in the form Tablet 10 mg
insert in alphabetical order in the column headed “Brand”: Olanzapine APOTEX
Schedule 5, entry for Olanzapine in the form Tablet 7.5 mg
insert in alphabetical order in the column headed “Brand”: Olanzapine APOTEX
Schedule 5, entry for Olanzapine in the form Tablet 5 mg
insert in alphabetical order in the column headed “Brand”: Olanzapine APOTEX
Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
omit from the column headed “Brand”: Salbutamol Sandoz
Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
omit from the column headed “Brand”: Salbutamol Sandoz
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