National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 7) (PB 58 of 2019) (Cth)
PB 58 of 2019
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 7)
National Health Act 1953
________________________________________________________________________
I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 26 July 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. 7).
(2)This Instrument may also be cited as PB 58 of 2019.
Commencement
This Instrument commences on 1 August 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 Acarbose in each of the forms: Tablet 50 mg; and Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | GLYBOSAY | RW | MP NP | 90 | 5 | 90 |
Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Aciclovir APOTEX | TY | MP NP | C5936 C5942 | P5936 | 50 | 0 | 50 |
Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 90; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Aciclovir APOTEX | TY | MP NP | C5936 C5942 | P5942 | 90 | 5 | 90 |
Schedule 1, entry for Aciclovir in the form Tablet 800 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Aciclovir APOTEX | TY | MP NP | C5959 C5967 | 35 | 0 | 35 |
Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
omit from the column headed “Responsible Person” for the brand “Neotigason”: UA substitute: TB
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P4851 P6437 P6445
(e)insert in numerical order in the column headed “Purposes”: P9064 P9069 P9078 P9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P4845
(e)omit from the column headed “Purposes”: P6439
(f)insert in numerical order in the column headed “Purposes”: P9063 P9105
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P4851 P6437 P6445
(e)insert in numerical order in the column headed “Purposes”: P9064 P9069 P9078 P9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4845 C4851
(b)omit from the column headed “Circumstances”: C6437 C6439 C6445
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P4845
(e)omit from the column headed “Purposes”: P6439
(f)insert in numerical order in the column headed “Purposes”: P9063 P9105
Schedule 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMILOXYN | RF | PDP | 20 | 0 | 20 |
Schedule 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMILOXYN | RF | MP NP MW | 20 | 1 | 20 |
Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMILOXYN | RF | PDP | 20 | 0 | 20 |
Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMILOXYN | RF | MP NP MW | 20 | 1 | 20 |
Schedule 1, omit entry for Aprepitant
Schedule 1, entry for Benzathine benzylpenicillin
substitute:
| Benzathine benzylpenicillin | Injection containing 600,000 units benzathine benzylpenicillin tetrahydrate in 1.17 mL single use pre-filled syringe | Injection | Bicillin L-A | PF | MP NP PDP | 10 | 0 | 10 |
| Injection containing 1,200,000 units benzathine benzylpenicillin tetrahydrate in 2.3 mL single use pre-filled syringe | Injection | Bicillin L-A | PF | MP NP PDP | 10 | 0 | 10 |
Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL
insert in numerical order in the column headed “Circumstances”: C9102 C9149 C9166
Schedule 1, entry for Calcitriol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | CALITROL | ED | MP NP | C5089 C5114 C5255 C5401 C5402 | 100 | 3 | 100 |
Schedule 1, entry for Calcium
substitute:
| Calcium | Tablet, chewable, 500 mg (as carbonate) | Oral | Cal-500 | PP | MP NP | C4586 | 240 | 1 | 60 |
| MP NP | C4586 | 240 | 1 | 120 | |||||
| Tablet 600 mg (as carbonate) | Oral | Calci-Tab 600 | AE | MP NP | C4586 | 240 | 1 | 240 |
Schedule 1, entry for Carbimazole
omit:
| Carbimazol ARISTO | PQ | MP NP | 200 | 2 | 100 |
Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4830 C4853 C6396 C6460 C6474
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185
(c)omit from the column headed “Purposes”: P4830
(d)insert in numerical order in the column headed “Purposes”: P9185
Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4830 C4853 C6396 C6460 C6474
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185
(c)omit from the column headed “Purposes”: P4853 P6474
(d)insert in numerical order in the column headed “Purposes”: P9063 P9105
Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 6;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4830 C4853 C6396 C6460 C6474
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185
(c)omit from the column headed “Purposes”: P6396 P6460
(d)insert in numerical order in the column headed “Purposes”: P9073 P9074 P9183
Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4830 C4853 C6396 C6460 C6474
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185
(c)omit from the column headed “Purposes”: P4830
(d)insert in numerical order in the column headed “Purposes”: P9185
Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4830 C4853 C6396 C6460 C6474
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185
(c)omit from the column headed “Purposes”: P4853 P6474
(d)insert in numerical order in the column headed “Purposes”: P9063 P9105
Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 6;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4830 C4853 C6396 C6460 C6474
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185
(c)omit from the column headed “Purposes”: P6396 P6460
(d)insert in numerical order in the column headed “Purposes”: P9073 P9074 P9183
Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
(c)omit from the column headed “Purposes”: P6905 P6906 P6926 substitute: P9059 P9098 P9100 P9136
Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
(c)omit from the column headed “Purposes”: P6905 P6906 P6926 substitute: P9059 P9098 P9100 P9136
Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
(c)omit from the column headed “Purposes”: P6905 P6906 P6926 substitute: P9059 P9098 P9100 P9136
Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
(c)omit from the column headed “Purposes”: P6905 P6906 P6926 substitute: P9059 P9098 P9100 P9136
Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6905 C6906 C6926
(b)insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136
Schedule 1, entry for Deferiprone in the form Tablet 500 mg
omit from the column headed “Maximum Quantity”: 600 substitute: 300
Schedule 1, after entry for Deferiprone in the form Tablet 500 mg
insert:
| Tablet 1000 mg | Oral | Ferriprox | TX | MP | C6380 C6403 C6442 C6448 | 300 | 5 | 50 | D(100) |
Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
omit:
| a | Diltiazem Sandoz | SZ | MP NP | 90 | 5 | 90 |
Schedule 1, entry for Enoxaparin in each of the forms: Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe; and Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe [Maximum Quantity: 20;
Number of Repeats: 0]
omit from the column headed “Number of Repeats” (all instances): 0 substitute: 1
Schedule 1, entry for Erythromycin in the form Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL
substitute:
| Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | E-Mycin 200 | AF | PDP | 1 | 0 | 1 |
| MP NP | 1 | 1 | 1 |
Schedule 1, entry for Erythromycin in the form Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL
substitute:
| Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | E-Mycin 400 | AF | PDP | 1 | 0 | 1 |
| MP NP | 1 | 1 | 1 |
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880 C8888
(c)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177
(d)omit from the column headed “Purposes”: P7177 P7220 P7224
(e)omit from the column headed “Purposes”: P8888
(f)insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880 C8888
(c)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177
(d)omit from the column headed “Purposes”: P7181 P7219 P7251
(e)omit from the column headed “Purposes”: P8880
(f)insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9162
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880
(c)omit from the column headed “Circumstances”: C8888
(d)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177
(e)omit from the column headed “Purposes”: P7177 P7220 P7224
(f)omit from the column headed “Purposes”: P8888
(g)insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880 C8888
(c)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177
(d)omit from the column headed “Purposes”: P7177 P7220 P7224
(e)omit from the column headed “Purposes”: P8888
(f)insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880
(c)omit from the column headed “Circumstances”: C8888
(d)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177
(e)omit from the column headed “Purposes”: P7181 P7217 P7219 P7251
(f)omit from the column headed “Purposes”: P8880
(g)insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9156 P9162
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880 C8888
(c)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177
(d)omit from the column headed “Purposes”: P7181 P7219 P7251
(e)omit from the column headed “Purposes”: P8880
(f)insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9162
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880
(c)omit from the column headed “Circumstances”: C8888
(d)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177
(e)omit from the column headed “Purposes”: P7177 P7220 P7224
(f)omit from the column headed “Purposes”: P8888
(g)insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880 C8888
(c)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177
(d)omit from the column headed “Purposes”: P7177 P7220 P7224
(e)omit from the column headed “Purposes”: P8888
(f)insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880
(c)omit from the column headed “Circumstances”: C8888
(d)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177
(e)omit from the column headed “Purposes”: P7181 P7217 P7219 P7251
(f)omit from the column headed “Purposes”: P8880
(g)insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9156 P9162
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251
(b)omit from the column headed “Circumstances”: C8880 C8888
(c)insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177
(d)omit from the column headed “Purposes”: P7181 P7219 P7251
(e)omit from the column headed “Purposes”: P8880
(f)insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9162
Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Fenocol | YC | MP NP | 30 | 5 | 30 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Fenofibrate Cipla | LR | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 11]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Fenocol | YC | MP | P7640 | 30 | 11 | 30 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
| a | Fenofibrate Cipla | LR | MP | P7640 | 30 | 11 | 30 |
Schedule 1, entry for Flucloxacillin
insert as first entry:
| Capsule 250 mg (as sodium) | Oral | Medsurge | DZ | PDP | C5298 | 24 | 0 | 28 |
| MP NP MW | C5414 | 24 | 0 | 28 |
Schedule 1, entry for Flucloxacillin in the form Capsule 250 mg (as sodium monohydrate)
omit from the column headed “Schedule Equivalent” (all instances): a
Schedule 1, after entry for Flucloxacillin in the form Capsule 250 mg (as sodium monohydrate)
insert:
| Capsule 500 mg (as sodium) | Oral | Medsurge | DZ | PDP | C5298 | 24 | 0 | 100 |
| MP | C5414 C6169 | P5414 | 24 | 0 | 100 | |||
| NP MW | C5414 | 24 | 0 | 100 | ||||
| MP | C5414 C6169 | P6169 | 48 | 1 | 100 |
Schedule 1, entry for Flucloxacillin in the form Capsule 500 mg (as sodium monohydrate)
omit from the column headed “Schedule Equivalent” (all instances): a
Schedule 1, after entry for Fluticasone in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate
500 micrograms per dose, 60 doses
insert:
| Fluticasone furoate | Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms per dose, 30 doses | Inhalation by mouth | Arnuity Ellipta | GK | MP NP | 1 | 5 | 1 |
| Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms per dose, 30 doses | Inhalation by mouth | Arnuity Ellipta | GK | MP NP | 1 | 5 | 1 |
Schedule 1, entry for Furosemide in the form Tablet 40 mg
omit:
| a | Frusemide Sandoz | SZ | MP NP | 100 | 1 | 100 |
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]
(a)omit from the column headed “Circumstances”: C4845 C4851 C6437 C6439 C6445
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155
(c)omit from the column headed “Purposes”: P4851 P6437 P6445
(d)insert in numerical order in the column headed “Purposes”: P9064 P9069 P9153 P9155
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]
(a)omit from the column headed “Circumstances”: C4845 C4851 C6437 C6439 C6445
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155
(c)omit from the column headed “Purposes”: P4845 P6439
(d)insert in numerical order in the column headed “Purposes”: P9063 P9105
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]
(a)omit from the column headed “Circumstances”: C4845 C4851 C6437 C6439 C6445
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155
(c)omit from the column headed “Purposes”: P4851 P6437 P6445
(d)insert in numerical order in the column headed “Purposes”: P9064 P9069 P9153 P9155
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]
(a)omit from the column headed “Circumstances”: C4845 C4851 C6437 C6439 C6445
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155
(c)omit from the column headed “Purposes”: P4845 P6439
(d)insert in numerical order in the column headed “Purposes”: P9063 P9105
Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 2 mg in 1 mL
(a)insert in the column headed “Schedule Equivalent” for the brand “Dilaudid”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | HYDROMORPHONE JUNO | JU | MP NP | 5 | 0 | 5 |
Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL
(a)insert in the column headed “Schedule Equivalent” for the brand “Dilaudid-HP”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | HYDROMORPHONE JUNO-HP | JU | MP NP | 5 | 0 | 5 |
Schedule 1, entry for Hypromellose
omit:
| Eye drops 3 mg per mL, 15 mL | Application to the eye | a | Genteal | AQ | AO | C6120 | 1 | 5 | 1 |
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | ||||
| NP | C6073 | 1 | 5 | 1 | |||||
| a | In a Wink Moisturising | IQ | AO | C6120 | 1 | 5 | 1 | ||
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | ||||
| NP | C6073 | 1 | 5 | 1 | |||||
| a | Genteal | AQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 | |
| a | In a Wink Moisturising | IQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, entry for Imatinib
substitute:
| Imatinib | Capsule 100 mg (as mesilate) | Oral | CIPLA IMATINIB ADULT | LR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 |
| Glivanib | JU | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |||
| IMATINIB AN | JO | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |||
| Imatinib GH | GQ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |||
| Imatinib-APOTEX | TX | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |||
| IMATINIB-DRLA | RZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |||
| CIPLA IMATINIB ADULT | LR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| Glivanib | JU | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| IMATINIB AN | JO | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| Imatinib GH | GQ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| Imatinib-APOTEX | TX | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| IMATINIB-DRLA | RZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| Capsule 400 mg (as mesilate) | Oral | CIPLA IMATINIB ADULT | LR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |
| Glivanib | JU | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |||
| IMATINIB AN | JO | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |||
| Imatinib GH | GQ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |||
| Imatinib-APOTEX | TX | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |||
| IMATINIB-DRLA | RZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |||
| CIPLA IMATINIB ADULT | LR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| Glivanib | JU | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| IMATINIB AN | JO | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| Imatinib GH | GQ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| Imatinib-APOTEX | TX | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| IMATINIB-DRLA | RZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| Tablet 100 mg (as mesilate) | Oral | Gilmat | CR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |
| Glivec | AF | MP | C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6498 P6510 P6526 P6538 P6557 P6559 P9086 P9124 | 60 | 2 | 60 | |||
| IMATINIB RBX | RA | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |||
| Imatinib-Teva | SZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 60 | 2 | 60 | |||
| Gilmat | CR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 | 60 | 5 | 60 | |||
| Glivec | AF | MP | C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| IMATINIB RBX | RA | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 60 | 5 | 60 | |||
| Imatinib-Teva | SZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 | 60 | 5 | 60 | |||
| Tablet 400 mg (as mesilate) | Oral | Gilmat | CR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |
| Glivec | AF | MP | C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6498 P6510 P6526 P6538 P6557 P6559 P9086 P9124 | 30 | 2 | 30 | |||
| IMATINIB RBX | RA | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |||
| Imatinib-Teva | SZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6510 P6526 P6538 P6557 P9086 P9124 | 30 | 2 | 30 | |||
| Gilmat | CR | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 | 30 | 5 | 30 | |||
| Glivec | AF | MP | C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| IMATINIB RBX | RA | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124 | P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 | 30 | 5 | 30 | |||
| Imatinib-Teva | SZ | MP | C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124 | P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 | 30 | 5 | 30 |
Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8562 C8583 C8591 C8592 C8602 C8612
(b)insert in numerical order in the column headed “Circumstances”: C9116 C9118 C9141 C9164 C9172 C9184 C9194
(c)omit from the column headed “Purposes”: P8562 P8583 P8591 P8592 P8602 P8612
(d)insert in numerical order in the column headed “Purposes”: P9116 P9118 P9141 P9164 P9172 P9184 P9194
Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8562 C8583 C8591 C8592 C8602 C8612
(b)insert in numerical order in the column headed “Circumstances”: C9116 C9118 C9141 C9164 C9172 C9184 C9194
Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe
insert in numerical order in the column headed “Circumstances”: C9161
Schedule 1, entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate) with diluent
omit from the column headed “Pack Quantity”: 5 substitute: 1
Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 150;
Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | MycoCept | RF | MP | 150 | 5 | 50 |
Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 300;
Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | MycoCept | RF | MP | P5554 P5555 P5794 P5795 | 300 CN5554 CN5555 CN5794 CN5795 | 5 CN5554 CN5555 CN5794 CN5795 | 50 | C(100) |
Schedule 1, entry for Pembrolizumab in each of the forms: Powder for injection 50 mg; and Solution concentrate for I.V. infusion 100 mg in 4 mL
(a)omit from the column headed “Circumstances”: C6801 C6806 C6817
(b)insert in numerical order in the column headed “Circumstances”: C9044 C9127 C9178
Schedule 1, entry for Potassium chloride
(a)omit:
| a | Duro-K | NM | MP NP | 200 | 1 | 100 |
| a | Slow-K | NV | MP NP | 200 | 1 | 100 |
(b)omit from the column headed “Schedule Equivalent” for the brand “Span-K”: a
Schedule 1, entry for Raloxifene
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | RALOVISTA | RF | MP NP | C6314 | 28 | 5 | 28 |
Schedule 1, entry for Reteplase
omit from the column headed “Responsible Person”: GN substitute: TB
Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| RIXALT | RF | MP NP | C5708 | 4 | 5 | 2 |
Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP | P7598 | 30 | 11 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP | P7598 | 30 | 11 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP | P7598 | 30 | 11 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Noumed Rosuvastatin | VO | MP | P7598 | 30 | 11 | 30 |
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484
(b)omit from the column headed “Circumstances”: C8217
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P6415
(e)insert in numerical order in the column headed “Purposes”: P9064
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484
(b)omit from the column headed “Circumstances”: C8217
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P6439
(e)omit from the column headed “Purposes”: P8217
(f)insert in numerical order in the column headed “Purposes”: P9063 P9105
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484
(b)omit from the column headed “Circumstances”: C8217
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P6415
(e)insert in numerical order in the column headed “Purposes”: P9064
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484
(b)omit from the column headed “Circumstances”: C8217
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P6439
(e)omit from the column headed “Purposes”: P8217
(f)insert in numerical order in the column headed “Purposes”: P9063 P9105
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484
(b)omit from the column headed “Circumstances”: C8217
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P6482 P6484
(e)insert in numerical order in the column headed “Purposes”: P9069 P9078 P9155
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484
(b)omit from the column headed “Circumstances”: C8217
(c)insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155
(d)omit from the column headed “Purposes”: P6482 P6484
(e)insert in numerical order in the column headed “Purposes”: P9069 P9078 P9155
Schedule 1, entry for Sodium acid phosphate
(a)omit from the column headed “Schedule Equivalent” for the brand “PHOSPHATE PHEBRA”: a
(b)omit:
| a | Phosphate Sandoz | FF | MP NP | C5089 C5095 C5114 C5123 | 100 | 5 | 100 |
Schedule 1, after entry for Tenofovir with emtricitabine and efavirenz in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg
insert:
| Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg | Oral | Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600 | AF | MP | C4470 C4522 | 60 | 5 | 30 | D(100) |
Schedule 1, entry for Testosterone in each of the forms: Transdermal patches 12.2 mg, 60; and Transdermal patches 24.3 mg, 30
omit from the column headed “Responsible Person”: GN substitute: TB
Schedule 1, after entry for Testosterone in the form Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2
insert:
| Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses | Transdermal | Testavan | FP | MP | C6324 C6910 C6919 C6933 C6934 | 1 | 5 | 1 |
Schedule 1, entry for Tocilizumab
omit:
| Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Actemra ACTPen | RO | MP | C8627 C8631 C8633 C8638 C8739 C8740 | P8631 P8638 P8739 P8740 | 4 | 3 | 4 |
| MP | C8627 C8631 C8633 C8638 C8739 C8740 | P8627 P8633 | 4 | 5 | 4 | ||||
| Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Actemra Subcutaneous Injection | RO | MP | C8627 C8631 C8633 C8638 C8739 C8740 | P8631 P8638 P8739 P8740 | 4 | 3 | 4 |
| MP | C8627 C8631 C8633 C8638 C8739 C8740 | P8627 P8633 | 4 | 5 | 4 |
Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL
insert:
| Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Actemra ACTPen | RO | MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P9052 P9096 P9133 P9134 P9135 | 4 | 1 | 4 |
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P9129 P9130 | 4 | 2 | 4 | ||||
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P8631 P8638 P8739 P8740 P9046 P9047 P9048 | 4 | 3 | 4 | ||||
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P8627 P8633 P9049 P9131 P9148 | 4 | 5 | 4 | ||||
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P9180 | 4 | 6 | 4 | ||||
| Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Actemra Subcutaneous Injection | RO | MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P9052 P9096 P9133 P9134 P9135 | 4 | 1 | 4 |
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P9129 P9130 | 4 | 2 | 4 | ||||
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P8631 P8638 P8739 P8740 P9046 P9047 P9048 | 4 | 3 | 4 | ||||
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P8627 P8633 P9049 P9131 P9148 | 4 | 5 | 4 | ||||
| MP | C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180 | P9180 | 4 | 6 | 4 |
Schedule 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8816 C8860 C8861 C8862 C8894 C8895
(b)insert in numerical order in the column headed “Circumstances”: C9064 C9069 C9116 C9141 C9155 C9157 C9170
(c)omit from the column headed “Purposes”: P8816 P8861 P8862
(d)insert in numerical order in the column headed “Purposes”: P9064 P9069 P9155 P9157
Schedule 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8816 C8860 C8861 C8862 C8894 C8895
(b)insert in numerical order in the column headed “Circumstances”: C9064 C9069 C9116 C9141 C9155 C9157 C9170
(c)omit from the column headed “Purposes”: P8860 P8894 P8895
(d)insert in numerical order in the column headed “Purposes”: P9116 P9141 P9170
Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ogivri | AF | MP | C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746 | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, entry for Trimethoprim with sulfamethoxazole in the form Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL
substitute:
| Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL | Oral | Septrin | RW | PDP | 1 | 0 | 1 |
| MP NP | 1 | 1 | 1 |
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C6378 C6419 C6459 C6469 C6504 C6588
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9116 C9122 C9160 C9175 C9176
(c)omit from the column headed “Purposes”: P6419 P6459 P6588
(d)insert in numerical order in the column headed “Purposes”: P9063 P9116
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6378 C6419 C6459 C6469 C6504 C6588
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9116 C9122 C9160 C9175 C9176
(c)omit from the column headed “Purposes”: P6378 P6469 P6504
(d)insert in numerical order in the column headed “Purposes”: P9122 P9160 P9175 P9176
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6378 C6419 C6459 C6469 C6504 C6588
(b)insert in numerical order in the column headed “Circumstances”: C9063 C9116 C9122 C9160 C9175 C9176
Schedule 3
omit:
| GN | Actavis Pty Ltd | 17 003 854 626 |
Schedule 3
omit:
| PQ | PIMP Pty Ltd | 39 114 633 117 |
Schedule 3
omit:
| UA | Actavis Pty Ltd | 17 003 854 626 |
Schedule 3, after details relevant to Responsible Person code VL
insert:
| VO | Avallon Pharmaceuticals Pty Limited | 63 126 872 848 |
Schedule 3, after details relevant to Responsible Person code XM
insert:
| YC | Cipla Australia Pty Ltd | 46 132 155 063 |
Schedule 4, Part 1, entry for Adalimumab
(a)omit:
| C4845 | P4845 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C4851 | P4851 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
(b)omit:
| C6437 | P6437 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide 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 initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. | Compliance with Written Authority Required procedures |
| C6439 | P6439 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. | Compliance with Written Authority Required procedures |
| C6445 | P6445 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug. Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased. Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C9063 | P9063 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9064 | P9064 | Severe psoriatic arthritis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9069 | P9069 | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9078 | P9078 | Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. 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 treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9105 | P9105 | Severe psoriatic arthritis Continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; 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: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9155 | P9155 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide 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 initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, omit entry for Aprepitant
Schedule 4, Part 1, entry for Bevacizumab
insert in numerical order after existing text:
| C9102 | Relapsed or recurrent glioblastoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed further symptomatic progression while being treated with this drug for this condition; AND The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR The treatment must not exceed a dose of 15 mg per kg every 3 weeks. Symptomatic progression is defined as: i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema. | Compliance with Written Authority Required procedures |
| C9149 | Relapsed or recurrent glioblastoma Grandfathering treatment Patient must have confirmed glioblastoma; AND Patient must have had radiologic evidence of evaluable disease at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND Patient must have had evidence of symptomatic progression at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND Patient must have failed to achieve an adequate response to, or be intolerant to, temozolomide; AND Patient must have been receiving non-PBS subsidised treatment with this drug for this condition prior to 1 August 2019; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND Patient must not have developed further symptomatic progression while being treated with this drug for this condition; AND The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR The treatment must not exceed a dose of 15 mg per kg every 3 weeks. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria. The authority application must be made in writing and must include: (1) a completed authority prescription form; (2) a completed Glioblastoma PBS Authority Application - Supporting Information Form, which includes the following: (a) evidence of confirmed glioblastoma confirmed by radiology report; and (b) confirmation that the patient has failed to achieve an adequate response to, or is intolerant to, temozolomide. Symptomatic progression is defined as: i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema. | Compliance with Written Authority Required procedures |
| C9166 | Relapsed or recurrent glioblastoma Initial treatment Patient must have confirmed glioblastoma; AND Patient must have radiologic evidence of evaluable disease; AND Patient must have evidence of symptomatic progression; AND Patient must have failed to achieve an adequate response to, or be intolerant to, temozolomide; AND Patient must not receive more than 8 weeks of treatment per initial treatment course authorised under this restriction; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND Patient must not have received prior treatment with this drug for this condition; AND The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR The treatment must not exceed a dose of 15 mg per kg every 3 weeks. The authority application must be made in writing and must include: (1) a completed authority prescription form; (2) a completed Glioblastoma PBS Authority Application - Supporting Information Form, which includes the following: (a) evidence of confirmed glioblastoma confirmed by radiology report; and (b) confirmation that the patient has failed to achieve an adequate response to, or is intolerant to, temozolomide. Symptomatic progression is defined as: i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Ustekinumab
(a)omit:
| C6378 | P6378 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have severe active psoriatic arthritis; AND Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be an adult. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide 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 initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. | Compliance with Written Authority Required procedures |
| C6419 | P6419 | Severe psoriatic arthritis Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have been receiving treatment with this drug for this condition prior to 1 May 2016; AND Patient must be receiving treatment with this drug for this condition at the time of application; AND Patient must have demonstrated a response to treatment as specified in the criteria for continuing PBS-subsidised treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be an adult. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. A patient may qualify for PBS-subsidised treatment under this restriction once only. | Compliance with Written Authority Required procedures |
| C6459 | P6459 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. | Compliance with Written Authority Required procedures |
| C6469 | P6469 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug. Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased. Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). | Compliance with Written Authority Required procedures |
| C6504 | P6504 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more), Initial 2 (change or recommencement of treatment) - balance of supply Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 28 weeks treatment; AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C6588 | P6588 | Severe psoriatic arthritis Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9063 | P9063 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9116 | P9116 | Severe psoriatic arthritis Continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; 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: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9122 | P9122 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide 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 initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9160 | P9160 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine 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 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9175 | P9175 | Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9176 | P9176 | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
Schedule 5, after entry for Fentanyl in the form Transdermal patch 2.1 mg [GRP-15898]
insert:
| Flucloxacillin | GRP-23238 | Capsule 250 mg (as sodium) | Oral | Medsurge |
| Capsule 250 mg (as sodium monohydrate) | Oral | APO-Flucloxacillin Flopen Staphylex 250 | ||
| GRP-23239 | Capsule 500 mg (as sodium) | Oral | Medsurge | |
| Capsule 500 mg (as sodium monohydrate) | Oral | APO-Flucloxacillin Flopen Staphylex 500 |
Schedule 5, entry for Imatinib in the form Tablet 100 mg (as mesilate) [GRP-21074]
insert in alphabetical order in the column headed “Brand”: Gilmat
Schedule 5, entry for Imatinib in the form Tablet 400 mg (as mesilate) [GRP-21079]
insert in alphabetical order in the column headed “Brand”: Gilmat
Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) [GRP-17623]
insert in alphabetical order in the column headed “Brand”: RIXALT
Schedule 5, after entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine
200 mg [GRP-21638]
insert:
| Tenofovir with emtricitabine and efavirenz | GRP-23241 | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg | Oral | Atripla |
| Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg | Oral | Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600 |
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