National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 9) (PB 81 of 2016) (Cth)
PB 81 of 2016
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 9)National Health Act 1953
I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 28th September 2016
PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 9).
(2) This Instrument may also be cited as PB 81 of 2016.
2 Commencement
This Instrument commences on 1 October 2016.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
[1]Schedule 1, entry for 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”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
[2]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
[3]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(e)omit from the column headed “Purposes”: P4609
(f)omit from the column headed “Purposes”: P4629
(g)omit from the column headed “Purposes”: P6069 P6092
(h)insert in numerical order: P6430 P6437 C6445 C6458
[4]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
[5]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(e)omit from the column headed “Purposes”: P4642
(f)omit from the column headed “Purposes”: P6081
(g)insert in numerical order: P6423 C6439
[6]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
[7]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
[8]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(i)omit from the column headed “Circumstances”: C4609
(j)omit from the column headed “Circumstances”: C4629 C4642
(k)omit from the column headed “Circumstances”: C6069 C6081 C6092
(l)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(m)omit from the column headed “Purposes”: P4609
(n)omit from the column headed “Purposes”: P4629
(o)omit from the column headed “Purposes”: P6069 P6092
(p)insert in numerical order: P6430 P6437 C6445 C6458
[9]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
[10]Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(e)omit from the column headed “Purposes”: P4642
(f)omit from the column headed “Purposes”: P6081
(g)insert in numerical order: P6423 C6439
[11]Schedule 1, entry for Alprazolam in the form Tablet 2 mg
(a)omit
Chem mart Alprazolam CH MP NP C5608 50 2 50 (b)omit:
Terry White Chemists Alprazolam TW MP NP C5608 50 2 50 [12]Schedule 1, entry for Amoxycillin in the form Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL
(a)omit from the column headed “Circumstances”: C5863
(b)insert in the column headed “Purposes”: P5863
[13]Schedule 1, entry for Ampicillin in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 5; Number of Repeats: 1]
(a)omit from the column headed “Brand”: Austrapen
(b)omit from the column headed “Responsible Person”: AL
[14]Schedule 1, entry for Aprepitant
substitute:
Aprepitant Capsule 165 mg Oral Emend MK MP NP C4211 C4215 C6370 C6444 1 5 1 MP C4216 C4223 C6383 C6464 1 5 1 C(100)
[15]Schedule 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride); Capsule
25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a APO-Atomoxetine TX MP C4578 C6279 56 5 28 [16]Schedule 1, entry for Atomoxetine in each of the forms: Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a APO-Atomoxetine TX MP C4578 C6279 28 5 28 [17]Schedule 1, entry for Bacillus Calmette and Guerin, Connaught strain
substitute:
Bacillus Calmette and Guerin, Connaught strain Powder for intravesical administration containing 6.6 to 19.2 x 10 8 CFU Intravesical ImmuCyst SW MP C5578 3 1 1 MP C5598 3 1 1 C(100) [18]Schedule 1, entry for Bacillus Calmette and Guerin, Tice strain
substitute:
Bacillus Calmette and Guerin, Tice strain Vial containing powder for intravesical administration approximately 5 x 10 8 CFU Intravesical OncoTICE MK MP C5540 3 1 3 MP C5597 3 1 3 C(100) [19]Schedule 1, entry for Bicalutamide
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)omit from the column headed “Brand”: Cosamide substitute: Cosamide 50
[20]Schedule 1, entry for Bortezomib in the form Powder for injection 1 mg
omit from the column headed “Circumstances”: C4082 C4103 C4127 C4141 C4163 substitute: C6372 C6384 C6466 C6472 C6478
[21]Schedule 1, after entry for Bortezomib in the form Powder for injection 1 mg
insert in the columns in the order indicated:
Powder for injection 3 mg Injection Velcade JC MP C4080 C4081 C4161 C4162 C6372 C6373 C6384 C6452 C6466 C6472 C6478 See Note 3 See
Note 31 D(100) [22]Schedule 1, entry for Bortezomib in the form Powder for injection 3.5 mg
(a)omit from the column headed “Circumstances”: C4079
(b)omit from the column headed “Circumstances”: C4126
(c)insert in numerical order: C6373 C6452
[23]Schedule 1, entry for Buprenorphine in each of the forms: Tablet (sublingual) 400 micrograms (as hydrochloride); Tablet (sublingual) 2 mg (as hydrochloride); and Tablet (sublingual) 8 mg (as hydrochloride)
(a)omit from the column headed “Circumstances”: See Note 3 substitute: C6451
(b)omit from the column headed “Purposes”: See Note 3
[24]Schedule 1, entry for Buprenorphine with naloxone in each of the forms: Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride); and Film (soluble) 8 mg (as hydrochloride-2 mg (as hydrochloride)
(a)omit from the column headed “Circumstances”: See Note 3 substitute: C6447
(b)omit from the column headed “Purposes”: See Note 3
[25]Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg
omit:
a Candesartan RBX RA MP NP 30 5 30 [26]Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
omit:
a Candesartan HCTZ RBX 32/12.5 RA MP NP C4374 30 5 30 [27]Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 50 mg in 5 mL; and Solution for I.V. injection 150 mg
in 15 mLomit:
Carbaccord EA MP See Note 3 See
Note 31 D(100) [28]Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg
omit:
Dilatrend 3.125 RO MP NP C5324 C5394 30 0 30 [29]Schedule 1, entry for Cefalotin
(a)omit from the column headed “Brand” (second instance): Hospira Pty Limited
(b)omit from the column headed “Responsible Person” (second instance): HH
[30]Schedule 1, entry for Celecoxib in the form Capsule 100 mg
omit:
Celecoxib Actavis ED MP NP C4907 C4962 60 3 60 [31]Schedule 1, entry for Celecoxib in the form Capsule 200 mg
omit:
Celecoxib Actavis ED MP NP C4907 C4962 30 3 30 [32]Schedule 1, entry for Certolizumab pegol
substitute:
Certolizumab pegol Injection 200 mg in 1 mL single use pre-filled syringe Injection Cimzia UC MP C4606 C4643 C4737 C4764 C4830 C4853 C6374 C6396 C6398 C6399 C6423 C6455 C6456 C6460 C6474 P4606 P4737 P4830 2 2 2 MP C4606 C4643 C4737 C4764 C4830 C4853 C6374 C6396 C6398 C6399 C6423 C6455 C6456 C6460 C6474 P4643 P4764 P4853 P6374 P6423 P6474 2 5 2 MP C4606 C4643 C4737 C4764 C4830 C4853 C6374 C6396 C6398 C6399 C6423 C6455 C6456 C6460 C6474 P6396 P6398 P6399 P6455 P6456 P6460 6 0 2 [33]Schedule 1, entry for Cetrorelix
omit from the column headed “Pack Quantity”: 10 substitute: 1
[34]Schedule 1, entry for Cholestyramine
(a)omit from the column headed “Brand” (second instance): Questran Lite
(b)omit from the column headed “Responsible Person” (second instance): QA
(c)omit from the column headed “Purposes”: P3035 substitute: P6429
[35]Schedule 1, entry for Choriogonadotropin alfa in each of the forms: Solution for injection 250 micrograms in 0.5 mL pre-filled syringe; and Solution for injection 250 micrograms in 0.5 mL pre-filled pen
omit from the column headed “Maximum Quantity”: 10 substitute: 1
[36]Schedule 1, entry for Chorionic Gonadotrophin in the form Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL [Maximum Quantity: 1; Number of Repeats: 5]
insert in the column headed “Authorised Prescriber”: MP
[37]Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Klacid GO MP NP 14 1 14 (c)omit:
Klacid GO MP P1434 P3325 100 CN1434 CN3325 2
CN1434 CN3325100 C(100) [38]Schedule 1, entry for Colestipol
omit from the column headed “Purposes”: P3035 substitute: P6429
[39]Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Cyprone 100 AF MP 50 5 50 [40]Schedule 1, entry for Daclatasvir in each of the forms: Tablet 30 mg; and Tablet 60 mg
omit:
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100) [41]Schedule 1, after entry for Darunavir in the form Tablet 800 mg (as ethanolate)
insert:
Darunavir with cobicistat Tablet containing darunavir 800 mg with cobicistat 150 mg Oral Prezcobix JC MP C6377 C6413 C6428 60 5 30 D(100) [42]Schedule 1, entry for Deferasirox in each of the forms: Tablet, dispersible, 125 mg; Tablet, dispersible, 250 mg; and Tablet, dispersible, 500 mg
omit from the column headed “Circumstances”: C3828 C3829 substitute: C6420 C6432
[43]Schedule 1, entry for Deferiprone in each of the forms: Tablet 500 mg; and Oral solution 100 mg per mL, 250 mL
omit from the column headed “Circumstances”: C1911 C1912 C3338 C3339 substitute: C6380 C6403 C6442 C6448
[44]Schedule 1, entry for Desferrioxamine in each of the forms: Powder for injection containing desferrioxamine mesylate 500 mg; and Powder for injection containing desferrioxamine mesylate 2 g
omit from the column headed “Circumstances”: C1085 C3340 substitute: C6394 C6408
[45]Schedule 1, entry for Diclofenac in the form Suppository containing diclofenac sodium 100 mg
omit:
MP NP MW P6149 40 3 20 substitute:
MP NP MW 40 3 20 MP NP P6149 40 3 20 [46]Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg
(a)omit:
a Diclofenac-GA ED PDP C6256 C6282 100 0 50 (b)omit:
a Diclofenac-GA ED MP NP C6149 C6214 C6283 100 3 50 [47]Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg
(a)omit:
a Diclofenac-GA ED PDP C6256 C6282 50 0 50 (b)omit:
a Diclofenac-GA ED MP NP C6149 C6214 C6283 50 3 50 [48]Schedule 1, entry for Dipyridamole
omit from the column headed “Circumstances”: C1725 C1726 C1727 substitute: C6385 C6411 C6473
[49]Schedule 1, entry for Dipyridamole with Aspirin
omit from the column headed “Circumstances” (all instances): C1728 substitute: C6424
[50]Schedule 1, entry for Disopyramide
omit:
Capsule 150 mg Oral Rythmodan SW MP NP 100 5 100 [51]Schedule 1, entry for Dorzolamide
omit from the column headed “Responsible Person” for the brand “Trusopt”: MK substitute: MF
[52]Schedule 1, entry for Dorzolamide with timolol
omit from the column headed “Responsible Person” for the brand “Cosopt”: MK substitute: MF
[53]Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as hydrochloride)
omit:
Doxy‑50 ED MP NP C4475 C4529 C4539 25 5 25 [54]Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Tixol AL MP NP C5650 28 0 28 [55] Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Tixol AL MP NP C5650 28 5 28 [56]Schedule 1, entry for Eptifibatide in each of the forms: Solution for I.V. injection 20 mg (as acetate) in 10 mL; and Solution for I.V. injection 75 mg (as acetate) in 100 mL
omit from the column headed “Circumstances”: C1884 substitute: C6435
[57]Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 P6445 P6458
(e)omit from the column headed “Purposes”: P4609
(f)omit from the column headed “Purposes”: P4629
(g)omit from the column headed “Purposes”: P6069 P6092
(h)insert in numerical order: P6430 P6437 P6445 P6458
[58]Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 P6445 P6458
(e)omit from the column headed “Purposes”: P4642
(f)omit from the column headed “Purposes”: P6081
(g)insert in numerical order: P6423 P6439
[59]Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 P6445 P6458
(e)omit from the column headed “Purposes”: P4609
(f)omit from the column headed “Purposes”: P4629
(g)omit from the column headed “Purposes”: P6069 P6092
(h)insert in numerical order: P6430 P6437 P6445 P6458
[60]Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 P6445 P6458
(e)omit from the column headed “Purposes”: P4642
(f)omit from the column headed “Purposes”: P6081
(g)insert in numerical order: P6423 P6439
[61]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”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 P6445 P6458
(e)omit from the column headed “Purposes”: P4609
(f)omit from the column headed “Purposes”: P4629
(g)omit from the column headed “Purposes”: P6069 P6092
(h)insert in numerical order: P6430 P6437 P6445 P6458
[62]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”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 P6445 P6458
(e)omit from the column headed “Purposes”: P4642
(f)omit from the column headed “Purposes”: P6081
(g)insert in numerical order: P6423 P6439
[63]Schedule 1, entry for Etoposide in the form Solution for I.V. infusion 100 mg in 5 mL vial
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pfizer Australia Pty Ltd PF MP See Note 3 See Note 3 1 PB(100) [64]Schedule 1, entry for Felodipine in the form Tablet 2.5 mg (extended release)
(a)omit from the column headed “Responsible Person” for the brand “Felodur ER 2.5 mg”: TX substitute: ZA
(b)omit from the column headed “Responsible Person” for the brand “Plendil ER”: GX substitute: AP
[65]Schedule 1, entry for Felodipine in the form Tablet 5 mg (extended release)
(a)omit from the column headed “Responsible Person” for the brand “Felodur ER 5 mg”: TX substitute: ZA
(b)omit from the column headed “Responsible Person” for the brand “Plendil ER”: GX substitute: AP
[66]Schedule 1, entry for Felodipine in the form Tablet 10 mg (extended release)
(a)omit from the column headed “Responsible Person” for the brand “Felodur ER 10 mg”: TX substitute: ZA
(b)omit from the column headed “Responsible Person” for the brand “Plendil ER”: GX substitute: AP
[67]Schedule 1, entry for Fingolimod
omit from the column headed “Circumstances”: C3845 C3846 substitute: C6418 C6457
[68]Schedule 1, entry for Flecainide in each of the forms: Tablet containing flecainide acetate 50 mg; and Tablet containing flecainide acetate 100 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Flecainide Sandoz SZ MP NP C5550 C5584 60 5 60 [69]Schedule 1, entry for Gabapentin in each of the forms: Capsule 300 mg; and Capsule 400 mg
omit:
Gantin EA MP NP C4928 100 5 100 [70]Schedule 1, entry for Gabapentin in the form Tablet 800 mg
omit:
Gantin ED MP NP C4928 100 5 100 [71]Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit:
Gemcitabine Sun RA MP See Note 3 See
Note 31 D(100) [72]Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit:
Gemcitabine Sun RA MP See Note 3 See
Note 31 D(100) [73]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”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(e)omit from the column headed “Purposes”: P4609
(f)omit from the column headed “Purposes”: P4629
(g)omit from the column headed “Purposes”: P6069 P6092
(h)insert in numerical order: P6430 P6437 P6445 P6458
[74]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”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(e)omit from the column headed “Purposes”: P4642
(f)omit from the column headed “Purposes”: P6081
(g)insert in numerical order: P6423 P6439
[75]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”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(e)omit from the column headed “Purposes”: P4609
(f)omit from the column headed “Purposes”: P4629
(g)omit from the column headed “Purposes”: P6069 P6092
(h)insert in numerical order: P6430 P6437 P6445 P6458
[76]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”: C4609
(b)omit from the column headed “Circumstances”: C4629 C4642
(c)omit from the column headed “Circumstances”: C6069 C6081 C6092
(d)insert in numerical order: C6423 C6430 C6437 C6439 C6445 C6458
(e)omit from the column headed “Purposes”: P4642
(f)omit from the column headed “Purposes”: P6081
(g)insert in numerical order: P6423 P6439
[77]Schedule 1, entry for Hydromorphone
(a)omit:
Tablet containing hydromorphone hydrochloride 2 mg Oral Dilaudid MF MP NP PDP C4926 C4959 20 0 20 Tablet containing hydromorphone hydrochloride 4 mg Oral Dilaudid MF MP NP PDP C4926 C4959 20 0 20 Tablet containing hydromorphone hydrochloride 8 mg Oral Dilaudid MF MP NP PDP C4926 C4959 20 0 20 substitute:
Tablet containing hydromorphone hydrochloride 2 mg Oral Dilaudid MF PDP C4926 20 0 20 MP NP C4959 20 0 20 Tablet containing hydromorphone hydrochloride 4 mg Oral Dilaudid MF PDP C4926 20 0 20 MP NP C4959 20 0 20 Tablet containing hydromorphone hydrochloride 8 mg Oral Dilaudid MF PDP C4926 20 0 20 MP NP C4959 20 0 20 (b)omit:
Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL Oral Dilaudid MF MP NP PDP C4926 C4959 1 0 1 substitute:
Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL Oral Dilaudid MF PDP C4926 1 0 1 MP NP C4959 1 0 1 [78]Schedule 1, entry for Hyoscine
substitute:
Hyoscine Injection containing hyoscine butylbromide 20 mg in 1 mL Injection Buscopan BY MP NP C6207 30
3
5 [79]Schedule 1, entry for Imatinib
substitute:
Imatinib Tablet 100 mg (as mesylate) Oral Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P3849 P3850 60 2 60 a Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P1816 P1817 P1818 P1819 P2766 P2767 P2978 P2979 P2980 P2981 P2982 P2984 P3033 P3034 P3144 60 2 60 a IMATINIB RBX RA MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C6183 C6184 C6198 P1816 P1817 P1818 P1819 P2766 P2767 P2978 P2979 P2980 P2981 P2982 P2984 P3033 P3034 P3144 60 2 60 a Imatinib-Teva TB MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C3033 C3144 C6183 C6184 C6198 P1816 P1817 P1818 P1819 P2766 P2767 P2978 P2979 P2980 P2981 P2982 P3033 P3144 60 2 60 Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P4342 P4355 60 5 60 a Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P6183 P6184 P6198 60 5 60 a IMATINIB RBX RA MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C6183 C6184 C6198 P6183 P6184 P6198 60 5 60 a Imatinib-Teva TB MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C3033 C3144 C6183 C6184 C6198 P6183 P6184 P6198 60 5 60 Tablet 400 mg (as mesylate) Oral Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P3849 P3850 30 2 30 a Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P1816 P1817 P1818 P1819 P2766 P2767 P2978 P2979 P2980 P2981 P2982 P2984 P3033 P3034 P3144 30 2 30 a IMATINIB RBX RA MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C6183 C6184 C6198 P1816 P1817 P1818 P1819 P2766 P2767 P2978 P2979 P2980 P2981 P2982 P2984 P3033 P3034 P3144 30 2 30 a Imatinib-Teva TB MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C3033 C3144 C6183 C6184 C6198 P1816 P1817 P1818 P1819 P2766 P2767 P2978 P2979 P2980 P2981 P2982 P3033 P3144 30 2 30 Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P4342 P4355 30 5 30 a Glivec AF MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C3849 C3850 C4342 C4355 C6183 C6184 C6198 P6183 P6184 P6198 30 5 30 a IMATINIB RBX RA MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C2984 C3033 C3034 C3144 C6183 C6184 C6198 P6183 P6184 P6198 30 5 30 a Imatinib-Teva TB MP C1816 C1817 C1818 C1819 C2766 C2767 C2978 C2979 C2980 C2981 C2982 C3033 C3144 C6183 C6184 C6198 P6183 P6184 P6198 30 5 30 [80]Schedule 1, entry for Indomethacin in the form Suppository 100 mg
omit:
MP NP P6149 40 3 20 substitute:
MP NP 40 3 20 MP NP P6149 40 3 20 [81]Schedule 1, entry for Interferon Alfa-2a
substitute:
Interferon alfa-2a Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO MP C1149 C1196 C1234 P1149 P1234 15 4 1 MP C3180 C3895 C3899 C4993 C5003 C5036 C5042 P3180 P3899 15 4 1 C(100) MP C1149 C1196 C1234 P1196 15 5 1 MP C3180 C3895 C3899 C4993 C5003 C5036 C5042 P3895 15 5 1 C(100) MP C3180 C3895 C3899 C4993 C5003 C5036 C5042 P4993 P5003 P5036 P5042 30 5 1 C(100) Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO MP C1196 C1234 P1234 5 4 1 MP C3895 C3899 C4993 C5003 C5036 C5042 P3899 5 4 1 C(100) MP C1196 C1234 P1196 5 5 1 MP C3895 C3899 C4993 C5003 C5036 C5042 P3895 5 5 1 C(100) MP C3895 C3899 C4993 C5003 C5036 C5042 P4993 P5003 P5036 P5042 30 5 1 C(100) Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO MP C1196 C1234 P1234 5 4 1 MP C3895 C3899 C4993 C5003 C5036 C5042 P3899 5 4 1 C(100) MP C1196 C1234 P1196 5 5 1 MP C3895 C3899 C4993 C5003 C5036 C5042 P3895 5 5 1 C(100) MP C3895 C3899 C4993 C5003 C5036 C5042 P4993 P5003 P5036 P5042 30 5 1 C(100) [82]Schedule 1, entry for Interferon Alfa-2b
(a)omit:
Solution for injection 18,000,000 I.U. in 1.2 mL multi‑dose injection pen Injection Intron A Redipen MK MP
C4974 C4993 C5003 C5033 C5036 C5042 2 5 1 C(100) MP
C1149 C1196 C1206 C3180 C3895 C3898 P1149 P3180 3 4 1 MP
C1149 C1196 C1206 C3180 C3895 C3898 P1196 P1206 P3895 P3898 3 5 1 substitute:
Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK MP C3180 C3895 C3898 C4974 C4993 C5003 C5033 C5036 C5042 P4974 P4993 P5003 P5033 P5036 P5042 2 5 1 C(100) MP C1149 C1196 C1206 P1149 3 4 1 MP C3180 C3895 C3898 C4974 C4993 C5003 C5033 C5036 C5042 P3180 3 4 1 C(100) MP C1149 C1196 C1206 P1196 P1206 3 5 1 MP C3180 C3895 C3898 C4974 C4993 C5003 C5033 C5036 C5042 P3895 P3898 3 5 1 C(100) (b)omit:
Solution for injection 30,000,000 I.U. in 1.2 mL multi‑dose injection pen Injection Intron A Redipen MK MP
C4974 C4993 C5003 C5033 C5036 C5042 2 5 1 C(100) MP
C1196 C1206 C3895 C3898 3 5 1 substitute:
Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK MP C3895 C3898 C4974 C4993 C5003 C5033 C5036 C5042 P4974 P4993 P5003 P5033 P5036 P5042 2 5 1 C(100) MP C1196 C1206 3 5 1 MP C3895 C3898 C4974 C4993 C5003 C5033 C5036 C5042 P3895 P3898 3 5 1 C(100) [83]Schedule 1, entry for Ivacaftor
omit from the column headed “Pack Quantity”: 1 substitute: 56
[84]Schedule 1, entry for Ketoconazole in each of the forms: Cream 20 mg per g, 30 g; Shampoo 10 mg per g, 100 mL; and Shampoo 20 mg
per g, 60 mLomit from the column headed “Circumstances”: C2354 substitute: C6434
[85]Schedule 1, entry for Letrozole
omit:
Lezole ED MP NP C5464 30 5 30 [86]Schedule 1, entry for Leuprorelin
substitute:
Leuprorelin I.M. injection (3 month modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe Injection Lucrin Depot Paediatric 30 mg PDS VE MP C6422 C6425 C6426 1 1 1 I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre-filled dual-chamber syringe Injection Lucrin Depot 7.5mg PDS VE MP C6409 1 5 1 I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre-filled dual-chamber syringe Injection Lucrin Depot 3 Month PDS VE MP C6409 1 1 1 I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe Injection Lucrin Depot 4 Month PDS VE MP C6409 1 1 1 I.M. injection (modified release), powder for injection containing leuprorelin acetate 45 mg with diluent in pre-filled dual-chamber syringe Injection Lucrin Depot 6-Month VE MP C6409 1 0 1 Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set Injection Eligard 1 month TL MP C6409 1 5 1 Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set Injection Eligard 3 month TL MP C6409 1 1 1 Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set Injection Eligard 4 month TL MP C6409 1 1 1 Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set Injection Eligard 6 month TL MP C6409 1 0 1
[87]Schedule 1, entry for Levetiracetam in the form Tablet 1 g
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)omit from the column headed “Brand”: Levetiracetam generichealth substitute: Levetiracetam GH
[88]Schedule 1, entry for Linagliptin
insert in numerical order in the column headed “Circumstances”: C6376
[89]Schedule 1, entry for Linagliptin with Metformin in each of the forms: Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride; Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride; and Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride
insert in numerical order in the column headed “Circumstances”: C6443
[90]Schedule 1, entry for Liothyronine
omit from the column headed “Circumstances”: C1182 C1219 C1858 C1859 substitute: C6382 C6410 C6475
[91]Schedule 1, omit entry for Megestrol
[92]Schedule 1, entry for Meloxicam in the form Capsule 7.5 mg
(a)omit:
Melox 7.5 EA MP NP C6220 C6239 30 3 30 (b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Moxicam AF MP NP C6220 C6239 30 3 30 [93]Schedule 1, entry for Meloxicam in the form Capsule 15 mg
(a)omit:
Melox 15 EA MP NP C6220 C6239 30 3 30 (b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Moxicam AF MP NP C6220 C6239 30 3 30 [94]Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a FORMET 500 RF MP NP 100 5 100 [95]Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a FORMET 850 RF MP NP 60 5 60 [96]Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a METEX XR 1000 RW MP NP 60 5 60 [97]Schedule 1, entry for Methadone
omit:
Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL Oral Biodone Forte MW MP NP See Note 3 See Note 3 See Note 3 See
Note 31 PB(100) Aspen Methadone Syrup QA MP NP C4902 C4941
See Note 2P4941
See Note 21
See Note 20
See
Note 21 MP NP C4902 C4941
See Note 2P4902
See Note 21
See Note 22
See
Note 21 Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L Oral Biodone Forte MW MP NP See Note 3 See Note 3 See Note 3 See
Note 31 PB(100) Aspen Methadone Syrup QA MP NP See Note 3 See Note 3 See Note 3 See
Note 31 PB(100) substitute:
Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L Oral a Aspen Methadone Syrup QA MP NP C6480 See Note 3 See Note 3 1 PB(100) a Biodone Forte MW MP NP C6480 See Note 3 See Note 3 1 PB(100) Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL Oral Aspen Methadone Syrup QA MP NP C4902 C4941 P4941 1 0 1 a Aspen Methadone Syrup QA MP NP C6480 See Note 2 See Note 2 1 C(100) a Biodone Forte MW MP NP C6480 See Note 2 See Note 2 1 C(100) Aspen Methadone Syrup QA MP NP C4902 C4941 P4902 1 2 1 [98]Schedule 1, entry for Methoxyflurane
omit from the columns headed “Circumstances” and “Purposes” respectively: See Note 4
[99]Schedule 1, entry for Methylprednisolone in the form Injection containing methylprednisolone acetate 40 mg in 1 mL
(a)insert in the column headed “Maximum Quantity” for each brand [Authorised Prescriber PDP]: 5
(b)insert in the column headed “Number of Repeats” for each brand [Authorised Prescriber PDP]: 0
(c)insert in the column headed “Pack Quantity” for each brand [Authorised Prescriber PDP]: 5
[100]Schedule 1, entry for Metronidazole in the form I.V. infusion 500 mg in 100 mL
omit:
DBL Metronidazole Intravenous Infusion HH MP NP C4592 C4593 10 0 5 PDP C4581 10 0 5 [101]Schedule 1, entry for Miconazole in each of the forms: Cream containing miconazole nitrate 20 mg per g, 30 g; Cream containing miconazole nitrate 20 mg per g, 70 g; Powder containing miconazole nitrate 20 mg per g, 30 g; and Tincture 20 mg per mL, 30 mL
omit from the column headed “Circumstances”: C2354 substitute: C6434
[102]Schedule 1, entry for Midazolam
(a)omit from the columns headed “Circumstances” and “Purposes” respectively: See Note 4
(b)insert in the column headed “Determined Quantity”: 10
(c)omit from the column headed “Section 100/Prescriber Bag only”: D(MP NP) substitute: D(MP) D(NP)
[103]Schedule 1, entry for Mycophenolic Acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid [Maximum Quantity: 240]
omit from the column headed “Number of Repeats”: 55 substitute: 5
[104]Schedule 1, entry for Nadroparin in each of the forms: Injection containing nadroparin calcium (11,400 I.U. anti-Xa) in 0.6 mL pre-filled syringe; Injection containing nadroparin calcium (15,200 I.U. anti-Xa) in 0.8 mL pre-filled syringe; and Injection containing nadroparin calcium (19,000 I.U. anti-Xa) in 1 mL pre-filled syringe
insert in the column headed “Responsible Person”: AS
[105]Schedule 1, entry for Nafarelin in the form Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C5046 C5186 C5368 substitute: C6416 C6436
(b)omit from the column headed “Purposes”: P5186 P5368
[106]Schedule 1, entry for Nafarelin in the form Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C5186 C5368
(b)omit from the column headed “Purposes”: P5046
[107]Schedule 1, entry for Naproxen in the form Tablet 250 mg
(a)omit from the column headed “Circumstances” [Authorised Prescriber PDP] (twice occurring): C1036 C1054 substitute: C6256 C6282
(b)omit from the column headed “Circumstances” [Authorised Prescriber MP NP] (twice occurring): C1036 C1054
(c)insert in numerical order [Authorised Prescriber MP NP]: C6214 C6283
[108]Schedule 1, entry for Naproxen in the form Tablet 500 mg
(a)omit from the column headed “Circumstances” [Authorised Prescriber PDP] (twice occurring): C1036 C1054 substitute: C6256 C6282
(b)omit from the column headed “Circumstances” [Authorised Prescriber MP NP] (twice occurring): C1036 C1054
(c)insert in numerical order [Authorised Prescriber MP NP]: C6214 C6283
[109]Schedule 1, entry for Naproxen in the form Tablet containing naproxen sodium 550 mg
(a)omit from the column headed “Circumstances” [Authorised Prescriber PDP] (twice occurring): C1036 C1054 substitute: C6368 C6387
(b)omit from the column headed “Circumstances” [Authorised Prescriber MP NP] (twice occurring): C1036 C1054
(c)insert in numerical order [Authorised Prescriber MP NP]: C6463 C6471
[110]Schedule 1, entry for Naproxen in the form Tablet 750 mg (sustained release)
(a)omit from the column headed “Circumstances” [Authorised Prescriber PDP] (twice occurring): C1036 C1054 substitute: C6256 C6282
(b)omit from the column headed “Circumstances” [Authorised Prescriber MP NP] (twice occurring): C1036 C1054
(c)insert in numerical order [Authorised Prescriber MP NP]: C6214 C6283
[111]Schedule 1, entry for Naproxen in the form Tablet 1 g (sustained release)
(a)omit from the column headed “Circumstances” [Authorised Prescriber PDP] (twice occurring): C1036 C1054 substitute: C6256 C6282
(b)omit from the column headed “Circumstances” [Authorised Prescriber MP NP] (twice occurring): C1036 C1054
(c)insert in numerical order [Authorised Prescriber MP NP]: C6214 C6283
[112]Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit:
Nevipin EA MP C4454 C4512 120 5 60 D(100) [113]Schedule 1, entry for Nystatin in the form Cream 100,000 units per g, 15 g
omit from the column headed “Circumstances”: C2354 substitute: C6434
[114]Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
omit from the column headed “Circumstances”: C2622 C2623 C3407 C3408 substitute: C6369 C6388 C6389 C6390 C6476 C6477
[115]Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium)
omit from the column headed “Responsible Person” for the brand “Omepral” (twice occurring): TX substitute: ZA
[116]Schedule 1, entry for Ondansetron in each of the forms: Wafer 4 mg; and Wafer 8 mg [Maximum Quantity: 10; Number of Repeats: 1]
(a)omit from the column headed “Brand”: Zofran Zydis
(b)omit from the column headed “Responsible Person”: AS
[117]Schedule 1, entry for Oxytocin
(a)omit from the columns headed “Circumstances” and “Purposes” respectively: See Note 4
(b)insert in the columns headed “Determined Quantity”: 5
[118]Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
omit:
Anzatax HH MP See Note 3 See
Note 31 D(100) [119]Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for
I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mLomit:
Paclitaxel Actavis EA MP See Note 3 See
Note 31 D(100) [120]Schedule 1, entry for Paraffin in the form Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g [Maximum Quantity: 2; Number of Repeats: 11]
(a)omit from the column headed “Brand”: Poly Visc
(b)omit from the column headed “Responsible Person”: IQ
[121]Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride)
(a)insert in the column headed “Authorised Prescriber” [Maximum Quantity: 90; Number of Repeats: 2]: MP
(b)insert in the column headed “Authorised Prescriber” [Maximum Quantity: 90; Number of Repeats: 5]: MP
[122]Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride)
(a)insert in the column headed “Authorised Prescriber” [Maximum Quantity: 60; Number of Repeats: 2]: MP
(b)insert in the column headed “Authorised Prescriber” [Maximum Quantity: 60; Number of Repeats: 5]: MP
[123]Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril AN ED MP NP 30 5 30 [124]Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg
(a)omit
Blooms the Chemist Perindopril Arginine IB MP NP 30 5 30 (b)omit:
Chem mart Perindopril Arginine CH MP NP 30 5 30 (c)omit:
IDAPREX ARG 2.5mg TZ MP NP 30 5 30 (d)omit:
PERINDO ARG 2.5mg TR MP NP 30 5 30 (e)omit:
Terry White Chemists Perindopril Arginine TW MP NP 30 5 30 [125]Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril AN EF MP NP 30 5 30 [126]Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg
(a)omit
Blooms the Chemist Perindopril Arginine IB MP NP 30 5 30 (b)omit:
Chem mart Perindopril Arginine CH MP NP 30 5 30 (c)omit:
IDAPREX ARG 5mg TZ MP NP 30 5 30 (d)omit:
PERINDO ARG 5mg TR MP NP 30 5 30 (e)omit:
Terry White Chemists Perindopril Arginine TW MP NP 30 5 30 [127]Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril AN EF MP NP 30 5 30 [128]Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg
(a)omit
Blooms the Chemist Perindopril Arginine IB MP NP 30 5 30 (b)omit:
Chem mart Perindopril Arginine CH MP NP 30 5 30 (c)omit:
IDAPREX ARG 10mg TZ MP NP 30 5 30 (d)omit:
PERINDO ARG 10mg TR MP NP 30 5 30 (e)omit:
Terry White Chemists Perindopril Arginine TW MP NP 30 5 30 [129]Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)
(a)omit:
a Blooms the Chemist Perindopril Arginine/ Amlodipine 5/5 IB MP NP C4398 C4418 30 5 30 (b)omit:
a Chem mart Perindopril Arginine/ Amlodipine 5/5 CH MP NP C4398 C4418 30 5 30 (c)omit:
a Deflectum 5/5 TZ MP NP C4398 C4418 30 5 30 (d)omit:
a Dynoval 5/5 TR MP NP C4398 C4418 30 5 30 (e)omit:
a Terry White Chemists Perindopril Arginine/ Amlodipine 5/5 TW MP NP C4398 C4418 30 5 30 [130]Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)
(a)omit:
a Blooms the Chemist Perindopril Arginine/ Amlodipine 5/10 IB MP NP C4398 C4418 30 5 30 (b)omit:
a Chem mart Perindopril Arginine/ Amlodipine 5/10 CH MP NP C4398 C4418 30 5 30 (c)omit:
a Deflectum 5/10 TZ MP NP C4398 C4418 30 5 30 (d)omit:
a Dynoval 5/10 TR MP NP C4398 C4418 30 5 30 (e)omit:
a Terry White Chemists Perindopril Arginine/ Amlodipine 5/10 TW MP NP C4398 C4418 30 5 30 [131]Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)
(a)omit:
a Blooms the Chemist Perindopril Arginine/ Amlodipine 10/5 IB MP NP C4398 C4418 30 5 30 (b)omit:
a Chem mart Perindopril Arginine/ Amlodipine 10/5 CH MP NP C4398 C4418 30 5 30 (c)omit:
a Deflectum 10/5 TZ MP NP C4398 C4418 30 5 30 (d)omit:
a Dynoval 10/5 TR MP NP C4398 C4418 30 5 30 (e)omit:
a Terry White Chemists Perindopril Arginine/ Amlodipine 10/5 TW MP NP C4398 C4418 30 5 30 [132]Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)
(a)omit:
a Blooms the Chemist Perindopril Arginine/ Amlodipine 10/10 IB MP NP C4398 C4418 30 5 30 (b)omit:
a Chem mart Perindopril Arginine/ Amlodipine 10/10 CH MP NP C4398 C4418 30 5 30 (c)omit:
a Deflectum 10/10 TZ MP NP C4398 C4418 30 5 30 (d)omit:
a Dynoval 10/10 TR MP NP C4398 C4418 30 5 30 (e)omit:
a Terry White Chemists Perindopril Arginine/ Amlodipine 10/10 TW MP NP C4398 C4418 30 5 30 [133]Schedule 1, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril and Indapamide AN 4/1.25 EF MP NP C4375 30 5 30 [134]Schedule 1, entry for Perindopril with indapamide in the form Tablet containing perindopril arginine 5 mg with indapamide hemihydrate
1.25 mg(a)omit from the column headed “Schedule Equivalent” for the brands “Coversyl Plus 5mg/1.25mg” and “Prexum Combi 5/1.25”: a
(b)omit
a Idaprex ARG Combi 5mg/1.25mg TZ MP NP C4375 30 5 30 (c)omit:
a Perindo ARG Combi 5mg/1.25mg TR MP NP C4375 30 5 30 [135]Schedule 1, entry for Pertuzumab
omit:
MP C4971 C5013 C5023 See Note 3 See Note 3 1 D(100) MP C4971 C5013 C5023 See Note 3 See Note 3 1 D(100) [136]Schedule 1, entry for Phytomenadione
insert in the columns headed “Determined Quantity”: 5
[137]Schedule 1, entry for Piroxicam in the form Capsule 10 mg
(a)omit:
Chem mart Piroxicam CH PDP C6214 50 0 50 (b)omit:
Terry White Chemists Piroxicam TW PDP C6214 50 0 50 (c)omit:
Chem mart Piroxicam CH MP NP C6214 50 3 50 (d)omit:
Terry White Chemists Piroxicam TW MP NP C6214 50 3 50 [138]Schedule 1, entry for Prasugrel in each of the forms: Tablet 5 mg (as hydrochloride); and Tablet 10 mg (as hydrochloride)
omit from the column headed “Circumstances”: C3208 substitute: C6454
[139]Schedule 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg
omit from the column headed “Maximum Quantity”: 1 substitute: 56
[140]Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
omit:
Quetiapine AN EA MP NP C4246 C5611 C5639 60 5 60 [141]Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg
(as hydrochloride)omit:
Aquinafil EA MP NP 30 5 30 [142]Schedule 1, entry for Ribavirin in each of the forms: Tablet 400 mg; and Tablet 600 mg
omit:
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100) [143]Schedule 1, entry for Ribavirin and Peginterferon Alfa‑2a
omit:
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P5956 1 2 1 MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100) MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207 2 5 1 C(100) Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P5956 1 2 1 MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100) MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207 2 5 1 C(100) substitute:
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C5956 1 2 1 MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 2 5 1 C(100) Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C5956 1 2 1 MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 2 5 1 C(100) [144]Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL
(a)omit from the column headed “Pack Quantity”: 1 substitute: 2
(b)omit from the columns headed “Maximum Quantity” and “Number of Repeats” respectively: See Note 2 substitute: See Note 3
[145]Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL
omit from the columns headed “Maximum Quantity” and “Number of Repeats” respectively: See Note 2 substitute: See Note 3
[146]Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium)
(a)omit:
a Rosuvastatin Actavis 5 ED MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30 NP C4226 C4263 30 5 30 (b)omit:
a Rosuvastatin AN EA MP C4225 C4226 P4226 30 5 30 NP C4226 30 5 30 (c)omit:
a Rosuvastatin Actavis 5 ED MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30 (d)omit:
a Rosuvastatin AN EA MP C4225 C4226 P4225 30 11 30 [147]Schedule 1, entry for Rosuvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg
(as calcium)(a)omit:
a Rosuvastatin AN EA MP C4225 C4226 P4226 30 5 30 NP C4226 30 5 30 (b)omit:
a Rosuvastatin AN EA MP C4225 C4226 P4225 30 11 30 [148]Schedule 1, entry for Secukinumab
substitute:
Secukinumab Injection 150 mg in 1 mL pre-filled pen Injection Cosentyx NV MP C6371 C6391 C6392 C6393 C6402 C6405 C6406 C6407 C6415 C6417 C6423 C6427 C6433 C6437 C6438 C6439 C6440 C6450 C6462 C6465 C6467 C6468 C6482 C6483 C6484 C6485 C6486 C6487 P6391 P6415 1 2 1 MP C6371 C6391 C6392 C6393 C6402 C6405 C6406 C6407 C6415 C6417 C6423 C6427 C6433 C6437 C6438 C6439 C6440 C6450 C6462 C6465 C6467 C6468 C6482 C6483 C6484 C6485 C6486 C6487 P6371 P6423 P6427 P6433 P6438 P6439 1 5 1 MP C6371 C6391 C6392 C6393 C6402 C6405 C6406 C6407 C6415 C6417 C6423 C6427 C6433 C6437 C6438 C6439 C6440 C6450 C6462 C6465 C6467 C6468 C6482 C6483 C6484 C6485 C6486 C6487 P6417 P6487 2 2 2 MP C6371 C6391 C6392 C6393 C6402 C6405 C6406 C6407 C6415 C6417 C6423 C6427 C6433 C6437 C6438 C6439 C6440 C6450 C6462 C6465 C6467 C6468 C6482 C6483 C6484 C6485 C6486 C6487 P6405 P6406 P6407 P6440 P6468 P6483 P6485 P6486 2 5 2 MP C6371 C6391 C6392 C6393 C6402 C6405 C6406 C6407 C6415 C6417 C6423 C6427 C6433 C6437 C6438 C6439 C6440 C6450 C6462 C6465 C6467 C6468 C6482 C6483 C6484 C6485 C6486 C6487 P6437 P6450 P6465 P6467 4 0 1 MP C6371 C6391 C6392 C6393 C6402 C6405 C6406 C6407 C6415 C6417 C6423 C6427 C6433 C6437 C6438 C6439 C6440 C6450 C6462 C6465 C6467 C6468 C6482 C6483 C6484 C6485 C6486 C6487 P6392 P6393 P6402 P6462 P6482 P6484 8 0 2 [149]Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
omit:
Xydep 50 EF MP NP C4755 C6277 C6289 30 5 30 [150]Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
omit:
Xydep 100 EF MP NP C4755 C6277 C6289 30 5 30 [151]Schedule 1, entry for Sevelamer
substitute:
Sevelamer Tablet containing sevelamer hydrochloride 800 mg Oral Renagel GZ MP NP C5491 180 5 180 MP C5454 C5530 360 5 180 C(100) [152]Schedule 1, entry for Sitagliptin in each of the forms: Tablet 25 mg (as phosphate monohydrate); Tablet 50 mg (as phosphate monohydrate); and Tablet 100 mg (as phosphate monohydrate)
insert in numerical order in the column headed “Circumstances”: C6376
[153]Schedule 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride; Tablet (modified release) containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride; and Tablet (modified release) containing 100 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
insert in numerical order in the column headed “Circumstances”: C6443
[154]Schedule 1, entry for Sofosbuvir
omit:
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)
[155]Schedule 1, entry for Somatropin
insert as first item in the columns in the order indicated:
Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative) Injection Genotropin MiniQuick PF MP C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 7 D(100) [156]Schedule 1, entry for Sorbitol with sodium citrate and sodium lauryl sulfoacetate
omit:
a Micolette AE MP See Note 2 4 0 12 C(100) a Microlax JT MP See Note 2 4 0 12 C(100) substitute:
a Micolette AE MP See Note 2 See Note 2 12 C(100) a Microlax JT MP See Note 2 See Note 2 12 C(100) [157]Schedule 1, entry for Sucroferric oxyhydroxide
substitute:
Sucroferric oxyhydroxide Tablet, chewable, 2.5 g (equivalent to 500 mg iron) Oral Velphoro FN MP NP C5491 90 5 90 MP C5454 C5530 180 5 90 C(100) [158]Schedule 1, entry for Tacrolimus in the form Capsule 2 mg [Maximum Quantity: 100; Number of Repeats: 3]
omit from the column headed “Authorised Prescriber”: Mp substitute: MP
[159]Schedule 1, entry for Tafluprost
omit from the column headed “Responsible Person”: MK substitute: MF
[160]Schedule 1, entry for Tamoxifen
substitute:
Tamoxifen Tablet 10 mg (as citrate) Oral Genox 10 AF MP NP C6470 60 5 60 Tablet 20 mg (as citrate) Oral Nolvadex-D AP MP NP C6421 C6449 P6421 30 5 30 a Genox 20 AF MP NP C6381 60 5 60 a GenRx Tamoxifen GX MP NP C6381 60 5 60 a Nolvadex-D AP MP NP C6421 C6449 P6449 60 5 30 a Tamosin QA MP NP C6381 60 5 60 a Tamoxifen Sandoz SZ MP NP C6381 60 5 60 [161]Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
(a)omit:
Terbinafine Actavis ED MP NP C2191 C2865 C3244 P2865 P3244 42 0 42 (b)omit:
Terbinafine Actavis ED MP NP C2191 C2865 C3244 P2191 42 1 42 [162]Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (all instances): C2191 C2865 C3244 substitute: C6395 C6404 C6453
(b)omit from the column headed “Purposes” (all instances): P2865 P3244 substitute: P6404 P6453
[163]Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (all instances): C2191 C2865 C3244 substitute: C6395 C6404 C6453
(b)omit from the column headed “Purposes” (all instances): P2191 substitute: P6395
[164]Schedule 1, entry for Terbinafine in the form Cream containing terbinafine hydrochloride 10 mg per g, 15 g
omit from the column headed “Circumstances”: C2354 C3243 substitute: C6412 C6434
[165]Schedule 1, entry for Timolol in the form Eye drops 5 mg (as maleate) per mL, 5 mL
omit from the column headed “Responsible Person” for the brand “Timoptol”: FR substitute: MF
[166]Schedule 1, entry for Timolol in each of the forms: Eye drops (gellan gum solution) 2.5 mg (as maleate) per mL, 2.5 mL; and Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL
omit from the column headed “Responsible Person”: MK substitute: MF
[167]Schedule 1, entry for Triptorelin
insert as first item in the columns in the order indicated:
Injection 100 micrograms in 1 mL pre-filled syringe Injection Decapeptyl FP MP C5046 28 0 7 PB(100) [168]Schedule 1, entry for Triptorelin in each of the forms: Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles; Powder for I.M. injection (prolonged release) 11.25 mg (as embonate) with solvent, syringe and needles; and Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles
omit from the column headed “Circumstances”: C5646 substitute: C6409
[169]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”: C6067 C6091 C6108 C6125 substitute:C6378 C6419 C6459 C6469
(b)omit from the column headed “Purposes”: P6067 P6125 substitute:P6419 P6459
[170]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”: C6067 C6091 C6108 C6125 substitute:C6378 C6419 C6459 C6469
(b)omit from the column headed “Purposes”: P6091 P6108 substitute:P6378 P6469
[171]Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)
omit:
Venlafaxine Actavis XR ED MP NP C5650 28 0 28 [172]Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
omit:
Venlafaxine Actavis XR ED MP NP C5650 28 5 28 [173]Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Voriconazole APOTEX TX MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 [174]Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Voriconazole APOTEX TX MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 C5748 56 2 56 [175]Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Voriconazole APOTEX TX MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 [176]Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Voriconazole APOTEX TX MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 C5748 56 2 56 [177]Schedule 3
omit:
TR Servier Laboratories (Aust.) Pty Ltd 54 004 838 500 [178] Schedule 3
omit:
TZ Servier Laboratories (Aust.) Pty Ltd 54 004 838 500 [179] Schedule 3, after details relevant to Responsible Person code YT
insert:
ZA AstraZeneca Pty Ltd 54 009 682 311 [180]Schedule 4, Part 1, entry for Adalimumab
(a)omit:
C4609 P4609 Active ankylosing spondylitis
Initial treatment – Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab or infliximab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 monthsPatient must be an adult
Must be treated by a rheumatologist
The application must include details of the NSAIDs trialled, their doses and duration of treatment
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per LThe BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment
The BASDAI must be no more than 1 month old at the time of initial application
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgmentThe assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
A maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures
(b)omit:
C4629 P4629 Ankylosing spondylitis
Initial treatment – Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapyPatient must be an adult
Must be treated by a rheumatologist
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information FormA maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures
C4642 P4642 Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drugPatient must be an adult
Must be treated by a rheumatologist
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baselineWhere only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information FormAll measurements provided must be no more than 1 month old at the time of application
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion
All applications for continuing treatment with this drug must include a measurement of response to the prior course of 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 following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures
[214]Schedule 4, Part 1, entry for Sevelamer
omit all codes from the column headed “Purposes Code”
[215]Schedule 4, Part 1, entry for Sitagliptin
insert in numerical order after existing text:
C6376 Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
Compliance with Authority Required procedures - Streamlined Authority Code 6376 [216] Schedule 4, Part 1, entry for Sitagliptin with metformin
insert in numerical order after existing text:
C6443 Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
Compliance with Authority Required procedures - Streamlined Authority Code 6443 [217]Schedule 4, Part 1, entry for Tamoxifen
substitute:
Tamoxifen C6381 Breast cancer
The condition must be hormone receptor positive.
C6421 Reduction of breast cancer risk
Patient must have a moderate or high risk of developing breast cancer; AND
The treatment must not exceed a dose of 20 mg per day; AND
The treatment must not exceed a lifetime maximum of 5 years for this condition.
C6449 Breast cancer
The condition must be hormone receptor positive.
C6470 Breast cancer
The condition must be hormone receptor positive.
[218]Schedule 4, Part 1, entry for Terbinafine
substitute:
Terbinafine C6395 P6395 Onychomycosis
The condition must be proximal or extensive (greater than 80% nail involvement); AND
Patient must have failed to respond to topical treatment; AND
The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; OR
The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.
The date of the pathology report must be provided at the time of application and must not be more than 12 months old
Compliance with Authority Required procedures C6404 P6404 Dermatophyte infection
Patient must have failed to respond to topical treatment.
Patient must be an Aboriginal or a Torres Strait Islander person.
Compliance with Authority Required procedures C6412 Fungal or yeast infection
The condition must be fungal; OR
The condition must be due to yeast.
Patient must be 18 years of age or less.
Compliance with Authority Required procedures - Streamlined Authority Code 6412 C6434 Fungal or yeast infection
Patient must be an Aboriginal or a Torres Strait Islander person.
Compliance with Authority Required procedures - Streamlined Authority Code 6434 C6453 P6453 Dermatophyte infection
Patient must have failed to respond to topical treatment; AND
Patient must have failed to respond to griseofulvin.
Patient must be 18 years of age or less.
Compliance with Authority Required procedures [219]Schedule 4, Part 1, entry for Triptorelin
substitute:
| Triptorelin | C5046 | Assisted Reproductive Technology The treatment must be for prevention of premature luteinisation and ovulation; AND Patient must be undergoing controlled ovarian stimulation; AND Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule. | Compliance with Authority Required procedures - Streamlined Authority Code 5046 |
| C6409 | Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate |
[220]Schedule 4, Part 1, entry for Ustekinumab
(a)omit:
C6067 P6067 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 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 C6091 P6091 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 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 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 C6108 P6108 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 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 C6125 P6125 Severe psoriatic arthritis
Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)
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.
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 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 (b)insert in numerical order after existing text:
C6378 P6378 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 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.
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)
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.
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; 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
[221] Schedule 5, after entry for Macrogol 3350
insert:
Meloxicam GRP-15468 Capsule 15 mg Oral APO-Meloxicam
Chem mart Meloxicam
Meloxicam Sandoz
Mobic
Movalis 15
Moxicam
Terry White Chemists MeloxicamTablet 15 mg Oral APO-Meloxicam
Chem mart Meloxicam 15 mg
Meloxiauro 15
Meloxibell
Meloxicam AN
Meloxicam-GA
Meloxicam Ranbaxy
Meloxicam Sandoz
Mobic
Movalis 15
Moxicam 15
Pharmacor Meloxicam 15
Terry White Chemists Meloxicam 15 mgGRP-15658 Capsule 7.5 mg Oral APO-Meloxicam
Chem mart Meloxicam
Meloxicam Sandoz
Mobic
Movalis 7.5
Moxicam
Terry White Chemists MeloxicamTablet 7.5 mg Oral APO-Meloxicam
Chem mart Meloxicam 7.5 mg
Meloxiauro 7.5
Meloxibell
Meloxicam AN
Meloxicam-GA
Meloxicam Ranbaxy
Meloxicam Sandoz
Mobic
Movalis 7.5
Moxicam 7.5
Pharmacor Meloxicam 7.5
Terry White Chemists Meloxicam 7.5 mg[222] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]
insert in alphabetical order in the column headed “Brand”: Perindopril AN
[223] Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg [GRP-15442]
(a)omit from the column headed “Brand”: Blooms the Chemist Perindopril Arginine
(b)omit from the column headed “Brand”: Chem mart Perindopril Arginine
(c)omit from the column headed “Brand”: IDAPREX ARG 5mg
(d)omit from the column headed “Brand”: PERINDO ARG 5mg
(e)omit from the column headed “Brand”: Terry White Chemists Perindopril Arginine
[224] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]
insert in alphabetical order in the column headed “Brand”: Perindopril AN
[225] Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg [GRP-15525]
(a)omit from the column headed “Brand”: Blooms the Chemist Perindopril Arginine
(b)omit from the column headed “Brand”: Chem mart Perindopril Arginine
(c)omit from the column headed “Brand”: IDAPREX ARG 10mg
(d)omit from the column headed “Brand”: PERINDO ARG 10mg
(e)omit from the column headed “Brand”: Terry White Chemists Perindopril Arginine
[226] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]
insert in alphabetical order in the column headed “Brand”: Perindopril AN
[227] Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg [GRP-15965]
(a)omit from the column headed “Brand”: Blooms the Chemist Perindopril Arginine
(b)omit from the column headed “Brand”: Chem mart Perindopril Arginine
(c)omit from the column headed “Brand”: IDAPREX ARG 2.5mg
(d)omit from the column headed “Brand”: PERINDO ARG 2.5mg
(e)omit from the column headed “Brand”: Terry White Chemists Perindopril Arginine
[228]Schedule 5, after entry for Perindopril [GRP-15965]
insert:
Perindopril with indapamide GRP-15765 Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg Oral Chem mart Perindopril/ Indapamide 4/1.25
GenRx Perindopril/ Indapamide 4/1.25
Idaprex Combi 4/1.25
Indosyl Combi 4/1.25
Perindo Combi 4/1.25
Perindopril and Indapamide AN 4/1.25
Perindopril and Indapamide CH 4/1.25
Perindopril Combi Actavis 4/1.25
Perindopril/ Indapamide GH 4/1.25
Terry White Chemists Perindopril/ Indapamide 4/1.25Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg Oral Coversyl Plus 5mg/1.25mg
Prexum Combi 5/1.25
0
0
0