National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 3) PB 17 of 2014 (Cth)
PB 17 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 3)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 21 March 2014
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 3).
(2) This Instrument may also be cited as PB 17 of 2014.
2 Commencement
This Instrument commences on 1 April 2014.
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
Schedule 1, entry for Abacavir in each of the forms: Tablet 300 mg (as sulfate); and Oral solution 20 mg (as sulfate) per mL, 240 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Abacavir with Lamivudine
omit from the column headed “Circumstances”: C3590 C3591 C3592 C3593 substitute: C4505 C4527 C4528 C4538
Schedule 1, entry for Abacavir with Lamivudine and Zidovudine
omit from the column headed “Circumstances”: C3979 C3980 C3981 C3982 substitute: C4472 C4480 C4495 C4523
Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Novatin | IA | MP | C1363 C1366 | 100 | 2 | 100 |
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”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
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”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
(d)omit from the column headed “Purposes”: P3520
(e)omit from the column headed “Purposes”: P3743
(f)insert in numerical order: P4492 P4501 P4518
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”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
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”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
(d)omit from the column headed “Purposes”: P3522
(e)omit from the column headed “Purposes”: P3744
(f)insert in numerical order: P4517 P4531
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”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
(d)omit from the column headed “Purposes”: P3520
(e)omit from the column headed “Purposes”: P3743
(f)insert in numerical order: P4492 P4501 P4518
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”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
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”: C3520 C3522
(b)omit from the column headed “Circumstances”: C3743 C3744
(c)insert in numerical order: C4492 C4501 C4517 C4518 C4531
(d)omit from the column headed “Purposes”: P3522
(e)omit from the column headed “Purposes”: P3744
(f)insert in numerical order: P4517 P4531
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Alendronate plus D3-DRLA | RZ | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
Schedule 1, entry for Atazanavir in each of the forms: Capsule 100 mg (as sulfate); Capsule 150 mg (as sulfate); Capsule 200 mg (as sulfate); and Capsule 300 mg (as sulfate)
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Azathioprine in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Azathioprine | TX | MP NP | 100 | 5 | 100 |
Schedule 1, after entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g
insert in the columns in the order indicated:
| Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g | Application | Daivobet 50/500 gel | LO | MP NP | C4506 | 1 | 1 | 1 |
Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g [Maximum Quantity: 1; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Optifresh eye gel | PP | MP | C1362 C3036 | P1362 | 1 | 5 | 1 |
| NP AO | C1362 | 1 | 5 | 1 |
Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g [Maximum Quantity: 1; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Optifresh eye gel | PP | MP | C1362 C3036 | P3036 | 1 | 11 | 1 |
Schedule 1, entry for Carmellose in the form Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Optifresh Tears | PP | MP NP | C1359 | 3 | 5 | 1 |
| AO | C2802 | 3 | 5 | 1 |
Schedule 1, entry for Carmellose in the form Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Optifresh Plus | PP | MP NP | C1359 | 3 | 5 | 1 |
| AO | C2802 | 3 | 5 | 1 |
Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Maximum Quantity: 10;
Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Cefaclor CD | TX | PDP | 10 | 0 | 10 |
Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Maximum Quantity: 10;
Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Cefaclor CD | TX | MP | 10 | 1 | 10 |
Schedule 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg
in 100 mL
(a)omit from the column headed “Circumstances”: C3843 C3844 C3903 C3904
(b)insert in numerical order: C4468 C4477 C4511 C4532
Schedule 1, after entry for Clindamycin
insert:
| Clobetasol | Shampoo containing clobetasol propionate 500 micrograms per mL, 125 mL | Application | Clobex | GA | MP | C4507 | 1 | 1 | 1 |
Schedule 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL
insert in numerical order in the column headed “Circumstances”: C4504
Schedule 1, entry for Didanosine in each of the forms: Capsule 125 mg (containing enteric coated beadlets); Capsule 200 mg (containing enteric coated beadlets); Capsule 250 mg (containing enteric coated beadlets); and Capsule 400 mg (containing enteric coated beadlets)
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, after entry for Docosahexaenoic acid with carbohydrate
insert:
| Dolutegravir | Tablet 50 mg (as sodium) | Oral | Tivicay | VI | MP See Note 1 | C4454 C4455 C4469 C4512 | 60 | 5 | 30 | D(100) |
Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
omit from the column headed “Brand”: Lipodox substitute: Liposomal Doxorubicin SUN
Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
omit from the column headed “Brand”: Lipodox 50 substitute: Liposomal Doxorubicin SUN
Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances): P1459 substitute: P4485
Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances): P1279 substitute: P4514
Schedule 1, entry for Doxycycline in each of the forms: Tablet 50 mg (as monohydrate); Tablet 50 mg (as hydrochloride); and
Capsule 50 mg (as hydrochloride) (containing enteric coated pellets)
omit from the column headed “Circumstances” (all instances): C1346 C1851 C1852 substitute: C4475 C4529 C4539
Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances): P1459 substitute: P4485
Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances): P1279 substitute: P4514
Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (twice occurring): P1459 substitute: P4485
Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (twice occurring): P1279 substitute: P4514
Schedule 1, entry for Efavirenz in each of the forms: Tablet 200 mg; Tablet 600 mg; and Oral solution 30 mg per mL, 180 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Emtricitabine
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and
Tablet 150 mg (as hydrochloride)
omit from the column headed “Circumstances”: C4362 C4386 C4387 C4403 C4406 substitute: C4473 C4481 C4525 C4536 C4537
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”: C3524
(b)omit from the column headed “Circumstances”: C3770 C3771
(c)insert in numerical order: C4457 C4458 C4482 C4483 C4503
(d)omit from the column headed “Purposes”: P3524
(e)omit from the column headed “Purposes”: P3770
(f)insert in numerical order: P4458 P4483 P4503
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”: C3524
(b)omit from the column headed “Circumstances”: C3770 C3771
(c)insert in numerical order: C4457 C4458 C4482 C4483 C4503
(d)omit from the column headed “Purposes”: P3771
(e)insert in numerical order: P4457 P4482
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”: C3524
(b)omit from the column headed “Circumstances”: C3770 C3771
(c)insert in numerical order: C4457 C4458 C4482 C4483 C4503
(d)omit from the column headed “Purposes”: P3524
(e)omit from the column headed “Purposes”: P3770
(f)insert in numerical order: P4458 P4483 P4503
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”: C3524
(b)omit from the column headed “Circumstances”: C3770 C3771
(c)insert in numerical order: C4457 C4458 C4482 C4483 C4503
(d)omit from the column headed “Purposes”: P3771
(e)insert in numerical order: P4457 P4482
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”: C3524
(b)omit from the column headed “Circumstances”: C3770 C3771
(c)insert in numerical order: C4457 C4458 C4482 C4483 C4503
(d)omit from the column headed “Purposes”: P3524
(e)omit from the column headed “Purposes”: P3770
(f)insert in numerical order: P4458 P4483 P4503
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”: C3524
(b)omit from the column headed “Circumstances”: C3770 C3771
(c)insert in numerical order: C4457 C4458 C4482 C4483 C4503
(d)omit from the column headed “Purposes”: P3771
(e)insert in numerical order: P4457 P4482
Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL
omit:
| Baxter Healthcare Pty Ltd | BX | MP NP | C3613 C3614 C3615 C3616 C3617 C3618 | 7 | 0 | 1 |
Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 400 mg in 200 mL
omit:
| Baxter Healthcare Pty Ltd | BX | MP NP | C3613 C3614 C3615 C3616 C3617 C3618 | 1 | 0 | 1 |
Schedule 1, entry for Flutamide
omit:
| Tablet 250 mg, 30 | Oral | Flutamide MYLAN | AF | MP NP | C3674 | 3 | 5 | 1 |
Schedule 1, entry for Fosamprenavir in each of the forms: Tablet 700 mg (as calcium); and Oral liquid 50 mg (as calcium) per mL, 225 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Gefitinib
omit from the column headed “Circumstances”: C4384 C4387 substitute: C4473 C4474
Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)
insert:
| Glycopyrronium | Capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler) | Inhalation by mouth | seebri breezhaler | NV | MP NP | C4516 | 30 | 5 | 30 |
Schedule 1, entry for Homatropine
omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP AO
Schedule 1, entry for Hydrocortisone in the form Rectal foam containing hydrocortisone acetate 90 mg per applicatorful, 14 applications, aerosol 21.1 g
omit from the column headed “Responsible Person”: AS substitute: HM
Schedule 1, entry for Indinavir
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Infliximab
substitute:
| Infliximab | Powder for I.V. infusion 100 mg | Injection | Remicade | JC | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
| MP See Note 1 | C4524 C4535 | P4535 | 1 | 1 | 1 | D(100) | |||||
| MP See Note 1 | C4524 C4535 | P4524 | 5 | 1 | 1 | D(100) |
Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL;
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL; I.V. injection containing irinotecan hydrochloride trihydrate
300 mg in 15 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
omit from the column headed “Circumstances” (all instances): C3184
Schedule 1, entry for Lamivudine in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Circumstances” (all instances): C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Lamivudine in the form Oral solution 10 mg per mL, 240 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Lamivudine with Zidovudine
omit from the column headed “Circumstances” (twice occurring): C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Leuprorelin in each of the forms: Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set; and Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set
omit from the column headed “Responsible Person”: HH substitute: TL
Schedule 1, entry for Linagliptin
omit from the column headed “Circumstances”: C4350 substitute: C4488
Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and
Oral liquid 400 mg-100 mg per 5 mL, 60 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Metoclopramide | TX | MP NP MW PDP | 25 | 0 | 25 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metoclopramide Actavis | GN | MP NP MW PDP | 25 | 0 | 25 |
Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metoprolol Actavis | GN | MP NP | 100 | 5 | 100 |
Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metoprolol Actavis | GN | MP NP | 60 | 5 | 60 |
Schedule 1, entry for Misoprostol
omit from the column headed “Circumstances”: C4266 substitute: C4463
Schedule 1, entry for Morphine
omit:
| Injection containing morphine sulphate 10 mg in 1 mL (with preservative) | Injection | Morphine Sulphate Wockhardt | HH | MP NP MW PDP | 10 | 0 | 10 |
Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit from the column headed “Circumstances” (all instances): C3586 C3587 C3588 C3589 substitute C4454 C4455 C4469 C4512
Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
omit from the column headed “Circumstances”: C3587 C3589 C3994 C3995 substitute: C4454 C4460 C4469 C4526
Schedule 1, entry for Nevirapine in the form Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, after entry for Nicotine in the form Transdermal patch 35 mg
insert in the columns in the order indicated:
| Transdermal patch 39.4 mg | Transdermal | nicorette 16hr Invisipatch | JT | MP NP | C4307 C4344 C4348 | 28 | 2 | 28 |
Schedule 1, entry for Oxaliplatin in each of the forms: Solution concentrate for I.V. infusion 50 mg in 10 mL; Powder for I.V. infusion
50 mg; I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL; Solution concentrate for I.V. infusion 100 mg in
20 mL; Powder for I.V. infusion 100 mg; and Solution concentrate for I.V. infusion 200 mg in 40 mL
omit from the column headed “Circumstances” (all instances): C3900 C3901 C3930 C3939
Schedule 1, entry for Oxycodone
omit:
| Tablet containing oxycodone hydrochloride 5 mg (controlled release) | Oral | OxyContin | MF | MP NP | C1062 | 28 | 0 | 28 |
Schedule 1, after entry for Pancrelipase
insert:
| Panitumumab | Solution concentrate for I.V. infusion 100 mg in 5 mL | Injection | Vectibix | AN | MP | C4462 C4498 C4530 C4543 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
| GenRx Perindopril | GX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit:
| GenRx Perindopril | GX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit:
| GenRx Perindopril | GX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Raltegravir in the form Tablet 400 mg (as potassium)
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Rilpivirine
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Salbutamol in each of the forms: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30;
and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Salbutamol | TX | MP NP | C1754 C1755 | 2 | 5 | 1 |
Schedule 1, entry for Saquinavir
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Saxagliptin
omit from the column headed “Circumstances”: C4350 substitute: C4520
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)
omit from the column headed “Circumstances”: C4350 substitute: C4519
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; and Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C4325 substitute: C4423
Schedule 1, omit entry for Sitagliptin with simvastatin
Schedule 1, entry for Stavudine in each of the forms: Capsule 20 mg; Capsule 30 mg; and Capsule 40 mg
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
(c)omit from the column headed “Purposes” (all instances): P2100 substitute: P4496
Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
(c)omit from the column headed “Purposes” (all instances): P2100 substitute: P4496
Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
(c)omit from the column headed “Purposes” (all instances): P2100 substitute: P4496
Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C2100
(b)insert in numerical order: C4496
(c)omit from the column headed “Purposes” (all instances): P2100 substitute: P4496
Schedule 1, entry for Temozolomide
omit:
| Capsule 180 mg | Oral | Astromide | GN | MP | C1736 C1737 C2101 | 5 | 5 | 5 |
| Orion Temozolomide | ON | MP | C1736 C1737 C2101 | 5 | 5 | 5 | ||
| Temodal | MK | MP | C1736 C1737 C2101 | 5 | 5 | 5 |
substitute:
| Capsule 180 mg | Oral | Astromide | GN | MP | C1736 C1737 C2101 C4496 | P1736 P1737 P2101 | 5 | 5 | 5 |
| Orion Temozolomide | ON | MP | C1736 C1737 C2101 C4496 | P1736 P1737 P2101 | 5 | 5 | 5 | ||
| Temodal | MK | MP | C1736 C1737 C2101 C4496 | P1736 P1737 P2101 | 5 | 5 | 5 | ||
| Astromide | GN | MP | C1736 C1737 C2101 C4496 | P4496 | 15 | 2 | 5 | ||
| Orion Temozolomide | ON | MP | C1736 C1737 C2101 C4496 | P4496 | 15 | 2 | 5 | ||
| Temodal | MK | MP | C1736 C1737 C2101 C4496 | P4496 | 15 | 2 | 5 |
Schedule 1, entry for Tenofovir
omit all codes from the column headed “Circumstances” and substitute:
C4454 C4455 C4469 C4476 C4489 C4490 C4499 C4509 C4510 C4512 C4544 C4545
Schedule 1, entry for Tenofovir with Emtricitabine
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 1, entry for Tenofovir with emtricitabine and efavirenz
omit from the column headed “Circumstances”: C3983 C3984 C3985 C3986 substitute: C4470 C4494 C4522 C4533
Schedule 1, entry for Tenofovir with Emtricitabine and Rilpivirine
omit from the column headed “Circumstances”: C3983 C3984 C3985 C3986 substitute: C4470 C4494 C4522 C4533
Schedule 1, entry for Testosterone in the form Subcutaneous implant 200 mg
omit from the column headed “Brand”: Schering-Plough Pty Limited substitute: Merck Sharp & Dohme (Australia) Pty Ltd
Schedule 1, after entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)
insert in the columns in the order indicated:
| Capsule containing powder for oral inhalation 28 mg (for use in podhaler) | Inhalation by mouth | TOBI podhaler | NV | MP | C4456 C4513 | P4456 | 224 | 0 | 224 |
| MP | C4456 C4513 | P4513 | 224 | 2 | 224 |
Schedule 1, entry for Tropisetron
omit:
| Capsule 5 mg (as hydrochloride) | Oral | Navoban | NV | MP NP See Note 1 | C3050 | 2 | 0 | 2 |
Schedule 1, entry for Tropisetron in the form I.V. injection 5 mg (as hydrochloride) in 5 mL
omit:
| Navoban | NV | MP NP See Note 1 | C3050 | 1 | 0 | 1 |
Schedule 1, entry for Vildagliptin
omit from the column headed “Circumstances”: C4350 substitute: C4467
Schedule 1, entry for Vildagliptin with metformin in each of the forms: Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride; Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride; and Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C4325 substitute: C4423
Schedule 1, entry for Zidovudine in each of the forms: Capsule 100 mg; Capsule 250 mg; and Syrup 10 mg per mL, 200 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
Schedule 3, after details relevant to Responsible Person code TK
insert:
| TL | Tolmar Australia Pty Ltd | 53 162 640 708 |
Schedule 4, Part 1, entry for Abacavir
substitute:
| Abacavir | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Abacavir with Lamivudine
substitute:
| Abacavir with Lamivudine | C4505 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures |
| C4527 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4527 | |
| C4528 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4528 | |
| C4538 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Abacavir with Lamivudine and Zidovudine
substitute:
| Abacavir with Lamivudine and Zidovudine | C4472 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; | Compliance with Written or Telephone Authority Required procedures |
| C4480 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4480 | |
| C4495 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4495 | |
| C4523 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; | Compliance with Written or Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Adalimumab
(a)omit:
| C3520 | P3520 | Juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing after a break of more than 12 months) Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who: (a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and (c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include: (i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: — hydroxychloroquine at a dose of at least 200 mg daily; or — leflunomide at a dose of at least 10 mg daily; or — sulfasalazine at a dose of at least 2 g daily; or (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs: — hydroxychloroquine at a dose of at least 200 mg daily; and/or — leflunomide at a dose of at least 10 mg daily; and/or — sulfasalazine at a dose of at least 2 g daily; or (iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: — azathioprine at a dose of at least 1 mg/kg per day; and/or — cyclosporin at a dose of at least 2 mg/kg per day; and/or — sodium aurothiomalate at a dose of 50 mg weekly; and where bDMARD means adalimumab or etanercept; and where the following conditions apply: if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable; the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances; the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs; if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD; failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following: (a) 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 (b) either: (i) an active joint count of at least 20 active (swollen and tender) joints; or (ii) at least 4 active joints from the following list: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder, cervical spine and/or hip (assessed as active if there is 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 joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application; if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied; the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement; a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle; a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures | ||
| C3522 | P3522 | Juvenile idiopathic arthritis — initial treatment 3 Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who: (a) has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) was receiving treatment with adalimumab prior to 1 March 2010; and (c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and (d) is receiving treatment with adalimumab at the time of application; and where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement; the course of treatment is limited to a maximum of 24 weeks of treatment; a patient is eligible for PBS-subsidised treatment under the above criteria once only | Compliance with Written Authority Required procedures |
| Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
(b)omit:
| C3743 | P3743 | Juvenile idiopathic arthritis — initial treatment 2 (change or recommencement after a break of less than 12 months) Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who: (a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and (c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy; a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures | ||
| C3744 | P3744 | Juvenile idiopathic arthritis — continuing treatment Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older: (a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) who has demonstrated an adequate response to treatment with adalimumab; and (c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and where bDMARD means adalimumab or etanercept; and where the following conditions apply: an adequate response to treatment is defined as: (a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and (b) either of the following: (i) an active joint count of fewer than 10 active (swollen and tender) joints; or (ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or (iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder, cervical spine and/or hip (assessed as active if there is 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 an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment; the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course; if the most recent course of adalimumab therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | Compliance with Written Authority Required procedures |
| Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Compliance with Written or Telephone Authority Required procedures |
(c)insert in numerical order following existing text:
| C4492 | P4492 | Severe active juvenile idiopathic arthritis Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application The following 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 (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied The authority application must be made in writing and must include: (1) a completed authority prescription form; and If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial adalimumab after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle | Compliance with Written Authority Required procedures |
| C4501 | P4501 | Severe active juvenile idiopathic arthritis Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply Patient must have received insufficient adalimumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4517 | P4517 | Severe active juvenile idiopathic arthritis Continuing treatment ― balance of supply Patient must have received insufficient adalimumab therapy under the Continuing treatment restriction to complete 24 weeks treatment; AND Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4518 | P4518 | Severe active juvenile idiopathic arthritis Initial treatment ― Initial 2 (change or recommencement of treatment after break of less than 24 months) Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab The authority application must be made in writing and must include: (1) a completed authority prescription form; and Applications for a patient who has received PBS-subsidised treatment with adalimumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment, within the timeframes specified below Where the most recent course of PBS-subsidised adalimumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased Where the most recent course of PBS-subsidised adalimumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a 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) an active joint count of fewer than 10 active (swollen and tender) joints; or (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or | Compliance with Written Authority Required procedures |
| C4531 | P4531 | Severe active juvenile idiopathic arthritis Continuing treatment Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a 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) an active joint count of fewer than 10 active (swollen and tender) joints; or (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response The authority application must be made in writing and must include: All applications for continuing treatment with adalimumab 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 with adalimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Atazanavir
substitute:
| Atazanavir | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Calcipotriol with betamethasone
insert in numerical order following existing text:
| C4506 | Chronic stable plaque type psoriasis vulgaris The condition must be on the patient's scalp; AND | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Carbomer with Triglyceride Lipids [Circumstances Code: C3036; Purposes Code: P3036]
omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: C3036
Schedule 4, Part 1, entry for Cetuximab
(a)omit:
| C3843 | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy | Compliance with Authority Required procedures |
| C3844 | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease | Compliance with Authority Required procedures |
| C3903 | Where the patient is receiving treatment at/from a Public Hospital Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy | Compliance with Authority Required procedures - Streamlined Authority Code 3903 |
| C3904 | Where the patient is receiving treatment at/from a Public Hospital Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease | Compliance with Authority Required procedures - Streamlined Authority Code 3904 |
(b)insert in numerical order following existing text:
| C4468 | Where the patient is receiving treatment at/from a Public Hospital Metastatic colorectal cancer Patient must have KRAS wild-type metastatic colorectal cancer; AND Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab | Compliance with Authority Required procedures - Streamlined Authority Code 4468 |
| C4477 | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Metastatic colorectal cancer Patient must have KRAS wild-type metastatic colorectal cancer; AND Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab | Compliance with Authority Required procedures |
| C4511 | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Metastatic colorectal cancer Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab | Compliance with Authority Required procedures |
| C4532 | Where the patient is receiving treatment at/from a Public Hospital Metastatic colorectal cancer Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab | Compliance with Authority Required procedures - Streamlined Authority Code 4532 |
Schedule 4, Part 1, after entry for Clindamycin
insert:
| Clobetasol | C4507 | Moderate to severe scalp psoriasis The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; OR Patient must be aged 18 years or older | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Denosumab
insert in numerical order following existing text:
| C4504 | Giant cell tumour of bone Patient must be one in whom surgical resection is not feasible; OR | Compliance with Authority Required procedures - Streamlined Authority Code 4504 |
Schedule 4, Part 1, entry for Didanosine
substitute:
| Didanosine | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, after entry for Docosahexaenoic acid with carbohydrate
insert:
| Dolutegravir | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Doxycycline
substitute:
| Doxycycline | C4475 | Chronic bronchitis Patient must be aged 8 years or older |
| P4485 | Urethritis | |
| P4514 | Pelvic inflammatory disease | |
| C4529 | Severe acne | |
| C4539 | Bronchiectasis Patient must be aged 8 years or older |
Schedule 4, Part 1, entry for Efavirenz
substitute:
| Efavirenz | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Emtricitabine
substitute:
| Emtricitabine | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Erlotinib
substitute:
| Erlotinib | C4473 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) The treatment must be as monotherapy; AND Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material | Compliance with Authority Required procedures |
| C4481 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) The treatment must be as monotherapy; AND Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR The authority application must be made in writing and must include: (1) a completed authority prescription form; and (i) evidence that the patient has been treated with platinum-based chemotherapy; AND | Compliance with Written Authority Required procedures | |
| C4525 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) The treatment must be as monotherapy; AND Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR The authority application must be made in writing and must include: (1) a completed authority prescription form; and (i) evidence that the patient has been treated with platinum-based chemotherapy; AND | Compliance with Written Authority Required procedures | |
| C4536 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) The treatment must be as monotherapy; AND Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR | Compliance with Authority Required procedures | |
| C4537 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) The treatment must be as monotherapy; AND Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material | Compliance with Authority Required procedures |
Schedule 4, Part 1, omit entry for Oxaliplatin
Schedule 4, Part 1, after entry for Pancrelipase
insert:
| Panitumumab | C4462 | Where the patient is receiving treatment at/from a Public Hospital Metastatic colorectal cancer Patient must have KRAS wild-type metastatic colorectal cancer; AND Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab | Compliance with Authority Required procedures - Streamlined Authority Code 4462 |
| C4498 | Where the patient is receiving treatment at/from a Public Hospital Metastatic colorectal cancer Patient must have received an initial authority prescription for panitumumab for treatment of KRAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab | Compliance with Authority Required procedures - Streamlined Authority Code 4498 | |
| C4530 | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Metastatic colorectal cancer Patient must have KRAS wild-type metastatic colorectal cancer; AND Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab | Compliance with Authority Required procedures | |
| C4543 | Where the patient is receiving treatment in the community setting or at/from a Private Hospital Metastatic colorectal cancer Patient must have received an initial authority prescription for panitumumab for treatment of KRAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Raltegravir
(a)omit:
| C3586 | Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures |
| C3587 | Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures |
| C3588 | Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 |
| C3589 | Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 |
(b)insert in numerical order following existing text:
| C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Rilpivirine
substitute:
| Rilpivirine | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Ritonavir
substitute:
| Ritonavir | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Saquinavir
substitute:
| Saquinavir | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Saxagliptin
substitute:
| Saxagliptin | C4520 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR 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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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: 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 A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with saxagliptin | Compliance with Authority Required procedures - Streamlined Authority Code 4520 |
Schedule 4, Part 1, entry for Sitagliptin
substitute:
| Sitagliptin | C4519 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR 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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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: 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 A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with sitagliptin | Compliance with Authority Required procedures - Streamlined Authority Code 4519 |
Schedule 4, Part 1, entry for Sitagliptin with metformin
(a)omit:
| C4325 | Diabetes mellitus type 2 Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR 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: 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 4325 |
(b)insert in numerical order following existing text:
| C4423 | Diabetes mellitus type 2 Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR 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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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: 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 A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination | Compliance with Authority Required procedures - Streamlined Authority Code 4423 |
Schedule 4, Part 1, omit entry for Sitagliptin with simvastatin
Schedule 4, Part 1, entry for Stavudine
substitute:
| Stavudine | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Temozolomide
(a)omit:
| C2100 | P2100 | Glioblastoma multiforme concomitantly with radiotherapy | Compliance with Authority Required procedures |
(b)insert in numerical order following existing text:
| C4496 | P4496 | Glioblastoma multiforme Patient must be undergoing concomitant radiotherapy | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Tenofovir
substitute:
| Tenofovir | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4476 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B Patient must have cirrhosis; AND Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4476 | |
| C4489 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B Patient must not have cirrhosis; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4489 | |
| C4490 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B Patient must not have cirrhosis; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4490 | |
| C4499 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B Patient must not have cirrhosis; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4509 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B Patient must have cirrhosis; AND Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures | |
| C4510 | Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B Patient must have cirrhosis; AND Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4510 | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 | |
| C4544 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B Patient must not have cirrhosis; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4545 | Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B Patient must have cirrhosis; AND Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy | Compliance with Written or Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Tenofovir with Emtricitabine
substitute:
| Tenofovir with Emtricitabine | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
Schedule 4, Part 1, entry for Tenofovir with emtricitabine and efavirenz
substitute:
| Tenofovir with emtricitabine and efavirenz | C4470 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470 |
| C4494 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures | |
| C4522 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naive | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522 | |
| C4533 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naive | Compliance with Written or Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Tenofovir with Emtricitabine and Rilpivirine
substitute:
| Tenofovir with Emtricitabine and Rilpivirine | C4470 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470 |
| C4494 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection | Compliance with Written or Telephone Authority Required procedures | |
| C4522 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naive | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522 | |
| C4533 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naive | Compliance with Written or Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Tobramycin
insert in numerical order following existing text:
| C4456 | Proven Pseudomonas aeruginosa infection Patient must have cystic fibrosis; AND Patient must be 6 years of age or older | Compliance with Authority Required procedures - Streamlined Authority Code 4456 |
| C4513 | Proven Pseudomonas aeruginosa infection Patient must have cystic fibrosis; AND Patient must be 6 years of age or older | Compliance with Authority Required procedures - Streamlined Authority Code 4513 |
Schedule 4, Part 1, entry for Vildagliptin
substitute:
| Vildagliptin | C4467 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR 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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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: 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 A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with vildagliptin | Compliance with Authority Required procedures - Streamlined Authority Code 4467 |
Schedule 4, Part 1, entry for Vildagliptin with metformin
(a)omit:
| C4325 | Diabetes mellitus type 2 Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR 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: 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 4325 |
(b)insert in numerical order following existing text:
| C4423 | Diabetes mellitus type 2 Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR 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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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: 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 A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination | Compliance with Authority Required procedures - Streamlined Authority Code 4423 |
Schedule 4, Part 1, entry for Zidovudine
substitute:
| Zidovudine | C4454 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454 |
| C4455 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4469 | Where the patient is receiving treatment at/from a private hospital HIV infection Patient must have previously received PBS-subsidised therapy for HIV infection; AND | Compliance with Written or Telephone Authority Required procedures | |
| C4512 | Where the patient is receiving treatment at/from a public hospital HIV infection Patient must be antiretroviral treatment naïve; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512 |
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0
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