National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 1) (PB 1 of 2017) (Cth)
PB 1 of 2017
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 1)
National Health Act 1953
I, LOUISE CLARKE, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 17 JANUARY 2017
LOUISE CLARKE
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 1).
(2) This Instrument may also be cited as PB 1 of 2017.
2 Commencement
This Instrument commences on 1 February 2017.
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 Abciximab
omit from the column headed “Responsible Person”: LY substitute: JC
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
omit from the column headed “Circumstances”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
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]
omit from the column headed “Circumstances”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
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]
omit from the column headed “Circumstances”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5144 P5184 P5223 P5294 P5335
substitute: P6695 P6726 P6727 P6728 P6753
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5265 P5336 P5369
insert in numerical order: P6696 P6755 P6756
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
omit from the column headed “Circumstances”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
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]
omit from the column headed “Circumstances”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
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]
omit from the column headed “Circumstances”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5144 P5184 P5223 P5294 P5335
substitute: P6695 P6726 P6727 P6728 P6753
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5265 P5336 P5369
insert in numerical order: P6696 P6755 P6756
Schedule 1, entry for Alprazolam
substitute:
| Alprazolam | Tablet 250 micrograms | Oral | a | Alprax 0.25 | QA | MP NP | C6773 | 10 | 0 | 50 |
| a | Kalma 0.25 | AF | MP NP | C6773 | 10 | 0 | 50 | |||
| Tablet 500 micrograms | Oral | a | Alprax 0.5 | QA | MP NP | C6773 | 10 | 0 | 50 | |
| a | Kalma 0.5 | AF | MP NP | C6773 | 10 | 0 | 50 | |||
| Tablet 1 mg | Oral | a | Alprax 1 | QA | MP NP | C6773 | 10 | 0 | 50 | |
| a | GenRx Alprazolam | GX | MP NP | C6773 | 10 | 0 | 50 | |||
| a | Kalma 1 | AF | MP NP | C6773 | 10 | 0 | 50 |
Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Aripiprazole | TX | MP NP | C4246 | 30 | 5 | 30 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Tevaripiprazole | TB | MP NP | C4246 | 30 | 5 | 30 |
Schedule 1, entry for Atenolol in the form Tablet 50 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Atenolol Amneal | EF | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride); Capsule
25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); Capsule 60 mg (as hydrochloride); Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | ATOMERRA | RW | MP | C4578 C6279 | 56 | 5 | 28 |
Schedule 1, entry for Bromocriptine
substitute:
| Bromocriptine | Tablet 2.5 mg (as mesylate) | Oral | Parlodel | SZ | MP | C5172 C6706 C6707 C6717 C6718 C6719 C6787 | P5172 | 30 | 0 | 30 |
| NP | C5172 | 30 | 0 | 30 | ||||||
| MP | C5172 C6706 C6707 C6717 C6718 C6719 C6787 | P6706 P6707 P6717 P6718 P6719 P6787 | 60 | 5 | 30 |
Schedule 1, entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone
500 micrograms (as dipropionate) per g, 30 g
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Calcipotriol/ Betamethasone Sandoz 50/500 | SZ | MP NP | C6358 | 1 | 1 | 1 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Daivobet”: a
Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)
omit:
| Hospira Ceftriaxone | PF | MP NP | C5826 C5881 C5890 | 5 | 0 | 1 |
Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)
(a)omit:
| Cephalexin generichealth | GQ | PDP | 20 | 0 | 20 |
(b)omit:
| Cephalexin generichealth | GQ | MP NP MW | 20 | 1 | 20 |
(c)omit:
| a | Cephalexin generichealth | GQ | MP | P4243 | 40 CN4243 | 2 CN4243 | 20 |
Schedule 1, after entry for Cephazolin in the form Powder for injection 2 g (as sodium)
insert:
| Ceritinib | Capsule 150 mg | Oral | Zykadia | NV | MP | C6732 C6771 C6799 | 150 | 1 | 150 |
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 20; Number of Repeats: 5]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | ANTERONE 50 | RW | MP | P5532 | 20 CN5532 | 5 CN5532 | 20 |
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100; Number of Repeats: 5]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | ANTERONE 50 | RW | MP | 100 | 5 | 50 |
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | ANTERONE 100 | RW | MP | 50 | 5 | 50 |
Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]
omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
(b)omit from the column headed “Purposes”: P3999 P4000 P4003 P4004
substitute: P6702 P6731 P6785 P6797 P6798
Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]
omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
(b)omit from the column headed “Purposes”: P3999 P4000 P4003 P4004
substitute: P6702 P6731 P6785 P6797 P6798
Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]
omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
(b)omit from the column headed “Purposes”: P3999 P4000 P4003 P4004
substitute: P6702 P6731 P6785 P6797 P6798
Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]
omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004
insert in numerical order: C6702 C6731 C6785 C6797 C6798
(b)omit from the column headed “Purposes”: P3999 P4000 P4003 P4004
substitute: P6702 P6731 P6785 P6797 P6798
Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| DESVEN | RW | MP NP | C4855 | 28 | 5 | 28 |
Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| DESVEN | RW | MP NP | C4855 | 28 | 5 | 28 |
Schedule 1, entry for Dorzolamide with timolol
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | DORZOLAMIDE/ TIMOLOL AN 20/5 | EA | MP | C4343 | 1 | 5 | 1 |
| AO | C5038 | 1 | 5 | 1 |
Schedule 1, entry for Electrolyte replacement, oral
substitute:
| Electrolyte replacement, oral | Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 | Oral | a | Repalyte New Formulation | SW | MP | C5889 C6786 | P5889 | 1 | 0 | 1 |
| NP | C5889 | 1 | 0 | 1 | |||||||
| a | restore O.R.S. | EA | MP | C5889 C6786 | P5889 | 1 | 0 | 1 | |||
| NP | C5889 | 1 | 0 | 1 | |||||||
| a | Repalyte New Formulation | SW | MP | C5889 C6786 | P6786 | 30 | 0 | 1 | |||
| a | restore O.R.S. | EA | MP | C5889 C6786 | P6786 | 30 | 0 | 1 |
Schedule 1, entry for Eplerenone in each of the forms: Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Eplerenone AN | EA | MP NP | C4937 | 30 | 5 | 30 |
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5144 P5184 P5223 P5294 P5335
insert in numerical order: P6695 P6726 P6727 P6728 P6753
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5265 P5336 P5369
insert in numerical order: P6696 P6755 P6756
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5144 P5184 P5223 P5294 P5335
insert in numerical order: P6695 P6726 P6727 P6728 P6753
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5265 P5336 P5369
insert in numerical order: P6696 P6765 P6756
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5144 P5184 P5223 P5294 P5335
insert in numerical order: P6695 P6726 P6727 P6728 P6753
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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369
insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756
(b)omit from the column headed “Purposes”: P5265 P5336 P5369
insert in numerical order: P6696 P6755 P6756
Schedule 1, entry for Glucose and Ketone Indicator—Urine
omit:
| Test strips, 50 (Keto‑Diabur‑Test 5000) | For external use | Keto‑Diabur‑Test 5000 | RD | MP NP | C5852 | 2 | 2 | 1 |
Schedule 1, entry for Glyceryl Trinitrate
omit:
| Tablets 600 micrograms, 100 | Buccal/ sublingual | Anginine Stabilised | RW | PDP | 1 | 0 | 1 |
| Lycinate | RF | PDP | 1 | 0 | 1 | ||
| Anginine Stabilised | RW | MP NP | 1 | 5 | 1 | ||
| Lycinate | RF | MP NP | 1 | 5 | 1 |
substitute:
| Tablets 300 micrograms, 100 | Buccal/ sublingual | Nitrostat | PF | PDP | 1 | 0 | 1 | |
| MP NP | 1 | 5 | 1 | |||||
| Tablets 600 micrograms, 100 | Buccal/ sublingual | a | Anginine Stabilised | RW | PDP | 1 | 0 | 1 |
| a | Lycinate | RF | PDP | 1 | 0 | 1 | ||
| Nitrostat | PF | PDP | 1 | 0 | 1 | |||
| a | Anginine Stabilised | RW | MP NP | 1 | 5 | 1 | ||
| a | Lycinate | RF | MP NP | 1 | 5 | 1 | ||
| Nitrostat | PF | MP NP | 1 | 5 | 1 |
Schedule 1, entry for Imatinib
substitute:
| Imatinib | Capsule 100 mg (as mesilate) | Oral | Imatinib-APOTEX | TX | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 | 60 | 2 | 60 |
| IMATINIB-DRLA | RZ | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 | 60 | 2 | 60 | |||
| Imatinib-APOTEX | TX | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 60 | 5 | 60 | |||
| IMATINIB-DRLA | RZ | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 60 | 5 | 60 | |||
| Capsule 400 mg (as mesilate) | Oral | Imatinib-APOTEX | TX | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 | 30 | 2 | 30 | |
| IMATINIB-DRLA | RZ | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 | 30 | 2 | 30 | |||
| Imatinib-APOTEX | TX | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 30 | 5 | 30 | |||
| IMATINIB-DRLA | RZ | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 30 | 5 | 30 | |||
| Tablet 100 mg (as mesilate) | Oral | Glivec | AF | MP | C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 | P6496 P6497 P6498 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 P6559 | 60 | 2 | 60 | |
| IMATINIB RBX | RA | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 | 60 | 2 | 60 | |||
| Imatinib-Teva | TB | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6549 P6550 P6557 P6558 | 60 | 2 | 60 | |||
| Glivec | AF | MP | C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 | P4342 P4355 P6703 P6743 P6744 | 60 | 5 | 60 | |||
| IMATINIB RBX | RA | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 60 | 5 | 60 | |||
| Imatinib-Teva | TB | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 60 | 5 | 60 | |||
| Tablet 400 mg (as mesilate) | Oral | Glivec | AF | MP | C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 | P6496 P6497 P6498 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 P6559 | 30 | 2 | 30 | |
| IMATINIB RBX | RA | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 | 30 | 2 | 30 | |||
| Imatinib-Teva | TB | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558 C6703 C6743 C6744 | P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6549 P6550 P6557 P6558 | 30 | 2 | 30 | |||
| Glivec | AF | MP | C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 | P4342 P4355 P6703 P6743 P6744 | 30 | 5 | 30 | |||
| IMATINIB RBX | RA | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 30 | 5 | 30 | |||
| Imatinib-Teva | TB | MP | C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558 C6703 C6743 C6744 | P6703 P6743 P6744 | 30 | 5 | 30 |
Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | INDAPAMIDE AN SR | EA | MP NP | 90 | 1 | 90 |
Schedule 1, entry for Interferon Beta-1a
omit:
| Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent | Injection | Avonex | BD | MP | C4881 C4887 | 4 | 5 | 4 |
Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Irbesartan AMNEAL | EF | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and Tablet 300 mg-25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Irbesartan HCTZ AMNEAL | EF | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, after entry for Ivermectin
insert:
| Ixekizumab | Injection 80 mg in 1 mL single dose pre-filled pen | Injection | Taltz | LY | MP | C6695 C6726 C6727 C6728 C6740 C6753 C6754 C6755 C6756 C6779 | P6740 P6754 P6755 P6756 P6779 | 2 | 2 | 2 |
| MP | C6695 C6726 C6727 C6728 C6740 C6753 C6754 C6755 C6756 C6779 | P6695 P6726 P6727 P6728 P6753 | 2 | 3 | 2 |
Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
omit from the column headed “Brand”: Lamotrigine generichealth substitute: Lamotrigine GH
Schedule 1, entry for Latanoprost with timolol
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Latanoprost/timolol AN 50/5 | EA | MP | C4343 | 1 | 5 | 1 |
| AO | C5038 | 1 | 5 | 1 |
Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g
insert in the columns in the order indicated after existing items:
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
| a | Glucophage | MQ | MP NP | 60 | 5 | 60 |
Schedule 1, entry for Milk protein and fat formula with vitamins and minerals—carbohydrate free
omit from the column headed “Circumstances”: C1578 C1579 C1580 C1581 substitute: C6658
Schedule 1, entry for Nilotinib in the form Capsule 150 mg (as hydrochloride monohydrate
omit from the column headed “Circumstances”: C4005 C4006 substitute: C6701 C6759 C6770
Schedule 1, entry for Nilotinib in the form Capsule 200 mg (as hydrochloride monohydrate)
omit from the column headed “Circumstances”: C4001 C4002 substitute: C6742 C6796
Schedule 1, after entry for Olanzapine in the form Powder for injection 405 mg (as pamoate monohydrate) with diluent
insert:
| Olaparib | Capsule 50 mg | Oral | Lynparza | AP | MP | C6704 C6705 C6714 C6715 C6716 C6772 | P6704 P6714 P6772 | 448 | 2 | 448 |
| MP | C6704 C6705 C6714 C6715 C6716 C6772 | P6705 P6715 P6716 | 448 | 5 | 448 |
Schedule 1, entry for Peginterferon Alfa-2a
omit:
| Injection 180 micrograms in 0.5 mL single use pre‑filled syringe | Injection | Pegasys | RO | MP | C5004 C5010 C5016 C5067 | 8 | 5 | 4 | D(100) |
substitute:
| Injection 180 micrograms in 0.5 mL single use pre-filled syringe | Injection | Pegasys | RO | MP | C6745 | 4 | 2 | 4 |
| MP | C5004 C5010 C5016 C5067 | 8 | 5 | 4 | C(100) |
Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pemetrexed Accord | OD | MP | C4789 C4792 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 1 g (as disodium)
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pemetrexed Accord | OD | MP | C4789 C4792 | See Note 3 | See Note 3 | 1 | D(100) |
(b)omit from the column headed “Responsible Person” for the brand “Pemetrexed MYX”: YN substitute: OC
Schedule 1, entry for Perindopril in each of the forms: Tablet containing perindopril erbumine 2 mg; Tablet containing perindopril erbumine 4 mg; and Tablet containing perindopril erbumine 8 mg
omit:
| Ozapace | RA | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole hydrochloride 375 micrograms; Tablet (extended release) containing pramipexole hydrochloride 750 micrograms; Tablet (extended release) containing pramipexole hydrochloride 1.5 mg; Tablet (extended release) containing pramipexole hydrochloride 2.25 mg;Tablet (extended release) containing pramipexole hydrochloride 3 mg; Tablet (extended release) containing pramipexole hydrochloride 3.75 mg; and Tablet (extended release) containing pramipexole hydrochloride 4.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | SIMIPEX XR | RW | MP NP | C5131 | 30 | 5 | 30 |
Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit:
| Seronia 25 | RF | MP NP | C4385 C4391 C4396 | 60 | 0 | 60 |
Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Quetiapine AN | EA | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | ACQUIN | RF | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
omit:
| Prabez | AF | MP NP | C5444 C5512 | 28 | 5 | 28 |
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a)omit:
| a | Prabez | AF | MP NP | C5444 C5445 C5512 | P5445 | 30 | 2 | 30 |
(b)omit:
| a | Prabez | AF | MP NP | C5444 C5445 C5512 | P5444 P5512 | 30 | 5 | 30 |
Schedule 1, entry for Ramipril in the form Tablet 2.5 mg
omit:
| Prilace 2.5 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Ramipril in the form Tablet 5 mg
omit:
| Prilace 5 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Ramipril in the form Capsule 10 mg
omit:
| Prilace 10 | RW | MP NP | 30 | 5 | 30 |
Schedule 1, omit entry for Ribavirin and Peginterferon Alfa-2a
Schedule 1, entry for Secukinumab [Maximum Quantity: 1; Number of Repeats: 2]
omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407
omit from the column headed “Circumstances”: C6417
omit from the column headed “Circumstances”: C6440
omit from the column headed “Circumstances”: C6462
omit from the column headed “Circumstances”: C6468
insert in numerical order: C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793
Schedule 1, entry for Secukinumab [Maximum Quantity: 1; Number of Repeats: 5]
omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407
omit from the column headed “Circumstances”: C6417
omit from the column headed “Circumstances”: C6440
omit from the column headed “Circumstances”: C6462
omit from the column headed “Circumstances”: C6468
insert in numerical order: C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793
Schedule 1, entry for Secukinumab [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407
omit from the column headed “Circumstances”: C6417
omit from the column headed “Circumstances”: C6440
omit from the column headed “Circumstances”: C6462
omit from the column headed “Circumstances”: C6468
insert in numerical order: C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793
(b)omit from the column headed “Purposes”: P6417
insert in numerical order: P6781
Schedule 1, entry for Secukinumab [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407
omit from the column headed “Circumstances”: C6417
omit from the column headed “Circumstances”: C6440
omit from the column headed “Circumstances”: C6462
omit from the column headed “Circumstances”: C6468
insert in numerical order: C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793
(b)omit from the column headed “Purposes”: P6405 P6406 P6407 P6440 P6468
insert in numerical order: P6782 P6792 P6793
Schedule 1, entry for Secukinumab [Maximum Quantity: 4; Number of Repeats: 0]
omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407
omit from the column headed “Circumstances”: C6417
omit from the column headed “Circumstances”: C6440
omit from the column headed “Circumstances”: C6462
omit from the column headed “Circumstances”: C6468
insert in numerical order: C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793
Schedule 1, entry for Secukinumab [Maximum Quantity: 8; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407
omit from the column headed “Circumstances”: C6417
omit from the column headed “Circumstances”: C6440
omit from the column headed “Circumstances”: C6462
omit from the column headed “Circumstances”: C6468
insert in numerical order: C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793
(b)omit from the column headed “Purposes”: P6392 P6393 P6402 P6462
insert in numerical order: P6697 P6713 P6730 P6769
Schedule 1, omit entry for Simeprevir
Schedule 1, entry for Sodium Acid Phosphate
omit from the column headed “Responsible Person”: NV substitute: PL
Schedule 1, entry for Soy protein and fat formula with vitamins and minerals—carbohydrate free
omit from the column headed “Circumstances”: C1578 C1579 C1580 C1581 substitute: C6658
Schedule 1, entry for Sucralfate
omit:
| Ulcyte | AF | MP NP | 120 | 2 | 120 |
Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
omit:
| Sumagran Aspen 50 | RW | MP NP | C5259 | 4 | 5 | 2 |
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 100; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pacrolim | AF | MP | 100 | 3 | 100 |
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pacrolim | AF | MP | P5569 P5602 | 200 CN5569 CN5602 | 5 CN5569 CN5602 | 100 | C(100) |
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 100; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pacrolim | AF | MP | 100 | 3 | 100 |
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 200; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pacrolim | AF | MP | P5569 P5602 | 200 CN5569 CN5602 | 5 CN5569 CN5602 | 100 | C(100) |
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 50; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pacrolim | AF | MP | 50 | 3 | 50 |
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 100; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pacrolim | AF | MP | P5569 P5602 | 100 CN5569 CN5602 | 5 CN5569 CN5602 | 50 | C(100) |
Schedule 1, entry for Tiotropium in the form Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 doses)
(a)omit from the column headed “Form”: (60 doses) substitute: (60 actuations)
(b)insert in numerical order in the column headed “Circumstances”: C6777
Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C6021 C6029 substitute: C6752 C6778
(b)omit from the column headed “Purposes”: P6021 substitute: P6778
Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6021 C6029 substitute: C6752 C6778
(b)omit from the column headed “Purposes”: P6029 substitute: P6752
Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C6021 C6029 substitute: C6752 C6778
(b)omit from the column headed “Purposes”: P6021 substitute: P6778
Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6021 C6029 substitute: C6752 C6778
(b)omit from the column headed “Purposes”: P6029 substitute: P6752
Schedule 1, entry for Ustekinumab [Maximum Quantity: 1; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C5159 C5203 C5204 C5205 C5206 C5276 C5425 C5426
insert in numerical order: C6698 C6699 C6700 C6758 C6783 C6784 C6794 C6795
(b)omit from the column headed “Purposes”: P5206 P5425 P5426
insert in numerical order: P6698 P6758 P6783
Schedule 1, entry for Ustekinumab [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C5159 C5203 C5204 C5205 C5206 C5276 C5425 C5426
insert in numerical order: C6698 C6699 C6700 C6758 C6783 C6784 C6794 C6795
(b)omit from the column headed “Purposes”: P5159 P5203 P5204 P5205 P5276
insert in numerical order: P6699 P6700 P6784 P6794 P6795
Schedule 1, entry for Valaciclovir
(a)omit:
| a | Valnir | QA | MP NP | C5940 C5960 C5961 C5962 C5968 | P5960 | 20 | 0 | 10 |
(b)omit:
| a | Valnir | QA | MP NP | C5940 C5960 C5961 C5962 C5968 | P5940 P5961 | 30 | 5 | 30 |
(c)omit:
| a | Valnir | QA | MP NP | C5940 C5960 C5961 C5962 C5968 | P5962 P5968 | 42 | 0 | 42 |
(d)omit:
| a | Zelitrex | FM | MP | C5939 C5975 | 500 | 2 | 100 | C(100) |
Schedule 3, after details relevant to Responsible Person code OC
insert:
| OD | Accord Healthcare Pty Ltd | 49 110 502 513 |
Schedule 3
omit:
| RD | Roche Diagnostics Australia Pty Limited | 29 003 001 205 |
Schedule 4, Part 1, entry for Adalimumab
(a)omit:
| C5144 | P5144 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Must be treated by a dermatologist | Compliance with Written or Telephone Authority Required procedures |
| C5184 | P5184 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment) Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must be aged 18 years or older Must be treated by a dermatologist For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab The authority application must be made in writing and must include: Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: | Compliance with Written Authority Required procedures |
| C5223 | P5223 | Severe chronic plaque psoriasis Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must be aged 18 years or older Must be treated by a dermatologist For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment (c) The most recent PASI assessment must be no more than 1 month old at the time of application The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C5265 | P5265 | Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must be aged 18 years or older Must be treated by a dermatologist For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: The most recent PASI assessment must be no more than 1 month old at the time of application Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline | Compliance with Written Authority Required procedures |
| C5294 | P5294 | Severe chronic plaque psoriasis Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must be aged 18 years or older Must be treated by a dermatologist For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab. Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C5335 | P5335 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment) Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must be aged 18 years or older Must be treated by a dermatologist For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab. Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment An adequate response to treatment is defined as: | Compliance with Written Authority Required procedures |
| C5336 | P5336 | Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must be aged 18 years or older Must be treated by a dermatologist For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab An adequate response to treatment is defined as: All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: The most recent PASI assessment must be no more than 1 month old at the time of application Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug | Compliance with Written Authority Required procedures |
| C5369 | P5369 | Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR Must be treated by a dermatologist | Compliance with Written or Telephone Authority Required procedures |
(b)insert in numerical order after existing text:
| C6695 | P6695 | Severe chronic plaque psoriasis Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the signed patient and prescriber acknowledgements. | Compliance with Written Authority Required procedures |
| C6696 | P6696 | Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND The treatment must be as systemic monotherapy (other than methotrexate). Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C6726 | P6726 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle. | Compliance with Written Authority Required procedures |
| C6727 | P6727 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value. | Compliance with Written Authority Required procedures |
| C6728 | P6728 | Severe chronic plaque psoriasis Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years ) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND The treatment must be as systemic monotherapy (other than methotrexate); AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C6753 | P6753 | Severe chronic plaque psoriasis Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot); AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the signed patient and prescriber acknowledgements. | Compliance with Written Authority Required procedures |
| C6755 | P6755 | Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 1 month old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. | Compliance with Written Authority Required procedures |
| C6756 | P6756 | Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 1 month old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Alprazolam
substitute:
| Alprazolam | C6773 | Panic disorder The treatment must be for use when other treatments have failed; OR The treatment must be for use when other treatments are inappropriate. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Bromocriptine
(a)omit:
| C5134 | P5134 | Acromegaly |
| C5170 | P5170 | Parkinson disease |
| C5171 | P5171 | Pathological hyperprolactinaemia Patient must be one in whom surgery is not indicated |
(b)omit:
| C5213 | P5213 | Pathological hyperprolactinaemia Patient must have had radiotherapy for this condition with incomplete resolution |
| C5356 | P5356 | Pathological hyperprolactinaemia Patient must have had surgery for this condition with incomplete resolution |
| C5397 | P5397 | Pathological hyperprolactinaemia Patient must be one in whom radiotherapy is not indicated |
(c)insert in numerical order after existing text:
| C6706 | P6706 | Pathological hyperprolactinaemia Patient must have had surgery for this condition with incomplete resolution. |
| C6707 | P6707 | Pathological hyperprolactinaemia Patient must be one in whom radiotherapy is not indicated. |
| C6717 | P6717 | Acromegaly |
| C6718 | P6718 | Parkinson disease |
| C6719 | P6719 | Pathological hyperprolactinaemia Patient must have had radiotherapy for this condition with incomplete resolution. |
| C6787 | P6787 | Pathological hyperprolactinaemia Patient must be one in whom surgery is not indicated. |
Schedule 4, Part 1, after entry for Cephazolin
insert:
| Ceritinib | C6732 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. | Compliance with Authority Required procedures |
| C6771 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 February 2017; AND The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have progressive disease. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. A patient may qualify for PBS-subsidised treatment under this restriction once only. | Compliance with Authority Required procedures | |
| C6799 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Dasatinib
omit:
| C3999 | P3999 | Initial treatment, as the sole PBS‑subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase who has failed an adequate trial of imatinib or nilotinib as first‑line treatment Failure of an adequate trial of imatinib or nilotinib is defined as: (i) Lack of response to initial imatinib or nilotinib therapy, defined as either: — failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or — failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or — failure to achieve a major cytogenetic response or a peripheral blood BCR‑ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR (ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR‑ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR (iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia Accelerated phase is defined by the presence of 1 or more of the following: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or (3) Peripheral basophils greater than or equal to 20%; or (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR Blast crisis is defined as either: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or (2) Extramedullary involvement other than spleen and liver; OR (v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first‑line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR‑ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals Applications for authorisation must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Chronic Myeloid Leukaemia ‑ Second and Third Line ‑ Supporting Information Form; and (c) a signed patient acknowledgement; and (d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT‑PCR level of BCR‑ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and (e) where there has been a loss of response to imatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement | Compliance with Written Authority Required procedures |
| C4000 | P4000 | Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has received initial PBS‑subsidised treatment with dasatinib for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR‑ABL level in the blood, to dasatinib in the preceding 18 months and thereafter at 12 monthly intervals Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia ‑ Second and Third Line ‑ Application Form for continuing treatment; and (3) demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or (b) a peripheral blood level of BCR‑ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided Definitions of response A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells A peripheral blood BCR‑ABL level of less than 1% on the international scale (Blood 108: 28‑37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response | Compliance with Written Authority Required procedures |
| C4003 | P4003 | Initial treatment, as the sole PBS‑subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR‑ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia ‑ Chronic Phase, First Line ‑ Supporting Information form; and (3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR‑ABL transcript in either peripheral blood or bone marrow; and (4) a signed patient acknowledgement form | Compliance with Written Authority Required procedures |
| C4004 | P4004 | Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has received initial PBS‑subsidised treatment with dasatinib for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR‑ABL level in the blood Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided; or (b) a peripheral blood level of BCR‑ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided Definitions of response A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells A peripheral blood BCR‑ABL level of less than 1% on the international scale (Blood 108: 28‑37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response | Compliance with Written Authority Required procedures |
substitute:
| C6702 | P6702 | Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have received initial PBS- subsidised second line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second line treatment with nilotinib for this condition; AND Patient must have demonstrated a major cytogenetic response in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and (3) demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report need be provided; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale on the international scale [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report need be provided. | Compliance with Written Authority Required procedures |
| C6731 | P6731 | Chronic Myeloid Leukaemia (CML) Initial treatment Patient must not have failed PBS-subsidised first line treatment with this drug for this condition; AND Patient must have failed an adequate trial of PBS-subsidised first line treatment with imatinib for this condition; OR Patient must have failed an adequate trial of PBS-subsidised first line treatment with nilotinib for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised second line treatment with nilotinib for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of an adequate trial of imatinib or nilotinib is defined as:(i) Lack of response to initial imatinib or nilotinib therapy, defined as either:- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR(iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or(3) Peripheral basophils greater than or equal to 20%; or(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); ORBlast crisis is defined as either:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or(2) Extramedullary involvement other than spleen and liver; OR(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals. Applications for authorisation must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and(c) a signed patient acknowledgement; and(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and(e) where there has been a loss of response to imatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement | Compliance with Written Authority Required procedures |
| C6785 | P6785 | Chronic Myeloid Leukaemia (CML) First continuing treatment The condition must be in the chronic phase; AND Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib for this condition; AND Patient must have demonstrated a major cytogenic response; OR Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. First continuing applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) demonstration of continued response to treatment as evidenced by either:(a) a major cytogenetic response [see Note explaining requirements]; or(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided. | Compliance with Written Authority Required procedures |
| C6797 | P6797 | Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure of response to the PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and (3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and (4) a signed patient acknowledgement form | Compliance with Written Authority Required procedures |
| C6798 | P6798 | Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment The condition must be in the chronic phase; AND Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib as a first line therapy for this condition; AND Patient must have maintained a major cytogenic response; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Subsequent authority applications for continuing therapy with this drug may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C6698 | P6698 | Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 1 month old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised. | Compliance with Written Authority Required procedures |
| C6699 | P6699 | Severe chronic plaque psoriasis Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the signed patient and prescriber acknowledgements. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C6700 | P6700 | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) restriction to complete 28 weeks treatment; AND The treatment must be as systemic monotherapy (other than methotrexate); AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions. Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C6758 | P6758 | Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND The treatment must be as systemic monotherapy (other than methotrexate). Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C6783 | P6783 | Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 1 month old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised. | Compliance with Written Authority Required procedures |
| C6784 | P6784 | Severe chronic plaque psoriasis Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot); AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the signed patient and prescriber acknowledgements. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C6794 | P6794 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle. | Compliance with Written Authority Required procedures |
| C6795 | P6795 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value. | Compliance with Written Authority Required procedures |
Schedule 4, Part 3, Section 3
(a)Item 1, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN
(b)Item 2, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN
(c)Item 5, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN
(d)Item 6, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN
(e)Item 7, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN
(f)Item 8, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN
(g)Item 9, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN
(h)Item 10, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN
(i)Item 11, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN
(j)Item 12, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN
(k)Item 15, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN
(l)Item 16, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN
(m)Item 17, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN
(n)Item 18, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN
(o)Item 19, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN
(p)Item 20, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN
Schedule 5, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg [GRP-16219]
insert in alphabetical order in the column headed “Brand”: DESVEN
Schedule 5, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg [GRP-16220]
insert in alphabetical order in the column headed “Brand”: DESVEN
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]
omit from the column headed “Brand”: Ozapace
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP- GRP-15525]
omit from the column headed “Brand”: Ozapace
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP- GRP-15965]
omit from the column headed “Brand”: Ozapace
Schedule 5, entry for Ramipril in the form Capsule 10 mg [GRP-15431]
omit from the column headed “Brand”: Prilace 10
Schedule 5, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [GRP-15928]
omit from the column headed “Brand”: Sumagran Aspen 50
0
0
0