National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 11) (PB 111 of 2020) (Cth)
PB 111 of 2020
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020
(No. 11)
National Health Act 1953
________________________________________________________________________
I, THEA CONNOLLY, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 26th November 2020
THEA CONNOLLY
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
Name of Instrument
(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 11).
(2)This Instrument may also be cited as PB 111 of 2020.
Commencement
This Instrument commences on 1 December 2020.
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, Part 1, entry for Ambrisentan in each of the forms: Tablet 5 mg; and Tablet 10 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Ambrisentan Mylan | AF | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 30 | D(100) |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Cipla Ambrisentan | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 30 | D(100) |
(c)insert in the column headed “Schedule Equivalent” for the brand “Volibris”: a
Schedule 1, Part 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium)
substitute:
| Powder for injection 1 g (as sodium) | Injection | a | Ampicyn | AF | PDP | 5 | 0 | 5 |
| MP NP | 5 | 1 | 5 |
Schedule 1, Part 1, entry for Arsenic
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Arsenic Trioxide Juno | JU | MP | C4793 C5997 C6018 | See Note 3 | See Note 3 | 10 | D(100) |
Schedule 1, Part 1, entry for Asenapine in each of the forms: Sublingual wafer 5 mg (as maleate); and Sublingual wafer 10 mg (as maleate)
omit from the column headed “Responsible Person”: LU substitute: OQ
Schedule 1, Part 1, after entry for Beclometasone in the form Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)
insert:
| Beclometasone with formoterol | Pressurised inhalation containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per dose,120 dose | Inhalation by mouth | Fostair | EU | MP NP | C11057 | 1 | 5 | 1 |
Schedule 1, Part 1, entry for Betamethasone in the form Cream 200 micrograms (as valerate) per g, 100 g
(a)omit from the column headed “Responsible Person” for the brand “Antroquoril”: FR substitute: OV
(b)omit from the column headed “Responsible Person” for the brand “Celestone-M”: MK substitute: OQ
Schedule 1, Part 1, entry for Betamethasone in each of the forms: Cream 500 micrograms (as dipropionate) per g, 15 g; and Ointment
500 micrograms (as dipropionate) per g, 15 g
(a)omit from the column headed “Responsible Person” for the brand “Diprosone” (all instances): MK substitute: OQ
(b)omit from the column headed “Responsible Person” for the brand “Eleuphrat” (all instances): FR substitute: OV
Schedule 1, Part 1, entry for Betamethasone in the form Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL
omit from the column headed “Responsible Person”: MK substitute: OQ
Schedule 1, Part 1, entry for Bleomycin
omit:
| Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial | Injection | Bleomycin for Injection, USP | QY | MP | C6224 C6275 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED CEFALEXIN | VO | MP NP MW PDP | 20 | 0 | 20 |
Schedule 1, Part 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate) [Maximum Quantity: 40; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED CEFALEXIN | VO | MP NP MW | P10410 | 40 CN10410 | 0 CN10410 | 20 |
Schedule 1, Part 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate) [Maximum Quantity: 40; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED CEFALEXIN | VO | MP | P6188 | 40 CN6188 | 1 CN6188 | 20 |
Schedule 1, Part 1, entry for Chorionic gonadotrophin in each of the forms: Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3; and Powder for injection 5,000 units with solvent
omit from the column headed “Responsible Person”: MK substitute: OQ
Schedule 1, Part 1, entry for Clopidogrel with aspirin
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Clopidogrel/Aspirin 75/100 | TY | MP NP | C5443 C5488 C5517 | 30 | 5 | 30 |
(b)omit:
| a | Clopidogrel/Aspirin Sandoz 75/100 | SZ | MP NP | C5443 C5488 C5517 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
300 units [Maximum Quantity: 4; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C5178
(b)insert in numerical order in the column headed “Circumstances”: C8929
(c)insert in numerical order in the column headed “Purposes”: P5178
(d)insert in numerical order in the column headed “Purposes”: P8929
Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
300 units [Maximum Quantity: 5; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C5178
(b)insert in numerical order in the column headed “Circumstances”: C8929
Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
500 units [Maximum Quantity: 2; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C5178
(b)insert in numerical order in the column headed “Circumstances”: C8929
(c)insert in numerical order in the column headed “Purposes”: P5178
(d)insert in numerical order in the column headed “Purposes”: P8929
Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
500 units [Maximum Quantity: 3; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C5178
(b)insert in numerical order in the column headed “Circumstances”: C8929
Schedule 1, Part 1, entry for Corifollitropin alfa in each of the forms: Solution for injection 100 micrograms in 0.5 mL single dose pre-filled syringe; and Solution for injection 150 micrograms in 0.5 mL single dose pre-filled syringe
omit from the column headed “Responsible Person”: MK substitute: OQ
Schedule 1, Part 1, entry for Dolutegravir with lamivudine
(a)omit from the column headed “Circumstances”: C9909 C9934
(b)insert in numerical order in the column headed “Circumstances”: C11066
Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
omit:
| a | Esitalo | SZ | MP NP | C4755 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Etonogestrel
omit from the column headed “Responsible Person”: MK substitute: OQ
Schedule 1, Part 1, entry for Follitropin beta in each of the forms: Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge; Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge; and Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge
omit from the column headed “Responsible Person”: MK substitute: OQ
Schedule 1, Part 1, entry for Furosemide
substitute:
| Furosemide | Injection 20 mg in 2 mL | Injection | Lasix | SW | MP NP | 5 | 0 | 5 |
| Oral solution 10 mg per mL, 30 mL | Oral | Lasix | SW | MP NP | 1 | 3 | 1 | |
| Tablet 20 mg | Oral | a | Frusemix-M | TY | MP NP | 100 | 1 | 50 |
| a | Lasix-M | SW | MP NP | 100 | 1 | 50 | ||
| a | Urex-M | RW | MP NP | 100 | 1 | 50 | ||
| a | APO-Frusemide | TX | MP NP | 100 | 1 | 100 | ||
| a | Frusemix-M | TY | MP NP | 100 | 1 | 100 | ||
| a | FUROSEMIDE AN | EA | MP NP | 100 | 1 | 100 | ||
| Tablet 40 mg | Oral | a | APO-Frusemide | TX | MP NP | 100 | 1 | 100 |
| a | Frusax | ER | MP NP | 100 | 1 | 100 | ||
| a | Frusemix | TY | MP NP | 100 | 1 | 100 | ||
| a | FUROSEMIDE AN | EA | MP NP | 100 | 1 | 100 | ||
| a | Lasix | SW | MP NP | 100 | 1 | 100 | ||
| a | Uremide | AF | MP NP | 100 | 1 | 100 | ||
| Urex | RW | MP NP | 100 | 1 | 100 | |||
| Tablet 500 mg | Oral | Urex-Forte | RW | MP NP | 50 | 3 | 50 |
Schedule 1, Part 1, entry for Ganirelix
omit from the column headed “Responsible Person”: MK substitute: OQ
Schedule 1, Part 1, entry for Infliximab
omit from the column headed “Responsible Person” for the brand “Renflexis”: MK substitute: OQ
Schedule 1, Part 1, entry for Ixekizumab
substitute:
| Ixekizumab | Injection 80 mg in 1 mL single dose pre-filled pen | Injection | Taltz | LY | MP | C6696 C8804 C8830 C8837 C8851 C8867 C8892 C8954 C9116 C9118 C9141 C9164 C9172 C9184 C9194 C9429 C9431 C9901 C9983 C10997 C11030 C11054 C11061 | P9429 P10997 P11054 P11061 | 2 | 1 | 2 |
| MP | C6696 C8804 C8830 C8837 C8851 C8867 C8892 C8954 C9116 C9118 C9141 C9164 C9172 C9184 C9194 C9429 C9431 C9901 C9983 C10997 C11030 C11054 C11061 | P6696 P8830 P8892 P9116 P9118 P9141 P9164 P9172 P9184 P9194 P9431 P11030 | 2 | 2 | 2 | |||||
| MP | C6696 C8804 C8830 C8837 C8851 C8867 C8892 C8954 C9116 C9118 C9141 C9164 C9172 C9184 C9194 C9429 C9431 C9901 C9983 C10997 C11030 C11054 C11061 | P8804 P8837 P8851 P8867 P8954 P9901 P9983 | 2 | 3 | 2 |
Schedule 1, Part 1, entry for Labetalol in the form Tablet containing labetalol hydrochloride 200 mg
omit:
| a | Presolol 200 | AF | MP NP | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Lansoprazole in the form Capsule 30 mg [Maximum Quantity: 28; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| NOUMED LANSOPRAZOLE | VO | MP NP | C8774 C8775 C8776 C8780 | P8774 P8775 | 28 | 1 | 28 |
Schedule 1, Part 1, entry for Lansoprazole in the form Capsule 30 mg [Maximum Quantity: 28; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| NOUMED LANSOPRAZOLE | VO | MP NP | C8774 C8775 C8776 C8780 | P8776 P8780 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Levodopa with carbidopa in the form Tablet (prolonged release) 200 mg-50 mg
omit from the column headed “Responsible Person”: MK substitute: OQ
Schedule 1, Part 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Lurasidone | CR | MP NP | C4246 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APX-Meloxicam | TY | MP NP | C4907 C4962 | 30 | 3 | 30 |
Schedule 1, Part 1, entry for Mercaptopurine in the form Tablet containing mercaptopurine monohydrate 50 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | MERCAPTOPURINE-LINK | LM | MP | 100 | 2 | 25 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Purinethol”: a
Schedule 1, Part 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 1 g per sachet
(a)omit from the column headed “Maximum Quantity”: 120 substitute: 100
(b)omit from the column headed “Pack Quantity”: 120 substitute: 100
Schedule 1, Part 1, entry for Mesalazine in the form Suppository 1 g
(a)omit from the column headed “Maximum Quantity”: 30 substitute: 28
(b)omit from the column headed “Pack Quantity”: 30 substitute: 28
Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg
(a)omit:
| Diaformin XR | AF | MP NP | 120 | 5 | 120 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Pharmacor Metformin XR | CR | MP NP | 120 | 5 | 120 |
Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Metformin | TY | MP NP | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Metformin | TY | MP NP | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Metformin XR | CR | MP NP | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Metformin | TY | MP NP | 90 | 5 | 90 |
Schedule 1, Part 1, entry for Methyldopa
omit:
| a | Hydopa | AF | MP NP | 100 | 5 | 100 |
Schedule 1, Part 1, entry for Minocycline
omit:
| a | Akamin 50 | AF | MP NP | C5995 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Naproxen in the form Tablet 250 mg
substitute:
| Tablet 250 mg | Oral | a | Naprosyn | IX | PDP | C6256 C6282 | 100 | 0 | 50 |
| MP NP | C6149 C6214 C6283 | 100 | 3 | 50 |
Schedule 1, Part 1, entry for Naproxen in the form Tablet 500 mg
substitute:
| Tablet 500 mg | Oral | a | Naprosyn | IX | PDP | C6256 C6282 | 50 | 0 | 50 |
| MP NP | C6149 C6214 C6283 | 50 | 3 | 50 |
Schedule 1, Part 1, entry for Nitrazepam
substitute:
| Nitrazepam | Tablet 5 mg | Oral | a | Mogadon | IL | MP NP PDP | 25 | 0 | 25 |
| MP NP | P6175 | 50 CN6175 | 3 CN6175 | 25 | |||||
| MP NP | P5661 P5771 P5941 P5950 | 50 CN5661 CN5771 CN5941 CN5950 | 5 CN5661 CN5771 CN5941 CN5950 | 25 |
Schedule 1, Part 1, entry for Norethisterone with ethinylestradiol in the form Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets
omit from the column headed “Schedule Equivalent” (all instances): a
Schedule 1, Part 1, after entry for Norethisterone with ethinylestradiol in the form Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets
insert:
| Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP | Oral | Pirmella 1/35 | DZ | MP NP | 4 | 2 | 3 |
Schedule 1, Part 1, entry for Obinutuzumab
(a)omit from the column headed “Circumstances”: C8184
(b)insert in numerical order in the column headed “Circumstances”: C11015 C11052
Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
omit from the column headed “Responsible Person” for the brand “Sevikar HCT 20/5/12.5”: MK substitute: AF
Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
omit from the column headed “Responsible Person” for the brand “Sevikar HCT 40/5/12.5”: MK substitute: AF
Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg
omit from the column headed “Responsible Person” for the brand “Sevikar HCT 40/5/25”: MK substitute: AF
Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg
omit from the column headed “Responsible Person” for the brand ”Sevikar HCT 40/10/12.5”: MK substitute: AF
Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg
omit from the column headed “Responsible Person” for the brand “Sevikar HCT 40/10/25”: MK substitute: AF
Schedule 1, Part 1, entry for Oxazepam
substitute:
| Oxazepam | Tablet 15 mg | Oral | a | Serepax | AS | MP NP PDP | 25 | 0 | 25 |
| MP NP | P6176 | 50 CN6176 | 3 CN6176 | 25 | |||||
| MP NP | P6217 P6230 P6262 | 50 CN6217 CN6230 CN6262 | 5 CN6217 CN6230 CN6262 | 25 | |||||
| Tablet 30 mg | Oral | a | APO-Oxazepam | TX | MP NP PDP | 25 | 0 | 25 | |
| a | Murelax | RW | MP NP PDP | 25 | 0 | 25 | |||
| a | Serepax | AS | MP NP PDP | 25 | 0 | 25 | |||
| a | APO-Oxazepam | TX | MP NP | P6176 | 50 CN6176 | 3 CN6176 | 25 | ||
| a | Murelax | RW | MP NP | P6176 | 50 CN6176 | 3 CN6176 | 25 | ||
| a | Serepax | AS | MP NP | P6176 | 50 CN6176 | 3 CN6176 | 25 | ||
| a | APO-Oxazepam | TX | MP NP | P6217 P6230 P6262 | 50 CN6217 CN6230 CN6262 | 5 CN6217 CN6230 CN6262 | 25 | ||
| a | Murelax | RW | MP NP | P6217 P6230 P6262 | 50 CN6217 CN6230 CN6262 | 5 CN6217 CN6230 CN6262 | 25 | ||
| a | Serepax | AS | MP NP | P6217 P6230 P6262 | 50 CN6217 CN6230 CN6262 | 5 CN6217 CN6230 CN6262 | 25 |
Schedule 1, Part 1, entry for Paracetamol
omit:
| Suppositories 500 mg, 24 | Rectal | Panadol | GC | MP NP | C6167 | 4 | 3 | 1 |
Schedule 1, Part 1, after entry for Paracetamol in the form Oral liquid 240 mg per 5 mL, 200 mL
insert:
| Suppositories 500 mg, 24 | Rectal | Panadol | GC | MP NP | C6167 | 4 | 3 | 1 |
| Suppository 500 mg | Rectal | Panadol | GC | MP NP | C6167 | 100 | 3 | 10 |
Schedule 1, Part 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)
omit:
| a | Pioglitazone Sandoz | SZ | MP NP | C4363 C4364 C4388 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Posaconazole
substitute:
| Posaconazole | Tablet (modified release) 100 mg | Oral | Posaconazole Juno | JU | MP NP | C5169 C5395 C5396 | 24 | 0 | 24 |
Schedule 1, Part 1, after entry for Protein formula with carbohydrate, fat, vitamins and minerals
insert:
| Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A | Oral liquid 125 mL, 24 (Renastep) | Oral | Renastep | VF | MP NP | C11070 | 8 | 5 | 1 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Quetiapine XR | TY | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in each of the forms: Tablet (modified release) 150 mg (as fumarate); and Tablet (modified release)
200 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Quetiapine XR | TY | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Quetiapine XR | TY | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Quetiapine XR | TY | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Rabeprazole Mylan | AF | MP NP | C8774 C8775 C8776 C8780 | P8774 P8775 | 30 | 1 | 30 |
Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Rabeprazole Mylan | AF | MP NP | C8774 C8775 C8776 C8780 | P8776 P8780 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
omit:
| a | Ranitidine Sandoz | SZ | MP NP MW | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
omit:
| a | Ranitidine Sandoz | SZ | MP NP | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Rifampicin
substitute:
| Rifampicin | Capsule 150 mg | Oral | Rimycin 150 | AF | MP NP | C5536 C5552 C5585 C11018 | P5536 P5585 | 10 | 0 | 10 |
| MP NP | C5536 C5552 C5585 C11018 | P5552 P11018 | 100 | 0 | 100 | |||||
| MP NP | C5536 C5552 C5585 C11018 | P11018 | 120 | 0 | 10 | |||||
| Capsule 300 mg | Oral | Rimycin 300 | AF | MP NP | C5536 C5552 C5585 C11018 | P5536 P5585 | 10 | 0 | 10 | |
| MP NP | C5536 C5552 C5585 C11018 | P5552 P11018 | 100 | 0 | 100 | |||||
| MP NP | C5536 C5552 C5585 C11018 | P11018 | 120 | 0 | 10 | |||||
| Syrup 100 mg per 5 mL, 60 mL | Oral | Rifadin | SW | MP NP | C5536 C5585 | 1 | 0 | 1 |
Schedule 1, Part 1, entry for Rivaroxaban
insert as first entry:
| Tablet 2.5 mg | Oral | Xarelto | BN | MP | C10992 C11013 | 60 | 5 | 60 |
| NP | C10992 | 60 | 5 | 60 |
Schedule 1, Part 1, entry for Tadalafil
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | TADALIS 20 | LR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 56 | D(100) |
Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
omit from the column headed “Responsible Person” for the brand “Ontruzant”: MK substitute: OQ
Schedule 1, Part 1, entry for Trimethoprim in the form Tablet 300 mg [Maximum Quantity: 7; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Trimethoprim Mylan | AL | MP NP | 7 | 1 | 7 |
Schedule 1, Part 1, entry for Trimethoprim in the form Tablet 300 mg [Maximum Quantity: 14; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Trimethoprim Mylan | AL | MP | P4243 | 14 CN4243 | 2 CN4243 | 7 |
Schedule 1, Part 1, entry for Trimethoprim in the form Tablet 300 mg [Maximum Quantity: 28; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Trimethoprim Mylan | AL | MP | P6163 | 28 | 0 | 7 |
Schedule 1, Part 1, entry for Venetoclax
substitute:
| Venetoclax | Pack containing 14 tablets venetoclax 10 mg and 7 tablets venetoclax 50 mg and 7 tablets venetoclax 100 mg and 14 tablets venetoclax 100 mg | Oral | Venclexta | VE | MP | C8607 C11053 | 1 | 0 | 1 |
| Tablet 10 mg | Oral | Venclexta | VE | MP | C10995 | 14 | 0 | 14 | |
| Tablet 50 mg | Oral | Venclexta | VE | MP | C10995 | 7 | 0 | 7 | |
| Tablet 100 mg | Oral | Venclexta | VE | MP | C11017 C11069 C11073 | P11017 | 120 | 4 | 120 |
| MP | C11017 C11069 C11073 | P11069 P11073 | 120 | 5 | 120 |
Schedule 1, Part 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
omit:
| a | Venlafaxine Sandoz XR | SZ | MP NP | C5650 | 28 | 5 | 28 |
Schedule 1, Part 2, omit entry for Aciclovir
Schedule 1, Part 2, after entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
insert:
| Ampicillin | Powder for injection 1 g (as sodium) | Injection | a | Austrapen | AL | PDP | 5 | 0 | 5 |
| MP NP | 5 | 1 | 5 |
Schedule 1, Part 2, after entry for Ampicillin
insert:
| Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial | Injection | Bleomycin for Injection, USP | QY | MP | C6224 C6275 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 2, entry for Cefazolin
omit from the column headed “Manner of Administration”: Oral substitute: Injection
Schedule 1, Part 2, after entry for Cefazolin
insert:
| Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulfate)-100 mg | Oral | a | Clopidogrel/Aspirin Sandoz 75/100 | SZ | MP NP | C5443 C5488 C5517 | 30 | 5 | 30 |
Schedule 1, Part 2, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Maximum Quantity: 28; Number of Repeats: 1]
omit from the column headed “Authorised Prescriber”: NP
Schedule 1, Part 2, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Purposes: P10099 P10100 P10108; Maximum Quantity: 28; Number of Repeats: 5]
omit from the column headed “Authorised Prescriber”: NP
Schedule 1, Part 2, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Circumstances: C10108: Maximum Quantity: 28; Number of Repeats: 5]
omit from the column headed “Authorised Prescriber”: MP
Schedule 1, Part 2, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Esitalo | SZ | MP NP | C4755 | 28 | 5 | 28 |
Schedule 1, Part 2, omit entry for Fluconazole
Schedule 1, Part 2, after entry for Ketoconazole
insert:
| Labetalol | Tablet containing labetalol hydrochloride 200 mg | Oral | a | Presolol 200 | AF | MP NP | 100 | 5 | 100 |
Schedule 1, Part 2, after entry for Levodopa with carbidopa
insert:
| Mesalazine | Sachet containing prolonged release granules, 1 g per sachet | Oral | Pentasa | FP | MP NP | C9443 C9444 | 120 | 5 | 120 |
| Suppository 1 g | Rectal | Pentasa | FP | MP NP | C4878 | 28 | 1 | 28 |
Schedule 1, Part 2, after entry for Mesalazine in the form Suppository 1 g
insert:
| Metformin | Tablet (extended release) containing metformin hydrochloride 500 mg | Oral | Diaformin XR | AF | MP NP | 120 | 5 | 120 |
Schedule 1, Part 2, after entry for Metformin
insert:
| Methyldopa | Tablet 250 mg (as sesquihydrate) | Oral | a | Hydopa | AF | MP NP | 100 | 5 | 100 |
Schedule 1, Part 2, after entry for Methyldopa
insert:
| Minocycline | Tablet 50 mg (as hydrochloride) | Oral | a | Akamin 50 | AF | MP NP | C5995 | 60 | 5 | 60 |
Schedule 1, Part 2, after entry for Minocycline
insert:
| Naproxen | Tablet 250 mg | Oral | a | Inza 250 | AF | PDP | C6256 C6282 | 100 | 0 | 50 |
| MP NP | C6149 C6214 C6283 | 100 | 3 | 50 | ||||||
| Tablet 500 mg | Oral | a | Inza 500 | AF | PDP | C6256 C6282 | 50 | 0 | 50 | |
| MP NP | C6149 C6214 C6283 | 50 | 3 | 50 |
Schedule 1, Part 2, after entry for Nifedipine
insert:
| Nitrazepam | Tablet 5 mg | Oral | a | Alodorm | AF | MP NP PDP | 25 | 0 | 25 |
| MP NP | P6175 | 50 CN6175 | 3 CN6175 | 25 | |||||
| MP NP | P5661 P5771 P5941 P5950 | 50 CN5661 CN5771 CN5941 CN5950 | 5 CN5661 CN5771 CN5941 CN5950 | 25 |
Schedule 1, Part 2, omit entry for Olanzapine
Schedule 1, Part 2, after entry for Oxaliplatin
insert:
| Oxazepam | Tablet 15 mg | Oral | a | Alepam 15 | AF | MP NP PDP | 25 | 0 | 25 |
| MP NP | P6176 | 50 CN6176 | 3 CN6176 | 25 | |||||
| MP NP | P6217 P6230 P6262 | 50 CN6217 CN6230 CN6262 | 5 CN6217 CN6230 CN6262 | 25 | |||||
| Tablet 30 mg | Oral | a | Alepam 30 | AF | MP NP PDP | 25 | 0 | 25 | |
| MP NP | P6176 | 50 CN6176 | 3 CN6176 | 25 | |||||
| MP NP | P6217 P6230 P6262 | 50 CN6217 CN6230 CN6262 | 5 CN6217 CN6230 CN6262 | 25 |
Schedule 1, Part 2, after entry for Phenoxybenzamine
insert:
| Pioglitazone | Tablet 15 mg (as hydrochloride) | Oral | a | Pioglitazone Sandoz | SZ | MP NP | C4363 C4364 C4388 | 28 | 5 | 28 |
Schedule 1, Part 2, after entry for Ranitidine in the form Tablet, effervescent, 150 mg (as hydrochloride)
insert:
| Tablet 150 mg (as hydrochloride) | Oral | a | Ranitidine Sandoz | SZ | MP NP MW | 60 | 5 | 60 |
| Tablet 300 mg (as hydrochloride) | Oral | a | Ranitidine Sandoz | SZ | MP NP | 30 | 5 | 30 |
Schedule 1, Part 2, after entry for Tramadol
insert:
| Venlafaxine | Capsule (modified release) 75 mg (as hydrochloride) | Oral | a | Venlafaxine Sandoz XR | SZ | MP NP | C5650 | 28 | 5 | 28 |
| Capsule (modified release) 150 mg (as hydrochloride) | Oral | a | Venlafaxine Sandoz XR | SZ | MP NP | C5650 | 28 | 5 | 28 |
Schedule 3
omit:
| FR | Merck Sharp & Dohme (Australia) Pty Ltd | 14 000 173 508 |
Schedule 3, after details relevant to Responsible Person code ON
insert:
| OQ | Organon Pharma Pty Ltd | 54 637 107 512 |
Schedule 3, after details relevant to Responsible Person code OU
insert:
| OV | Organon Pharma Pty Ltd | 54 637 107 512 |
Schedule 4, Part 1, after entry for Beclometasone
insert:
| Beclometasone with formoterol | C11057 | Asthma Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 18 years or older. | Compliance with Authority Required procedures - Streamlined Authority Code 11057 |
Schedule 4, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex
(a)insert as first entry:
| C5178 | P5178 | Moderate to severe spasticity of the upper limb Patient must have cerebral palsy. Patient must be aged from 2 to 17 years inclusive. Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a paediatrician; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon. | Compliance with Authority Required procedures - Streamlined Authority Code 5178 |
(b)insert after entry for Circumstances Code “C8822”:
| C8929 | P8929 | Moderate to severe spasticity of the upper limb Patient must have cerebral palsy. Patient must be aged 18 years or older. Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a paediatrician; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon. | Compliance with Authority Required procedures - Streamlined Authority Code 8929 |
Schedule 4, Part 1, entry for Dolutegravir with lamivudine
(a)omit:
| C9909 | HIV infection Grandfathered treatment Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND Patient must have been antiretroviral treatment naive prior to initiating this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9909 |
| C9934 | HIV infection Continuing treatment Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9934 |
(b)insert in numerical order after existing text:
| C11066 | HIV infection Continuing or change of treatment Patient must have previously received PBS-subsidised therapy for HIV infection. | Compliance with Authority Required procedures - Streamlined Authority Code 11066 |
Schedule 4, Part 1, entry for Ixekizumab
(a)insert after entry for Circumstances Code “C9194”:
| C9429 | P9429 | Ankylosing spondylitis Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C9431 | P9431 | Ankylosing spondylitis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C10997 | P10997 | Ankylosing spondylitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. All measurements provided must be no more than 4 weeks old at the time of application. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11030 | P11030 | Ankylosing spondylitis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. All measurements provided must be no more than 4 weeks old at the time of application. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11054 | P11054 | Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; 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 rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form which includes the following: (i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a BASDAI score. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C11061 | P11061 | Ankylosing spondylitis Initial treatment - Initial 1 (new patient) The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; 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 rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form which includes the following: (i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Obinutuzumab
(a)omit:
| C8184 | Chronic lymphocytic leukaemia (CLL) The condition must be CD20 positive; AND The condition must be previously untreated; AND Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND The treatment must be in combination with chlorambucil; AND Patient must have a creatinine clearance 30 mL/min or greater; AND Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR Patient must have a creatinine clearance less than 70 mL/min. Treatment must be discontinued in patients who experience disease progression whilst on this treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 8184 |
(b)insert in numerical order after existing text:
| C11015 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy The condition must be untreated; AND The treatment must be in combination with PBS-subsidised venetoclax. | Compliance with Authority Required procedures - Streamlined Authority Code 11015 |
| C11052 | Chronic lymphocytic leukaemia (CLL) Combination use with chlorambucil only The condition must be CD20 positive; AND The condition must be previously untreated; AND Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND The treatment must be in combination with chlorambucil; AND Patient must have a creatinine clearance 30 mL/min or greater; AND Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR Patient must have a creatinine clearance less than 70 mL/min. Treatment must be discontinued in patients who experience disease progression whilst on this treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 11052 |
Schedule 4, Part 1, entry for Posaconazole
omit:
| C5617 | Fungal infection The condition must be fusariosis; OR The condition must be zygomycosis; OR The condition must be coccidioidomycosis; OR The condition must be chromoblastomycosis; OR The condition must be mycetoma; AND Patient must be unable to tolerate alternative therapy; OR Patient must have disease refractory to alternative therapy. | Compliance with Authority Required procedures |
| C5724 | Prophylaxis of invasive fungal infections including both yeasts and moulds Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre), for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; OR Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or extensive chronic GVHD, and receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant. No more than 6 months therapy per episode will be PBS-subsidised | Compliance with Authority Required procedures |
| C5747 | Invasive aspergillosis Patient must be unable to tolerate alternative therapy; OR Patient must have disease refractory to alternative therapy. | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Protein formula with carbohydrate, fat, vitamins and minerals
insert:
| Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A | C11070 | Chronic renal failure Patient must be a child aged 3 years or older. Patient must require treatment with a low protein and a low phosphorus diet; OR Patient must require treatment with a low protein, low phosphorus and low potassium diet. | Compliance with Authority Required procedures - Streamlined Authority Code 11070 |
Schedule 4, Part 1, entry for Rifampicin
insert in numerical order after existing text:
| C11018 | P11018 | Mycobacterium ulcerans infection (Buruli ulcer) The treatment must be used in combination with another antibiotic for the treatment of Buruli ulcer. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Rivaroxaban
insert in numerical order after existing text:
| C10992 | Chronic stable atherosclerotic disease Continuing treatment Patient must have received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with aspirin, but not with any other anti-platelet therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10992 |
| C11013 | Chronic stable atherosclerotic disease Initial treatment The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors: (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; OR Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors: (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND Patient must have at least one of the following if coronary artery disease is present: (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; OR Patient must have at least one of the following if peripheral arterial disease is present: (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND The condition must be diagnosed by at least one of: (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND Patient must have clinical findings/observations by the treating physician that exclude each of the following: (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy. Must be treated by a specialist physician; OR Must be treated by a physician who has consulted a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 11013 |
Schedule 4, Part 1, entry for Venetoclax
(a)omit:
| C8586 | Chronic lymphocytic leukaemia (CLL) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment with this drug for this condition, whichever comes first. | Compliance with Authority Required procedures |
(b)omit:
| C8699 | Chronic lymphocytic leukaemia (CLL) Initial treatment - Extension of dose titration Patient must have experienced a treatment interruption during the PBS-subsidised dose titration with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be used as monotherapy for this condition under this restriction. | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| C10995 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Dose modification The treatment must be for dose titration purposes. | Compliance with Authority Required procedures | |
| C11017 | P11017 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND The treatment must cease upon disease progression. | Compliance with Authority Required procedures |
| C11053 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule) The condition must be untreated; AND Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND Patient must have a creatinine clearance 30 mL/min or greater; AND Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR Patient must have a creatinine clearance less than 70 mL/min. | Compliance with Authority Required procedures | |
| C11069 | P11069 | Chronic lymphocytic leukaemia (CLL) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first. | Compliance with Authority Required procedures |
| C11073 | P11073 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must cease upon disease progression; OR The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first. | Compliance with Authority Required procedures |
Schedule 5, entry for Lansoprazole in the form Capsule 30 mg [GRP-14641]
insert in alphabetical order in the column headed “Brand”: NOUMED LANSOPRAZOLE
Schedule 5, entry for Meloxicam in the form Tablet 15 mg [GRP-15468]
insert in alphabetical order in the column headed “Brand”: APX-Meloxicam
Schedule 5, entry for Meloxicam in the form Tablet 7.5 mg [GRP-15658]
insert in alphabetical order in the column headed “Brand”: APX-Meloxicam
Schedule 5, entry for Metforminin the form Tablet (extended release) containing metformin hydrochloride 500 mg [GRP-24200]
insert in alphabetical order in the column headed “Brand”: Pharmacor Metformin XR
Schedule 5, after entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL [GRP-20890]
insert:
| Norethisterone with ethinylestradiol | GRP-24444 | Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets | Oral | Brevinor-1 Norimin-1 28 Day |
| Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP | Oral | Pirmella 1/35 |
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